Chapter 9 - Determination that Project is Not Research, or Does Not Involve Human Subjects

The IRB does not have jurisdiction over projects that do not meet the definition of Research or do not involve Human Subjects. However, there are some sponsors, funding agencies and/or journals that require a formal determination. Contacting the IRB in advance of submitting into PittPRO will enable the IRB staff to discuss the best course of action including the appropriate exempt form to submit if necessary. Regardless of the type of submission in PittPRO, the Designated Reviewer can make the determination that a project does not meet the regulatory definition of Research involving Human Subjects.

Provision of Review Materials

The Designated Reviewer has access to the complete submission in PittPRO.

Criteria for Determination of No Human Subject Research

The Designated Reviewer can make the following determinations:

• The activity does not meet either the definition of research as specified under 45 CFR 46.102 (l) or the definition of clinical investigation as specified in 21 CFR 56.102 (l).
• The activity is research but does not involve human subjects 45 CFR 102 (e)(1) or 21 CFR 56.102(e).

In making this determination, the following are used as references:

OHRP Decision Chart

The Designated Reviewer refers to the OHRP’s decision Chart #1 "Is An Activity Research Involving Human Subjects?"

FDA Regulations

The Designated Reviewer refers to 21 CFR 50.1(a) for a definition of the scope of clinical investigations regulated by the U.S. Food and Drug Administration. Activities that meet any of the following criteria do not qualify for the "No Human Subject Research Designation."

• Any use of a drug or medical device not approved by the FDA, regardless of the presence of an IND or IDE.
• Any use of a drug in any manner (even if approved and even if used in an activity which does not meet the DHHS definition of research) other than the use of an FDA approved drug in the course of medical practice.
• Any use of a medical device in any manner (even if approved and even if used in an activity which does not meet the DHHS definition of research) other than the use of an FDA approved medical device in the course of medical practice.
• Any use of an FDA regulated item in which the data will be submitted to or held for inspection by FDA.

Department of Justice

When conducting research within the Bureau of Prisons, Department of Justice, implementation of Bureau programmatic or operational initiatives made through pilot projects is not considered to be research.

Investigator Communications

Comments or concerns of the Designated Reviewer with regard to a designation of “no human subject research” are documented and communicated via PittPRO or e-mail to the principal investigator, consistent with the procedures described in Chapter 8.

Responses of the principal investigator are returned to the Designated Reviewer who conducted the initial review (or to another Designated Reviewer if the initial reviewer is not available for an extended time).

Determination that an activity IS NOT Human Subject Research

After reviewing the protocol submission, the Designated Reviewer documents his/her determination in the PittPRO. Designated Reviewers have the ability to request an additional review by the Chair, Vice Chair, or a member of the IRB with appropriate expertise.

The principal investigator of the project is notified of IRB designation of “no human subject research” thourgh PittPRO or via email.

• The determination letter specifies at a minimum:
• The IRB number assigned to the submission;
• Concurrence that the project does not meet either the definition of “research” as defined in  45 CFR 46.102(l) or 21 CFR 56.102(c); or the definition of “human subject” at 45 CFR 46.102(e)(1) or 21 CFR 56.102(e); and
• That the IRB should be notified in advance of any proposed substantive modifications of the activity.

Determination that an activity IS Human Subject Research

The Designated Reviewer may determine that the proposed activity is human subject research because it meets the DHHS definition of research [45 CFR 46.102(l)]; and involves individuals who meet the definition of human subject [45 CFR 46.102(e)(1)]; or meets the FDA definition of clinical investigation as described above.

For activities determined by the Designated Reviewer to meet either the DHHS or FDA definition of “human subject research,” the principal investigator is prompted to make appropriate changes and resubmit for further review.

5.6.2021