Human Research Protection Program

IRB Review of Protocol Resources

Adopted By: All Campus IRB

Adoption Date: January 5, 2006

Purpose:  This document describes UW-Madison’s policy on IRB review of whether protocol resources are adequate to protect research participants and describes the process by which this review is performed.

Policy

I.  To approve research involving human participants, the IRB must determine that:

A.  risks are minimized (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes 

B.  when appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of participants.

II.     In reviewing a research protocol, UW-Madison IRBs evaluate whether the protocol provides adequate resources for human research protection, care of research participants, and safety during the conduct of the research.  The exact resources considered adequate are protocol specific.  The investigators involved in the research must be qualified to accomplish the research goals, perform the study or treatment procedures, and protect research participants from harm, and each site or facility must be appropriate and adequate for the procedures to be performed safely and effectively. 

III.    In performing the evaluation of protocol resources, the IRBs may call upon the expertise of other independent University committees to conduct resource and safety reviews of particular protocols.

Procedure

I.      In the application for initial review, the investigator is required to describe not only the research study itself, but also to identify the study personnel, their roles, and their qualifications, the facilities and equipment to be used and the sources of funding. 

II.     In reviewing a protocol, an IRB considers the practicality of implementing the study as part of its review of the study design.  The IRB may consider the following factors:

A.  whether key personnel have the requisite expertise and training.

B.  whether there are sufficient personnel to conduct the study.

C.  whether the facilities are adequate to conduct the research while protecting the safety, privacy and confidentiality of participants.

D.  the adequacy and source of funding, if relevant.

E.  whether adequate translation services, participant complaint procedures and aftercare services or referrals are in place, when needed. 

III.    If an IRB has concerns about whether the protocol provides adequate resources for human research protection, care of research participants, and safety during the conduct of the research, the IRB may:

A.  defer the protocol and request additional information from the investigator,

B.  request modification of the protocol, or

C.  request additional review of the protocol by individual(s) with relevant expertise.