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HS-IRBs News - July 2010
Health Sciences and Minimal Risk IRBs, IRB News / Volume 2, Number 7, July 2010
HS IRBs on Twitter!
As another way to reach out to the research community, the Health Sciences and Minimal Risk IRBs are now on Twitter. Follow @UW_HS_IRB for the latest IRB news, updates, website links, and ARROW information.
- The second phase of ARROW went live on July 14th with study teams from the Comprehensive Cancer Center, Family Medicine, GRECC, HIP, and Obstetrics and Gynecology. We wish to thank everyone involved in this second phase of rollout for their participation in the ARROW training sessions and their help in making this transition as smooth as possible.
- The final phase of ARROW rollout will occur later this fall. We expect to be offering ARROW orientation and training sessions later this summer, so please stay tuned to the newsletter and the HS-IRBs website for details.
- Are you not yet using ARROW and curious about the system? A variety of ARROW resources can be found on Health Sciences IRBs ARROW Help of the HS-IRBs website, including demonstration videos which provide a good idea of what the system looks like and how it works.
- ARROW users can get assistance with using ARROW by calling the Help Line (262-0041) from 9-3 Monday through Friday. Questions also can be emailed to email@example.com.
- ARROW Open Lab Sessions: We have added 2 open lab sessions in August (8/11 and 8/25) to provide in-person assistance to current ARROW users. Study teams are welcome to bring any questions they may have about ARROW to open lab sessions. Those planning to attend open lab sessions must register through the OHRD catalog.
HS-IRBs User Survey Now Available
The Health Sciences IRBs Office is conducting a survey of HS-IRBs users. This is a good opportunity for study teams to let us know how we are doing as well as how we can improve our services. We do appreciate your feedback, so please take a few minutes to complete the survey, which can be accessed via this link. Survey results will be reported in future newsletter issues.
VA Update: Separation of VA and UW-Madison IRB Applications
Effective immediately, study teams planning to conduct studies jointly with VA AND UW-Madison MUST submit separate IRB applications for the VA and UW-Madison components when they are distinct (e.g., study procedures for UW subjects only occur at the UW and those for VA subjects only occur at the VA). This requirement is being instituted primarily because of the increasing complexity of VA regulations as well as how compliance with those regulations must be monitored. This requirement will have several effects on the review process, including:
- No additional IRB fees will apply when submitting separate applications for the VA and UW-Madison “arms” of a particular study. Only the UW-Madison component of the study will be subject to IRB fees, as applicable.
- The IRB review process will be more straightforward for the UW-Madison component of joint VA/UW studies as VA regulations will not need to be applied to the UW component of these studies.
- Study teams using ARROW will be able to use the Copy Application activity to create a template application that can be modified to create a VA application, which will significantly reduce the amount of effort required by study teams to submit dual applications.
Research Involving Embryonic Stem Cells or Induced Pluripotent Stem Cells
The Health Sciences IRBs developed a decision tree to assist researchers in determining whether their protocol requires review by the campus Stem Cell Research Oversight Committee (SCRO) and/or an IRB. This tool, Stem Cell Logic Tree, is available on the HS-IRBs website under the Policies and Guidance page. The SCRO reviews any research that involves human embryonic stem cells or their derivatives and certain types of research that involves human pluripotent stem cells from non-embryonic sources,
FAQs: Can study teams conduct data queries after a study has been closed without reopening the study with the IRB?
In some cases, study teams may conduct data queries after a study has been closed (e.g., to respond to sponsor requests) without needing to reopen the study with the IRB. Data queries after study closure may proceed without reopening the study with the IRB if both of the following apply:
- The data being queried is limited to that originally collected for the study as specified in the consent and authorization forms signed by subjects and/or the study protocol. No new data may be collected after study closure without prior IRB approval. AND
- The data being queried is limited to the original timeframe during which data was collected for the study. No data outside the original timeframe for data collection can be queried after study closure without prior IRB approval.
- 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 firstname.lastname@example.org. 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 email@example.com.
- 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.
- 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.