COE: Don’t panic! Review compliance guidelines

By J. Mark Waxman, JD
General Counsel
CareGroup Healthcare System
Boston

Spotlight on Compliance

The Office of Human Research Protections (OHRP) is the Department of Health and Human Services (HHS) agency chiefly responsible for compliance activities in human subjects research. OHRP is the agency that evaluates noncompliance with either the applicable regulations or any aspect of the Assurance of Compliance that must be submitted by entities receiving federal funds for human subject research. The principal means by which OHRP investigates possible violations is a Compliance Oversight Evaluation (COE). A COE is designed to determine the factual basis for any allegations or indications of noncompliance. Absent a situation where "sound ethics" dictate a need to act immediately, advance written notice of a COE is provided and the institution is allowed to submit detailed information directed to the specific allegation being made.

Though the information provided (and the allegation) will be treated confidentially while the investigation is pending, once the COE has been completed and a determination letter is issued, that letter will be made accessible on the OHRP web site shortly, within 10 days, after its issuance to the institution. Once the determination is made to initiate a COE, OHRP may communicate directly with investigators in addition to the institutional personnel. It is OHRP policy where an allegation involves a specific individual to notify that individual directly.

Following receipt of the responsive report concerning the allegation at issue, OHRP will determine whether more information is required, and where appropriate, conduct in-person or telephone interviews. As this process goes forward, the quality of the Assurance of Compliance filed by the institution is also being evaluated.

If a COE determines that a violation of the regulations has occurred, there are several types of actions that may follow, all principally designed to bring the institution into compliance and protect human subjects, which include:

• Development and implementation of a plan of correction.

• Mandated improvements to the Assurance of Compliance to enhance processes designed to protect human subjects.

• Restricted approval of an Assurance of Compliance, allowing affected research projects to continue to be supported only if the restrictive terms are being satisfied (e.g., requiring prior OHRP review of some or all research projects, requiring special education for IRB members or research administration personnel).

• Withdrawal of approval of the Assurance of Compliance, thereby effectively shutting down all research activities.

• Suspension or permanent removal of the right of an institution or researcher to participate in specific projects.

In extreme cases, OHRP may recommend to HHS that the institution or individual be subject to "debarment," an order declaring them to be ineligible to participate in HHS-sponsored research. It is noteworthy that these compliance steps are similar to those an IRB may take when IRB requirements on a research project have not been met.

One of the interesting questions institutions face when individuals are the subjects of OHRP review that determines that a violation has occurred is the extent to which other disciplinary processes within the institution are implicated. Specifically, two questions may arise:

• Is the peer review committee at the hospital to be notified and the matter processed there?

• Has there been a violation of the institution’s rules such that "employee" discipline should be involved?

If no policy or guidance is provided, then such policies should be considered and created. Because of the overlap between confidentiality and patient protection requirements with employment and peer review processes and protections, these policies should pay close attention to ensure all of the necessary institutional and regulatory privileges and requirements are considered.