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Vol 61, No 7, September 2014

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Independent committee of inquiry report

(April 23, 2013) An independent investigation into the seizure of the research records of two former University of Ottawa professors by the Institute of Mental Health Research and the Royal Ottawa Hospital concludes that this seizure was unjustified, raised research ethics concerns, and put the privacy of research subjects at risk.

“The seizure of research records is a serious measure that can be justified in extreme circumstances only, where no other reasonable options are available,” the Committee notes in its report.

In March 2005, employees of the Royal Ottawa Hospital and the Institute of Mental Health Research (IMHR) without warning seized research and clinical files, computer files, and some personal documents related to research being conducted by Drs. Anne Duffy and Paul Grof. It was alleged that some people volunteering to participate in the studies had not signed proper consent forms. The report points out that it is “very unlikely that research subjects were participating in any of Dr. Duffy’s research without providing proper consent” and that “even if consent forms had been missing from the research files, this would have warranted only corrective action…”

According to the committee of inquiry, “the seizure of these research records for allegedly missing informed consent forms from some research records with the purpose of ascertaining adherence to research ethics standards” was “a breach of institutional responsibility, as the informed consent in these studies was signed for the protection of patient’s privacy and confidentiality of the information in the records.”

The investigation attributes the seizure of the research records to ongoing tensions between Drs. Duffy and Grof and officials with the IMHR, the Royal Ottawa Hospital and the University of Ottawa, and to the confounding of informed consent aimed at the protection of privacy and confidentiality with informed consent aimed at obtaining consent for exposure to potential harm in research. The Committee emphasizes that when informed consent is focused on ensuring that researchers protect the privacy of sensitive health information, such seizure appears to violate the essence for which informed consent was obtained.

To prevent a re-occurrence of the problems in this case, the committee’s report recommends, among other things, that the ownership of research records be clarified, with the presumption that the researchers and not the institutions have ownership; that for each research project in which informed consent is signed, it should be clearly identified whether the consent was obtained for the protection of research subjects from being exposed to potential harm, or for the protection of their privacy and the confidentiality of the information they provide to the researchers; that institutional responsibility for ensuring that researchers follow established research ethics standards be clarified; and that policies be adopted to make it explicit that research records may be seized only as “a last resort, where there is an immediate and serious threat to the wellbeing of research subjects.”

The committee was commissioned by the Canadian Association of University Teachers but operated entirely independently. Members of the committee were: Dr. Trudo Lemmens LicJur, LLM(bioethics), DCL, Scholl Chair in Health Law and Policy and Associate Professor, Faculties of Law and Medicine, University of Toronto (Chair); Dr. Thomas A. Ban, MD, FRCPC, Emeritus Professor of Psychiatry, Vanderbilt University; and Dr. Louis C. Charland, PhD, Professor, Departments of Philosophy and Psychiatry, and School of Health Studies, Western University.

The committee’s report is available here: Report of the Independent Committee of Inquiry into the University of Ottawa, the Institute for Mental Health Research and the Royal Ottawa Hospital.