Office of Civil Rights (OCR) – Health Insurance Portability and Accountability Act (HIPAA) The OCR is charged with administering the Act and standards for protection of personal health information. This site includes summaries of the Act and links to information about HIPAA. . HHS educational materials on the Privacy Rule for the research community can be found on the OCR HIPAA Privacy web site.
NIH: HIPAA - The Health Insurance Portability and Accountability Act or Privacy Rule is the first comprehensive Federal protection for the privacy of personal health information. Research organizations and researchers may or may not be covered by the HIPAA Privacy Rule. This website provides information on the Privacy Rule for the research community. The site links to a booklet and slides for researchers. Links address the applicability of HIPAA to clinical and health services research and its impact on IRBs and information in databases and repositories. Institutional Review Boards and the HIPAA Privacy Rule - NIH Fact Sheet
NIH: Clinical Research and Policy Analylsis - this site includes information on clinical research policies including NIH information and educational materials about the HIPAA Privacy Rule
Protection of Third Party Information in Research: Recommendations ..(2001) Recommendations and rules of thumb developed by the NIH on whether third parties about whom information is collected are defined as human subjects of research.
FDA IRB Information Sheet (2003) – Provides guidance for IRBs for Stand-Alone HIPAA Authorizations under FDA Regulations.
Lawrence Livermore National Laboratory – Site provides information about human subjects research including educational information about HIPAA and its requirements for investigators.
Privacy and Confidentiality: Duke University Office of Research Support - Educational material and resources on privacy and confidentiality in research.
Privacy/Data Protection Project A plain language summary of the HIPAA Privacy Rule and it related to research by the University of Miami.
Guidance on Certificates of Confidentiality (2003) Guidance for the OHRP on Certificates of Confidentiality which may protect researchers from involuntary disclosure of research information. Certificates of Confidentiality Kiosk of NIH provides information for investigators on Certificates of Confidentiality and how to apply for them. Includes background information including legislative authority and NIH staff contacts with whom to discuss appropriateness of such Certificates.
NIH Guidance for Informed Consent for Gene Transfer Research The Office of Bioetechology Activities, NIH guidance on information investigators should share with research participants about who will have access to the personal information and research results.
Privacy and Confidentiality in Research: Canadian Institutes for Health Research (2006) Canadian legistlation, policies and best practices to protect research privacy and confidentiality.
Reconsidering Privacy and Confidentiality: A Discussion Paper of the Social Sciences and Humanities Research Working Group (Canada 2006) This discussion paper by an interagency advisory panel of the social sciences and humanities working group (Canada) was prepared to inform policy development for the Canadian government. It summarizes concerns about privacy from several viewpoints and addresses confidentiality as a means to protecting privacy. A selected bibliography is at the end of the paper.
Privacy in Research Ethics and Law PRIVIREAL, a European Commision Framework 5 project that ended in 2005, examined the implementation of the Data Protection Directive 95/46/EC in relation to medical research and the role of ethics committees. The project was created to gather information regarding the implementation of this Directive aimed at removing obstacles to the flow of personal data by requiring protection of privacy. At this site, click the sidebar on Data Protection by Country. There is also a bibliography on research privacy.
The recommendations relate to the adequacy of implementation and focus on medical research. Attention was given to the role of Research Ethics Committee review in relation to the protection of rights granted to research participants by this Directive.