HS-IRBs News - June 2010

Health Sciences and Minimal Risk IRBs, IRB News / Volume 2, Number 6, June 2010

Printer Friendly Newsletter June 2010

ARROW Updates

Phase 2 of ARROW rollout will be happening in July. Study teams who will begin using ARROW in this round of the rollout have already been identified and include the Cancer Center, Family Medicine, some GRECC groups, HIP, and study teams from OB-GYN. HS-IRBs staff will begin ARROW training with these groups starting in late June.
The final phase of ARROW rollout will happen this fall. Announcements about ARROW training and additional information about the final rollout will be coming later this summer, so please stay tuned to the newsletter and listserv for details.
The HS-IRBs Office recently conducted a brief survey of the pilot group of ARROW users and here are some highlights:

When asked to rate their satisfaction with the system, 88% of respondents indicated they were either very satisfied or satisfied with the system.
When asked to give a reason for this rating, most respondents noted that working with IRB applications in ARROW seemed faster and easier than preparing paper submissions.
When asked whether they thought ARROW made the IRB review process easier, harder, or had no effect, 86% of respondents indicated ARROW made the process easier.

Modified IRB Meeting Dates Due to July 4^th Holiday

The HS-IRBs Office will be closed on Monday, July 5th for the 4^th of July holiday.

As a result, there is no HS-IRB meeting the week of July 5^th. After the June 28^th HS-IRB meeting, the next HS-IRB meeting is July 13^th. The deadline for continuing reviews to be reviewed at the July 13^th HS-IRB meeting is Friday, June 25.
There is no MR-IRB meeting the week of July 5^th. After the June 21^st MR-IRB meeting, the next MR-IRB meeting is July 12^th.

Separation of Continuing Reviews and Changes of Protocol

Please remember that since early 2009, the HS-IRBs have not concurrently reviewed continuing reviews with changes of protocol. This includes both full changes of protocol and expedited changes. If you wish to submit a change of protocol but your study is within one month of expiring, please submit the continuing review progress report first, separately from the change form. After you have received approval for the continuing review, you can then submit the change of protocol.

Review of Reportable Events and Changes of Protocol

The HS-IRBs office has moved toward specialization in staff reviewer roles. As such, please note that if a reportable event and related change of protocol are submitted to the HS-IRBs simultaneously, they will not be reviewed concurrently. The reportable event will be reviewed first, with the change of protocol reviewed after. This process has been put into place to (a) increase consistency in how reportable events are reviewed, (b), ensure any subject safety the reports suggest are addressed in a timely manner and (c) prepare for ARROW, where simultaneous review of multiple submission types is not possible.

Please note, too, that a revised Serious Adverse Event Reporting form has been posted on the Health Sciences IRBs website and should now be used instead of the previous version.

HS-IRBs User Survey coming in June

The HS-IRBs will be conducting another IRBs user survey in June 2010. We want to hear your thoughts on how we can improve our services. All key personnel listed on a research project reviewed by the HS-IRBs and all people on the HS-IRBs listserv will receive an invitation to complete this survey. The survey will take approximately 20 minutes to complete and be completely anonymous.

Human Subjects and HIPAA Training Reminders

HS-IRBs staff has noticed that some personnel change forms submitted to the office indicate that personnel to be added have completed the required training modules, yet the campus training database shows they have not. This is a friendly reminder that all personnel to be listed on human subjects protocols must complete the required human subjects research training module before they can be added to the list of key personnel. Information about the CITI training module is available on the Graduate School website.

Personnel who are considered to be part of the health care component or affiliated covered entity also must complete HIPAA privacy rule training. Information about HIPAA privacy rule training can be found on the HIPAA privacy rule research guidance website.

If you are not sure whether new personnel have completed the required training modules, please consult the campus training database to make sure the personnel have completed the training before submitting a personnel change. The HS-IRBs Office does check this database when reviewing personnel changes and these changes will be placed on hold until all new personnel have completed their training per campus policy.

Protocol Development Activities (PDA) Applications

The Health Sciences IRBs developed the Application for IRB Review of Proposal for Protocol Development Activities Only submission form (also known as a PDA) to facilitate the submission of grant applications to the IRB for review when research activities involving human subjects are planned in future but have not been finalized (e.g., the grant incorporates a planning stage) or when an agency or organization requires IRB approval of the concept as part of the application for funding. In order to obtain approval to perform research activities involving human subjects, a separate Initial Review Application or Application for Exemption from IRB Review will be required. Only planning activities that do not involve human subjects can be covered by this administrative approval. In some cases, an Application for Exemption may be a more appropriate form to submit.

When the activities covered by a PDA are complete, please submit a Protocol Closure form to the IRB that reviewed the application.

WIRB Updates

ACRRF
The UW-HS-IRBs WIRB Annual Continuing Review Report Form (ACRRF) submissions process has been modified effective June 1, 2010. Please see the Power Point presentation posted on the UW-HS-IRBs/WIRB web page for guidance. If you have any questions, please email them to submitwirb@medicine.wisc.edu.

Information Sheet
The subject information sheet submitted to WIRB will arrive with your approved documents containing tracked changes. Because WIRB views this document as subject material, you will not receive a clean copy of this document. It is the research team’s responsibility to prepare the clean copy for the research subject.

WIRB On Campus
Mark your calendars for September 21 and 22, 2010 for the WIRB On Campus educational seminars presented by Sherry Felchlin, WIRB Account Executive, New Business Development. If you would like to suggest an educational topic to be covered, please email Colette Wagner at caw@medicine.wisc.edu.

Financial Information for HS-IRBs Submission Cover Sheet
Submitwirb@medicine.wisc.edu will no longer accept HS-IRBs Submission Cover Sheets without questions 2a, 2b, 2c(1), 2c(2) and 2c(3) filled out. Even though the form indicates that questions 2c(1), 2c(2) and 2c(3) need to be filled out for initial application only, we are now requiring this information just in case a typo occurs for question 2b. If your research has yet to be approved by WIRB, your response for question 2b should read “Waiting for approval.” Thank you in advance for your assistance with this matter.

Modification to the Requirement for Licenses
It has been brought to our attention that WIRB has modified their requirements for submission of licenses. Please note that research teams need only to supply the license for the Principal Investigator of the study with their initial application submission from now on. There is no need to send all other staff licenses, but, they will be submitted if you still wish to attach them to your initial submission. This change does not modify the requirements previously used for CVs. Please submit CVs as you have done in the past.

Business Associate Agreement (BAA)
WIRB is now sending a BAA with approved research. WIRB believes they are engaged in this type of agreement with our research teams. UW Legal Services disagrees with WIRBs assertion that we are engaged in a BAA and have asked the research team to disregard this document if received. Currently UW Legal Services are working on resolving the situation with WIRB. UW Legal services have requested that research teams alert submitwirb@medicine.wisc.edu to identify what studies have received this document. Therefore, if you have in the past or you do in the future receive this document for your study please send a quick email documenting the receipt of the BAA. Thank you in advance for your assistance with this matter.

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.