HS-IRBs News August 2015
Health Sciences and Minimal Risk IRBs, IRB News / Volume 7, Number 8, August 2015
Changes in Western IRB (WIRB) and UW IRB Fees
Dean Marc Drezner, Senior Associate Dean for Clinical & Translational Research in the School of Medicine and Public Health (SMPH), recently issued two memoranda regarding IRB fees. One memorandum describes changes to the WIRB fee process and the other provides clarifications regarding the School of Medicine and Public Health's IRB fee policy for studies reviewed by a UW Health Sciences IRB. These new fee schedules go into effect September 1, 2015 and apply only to NEW studies submitted for WIRB or UW IRB review. Please note while all studies that are fully industry-sponsored are charged a fee for IRB review, only certain studies conducted by investigators under their SMPH appointments are assessed an IRB review fee.
The key changes for WIRB Studies are:
- The WIRB and UW IRB fee structures and processes no longer parallel one another. For new studies that qualify for WIRB review, industry sponsors will receive direct billing for reviews performed. The submission will be charged in accordance with the WIRB fee schedule in effect at the time of submission (or according to a fiscal agreement that the sponsor may have with WIRB). A one-time UW Institutional Compliance Review fee of $1500 will be charged at the time of initial review to offset the UW’s costs for processing these reviews
- For all studies submitted to WIRB on or after September 1, 2015, UW researchers must indicate the name and address of the Sponsor in the “Billing Information” section of the WIRB submission form. This information will alert WIRB to the industry partner that will pay WIRB fees. The WIRB Billing Verification form also must be completed and submitted in conjunction with other initial review documents.
The primary updates for studies reviewed by a UW Health Sciences IRB are:
- The fee for change in principal investigator has been reduced to the cost assessed for a change of protocol.
- The memorandum clarifies that IRB review fees will be not charged for studies wherein 1) greater than 50% of the funding is provided by federal or other non-industry sources and 2) indirect costs from these sources are 10% or greater.
- Other clarifications include the definition of student and trainee projects.
The new IRB review fee memoranda, as well as prior fee schedules, are available on the UW-Madison Fee Schedule page of the HS IRBs' website. If you have questions about these changes, please contact the HS IRBs' fee point person, Faye Levine (263-4922).
New: HIPAA Training Course Completion Information Now Available
Completion information for the new Learn@UW HIPAA training course is now available in the campus training record lookup tool.
Reminder about Upcoming Important Changes to Human Subjects Research Regulations
In 2011, the Department of Health and Human Services (HHS) issued an advance notice of proposed rulemaking regarding revisions to the federal regulations governing human subjects research (i.e. the Common Rule). Following a period of public comment, the proposed revisions have been making their way through the administrative approval process at the federal level. The next step will be for HHS to post the revised Common Rule for a final round of public comment.
Although it is not yet known when the revised Common Rule will be made available for public comment, researchers are advised to look for this announcement. The revised Common Rule will likely include changes that will affect a broad range of research and study teams may wish to comment on the proposed changes. When the revised Common Rule is posted for public comment, an announcement will be sent via the HS IRBs listserv as well as being posted on our website.
Update on Campus Post-Approval Monitoring Program
The Office of the Vice Chancellor for Research and Graduate Education launched the Post-Approval Monitoring (PAM) Program in March 2015. Under the PAM Program, active, non-exempt studies have begun being selected randomly for routine monitoring. To date, the PAM group has conducted over 45 reviews of studies approved by the HS and MR IRBs. Common issues noted in PAM reports include the following:
- Consenting subjects with expired or not the most currently approved version of consent documents
- Completing study procedures not previously approved by the IRB as well as omitting study procedures previously approved by the IRB
- Subjects consented by study team members not listed on the IRB application as key personnel
These are all examples of the types of events that need to be reported to the IRB as noncompliance. For more examples of issues that require reporting to the IRB, please see the following guidance documents on our website:
IRB Group Presentations Available
The HS IRBs office provides group presentations on topics of interests to researchers, staff, and students at the UW. The HS IRBs office is always looking to develop presentations based on the needs of the research community and can tailor presentations to the interests of each particular group making a request. Past presentations include performing research with children, incorporating the regulatory requirements into the design of research protocols, and strategies for ensuring adequate privacy and confidentiality protections.
If you would like to make a presentation request, please visit our presentation request page and complete the presentation request form. After the request form is received, you will be contacted by someone from our office to discuss your presentation request. Presentation requests should be made 4 weeks prior to the preferred presentation date. If you would like additional information about the presentations, please contact Jake Rome (firstname.lastname@example.org).
Due to upgrades and maintenance, ARROW will be unavailable September 19th, from 1PM to 5PM. We apologize for any inconvenience.
- 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.