University of Pennsylvania w Institutional Review Board

Human Research Determination Form

Before completing this form, please refer to the IRB Guidance Document: Is IRB Review Required?

Submission of this Worksheet to the IRB is OPTIONAL. The worksheet does not have to be submitted to the Penn IRB, but the IRB will review it upon request.

This worksheet is a guide to help the investigators determine if the activity is human research as defined by the Health and Human Services (HHS) or Food and Drug Administration (FDA). Instructions appear as italicized blue text.

Activities that meet the definition of human research will require submission of either a Claim of Exemption Form or an IRB Application Form.

If the activity is research involving coded biological specimens or data AND the investigator cannot link specimens or data back to individual subjects, submit this form so that the IRB may determine that no further review is required.

Project Title:
Principal Investigator / Ed.D. J.D. M.D. Ph.D.
Pharm.D. R.N. Other (specify):
Name:
Job Title: / Phone: / Fax:
Address: / Cell phone: / Pager:
PennCard ID: / Email:

Provide a summary of the purpose of the proposed activity.

Describe the procedures and methodology.

I. HHS Determination: Human Research

Review the questions below to determine if the research is subject to HHS regulations.

I.A. Does the proposed activity meet the HHS definition of “research”?

Check either box 1 or 2 below.

1. A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

If so, proceed to Question I.B.

2. NOT a systematic investigation designed to contribute or develop to generalizable knowledge (e.g., medical case reports of 3 or fewer patients, QA or QI activities developed for a specific unit with no intent to publish or disseminate the results).

The activity does not meet the HHS definition of research; however, if the activity involves an FDA regulated product, proceed to Section II.

I.B. Does the activity involve “human subject(s)” under the HHS definition?

Check either 1 or 2 below.

1. The research involves human subject(s).

If so, proceed to I.D.

2. The research does not involve a human subject(s).

If no subjects are living, the activity does not constitute human research under HHS regulations. If none of the subjects are living, the activity does not involve a human subject under the HHS or FDA regulations and does not require review by the IRB.

Note that the activity may require compliance with HIPAA regulations.

Also note that pursuant School of Medicine policy, research involving cadavers or recognizable body parts requires submission to the morgue.

I.C. Research with coded data or specimens that were not collected for the currently proposed research

1. The research involve the use of coded private information or biological specimens that were not collected for the currently proposed research; AND, the investigator cannot link the coded data/specimens back to individual subjects.

If, you checked I.C.1, above, the research may not involve human subjects as defined by the regulations. Please DESCRIBE AND SUBMIT TO IRB FOR VERIFICATION. If the research involves an FDA regulated product, proceed to Section II.

I.D. Indicate the type of information that will be collected by checking item 1 or 2 below:

1. The research involves collecting data through an interaction or intervention with the subjects. This research includes interviews (in person or not), surveys, physical procedures, manipulations of the subject’s environment, and any other direct contact or communication with a subject.

2. The research involves obtaining private identifiable information about the subject. This research includes chart reviews, lab studies on tissue/specimens, using information from data or tissue repositories.

If you checked 1 or 2 above, the research involves human subjects under HHS regulations and requires review by the IRB. Submit either this Claim of Exemption form or a complete IRB Application via HSERA

II. FDA Determination: Human Research (Clinical Investigation)

Review the questions below to determine if the research is subject to FDA regulations.

II.A. Does the research involve use of any of the following FDA regulated products?

1. Drug or Biologic

2. Medical Device

3. Dietary Supplement where the supplement is used for diagnosing, mitigating, treating or curing a specific disease or class of diseases

In this case, the dietary supplement is subject to FDA drug regulations.

If you did not check any of the boxes above → STOP. You do not need to submit to the IRB.

If yes, proceed to II.B.

II.B. Is the activity subject to FDA human research regulations?

Check the appropriate description of the activity.

1. The activity involves the use of a drug or medical device other than the use of an approved drug in the course of medical treatment.

2. The results of the activity are being submitted to FDA or held for inspection by the FDA.

3. Tissue specimens are being held to test the effectiveness of a medical device (including in vitro diagnostic devices) and the information is being submitted to the FDA for FDA approval of the device.

If you checked 1, 2, or 3 above, the activity may be subject to FDA regulations. Proceed to Question II.C.

4. The activity involves retrospective chart review of outcomes of patients on a drug or device in the course of medical practice.

5. The activity involves a prospective study of outcomes of patients who have received a prescribed drug or device by their personal physician(s); or, the activity compares diagnostic results of tests or scans ordered by the subjects’ personal physician(s).

If you checked 4 or 5 above, the activity is not FDA regulated and will be reviewed under HHS regulations and requires submission to the IRB.

II.C. Does the activity involve a “human subject” as defined by FDA regulations?

1. An individual who is or becomes a participant in research, either as a recipient of an FDA regulated product (approved or experimental) or as a control, as directed by a research protocol and not by medical practice.

2. An individual who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control.

3. Tissue specimens are being used to test the effectiveness of a medical device (including in vitro diagnostic devices).

If you have checked 1, 2, or 3 above, the activity involves a human subject under the FDA regulations and IRB submission is required.

The activity requires submission to the IRB using the Biomedical Research Application.

Note: Research subject to FDA regulations does NOT qualify for IRB Exemption Categories 1-5 and requires expedited review and approval.

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