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IRB policies and procedures are guided by the Code of Federal Regulations Title 45 CFR Part 46, “Protection of Human Subjects” (Revised June 23, 2005), of the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), the Office for Human Research Protections (OHRP) or any other successor office, and The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.
Students and researchers are expected to adhere to the ethical guidelines of their respective professional associations. Students should attach a copy of the ethical guidelines for their professional associations to their IRB applications and research proposals.
Laws, regulations, and guidelines governing human subjects research in 113 countries may be found in the International Compilation of Human Subject Research Protections. Researchers who plan to conduct research studies in other countries are required to verify that they are complying with local laws and regulations regarding human subjects research in the designated country(ies).
The International Compilation, prepared by the Office of Human Research Protections of the U.S. Department of Health and Human Services, lists over 1,000 laws, regulations, and guidelines on human subject protections in the listed countries, as well as standards issued by several international and regional organizations. The lists are organized into seven (7) categories:
If a proposed study is related to the requirements of the Health Insurance Portability and Accountability Act (HIPAA) of 1966 and the HIPAA Privacy Rule of 2001, the National Institutes of Health publication, Clinical Research and the HIPAA Privacy Rule, and other publications available on the NIH HIPAA Privacy Rule Web site may be helpful.
Additional information about HIPAA and research is available from the American Psychological Association’s Web site: Impact of HIPAA on Research.
Researchers who follow the APA Ethical Guidelines for conducting research are required to keep all study records in a secure location for seven (7) years. (See the APA Record Keeping Guideline to view the guideline in pdf.)