Health Sciences and Minimal Risk IRBs, IRB News / Volume 1, Number 5, April 2009
Printer Friendly Newsletter April 2009
PI Status Policy
Please note that the University’s PI status policy has been updated. Individuals listed as PI on an IRB application must meet the criteria to serve as PI listed in this policy. Individuals who do not meet one of the criteria listed may apply to PI status using the form that is available here: http://www.grad.wisc.edu/hrpp/10238.doc. The form must be submitted to the individual’s department chair or center director for approval.
MRIs and Pregnancy Status
New guidance on MRIs and pregnancy status has been posted to the HS-IRBs website. The purpose of this document is to present guidelines for the method of determining pregnancy status as part of eligibility screening for studies in which (a) MRIs are performed for research rather than clinical purposes and (b) the study does not propose to enroll pregnant women. In parallel with clinical practice, pregnancy testing would not be required for these studies. Instead, research teams should incorporate questions about pregnancy status in their screening procedures. Please consult this guidance document for specific suggestions for screening questions and consent form language.
Reminders About Closing Studies
The HS-IRBs want to remind researchers that studies should be closed when possible to avoid the need to submit additional continuing reviews and other documentation to the IRB office. Studies should be closed in the following situations:
For more detailed guidance on protocol closures, see the guidance posted on the HS-IRBs website.
Please join Colette Wagner, Commercial IRB Specialist, for a WIRB Brown Bag Seminar on April 30, 2009, 12:15 pm to 1:00pm in HSLC 1345. The main topics being presented include:
Helpful Reminders and Tips
With each newsletter, the HS-IRBs office will now be offering reminders and tips to help make the IRB submission process as smooth as possible. This month’s tips are:
Final Survey Results
In December 2007 and January 2008, the HS IRBs invited people listed as key personnel on HS IRB protocols to complete a user satisfaction survey. A total of 330 people from 52 different departments/groups responded to provide feedback. In last month’s newsletter, we shared results regarding user perceptions of the IRB process and ease of use. This month, we’re sharing the last of the results.
According to the survey, people generally agreed that the primary goal of the IRB is to protect human subjects. On a scale of 1 to 5, with 1 being strongly disagree and 5 being strongly agree, 246 respondents agreed or strongly agreed the primary goal of the IRB is to protect the rights and welfare of human subjects, and 40 disagreed or strongly disagreed.
Regarding IRB policies, application instructions, and guidance, 132 respondents agreed or strongly disagreed these were easy to understand, while 100 disagreed or strongly disagreed they were easy to understand.
Finally, 53 respondents agreed or strongly agreed with the statement “The IRB review process never allows for input from me.” A total of 198 respondents disagreed or strongly disagreed.
We’d like to thank those of you who responded to our survey. These survey results are being taken into consideration during this time of change in our office. As always, if you have any questions or comments regarding the IRB process, please feel free to contact us via the methods noted above.
Whether you have a question about a specific protocol, a general question about the submission process, or need clarification about research policy, we have several ways you can reach us.