HS-IRBs News - May 2011
Health Sciences and Minimal Risk IRBs, IRB News / Volume 3, Number 5, May 2011
Update: HS-IRBs Website Migration
As noted in the April newsletter, the HS-IRBs website is moving to a new platform that includes a robust search engine and allows visitors to leave feedback on posted documents. Some of the pages now on the new platform and searchable by keyword and full text include:
- News and updates, including an archive of past newsletters
- VA Research
- Training and Education
- ARROW information, including all FAQs and reference materials
- Multisite Research
We hope visitors to the website find the new search engine helpful and we welcome everyone to provide their feedback on the posted documents, which will help us improve our services to the research community.
HS-IRBs Office Closed May 30th
HS-IRBs office will be closed on Monday, May 30th, in observance of Memorial Day.
Reminder: ICSC Drop Box Discontinued after May 31, 2011
As the transition to ARROW continues, the number of submissions received in paper continues to decrease. As a result, the HS-IRBs will be discontinuing the ICSC drop box location in the HSLC on May 31, 2011. All paper submissions after that date must be sent to the HS-IRBs office via mail or dropped off in person during regular business hours.
ARROW Helpline: Please Leave a Message
When calling the ARROW helpline, please leave a detailed message if helpline personnel are not available to answer your call. Given the volume of calls the helpline receives, callers may be routed to voicemail more frequently than in previous months. Please note that the helpline is not staffed on weekends. Calls to the helpline are typically returned within 1 business day.
Update: UW-Madison Human Research Protection Program Accreditation
In December 2008, UW-Madison’s Human Research Protection Program (HRPP) received accreditation from the Association for Accreditation of Human Research Protection Programs (AAHRPP). Accreditation is awarded to institutions that demonstrate human subject safeguards which surpass the threshold of state and federal rules and regulations. The original accrediation process resulted in several changes to institutional policies, guidelines, and IRB forms and procedures.
UW-Madison is currently preparing for reaccreditation of its HRPP. The Office of Research Policy within the Graduate School is working with the IRBs and other offices across campus to review and, if needed, revise current HRPP guidelines, policies, forms, and processes. The HS-IRBs office will do its best to keep study teams informed of any revisions to HRPP documents or processes that could directly affect them.
In September 2011, AAHRPP will return to campus for a site visit to evaluate the HRPP. The site visit will again involve interviews of various representatives of the HRPP, including study teams (PIs and Coordinators), IRB members and staff, and other research support services. Research personnel may be contacted in late summer in preparation for these site visits. Please watch for updates regarding the upcoming site visit and the reaccreditation process in future issues of the newsletter.
ARROW Tip: Mozilla Firefox and Resizing Text Boxes
The most recent version of Mozilla Firefox includes a feature that allows users to resize text boxes, including those in ARROW. This feature allows users to expand the text box to whatever size they wish while working on a particular page in the application. The text box will revert to its normal size if the browser is refreshed, the application is exited, or the continue button is used to move to the next page.
To enable this feature, update Mozilla Firefox to the most recent version. Open an application in ARROW and the resizing feature should then appear in the lower right-hand corner of text boxes in the application forms.
Do you have study team members leaving the UW-Madison/UWHC/Madison VA?
With the end of the academic and fiscal years upon on us, please keep the following in mind if you have study team members leaving the UW-Madison/UWHC/Madison VA:
- Per the recently issued guidance on updates to study personnel, study teams must report the removal of any study team members to the HS-IRBs within 1 month of removing any personnel from the study, regardless of role.
- If personnel leaving UW-Madison/UWHC/Madison VA will continue to be engaged in human subjects research for a study at the UW, the HS-IRBs cannot automatically remain the IRB of record for these personnel. The study team must contact the HS-IRBs office to discuss what additional steps may need to be taken to ensure these personnel continue to have appropriate IRB oversight for their study activities.
New: Communicable Diseases Reporting and Consent Guidance
A new guidance document regarding the reporting and consent document requirements for testing of communicable diseases is now available on the Policies and Guidance page of the HS-IRBs website. The document is designed to assist study teams with understanding which test results need to be reported to the state epidemiologist or local health department as well as what language needs to be included in the consent document when study teams plan to test subjects for communicable diseases (whether as part of screening for eligibilty or as part of the research study).
When to Submit a Continuing Review Progress Report
During the transition to ARROW, when to submit a continuing review progress report depends in part on whether the study is a legacy study (i.e., an existing study migrated in to ARROW) or a new study initiated in ARROW. Here are some timelines to keep in mind for continuing reviews:
- For studies initiated in ARROW (i.e., studies that were never submitted in paper), continuing reviews should be submitted 6 weeks prior to the expiration date.
- For legacy studies migrated in to ARROW that have already had 1 continuing review completed in ARROW, continuing reviews should be submitted 6 weeks prior to the expiration date.
- For legacy studies migrated in to ARROW that are undergoing continuing review for the first time in ARROW (including review of the legacy application), continuing reviews must be submitted no later than 2 months prior to the expiration date.
Please keep in mind that changes of protocol (including personnel changes) cannot be requested via the continuing review process in ARROW and must be submitted separately as changes of protocol and/or personnel changes.
The HS-IRBs website has a new VA Research - Overview . This webpage provides information for research teams who conduct studies that fall under Madison VA purview, including several important updated VA documents such as contact information for research personnel at the Madison VA, updated VA consent template, and a description of what reseach falls under VA purview.
Need Help with ARROW?
ARROW consultations are now available by appointment only at the HS-IRBs office in the University Bay Office Building (free 2 hour parking is available). If you would like in-person assistance with ARROW or an individual quick-start session, please email your request to firstname.lastname@example.org. When emailing your request, please put ARROW consultation or small group demonstration in the subject line.
- 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 email@example.com. 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 firstname.lastname@example.org.
- Assistance with ARROW or technical questions, email email@example.com.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing firstname.lastname@example.org.
- 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.