Multi-Site Considerations

Consent forms (CFs) need to contain NYSPI-IRB required language in certain sections (see subheading Template Language), and need to conform to the NYSPI-IRB format.  However, beyond that, the CFs provided by the sponsor of a multi-site trial sometimes contain elements that the NYSPI-IRB does not usually favor.  For example, CFs sometimes contain lists of all the procedures carried out for each study visit, going on for many pages.  The NYSPI-IRB typically favors shorter consent forms.  The NYSPI-IRB’s main concern is that overlong CFs interfere with the informed consent process, by providing a document where the important issues of risk and alternatives and so forth can get lost in all the details. However, the NYSPI-IRB will consider accepting such elements (such as long lists of procedures) if it is justified and offset by other features.  For example, a clearly worded Cover Summary Sheet helps to provide potential participants an overview before launching into the details of the main consent.   Also helpful are explicit details in the PSF about the consent process and how sufficient time will be allotted for review and discussion of the CF.