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:6/24/2016)... ... 2016 , ... People across the U.S. are sharpening their pencils and honing ... contest in which patients and their families pay tribute to a genetic counselor by ... Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In ...
(Date:6/24/2016)... York, NY (PRWEB) , ... June 24, 2016 ... ... publication Haute Living, is proud to recognize Dr. Barry M. Weintraub as a ... that “the most beautiful women in the world, and the most handsome men, ...
(Date:6/24/2016)... ... June 24, 2016 , ... Strategic Capital Partners, LLC ... by obtaining investment capital for emerging technology companies. SCP has delivered investment ... resulted in more than a million dollars of capital investment for five companies. ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Venture Construction ... Classic Tournament held on June 20th at the Woodmont Country Club at 1201 ... Wings, an organization dedicated to helping service members that have been wounded in battle ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... the upcoming 2016 Miss Arizona pageant as its official Medspa Sponsor. Dr. Josh ... Mesa, and Chandler, Arizona. , Dr. Olson says the decision to support ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 ... Oticon , industry leaders in advanced ... launch of Oticon Opn ™, the world,s first ... of possibilities for IoT devices.      (Photo: ... Oticon introduces a number of ,world firsts,: ...
(Date:6/23/2016)... , June 23, 2016 The vast majority ... outpatient dialysis facility.  Treatments are usually 3 times a ... per visit, including travel time, equipment preparation and wait ... but especially grueling for patients who are elderly and ... skilled nursing and rehabilitation centers for some duration of ...
(Date:6/23/2016)... 2016  Experian Health, the healthcare industry ... patient payment and care experience, today announced ... and services that will enhance the breadth ... These award-winning solutions will enable healthcare professionals ... in an ever-changing environment and redefine front-office ...
Breaking Medicine Technology: