This monthly feature presents questions from clinical trial professionals with answers from experts. In this issue, we feature insights from Lindsay Abraham, WCG regulatory chair director and Bridget Brave, WCG director of expedited review IRB operations, on types of research that are exempt from the provisions of the Common Rule found in 45 CFR Part 46.

Question: When are research activities exempt from the Common Rule?

Answer: Research activities are exempt from the requirements of the Common Rule in eight specific instances involving minimal-risk activities that are not FDA-regulated, are ethically consistent with the principles of the Belmont Report and generally do not involve minors or prisoners as participants, with limited exceptions.

Exempt research must still protect the privacy of participants and data confidentiality, where applicable.

The following research categories are exempt:

1. Education research conducted in established or commonly accepted educational practices (e.g., classroom, doctor’s office, professional meeting, church, support group) that involves normal educational practices unlikely to adversely impact students’ opportunity to learn required content or assessments of educators who provide instructions, such as an evaluation of an educational practice or an assessment of a program on classroom management.
2. Interactions involving educational tests (e.g., aptitude, diagnostic, cognitive, or achievement), survey procedures, interview procedures, or observation of public behavior.
3. Behavioral interventions in conjunction with information collection through verbal or written responses or audiovisual recording. Participants must all prospectively agree to the behavioral intervention/recording, which must be brief in duration (a few minutes to a few hours), harmless, painless, not physically invasive and not likely to have a significant adverse lasting impact on the participants. Interventions may not include data-gathering with devices (EEG, ECG, MRI, etc.).
4. Secondary research without consent using either identifiable private information or identifiable biospecimens that are: publicly available; recorded in a way that hides participants’ identity; used for information collection and analysis for purposes of healthcare operations, research or public health activities and purposes; or used in research conducted by, or on behalf of, a federal department or agency.
5. Federal demonstration projects designed to study, evaluate, improve or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs/procedures or possible changes in methods or levels of payment for program benefits/services.
6. Taste and food research involving quality evaluation and consumer acceptance studies.
7. Collection of data for secondary research with consent that requires IRB review.
8. Use of data for secondary research with consent.