Dr. Sameer Mathur, MD, PhD, is a faculty member in the Division of Allergy, Pulmonary and Critical Care Medicine within the Department of Medicine. He currently serves as the program director of the Allergy and Immunology fellowship program. Dr. Mathur has been a member of the HS IRB since 2013 and volunteered to serve as a panel Chair with the reorganization of the committee structure in April 2021!
When not emceeing IRB meetings, Dr. Mathur can be found on a tennis court playing USTA league tennis on a 40+ team at the 3.5 level that has been the Wisconsin State Champion for 2 years in a row (!), or doing yoga, noting “especially during the pandemic, I have found yoga and self-care to provide miraculous benefits physically and mentally and would love to see more clinical protocols exploring this further.”
Introducing New IRB Staff
We are excited to introduce the three newest additions to the IRB Office, Aly Vanderweide, Jennifer Wang, and Marley Kreger!
Aly is our new IRB Office Administrator. Aly has a bachelor’s degree in political science and a paralegal associates degree. She has years of experience as an office manager for several Madison-based public/government relations and lobbying firms. In addition to serving as the liaison with HR, Aly manages the complex task of scheduling IRB members and meetings for 8 panels across both the HS and MRR IRBs!
Jennifer is our newest staff reviewer, working primarily with the HS IRB. Jennifer has a bachelor’s degree in genetics from UW Madison, has worked as a study coordinator, and most recently as a regulatory manager in the Orthopedics/Rehabilitation and Urology Divisions. We are looking forward to her bringing this expertise to the staff reviewer position!
Marley is our student assistant. Marley is a junior majoring in marketing and international business with a certificate in Spanish. She is originally from a little town called Erin, Wisconsin. In her free time, she enjoys weightlifting, going hiking, and traveling. On campus, she can typically be found at the gym, a coffee shop, or studying at the Wisconsin School of Business.
2022 Meeting Scheduling
At this point you have received information about 2022 meeting schedules. Thank you for following up. We will soon be sending calendar invitations followed by meeting reminders. To continue to have successful meetings, please be sure to respond to emails from firstname.lastname@example.org and/or email@example.com. Your timely reply ensures we have quorum and enough reviewers to carry on our important work.
Continuing Education Materials
IRB Staff have been conducting mini-trainings at the start of most panel meetings and have received great feedback so far! If you have specific topics that you would like to see covered in a mini-training, please email IRB member liaisons Jackie Lee (firstname.lastname@example.org) or Jessie Johnson (email@example.com), or your panel administrator.
IRB Members Summarizing Continuing Reviews at HS IRB meetings
The responsibility for summarizing continuing reviews at HS IRB meetings is shifting from the staff reviewer, usually Joscelyn, to the primary IRB member reviewer assigned. Joscelyn has created a guidance document that is posted on our website, outlining what is typically included in a summary. Please contact Joscelyn (firstname.lastname@example.org) with any questions!
IRB Member Survey Results
A member survey was recently sent to all HS and MRR members to solicit feedback regarding training, use of the Toolkit, and IRB Office support. 33 responses were received (25 HS and 8 MRR) – THANK YOU to all of those who completed the survey! Some highlights:
- Responses were mostly positive with very positive comments about IRB staff.
- Members want more training on ARROW, Toolkit and presenting/discussing protocols they are assigned.
- Trainings on these topics have already started and more will be developed to address these concerns.
Introduction to RELIANT
As a reminder, IRB Members can refer colleagues to the Reliance and Navigation Team (RELIANT) for assistance with collaborative and multi-site research issues, including helping identify the best single IRB review option for their studies and facilitating reliance agreements. RELIANT also supports study teams in navigating institutional requirements that lie outside the IRB approval process.
In the News
From Science, a must-read: “Failure to Protect? A study of asthmatic children, most of them Black, shows how a common clinical trial design can expose vulnerable participants to serious risks” – This study is facing intense scrutiny about the ethics of its study design. In addition to the initial design, the consent forms did not adequately inform subjects about the risks, researchers kept children on the placebo arm after ending the study early following a futility analysis – further delaying potential treatment of their Vitamin D deficiencies, and the kids appeared to experience twice the number of fractures as they would otherwise. This study was funded by the NIH, and approved by the IRB at the University of Pittsburgh. It raises concerns about the IRB’s basic failures to follow the standards of The Belmont Report and the goals of the Common Rule.
Continuing Education – Modifications Required versus Deferral
Under federal regulations, an IRB can approve a research study (a.) as submitted, or (b.) with conditions/modifications; Defer the study for further review after the required modifications and clarifications are submitted; or Disapprove the study. Knowing when revisions can be handled as a modification versus a deferral is an important distinction.
When an IRB approves research with conditions (i.e., action of “modifications requested”), full IRB review of an investigator’s response is not required. Conditions of approval should be limited to specified changes to the study materials, confirmations of specific understandings on the part of the IRB, or the submission of additional documentation. Examples of modifications an IRB could stipulate as part of a “modifications requested” determination include: addition of specified eligibility or screening criteria (e.g., add history of aspirin use and exclusion of those using aspirin within x days), confirmation that standard imaging contrast material will be limited to specified agents and dose levels, or provision of a plan to inform subjects about the results of clinical tests and associated referral to clinical follow-up.
If, however, an IRB is unable to make the required determinations under the 111 criteria (e.g., risks and benefits, adequacy of consent process, appropriate safety monitoring, etc.) or the subparts addressing special populations (e.g., minors), an IRB would need to defer the study. Examples of modifications or clarifications that would require deferral include: provision of a justification for withholding or withdrawing available treatment for a serious medical condition, provision of a justification for the inclusion of minors, modifications to the hypothesis and design, or provision of new information or clarifications in order to assess the risks.