Multimedia consent

There may be circumstances where it is appropriate to provide consent materials in alternative formats as a supplement to, or replacement of, traditional consent methods. The Medicines & Healthcare products Regulatory Agency (MHRA) and the HRA have produced a joint statement on the use of electronic methods for seeking and documenting consent in research. These include the use of multimedia such as videos, websites, audio, text, graphics, and podcasts, where consent is sought through smartphones, computers, or tablet devices.

Researchers should carefully consider the needs of their participant populations when deciding what methods to use when providing consent materials, for example some participant groups may be uncomfortable accessing consent materials only through a mobile app. Consent gathered electronically or otherwise must adhere to the principles of GCP and researchers should be confident that participants have made an informed decision during the consent process.

Multimedia tools may be useful for researchers using tiered (also called proportionate or layered) consent. Tiered approaches to consent involve providing information in enough detail to satisfy the requirements of adequately informing participants without providing so much information as to overwhelm them. An example of using multimedia and tiered consent would be an electronic consent module directing a participant to a separate link to further information. This gives the participant agency in deciding whether they will seek further, more detailed information (ie more layers) or if they are satisfied with the information they have been provided.

Trials using health systems data may consider multimedia consent to allow participants to visualise how their data will be used, where it will be stored, what it will be used for, and how it will be kept safe. Trialists may also consider using multimedia tools to explain the lawful basis for data processing and the rights of the participants.

I think using a layered or step-by-step approach to consent might make it easier for participants, especially those who feel overwhelmed by too much information at once. 
PAG member