Human Subject Protection Instructions

Research involving human subjects raises a number of ethical and practical considerations. To ensure that human subjects are adequately protected from unreasonable risks and properly informed of the potential harms and benefits from their participation in research, the National Institute of Justice (NIJ) and recipients of NIJ funds[1] are required to comply with the Department of Justice regulations at 28 CFR Part 46 (Protection of Human Subjects). These regulations, which are often referred to as the "Common Rule," generally require that recipients of Federal monies for research involving human subjects have their project reviewed and approved by an Institutional Review Board (IRB) prior to the expenditure of Federal funds for that research. However, the regulations define certain categories of research that are exempt from IRB review, either because of the nature of the research itself or the manner in which the research is carried out. [See 28 CFR § 46.101(b).] Nevertheless, all decisions concerning IRB review are made on an applicant-by-applicant basis by NIJ based on all the information provided by each individual applicant for funding.

If IRB approval is required for a project, applicants must submit a copy of the IRB's approval as well as supporting documentation concerning the IRB's institutional affiliation, necessary assurances, etc., to NIJ prior to the initiation of any research activities that are not exempt from the requirements of 28 CFR Part 46. If the research is determined to be exempt from the regulations by an IRB, applicants must submit supporting documentation concerning the IRB's approval of the exemption. If the project does not involve human subjects, applicants must provide appropriate documentation to support the lack of human subject involvement. Applicants should review 28 CFR Part 46, a copy of which can be found on this Web site, to determine their individual project requirements.

In order to assist you in determining what information must be included in your application regarding compliance with 28 CFR Part 46, we have provided additional materials outlining the necessary documentation on this Web site.