How Assertive Should You Be In Fulfilling Your Role As An IRB Member?

1. How Assertive Should You Be In Fulfilling Your Role As An IRB Member? A Non-Scientist Non-Affiliated IRB Member’s Suggestions for the Development of Goals and Guidelines to Give Basis to Your Assertions Kenneth A. von Kluck, J.D.

2. There are times when it is important to strongly assert a particular opinion: • preparing a written review of a protocol, • participating in the discussion of a proposed consent or • voting on a study While your opinion may be deeply held and totally correct, your ability to support it and the confidence with which you assert it will probably benefit if the opinion is consistent with your the methods and guidelines you use and the goals you have for your actions as a member of an IRB.

3. Even if you have served as an IRB member for a relatively long period, you might not have tried to recognize and refine even the basic processes, concepts, ideas and thoughts that govern your IRB participation. • Such an exercise would help members better understand their approach used in reviewing research projects and give you more confidence in asserting a particular belief or opinion. • In order to try to accomplish this, review the following series of questions to help identify the processes and guidelines you use and the goals you have in serving as an IRB member.

4. Preliminary questions related to my role on the IRB • Why was I been appointed to the IRB? • Do I represent a particular group or segment of my community and, if so, how do I define the group? • Do I have any particular function or functions on the IRB and, if so, what is the function? • Do I have a unique skill or expertise useful to the IRB and, if so, what is the skill or expertise?

5. Questions related to participation as a member of the IRB 1. Do I have an agenda that defines or affects how I participate in the IRB and, if so, what is the agenda and is it appropriate? 2. Do I have a particular viewpoint or bias that I bring to the IRB and, if so, what is the bias and is it appropriate? 3. Do I consistently apply the agenda, viewpoint or bias in acting as a member of the IRB? 4. Does doing so have a positive or negative effect on my participation in the IRB?

6. Questions related to methods or processes used to review research projects • What am I looking for or what do I take note of when reading a research protocol? • What standards or criteria do I apply to form an opinion about a research protocol? • Do I consistently use the same standards in reviewing research protocols? • To what extent do I measure research protocols by the following criteria approval; (a) that risks to subjects are minimized, (b) that risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result, and (c) that selection of subjects is equitable. • What criteria do I use to make a risk/benefit analysis of a research project?

7. Questions related to methods or processes used to review proposed consent forms • What am I looking for when I review a proposed consent form? • What standards or criteria do I apply to form an opinion about a proposed consent form? • Do I consistently use the same standards in reviewing proposed consent forms? • If I am preparing a written review of a study for the IRB, how strongly do I insist that the proposed consent form follow the requirements specified in the Common Rule?

8. Questions related to methods or processes used to review proposed consent forms (Cont.) • If I am participating in a discussion about a consent form, how strongly do I insist that the consent form follow the requirements specified in the Common Rule? • How vigorously do I insist that consent forms should be written at the eighth grade level? • How do I determine whether the proposed consent form is written at the eighth grade level? • When I review a proposed consent can I objectively determine whether a subject can understand it and have the ability to give an informed consent?

9. Questions related to methods or processes used to review and discuss the consent process 1. How do I determine that the consent procedure actually involves an informative discussion instead of a simple request that the subject sign the form and ask any questions the subject may have? 2. How closely do I review the representations of the Principal Investigator that safeguards exist so that there is no undue influence or coercion during the consent process?

10. Questions related to methods or processes used to review and discuss the consent process (Cont.) • 3. How do I determine the safeguards against undue influence and therapeutic misconception when the treating physician and the principal investigator are the same individual?

11. Questions relating to human research • What are my opinions about placebo controlled trials? • What ethical standards should be applied to human subject research? • How do I balance my conclusion that a study does not satisfy my risk/benefit analysis with the subject’s right to autonomy? • What procedural shortcoming will cause me to recommend that a study not be approved?

12. Questions relating to human research (Cont.) • What ethical shortcoming will cause me to recommend that a study not be approved? • What ethical standards do I believe should apply to phase I studies? • What ethical standards do I believe should apply to post marketing studies?