ARTICLES RESEARCH ON PRISONERS – A COMPARISON BETWEEN THE IOM COMMITTEE RECOMMENDATIONS (2006) AND EUROPEAN REGULATIONS BERNICE S. ELGER AND ANNE SPAULDING Keywords research, vulnerable populations, prisoners, ethics ABSTRACT The Institute of Medicine (IOM) Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research published its report in 2006. It was charged with developing an ethical framework for the conduct of research with prisoners and identifying the safeguards and conditions necessary to ensure that research with prisoners is conducted ethically. The recommendations contained in the IOM report differ from current European regulations in several ways, some being more restrictive and some less so. For example, the IOM report suggests limiting the percentage of prisoners that should be involved in a biomedical study to 50%, a limit that does not exist in Europe. However, the report does not specifically advise against research without a direct benefit to an individual prisoner: the European regulations are more restrictive than the IOM committee recommendations in this respect. The definition of minimal risk varies, as well as the proposed role of the minimal risk require- ment and of the principle of subsidiarity (research that can only be done effectively in prisons). The IOM report proposes a number of thoughtful suggestions, which it would be beneficial to implement everywhere, such as registers of research on prisoners. The European regulations offer prag- matic solutions to several thorny issues. In summary, the IOM committee report represents an admirable effort to tackle the present inconsistencies and deficiencies of federal regulations in the US on research on prisoners (45 CFR 46 Subpart C). Nonetheless, before acting on the recommenda- tions, US regulators might consider revisiting international guidelines such as those published by the Council for International Organizations of Medical Science (CIOMS) and the Declaration of Helsinki. INTRODUCTION The IOM Committee on Ethical Considerations for Revi- sions to DHHS Regulations for Protection of Prisoners 1 1 In the following, the terms ‘prison’ and ‘prisoners’ in its British meaning are used to comprise all kinds of correctional institutions and detainees. When we refer to ‘prisons’ this term is meant to include all places of detention including police stations, remand prisons (US: jails) or penitentiaries (US: prisons). A prisoner is any person detained in any of these facilities. It should be noted that the definition of incarceration varies by country. Also, the reliability of data reporting related to imprisonment, incarceration as well as custody differs. In this text we used the terms imprisonment and incarceration in a broad way, in line with the IOM report’s request for an enlarged definition of the term ‘prisoner’. The IOM report recommended that regulators broaden the definition of ‘prisoner’ to include precisely all of the individuals con- fined in the afore-mentioned settings. Not included in the proposed new definition of the IOM report are persons involuntarily confined in psy- chiatric facilities and juveniles. These are enormous problems in the United States that were outside the charge to the IOM committee. Address for correspondence: Bernice Elger, Centre universitaire romand de médecine légale, 9, av. de Champel, 1211 Geneva 4, Switzerland. Tel.: 0041/22/379 55 89 or 0041/22/379 56 00, Fax: 0041/22/789 24 17, Email: Bernice.Elger@unige.ch Bioethics ISSN 0269-9702 (print); 1467-8519 (online) doi:10.1111/j.1467-8519.2009.01776.x Volume 24 Number 1 2010 pp 1–13 © 2009 Blackwell Publishing Ltd., 9600 Garsington Road, Oxford OX4 2DQ, UK and 350 Main Street, Malden, MA 02148, USA.