HS-IRBs News - 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:

• Studies for which all study activities have been completed
• Studies for which all study interventions have been completed AND all data has been de-identified
• Exemptions or PDAs that are no longer active
• Protocols that have been replaced by a new protocol (e.g., as a result of the 5 year rule)
• Studies that have been expired for more than 6 months
• Applications that have been in the IRB review process (e.g., pre-review) for more than 6 months and for which a response from the study team is still pending

For more detailed guidance on protocol closures, see the guidance posted on the HS-IRBs website.

WIRB Update

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:

• new WIRB fees which start June 1, 2009
• WIRB’s new interpretation of what is considered a study site
• application preparation
• changes to how the UW can submit consent documents starting June 1, 2009
• introduction of WIRB back-up Molly Lumley

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:

1. When responding to a modification response, please make sure to provide hard copies of all materials. The materials should include a point-by-point response to the modifications requested. This response should be signed by the PI of the study.
2. Please note that there is a difference between coded data and deidentified data.
1. If data are coded, this means there is a code that links data to an individual.
1. Example: Data are sent from a UW PI to a collaborator at another site. The data sent includes subject code, but no other subject identifiers such as name, date of birth, etc. If the UW PI still holds the code key (i.e. is able to trace back specific data to an individual), this is considered coded data.
2. If data are deidentified, this means there is no way for anyone to determine from which individual the data came.
1. Example: Data are sent from a UW PI to a collaborator at another site. The data sent does not include any identifiers, and does not include the subject code. The data sent to the non-UW collaborator would be considered deidentified.

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.

• Urgent issues (e.g., subject safety concerns), please call our main line (608-263-2362) and ask to speak with the staff reviewer on call for the day. Please do NOT use email for these kinds of questions.
• General IRB questions, please call our main line (608-263-2362) to speak with the staff reviewer on call or email asktheirb@hsirb.wisc.edu. These are the quickest ways to get help with general questions.
• Specific questions regarding the status of your review and/or reviewer notes, please contact the staff reviewer assigned to your application.
• Help with single IRB review and reliance questions, email irbreliance@wisc.edu.

• Assistance with ARROW or technical questions, email askarrowirb@hsirb.wisc.edu.
• Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing join-hs_irbs_announcements@lists.wisc.edu.
• Consultations: For investigators seeking assistance on a specific program or application, HS-IRBs staff are available for individual consultations. To request a consultation, complete the HS-IRBs Presentation and Consultation Request Form.
• Presentations: The HS-IRBs office is available to provide the research community with presentations and trainings on a variety of topics. To request a presentation, complete the HS-IRBs Presentation and Consultation Request Form.