Thursday, November 15, 2012
Learning From Unethical Experiments in Guatemala
In a report to a subcommittee of the Presidential Commission, the Community Ethics Committee made these recommendations related to the Guatemala study:
That empowered, informed and truly independent Participant Advocates be assigned to research participants and that those advocates stay with individual participants from the initiation of the informed consent process, through the clinical trial, and for follow-up after the trial closes.
That local Community Groups be included as an authentic voice in the review, monitoring and management of clinical trials.
That, while recognizing that numerous laws and regulations contain enforcement mechanisms for breaches of clinical trial protocols, real and significant Consequences, such as loss of licensure and public censure, be
imposed upon individual professionals involved in research which is not ethically supportable, as a way to minimize both community and individual harms.
And, given the pervasive nature of clinical trials in current medical practice, that medical schools require a Course in Medical and Research Ethics and clinical trial protocols.
Read the CEC’s full report to the Presidential Commission here.
By Paul McLean at 8:23 PM