Human Research Protection Program: Policy

Expert Review of Protocols

 

Adopted By: All Campus IRB

Adoption Date: November 10, 2005

Revised: June 7, 2007

Revised: January 22, 2009

 

Purpose:  This document describes how UW-Madison assures that research protocols are reviewed by individuals with appropriate scientific or scholarly expertise.

 

Policy

I.      UW-Madison requires that each research protocol undergo an in-depth review by at least one IRB member with relevant scientific or scholarly expertise. 

 

Procedure

II.     Multiple, Specialized IRBs.  To assure that each protocol receives a review by at least one IRB member with the requisite expertise, UW-Madison has established multiple IRBs, each of which specializes in reviewing particular types of research.  Protocols are directed to the IRB with the expertise relevant to the particular protocol. 

A.  The Education Research IRB (ED IRB) specializes in education research.  It does not review FDA-regulated research or prisoner research.  It does not have appropriate expertise for review of medical research, but may review research protocols involving minimal risk health-related studies, such as those involving exercise, tape sensors, and single venipuncture, where medical training is not necessary for the evaluation of risk to research participants.[D1]  

Education research focuses on expanding knowledge and information about the education process, practices that improve academic administration and academic achievement, the effectiveness of education programs as well as child development and social adjustment.  Included is all K-12 classroom-based research and educational or learning-related research conducted in other contexts, such as libraries, religious schools, summer camps, after school programs, public/private adult service agencies, public/private treatment centers, workplaces, community based organizations, and any other learning-related context. 

B.  The Social and Behavioral Science IRB (SBS IRB) specializes in social and behavioral science research.  The SBS IRB reviews all non-medical[D2]  prisoner protocols.  It does not review FDA-regulated research.  It does not have appropriate expertise for review of medical research, but may review research protocols involving minimal risk health-related studies, such as those involving exercise, tape sensors, and single venipuncture, where medical training is not necessary for the evaluation of risk to research participants.  The SBS IRB reviews some social and behavioral research involving genetic testing.  See, Review of Social & Behavioral Genetic Research Protocols Policy.  

Social and behavioral research focuses on individual and group behavior, mental processes, or social constructs and usually generates data by means of surveys and questionnaires, interviews, observations, studies of existing records, and experimental designs involving exposure to some type of stimulus or environmental intervention.  It also can include physiological manipulations and recording, descriptive methods, laboratory and field experiments, standardized tests, economic analyses, statistical modeling, ethnography, and evaluation. 

 

C.  The HS IRB reviews research protocols involving medical interventions or procedures where medical expertise is required for evaluation.  Generally, FDA-regulated research is reviewed by this board.  Any research involving experimental devices is reviewed by this IRB. 

 

D. The MR IRB reviews primarily research protocols that present minimal risk to subjects and that involve medical interventions or procedures requiring medical expertise or that require knowledge of the health care setting (e.g., medical records research, research database and tissue banking projects, survey and interview research, and exemption applications). The MR IRB can review more than minimal risk research, when the committee consists of members with the appropriate expertise or ad hoc consultant(s) are appointed, should additional expertise be necessary.

 

     Examples of types of research activities reviewed by HS IRB and MR IRB:

§          Therapeutic interventions (e.g., experimental devices, drugs and biologics)

§          VA research

§          Studies involving devices

§          Research involving medical interventions regardless of whether therapeutic in nature (e.g., functional MRIs)

§          Clinical trials of FDA approved drugs to test for new indications

§          Observational studies involving collection of medical information

§          Studies involving genetic testing

§          Studies of:

-         Medical records

-         Body materials (biological specimens), such as cells, blood, urine, tissues, organs, hair, nail clippings, or DNA

-         Medical databases used for research purposes that contain protected health information

-         Clinical education research (medical school and continuing medical education)

III.    The UW-Madison’s Review of Prisoner Research Policy requires all federally funded research involving prisoners to be reviewed by the HS IRB or the SBS IRB.  The ED IRB will refer all protocols involving prisoners, regardless of funding, to the HS IRB or SBS IRB.  The MR IRB may review non-federally funded research involving prisoners that is expected to present minimal risk to subjects.  The MR IRB will consult with the HS IRB prisoner advocate, as needed, to ensure that prisoners in non-federally funded research are accorded protections equal to or greater than the protections outlined in the Subpart C of the DHHS regulations.

IV.   Selection of IRB Members.  In selecting IRB members, each IRB looks for individuals who have expertise in the subject matter areas most frequently represented in the protocols directed to that IRB. 

V.    Staff Reviewer System.  The HS IRB and MR IRB use a staff reviewer system.  Protocols are reviewed by professionally trained IRB staff reviewers who are highly knowledgeable about federal regulations, including the Common Rule, FDA regulations, VA regulations and HIPAA Privacy Rule.  Staff reviewers provide detailed analysis and summaries of protocols to primary reviewers, the IRB chair, vice-chair and director and to the full IRB, when appropriate.

VI.   Primary Reviewer System.  To further assure that protocols are reviewed by members with the requisite expertise, the IRBs use a primary reviewer system.  Under the primary reviewer system, the IRB directors are responsible for assigning research protocols to one or more IRB members with relevant expertise, who are given a complete copy of the materials submitted by the investigator.  The assigned reviewers are responsible for a detailed analysis of each assigned protocol and one of the assigned reviewers leads the discussion of the protocol at the full IRB meeting. 

If no IRB member has the relevant expertise, the IRB director (or designee) will request the assistance of a consultant or refer the protocol to another IRB with the relevant expertise (See, Sections VII and VIII, below).

VII.   Request for Assistance.  For exempt and expedited protocols, IRB members and subcommittees may request advice and assistance from the IRB chair or other IRB members if additional expertise is needed to make a determination.

VIII.  Referral of Protocols.  If an IRB director determines, based on the description of the research in the protocol application submitted to the IRB office, that the protocol is not within the IRB’s jurisdiction, the IRB director will refer the research to an IRB with the appropriate expertise.  The referring IRB will contact the investigator to notify him or her that the protocol requires transfer to the other IRB and state the reason for the transfer and will give the investigator the contact information for the other IRB.

VX.  Use of Consultants.  If a protocol requires expertise beyond or in addition to that available on the IRB, an IRB may invite individuals with competence in special areas to assist in the review of protocols as described in the IRB Consultants Policy.