Human Subjects Protections and Bioethics 

The U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) provides leadership in the protection of human subjects participating in such research by providing clarification and guidance, developing educational programs and materials, and maintaining regulatory oversight as described at: http://www.hhs.gov/ohrp/about/ohrpfactsheet.htm.

OHRP provides quality improvement consultation and research ethics training to domestic and foreign institutions involved in international biomedical and behavioral research. These services help ensure that recognized ethical protections are afforded to persons participating in research conducted in countries outside the United States. (See http://www.hhs.gov/ohrp/international/)

Are Human Subjects Involved?

OHRP and NIH follow a strict legal definition of “Human Subjects Research”. To verify that your research project is engaged in human subject research according to our definition, please read the “HHS Guidance on Engagement of Institutions in Human Subjects Research” http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.html.

Requirements

NIH requirements and resources for applicants and grantees involved in human subjects research are found at http://grants.nih.gov/grants/policy/hs/. Grantees must comply with the NIH policies on human subject research. Additional information on regulations, policies and guidance is found at: http://grants.nih.gov/grants/policy/hs/hs_policies.htm.

All proposed NIH-funded human subjects research, domestic or foreign, must include the following:

• Institutional Federalwide Assurance (FWA) with the HHS Office for Human Research Protections (OHRP), as described at: http://www.hhs.gov/ohrp/assurances/assurances_index.html
• Steps to File an International (non-U.S.) Federalwide Assurance (FWA) http://www.hhs.gov/ohrp/assurances_index.html#international

• Annual review and approval of proposed research by an Institutional Review Board (IRB) or Institutional Ethics Committee (IEC) registered under the FWA, as described at: http://www.hhs.gov/ohrp/assurances/.
• List of International Assurances (FWA), International Institutional Review Boards (IRBs) and International IRB Organizations (IORGs) http://ohrp.cit.nih.gov/search/asearch.asp#ASUR.
  
  
• Human subjects education for all personnel involved with the design or conduct of human subjects research. Free online training to fulfill this requirement can be found at: http://phrp.nihtraining.com/users/login.php.

In addition to these requirements, foreign grantees may also need to comply with local regulations and policy requirements. Resources for identifying these local policies include:

• OHRP’s Compilation of International Human Research Protections: http://www.hhs.gov/ohrp/international/HSPCompilation.pdf (PDF - 1.3 MB) - a listing of the laws, regulations, and guidelines that govern human subjects research in many countries around the world.

  Disclaimer: Though this Compilation contains information of a legal nature, it has been developed for informational purposes only and does not constitute legal advice or opinions as to the current operative laws, regulations, or guidelines of any jurisdiction. In addition, because new laws, regulations, and guidelines are issued on a continuing basis, this Compilation is not an exhaustive source of all current applicable laws, regulations, and guidelines relating to international human subject research protections. While reasonable efforts have been made to assure the accuracy and completeness of the information provided, researchers and other individuals should check with local authorities and/or research ethics committees before starting research activities.

• FIC’s Division of International Relations’ regional information and country-specific instructions: http://www.fic.nih.gov/about/dir.htm.

Bioethics Resources

• NIH Office of Science Policy’s International Research Ethics resource page: http://bioethics.od.nih.gov/internationalresthics.html.
• The Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidance for Biomedical Research Involving Human Subjects: http://www.cioms.ch/frame_guidelines_nov_2002.htm.
• FIC’s International Research Ethics Education and Curriculum Development Program: http://www.fic.nih.gov/programs/training_grants/bioethics/index.htm.
• Online ethics training module for International Researchers: https://www.citiprogram.org/dev/announcementview.asp?language=english&announcement=15
• UK Department of Health Clinical Trials Tool Kit: http://www.ct-toolkit.ac.uk/.

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