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

Because investigators sometimes require a formal determination from the IRB that their project is either not research, or does not involve human subjects (e.g., dissertation committee requirements), investigators may submit a “Request for a Determination that Planned Activity Does Not Involve Human Subject Research” form. Note: If the project uses biological specimens, investigators should submit the “Biological Specimens” form.  Regardless of the form submitted by the investigator, the IRB reviewer may make the determination that a project does not involve human subjects.

The IRB will not provide a formal written determination after the project has been initiated.

Reviewer Designation

All such requests are reviewed by a designated IRB member (including Exempt and Expedited Research Review Coordinators).

Provision of Review Materials

The reviewer has access to the complete submission. Submission forms are available at www.osiris.pitt.edu.

Criteria for Determination of No Human Subject Research

The IRB Reviewer can make the following determinations:

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

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

OHRP Decision Chart

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

FDA Regulations

The IRB 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 IRB reviewer with regard to a designation of “no human subject research” are documented and communicated via OSIRIS or e-mail to the principal investigator, consistent with the procedures described in Chapter 8.

Responses of the principal investigator are returned to the IRB reviewer who conducted the initial review (or to another IRB 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 IRB reviewer documents his/her determination in OSIRIS. The chair or vice chair reviews the protocol submission along with the IRB reviewer's determination and then makes the final determination surrounding the protocol submission.

The principal investigator of the activity is notified of IRB designation of “no human subject research” in OSIRIS 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(d) or 21 CFR 56.102(c); or the definition of “human subject” at 45 CFR 46.102(f) 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 IRB Reviewer may determine that the proposed activity is human subject research because it meets the DHHS definition of research (45 CFR 46.102(d)); and involves individuals who meet the definition of human subject (45 CFR 46.102(f); or meets the FDA definition of clinical investigation as described above.

For activities determined by the IRB Reviewer to meet either the DHHS or FDA definition of “human subject research,” the principal investigator is advised to resubmit the research for exempt, expedited or full-board IRB review, as appropriate.

version 12.10.2015