Common Rule and FDA Regulation Comparison

1. Common Rule and FDA Regulation Comparison David Forster Jeff Cooper Gary Chadwick

2. Outline • Genesis of Panel • Other topics considered • Topics for today’s panel

3. Genesis of Panel SACHRP Charter: • The Committee shall advise, consult with, and make recommendations on matters pertaining to the continuance and improvement of functions within the authority of the Department of Health and Human Services (HHS) directed toward protections for human subjects in research.

4. Genesis of Panel • In addition, the Committee shall be responsible for reviewing selected ongoing work and planned activities of the Office of Human Research Protections (OHRP) and other offices/agencies within HHS responsible for human subjects protection.

5. Genesis of Panel • DeGette Bill, “Protection for Participants in Research Act of 2009.” • If passed, requires the Secretary of HHS to make a comparison of the Common Rule and FDA regulations Parts 50 and 56.

6. Possible Topics • HHS definition of “research” compared to FDA definition of “clinical investigation.” • HHS definition of “human subject” compared to FDA definition of “human subject.” • HHS exemption categories compared to FDA exemption categories. • HHS waiver of consent regulations compared to FDA waiver of consent regulations.

7. Possible Topics • HHS waiver of documentation of consent regulations compared to FDA waiver of document of consent regulations. • OHRP guidance on enrollment of Non-English speaking subjects compared to FDA guidance. • OHRP guidance on establishing the anniversary date for IRB continuing review and FDA lacuna regarding this issue. • FDA guidance on recruitment for research compared to OHRP guidance.

8. Possible Topics • OHRP guidance on screening medical records prior to consent compared to FDA guidance.

9. Topics for this panel • Is a planned protocol deviation for a single subject a change in research that needs prior IRB review? • Definition of “minor changes in previously approved research” that qualify for expedited review.

10. I.  Protocol Deviations • Regarding one-time planned variations (OTPVs), SACHRP recommends that: • 1.  FDA and OHRP issue joint or consistent guidance; • 2.  FDA and OHRP do not consider OTPVs to be changes in approved research automatically requiring IRB review;

11. Protocol Deviations • 3.  FDA and OHRP require that OTPVs not be allowed unless the criteria and process for allowing OTPVs are described in the IRB-approved protocol.

12. II.  Minor Changes • Regarding the definition of "minor changes in previously approved research during the period (of one year or less) for which approval is authorized," SACHRP recommends that: • 1.  FDA and OHRP issue joint or consistent guidance;

13. Minor Changes • 2.  the definition of a minor change in research is;  "A change that does not increase risk and does not materially change the risk/benefit ratio.”