HS-IRBs News - September 2009
Health Sciences and Minimal Risk IRBs, IRB News / Volume 1, Number 9, September 2009
Federal Requirements for IRB Review of Grants
Federal regulations require that each grant application or proposal for Department of Health and Human Services supported human subjects research be reviewed and approved by an IRB. As part of this review, IRBs are required to ensure that the activities described in the grant are consistent with the proposed or IRB-approved protocol. Any discrepancies between the IRB protocol and grant must be resolved before the grant can be approved for addition to the research study.
Although this is not a new federal requirement, the University’s office of Research and Sponsored Programs recently identified several cases where researchers were unaware that specific IRB approval of federal grants is required. Here are some helpful hints should you have federally funded research:
Submitting Federal Grants with New IRB Applications:
- When submitting a new application to the IRB for a study that will be supported by federal funding (including studies that may qualify for exemption), provide a copy of any federal grant that will support the research described in the IRB application.
- If federal funding is still pending when a new IRB application is submitted, note this in your application. Should the funding be finalized during the review process, please inform the staff reviewer handling the protocol and provide him or her with a copy of the grant.
Adding Federal Funding to an IRB-Approved Study (Non-Exempt):
- For non-exempt human subjects research, submit an expedited change along with a complete copy of the grant. The expedited change should list the principal investigator on the grant as well as the grant number and title. In addition, please note in the expedited change application whether the grant application includes any new activities not previously approved by the IRB.
- If only specific aims of the grant fall within the scope of the IRB protocol to which the grant is being added, please note this in the expedited change application. Similarly, if additional IRB applications will be submitted to cover some components of the grant, also note this in the expedited change.
- Please note: if the grant describes activities that are not already approved by the IRB, a full change of protocol that updates the study protocol (e.g., adding new procedures or expanding the subject population) is generally required instead of an expedited change. A complete copy of the grant should be submitted in this case as well.
Adding Federal Funding to an IRB-Approved Study (Exemptions):
- For exempt human subjects research, send an email to the IRB staff reviewer who handled the exemption and indicate new federal funding has been obtained and provide a copy of the grant. The reviewer will then ensure that the activities described in the grant match those with the exemption application and work with the research team should any questions arise. The IRB staff reviewer will then send the research team an email confirming the review and acceptance of the addition of the grant.
Federal Funding and New Personnel
- When new personnel need to be added to the study as part of the new funding, submit a Personnel Change Form in addition to a change of protocol.
- When new collaborations with researchers who are not under UW purview will occur as a result of the new funding, clarify in the change of protocol whether the other sites’ IRBs will approve the collaborators’ activities or whether you will seek for the UW to serve as IRB of record for all involved.
Other Ways to Meet RSP and Federal IRB Requirements
- If you do not have any immediate plans to conduct human subjects research (e.g., year 1 of the grant constitutes a planning phase), need IRB approval of the study concept for the funding agency, or require IRB approval to effect the release of funds from Research and Sponsored Programs (RSP), submit an Application for IRB Review of Proposal for Protocol Development Activities (PDA) to the IRB. This application is brief and generally allows sponsors and RSP to release funds to begin activities that do not involve human subjects, such as hiring study staff and writing IRB applications. The PDA should be followed, generally within 1 year, with the submission of an Application for Initial Review of Research Involving Human Subjects.
- In some cases, such as for cooperative group or training grants, the funding agency requires IRB approval and ongoing review of the grant itself. In these instances, please submit an Application for Initial Review of Research Involving Human Subjects. This application allows researchers to forgo most of the questions that apply to actual research studies.
ARROW Sneak Peek 10/28/2009
As part of an “Afternoon with ICTR” event, IRB office staff will be providing a brief overview of ARROW as well as a sneak peek of the system. The event will be held from 12:30-3:30 on 10/28 in the HSLC. The schedule is currently being finalized, so please consult the ICTR website for additional information as the date draws nearer.
ARROW: Beta Testers Needed
Internal testing of ARROW for bugs and additional development of the system continues at a quick pace. After internal testing is complete, the HS-IRBs office will move toward alpha and beta testing. We are still looking for volunteers to help us with beta testing, which we expect to begin late this year or early next year. Following an initial training session, volunteers will be asked to commit between 2-4 hours per week for about 3 weeks. Beta testing will involve going through different parts of the system and helping identify bugs and other issues. This is a great chance to get early exposure to ARROW and provide feedback about the system. If you are interested in being involved in beta testing ARROW, please contact Carol Pech at firstname.lastname@example.org.
WIRB Educational Sessions
Western IRB on Campus Educational Sessions have been rescheduled for October 7 and 8, 2009. It is highly recommended that research staff attend these sessions.
- October 7, 2009 (Please note room assignments have been changed for 10/7/09 due to time slot popularity.)
- How to Use WIRBnet: Clinical Science Center (CSC), G5/11, 9am to 10am
- Certificate of Confidentiality (CoC) WIRB Presentation: Health Sciences Learning Center (HSLC), Room #1309, 1pm to 2 pm
- How to Submit an AE to the Western IRB: HSLC, Room #1309, 3pm to 4 pm
- October 8, 2009
- Certificate of Confidentiality (CoC) WIRB Presentation: Health Sciences Learning Center (HSLC) Room #1248, 8am to 9 am
- How to Submit an AE to the Western IRB: HSLC Room #1248, 9am to 10am
- How to Use WIRBnet: HSLC Room #1244, 3pm to 4pm
IRB Submission Tips
A recent change in Submission Cover Sheet format and reminder: All submission cover sheets submitted electronically should be sent in MS Word format (the website instructions will be updated) with a submission for IRB review. This change in requested document format is a result of internal fee processing in collaboration with OCT.
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 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 irbreliance.wisc.edu.
- Assistance with ARROW or technical questions, email firstname.lastname@example.org.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing email@example.com.
- WIRB updates, please sign up for the WIRB listsserv by emailing firstname.lastname@example.org 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.