Human Research Protection Program: Policy
Evaluating the Scientific or Scholarly Merits of Proposed Research
Adopted By: Chancellor, UW-Madison
Adoption Date: December 8, 2005
Revised: December 5, 2008
Purpose: This policy describes the principles applied by UW-Madison
IRBs in evaluating the scientific or scholarly merits of research
protocols and how this evaluation is performed.
Policy
I. UW-Madison IRBs are required to
evaluate the merits of a proposed research design to the extent necessary to
determine whether (a) the study is designed so that the risks to subjects are
minimized, and (b) the risks to participants are reasonable in relation to
anticipated benefits, if any, to participants, and the importance of the
knowledge that may be expected to result. See, 45 CFR 46.111(a)(1); 21 CFR 56.111(a)(1).
II. Merit reviews of proposed study
designs may be performed by IRB members based on their areas of expertise and/or
by independent consultants identified by an IRB specifically to render a
judgment on a study because of the consultant’s field of expertise.
III. In some cases, the UW-Madison
requires that, in addition to review by the Health Sciences IRBs, health
science protocols be reviewed by other independent, specialized committees that
review or contribute to the review of the scientific merit of the proposed
research and the specific protocol procedures. See, HS IRB Application for
Initial Review, Section V. Ancillary Approvals.
IV. Any consultant used by an IRB to
evaluate the merits of a proposed study design must satisfy UW-Madison’s
conflicts of interest policy applicable to IRB members and consultants. See, IRB
Conflict of Interest Policy.
Procedure
V. The UW-Madison has established IRBs
that have different expertise in the type of research they review. Investigators
submit research protocols to one of the UW-Madison’s IRBs based on the
subject matter expertise required to review the protocol. An IRB reserves the
right to refer a protocol to another IRB based on the IRBs’ evaluation of
which one is best able to provide the necessary expertise.
VI. Investigators are required to submit an
application for initial review of research, including all required information
regarding the purpose of the research, study design, potential risks and potential
benefits of the research. The IRBs will request additional information from an
investigator about research design if necessary to assure that the required
review can be performed.
VII. Review of Study Design
A. Study designs used in research protocols that present more than minimal
risk receive scientific or scholarly review on the merits. See, Section III
of this policy.
B. Study designs used in minimal risk protocols, including those that are
reviewed as expedited and exempt protocols, receive a level of merit review
commensurate with the lower level of risk.
VIII. UW-Madison’s IRBs use a variety
of means for ensuring the adequacy of a protocol's study design.
A. All IRBs use a primary reviewer system in which two experienced IRB
members are assigned to a protocol and assume responsibility for reviewing the
protocol in detail, including an assessment of the merits of the study design.
B. If a protocol is reviewed under the expedited or exempt procedures, the
reviewer considers whether the study design is adequate relative to the risk
level of the protocol.
IX. If an IRB believes that additional
expertise is needed to evaluate a research proposal, the IRB may request the
assistance of an independent consultant. The consultant may be a UW-Madison
employee or an outside expert. The consultant’s review is communicated
to the IRB as part of the process for review and approval.
X. If there is a question about the study
design, the IRB may:
A. ask the investigator to provide additional information to:
1. explain and/or justify the design, or
2. change the design to satisfy the IRB’s concerns;
B. disapprove the research, if the concerns about study design cannot be
resolved.
