HS-IRBs News - July 2011

AAHRPP Re-Accreditation Site Visit This Fall

UW-Madison's human research protection program  (HRPP) is fully accredited by AAHRPP (Association for the Accreditation of Research Protection Programs). Accreditation must be renewed every 3 years and UW-Madison's HRPP is currently undergoing re-accreditation. As part of this process, AAHRPP will be conducting a site visit at UW-Madison beginning on September 27th. AAHRPP will select several PIs, study coordinators, and other research staff that site visitors will meet with during their visit. Study teams will be notified by the Office of Research Policy if they have been selected by AAHRPP for an interview. The HS-IRBs office also will contact those study teams selected by AAHRPP to assist them in preparing for the site visit.

The types of questions AAHRPP may ask study teams include the following:

• What is meant by minimizing risk?
• How do you approach a subject?
• How can an investigator oversee research staff effectively?
• Give an example of an unanticipated problem involving risks to subjects or others.
• How do you ensure your study files are secure?

 Please watch future newsletters for more details about the upcoming site visit.

Need a PDF of a Newsletter?

If you need a PDF of a newsletter that is available only through the website, please keep in mind that you can create a PDF by either printing the newsletter to PDF (if you are using Mozilla Firefox) or using the convert to PDF button in the toolbar (if you are using a recent version of Internet Explorer).

Revised Guidance on 5-Year Renewal Policy and Replacement Studies

Revised guidance on the 5-year policy and submission of replacement studies has been posted: Guidance on the Five Year Renewal Policy and Replacement Studies in ARROW . Some highlights of the revised guidance include the following:

• Recommendation to submit replacement studies no later than 90 days prior to expiration of IRB approval for the study being replaced. Previous guidance had recommended 60 days.
• Clarification that the study being replaced should be closed, but NOT until the replacement study has been approved by the IRB.
• Clarification that changes to the original study can be made as part of the replacement study, but cannot be implemented until the replacement study is approved or a change of protocol has been approved for the original study.

Please see the full text of the revised guidance for more details.

New ARROW FAQ: Utilizing the Study Workspace to Find Study Specific Information in ARROW

The ARROW helpline receives a lot of questions from study teams regarding the status of submissions in ARROW. A new ARROW FAQ has been developed to help study teams use the study workspace to check on a submission's status, which IRB staff reviewer is assigned to the submission, and whether reviewer notes have been successfully responded to. Please see the full FAQ for more information: [Link for document 19295 is unavailable at this time.]

Using the Edit External Personnel Access Activity in ARROW

ARROW includes an activity called Edit External Personnel Access. This activity can be used by study teams to grant read-only access to individuals who should NOT be listed as key personnel in the IRB application. People should only be listed as key personnel if they are engaged in human subjects research AND the UW-Madison is serving as IRB of record for them. The Edit External Personnel Access activity should be used in the following situations:

• To add personnel not engaged in human subjects research who are external to the UW-Madison/UWHC/Madison, such as study monitors:  Individuals such as study monitors who are not engaged in human subjects research need to obtain a netID and password, but should NOT be added to the study team as key personnel in the IRB application. The study team should instead use the Edit External Personnel Access activity to grant them access. Please see this FAQ for details: [Link for document 16993 is unavailable at this time.]
  
• To add personnel external to the UW-Madison/UWHC/Madison who are engaged in human subjects research but for whom the UW is NOT serving as IRB of record: External personnel who are engaged in human subjects research but whose activities on a study are overseen by a non-UW IRB also should NOT be added to the study team pages in the IRB application. Their role should be described in the IRB application and the study team can use the Edit External Personnel Access activity to grant these individuals read-only access to the IRB application. Please see this FAQ for details: [Link for document 17022 is unavailable at this time.]
• To add administrative personnel within the UW who are NOT engaged in human subjects research:  A new activity - called Edit Administrative Access -  will be added to ARROW in August. This new activity will allow study teams to grant read-only access to administrative personnel within the UW who are NOT engaged in research, such as departmental administrators. This new functionality will be announced in an upcoming  newsletter.

Study teams do NOT need IRB approval to use the Edit External Personnel Access activity, but will be asked in the activity form to confirm that the personnel being added are either external personnel not engaged in human subjects research OR are engaged in research being overseen by a non-UW-Madison IRB. If you have questions about how to grant access to application in ARROW, please contact the ARROW helpline or email askarrowirb@medicine.wisc.edu.

New Time Frames for Automatic Closure of Expired Studies 

ARROW currently automatically closes studies for which IRB approval has lapsed for 6 months. This time frame is being changed in August. Any studies that are in the Expired state will automatically be closed by ARROW after 3 months. Study teams can submit a continuing review application at any point during the 3 months the study is in the Expired state. ARROW will continue to send study team 3 email notifications prior to closing a study. Study teams will be able to request that closed studies be reopened, but are strongly encouraged to promptly submit continuing review applications to avoid the need to do so.

Reminder: Using Preview Final Documents

A new activity - called Preview Final Documents - is now available in ARROW. Preview Final Documents generates a PDF preview of what uploaded consent and assent documents will look like after they have been approved and stamped in ARROW. Beginning immediately, study teams will be responsible for using the Preview Final Documents activity to check their uploaded documents for formatting issues. Instructions and additional information on the Preview Final Documents activity is now posted on the ARROW page of the HS-IRBs website: Using the Preview Final Documents Activity in ARROW . Please note that after August 1, 2011, study teams that do not use the Preview Final Documents activity may incur IRB fees if a change of protocol is required to fix a formatting error in an approved consent document.

Your Feedback Still Needed on HS-IRBs Documents!

With the migration of the HS-IRBs website to a new platform, study teams are able to provide feedback on many HS-IRBs documents. At the bottom at these pages, study teams can let the HS-IRBs Office know if they found a document to be helpful or not as well as leave more detailed feedback. If you have ever found a document posted on our website to be confusing or to not quite answer your question, this is your chance to let us know. Website feedback is reviewed regularly, so please let us hear from you so we can continue to improve our services to researchers.

Questions? We're Here to Help!

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.

• 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@medicine.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@medicine.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.
• WIRB updates, please sign up for the WIRB listsserv by emailing submitwirb@medicine.wisc.edu with a request to be put on the list.
• 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.