Member Spotlight

Meet one of our newest HS IRB Vice-Chairs, Rowan Karaman! Dr. Karaman is an endocrinologist at the William S Middleton Memorial Veterans Hospital and was formerly the Medical Director and Patient Advocate for the Clinical Research Unit. Her research interests include devices to simplify the care of diabetes.

Dr. Karaman currently chairs Panel F, and this leadership role is her first time serving on the IRB. Dr. Karaman jumped into the role, quickly learning both the review aspect as well as the committee management aspect- no easy feat!

When not working…Rowan can be found reading books about financial scandals, watching shows about interpersonal scandals (think Succession) and spending time in sunny warm climates…hopefully enjoying her favorite fruits: passionfruit, jackfruit, and guava.

It’s Our Anniversary!

Almost exactly one year ago, the HS and MRR IRBs underwent a massive transition, reorganizing into our current structure of 6 HS IRB panels and 2 MRR IRB panels. This meant onboarding new chairs and vice-chairs along with many many new panel members. This was also a huge transition for IRB staff who jumped into the new roles of panel administrator, back-up administrator, and administrative support for each of the 8 panels. Thanks to everyone who participates in these meetings- from reviewing submissions, to scheduling, to keeping track of votes- this transition has been smooth (mostly!) and successful and we look forward to our panels continuing to gain experience over the coming year. Thank you!

Updates and Announcements

With great sadness and appreciation, we are saying goodbye to a long time HS IRB member, Dr. Donna Blankenbaker (Radiology). Dr. Blankenbaker has served as an IRB member for over 17 years, beginning in 2005 and in 2021, she stepped into a leadership role, serving as Vice-Chair of Panel C. She has provided invaluable expertise over the years and will be greatly missed, but we are glad to see her have time for new opportunities.

To fill Dr. Blankenbaker’s role, we are excited to announce that Dr. Andrew Knox will be stepping into the Vice-Chair role for Panel C. Dr. Knox currently serves as a member of Panel E and we are so glad that he has agreed to bring his knowledge of IRB practices and thorough reviews to the role of Vice-Chair. Dr. Knox (Neurology) has served as an IRB member since 2019.

Do you have a conflict of interest?

In addition to financial conflicts of interest (COI), you may have a conflict of interest if your spouse/domestic partner or dependents are a primary investigator or a study team member on a given study. These types of conflicts must be reported to the IRB in the same way as financial conflicts.

Note too that you may identify ‘unofficial’ conflicts, such as a neighbor or friend who is serving as a PI or a study team member. While these do not need to be reported to the IRB and will not be documented on the agenda, you can always request not to review the item, or abstain from voting. This is a decision that each member can make based on their ability to conduct a fair and unbiased review.

What happens if I have a conflicted item at a meeting I am attending?

If you are attending a meeting and an item is being reviewed for which you have a COI, it will be noted on the agenda and the conflicted member will be placed in a virtual waiting room for final discussion and the vote. Ideally, the removal will be announced but sometimes discussions move quickly, and you will be plopped into the virtual waiting room without notice. Please be patient, after the vote you be moved back into the meeting space.

Conflicted members may participate in the initial discussion and answer questions other members may have. You may ask to leave the discussion at any point.

Please reach out to the IRB Office if you have any other questions regarding conflicts of interest.

Mini-training Material Reminders

We have received great feedback on the in-meeting mini-trainings so far! If you have suggestions or requests for a future topic, please email your panel administrator- we would love to have your suggestions.

Remember that all past trainings are posted on the IRB Member page of the IRB website and can be accessed anytime!

In the News

Recently, one of the HS IRB panels reviewed and discussed the use of “geo-fencing” in a research study’s recruitment plans. Geo-fencing is likely to come up in future studies, both in social behavioral research as well as biomedical research. We recommend this article for an orientation to the concept and its potential applications, which include sending push notifications to people’s electronic devices based on their location, tracking movement, and limiting the sharing of information to people within a specific location. These different utilities raise many questions about privacy. It could raise ethical ones, as well. When is it permissible to target low-income housing complexes for recruitment messages, for example? This term was new to staff, so we wanted to share it with you for future considerations.

Continuing Education – Understanding “Minimal Risk”

Categorizing research by risk of harm is fundamental to the IRB approval process, and this categorization can have significant impact on other necessary regulatory determinations. The regulatory intent of the minimal risk categorization is to provide a threshold of anticipated harm or discomfort that is ‘low enough’ to justify other IRB actions. When a study is categorized as minimal risk, a review board may sometimes: (1.) expedite review and/or waive continuing review, (2.) waive or modify some or all elements of informed consent, (3.) allow for the enrollment of specified vulnerable subjects (e.g., non-therapeutic research in minors, prisoners, or those lacking consent capacity).

Research can be classified as minimal risk under 45 CFR 46.102(i) if it is determined that “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those encountered in daily life or during the performance of routine physical or psychological examinations or tests.”

While judgments about minimal risk categorization include factual considerations, they also are heavily intuitive in nature. The likelihood of harms ordinarily encountered in daily life differ widely between individuals and sub-populations. Standard interpretations and guidance appeal to the notion of a hypothetical typical or average person. An ethically meaningful notion of the probability and magnitude of ordinarily encountered risks should reflect background risks that are of similar magnitude and likelihood that are part of the routine experience of life for the average person in the general population. [It should not be based on risks relative to those encountered specifically in the daily lives of the study-specific population. E.g., while treatment with chemotherapy agents may be part of daily life risks for a cancer-patient population, the magnitude and likelihood of such drug-related risks are not commensurate with the background risks for the average person.]

A minimal risk determination does not require the absence of potentially serious risks or that study risks are identical to those associated with daily life. The risks of daily life include serious events, such as home and auto accidents, that occur at a low but not inconsequential rate. If evidence suggested that study procedures included a rare potential for a serious event, a minimal risk finding could be appropriate (e.g., many over-the counter medications, exercise testing in an appropriately screened population). Finally, a minimal risk determination does not require that the study risks are identical to those associated with daily life; Rather, the relevant comparison is limited to magnitude and likelihood.