Is there a specific format or template for the written documentation sites must provide when a site deletes or makes any substantive change to basic and/or additional elements as presented in the DAIDS-approved sample informed consent (SIC)?
There is no specific format or template. Examples of written documentation include but are not limited to the following:
- A memo from the Investigator of Record (IoR) or designee
- A copy of the submission letter from the site to the IRB/EC detailing the changes to the site-specific ICFs
- A copy of the letter(s) from the IRB/EC documenting queries and changes required to the site-specific ICFs
Can you provide examples of “substantive change to basic and/or additional elements”?
Examples of these changes may include but are not limited to: deleting risks, deleting sections that are in the DAIDS-approved SIC, stating that there is compensation for research-related injury when the DAIDS-approved SIC states that there is none, etc.
What if my IRB/EC requires language in the DAIDS-approved SIC to be removed or requires language to be added to our site-specific ICFs?
If an IRB/EC/RE requires language in a site-specific ICF specific to the institution or based on local regulations/requirements, the site should include that information in the site-specific ICF and must provide documentation from IRB/EC/RE regarding the required language in the site-specific ICF. However, even though an IRB/EC/RE requires language in site-specific ICF, none of the basic and additional elements found in the Sample IC (SIC) should be removed. Refer to the DAIDS RSC regarding the development of site-specific ICFs.
What if there is a pregnancy consent included in the DAIDS-approved SIC but my site only enrolls men. Am I required to submit a pregnancy consent?
No, only site-specific ICFs that will be used at the site are required to be submitted to the DAIDS PRO. However, the site should provide documentation stating that the ICF will not be used and why with the protocol registration submission to avoid delays or a disapproval.
If my site develops a long form and concise form and we only plan to utilize the concise form, am I required to submit both to the DAIDS PRO?
Yes, the long form and concise form should be submitted for DAIDS PRO review.
If there is information that affect subject participation as a result of protocol amendment /LoA, should the participants re-consented?
Re-consenting participants as a result of an amendment and/or LoA (Change or new information that may affect subject participation) is the decision of the CRS’s IRB/EC. CRSs should follow their IRB/EC/RE/Approving Entity instructions for re- consenting participants as a result of the amendment and/or LoA.