IRB Member Newsletter--Volume 8 (Winter 2013)
Updates for IRB Members
- New and Departing IRB Members
- Tips for Meeting Preparation
- Reminder: Guidance Available on Website
- 2014 Meeting Schedule
- Reminder: Point-Of-Contacts (POC) for IRB Member Questions
- Spotlight on HRPP Policy: VA Regulations
IRB Member Changes
We are happy to welcome the following new members to the Health Sciences (HS) and Minimal Risk (MR) IRBs:
- Melissa Meredith, MD, Endocrinology
- Allen Jhagroo, MD, Nephrology
- Mary Zasadil, MD, Cardiology
- John Kuo, MD, PhD, Neurosurgery
- Sameer Mathur, MD, PhD, Allergy and Immunology
- Reginald Bruskewitz, MD, Urology
- Vaishalee Kenkre, MD, Hematology-Oncology
- Mihaela Teodorescu, MD, MS, FCCP, FAASM, VA and Allergy/Pulmonology
- Adam Stevenson, JD, Law School
- Elizabeth Leigh, PhD, VA Audiology and Speech Pathology
- David Kreling, RPh, PhD, School of Pharmacy
- Claire Finando, JD, UWHC
We look forward to working with you over the coming year!
Thank you to the following IRB members who are leaving the committees. We appreciate your service to the IRBs.
- Russell Dixon
- Karen Hansen
- Maha Mohamed
- John Morledge
- Karl Sillay
- Josh Medow
- Donita Croft
- Tracy Downs
- Jeremy Cetnar
- Mike Koenigs
- Dinesh Shah
- Amanda Margolis
Tips for Meeting Preparation
Adequately preparing for IRB meetings is critical in keeping meetings running smoothly and efficiently. The following is a list of tips for IRB meeting preparation for primary reviewers, as well as for IRB members not assigned as reviewers:
Primary Reviewers: Prior to the Meeting
If you are assigned as one of the two primary reviewers on an initial review, you should come to the meeting prepared to:
- Summarize the study, including overall goals, subject population, and major study procedures
- Outline your primary concerns or questions
- Propose a motion (e.g. "I recommend this item be approved, once the following modifications are addressed by the research team...")
- IRB Application (i.e., the ARROW application)
- Formal study protocol
- Consent documents
- Investigator Drug Brochures
- Recruitment materials, such as letters to subjects or emails
- Study instruments, such as interviews or questionnaires
- Primary Reviewer Form for Initial Review Applications, a document completed by IRB members that is prepared by a staff reviewer and summarizes the major components of the study, concerns that require particular consideration, questions specifically for reviewers, and regulatory findings that must be made.
Primary reviewers: At the meeting
- Many IRB members choose to bring their laptops or tables to the meetings as an easy way to pull up study related documents and meeting agendas from ARROW as well as to reference specific research regulations.
- The primary reviewer listed first on the agenda will summarize the study and propose a motion. See Guidance for UW Madison Health Sciences IRB & Minimal Risk IRB Primary Reviewers for Summarizing Initial Review Applications for more details
- Primary reviewers must submit the completed Primary Reviewer Form at the IRB meeting or shortly thereafter. There are two ways in which reviewers can submit their initial review checklists:
- DIRECTIONS FOR ELECTRONIC SUBMISSION: Click the "Print Reviewer Checklist" button in the study workspace in ARROW and then click SAVE. This will create an editable word document in which you may type notes and comments into the review. You can then submit your completed review directly after the IRB meeting from your personal email account to firstname.lastname@example.org without the need to print out anything. There is no need to "sign" this electronic submission as submitting it from your personal email account will suffice in providing the necessary documentation of who completed the review.
- PAPER SUBMISSION: Click the "Print Reviewer Checklist" button in the study workspace and then click PRINT. You can then write in your comments, bring the printed checklist to the meeting, write any additional comments if necessary during the meeting discussion and put the completed printed checklist in the basket at the end of the meeting.
Preparation for members not assigned as primary reviewers
Even though you may not be assigned as a primary reviewer for scheduled items, you are still expected to prepare in sufficient detail to be able to take part in the discussion and to address a specific issue raised that may be your area of expertise. To prepare for a meeting, ALL IRB members should:
- Closely review the agenda, noting any item for which you are assigned as a reviewer and items that will be discussed by the full IRB (initial reviews, deferral responses, modification responses, reportable events). For the HS IRB members, also look over the agenda for changes of protocol and continuing reviews marked for full committee discussion.
- For items for which you are not assigned that will be discussed, review the following materials at minimum:
- For all submissions: staff review
- For changes of protocol, reportable events, and continuing reviews: the ARROW form for that submission
- Any other documents that you think may inform your participation in the discussion.
A few IRB members have clicked on the activity called "Reviewer Checklist" in ARROW, which appears in the initial review workspace. This activity is located under the ED/SBS IRB heading and is not for use with the HS and MR IRBs. Please continue to follow HS and MR IRBs' member instructions for completing reviews of new protocols. If you have questions about completing your review, please contact your IRB staff liaison.
- The VA does not allow for the use of Preparatory to Research to cover review of medical records for screening for potential subjects and instead requires the IRB to waive authorization under the HIPAA Privacy Rule to allow for this activity to occur.
- The VA currently requires documents to be retained indefinitely. Thus, no VA data can be destroyed.
- Data and samples must be stored on VA premises. If data are released, a copy of the data must be retained at the VA.
- Only study team members with VA appointments can view VA data or VA protected health information (PHI) until subjects sign a consent and authorization form to permit the disclosure of this information to individuals who do not have VA appointments.
- The VA requires the HIPAA authorization form to be separate from the consent document.
- The VA does not allow research to involve certain subject populations, such as children and prisoners, or certain research areas (e.g., emergency or international research).
- The IRB is required to determine whether subjects’ study participation should be flagged in their VA medical record.
- Special requirements apply if subjects will be paid. The VA tends to be restrictive regarding remuneration.
- Special requirements apply for the inclusion of non-veterans and individuals with impaired decision-making capacity.