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HS-IRBs News - November/December 2009
Health Sciences and Minimal Risk IRBs, IRB News / Volume 1, Number 11, November, December 2009
The HS-IRBs office has held several sneak peek demos of ARROW for research personnel and we would like to thank everyone who took the time to attend. We received a lot of good questions and feedback about ARROW was quite positive. IRB staff are currently conducting unit testing of ARROW (e.g., reviewing the various applications, checking system functionality for agenda and minutes creation) and will begin alpha testing in early January.
IRB Fee Increase
Marc K Drezner, MD, Senior Associate Dean for Clinical & Translational Research sent out a memorandum earlier this fall alerting research investigators to changes in the Health Sciences Institutional Review Boards (HS-IRBs) Fee Schedule for those protocols reviewed by the Western Institutional Review Board (WIRB). On June 1, 2009 WIRB modified its Fee Schedule instituting a separate charge ($300) for each consent form submitted as part of an initial review beyond the first consent form. The fee applies to the first site for a protocol reviewed by WIRB or any subsequent site that uses consent forms that are in addition to those already approved by WIRB. The Information Sheet required by the Clinical & Translational Research Core is not considered a consent form. As a result of the changes in WIRB fees, the following changes to the HS-IRBs Fee Schedule have been made:
- The HS-IRBs Fee Schedule will now differentiate fees based on which IRB is being utilized (HS-IRBs or WIRB). At this time, the HSIRBs will not impose the new consent form fees mandated by WIRB.
- Effective January 1, 2010, a fee of $325 will be charged for each consent form beyond the first submitted at the time a protocol is sent to WIRB for initial review when the UW is the first site to have submitted this protocol to WIRB. This fee also will be applied if the UW is not the original site reviewed by WIRB for the study, but the UW research team submits additional consent forms not approved by WIRB previously for prior sites. For example, the fee would be assessed for any substudy consent forms that are in addition to the consent document for the main study.
An application specifically designed for researchers doing non-exempt medical records research is available. This application is available to researchers who are planning a study that does not qualify for exemption (e.g., the medical record data is not currently in existence or the researcher wishes to maintain a link to identifiable information). This application can be used for research studies that solely involve the collection of medical information from medical records (including radiological imaging records) and databases or follow-up medical information from the research subject. If the research study involves any other activities, such as a medical procedure, analysis of tissue, the creation of a research database, or if the researcher is serving as a reading center, statistical analysis center, or core lab this application cannot be used. In these cases, a full Application for Initial Review of Research Projects Involving Human Subjects should be submitted to the IRB.
Tips on Filling Out the Personnel Change Form
The Personnel Change form can be used to add or remove key personnel and to change the point of contact for a research study. Please keep the following in mind when completing this form:
- This form should not be used to add individuals to a study that fall under the purview of another IRB (e.g., collaborators at another institution). Personnel from another institution can only be added using the Personnel Change form if the UW has agreed to serve as the IRB of record for that site.
- Personnel Change forms generally should not be submitted for research that has been determined to be exempt from further IRB review.
- Please ensure that personnel being added have completed required human subjects protection and HIPAA Privacy Rule training. The following are reminders about what training is required.
- All UW personnel must complete human subjects protection training via the CITI platform.
- UW personnel can take the VA human subjects protection training instead of the CITI modules the UW requires.
- Researchers who interact with veterans or view health information about veterans are generally required to take the VA human subjects training.
- CITI training does not include HIPAA Privacy Rule training. Anyone who is within the Health Care Component of the UW is required to take the UW HIPAA Researcher Training
- If someone views protected health information from both UW and VA subjects for a research study, both UW and VA HIPAA Privacy Rule training must be completed
- Please make sure the questions on page 3 of the form are completed if new staff are being added. These questions are often not recognized as being part of Section C.
HS-IRBs Office Holiday Schedule
During the holidays, the HS-IRBs will be closed on certain days. As such, the continuing review deadline for the 1/12/10 HS-IRB meeting is unusual. In addition, WIRB coverage will be affected.
- Please note that the HS-IRBs office will be closed on the following days:
- December 24-25 (UW-Madison holidays)
- December 30 (UW-Madison required furlough day)
- December 31-January 1 (UW-Madison holidays)
- Reduced WIRB coverage
- Starting December 21, 2009 through January 1, 2010 there will be very limited coverage for WIRB related institutional review and assistance from the UW-HS-IRBs office. If you require immediate assistance please contact the WIRB Institutions Help Desks with all questions of substance (which are non-UW requirement or process questions) at 1-866-956-2467 or 1-800-562-4789 for all very general WIRB questions. If you need immediate assistance with any WIRB UW requirements or processes please contact our main phone line 263-2362 and ask to be directed to the WIRB Point of Contact.
- The Western IRB will be closed on December 25, 2009 and January 1, 2010.
- Unusual IRB deadline
- For Protocol Progress submissions to be reviewed at the 1/12/2010 IRB meeting, please note the submission deadline is Wednesday 12/23/2009 due to the Christmas holidays.
- 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.