While the elements of consent are consistent for research, the setting in which consent is obtained varies depending upon the study. There are times when an in-person consent process is not feasible. In these cases, the IRB will consider if a remote consent process is appropriate and acceptable.
Telephone Consent and Consent Using Facilitated Technology (e.g. Zoom)
Research does not need to be specifically approved for telephone consent; however, the research team must ensure they have resources to obtain a signed consent form prior to the research subject completing any study related activities unless the study has been granted a waiver of documentation of consent. When consent is done remotely, the requirements are the same as if the research team were conducting the consent process in person. The research subject or LAR should be provided a copy of the consent document. After having the research team provide the potential subject or LAR information about the study, the subject/LAR should have an opportunity to ask questions and be given adequate time to make an informed decision about participation.
Faxing of Signed Consent Forms
When consent is conducted over the phone or using facilitated technology (e.g. Skype), it is permissible for subjects to fax a signed copy of the consent form to the research team. If there are questions and/or check boxes embedded throughout the document for the subject to complete, the research team should check to ensure that these pages are included. Good Clinical Practice (GCP) or other guidelines may require that the study team receive a complete copy of the signed consent form. In cases where subjects are faxing a consent form to the research team, the subject need not provide the investigator with the original signed consent document.
Online Consent
For web-based surveys or questionnaires, the consent form may be presented online, and require participants to perform some action, such as clicking “I agree,” before proceeding with any research activities (e.g., answering survey questions on a website). This is an acceptable approach for minimal risk research conducted online. However, be aware that this method does not document informed consent and therefore may only be used if the IRB has waived documentation of consent for the study.
For research that poses more than minimal risk, the research team should consider how they will be able to evaluate a subject’s understanding of the procedures and risks related to their participation. Tools to evaluate this understanding could include a comprehension quiz requiring a score of 100% in order to proceed, or the provision of contact information of a member(s) of the study team, in order to enable direct communication for subjects who have questions or concerns, among other options.
Confirming Identities in Online Research
A study’s data validity or reliability could be fallible without verifying subjects’ identities. Examples include when there are critical eligibility criteria, or when there is a likelihood of repeat or fraudulent participation, whether for mischief or to collect multiple payments. When designing a research study, investigators should take into consideration the importance of identity to their study.
Studies that pose more than minimal risk, or that involve the transmission of sensitive information, may consider implementing a process by which they confirm identities using authentication that relies upon multiple factors, for example a password that is delivered to subjects by telephone or by postal service, or by using identity verification software.
For FDA-regulated studies, if any or all of the consent process takes place remotely and is not personally witnessed by study personnel, the electronic system must include a method of identity verification. Acceptable examples include state-issued ID, biometric methods, visual methods, or personal questions.
