There are three levels of IRB review for human subjects research: full, expedited, and exempt. The next step after determining whether work is human subjects research is to determine whether that research must undergo review and approval through the IRB process and what level of review is required.
Full Board Review
Research may qualify for a full review if it involves more than minimal risk to the study participants and is not eligible for expedited or exempt review. It is possible that a research study that only has minimal risk but involves a vulnerable population may require a full review. A full review is usually completed by a convened IRB board where the diverse membership of the IRB reviews the proposed research. A full review can be a lengthy process. A local IRB should be consulted to determine if a project is human subjects research and what kind of review it requires.
Expedited Review
If a research study poses no more than minimal risk to the participants, it may qualify for an expedited review. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Follow this link for a description of some of the social and behavioral research activities that are commonly eligible for expedited review.
Exempt Review
There are six categories of research with human subjects that are exempt from ongoing IRB oversight. These categories are detailed in full in Title 45, Part 46, Subpart A, the Common Rule. Research exempt from review includes research in commonly accepted educational settings that involves accepted educational practices, research using existing documents or records if they are publicly available and subjects cannot be identified, and taste and food quality research.
Follow this link for more on research that qualifies for exempt review: Title 45, Part 46, Subpart A, the Common Rule.
There are six categories of research involving children that may also qualify for exempt review. An institution should be consulted for further information about what kinds of research qualify for an exempt review.
Examples of Studies Qualifying for Exempt Review
- Research conducted in educational settings involving normal educational practices
- Research about educational tests
- Observations of children in public settings, providing the researcher does not participate
- Studies using existing data about children if (a) the data are publicly available or if (b) they are recorded in such a way by the investigator that the identity of the children cannot be determined
- Studies conducted by federal departments or agencies about government programs
- Taste and food quality evaluations
Research Involving Vulnerable Populations
Any research study involving vulnerable populations may require additional safeguards.
List of Possible Vulnerable Populations
- Pregnant women, fetuses, and neonates
- Children
- Prisoners
- Persons at risk for suicide
- Persons with impaired decisional capacity
Working with minors (youth under the age of 18), for example, requires obtaining consent from parents or legal guardians and assent from the youth themselves. Follow this link to read about additional regulations for vulnerable populations as outlined by HHS.
Research in Schools
Research in schools often qualifies for exempt review as outlined in Title 45, Part 46, Subpart A, the Common Rule, meaning IRB oversight is not federally required. Examples of exempt research include research done in an educational setting on instructional strategies, educational tests, or on publicly available data. When working with children in public schools, there are additional policies that guide research.
Additional Policies in Research Involving Children in Public Schools
- FERPA
- The Family Education Rights and Privacy Act (FERPA) gives parents and students (who are 18 years old or older) specific rights as to who sees their education records. FERPA also outlines what records can be released and to whom without obtaining prior consent.
- PPRA
- The Protection of Pupil Rights Amendment (PPRA) provides rights to parents to approve certain research (surveys, development of instructional materials) conducted by third parties. Parental approval is required for research pertaining to eight identified sensitive topics:
- Political affiliations
- Mental and psychological problems potentially embarrassing to the student and his/her family
- Sex behavior and attitudes
- Illegal, antisocial, self-incriminating, and demeaning behavior
- Critical appraisals of other individuals with whom respondents have close family relationships
- Legally recognized privileged or analogous relationships, such as those of lawyers, physicians, and ministers
- Religious practices, affiliations, or beliefs of the student or student's parent
- Income (other than that required by law to determine eligibility for participation in a program or for receiving financial assistance under such a program)
- The Protection of Pupil Rights Amendment (PPRA) provides rights to parents to approve certain research (surveys, development of instructional materials) conducted by third parties. Parental approval is required for research pertaining to eight identified sensitive topics:
Research With Tribal Communities
Because Native American Tribal Communities are sovereign entities, research conducted with tribes must be done in accordance with local protocols and procedures. Contact your state's Department of Indian Affairs to find out what additional approval and coordination might be necessary for your project. More importantly, consider the best way to discuss your research with these communities, and involve them early in the process.
It is likely that approval (or near approval) to conduct research with tribal communities will have to be obtained from the tribe prior to proposal submission to any IRB. Individual institutions should be consulted for further information regarding working with Native American populations.