IRB Policies & Procedures Manual

Elon University Institutional Review Board Standard Operating Procedures for Protection of Human Subjects in Research

Federal Regulations

Title 45, Part 46

View the Federal Regulations governing the protection of Human Subjects provided by the U.S. Department of Health and Human Services.

International Regulations

The 2019 edition of the International Compilation of Human Research Standards has been released and is now available online. The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 131 countries, as well as standards issued by a number of international and regional organizations.

The updated edition includes hundreds of updates from the previous year. One new country is included in the 2019 edition: El Salvador.

The listings are organized into nine categories:

1.    General Research
2.    Drugs and Devices
3.    Clinical Trial Registries
4.    Research Injury
5.    Social-Behavioral Research
6.    Privacy/Data Protection
7.    Human Biological Materials
8.    Genetic Research
9.    Embryos, Stem Cells, and Cloning

Most of the listings include a hyperlink that allows the user to directly access the law, regulation, or guideline of interest.

Prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services, the Compilation is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world. The Compilation was first published in 2005 and is updated annually.

School System Policies

The Belmont Report

“SUMMARY: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings.”

Read more about the Belmont Report

Decision Charts

The Office for Human Research Protections (OHRP) provides graphic aids for use as a guide for (as noted at the linked site) “institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46.”

View the decision charts