HS-IRBs News February 2013
Health Sciences and Minimal Risk IRBs, IRB News / Volume 5, Number 2, February 2013
New FAQs on Human Subjects Research/CITI Training
Two new documents have been developed by the Graduate School to assist study teams with complying with campus human subjects training requirements and navigating CITI. Please see Frequently Asked Questions about UW-Madison CITI Human Subjects Training and Instructions for Instructions for Accessing and Completing CITI Training for more information.
ARROW Open Lab on March 11th
HS-IRBs office has previously held open lab sessions for study teams
seeking assistance with using ARROW. We are again offering an open lab
for anyone who wants help using ARROW. No formal training will be
offered, but HS-IRBs staff will be available to answer any questions
study teams have about ARROW.
The ARROW open lab will be held on Monday , March 11th from 11AM to noon in the HSLC computer lab (HSLC 2121). Registration is required and capped at 20 participants. To register, please email firstname.lastname@example.org.
New: Health Sciences IRBs Pilot a Research Decision Tool
The role of an IRB is to protect the rights and welfare of human subjects in research. Determining whether a project constitutes human subjects research rather than quality improvement or program evaluation is one of the most complex decisions the IRB makes. Furthermore, it is an important decision because it determines whether IRB review and oversight of a project is needed. In the past several years, the Health Sciences IRBs Office has seen a significant increase in submissions requesting that the IRB make a formal determination that a project falls outside of the federal definition of research. Often times, IRB review of these projects isn’t required; however, formal determinations are requested by study teams so that they have documentation of IRB review to provide to journals, funding sources, and others.
With an eventual goal of allowing study teams to make these decisions independent of the IRB and minimizing the requests submitted for formal IRB review, the HS IRBs Office has developed a Research Decision Tool. The Research Decision Tool is designed to help project teams determine whether their project constitutes research or whether it is quality improvement or program evaluation such that IRB review isn’t required. The HS IRBs Office will be asking study teams to assist in piloting the Research Decision Tool in the coming months to determine whether it can be used as a supplement the current submission process. Updates on the outcome of the pilot project will be included in future newsletters. If you have any questions regarding the pilot project, please email Chelsea Dahmen (email@example.com).
Revised 2013 MR IRB Meeting Dates
The 2013 schedule for MR IRB meetings has been revised to remove the last meeting December (12/23/2013). This meeting has been canceled due to conflicts with holiday scheduling. The IRB Meeting Dates page has been updated to reflect the revised meeting schedule.
How to Provide Enrollment and Collection Numbers at Continuing ReviewIf the IRB has not approved a specific number of subjects for enrollment and/or data/specimens/images for collection, please enter 0 in response to relevant questions in the continuing review form. The 2 main questions affected are a) number of subjects or data/specimens/images approved for enrollment or collection by the IRB and b) subjects or data/specimens/images yet to be recruited or collected. If the IRB did not approve a specific number for enrollment or collection, the answers to these questions should be 0.
VA Update: Change to Payment Process for VA Subjects
The Department of Veterans Affairs recently changed its process regarding how research subjects will be paid. Institutions are now required to pay subjects through electronic funds transfer (EFT) rather than via check. In order to complete payment through EFT, additional information will need to be collected from research participants, either a voided check or completion of a form that includes Social Security Number (SSN) and banking account information. If subjects do not have a bank account the study team can still pay subjects via check, but this requires additional justification and lengthens the payment process.
If a researcher will pay study participants via EFT, the research subjects should be notified of the information that will be collected to effect the payment. The collection of this information should be disclosed in the consent form. For example, the section of the consent form that describes payment to subjects could state, “To receive payment for your participation in this study, you may be required to provide your social security number and bank account information. This information will be used by the VA to pay you for this study and will not be kept by the study team.” Researchers should add this language to relevant studies at the time of initial IRB review or submit a change of protocol to the IRB to update consent forms when possible (e.g., incorporating revisions with a change of protocol needed for other reasons). If the additional information is collected from subjects in order to pay them and prior to IRB approval of the change to the consent document, the IRB determined that such action would not be considered a protocol violation or noncompliance given that this is a VA-mandated requirement. However, because the payments to subjects are as a result of their participation in the research study, the IRB has requested that language regarding the additional information collected to pay subjects be incorporated into study consent forms when possible.
The IRB also has determined that the collection of SSNs
solely to pay subjects does not fall under the VA Handbook 1200.05 requirements
and restrictions related to the collection and use of SSNs because the
collection of SSNs is required by the VA for accounting purposes rather than
for use in a research study.