Eligible Categories of Research: Federal Regulations

Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in the Federal Register.

Procedures that can be reviewed by the campus IRB include:

1. The collection of blood samples using finger sticks.
2. Collection of biological specimens for research purposes by non-invasive means, such as buccal swabs.
3. The collection of data through non-invasive procedures routinely employed in clinical practice, such as measures of respiration and galvanic skin response.
4. Research involving data already collected for research purposes or data collected for non-research purposes.
5. Collection of data from voice, video, digital, or image recordings made for research purposes.
6. Research on individual or group characteristics employing surveys, interviews, oral history, and focus groups (if not otherwise exempt).
7. Research in which the primary risk is breach of confidentiality and the risk has been managed to no more than minimal.

Duke Restrictions

1. If a researcher wishes to use students in his or her own classes as research subjects, or if a Duke employer wishes to use his or her employees as research subjects, the research must be reviewed by the full IRB.
2. Research involving deception is usually reviewed by the full IRB.

Submission Deadlines

None

Review Process

1. An IRB staff member will conduct a pre-review of the protocol and will provide feedback designed to prepare the protocol for review by an IRB member. The staff member will also check the researcher's transcript to be sure the researcher's certification is up to date.
2. After an IRB member reviews the protocol, using the Reviewer Checklist and the Consent Form Checklist, feedback will be communicated to the researcher, either by the IRB member or a staff member. Once revised, the protocol can be approved.

Approximate Review Time