Consent Forms for Multi-Center Research
When first submitting a consent form for a multi-center protocol, sponsors and CROs should clearly identify all placeholders for site-specific information within the template consent form. Placeholders should be formatted using red font and enclosed in brackets (e.g., [Insert Site Name]).
Providing clearly formatted placeholders supports accurate and efficient incorporation of site-specific details. Please note that if required site-specific information is not provided at the time of the Investigator’s initial submission, delays in processing of the site-level consent form and initial review may occur.
Once the Board has reviewed and approved a consent form for a multi-center protocol, the IRB will provide an approved version of that form, unless the submitter provided alternate instructions. Reliance on the previously approved version can significantly reduce the processing time and result in more rapid receipt of approval documents. By using the consent form template, you can be confident that you are starting with the most recent IRB and sponsor-approved language, thereby ensuring accurate version control, while saving you time and effort. WCG IRB will generate a consent form for the PI by incorporating any institutionally required language that has been provided to the IRB and the site-specific information such as payment information, etc. into the previously approved consent form template.
Site-specific information which must be provided on the WCG IRB submission form includes:
- All telephone numbers for the consent form, including a 24-hour number for emergencies (for research that is greater than minimal risk).
- Payment for participation information. Indicate either “no payment” or provide a statement explaining the payment plan as you would like it to appear in the consent form (amounts, visits not paid, when payment will be made). Please double-check your math, and please submit to us the exact wording you would like to have used. Misunderstandings concerning the research payment plan are a major source of corrections and research participant complaints. Also, please be sure your payment plans agree with the sponsor’s preferences, if any.
To determine if a previously approved consent form is available for a particular protocol or request to preview it, contact Client Care at 1-855-818-2289 or check the ClinSphere® eReview Manager page for that protocol (your sponsor or CRO contact can grant you access). If you require customized language, track (redline) your changes on the approved informed consent so we can easily identify your site-specific customizations. Please manually track your changes and do not use Word’s “compare” feature to create your redlined consent form, as this may result in more holds and a longer processing time (the compare feature often introduces extraneous formatting changes, duplicative changes, or other changes that are not meaningful, and potentially reverses Board-directed changes).
We require the use of IRB-approved informed consent(s) for initial review submissions of new principal investigators (PIs).
WCG IRB Template Consent Form Maintenance:
In order to ensure WCG IRB’s approved consent template always contains all the current and correct information about the research, any time we receive updated protocol information, risk profile changes, or consent form changes that impact the template, the Board will make the necessary changes to the template and provide the sponsor/CRO with the updated consent form. Please note that if we receive information that affects the template from a site, we do not routinely place that change on hold and request sponsor or CRO approval to proceed with the template update. This ensures that we are able to make the necessary changes to the template without delay. If you have questions or concerns about this policy, contact WCG IRB Client Care at 855-818-2289, or e‑mail clientcare@wcgclinical.com.