Updates for IRB Members
As you may know, UW-Madison’s Human Research Protections Program (HRPP) is accredited by the Association for Accreditation of Human Research Protection Programs (AAHRPP). Part of retaining accreditation is implementing mechanisms that help ensure the quality of IRB performance. One mechanism to help ensure a high level of IRB function is providing feedback on IRB member performance.
The Health Sciences (HS) IRBs Office designed a formal tool that is used to provide feedback on IRB member performance. The evaluation focuses on IRB member knowledge of federal regulations and institutional policies governing human subjects research, attendance at IRB meetings, communication with IRB staff and responsiveness to IRB office requests. An evaluation schedule is created by the HS IRBs Office so that each member receives at least one formal evaluation during his or her term on the IRB. Evaluations are based on feedback from the IRB chair, vice-chair (if applicable), and the IRB staff.
Although the evaluations may identify instances in which IRB members are not performing at a level necessary for continued membership, the primary goal is to identify and acknowledge those members who demonstrate exemplary performance.
Please contact Nichelle Cobb (262-1980), Gretchen Anding (263-4170), Yoram Shenker, M.D. (262-8605), or Peter Rahko, M.D. (263-8838) with questions.
In the fall, we plan on conducting a survey in Qualtrics of all IRB Members to provide the HS IRBs Office and Chair(s) with feedback. The questions are meant to elicit your thoughts about the IRB Chairs (and their management of meetings), the HS IRBs Office Staff (and their communication with you, as well as the materials they prepare for meetings), educational materials and experiences, and feelings about being an IRB Member. Please keep an eye out for an email asking you to take the survey. If you have any additional questions about the survey, please contact Emily Jenner (262-3752) or Chelsea Dahmen (265-4389).
IRB Member Training Requirement
UW-Madison’s HRPP requires IRB Members to take the IRB Member Training course through the Collaborative Institutional Training Initiative (CITI) Program as part of ongoing education and training. IRB Members are required to complete this course once to ensure compliance with the HRPP Education and Training Policy. IRB Members are also required to complete the Human Subjects Protection for Biomedical Researchers course through CITI, which expires every three years. To ensure compliance with this policy, the HS IRBs office will be sending out email reminders to IRB Members who have not completed one or both of these courses at the end of June.
Please contact Emily Jenner (262-3752) or Chelsea Dahmen (265-4389) with questions.
Review Tips: Summarizing Initial Review Applications at a Meeting
The Health Sciences IRBs assign two primary reviewers to every submission discussed at IRB meetings. Two primary reviewers are assigned to ensure that at least two members conduct an in-depth review of a submission. When assigned as a primary reviewer for an initial review application, both reviewers should be prepared to briefly summarize the study; the second primary reviewer may need to present the study if the primary reviewer cannot attend the meeting. The summary should include the following aspects:
Reviewers should also discuss whether the study meets the “111 criteria” (i.e., the federal criteria that must be met for an IRB to approve a study), or what changes need to be made in order for the study to meet 111 criteria. Specific areas that need to be mentioned (and documented) are:
Other aspects of the study may need to be discussed, as outlined in the reviewer checklist prepared by the assigned staff reviewer for a study. If any questions arise while reviewing a study, please feel free to contact the assigned staff reviewer (staff contact information) or one of the IRB member points of contact.
For more information on summarizing initial review applications, please see the following additional guidance on our website:
Guidance for UW Madison Health Sciences IRB & Minimal Risk IRB Primary Reviewers for Summarizing Initial Review Applications
Making a Motion at IRB Meetings
Primary Reviewer Guidance for Initial Reviews
IRB Members Website Spotlight: "Childrens: Regulations" Fact Sheet
When the IRB is reviewing a study involving the enrollment of children, additional determinations need to be made based upon the federal regulations for protecting the welfare of children involved as subjects of research (45 CFR 46, Subpart D). In order to approve the enrollment of children, a study must fall into one of the following categories:
The board may also determine that a waiver of parental or guardian permission is acceptable under 46.408(c) if the study otherwise meets the criteria for a waiver of consent.
For more information on research with children, please see the following additional guidance on our website:
HS IRBs Guidance Spotlight: DHS Variance Guidance
There is a Wisconsin Department of Health Services (DHS) regulation that applies to some human subjects research studies using x-ray. IRB members may see this being addressed in staff reviews. For more information about the DHS statute and the process UW-Madison researchers need to follow to request a variance, please see the following guidance: Guidance for X-Ray Radiation Use in Research Studies for Non-Healing Arts Purposes
Article Spotlight: "Biobanking Research and Human Subjects Protections: Perspectives of IRB Leaders" Summary
The researchers for this article wanted to examine differences (and similarities) on IRB policies and procedures for collecting, storing and sharing biospecimens. IRBs at institutions that are members of the NIH’s Clinical and Translational Science Awards (CTSA) consortium were asked to be interviewed after completing a survey; the institutions with “divergent responses” on the survey (defined as extreme responses, such as “always” or “never” on policy options) were the institutions that were chosen to be interviewed. Key study results outlined in the article are as follows:
In summary, the investigators found that researchers’ need for access to banked specimens and data remain. However, institutions need to balance the need for samples with the need to protect the interests and welfare of the participants. Most institutions supported broad consent to minimize the difficulties associated with tracking use of biospecimens when participants are given the option to decide specifically how specimens are used. There also remains concerns about when the use of biospecimens constitutes human subjects research, largely due to the Department of Health and Human Services proposal to change the Common Rule so that biospecimens are inherently reidentifiable. Due to variation across IRBs regarding guidance for biobank-related research, there remains difficulties with multi-site studies that either create or use banked specimens.
For further information regarding this study, please see the following article: BiobankingArticle.pdf
Rothwell E, Maschke KJ, Botkin JR, et al. Biobanking research and human subjects protections: Perspectives of IRB leaders, IRB: Ethics & Human Research 2015;37(2):8-13.