May 14, 2014 Elyse I. Summers, JD President and Chief Executive Officer Association for the Accreditation of Human Research Protection Programs 2301 M Street, NW Suite 500 Washington D.C. 20037
Re: How the University of Minnesota Is Misusing AAHRPP Accreditation to Deflect Calls for an Investigation of Psychiatric Research Misconduct
Dear Ms. Summers: I am contacting you because I am concerned that my employer, the University of Minnesota, is using accreditation by AAHRPP as a public relations shield to deflect calls for an independent investigation of alleged psychiatric research misconduct. According to your response to Professor Carl Elliott, “AAHRPP is not an investigative body but rather, a non-governmental organization that accredits high quality human research protections. As such, our role is limited to evaluating whether an applicant or accredited organization complies with our Standards and Procedures.” What the University of Minnesota needs right now is a thorough investigation by a law enforcement agency or an independent investigative body with subpoena power. Such an investigation must examine claims that rights of mentally ill patients have been violated. An investigation must also address functioning of institutional human research protection programs and the conduct of senior university officials responsible for denying all calls for an investigation of possible research misconduct. It also needs to determine how many research subjects have died or suffered serious injury while enrolled in psychiatric clinical trials. Among the issues requiring investigation are whether mentally ill individuals have been enrolled in clinical trials as “consenting research subjects” despite lacking decision-making capacity; whether threats of involuntary institutionalization have been used to coerce mentally ill research subjects into participating in clinical trials; whether HIPAA violations have occurred in psychiatric clinical trials; whether researchers have failed to disclose study-related risks in a timely manner; whether financial conflicts-of-interest have resulted in aggressive recruitment tactics and inadequate oversight by the IRB and other institutional oversight bodies; and whether the IRB and other components of the university’s human research protection program have failed to make reasonable inquiries in response to reports of research misconduct.