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:10/12/2017)... ... October 12, 2017 , ... Information about the technology: ... develop to enable prevention of a major side effect of chemotherapy in children. ... pediatric patients. For cisplatin, hearing loss is FDA listed on-label as a dose ...
(Date:10/12/2017)... , ... October 12, 2017 , ... HMP , ... recipient of a 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ ... on October 11, 2017. , The annual award competition recognizes editorial and design excellence ...
(Date:10/12/2017)... FL (PRWEB) , ... October 12, 2017 , ... On ... holding a treadmill relay – Miles by Moonlight to raise money for the American ... $300 or more. , Teams will work together to keep their treadmills moving ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... the nation's first interactive health literacy software tool, and the Cancer Patient Education ... of cancer patient education, today announce a new strategic alliance. , As ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... wound care advancements to physician colleagues, skilled nursing facility medical directors and other ... Treacherous Waters of Wound Care." , "At many of these conferences we get ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... 25, 2017   Montrium , an industry ... today—from the IQPC Trial Master Files & Inspection ... that EastHORN Clinical Services has selected eTMF ... TMF management. EastHORN, a leading European contract research ... increase transparency to enable greater collaboration with sponsors, ...
(Date:9/19/2017)... Mich. , Sept. 19, 2017 HistoSonics, Inc., a venture-backed medical device company ... destruction of targeted tissues, announced three leadership team developments today:   ... PhD ... ... Veteran medical device executive Josh ...
(Date:9/12/2017)... NEW YORK , Sept. 12, 2017   EcoVadis ... global supply chains, has published the first annual edition of its Global ... more than 20,400 companies evaluated by EcoVadis, based on Scorecard Ratings that ... ... Risk & Performance Index ...
Breaking Medicine Technology: