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.
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.
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