The Office of Human Research Protections (OHRP) has received your letter concerning research conducted at William Beaumont Hospital. I apologize for the delay in responding you.
OHRP has responsibility for oversight of compliance with the U.S. Department of Health and Human Services (HHS) regulations for the protections of human research subjects (see 45 CFR Part 46 at http://www.dhhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). In carrying out this responsibility, OHRP evaluations, at OHRP's discretion, substantive allegations of noncompliance involving human subject research projects conducted or supported by HHS or that are otherwise subject to the regulations (see OHRP memorandum dated October 14, 2009 at http://www.hhs.gov/ohrp/compliance/ohrpcomp.pdf for an explanation of OHRP's jurisdiction).
OHRP has initiated an evaluation of the matter reference in your letter. We notified the funding agency of your allegations and they have stopped enrollment into the study. We will advise you when the evaluation has been completed.
OHRP appreciates your concern about the protection of human research subjects. Please do not hesitate to contact me at any time should you have any questions or wish to provide additional information.
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