HRPP Policy Innovation and Demonstration Initiative

Background

In its interactions with individuals within the University and in the community in pursuit of its research, teaching, and service missions, The University of Michigan subscribes to the fundamental ethical principles of respect for persons, beneficence, and justice. Exactly how those principles are operationalized or become manifest depends on many factors, such as federal, state, or local laws and regulations, disciplinary codes of ethics, individual responsibility, and institutional policy.

Research with human subjects by agents of the University of Michigan is governed by the policies and procedures associated with the Human Research Protection Program (HRPP), which includes the University's Institutional Review Boards (IRBs).

The HRPP incorporates federal, state, and local laws and regulations as they apply to research with human subjects. In those areas in which external regulations allow policy or process flexibility or in those circumstances in which external regulations do not apply, the HRPP strives to minimize or eliminate administrative burden for investigators by focusing on performance, as opposed to process, standards.

There are strong voices, expecially in the community of social and behavioral researchers who conduct minimal-risk investigations, that process standards imposed by external regulation (or self-imposed) are overly restrictive and poorly tuned to the human subject risk inherent in some of those activities. OVPR concurs that there are conventions and constraints that have accumulated over time that warrant recasting and reduction or elimination, given our underlying commitment to performance rather than process standards.

The Initiative

OVPR is embarking upon a systematic attempt to identify (and prioritize for action) existing HRPP policy or process constraints that constitute a burden on investigators and on the institution above and beyond what is reasonable and responsible considering risks to human subjects.

Policy or process changes may be innovations, that is, changes made outright, or "demonstrations," that is, temporary policy or process changes made with an eye to demonstrating at some future checkpoint that the policy alteration or process streamlining or reduction has not inappropriately increased risks to human subjects nor otherwise adversely impacted subjects' rights or welfare.

In pursuing this initiative, it is acceptable to consider departing from process standards incorporated in federal regulations (and associated guidance by federal regulatory agencies) for those categories of research to which those regulations do not apply. Federal regulations do not apply to research that is not federally-supported, does not fall under FDA jurisdiction, or is not held to federal regulation by contract.

Policy innovations and demonstrations will be overseen by the IRB Council, with periodic reports to the Research Associate Deans (RADs), the Senate Assembly Research Policy Committee (RPC), and the Human Research Coordinating Council (HRCC). The IRB Council may enlist the aid of the Office of the Human Research Compliance Review (OHRCR) in reviewing the success of demonstrations.

The policy innovation and demonstration initiative is separate from but related to two other initiatives designed to improve the HRPP. One of those is the eResearch application streamlining initiative. The other is the HRPP education initiative that is evaluating educational offerings, including the development of an enhanced "help" function to be embedded in the eResearch application.

Innovation and Demonstration Categories

Innovations and demonstrations may be considered in any HRPP policy or process. The following areas have been identified at the outset:

Innovations in the definition of "research" subject to HRPP oversight.

The HRPP Class Activities Policy and the table in the HRPP Operations Manual distinguishing regulated from non-regulated research are examples of starting points for additional policy innovations or demonstrations.

The IRB Council should consider elmination, alteration, or transfer of oversight over release of private name-linked data for research conducted outside UM.

Innovations in the categories of human research "exempt" from HRPP oversight.

UM has already departed from federal regulations by creating a new "exemption" parallel to existing Exemption 5 (Federal research to examine public benefit and service programs) for projects sponsored by the State of Michigan. Additional exemptions may be considered, or additional flexibility in applying exemption categories may be considered, for non-federally sponsored research that poses little or no risk to subjects or for which another institutional oversight mechanism is better designed.

UM has already created a process for "pre-exemption" of research with certain identified "public use data sets" the use of which has been determined to present little or no risk of indirect identification of individuals. The IRB Council may be able to identify other "pre-exemption" categories.

Link to: Demonstration Project: New Exemption Category #7

Demonstrations with regard to who is empowered to make "exempt" determinations

Innovations in categories of human research eligible for "expedited" review.

Federal regulations define certain categories of research eligible for expedited review. The IRB Council may be able to identify other minimal risk categories of research appropriate for expedited review if not tied by federal sponsorship, by FDA jurisdiction, or by contract to the limits of existing federal categories.

Innovations in standards for constitution of an IRB

The IRB Council is free to consider whether the human research not tied to external process standards might still be responsibly reviewed and overseen by a body that does not conform to all the requirements placed on IRBs by federal regulation.

Innovative flexibility in applications.

The IRB Council is encouraged to find ways to test controlled, pre-approved flexibility for Investigators to alter their research plans without advance approval by the IRB.

Innovative policies for determining when IRB oversight may end.

Demonstration policies allowing a "grace period" for certain minimal risk research to continue after approval expiration.

Demonstrations allowing for approval periods longer than a year.

Link to: Demonstration Project: Two Year Approval Period

Demonstration projects giving authority to staff for certain judgments and determinations assigned by federal regulations to IRB members.

 

Version 1/21/07