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HS-IRBs News May 2014
Health Sciences and Minimal Risk IRBs, IRB News / Volume 6, Number 5, May 2014
HS-IRBs Office Closed on Memorial DayThe
HS-IRBs Office will be closed Monday, May 26th in observance of
Memorial Day. The ARROW helpline also will not be staffed on May 26th.
Tips for Handling Study Team TransitionsWith the end of the academic year upon us, some researchers may be leaving the UW. The following tips may be helpful in handling these study team transitions:
- Update the List of Study Team Members: Study team members who are leaving the UW and will no longer be involved in the conduct of a study must be removed via a personnel or other change of protocol. For additional information, see Principal Investigator Changes and Personnel Updates Guidance .
- Clarify IRB of Record Issues: UW-Madison IRB review does NOT automatically cover someone who leaves the UW, but continues to be involved in the conduct of a study open at the UW. Study teams who wish to keep someone on the study team after they leave the UW should contact firstname.lastname@example.org for assistance.
- Consider Whether a PI Change or Study Transfer Is Needed: Study teams may need to submit a change in PI if the current PI is leaving the UW or make arrangements for the PI to retain PI status at the UW for up to one year in order to complete the study. PIs leaving the UW also may wish to consider transferring IRB oversight for their study to another institution. For additional information, please see How do you change the responsible principal investigator (PI)? or email email@example.com for assistance.
Consent Document Changes and Changes of Protocol
When submitting a change of protocol that includes revisions to the consent documents, please include the following information in the change of protocol form:
- Will these changes result in suspension of enrollment for the study?
- If not, be prepared to provide justification as to why a halt to enrollment is not necessary.
- Will these changes require re-consent of study subjects (both those currently on study and those who have come off study)?
- Even if no subjects have been enrolled AND enrollment is NOT being halted, study teams must still address whether re-consent is required as it is possible that subjects may be enrolled while the the change of protocol is under IRB review.
- When addressing re-consent in the change of protocol form, keep the following in mind:
- Provide a timeline for when subjects will be re-consented (e.g., at the next in-person study visit).
- Study teams are generally expected to orally inform subjects of any new risk information prior to formal re-consenting. The study team should document this communication in the subject's research file.
- If subjects are not re-consented within the time frame provided by the study team, a noncompliance report may be required.
The following is an example of language that could be used by study teams in the Informed Consent section of the Change of Protocol form:
“Enrollment to the study will not be halted while this change in risk information is being reviewed because we do not think the new risk information substantially alters the risks for subjects. The new information will be conveyed to study subjects orally, while we wait for the revised consent forms to be approved. Once the revised consent forms are approved by the IRB we will formally re-consent study subjects at their next in-person study visit. Subjects who are no longer on study do not need to be re-consented as this new risk information will not affect these participants (i.e., this risks are not late effects of the drugs).”
Please see Re-Consenting Subjects Guidance for additional information.
ARROW Outage May 31st
ARROW will be offline for scheduled maintenance on Saturday, May 31st from 1PM to 5PM. We apologize for any inconvenience.
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