Exempt Self-Determination

The revised Common Rule overseeing human subject research broadens the type of research that may fall under the Exempt Category of review (45 CFR 46.104). For example, starting January 21, 2019 some benign behavioral interventions (e.g. survey, interview, audio/visual recording) with adults may be eligible for exemption. A benign behavioral intervention is defined as “…brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.”46.104(3)(ii)

The following categories listed below may be eligible for exempt self-determination:

Category 1: Research in Established or Commonly Accepted Educational Settings
Category 2: Educational Tests, Surveys, Interviews, Observations of Public Behavior (that do not involve children)
Category 3: Benign Behavioral Interventions in Conjunction with the Collection of Information from Adult Subjects
Category 4: Secondary Research Uses of Identifiable Private Information or Identifiable Biospecimens for Which Consent is Not Required
Category 5: Research and Demonstration Projects that Are Conducted or Supported by a Federal Department or Agency
Category 6: Taste/Food Quality Evaluation and Consumer Acceptance

NOTE: NU will not implement Exemptions #7 and #8 at this time.

If none of the above categories apply or if your study includes research with children, deception/manipulation/incomplete information, physiological data collection methods, linking to additional personally-identifiable data, and/or is greater than minimal risk, please complete the full IRB application.

Need for review

It is the policy of Northeastern University that no activity involving human subjects be undertaken until those activities have been reviewed and approved by the University’s IRB.

Accordingly, all university research involving human subjects must first be reviewed by the Office of Human Subject Research Protection.

EXEMPT STUDY SUBMISSION FORMS

1. Exempt Self-Determination Application Form

2. Research Plan for Exempt Determinations

3. Exempt Study Participant Information Sheet (if applicable)