HS-IRBs News May 2013
Health Sciences and Minimal Risk IRBs, IRB News / Volume 5, Number 5, May 2013
HS-IRBs Staff Update
The HS IRBs Office has had the privilege of counting Gemma Gliori amongst its staff since she joined the office in 2008 as a staff reviewer. Gemma has accepted a position in the Department of Radiology as their regulatory specialist. The good news for us is that we will be able to continue working with her and will benefit from the application of her knowledge and skills to IRB submissions from that department. The sad news for us and the wider research community that works with the HS IRBs is that we are losing a wonderful colleague who took the mission of customer service seriously and went out of her way to assist study teams, IRB members, and her co-workers. Gemma, we will miss especially your intelligence, humor and kindness. Please join us in wishing Gemma the best in her new position.
Tips for Completing Continuing Review Applications
To help ensure the continuing review process goes as smoothly as possible, please keep the following tips in mind when preparing a continuing review application:
- Information provided in the continuing review application should be consistent with the previous continuing review application or the initial review application (whichever is most recent). This is especially important for subject enrollment and record or specimen collection numbers. If you are unsure where to find the previous continuing review, please contact the ARROW helpline for assistance.
- Study teams are responsible for reviewing all correspondence received from the IRB, which may include specific requests for additional action like submitting a change of protocol. When preparing a continuing review, study teams should review the study file to ensure that all IRB requests from the past year have been addressed.
- For studies involving investigator's drug brochures (IDBs), any IDB logs submitted with a continuing review should be a running list that is updated yearly rather than a list of only those IDBs not previously reported since the last continuing review.
If you have any questions about the continuing review process, please contact Jessica Johnson or Carol Pech.
Improved Training Snapshot Activity in ARROW
The Record Human Subjects Training activity in ARROW now displays the names of anyone on the study team who has not completed human subjects research training, has expired training certification, or has taken the required training without using a netID. The names will display in the history tab after the snapshot activity is used.
Study teams must use the snapshot activity when submitting a new application or a personnel change. All study team members must have current human subjects research training certification before a new application or personnel change can be approved.
Update: Submitting IDBs at Continuing Review
Per HS-IRBs guidance, study teams may submit IDBs (investigator's drug brochures) at continuing review if the IDB does not contain new risk information. As a result, these revised IDBs are uploaded only in the continuing review application and not in the initial review application. In some cases, sponsors have requested that the study team “move” these IDBs from the continuing review application to the initial review application, which requires the study team to submit a change of protocol.
Rather than submit changes of protocols that are otherwise not needed, study teams are advised to direct sponsors to the appropriate continuing review application for documentation that the IDB was reviewed by the IRB. If the sponsor requests additional documentation after being directed to the appropriate continuing review application, please contact the IRB for further assistance.
Updates to VA Template Consent and Authorization Forms
Updates were made to VA Template Documents . The VA HIPAA authorization template was revised to change the title from “VA Consent Form” to “VA Authorization Form” and now contains highlights to better direct study teams to the sections that require either revision or insertion of language.
The VA consent template also has been revised to address the following:
- Addition of a study sponsor section. VA regulations require study sponsors to be identified in consent forms.
- Wording was included for FDA-regulated studies. The FDA requires that consent forms for research under their purview state the following: “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.”
- A line to capture the date the person obtaining consent signed the document was added. The VA requires this date to appear on the consent document when the IRB requires signed consent. This line was inadvertently dropped from an earlier version of the template.
The template also was recently revised to reference language that should be included if study teams are paying subjects or if they are using the UW’s OnCore system to manage the study and store subject data.
Reminder: ARROW Helpline Voicemail Support Ended
As previously announced, voicemail support for the HS-IRBs' ARROW helpline has been phased out. We will continue to provide email support for ARROW through email@example.com. ARROW guidance documents also are available on the Health Sciences IRBs ARROW Help page.
- 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.