Health Sciences and Minimal Risk IRBs, IRB News / Volume 3, Number 8, August 2011
In observance of the Labor Day holiday, the HS-IRBs office will be closed on Monday, September 5th. The ARROW helpline also will not be staffed on September 5th.
From September 27th through 30th, 2011, UW-Madison will host a site visit by AAHRPP, the accreditation body for the UW-Madison's Human Research Protection Program, which encompasses the four campus IRBs.
The site visit involves interviews of UW-Madison personnel and review of IRB records. Currently, AAHRPP has identified 140 UW-Madison personnel for interviews, including study team members, IRB members, IRB staff, compliance staff, ICTR and SMPH personnel, research center directors, and members of the UW-Madison administration. The Office of Research Policy, Graduate School, is in the process of contacting interviewees by email to confirm the availability of each selected interviewee. Interviews will be held at Bascom Hall.
The IRB offices and/or the Office of Research Policy will contact interviewees over the next 3-4 weeks to set up group and individual sessions to help interviewees prepare for the site visit interview. The final agenda and all prep session materials will be posted on the HRPP website.
information, please call the Office of Research Policy at 608-265-2800 or email
During the first week of August, the HS-IRB underwent a detailed FDA routine surveillance inspection. These inspections typically occur every 5 years and the last inspection of the HS-IRB had been in 2006. The FDA auditors reviewed HS-IRB policies, guidance, procedures, and IRB records (including those in ARROW). The audit was very successful, with the FDA making only a few recommendations for improvements. These changes will not be implemented until later this fall and will be announced in future newsletters.
A new activity has been added to ARROW, called Edit Administrative Access. This activity can be used by study teams to grant read-only access to the IRB application in ARROW to administrative personnel NOT engaged in human subjects research AND who are affiliated with UW Madison/UW Health/Madison VA. Such administrative personnel may include financial or departmental administrators. Study teams do NOT need IRB approval to use this activity. For more information on how to use the Edit Administrative Access activity, please see this FAQ: Accessing ARROW for Administrative Personnel at UW-Madison Not Engaged in Human Subjects Research
As part of the revisions to the HS-IRBs website, a new section
will soon be added to the homepage of the website. This section will include a
list of the most frequently asked questions received by the HS-IRBS office,
including both IRB and ARROW related topics. This FAQ section will include a
brief answer to the question as well as links to other relevant documents. The addition of FAQs to this new section of the website will be announced in future newsletters.
The Office of the Secretary of the Department of Health and Human Services (HHS) is proposing revisions to the federal regulations governing human subjects research (i.e. the Common Rule). The proposed revisions are broad and HHS is inviting the public to comment on the potential changes. The comment period is open until September 26, 2011.
A summary of the proposed revisions can be found here: http://www.hhs.gov/ohrp/humansubjects/anprmchangetable.html.
The full description can be found here: http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18792.htm
When preparing a change of protocol, please remember to use only the Upload Revisions button when uploading revised documents in the IRB application in ARROW. Do not use the Delete button unless you intend to completely remove the document from the study (e.g., no longer using a flyer to recruit subjects, removing a study arm and no longer need the relevant consent document for that arm). For more details on how to upload revised documents to the IRB application, please review this FAQ: [Link for document 17339 is unavailable at this time.] .
The HS-IRBs office has heard from several study teams that they find the newsletter to be a useful resource for getting updates and information about the HS-IRBs. We are always looking for new ideas for the newsletters, however, so please let us know if you have topics or suggestions for future newsletters. Please email your suggestions to Carol Pech at firstname.lastname@example.org.
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.