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:6/25/2016)... ... June 25, 2016 , ... ... issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the ... several important health care topics including advance care planning, healthcare costs and patient ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern ... Laude and his M.D from the David Geffen School of Medicine at UCLA. He ... Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program ...
(Date:6/24/2016)... ... 2016 , ... Those who have experienced traumatic events may suffer from a ... such as drug or alcohol abuse, as a coping mechanism. To avoid this pain ... following a traumatic event. , Trauma sufferers tend to feel a range of emotions, ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas of ... AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute Beauty ... Barry M. Weintraub as a prominent plastic surgeon and the network’s newest partner. ... and the most handsome men, look naturally attractive. Plastic surgery should be invisible.” ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... VEGAS , June 26, 2016 ... to value-based care operating models within the health care ... enable greater financial efficiency , Deloitte offers a ... the key business issues impacting efficient cost optimization: labor ... , These services facilitate better outcomes and better ...
(Date:6/24/2016)... , June 24, 2016   Bay ... Rehabilitation Network,s Dean Center for Tick Borne ... Medicine and Rehabilitation, MIT Hacking Medicine, University of ... Innovation, today announced the five finalists of ... Lyme disease.  More than 100 scientists, clinicians, researchers, ...
(Date:6/24/2016)... BEIJING , June 24, 2016 Dehaier ... or the "Company"), which develops, markets and sells medical ... China , signed a strategic cooperation agreement with ... as "Hongyuan Supply Chain") on June 20, 2016, to ... Under the strategic cooperation agreement, Dehaier will leverage Hongyuan ...
Breaking Medicine Technology: