Subcommittee on Harmonization

Mark Barnes

David Forster

• Genesis of Panel

• Charter and membership

• Issues for SACHRP comment

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.

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.

Test Run

Panel on two issues at SACHRP meeting of March 4, 2009:

• 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.

• For both issues, addressed FDA and OHRP.

• Recommendation to establish SOH was made and approved at the July 22, 2009 SACHRP meeting.

SOH Charter

• “The Subcommittee will identify and prioritize areas in which regulations and/or guidelines for human subjects research adopted by various agencies or offices within HHS would benefit from harmonization, consistency, clarity, simplification and/or coordination.”

SOH Charter

• “The Subcommittee will then develop recommendations, for consideration and possible adoption by SACHRP, to harmonize and simplify these guidelines and regulations. The goal of this subcommittee effort is to reduce unnecessary burdens on research efforts, thus resulting in better allocation of research resources and promoting the safety and welfare of human subjects.”

Membership

• Broad base of experience in working with HHS, FDA, and OCR regulations.

• Include perspectives of investigators, social behavioral community, accrediting body, and variety of IRB/institutional settings.

• Bios in handout materials.

Focus

• Focus will be on harmonization within DHHS regulations and guidance.

• Initial emphasis on OHRP, FDA, and OCR regulations and guidance.

Background

• Different sets of Congressional legislation.

• For example, FDA position on waiver of consent limited by Food and Drug Act to emergency situations.

Background

• Different agency purposes.

• For example, NIH funds and conducts research, while FDA is a consumer protection agency that regulates research conducted by other parties.

Range of Harmonization Issues

1. Direct conflict between regulations.

• Limited in number.

• Difficult to change regulations, particularly the Common Rule, and thus difficult to resolve.

Range of Harmonization Issues

2. Direct conflict between guidance documents.

• Limited in number.

• Easier to change guidance than regulation.

Range of Harmonization Issues

3. One agency has guidance, other agency (or agencies) silent.

Range of Harmonization Issues

4. Guidance documents don’t conflict, but don’t correspond either.

Range of Harmonization Issues

5. HHS positions not aligned with state laws, legal trends, or regulations of agencies outside of HHS.

• Currently, outside of SOH scope.

Questions for SACHRP

• Are there other foundational issues or situations that SOH should consider?

Examples of direct conflicts in regulations

• 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.

Examples of Conflicting Guidance

• OHPR guidance on enrollment of Non-English speaking subjects compared to FDA guidance.

One agency has guidance, other silent

FDA FAQ on telling subjects about IRB approval:• “FDA also believes that an explicit statement that

an IRB has approved solicitation of subjects to participate in research could mislead or unduly induce subjects. Subjects might think that, because the IRB had approved the research, there is no need to evaluate the study for themselves to determine whether or not they should participate.”

Bramble thickets

• OHRP, FDA, and OCR positions/guidance on screening medical records prior to consent.

Questions for SACHRP

• Other examples you would like to see SOH address?