A: IRBs are important to the research process, but we haven't had any empirical data on what they're doing across the county or what researchers are expecting from them. Based on our initial survey of investigators in biomedical and social-behavioral sciences, we've developed a tool for assessing how investigators perceive IRBs. The IRB-RAT allows investigators to rate their IRBs on 8 factors and to indicate the importance of those same factors in their ideal IRBs. As more researchers use the IRB-RAT, we'll have a clearer picture of how IRBs are functioning and what's important to researchers.

There are two versions of the instrument. Version A contains 90 items. There are 45 items to rate the characteristics of an ideal IRB on a 7-point scale from "absolutely essential to you as an investigator" to "not important to you." Those 45 items are then repeated for rating one's own IRB on a 7-point scale from "describes our IRB exceptionally well" to "definitely does not describe our IRB." This version allows for the most direct comparison to our original sample, which is important if one is conducting research rather than conducting a self-study of an IRB. Version B contains 45 items that require two responses each, and the items are grouped by factor clusters. This version will seem shorter to participants, but the structural differences may impact the ability to compare scores from it to our original sample.

A: Procedural justice (how the decision-making process is carried out)
Example item: An IRB that conducts a conscientious and complete review of protocols

Interpersonal justice (respectfulness, cooperativeness)
Example item: An IRB that treats investigators with respect

Impartiality (lack of bias)
Example item: An IRB whose members hold no preconceived biases against particular research topics

Pro-science sensitivity
Example item: An IRB that views itself as an investigator's ally rather than as a hurdle to clear

Competence (how well IRB functions are performed)
Example item: An IRB that conducts a conscientious analysis of potential benefits weighed against potential risks before making decisions

Outreach by the IRB (offering consultation, etc.)
Example item: An IRB that offers information to improve the chances of gaining IRB approval

Formal functioning, structure, and composition of IRBs
Example item: An IRB whose members fully understand and act within the scope of their function

IRB indications that the rights of human participants are being upheld
Example item: An IRB that takes timely and appropriate action whenever scientific misconduct is alleged

A: We began this research assuming that differences in the researchers such as field of study, type of research, and prior experience as an IRB member would impact perceptions of the ideal IRB. Although we found some small differences between groups, researchers seemed in agreement about the important qualities in an IRB. This has allowed us to develop a tool that we believe any institution can use in a study of its own IRB and compare to our original sample.

A:

1. An IRB that reviews protocols in a timely fashion


2. An IRB with members who do not allow personal biases to affect their evaluation of protocols


3. An IRB that does a good job of upholding participants' rights while, at the same time, facilitating the conduct of research


4. An IRB that does not use its power to suppress research that is otherwise methodologically sound and in compliance with federal policy whenever it perceives potential criticism from outside the scientific community


5. An IRB with members who are very knowledgeable about IRB procedures and federal policy


6. An IRB that conducts a conscientious and complete review of protocols


7. An IRB that views protection of human participants as its primary function


8. An IRB that responds in a timely manner to investigators' inquiries about its processes and decisions


9. An IRB that gives a complete rationale for any required changes to or disapprovals of protocols


10. An IRB that works with investigators to find mutually satisfying solutions whenever disagreements exist