Serious and/or Continuing Noncompliance Committee

Determination of Serious and/or Continuing Noncompliance in Human Subject Research Studies at UM

1) Why do we need to determine if noncompliance in human subject research is “serious or continuing”?

According to federal regulations (45 CFR 46.103(a) and (b)(5), for the Department of Health and Human Services, and 21 CFR 56.108(b), for the Food and Drug Administration), the institution is required to report to OHRP and/or the FDA, any instance of the following in an applicable study:

  1. unanticipated problems involving risks to subjects or others;
  2. suspension or termination of IRB approval; and
  3. serious or continuing noncompliance with applicable federal regulations or the requirements or determinations of the IRB

To meet these requirements the university needs to have a mechanism for identifying “serious or continuing noncompliance”.

2) This sounds simple. Don’t the federal regulations define “serious or continuing”?

No, the regulations do not provide definitions of these terms; it is up to the institution to define.

3) How does the University define “serious or continuing”?

Serious noncompliance can be defined as failure to comply with regulations, university policies, or the requirements/determinations of the IRB, when, in the judgment of the institution, such failure actually or potentially increases risks to subject welfare, subject rights, or data integrity. Continuing noncompliance may be defined as a recurring pattern of behavior or minor noncompliance that, if unremediated, may compromise any of the above.

4) I have heard about a new committee called the “Serious or Continuing Noncompliance Committee”, or SNCC, responsible for identifying serious noncompliance. Does this mean UM had no prior mechanism for making such determinations?

No, UM has always had the same responsibility for identifying and reporting serious and continuing noncompliance. Before the advent of the SNCC, individual IRB Boards were responsible for making this identification, and did so each time they considered audit reports and audit responses at convened meetings.

5) Why did UM decide to make this change, if we had a perfectly good system in place?

The HSRO/IRB leadership suggested to the Institutional Official (IO) that we move to a committee approach for two main reasons. First, individual IRB members were sometimes uncomfortable deciding that research carried out by their colleagues (often working in the same area) involved serious noncompliance. Second, and more importantly, the different IRB Boards were not uniform in their approach to making this decision. The SNCC is a central body that is in a position to make more consistent decisions. The committee approach was a “best practice” adapted from that of certain aspirational peer institutions.

6) How does the SNCC work?

Noncompliance issues are brought before the SNCC, most often as a result of an internal audit, but issues may also be identified in the course of IRB oversight or by other means. Most commonly, internal audit reports, together with the PIs’ responses to these reports, are provided to each member of the SNCC. If any member of the SNCC believes that there is a possibility of this noncompliance meeting the standards for “serious” or “continuing” noncompliance, the Committee meets to discuss the issues and make a determination. Decisions by the SNCC are delivered to the appropriate IRB Board to use during its deliberations prior to issuing a determination letter.

7) Investigators have the opportunity to appear before the IRB Board overseeing their research to provide information regarding, for example, audit findings and their corrective and preventive actions in response to these findings. Do investigators have a chance to provide information to the SNCC?

Yes, when the SNCC is considering noncompliance in order to make a decision about “serious or continuing”, the PI will be notified of the meeting and provided with a chance to speak (or to provide written information). Note that this is not an “appeal”, but as with the previous practice, an opportunity to clarify issues that the PI may believe not adequately explained.

8) Who are the members of the SNCC? How are they chosen?

SNCC members are appointed by the Vice Provost (Institutional Official) after consultation with the Associate Vice Provost for Human Subject Research, who is himself a voting member of the SNCC. The other members are chosen to represent the knowledge and expertise of the different IRB Boards, and also to represent UM’s research community. As of April 2015, the voting members of the SNCC comprised Dushyantha Jayaweera, MD (Associate Vice Provost for Human Subject Research), Tom Sick, PhD (IRB Board A), Abdul Mian, PhD (IRB Board B), Gene Burkett, MD (IRB Board C), Nelson Claure, PhD (Pediatrics), Jean Sparling, RN (Surgery), and Victoria Mitrani, PhD, representing the IRB SBS Board. The Institutional Official (Dr. Bixby) and the Executive Director for Human Subject Research Compliance (Johanna Stamates) are ex officio (non-voting) members of the SNCC.