The IRB, when approving research, is required to ensure that informed consent will be sought from each subject, or subject representative, as required by federal regulations (that’s the fourth criterion for approval), and that consent will be appropriately documented to the extent required by the regulations (the fifth criterion).
We’ve said it before, and we’ll say it again – informed consent is a process. It’s not a form. IRB reviewers are encouraged to think creatively about informed consent when reviewing research. What’s the best way to approach and present information to the particular population being studied?
Many consent forms we see are 20 or more pages long and include a lot of technical-sounding language. In this day and age, reading long documents may no longer be the primary way of receiving information for some populations. While a complete written consent document may be required for some research, there may be cases where the IRB feels it would be helpful to provide information in a different format, such as via a simplified brochure or multimedia presentation, to supplement the required form. There are also occasions where some or all of the requirements of the usual informed consent process or document can be waived — see IRB Policy 15.3 for details. Consider also the description of the informed consent process included in new submissions. If you don’t feel the proposed process is adequate, please feel free to mention that at the meeting and to discuss ideas for possible improvements.