Navigation Links
BMJ editorial: India's research participant protection policy
Date:7/31/2013

In an editorial published online today in BMJ, Johns Hopkins bioethicist Jeremy Sugarman and other experts warn that action is urgently needed to deal with possible unintended consequences of India's new policy protecting research participants.

Passed earlier this year, the Drugs and Cosmetics Act (First Amendment) Rules, was meant to mitigate ethical concerns with potential serious consequences for public health, as well as India's viability as a continued global leader in clinical research. However, Sugarman and his co-authors highlight specific concerns that could lead to the policy having the opposite effect, including a table of the policy's "Conditions attributable to clinical trial injury or death." One of these is "use of placebo in a placebo controlled trial," to which the authors respond that "placebos are not necessarily harmful. Indeed the use of a placebo is often the only way of truly assessing whether the agent under study is associated with undue risk or significant benefit."

Among the authors other concerns is the policy's call to compensate research participants for injury for "failure of investigational product to provide intended therapeutic benefit," arguing that the purpose of the trial is to determine just that.

The authors give short and anticipated long-term ramifications of the policy, noting that at least 35 collaborative research projects funded by the US National Institutes of Health have been suspended since March 2013, most investigating large scale public health problems. They also note that India is the main supplier of antiretrovirals to donor supported HIV treatment programs in developing countries, and the dramatic fall in clinical trial applications that is already taking place could have a ripple effect on the availability of registered drugs.

"It is essential that the unintended consequences of the new policy are dealt with effectively but rapidly," the authors write. "The relevance, impact, and quality of global health research have been greatly strengthened by engagement of Indian scientists and participation of Indian research volunteers. Advances in health research need India's leadership and participation."


'/>"/>

Contact: Leah Ramsay
lramsay@jhu.edu
202-642-9640
Johns Hopkins Medicine
Source:Eurekalert

Related medicine news :

1. Eighth Annual Bladder Cancer Think Tank Set to Move Research Forward to Improve Treatment Landscape
2. Survey by Dissertation-Texas Reveals Exceptional Rise in Research Projects
3. U.S. Label Market Worth $19 Billion in 2017 Research Reports Now Available at ReportsnReports.com
4. Nanobiotechnology Market - New Industry Research Report is Now Available for Pre-Order at Transparency Market Research
5. New grant empowers young researchers to find a cure for pancreatic cancer
6. HealthCarePoint and ViS Research Streamline Sharing of Qualifications by Medical Researchers
7. Global Markets for Rapid Medical Diagnostic Kits (Mdks) to Surpass $24.2 Billion by 2017: BCC Research
8. Poland Health Insurance Market Analysis and 2015 Forecasts in New Research Report at RnRMarketResearch.com
9. China Poultry Vaccine Industry Analysis in New Market Research Report at ReportsnReports.com
10. Beaumont Health System Launches Research Trial of Bioresorbable Heart Scaffold
11. Parents dont fully understand biobank research, study finds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/28/2016)... , ... May 28, 2016 , ... In a part of the city where’s it’s ... new farm-to-table Kelowna restaurants is hoping to attract diners with a taste for ... Suites officially opened the doors to Cornerstone Grill, an urban casual restaurant focusing on ...
(Date:5/27/2016)... ... 27, 2016 , ... W.S. Badger Co. Inc ., the maker of ... recognized as one of the best small businesses for new dads by Fatherly, the ... small businesses providing progressive benefits to new parents on the organization’s 2016 Best ...
(Date:5/27/2016)... ... May 27, 2016 , ... An educational campaign aimed at ... stories, courtesy of awareness-driven celebrities and thought leaders. It also provides insight to ... industry leaders such as Bioness. , As patients feel increasingly concerned about ...
(Date:5/27/2016)... NY (PRWEB) , ... May 27, 2016 , ... Aimed ... inspiring human interest stories, which come courtesy of leaders in the nursing and health ... industry, from leading advocates and associations—namely Abilene Christian University. , As the nursing ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... There are ... Hot Dog and Sausage Council (NHDSC) suggests that Americans prefer their dogs straight off ... 63 percent say grilling is their favorite way to cook a hot dog, far ...
Breaking Medicine News(10 mins):
(Date:5/30/2016)... - DCGI grants limited approval to market ... - Stempeucel® becomes 5th off-the-shelf Stem cell product to ... - Buerger,s Disease (also known as Thromboangiitis Obliterans) is a ... Globally - Prevalence of Buerger,s Disease is estimated to ... 10,000 persons in the European Community & USA ...
(Date:5/27/2016)... , May 27, 2016 According ... of hypertension is driving ambulatory blood pressure monitoring system ... elasticity and their ability to respond to different pressure ... condition can lead to various cardiovascular disorders such as ... disease. These diseases are growing in prevalence each year. ...
(Date:5/26/2016)... , May 26, 2016 According to ... Waste Management Market - U.S. Industry Analysis, Size, Share, Growth, ... market in the U.S. was valued at US$ 5.89 Bn ... of 3.4% from 2015 to 2023 to reach US$ 7.99 ... of current and emerging needle free drug delivery devices and ...
Breaking Medicine Technology: