Deprecated (16384): The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 73 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php. [CORE/src/Core/functions.php, line 311]Code Context
trigger_error($message, E_USER_DEPRECATED);
}
$message = 'The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 73 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.' $stackFrame = (int) 1 $trace = [ (int) 0 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/ServerRequest.php', 'line' => (int) 2421, 'function' => 'deprecationWarning', 'args' => [ (int) 0 => 'The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead.' ] ], (int) 1 => [ 'file' => '/home/brlfuser/public_html/src/Controller/ArtileDetailController.php', 'line' => (int) 73, 'function' => 'offsetGet', 'class' => 'Cake\Http\ServerRequest', 'object' => object(Cake\Http\ServerRequest) {}, 'type' => '->', 'args' => [ (int) 0 => 'catslug' ] ], (int) 2 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Controller/Controller.php', 'line' => (int) 610, 'function' => 'printArticle', 'class' => 'App\Controller\ArtileDetailController', 'object' => object(App\Controller\ArtileDetailController) {}, 'type' => '->', 'args' => [] ], (int) 3 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/ActionDispatcher.php', 'line' => (int) 120, 'function' => 'invokeAction', 'class' => 'Cake\Controller\Controller', 'object' => object(App\Controller\ArtileDetailController) {}, 'type' => '->', 'args' => [] ], (int) 4 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/ActionDispatcher.php', 'line' => (int) 94, 'function' => '_invoke', 'class' => 'Cake\Http\ActionDispatcher', 'object' => object(Cake\Http\ActionDispatcher) {}, 'type' => '->', 'args' => [ (int) 0 => object(App\Controller\ArtileDetailController) {} ] ], (int) 5 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/BaseApplication.php', 'line' => (int) 235, 'function' => 'dispatch', 'class' => 'Cake\Http\ActionDispatcher', 'object' => object(Cake\Http\ActionDispatcher) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {} ] ], (int) 6 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php', 'line' => (int) 65, 'function' => '__invoke', 'class' => 'Cake\Http\BaseApplication', 'object' => object(App\Application) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {}, (int) 2 => object(Cake\Http\Runner) {} ] ], (int) 7 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Routing/Middleware/RoutingMiddleware.php', 'line' => (int) 162, 'function' => '__invoke', 'class' => 'Cake\Http\Runner', 'object' => object(Cake\Http\Runner) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {} ] ], (int) 8 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php', 'line' => (int) 65, 'function' => '__invoke', 'class' => 'Cake\Routing\Middleware\RoutingMiddleware', 'object' => object(Cake\Routing\Middleware\RoutingMiddleware) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {}, (int) 2 => object(Cake\Http\Runner) {} ] ], (int) 9 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Routing/Middleware/AssetMiddleware.php', 'line' => (int) 88, 'function' => '__invoke', 'class' => 'Cake\Http\Runner', 'object' => object(Cake\Http\Runner) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {} ] ], (int) 10 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php', 'line' => (int) 65, 'function' => '__invoke', 'class' => 'Cake\Routing\Middleware\AssetMiddleware', 'object' => object(Cake\Routing\Middleware\AssetMiddleware) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {}, (int) 2 => object(Cake\Http\Runner) {} ] ], (int) 11 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Middleware/ErrorHandlerMiddleware.php', 'line' => (int) 96, 'function' => '__invoke', 'class' => 'Cake\Http\Runner', 'object' => object(Cake\Http\Runner) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {} ] ], (int) 12 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php', 'line' => (int) 65, 'function' => '__invoke', 'class' => 'Cake\Error\Middleware\ErrorHandlerMiddleware', 'object' => object(Cake\Error\Middleware\ErrorHandlerMiddleware) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {}, (int) 2 => object(Cake\Http\Runner) {} ] ], (int) 13 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php', 'line' => (int) 51, 'function' => '__invoke', 'class' => 'Cake\Http\Runner', 'object' => object(Cake\Http\Runner) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {} ] ], (int) 14 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Server.php', 'line' => (int) 98, 'function' => 'run', 'class' => 'Cake\Http\Runner', 'object' => object(Cake\Http\Runner) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\MiddlewareQueue) {}, (int) 1 => object(Cake\Http\ServerRequest) {}, (int) 2 => object(Cake\Http\Response) {} ] ], (int) 15 => [ 'file' => '/home/brlfuser/public_html/webroot/index.php', 'line' => (int) 39, 'function' => 'run', 'class' => 'Cake\Http\Server', 'object' => object(Cake\Http\Server) {}, 'type' => '->', 'args' => [] ] ] $frame = [ 'file' => '/home/brlfuser/public_html/src/Controller/ArtileDetailController.php', 'line' => (int) 73, 'function' => 'offsetGet', 'class' => 'Cake\Http\ServerRequest', 'object' => object(Cake\Http\ServerRequest) { trustProxy => false [protected] params => [ [maximum depth reached] ] [protected] data => [[maximum depth reached]] [protected] query => [[maximum depth reached]] [protected] cookies => [ [maximum depth reached] ] [protected] _environment => [ [maximum depth reached] ] [protected] url => 'latest-news-updates/video-recording-of-consent-for-clinical-trials-driving-away-subjects-sc-told-dhananjay-mahapatra-24078/print' [protected] base => '' [protected] webroot => '/' [protected] here => '/latest-news-updates/video-recording-of-consent-for-clinical-trials-driving-away-subjects-sc-told-dhananjay-mahapatra-24078/print' [protected] trustedProxies => [[maximum depth reached]] [protected] _input => null [protected] _detectors => [ [maximum depth reached] ] [protected] _detectorCache => [ [maximum depth reached] ] [protected] stream => object(Zend\Diactoros\PhpInputStream) {} [protected] uri => object(Zend\Diactoros\Uri) {} [protected] session => object(Cake\Http\Session) {} [protected] attributes => [[maximum depth reached]] [protected] emulatedAttributes => [ [maximum depth reached] ] [protected] uploadedFiles => [[maximum depth reached]] [protected] protocol => null [protected] requestTarget => null [private] deprecatedProperties => [ [maximum depth reached] ] }, 'type' => '->', 'args' => [ (int) 0 => 'catslug' ] ]deprecationWarning - CORE/src/Core/functions.php, line 311 Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421 App\Controller\ArtileDetailController::printArticle() - APP/Controller/ArtileDetailController.php, line 73 Cake\Controller\Controller::invokeAction() - CORE/src/Controller/Controller.php, line 610 Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 120 Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94 Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 88 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51 Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98
Deprecated (16384): The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 74 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php. [CORE/src/Core/functions.php, line 311]Code Context
trigger_error($message, E_USER_DEPRECATED);
}
$message = 'The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 74 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.' $stackFrame = (int) 1 $trace = [ (int) 0 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/ServerRequest.php', 'line' => (int) 2421, 'function' => 'deprecationWarning', 'args' => [ (int) 0 => 'The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead.' ] ], (int) 1 => [ 'file' => '/home/brlfuser/public_html/src/Controller/ArtileDetailController.php', 'line' => (int) 74, 'function' => 'offsetGet', 'class' => 'Cake\Http\ServerRequest', 'object' => object(Cake\Http\ServerRequest) {}, 'type' => '->', 'args' => [ (int) 0 => 'artileslug' ] ], (int) 2 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Controller/Controller.php', 'line' => (int) 610, 'function' => 'printArticle', 'class' => 'App\Controller\ArtileDetailController', 'object' => object(App\Controller\ArtileDetailController) {}, 'type' => '->', 'args' => [] ], (int) 3 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/ActionDispatcher.php', 'line' => (int) 120, 'function' => 'invokeAction', 'class' => 'Cake\Controller\Controller', 'object' => object(App\Controller\ArtileDetailController) {}, 'type' => '->', 'args' => [] ], (int) 4 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/ActionDispatcher.php', 'line' => (int) 94, 'function' => '_invoke', 'class' => 'Cake\Http\ActionDispatcher', 'object' => object(Cake\Http\ActionDispatcher) {}, 'type' => '->', 'args' => [ (int) 0 => object(App\Controller\ArtileDetailController) {} ] ], (int) 5 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/BaseApplication.php', 'line' => (int) 235, 'function' => 'dispatch', 'class' => 'Cake\Http\ActionDispatcher', 'object' => object(Cake\Http\ActionDispatcher) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {} ] ], (int) 6 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php', 'line' => (int) 65, 'function' => '__invoke', 'class' => 'Cake\Http\BaseApplication', 'object' => object(App\Application) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {}, (int) 2 => object(Cake\Http\Runner) {} ] ], (int) 7 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Routing/Middleware/RoutingMiddleware.php', 'line' => (int) 162, 'function' => '__invoke', 'class' => 'Cake\Http\Runner', 'object' => object(Cake\Http\Runner) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {} ] ], (int) 8 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php', 'line' => (int) 65, 'function' => '__invoke', 'class' => 'Cake\Routing\Middleware\RoutingMiddleware', 'object' => object(Cake\Routing\Middleware\RoutingMiddleware) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {}, (int) 2 => object(Cake\Http\Runner) {} ] ], (int) 9 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Routing/Middleware/AssetMiddleware.php', 'line' => (int) 88, 'function' => '__invoke', 'class' => 'Cake\Http\Runner', 'object' => object(Cake\Http\Runner) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {} ] ], (int) 10 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php', 'line' => (int) 65, 'function' => '__invoke', 'class' => 'Cake\Routing\Middleware\AssetMiddleware', 'object' => object(Cake\Routing\Middleware\AssetMiddleware) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {}, (int) 2 => object(Cake\Http\Runner) {} ] ], (int) 11 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Middleware/ErrorHandlerMiddleware.php', 'line' => (int) 96, 'function' => '__invoke', 'class' => 'Cake\Http\Runner', 'object' => object(Cake\Http\Runner) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {} ] ], (int) 12 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php', 'line' => (int) 65, 'function' => '__invoke', 'class' => 'Cake\Error\Middleware\ErrorHandlerMiddleware', 'object' => object(Cake\Error\Middleware\ErrorHandlerMiddleware) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {}, (int) 2 => object(Cake\Http\Runner) {} ] ], (int) 13 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php', 'line' => (int) 51, 'function' => '__invoke', 'class' => 'Cake\Http\Runner', 'object' => object(Cake\Http\Runner) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\ServerRequest) {}, (int) 1 => object(Cake\Http\Response) {} ] ], (int) 14 => [ 'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Server.php', 'line' => (int) 98, 'function' => 'run', 'class' => 'Cake\Http\Runner', 'object' => object(Cake\Http\Runner) {}, 'type' => '->', 'args' => [ (int) 0 => object(Cake\Http\MiddlewareQueue) {}, (int) 1 => object(Cake\Http\ServerRequest) {}, (int) 2 => object(Cake\Http\Response) {} ] ], (int) 15 => [ 'file' => '/home/brlfuser/public_html/webroot/index.php', 'line' => (int) 39, 'function' => 'run', 'class' => 'Cake\Http\Server', 'object' => object(Cake\Http\Server) {}, 'type' => '->', 'args' => [] ] ] $frame = [ 'file' => '/home/brlfuser/public_html/src/Controller/ArtileDetailController.php', 'line' => (int) 74, 'function' => 'offsetGet', 'class' => 'Cake\Http\ServerRequest', 'object' => object(Cake\Http\ServerRequest) { trustProxy => false [protected] params => [ [maximum depth reached] ] [protected] data => [[maximum depth reached]] [protected] query => [[maximum depth reached]] [protected] cookies => [ [maximum depth reached] ] [protected] _environment => [ [maximum depth reached] ] [protected] url => 'latest-news-updates/video-recording-of-consent-for-clinical-trials-driving-away-subjects-sc-told-dhananjay-mahapatra-24078/print' [protected] base => '' [protected] webroot => '/' [protected] here => '/latest-news-updates/video-recording-of-consent-for-clinical-trials-driving-away-subjects-sc-told-dhananjay-mahapatra-24078/print' [protected] trustedProxies => [[maximum depth reached]] [protected] _input => null [protected] _detectors => [ [maximum depth reached] ] [protected] _detectorCache => [ [maximum depth reached] ] [protected] stream => object(Zend\Diactoros\PhpInputStream) {} [protected] uri => object(Zend\Diactoros\Uri) {} [protected] session => object(Cake\Http\Session) {} [protected] attributes => [[maximum depth reached]] [protected] emulatedAttributes => [ [maximum depth reached] ] [protected] uploadedFiles => [[maximum depth reached]] [protected] protocol => null [protected] requestTarget => null [private] deprecatedProperties => [ [maximum depth reached] ] }, 'type' => '->', 'args' => [ (int) 0 => 'artileslug' ] ]deprecationWarning - CORE/src/Core/functions.php, line 311 Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421 App\Controller\ArtileDetailController::printArticle() - APP/Controller/ArtileDetailController.php, line 74 Cake\Controller\Controller::invokeAction() - CORE/src/Controller/Controller.php, line 610 Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 120 Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94 Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 88 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51 Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98
Warning (512): Unable to emit headers. Headers sent in file=/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php line=853 [CORE/src/Http/ResponseEmitter.php, line 48]Code Contextif (Configure::read('debug')) {
trigger_error($message, E_USER_WARNING);
} else {
$response = object(Cake\Http\Response) { 'status' => (int) 200, 'contentType' => 'text/html', 'headers' => [ 'Content-Type' => [ [maximum depth reached] ] ], 'file' => null, 'fileRange' => [], 'cookies' => object(Cake\Http\Cookie\CookieCollection) {}, 'cacheDirectives' => [], 'body' => '<!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN" "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd"> <html xmlns="http://www.w3.org/1999/xhtml"> <head> <link rel="canonical" href="https://im4change.in/<pre class="cake-error"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f3a4769196c-trace').style.display = (document.getElementById('cakeErr67f3a4769196c-trace').style.display == 'none' ? '' : 'none');"><b>Notice</b> (8)</a>: Undefined variable: urlPrefix [<b>APP/Template/Layout/printlayout.ctp</b>, line <b>8</b>]<div id="cakeErr67f3a4769196c-trace" class="cake-stack-trace" style="display: none;"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f3a4769196c-code').style.display = (document.getElementById('cakeErr67f3a4769196c-code').style.display == 'none' ? '' : 'none')">Code</a> <a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f3a4769196c-context').style.display = (document.getElementById('cakeErr67f3a4769196c-context').style.display == 'none' ? '' : 'none')">Context</a><pre id="cakeErr67f3a4769196c-code" class="cake-code-dump" style="display: none;"><code><span style="color: #000000"><span style="color: #0000BB"></span><span style="color: #007700"><</span><span style="color: #0000BB">head</span><span style="color: #007700">> </span></span></code> <span class="code-highlight"><code><span style="color: #000000"> <link rel="canonical" href="<span style="color: #0000BB"><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">Configure</span><span style="color: #007700">::</span><span style="color: #0000BB">read</span><span style="color: #007700">(</span><span style="color: #DD0000">'SITE_URL'</span><span style="color: #007700">); </span><span style="color: #0000BB">?><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$urlPrefix</span><span style="color: #007700">;</span><span style="color: #0000BB">?><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-></span><span style="color: #0000BB">category</span><span style="color: #007700">-></span><span style="color: #0000BB">slug</span><span style="color: #007700">; </span><span style="color: #0000BB">?></span>/<span style="color: #0000BB"><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-></span><span style="color: #0000BB">seo_url</span><span style="color: #007700">; </span><span style="color: #0000BB">?></span>.html"/> </span></code></span> <code><span style="color: #000000"><span style="color: #0000BB"> </span><span style="color: #007700"><</span><span style="color: #0000BB">meta http</span><span style="color: #007700">-</span><span style="color: #0000BB">equiv</span><span style="color: #007700">=</span><span style="color: #DD0000">"Content-Type" </span><span style="color: #0000BB">content</span><span style="color: #007700">=</span><span style="color: #DD0000">"text/html; charset=utf-8"</span><span style="color: #007700">/> </span></span></code></pre><pre id="cakeErr67f3a4769196c-context" class="cake-context" style="display: none;">$viewFile = '/home/brlfuser/public_html/src/Template/Layout/printlayout.ctp' $dataForView = [ 'article_current' => object(App\Model\Entity\Article) { 'id' => (int) 23909, 'title' => 'Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra', 'subheading' => '', 'description' => '<div align="justify"> -The Times of India </div> <p align="justify"> <br /> <em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. </p> <p align="justify"> The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial. </p> <p align="justify"> This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial. </p> <p align="justify"> The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment. </p> <p align="justify"> Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of &quot;any reasonably foreseeable risks or discomforts to the subject&quot; as well as possible benefits. </p> <p align="justify"> It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. &quot;In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required,&quot; it said. </p> <p align="justify"> Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed. </p> <p align="justify"> From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug. </p> <p align="justify"> The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p>', 'credit_writer' => 'The Times of India, 31 January, 2014, http://timesofindia.indiatimes.com/india/Video-recording-of-consent-for-clinical-trials-driving-away-subjects-SC-told/articleshow/29626348.cms', 'article_img' => '', 'article_img_thumb' => '', 'status' => (int) 1, 'show_on_home' => (int) 1, 'lang' => 'EN', 'category_id' => (int) 16, 'tag_keyword' => '', 'seo_url' => 'video-recording-of-consent-for-clinical-trials-driving-away-subjects-sc-told-dhananjay-mahapatra-24078', 'meta_title' => null, 'meta_keywords' => null, 'meta_description' => null, 'noindex' => (int) 0, 'publish_date' => object(Cake\I18n\FrozenDate) {}, 'most_visit_section_id' => null, 'article_big_img' => null, 'liveid' => (int) 24078, 'created' => object(Cake\I18n\FrozenTime) {}, 'modified' => object(Cake\I18n\FrozenTime) {}, 'edate' => '', 'tags' => [ [maximum depth reached] ], 'category' => object(App\Model\Entity\Category) {}, '[new]' => false, '[accessible]' => [ [maximum depth reached] ], '[dirty]' => [[maximum depth reached]], '[original]' => [[maximum depth reached]], '[virtual]' => [[maximum depth reached]], '[hasErrors]' => false, '[errors]' => [[maximum depth reached]], '[invalid]' => [[maximum depth reached]], '[repository]' => 'Articles' }, 'articleid' => (int) 23909, 'metaTitle' => 'LATEST NEWS UPDATES | Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra', 'metaKeywords' => 'Health,medicines,drug trial,Clinical Trials', 'metaDesc' => ' -The Times of India NEW DELHI: The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. The protocol has...', 'disp' => '<div align="justify">-The Times of India</div><p align="justify"><br /><em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions.</p><p align="justify">The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial.</p><p align="justify">This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial.</p><p align="justify">The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment.</p><p align="justify">Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of &quot;any reasonably foreseeable risks or discomforts to the subject&quot; as well as possible benefits.</p><p align="justify">It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. &quot;In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required,&quot; it said.</p><p align="justify">Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed.</p><p align="justify">From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug.</p><p align="justify">The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p>', 'lang' => 'English', 'SITE_URL' => 'https://im4change.in/', 'site_title' => 'im4change', 'adminprix' => 'admin' ] $article_current = object(App\Model\Entity\Article) { 'id' => (int) 23909, 'title' => 'Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra', 'subheading' => '', 'description' => '<div align="justify"> -The Times of India </div> <p align="justify"> <br /> <em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. </p> <p align="justify"> The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial. </p> <p align="justify"> This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial. </p> <p align="justify"> The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment. </p> <p align="justify"> Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of &quot;any reasonably foreseeable risks or discomforts to the subject&quot; as well as possible benefits. </p> <p align="justify"> It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. &quot;In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required,&quot; it said. </p> <p align="justify"> Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed. </p> <p align="justify"> From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug. </p> <p align="justify"> The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p>', 'credit_writer' => 'The Times of India, 31 January, 2014, http://timesofindia.indiatimes.com/india/Video-recording-of-consent-for-clinical-trials-driving-away-subjects-SC-told/articleshow/29626348.cms', 'article_img' => '', 'article_img_thumb' => '', 'status' => (int) 1, 'show_on_home' => (int) 1, 'lang' => 'EN', 'category_id' => (int) 16, 'tag_keyword' => '', 'seo_url' => 'video-recording-of-consent-for-clinical-trials-driving-away-subjects-sc-told-dhananjay-mahapatra-24078', 'meta_title' => null, 'meta_keywords' => null, 'meta_description' => null, 'noindex' => (int) 0, 'publish_date' => object(Cake\I18n\FrozenDate) {}, 'most_visit_section_id' => null, 'article_big_img' => null, 'liveid' => (int) 24078, 'created' => object(Cake\I18n\FrozenTime) {}, 'modified' => object(Cake\I18n\FrozenTime) {}, 'edate' => '', 'tags' => [ (int) 0 => object(Cake\ORM\Entity) {}, (int) 1 => object(Cake\ORM\Entity) {}, (int) 2 => object(Cake\ORM\Entity) {}, (int) 3 => object(Cake\ORM\Entity) {} ], 'category' => object(App\Model\Entity\Category) {}, '[new]' => false, '[accessible]' => [ '*' => true, 'id' => false ], '[dirty]' => [], '[original]' => [], '[virtual]' => [], '[hasErrors]' => false, '[errors]' => [], '[invalid]' => [], '[repository]' => 'Articles' } $articleid = (int) 23909 $metaTitle = 'LATEST NEWS UPDATES | Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra' $metaKeywords = 'Health,medicines,drug trial,Clinical Trials' $metaDesc = ' -The Times of India NEW DELHI: The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. The protocol has...' $disp = '<div align="justify">-The Times of India</div><p align="justify"><br /><em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions.</p><p align="justify">The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial.</p><p align="justify">This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial.</p><p align="justify">The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment.</p><p align="justify">Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of &quot;any reasonably foreseeable risks or discomforts to the subject&quot; as well as possible benefits.</p><p align="justify">It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. &quot;In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required,&quot; it said.</p><p align="justify">Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed.</p><p align="justify">From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug.</p><p align="justify">The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p>' $lang = 'English' $SITE_URL = 'https://im4change.in/' $site_title = 'im4change' $adminprix = 'admin'</pre><pre class="stack-trace">include - APP/Template/Layout/printlayout.ctp, line 8 Cake\View\View::_evaluate() - CORE/src/View/View.php, line 1413 Cake\View\View::_render() - CORE/src/View/View.php, line 1374 Cake\View\View::renderLayout() - CORE/src/View/View.php, line 927 Cake\View\View::render() - CORE/src/View/View.php, line 885 Cake\Controller\Controller::render() - CORE/src/Controller/Controller.php, line 791 Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 126 Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94 Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 88 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51</pre></div></pre>latest-news-updates/video-recording-of-consent-for-clinical-trials-driving-away-subjects-sc-told-dhananjay-mahapatra-24078.html"/> <meta http-equiv="Content-Type" content="text/html; charset=utf-8"/> <link href="https://im4change.in/css/control.css" rel="stylesheet" type="text/css" media="all"/> <title>LATEST NEWS UPDATES | Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra | Im4change.org</title> <meta name="description" content=" -The Times of India NEW DELHI: The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. The protocol has..."/> <script src="https://im4change.in/js/jquery-1.10.2.js"></script> <script type="text/javascript" src="https://im4change.in/js/jquery-migrate.min.js"></script> <script language="javascript" type="text/javascript"> $(document).ready(function () { var img = $("img")[0]; // Get my img elem var pic_real_width, pic_real_height; $("<img/>") // Make in memory copy of image to avoid css issues .attr("src", $(img).attr("src")) .load(function () { pic_real_width = this.width; // Note: $(this).width() will not pic_real_height = this.height; // work for in memory images. }); }); </script> <style type="text/css"> @media screen { div.divFooter { display: block; } } @media print { .printbutton { display: none !important; } } </style> </head> <body> <table cellpadding="0" cellspacing="0" border="0" width="98%" align="center"> <tr> <td class="top_bg"> <div class="divFooter"> <img src="https://im4change.in/images/logo1.jpg" height="59" border="0" alt="Resource centre on India's rural distress" style="padding-top:14px;"/> </div> </td> </tr> <tr> <td id="topspace"> </td> </tr> <tr id="topspace"> <td> </td> </tr> <tr> <td height="50" style="border-bottom:1px solid #000; padding-top:10px;" class="printbutton"> <form><input type="button" value=" Print this page " onclick="window.print();return false;"/></form> </td> </tr> <tr> <td width="100%"> <h1 class="news_headlines" style="font-style:normal"> <strong>Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra</strong></h1> </td> </tr> <tr> <td width="100%" style="font-family:Arial, 'Segoe Script', 'Segoe UI', sans-serif, serif"><font size="3"> <div align="justify">-The Times of India</div><p align="justify"><br /><em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions.</p><p align="justify">The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial.</p><p align="justify">This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial.</p><p align="justify">The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment.</p><p align="justify">Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of "any reasonably foreseeable risks or discomforts to the subject" as well as possible benefits.</p><p align="justify">It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. "In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required," it said.</p><p align="justify">Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed.</p><p align="justify">From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug.</p><p align="justify">The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p> </font> </td> </tr> <tr> <td> </td> </tr> <tr> <td height="50" style="border-top:1px solid #000; border-bottom:1px solid #000;padding-top:10px;"> <form><input type="button" value=" Print this page " onclick="window.print();return false;"/></form> </td> </tr> </table></body> </html>' } $maxBufferLength = (int) 8192 $file = '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php' $line = (int) 853 $message = 'Unable to emit headers. Headers sent in file=/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php line=853'Cake\Http\ResponseEmitter::emit() - CORE/src/Http/ResponseEmitter.php, line 48 Cake\Http\Server::emit() - CORE/src/Http/Server.php, line 141 [main] - ROOT/webroot/index.php, line 39
Warning (2): Cannot modify header information - headers already sent by (output started at /home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php:853) [CORE/src/Http/ResponseEmitter.php, line 148]Code Context$response->getStatusCode(),
($reasonPhrase ? ' ' . $reasonPhrase : '')
));
$response = object(Cake\Http\Response) { 'status' => (int) 200, 'contentType' => 'text/html', 'headers' => [ 'Content-Type' => [ [maximum depth reached] ] ], 'file' => null, 'fileRange' => [], 'cookies' => object(Cake\Http\Cookie\CookieCollection) {}, 'cacheDirectives' => [], 'body' => '<!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN" "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd"> <html xmlns="http://www.w3.org/1999/xhtml"> <head> <link rel="canonical" href="https://im4change.in/<pre class="cake-error"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f3a4769196c-trace').style.display = (document.getElementById('cakeErr67f3a4769196c-trace').style.display == 'none' ? '' : 'none');"><b>Notice</b> (8)</a>: Undefined variable: urlPrefix [<b>APP/Template/Layout/printlayout.ctp</b>, line <b>8</b>]<div id="cakeErr67f3a4769196c-trace" class="cake-stack-trace" style="display: none;"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f3a4769196c-code').style.display = (document.getElementById('cakeErr67f3a4769196c-code').style.display == 'none' ? '' : 'none')">Code</a> <a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f3a4769196c-context').style.display = (document.getElementById('cakeErr67f3a4769196c-context').style.display == 'none' ? '' : 'none')">Context</a><pre id="cakeErr67f3a4769196c-code" class="cake-code-dump" style="display: none;"><code><span style="color: #000000"><span style="color: #0000BB"></span><span style="color: #007700"><</span><span style="color: #0000BB">head</span><span style="color: #007700">> </span></span></code> <span class="code-highlight"><code><span style="color: #000000"> <link rel="canonical" href="<span style="color: #0000BB"><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">Configure</span><span style="color: #007700">::</span><span style="color: #0000BB">read</span><span style="color: #007700">(</span><span style="color: #DD0000">'SITE_URL'</span><span style="color: #007700">); </span><span style="color: #0000BB">?><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$urlPrefix</span><span style="color: #007700">;</span><span style="color: #0000BB">?><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-></span><span style="color: #0000BB">category</span><span style="color: #007700">-></span><span style="color: #0000BB">slug</span><span style="color: #007700">; </span><span style="color: #0000BB">?></span>/<span style="color: #0000BB"><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-></span><span style="color: #0000BB">seo_url</span><span style="color: #007700">; </span><span style="color: #0000BB">?></span>.html"/> </span></code></span> <code><span style="color: #000000"><span style="color: #0000BB"> </span><span style="color: #007700"><</span><span style="color: #0000BB">meta http</span><span style="color: #007700">-</span><span style="color: #0000BB">equiv</span><span style="color: #007700">=</span><span style="color: #DD0000">"Content-Type" </span><span style="color: #0000BB">content</span><span style="color: #007700">=</span><span style="color: #DD0000">"text/html; charset=utf-8"</span><span style="color: #007700">/> </span></span></code></pre><pre id="cakeErr67f3a4769196c-context" class="cake-context" style="display: none;">$viewFile = '/home/brlfuser/public_html/src/Template/Layout/printlayout.ctp' $dataForView = [ 'article_current' => object(App\Model\Entity\Article) { 'id' => (int) 23909, 'title' => 'Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra', 'subheading' => '', 'description' => '<div align="justify"> -The Times of India </div> <p align="justify"> <br /> <em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. </p> <p align="justify"> The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial. </p> <p align="justify"> This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial. </p> <p align="justify"> The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment. </p> <p align="justify"> Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of &quot;any reasonably foreseeable risks or discomforts to the subject&quot; as well as possible benefits. </p> <p align="justify"> It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. &quot;In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required,&quot; it said. </p> <p align="justify"> Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed. </p> <p align="justify"> From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug. </p> <p align="justify"> The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p>', 'credit_writer' => 'The Times of India, 31 January, 2014, http://timesofindia.indiatimes.com/india/Video-recording-of-consent-for-clinical-trials-driving-away-subjects-SC-told/articleshow/29626348.cms', 'article_img' => '', 'article_img_thumb' => '', 'status' => (int) 1, 'show_on_home' => (int) 1, 'lang' => 'EN', 'category_id' => (int) 16, 'tag_keyword' => '', 'seo_url' => 'video-recording-of-consent-for-clinical-trials-driving-away-subjects-sc-told-dhananjay-mahapatra-24078', 'meta_title' => null, 'meta_keywords' => null, 'meta_description' => null, 'noindex' => (int) 0, 'publish_date' => object(Cake\I18n\FrozenDate) {}, 'most_visit_section_id' => null, 'article_big_img' => null, 'liveid' => (int) 24078, 'created' => object(Cake\I18n\FrozenTime) {}, 'modified' => object(Cake\I18n\FrozenTime) {}, 'edate' => '', 'tags' => [ [maximum depth reached] ], 'category' => object(App\Model\Entity\Category) {}, '[new]' => false, '[accessible]' => [ [maximum depth reached] ], '[dirty]' => [[maximum depth reached]], '[original]' => [[maximum depth reached]], '[virtual]' => [[maximum depth reached]], '[hasErrors]' => false, '[errors]' => [[maximum depth reached]], '[invalid]' => [[maximum depth reached]], '[repository]' => 'Articles' }, 'articleid' => (int) 23909, 'metaTitle' => 'LATEST NEWS UPDATES | Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra', 'metaKeywords' => 'Health,medicines,drug trial,Clinical Trials', 'metaDesc' => ' -The Times of India NEW DELHI: The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. The protocol has...', 'disp' => '<div align="justify">-The Times of India</div><p align="justify"><br /><em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions.</p><p align="justify">The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial.</p><p align="justify">This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial.</p><p align="justify">The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment.</p><p align="justify">Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of &quot;any reasonably foreseeable risks or discomforts to the subject&quot; as well as possible benefits.</p><p align="justify">It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. &quot;In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required,&quot; it said.</p><p align="justify">Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed.</p><p align="justify">From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug.</p><p align="justify">The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p>', 'lang' => 'English', 'SITE_URL' => 'https://im4change.in/', 'site_title' => 'im4change', 'adminprix' => 'admin' ] $article_current = object(App\Model\Entity\Article) { 'id' => (int) 23909, 'title' => 'Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra', 'subheading' => '', 'description' => '<div align="justify"> -The Times of India </div> <p align="justify"> <br /> <em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. </p> <p align="justify"> The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial. </p> <p align="justify"> This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial. </p> <p align="justify"> The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment. </p> <p align="justify"> Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of &quot;any reasonably foreseeable risks or discomforts to the subject&quot; as well as possible benefits. </p> <p align="justify"> It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. &quot;In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required,&quot; it said. </p> <p align="justify"> Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed. </p> <p align="justify"> From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug. </p> <p align="justify"> The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p>', 'credit_writer' => 'The Times of India, 31 January, 2014, http://timesofindia.indiatimes.com/india/Video-recording-of-consent-for-clinical-trials-driving-away-subjects-SC-told/articleshow/29626348.cms', 'article_img' => '', 'article_img_thumb' => '', 'status' => (int) 1, 'show_on_home' => (int) 1, 'lang' => 'EN', 'category_id' => (int) 16, 'tag_keyword' => '', 'seo_url' => 'video-recording-of-consent-for-clinical-trials-driving-away-subjects-sc-told-dhananjay-mahapatra-24078', 'meta_title' => null, 'meta_keywords' => null, 'meta_description' => null, 'noindex' => (int) 0, 'publish_date' => object(Cake\I18n\FrozenDate) {}, 'most_visit_section_id' => null, 'article_big_img' => null, 'liveid' => (int) 24078, 'created' => object(Cake\I18n\FrozenTime) {}, 'modified' => object(Cake\I18n\FrozenTime) {}, 'edate' => '', 'tags' => [ (int) 0 => object(Cake\ORM\Entity) {}, (int) 1 => object(Cake\ORM\Entity) {}, (int) 2 => object(Cake\ORM\Entity) {}, (int) 3 => object(Cake\ORM\Entity) {} ], 'category' => object(App\Model\Entity\Category) {}, '[new]' => false, '[accessible]' => [ '*' => true, 'id' => false ], '[dirty]' => [], '[original]' => [], '[virtual]' => [], '[hasErrors]' => false, '[errors]' => [], '[invalid]' => [], '[repository]' => 'Articles' } $articleid = (int) 23909 $metaTitle = 'LATEST NEWS UPDATES | Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra' $metaKeywords = 'Health,medicines,drug trial,Clinical Trials' $metaDesc = ' -The Times of India NEW DELHI: The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. The protocol has...' $disp = '<div align="justify">-The Times of India</div><p align="justify"><br /><em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions.</p><p align="justify">The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial.</p><p align="justify">This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial.</p><p align="justify">The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment.</p><p align="justify">Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of &quot;any reasonably foreseeable risks or discomforts to the subject&quot; as well as possible benefits.</p><p align="justify">It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. &quot;In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required,&quot; it said.</p><p align="justify">Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed.</p><p align="justify">From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug.</p><p align="justify">The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p>' $lang = 'English' $SITE_URL = 'https://im4change.in/' $site_title = 'im4change' $adminprix = 'admin'</pre><pre class="stack-trace">include - APP/Template/Layout/printlayout.ctp, line 8 Cake\View\View::_evaluate() - CORE/src/View/View.php, line 1413 Cake\View\View::_render() - CORE/src/View/View.php, line 1374 Cake\View\View::renderLayout() - CORE/src/View/View.php, line 927 Cake\View\View::render() - CORE/src/View/View.php, line 885 Cake\Controller\Controller::render() - CORE/src/Controller/Controller.php, line 791 Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 126 Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94 Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 88 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51</pre></div></pre>latest-news-updates/video-recording-of-consent-for-clinical-trials-driving-away-subjects-sc-told-dhananjay-mahapatra-24078.html"/> <meta http-equiv="Content-Type" content="text/html; charset=utf-8"/> <link href="https://im4change.in/css/control.css" rel="stylesheet" type="text/css" media="all"/> <title>LATEST NEWS UPDATES | Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra | Im4change.org</title> <meta name="description" content=" -The Times of India NEW DELHI: The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. The protocol has..."/> <script src="https://im4change.in/js/jquery-1.10.2.js"></script> <script type="text/javascript" src="https://im4change.in/js/jquery-migrate.min.js"></script> <script language="javascript" type="text/javascript"> $(document).ready(function () { var img = $("img")[0]; // Get my img elem var pic_real_width, pic_real_height; $("<img/>") // Make in memory copy of image to avoid css issues .attr("src", $(img).attr("src")) .load(function () { pic_real_width = this.width; // Note: $(this).width() will not pic_real_height = this.height; // work for in memory images. }); }); </script> <style type="text/css"> @media screen { div.divFooter { display: block; } } @media print { .printbutton { display: none !important; } } </style> </head> <body> <table cellpadding="0" cellspacing="0" border="0" width="98%" align="center"> <tr> <td class="top_bg"> <div class="divFooter"> <img src="https://im4change.in/images/logo1.jpg" height="59" border="0" alt="Resource centre on India's rural distress" style="padding-top:14px;"/> </div> </td> </tr> <tr> <td id="topspace"> </td> </tr> <tr id="topspace"> <td> </td> </tr> <tr> <td height="50" style="border-bottom:1px solid #000; padding-top:10px;" class="printbutton"> <form><input type="button" value=" Print this page " onclick="window.print();return false;"/></form> </td> </tr> <tr> <td width="100%"> <h1 class="news_headlines" style="font-style:normal"> <strong>Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra</strong></h1> </td> </tr> <tr> <td width="100%" style="font-family:Arial, 'Segoe Script', 'Segoe UI', sans-serif, serif"><font size="3"> <div align="justify">-The Times of India</div><p align="justify"><br /><em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions.</p><p align="justify">The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial.</p><p align="justify">This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial.</p><p align="justify">The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment.</p><p align="justify">Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of "any reasonably foreseeable risks or discomforts to the subject" as well as possible benefits.</p><p align="justify">It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. "In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required," it said.</p><p align="justify">Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed.</p><p align="justify">From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug.</p><p align="justify">The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p> </font> </td> </tr> <tr> <td> </td> </tr> <tr> <td height="50" style="border-top:1px solid #000; border-bottom:1px solid #000;padding-top:10px;"> <form><input type="button" value=" Print this page " onclick="window.print();return false;"/></form> </td> </tr> </table></body> </html>' } $reasonPhrase = 'OK'header - [internal], line ?? Cake\Http\ResponseEmitter::emitStatusLine() - CORE/src/Http/ResponseEmitter.php, line 148 Cake\Http\ResponseEmitter::emit() - CORE/src/Http/ResponseEmitter.php, line 54 Cake\Http\Server::emit() - CORE/src/Http/Server.php, line 141 [main] - ROOT/webroot/index.php, line 39
Warning (2): Cannot modify header information - headers already sent by (output started at /home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php:853) [CORE/src/Http/ResponseEmitter.php, line 181]Notice (8): Undefined variable: urlPrefix [APP/Template/Layout/printlayout.ctp, line 8]Code Context$value
), $first);
$first = false;
$response = object(Cake\Http\Response) { 'status' => (int) 200, 'contentType' => 'text/html', 'headers' => [ 'Content-Type' => [ [maximum depth reached] ] ], 'file' => null, 'fileRange' => [], 'cookies' => object(Cake\Http\Cookie\CookieCollection) {}, 'cacheDirectives' => [], 'body' => '<!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN" "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd"> <html xmlns="http://www.w3.org/1999/xhtml"> <head> <link rel="canonical" href="https://im4change.in/<pre class="cake-error"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f3a4769196c-trace').style.display = (document.getElementById('cakeErr67f3a4769196c-trace').style.display == 'none' ? '' : 'none');"><b>Notice</b> (8)</a>: Undefined variable: urlPrefix [<b>APP/Template/Layout/printlayout.ctp</b>, line <b>8</b>]<div id="cakeErr67f3a4769196c-trace" class="cake-stack-trace" style="display: none;"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f3a4769196c-code').style.display = (document.getElementById('cakeErr67f3a4769196c-code').style.display == 'none' ? '' : 'none')">Code</a> <a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f3a4769196c-context').style.display = (document.getElementById('cakeErr67f3a4769196c-context').style.display == 'none' ? '' : 'none')">Context</a><pre id="cakeErr67f3a4769196c-code" class="cake-code-dump" style="display: none;"><code><span style="color: #000000"><span style="color: #0000BB"></span><span style="color: #007700"><</span><span style="color: #0000BB">head</span><span style="color: #007700">> </span></span></code> <span class="code-highlight"><code><span style="color: #000000"> <link rel="canonical" href="<span style="color: #0000BB"><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">Configure</span><span style="color: #007700">::</span><span style="color: #0000BB">read</span><span style="color: #007700">(</span><span style="color: #DD0000">'SITE_URL'</span><span style="color: #007700">); </span><span style="color: #0000BB">?><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$urlPrefix</span><span style="color: #007700">;</span><span style="color: #0000BB">?><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-></span><span style="color: #0000BB">category</span><span style="color: #007700">-></span><span style="color: #0000BB">slug</span><span style="color: #007700">; </span><span style="color: #0000BB">?></span>/<span style="color: #0000BB"><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-></span><span style="color: #0000BB">seo_url</span><span style="color: #007700">; </span><span style="color: #0000BB">?></span>.html"/> </span></code></span> <code><span style="color: #000000"><span style="color: #0000BB"> </span><span style="color: #007700"><</span><span style="color: #0000BB">meta http</span><span style="color: #007700">-</span><span style="color: #0000BB">equiv</span><span style="color: #007700">=</span><span style="color: #DD0000">"Content-Type" </span><span style="color: #0000BB">content</span><span style="color: #007700">=</span><span style="color: #DD0000">"text/html; charset=utf-8"</span><span style="color: #007700">/> </span></span></code></pre><pre id="cakeErr67f3a4769196c-context" class="cake-context" style="display: none;">$viewFile = '/home/brlfuser/public_html/src/Template/Layout/printlayout.ctp' $dataForView = [ 'article_current' => object(App\Model\Entity\Article) { 'id' => (int) 23909, 'title' => 'Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra', 'subheading' => '', 'description' => '<div align="justify"> -The Times of India </div> <p align="justify"> <br /> <em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. </p> <p align="justify"> The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial. </p> <p align="justify"> This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial. </p> <p align="justify"> The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment. </p> <p align="justify"> Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of &quot;any reasonably foreseeable risks or discomforts to the subject&quot; as well as possible benefits. </p> <p align="justify"> It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. &quot;In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required,&quot; it said. </p> <p align="justify"> Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed. </p> <p align="justify"> From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug. </p> <p align="justify"> The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p>', 'credit_writer' => 'The Times of India, 31 January, 2014, http://timesofindia.indiatimes.com/india/Video-recording-of-consent-for-clinical-trials-driving-away-subjects-SC-told/articleshow/29626348.cms', 'article_img' => '', 'article_img_thumb' => '', 'status' => (int) 1, 'show_on_home' => (int) 1, 'lang' => 'EN', 'category_id' => (int) 16, 'tag_keyword' => '', 'seo_url' => 'video-recording-of-consent-for-clinical-trials-driving-away-subjects-sc-told-dhananjay-mahapatra-24078', 'meta_title' => null, 'meta_keywords' => null, 'meta_description' => null, 'noindex' => (int) 0, 'publish_date' => object(Cake\I18n\FrozenDate) {}, 'most_visit_section_id' => null, 'article_big_img' => null, 'liveid' => (int) 24078, 'created' => object(Cake\I18n\FrozenTime) {}, 'modified' => object(Cake\I18n\FrozenTime) {}, 'edate' => '', 'tags' => [ [maximum depth reached] ], 'category' => object(App\Model\Entity\Category) {}, '[new]' => false, '[accessible]' => [ [maximum depth reached] ], '[dirty]' => [[maximum depth reached]], '[original]' => [[maximum depth reached]], '[virtual]' => [[maximum depth reached]], '[hasErrors]' => false, '[errors]' => [[maximum depth reached]], '[invalid]' => [[maximum depth reached]], '[repository]' => 'Articles' }, 'articleid' => (int) 23909, 'metaTitle' => 'LATEST NEWS UPDATES | Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra', 'metaKeywords' => 'Health,medicines,drug trial,Clinical Trials', 'metaDesc' => ' -The Times of India NEW DELHI: The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. The protocol has...', 'disp' => '<div align="justify">-The Times of India</div><p align="justify"><br /><em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions.</p><p align="justify">The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial.</p><p align="justify">This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial.</p><p align="justify">The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment.</p><p align="justify">Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of &quot;any reasonably foreseeable risks or discomforts to the subject&quot; as well as possible benefits.</p><p align="justify">It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. &quot;In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required,&quot; it said.</p><p align="justify">Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed.</p><p align="justify">From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug.</p><p align="justify">The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p>', 'lang' => 'English', 'SITE_URL' => 'https://im4change.in/', 'site_title' => 'im4change', 'adminprix' => 'admin' ] $article_current = object(App\Model\Entity\Article) { 'id' => (int) 23909, 'title' => 'Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra', 'subheading' => '', 'description' => '<div align="justify"> -The Times of India </div> <p align="justify"> <br /> <em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. </p> <p align="justify"> The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial. </p> <p align="justify"> This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial. </p> <p align="justify"> The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment. </p> <p align="justify"> Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of &quot;any reasonably foreseeable risks or discomforts to the subject&quot; as well as possible benefits. </p> <p align="justify"> It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. &quot;In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required,&quot; it said. </p> <p align="justify"> Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed. </p> <p align="justify"> From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug. </p> <p align="justify"> The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p>', 'credit_writer' => 'The Times of India, 31 January, 2014, http://timesofindia.indiatimes.com/india/Video-recording-of-consent-for-clinical-trials-driving-away-subjects-SC-told/articleshow/29626348.cms', 'article_img' => '', 'article_img_thumb' => '', 'status' => (int) 1, 'show_on_home' => (int) 1, 'lang' => 'EN', 'category_id' => (int) 16, 'tag_keyword' => '', 'seo_url' => 'video-recording-of-consent-for-clinical-trials-driving-away-subjects-sc-told-dhananjay-mahapatra-24078', 'meta_title' => null, 'meta_keywords' => null, 'meta_description' => null, 'noindex' => (int) 0, 'publish_date' => object(Cake\I18n\FrozenDate) {}, 'most_visit_section_id' => null, 'article_big_img' => null, 'liveid' => (int) 24078, 'created' => object(Cake\I18n\FrozenTime) {}, 'modified' => object(Cake\I18n\FrozenTime) {}, 'edate' => '', 'tags' => [ (int) 0 => object(Cake\ORM\Entity) {}, (int) 1 => object(Cake\ORM\Entity) {}, (int) 2 => object(Cake\ORM\Entity) {}, (int) 3 => object(Cake\ORM\Entity) {} ], 'category' => object(App\Model\Entity\Category) {}, '[new]' => false, '[accessible]' => [ '*' => true, 'id' => false ], '[dirty]' => [], '[original]' => [], '[virtual]' => [], '[hasErrors]' => false, '[errors]' => [], '[invalid]' => [], '[repository]' => 'Articles' } $articleid = (int) 23909 $metaTitle = 'LATEST NEWS UPDATES | Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra' $metaKeywords = 'Health,medicines,drug trial,Clinical Trials' $metaDesc = ' -The Times of India NEW DELHI: The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. The protocol has...' $disp = '<div align="justify">-The Times of India</div><p align="justify"><br /><em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions.</p><p align="justify">The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial.</p><p align="justify">This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial.</p><p align="justify">The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment.</p><p align="justify">Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of &quot;any reasonably foreseeable risks or discomforts to the subject&quot; as well as possible benefits.</p><p align="justify">It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. &quot;In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required,&quot; it said.</p><p align="justify">Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed.</p><p align="justify">From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug.</p><p align="justify">The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p>' $lang = 'English' $SITE_URL = 'https://im4change.in/' $site_title = 'im4change' $adminprix = 'admin'</pre><pre class="stack-trace">include - APP/Template/Layout/printlayout.ctp, line 8 Cake\View\View::_evaluate() - CORE/src/View/View.php, line 1413 Cake\View\View::_render() - CORE/src/View/View.php, line 1374 Cake\View\View::renderLayout() - CORE/src/View/View.php, line 927 Cake\View\View::render() - CORE/src/View/View.php, line 885 Cake\Controller\Controller::render() - CORE/src/Controller/Controller.php, line 791 Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 126 Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94 Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 88 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51</pre></div></pre>latest-news-updates/video-recording-of-consent-for-clinical-trials-driving-away-subjects-sc-told-dhananjay-mahapatra-24078.html"/> <meta http-equiv="Content-Type" content="text/html; charset=utf-8"/> <link href="https://im4change.in/css/control.css" rel="stylesheet" type="text/css" media="all"/> <title>LATEST NEWS UPDATES | Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra | Im4change.org</title> <meta name="description" content=" -The Times of India NEW DELHI: The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. The protocol has..."/> <script src="https://im4change.in/js/jquery-1.10.2.js"></script> <script type="text/javascript" src="https://im4change.in/js/jquery-migrate.min.js"></script> <script language="javascript" type="text/javascript"> $(document).ready(function () { var img = $("img")[0]; // Get my img elem var pic_real_width, pic_real_height; $("<img/>") // Make in memory copy of image to avoid css issues .attr("src", $(img).attr("src")) .load(function () { pic_real_width = this.width; // Note: $(this).width() will not pic_real_height = this.height; // work for in memory images. }); }); </script> <style type="text/css"> @media screen { div.divFooter { display: block; } } @media print { .printbutton { display: none !important; } } </style> </head> <body> <table cellpadding="0" cellspacing="0" border="0" width="98%" align="center"> <tr> <td class="top_bg"> <div class="divFooter"> <img src="https://im4change.in/images/logo1.jpg" height="59" border="0" alt="Resource centre on India's rural distress" style="padding-top:14px;"/> </div> </td> </tr> <tr> <td id="topspace"> </td> </tr> <tr id="topspace"> <td> </td> </tr> <tr> <td height="50" style="border-bottom:1px solid #000; padding-top:10px;" class="printbutton"> <form><input type="button" value=" Print this page " onclick="window.print();return false;"/></form> </td> </tr> <tr> <td width="100%"> <h1 class="news_headlines" style="font-style:normal"> <strong>Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra</strong></h1> </td> </tr> <tr> <td width="100%" style="font-family:Arial, 'Segoe Script', 'Segoe UI', sans-serif, serif"><font size="3"> <div align="justify">-The Times of India</div><p align="justify"><br /><em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions.</p><p align="justify">The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial.</p><p align="justify">This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial.</p><p align="justify">The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment.</p><p align="justify">Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of "any reasonably foreseeable risks or discomforts to the subject" as well as possible benefits.</p><p align="justify">It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. "In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required," it said.</p><p align="justify">Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed.</p><p align="justify">From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug.</p><p align="justify">The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p> </font> </td> </tr> <tr> <td> </td> </tr> <tr> <td height="50" style="border-top:1px solid #000; border-bottom:1px solid #000;padding-top:10px;"> <form><input type="button" value=" Print this page " onclick="window.print();return false;"/></form> </td> </tr> </table></body> </html>' } $cookies = [] $values = [ (int) 0 => 'text/html; charset=UTF-8' ] $name = 'Content-Type' $first = true $value = 'text/html; charset=UTF-8'header - [internal], line ?? Cake\Http\ResponseEmitter::emitHeaders() - CORE/src/Http/ResponseEmitter.php, line 181 Cake\Http\ResponseEmitter::emit() - CORE/src/Http/ResponseEmitter.php, line 55 Cake\Http\Server::emit() - CORE/src/Http/Server.php, line 141 [main] - ROOT/webroot/index.php, line 39
<head>
<link rel="canonical" href="<?php echo Configure::read('SITE_URL'); ?><?php echo $urlPrefix;?><?php echo $article_current->category->slug; ?>/<?php echo $article_current->seo_url; ?>.html"/>
<meta http-equiv="Content-Type" content="text/html; charset=utf-8"/>
$viewFile = '/home/brlfuser/public_html/src/Template/Layout/printlayout.ctp' $dataForView = [ 'article_current' => object(App\Model\Entity\Article) { 'id' => (int) 23909, 'title' => 'Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra', 'subheading' => '', 'description' => '<div align="justify"> -The Times of India </div> <p align="justify"> <br /> <em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. </p> <p align="justify"> The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial. </p> <p align="justify"> This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial. </p> <p align="justify"> The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment. </p> <p align="justify"> Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of "any reasonably foreseeable risks or discomforts to the subject" as well as possible benefits. </p> <p align="justify"> It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. "In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required," it said. </p> <p align="justify"> Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed. </p> <p align="justify"> From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug. </p> <p align="justify"> The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p>', 'credit_writer' => 'The Times of India, 31 January, 2014, http://timesofindia.indiatimes.com/india/Video-recording-of-consent-for-clinical-trials-driving-away-subjects-SC-told/articleshow/29626348.cms', 'article_img' => '', 'article_img_thumb' => '', 'status' => (int) 1, 'show_on_home' => (int) 1, 'lang' => 'EN', 'category_id' => (int) 16, 'tag_keyword' => '', 'seo_url' => 'video-recording-of-consent-for-clinical-trials-driving-away-subjects-sc-told-dhananjay-mahapatra-24078', 'meta_title' => null, 'meta_keywords' => null, 'meta_description' => null, 'noindex' => (int) 0, 'publish_date' => object(Cake\I18n\FrozenDate) {}, 'most_visit_section_id' => null, 'article_big_img' => null, 'liveid' => (int) 24078, 'created' => object(Cake\I18n\FrozenTime) {}, 'modified' => object(Cake\I18n\FrozenTime) {}, 'edate' => '', 'tags' => [ [maximum depth reached] ], 'category' => object(App\Model\Entity\Category) {}, '[new]' => false, '[accessible]' => [ [maximum depth reached] ], '[dirty]' => [[maximum depth reached]], '[original]' => [[maximum depth reached]], '[virtual]' => [[maximum depth reached]], '[hasErrors]' => false, '[errors]' => [[maximum depth reached]], '[invalid]' => [[maximum depth reached]], '[repository]' => 'Articles' }, 'articleid' => (int) 23909, 'metaTitle' => 'LATEST NEWS UPDATES | Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra', 'metaKeywords' => 'Health,medicines,drug trial,Clinical Trials', 'metaDesc' => ' -The Times of India NEW DELHI: The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. The protocol has...', 'disp' => '<div align="justify">-The Times of India</div><p align="justify"><br /><em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions.</p><p align="justify">The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial.</p><p align="justify">This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial.</p><p align="justify">The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment.</p><p align="justify">Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of "any reasonably foreseeable risks or discomforts to the subject" as well as possible benefits.</p><p align="justify">It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. "In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required," it said.</p><p align="justify">Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed.</p><p align="justify">From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug.</p><p align="justify">The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p>', 'lang' => 'English', 'SITE_URL' => 'https://im4change.in/', 'site_title' => 'im4change', 'adminprix' => 'admin' ] $article_current = object(App\Model\Entity\Article) { 'id' => (int) 23909, 'title' => 'Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra', 'subheading' => '', 'description' => '<div align="justify"> -The Times of India </div> <p align="justify"> <br /> <em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. </p> <p align="justify"> The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial. </p> <p align="justify"> This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial. </p> <p align="justify"> The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment. </p> <p align="justify"> Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of "any reasonably foreseeable risks or discomforts to the subject" as well as possible benefits. </p> <p align="justify"> It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. "In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required," it said. </p> <p align="justify"> Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed. </p> <p align="justify"> From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug. </p> <p align="justify"> The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p>', 'credit_writer' => 'The Times of India, 31 January, 2014, http://timesofindia.indiatimes.com/india/Video-recording-of-consent-for-clinical-trials-driving-away-subjects-SC-told/articleshow/29626348.cms', 'article_img' => '', 'article_img_thumb' => '', 'status' => (int) 1, 'show_on_home' => (int) 1, 'lang' => 'EN', 'category_id' => (int) 16, 'tag_keyword' => '', 'seo_url' => 'video-recording-of-consent-for-clinical-trials-driving-away-subjects-sc-told-dhananjay-mahapatra-24078', 'meta_title' => null, 'meta_keywords' => null, 'meta_description' => null, 'noindex' => (int) 0, 'publish_date' => object(Cake\I18n\FrozenDate) {}, 'most_visit_section_id' => null, 'article_big_img' => null, 'liveid' => (int) 24078, 'created' => object(Cake\I18n\FrozenTime) {}, 'modified' => object(Cake\I18n\FrozenTime) {}, 'edate' => '', 'tags' => [ (int) 0 => object(Cake\ORM\Entity) {}, (int) 1 => object(Cake\ORM\Entity) {}, (int) 2 => object(Cake\ORM\Entity) {}, (int) 3 => object(Cake\ORM\Entity) {} ], 'category' => object(App\Model\Entity\Category) {}, '[new]' => false, '[accessible]' => [ '*' => true, 'id' => false ], '[dirty]' => [], '[original]' => [], '[virtual]' => [], '[hasErrors]' => false, '[errors]' => [], '[invalid]' => [], '[repository]' => 'Articles' } $articleid = (int) 23909 $metaTitle = 'LATEST NEWS UPDATES | Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra' $metaKeywords = 'Health,medicines,drug trial,Clinical Trials' $metaDesc = ' -The Times of India NEW DELHI: The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. The protocol has...' $disp = '<div align="justify">-The Times of India</div><p align="justify"><br /><em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions.</p><p align="justify">The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial.</p><p align="justify">This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial.</p><p align="justify">The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment.</p><p align="justify">Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of "any reasonably foreseeable risks or discomforts to the subject" as well as possible benefits.</p><p align="justify">It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. "In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required," it said.</p><p align="justify">Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed.</p><p align="justify">From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug.</p><p align="justify">The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p>' $lang = 'English' $SITE_URL = 'https://im4change.in/' $site_title = 'im4change' $adminprix = 'admin'
include - APP/Template/Layout/printlayout.ctp, line 8 Cake\View\View::_evaluate() - CORE/src/View/View.php, line 1413 Cake\View\View::_render() - CORE/src/View/View.php, line 1374 Cake\View\View::renderLayout() - CORE/src/View/View.php, line 927 Cake\View\View::render() - CORE/src/View/View.php, line 885 Cake\Controller\Controller::render() - CORE/src/Controller/Controller.php, line 791 Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 126 Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94 Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 88 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96 Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65 Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
![]() |
Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra |
-The Times of India
The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial. This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial. The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment. Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of "any reasonably foreseeable risks or discomforts to the subject" as well as possible benefits. It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. "In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required," it said. Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed. From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug. The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. |