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Preparing Consent and Authorization Documents When Relying on an External IRB Review
Version: March 2019
When study teams rely on an external IRB for studies that will enroll subjects at UW-Madison or UW Health and written informed consent will be required, they will need to prepare consent and, if applicable, authorization documents that include institutionally required language. This document describes how to prepare these consent and authorization documents, which should be submitted with any request to cede IRB review to an external IRB. NOTE: This guidance does not apply to studies reviewed by independent IRBs or NCI CIRB.
Instructions for Preparing Consent Documents
- Please start with the model consent template, which should be provided by the lead study team. If you have not received a consent template, please contact the lead study team and ask them to provide the template to you. For multi-site studies where no consent template was provided, use the Health Sciences IRBs consent templates found here.
- Adjust the lead site consent template using track changes to include site specific information and UW-Madison institutional language as described below. Submit the proposed consent with the Request to Cede IRB Review to an External IRB in ARROW. For an overview of the roles related to preparing consent documents when relying on an external IRB, see the SMART IRB Guidance on Inserting “Local Context” Language in Informed Consent Documents.
- When reviewing requests to cede IRB review, the HS IRBs Reliance Team will review the documents to ensure the required consent elements and any institutionally required language have been included. NOTE: This same process can be followed for preparing assent documents. Generally, UW-Madison can accept the assent process approved by the reviewing IRB. In Wisconsin, the age of majority for most treatments or procedures is 18 years of age. For questions about state law, please see Issues in Human Subjects Research When State Law May Apply.
- If a study falls under the revised Common Rule, the consent should include a concise and focused presentation of the key information at the beginning of the document.
- No institutionally required language may be needed unless the below apply to your study. Please see our website for required language for the following items:
- UW Hospital policy 4.24 requires a copy of the consent to go into the medical record, unless an IRB determines otherwise. If a UW Health medical record will be created for subjects or subjects already have a UW Health medical record, specify whether information will or will not be put into subjects’ medical record.
- For informed consent templates that ask or allow for site specific confidentiality language, and/or authorization language, please see “Physical Risk Template plus HIPAA” here for model UW language.
- Please determine whether the sponsor will pay for research-related injuries and choose the language from the UW-Madison consent template under “What happens if I am injured or get sick because of this study?”
- Note that the UW-Madison study team is responsible for ensuring that any compensation for injury language in consent documents is consistent with any language in the funding agreement or contract supporting that study which addresses compensation for injury.
- If child or elder abuse or neglect could be identified through study activities, please include language as applicable from the additional language table for "Home Visits, Abuse/Neglect Reporting."
- If anyone on the study team has a conflict of interest which has a management plan, include language as applicable from the additional language table for "Conflicts of Interest."
- The reviewing IRB may make changes to this requirement, as appropriate per Conflict of Interest Policy.
- In addition to the minimum institutionally required language, other areas of a sponsor/lead site consent template may need to be altered to include UW-Madison recommended language if these items are not otherwise addressed in the consent template. These items include, but are not limited to, language related to adventitious findings, registration on clinicaltrials.gov, a certificate of confidentiality, sponsor and funding sources, commercial products, genetic testing, whole genome sequencing, tissue or data stored for research, and ICH-GCP guidelines. For UW-Madison model language related to these areas, please see Informed Consent: Additional Model Language.
- For a quick reference chart of required consent language, click here.
Instructions for Preparing Authorization Documents:
- As with the consent document, the lead study team will typically provide relying study teams with an authorization template or combined consent and authorization template. The HS IRBs will accept either format. In the event the lead study team and/or reviewing IRB does not provide a template authorization document, the UW-Madison templates should be used.
- The Reliance Team will review the authorization language to determine whether the required elements are present, but no other institutionally-required language is typically needed.