HS-IRBs News-December 2011
Health Sciences and Minimal Risk IRBs, IRB News / Volume 3, Number 12, December 2011
HS-IRBs Holiday Office Hours
The HS-IRBs office will be closed December 26th in observance of the Christmas holiday and January 2nd in observance of the New Year holiday. The ARROW helpline also will not be staffed on these days.
Western IRB Holiday Office Hours and Closings
The HS-IRBs office will have no coverage for WIRB on December 26th, 29th, and 30th as well as January 2nd. Limited coverage will be available on January 3rd. Please note that the WIRB office also will be closed on December 26th and January 2nd.
2012 HR IRB and MR IRB Meeting Dates
2012 meeting dates for the HS and MR IRBs are now posted. Please see IRB Meeting Dates for a full list of dates.
Reminder: ARROW Helpline Available Via Voicemail Only
Effective December 5th, 2011, all calls to the
ARROW helpline are being directed to voicemail only. IRB staff will monitor voicemails from 9AM to
3PM Monday through Friday and will return all calls received before 3PM on that
same day. Calls received after 3PM will be returned the next business day. The firstname.lastname@example.org email help system continues unchanged.
The ARROW Guidance page of the HS-IRBs website also contains a variety of help materials, including FAQs and brief instructional videos. ARROW consultations and in-services continue to be available by request and study teams are encouraged to request training as needed. All training requests should be emailed to email@example.com.
Updated: Guidance on Presenting Changes of Protocol to the IRB
Study teams can find it challenging to describe changes of protocol, especially how changes affect the study as previously approved by the IRB. The HS-IRBs
Office has updated Policy and Guidance to reflect the ARROW forms and process for presenting
changes of protocol. The document explains the difference between the change
form and the modified application. This guidance also clarifies:
- IRB expectations about the types and level of detail required in the change form,
- what sections of the application may be affected by the change of protocol and require revisions,
- what documents should be updated as a result of the change, and
- where and how to upload revised study documents.
Revisions to Initial Review Application in ARROW
Several revisions to the ARROW initial review application were implemented on December 14th, 2011. Although many of the revisions are relatively minor, study teams should be alert to the following changes:
- VA Study Information Page: The
form no longer asks for a copy of the VA's endorsement letter or
date of VA R&D Committee review. This change has been made to
reflect the workflow between the HS-IRBs and VA R&D Committee. A
note also has been added to the top of the page to provide study teams with contact information for the VA R&D committee.
- Study Location Section: Several changes are being made to this section, including new branching that will require all study teams to indicate where at the UW their study activities will occur. Study teams participating in multisite studies that are not cooperative group or fully-sponsored industry trails will now need to provide a list of all participating study sites.
- Special Considerations and Procedures Page: The radiological imaging option has now been revised to be just imaging. This means that the imaging section now applies to all types of imaging (including ultrasound) and is not restricted to radiological imaging.
- Recruitment Methods Page: A new question has been added to this page to ask for a general description of the study's recruitment plan. Another question has been revised to ask more specific information about which ads will be posted where.
New FAQs Posted
Several new FAQs have been posted to the HS-IRBs homepage. Some of the new FAQs include:
- How can I tell if my study is exempt, and what categories of exemption can I choose from?
- What type of application do I need to submit to use samples/images/data for research purposes?
- When does something qualify as a Health Care Records Review Only application?
Please visit the HS-IRBs homepage for the full list of FAQs.
Coming Soon: Revised Multisite and Collaborative Research Webpage
HS-IRBs staff are in the process of revising the multisite webpage, including reorganizing the format and updating current guidance. New documents to be posted include a FAQ on exemptions (including not human subjects research projects) and multisite/collaborative research. The revised multisite research page will be announced in a future newsletter. If you have suggestions for the mulitisite and collaborative research page, please contact Carol Pech at firstname.lastname@example.org.
Updated: Commercial Products Language for Consent Forms
The HS-IRBs require specific language be
included in a consent form if any potential exists for tissue or blood samples
collected for a study to lead to a test, technology, cell line, or other
product that could be patented or sold for commercial gain. The [Link for document 18644 is unavailable at this time.] document has been updated to recognize that data
collected from research participants may be used in developing commercial
products, such as new software. Effective immediately, study teams should include the new language, when applicable.
New: FDA-Mandated Consent Form Language for Clinicaltrials.gov
The FDA adopted a new required element of informed consent in an effort to inform potential subjects that information about the study has been or will be entered into the publicly available database at www.ClinicalTrials.gov. Beginning March 7, 2012, studies that are FDA-regulated and require registration with www.ClinicalTrials.gov must include the following statement verbatim in the consent form: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.’’
Subjects who were enrolled in studies prior to this change in informed consent requirements do not have to be re-consented or sign a consent form addendum. The HS IRBs have created a new consent form template for FDA-regulated studies that includes this new language as well as other FDA-required language.
More information on which studies must be registered at www.ClinicalTrials.govcan be found at http://www.grad.wisc.edu/research/hrpp/ctregistration.html. More information on the FDA’s rule can be found at http://edocket.access.gpo.gov/2011/pdf/2010-33193.pdf.