Listing last updated: September 3, 2007

Clinical research guidelines

• Ownership, Control, Access and Possession (PDF: FNC-OCAP_001.pdf) —National Aboriginal Health Organization (www.naho.ca).
  This guide explains the principles of OCAP and all that they encompass. It also provides some useful models in the form of policies, protocols, or strategies that reflect OCAP and have been adopted by First Nations to regulate all research activities that affect their people and communities. These principals are a way to help improve research relevance; to say "yes" to beneficial research and "no" to research that may result in harm.
• Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (PDF: TRICOUNCIL-ETHICS.PDF) — Medical Research Council of Canada (www.mrc.gc.ca), Natural Sciences and Engineering Research Council of Canada (www.nserc.ca), Social Sciences and Humanities Research Council of Canada (www.sshrc.ca), June, 2003.
  The Councils believe that this policy statement will benefit research through addressing the paramount need for the highest ethical standards. The key is sensitive and thoughtful implementation of the spirit and requirements of the document.
• Strictly Confidential: Integrity and the Disclosure of Criminological and Socio-Legal Research (PDF: ISRAEL-CONFIDENTIAL.PDF) — By Mark Israel, School of Law, Flinders University, Adelaide, Australia, British Journal of Criminology Advance Access, May 7, 2004.
  When people allow researchers to investigate them, they often negotiate terms for the agreement. Participants in research may, for example, consent on the basis that the information obtained about them will be used only by the researchers and only in particular ways. The information is private and is voluntarily offered to the researcher in confidence.
• Central Office for Research Ethics Committees (COREC) — National Patient Safety Agency, U.K.
  Web: www.corec.org.uk
  Guidelines for information sheets and consent forms for research participants which take into account legal changes which have implications for the principle of informed consent.
• Ownership, Control, Access, and Possession (OCAP) or Self-Determination Applied to Research: A Critical Analysis of Contemporary First Nations Research and Some Options for First Nations Communities (PDF: SCHNARCH-OCAP.PDF) — By Brian Schnarch, First Nations Centre, National Aboriginal Health Organization (www.naho.ca), Canada, January 2004.
  A critical review of colonial research practices followed by a formula for First Nations' self-determination in research. Key ingredients include collective ownership of, control over, management of access to, and physical possession of research data.
• U.K. Network of Sex Work Projects (UKNSWP) Research Ethics Guidelines — (www.uknswp.org) May 2005.
  UKNSWP sets out basic guidelines for member projects dictated by the U.K. Department of Health.
• Ethics Review of Social Care Research: Options Appraisal and Guidelines (PDF: UKDH-ETHICS.PDF) — Public Consultation, U.K. Department of Health (www.dh.gov.uk), Sept. - Dec., 2004.
  All health and social care research requires an independent ethics review. This public consultation describes four models for a national social care ethics review system for comparison and seeks ideas on possible alternatives.
• Research Governance Framework For Health and Social Care (PDF: UKDH-RESEARCH.PDF) — U.K. Department of Health (www.dh.gov.uk), February 2001.
  These standards apply to all research concerned with the protection and promotion of public health, research undertaken in or by the Department of Health, its non-departmental public bodies and research undertaken by industry, the charities, the research councils and universities within the health and social care systems.
• Sex Workers' Health, HIV/AIDS, and Ethical Issues in Care and Research. Research for Sex Work, June 2004 (PDF: R4SW-07.PDF)
  Articles about mandatory testing, collaborative research and community involvement, HIV treatment options and the Tenofovir clinical trials…
• The Nuremburg Code: Directives for Human Experimentation
  Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182. Washington, D.C.: U.S. Government Printing Office, 1949.
• International Committee for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
  ICH is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. (Off site)
  www.ich.org
• Good Clinical Practice in FDA-Regulated Clinical Trials
  Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. U.S. Food and Drug Administration. (Off site)
  www.fda.gov/oc/gcp/default.htm

Community-based research

• Ethical Goals of Community Consultation in Research (PDF: DICKERT-ETHICALGOALS.PDF) — By Neal Dickert & Jeremy Sugarman, American Journal of Public Health; July 2005.
  In response to the traditional emphasis on the rights, interests, and well-being of individual research subjects, there has been growing attention focused on the importance of involving communities in research development and approval.
• The Community-Based Research Centre (www.cbrc.net)
  The Canadian non-profit organization advocates for the principles of community-based research; conducts community-based research; and specializes in applied research in the areas of HIV/AIDS and gay men's health.



• Concepts, Definitions and Models for Community-Based HIV Prevention Research (PDF: COMMUNITY.PDF). By Dan Allman, T. Myers and R. Cockerill; Behavioural and Epidemiological Studies Unit, University of Toronto, 1997. (This document is 29.9 MB!)
  "This document is more about one research ethic — a community role in research — than 'ethics'. Perhaps it helped push things forward here a bit in Canada, in that it pushed for a democratization of research, but it is not classic ethics like a Nuremberg code."
• Aussi en français! — La recherche communautaire en prévention du VIH au Canada : concepts, définitions et modeles (PDF: COMMUNAUTAIRE.PDF). Par Dan Allman, T. Myers et R. Cockerill; Behavioural and Epidemiological Studies Unit, University of Toronto, 1997. (Cet document est 37.7 MB!)