Frequently Asked Questions
- Q: Should I submit the sponsor templates for informed consent form(s) along with the “tracked changes” document(s)? A: No, to avoid any confusion that an unmodified sponsor template might cause, please do not send these documents with your submission.
- Q: Should I include the UW Hospital/UW Medical Foundation patient relations contact information for questions about research subject rights, which is required for studies reviewed by the UW Health Sciences IRBs, in informed consent documents sent to WIRB for review? A: No, WIRB requires that WIRB contact information be included regarding questions about subjects’ rights. Do not include the UW Hospital/UW Medical Foundation patient relations contact information.
- Q: I'm working on an initial submission for an upcoming research study. There is a main study and an optional sub-study. Is there a requirement that sub-studies have their own separate consent form or is it possible to combine the main study and sub-study into one consent form? A: No, UW nor WIRB require the optional sub-studies to be described in a separate consent form.
Consent Check List
- Q: How can I tell if banked samples are truly de-identified (as opposed to being coded)? A: The samples are likely truly de-identified if the link between the code and the samples is destroyed or if the protocol states that subjects will not be able to withdraw their permission for the use of donated samples because their specimens cannot be identified in order to withdraw them. If the protocol indicates that a code will be maintained, this suggests that someone will still be able to link identifiable information to the samples and, thus, the samples cannot be considered de-identified.
- Q: Do I need to mention we will be collecting payment W-9 information in the HIPAA authorization document? A: No, this is no longer necessary. The UW’s Business Services has updated its policy on Payments to Research Participants. This policy outlines the payment mechanisms that can be used to pay subjects and when gathering tax information from research participants is required. Of note, this policy clarifies that if information, such as Social Security Number, will only be collected to pay subjects and not for the research study otherwise, this information does not need to be disclosed in the consent and HIPAA authorization documents. If study teams are required to collect tax information from subjects, they are recommended to have participants complete a form, which is maintained separately from research records, to obtain relevant information and that also alerts the participant that the payment will be reported by the UW to the IRS.
- Q: The submission of this study is time sensitive; am I required to have the Principal Investigator (PI) signature on the WIRB Application before submitting the application for UW institutional review? A: The PI signature is required on the WIRB application to demonstrate that he or she has reviewed and agrees with the submission of the study materials prepared and is taking responsibility for the study. The Reliance Team cannot take any action on a submission that is not signed by the UW PI.
- Q: The submission of this study is time sensitive; am I required to have negotiations complete for the Clinical Trial Agreement (CTA) in order to submit the application for UW institutional review? A: No. It is up to the study team whether they wish to move forward with WIRB review prior to having a finalized CTA in place.
WIRB Connexus Portal
- Q: Connexus requires an IND document to be uploaded for submission; I don’t have a separate IND document for the study, what do I upload in WIRB Connexus? A: When the sponsor/CRO has not provided a separate document that provides the IND number(s) for the study drug(s), upload the study protocol into WIRB Connexus to address this requirement if the protocol includes the IND number. If the study protocol does not include the IND number, the sponsor will need to provide a document attesting to the IND number issued for the study.
- Q: When I look at the “Site Participants” listed in WIRB Connexus there are people I don’t know. Why are they listed with the study? Should I delete them? A: Our institution, the sponsor, or CRO may have administrative employees that require access to the study. At the UW, there are administrative staff that must have access to all studies to provide institutional oversight (e.g., members of the Reliance Team in the Health Sciences IRBs Office). Please do not delete any staff that you are unfamiliar with. WIRB carefully monitors and assigns access to your study to ensure that only necessary stakeholders are allowed access to your study. If you have concerns about who is listed on a study, please contact email@example.com.
Leave of Absence
- Q: If the Principal Investigator is taking a short-term leave of absence (e.g. maternity leave), what should be submitted to WIRB? A: WIRB requests an email be sent to Client Services providing the name of the Principal Investigator, study numbers, explanation of the leave (including length), and the plan proposed for a designee to be named in the short term. It is the IRB’s decision from the information provided to allow the designee to step in for the short term, or to require that a change of principal investigator take place.