Rev. Russell Myers, Sheilia Withrow, B.S.N. and Craig E. Litz, MD on chaplains and Institutional Review Boards

Patients Place Their Trust in IRB Members to Safeguard Their Rights —
Who Can Better Represent Their Interests?

Many chaplains are familiar with the Food and Drug Administration (FDA) regulations regarding research on human subjects. Such research must be reviewed and monitored by an Institutional Review Board, or IRB. For those who are unfamiliar with the IRB process, here are a couple of definitions:

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.
(http://www.fda.gov/oc/ohrt/irbs/faqs.html#IRBOrg #1)

FDA regulations require at least one member of the IRB to have primary concerns in the scientific area and at least one to have primary concerns in the non-scientific area. Most IRBs include physicians and Ph.D-level physical or biological scientists. Such members satisfy the requirement for at least one scientist... FDA believes the intent of the requirement for diversity of disciplines was to include members who had little or no scientific or medical training or experience. In the past, lawyers, clergy and ethicists have been cited as examples of persons whose primary concerns would be in non-scientific areas. (http://www.fda.gov/oc/ohrt/irbs/faqs.html#IRBOrg #17)

We serve together on the Institutional Review Board of US Oncology, whose mission statement is: To safeguard the rights and welfare of research participants while enhancing the clinical research process. In that endeavor, we find the interdisciplinary makeup of the IRB to be a critical component of the review process. Each board member brings a unique and necessary voice to the table. It is our observation that hospital-based chaplains provide a valuable contribution to the healthcare enterprise by serving on IRBs. The chaplain brings:

1. Familiarity with the healthcare setting: The chaplain knows the culture of the hospital and is comfortable relating to physicians as peers in the interdisciplinary care team.
2. Professional expertise: Chaplains review the Consent Form from a non-medical perspective. They look for language that may confuse or frighten the patient, who may be anxious due to the diagnosis, and/or ready to take unnecessary risks to improve their health condition.
3. Conscious awareness of one’s limits: e.g. "I'm an educated person and if I don't understand the medical terms used in the consent form, maybe the patient won’t either."

Every hospital or healthcare organization that participates in clinical trials of experimental medical devices or experimental study drugs has an Institutional Review Board. If you haven’t been involved already, we encourage you to consider serving a term on an IRB. You will be asked to read a fair amount of material prior to the meetings, and to serve as primary reviewer for some of the studies. You will wade through pages of reports, looking at the Consent Forms for unfamiliar terms or phrases. You may wonder at times if you are making an impact. We can assure you of the following:

1. The process depends on the active participation of non-scientific board members;
2. The patients on the receiving end of the experimental drugs and medical devices are placing their trust in the IRB members to safeguard their rights and welfare; and
3. The medical professionals in your midst will look to you for your expertise as you work together toward that goal.

Sheilia J. Withrow, B.S.N. is project coordinator for the US Oncology, Inc. IRB in Dallas, TX. She has worked in research since May of 2000 as a research report coordinator, senior regulatory safety coordinator, and senior coordinator for the IRB.

Craig E. Litz, MD, is currently the co-chair of the US Oncology Internal Review Board (IRB) on which he has sat for seven years. He works as a pathologist at St. Paul University Hospital in Dallas, TX. Prior to this he was an associate professor in hematopathology at the University of Minnesota Medical School in Minneapolis.

Do you have thoughts about advocacy you’d like to share with your colleagues? Send an e-mail to info@PlainViews.org.