HS-IRBs News February 2012
Health Sciences and Minimal Risk IRBs, IRB News / Volume 4, Number 2, February 2012
New FAQs Now Posted
Several new FAQs have been posted to the HS-IRBs website, including some that provide brief overviews of key human research protection program (HRPP) policies. The new FAQs include the following:
- Document 22427 is unavailable at this time.
- Can changes of protocol be submitted for exemptions?
- What are the criteria to be engaged in human subjects research at UW-Madison?
- What are the Human Subjects Research training (and other training) requirements?
Important Consent Form Language Reminders
On March 7, 2012, the FDA requirement to include language in consent forms about listing trials in clinicaltrials.gov goes into effect. We
thought we would take this opportunity to remind you of other recent changes in
language requirements that are frequently missed in consent forms submitted to the HS-IRBs:
- Signature Page: On the signature page of a consent form, the signature line for the person obtaining informed consent should read "Signature of Person Obtaining Consent." Do not label the line "Signature of Physician or Person Obtaining Informed Consent." Also keep in mind that a separate signature line for the PI is NOT needed.
- Genetic Research: If
a study involves genetic testing of samples collected from subjects, information about the risks of genetic testing as well as about the Genetic Information Nondiscrimination Act (GINA) (and its limitations) should be included. See the Genetic Information Nondiscrimination Act (GINA) document for template language regarding GINA.
- Contact for Complaints About Research: The section of the consent form that describes whom subjects can contact about the rights of research subjects also should provide a contact for complaints about the research study that could not be resolved with the research team. For the Health Sciences IRBs, this contact is the UWHC or UWMF patient relations offices. The HS-IRBs Consent Form Templates have been updated to include this information.
- Commercial Products: If a study involves the potential for samples or information from subjects to lead to development of a product that could be patented or sold for commercial gain, the consent form needs to inform subjects of this possibility. See the Commercial Products Language document for standard language to include in consent documents to describe the development of commercial products.
- 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.’’
Coming Soon to ARROW: Ability to Check Human Subjects Research/CITI Training for Study Team Members
This spring, a new activity will be added to ARROW that will allow study teams to check the human subjects research/CITI training status for all study team members listed in the IRB application. The information provided about training in ARROW will include whether a study team member has completed the training, which course was completed, and expiration date for training certification. After this functionality becomes available, study teams will be expected to check the training status of all study team members prior to submitting initial review applications or personnel changes to the HS-IRBs. A FAQ about how to use this new activity will be available soon. If you have questions about this new ARROW feature in the interim, please contact Carol Pech at firstname.lastname@example.org.
Personnel Change Reminders
When submitting personnel changes, study teams should keep the following in mind:
- Study team members MUST complete the required human subjects research/CITI training course before they can begin conducting research activities and the personnel change can be approved. Study teams should check the training status for personnel being added using the campus lookup system available here: https://my.gradsch.wisc.edu/lookups/citi/trainingStatus.html. NOTE: Training certifications do expire, so study teams should ensure that all study teams members' training certifications are current.
- Study team members added to a study may begin study activities before a personnel change is approved if they meet the criteria described in the Personnel Change Guidance . NOTE: This does NOT apply to changes in PI, which must be submitted as full changes of protocol.
IRBs are audited, too: The Office for Human Research Protections (OHRP) Begins Audit of UW-Madison
UW-Madison was recently informed that OHRP is beginning
an audit of the institution. OHRP is the federal agency that regulates the
protection of human subjects that participate in research funded by the
Department of Health and Human Services (DHHS). The audit is “not for cause”,
which means that OHRP will conduct a general inspection of the UW’s human
research protection program. The audit will focus on IRB function and initially involve a review of HRPP-related documents (e.g., policies
and guidelines, information about IRB members and staff, and a list of
DHHS-supported studies). OHRP may
conduct interviews of research teams as well as a site visit in future. The last
time OHPR visited UW-Madison was in 2000.
In addition to the new OHRP audit, the HS IRBs have undergone 5 audits since 2006. Audits can affect what the IRBs ask for and how regulations are interpreted. Researchers frequently wonder why IRBs ask them to answer so many questions in the IRB application. These questions are to designed to help the IRB obtain sufficient information from study teams to assess and document whether a study meets the federal regulations governing human subjects research. Just like study teams, the IRB must be able to demonstrate to auditors the reason why it took the actions it did.
Reminder: Incarceration and Unanticipated Problem Reports
Study teams are reminded that if a subject enrolled in a research study becomes incarcerated, this must be reported to the IRB as an unanticipated problem in accordance with campus policy. For more information, see the campus Reporting Unanticipated Problems policy as well as the Unanticipated Problems/Adverse Event Reporting Decision Guide.
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.
- For 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.
- For 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.
- For assistance with ARROW or technical questions, email firstname.lastname@example.org.
- To receive the newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing email@example.com.
- To receive updates about WIRB, 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.