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FDA Human Subject Protection (HSP)/Bioresearch Monitoring (BIMO) Initiative May 2012 update

post #1 of 2
Thread Starter 

The FDA has published a series of new regulations and guidance documents which should, in theory, make things more difficult for circumcision-promoters, for example to obtain approval for new circumcision devices.

Many of these changes have come about, in part, as a result of earlier community consultations about such matters as extending limitations on disqualified investigators and strengthening human research protections.

Recent moves by government agencies to strengthen informed consent requirements and increase subject privacy protections, should also help circumcision opponents in the U.S. call into question the ethics and methodology of those African RCTs conducted in the early- to mid-2000s.

 

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm305275.htm

 

Excerpt:

 

 

Quote:
The Food and Drug Administration (FDA) has continued the Human Subject Protection (HSP)/Bioresearch Monitoring (BIMO) Initiative, , intended to modernize and strengthen the agency’s oversight and protection of subjects in clinical trials and the integrity of resulting data. The HSP/BIMO Initiative encompasses all FDA-regulated clinical trials, that is, those related to human drugs and biological drug products, devices, foods, and veterinary medicine. The overarching goals of the agency's BIMO program are to protect the rights, safety, and welfare of subjects involved in FDA-regulated clinical trials; to determine the accuracy and reliability of clinical trial data submitted to FDA in support of research or marketing applications; and to assess compliance with FDA's regulations governing the conduct of clinical trials, including those for informed consent and ethical review.

Edited by Minuteman - 5/29/12 at 8:50pm
post #2 of 2

The "African Trials" have been roundly criticized by both laymen and professionals as unreliable and possibly out and out fraudulent.  This has been a blotch on medical research and they are trying to correct the situation.

 

There is another effort going on to do the same thing.  Hopefully, one will be successful and we won't see this deception in the future.

 

 

 

Frank

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