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HS-IRBs News May 2012
Health Sciences and Minimal Risk IRBs, IRB News / Volume 4, Number 5, May 2012
HS-IRBs Office Closed on Memorial DayThe HS-IRBs Office will be closed Monday, May 28th in observance of Memorial Day. The ARROW helpline also will not be staffed on May 28th.
Update: Checking Human Subjects Research Training/CITI Certification
As mentioned in the March and April newsletters, a new activity in ARROW is now available for study teams to check human subjects research training/CITI certifications for all study team members. The new Record Human Subjects Training Snapshot activity lists
training expiration dates for all study team members listed in the IRB
application. It also will display in the History tab whether any study
team members do not have the required training or have expired human
subjects research training certification.
Per campus policy, all PIs are responsible for ensuring that study team members have completed the required human subjects research training. Beginning June 4th, study teams will be expected to use this activity before submitting any new applications or personnel changes. If the History tab for a submission indicates that a study team has not used the Record Human Subjects Training Snapshot activity, the study team will be asked to do so via a reviewer note during IRB administrative review or IRB pre-review. For information on how to check training certifications in ARROW, see [Link for document 23550 is unavailable at this time.].
NOTE: If a study team member's training information appears to be inaccurate or incomplete in the list generated by the Record Human Subjects Training Snapshot, please email firstname.lastname@example.org. Training information may need to be manually updated by the HS-IRBs Office for study team members who took the training without using their UW-Madison netID and password.
New Guidance Documents on the Scientific Review and IRB Pre-Review Processes Now Available
Two new guidance documents describing what happens to an IRB application during the scientific review and IRB pre-review processes have been posted to the new investigators page of the HS-IRBs website:
- What Happens After an Application Is Submitted to the Health Sciences or Minimal Risk IRB: Scientific Review
- What Happens After a New Application Is Submitted to the Health Sciences or Minimal Risk IRB: IRB Administrative Review and IRB Pre-Review
Reminder: Keep Your List of Study Members Current
HS-IRBs guidance requires that study teams report the removal of
study personnel within one (1) month of the removal of any personnel
from the study, regardless of their role. No additional steps are
required for the removal of personnel not affiliated with
UW-Madison, UWHC, or Madison VA, or who do not fall under UW-Madison IRB
purview. Study team members who leave the UW and who are still listed as study team members often have expired human subjects training certification. These expired certifications can cause delays in processing personnel changes. For more information on when to submit personnel changes, see Principal Investigator Changes and Personnel Updates Guidance .
Guidance - new or revised - will be forthcoming soon on the following topics and announced in future newsletters:
- Reporting drug shortages
- Time frames for submitting changes of protocol
- Revised HS-IRBs Guidelines for Deferring IRB Review
- 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 email@example.com. 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 firstname.lastname@example.org.
- Assistance with ARROW or technical questions, email email@example.com.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing firstname.lastname@example.org.
- 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.