While an exemption request may not be the most expeditious way to meet the requirements of this rule, the regulation for Protection of Human Subjects, 28 CFR Part 46 §46.101(b)(1)-(6), defines categories of research involving human subjects that are exempt from its provisions. It is important to note that these exemptions do not apply to studies involving prisoners, fetuses, pregnant women, or human in vitro fertilization. The exemption in section 46.101(b)(2) does not apply to children except for research involving observation of public behavior when the investigator does not participate in the study.
Certain research studies sponsored by NIJ may fall within the scope of these exemptions because of the statutory protection for the confidentiality of data collected for research or statistical purposes granted to OJP/NIJ under the authority of the Omnibus Crime Control and Safe Streets Act of 1968 (as amended). The exemptions are as follows:
28 CFR §46.101(b). Unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
- Research on regular and special education instructional strategies, or
- Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless:
- Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
- Any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:
- The human subjects are elected or appointed public officials or candidates for public office; or
- Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
- Public benefit or service programs;
- Procedures for obtaining benefits or services under those programs;
- Possible changes in or alternatives to those programs or procedures; or
- Possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies, if:
- Wholesome foods without additives are consumed; or
- A food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
How do I document that the proposed research qualifies for one of the exemptions under section 46.101(b)?
Two possible mechanisms exist for determining if your proposed research study is eligible for an exemption:
1. Does your institution have a current Federalwide Assurance (FWA), appropriate for the study, on file with the U.S. Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP)? If yes, your institution's Institutional Review Board (IRB) must review the study under 28 CFR Part 46.101(b) and make a determination whether or not the study is exempt. After the IRB has reviewed the study and made its determination whether or not the study is exempt, submit a copy of the written exemption documentation to NIJ. Please be sure that the FWA number provided by OHRP is included.
2. If your institution does not have an FWA as described above, you may retain the services of a commercial Institutional Review Board (IRB) and seek an exemption determination under 28 CFR §46.101(b) from that commercial IRB.
[note 1] An FWA is a document to assure that an institution has a process in place for reviewing human subject research, consistent with the policies described in the "Common Rule" or 28 CFR Part 46. The Office for Human Research Protections at HHS provides the institution with an FWA number after the institution submits documentation to HHS that the institution is operating according to policies described in the Common Rule and a properly constituted IRB is in place for reviewing studies involving human subjects. At institutions with an FWA, multiple research studies may be reviewed by the approved IRB at the institution without further involvement of HHS. Under the Common Rule, other Federal agencies, including NIJ, may accept the FWA number as documentation that the research institution has an acceptable program and process for reviewing studies involving humans.