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Office for Human Subject Protection
Office of the Vice President for Research

Remote Consent

Obtaining consent remotely is not necessarily a new notion in the conduct of human subject. However, the onset of the COVID-19 pandemic has resulted in a tremendous increase in the number of study teams seeking options for obtaining consent from subjects in a remote manner.

Study teams often assume that ‘remote consent’ equates to electronic consent (or e-Consent) but this isn’t always the case. Remote consent can be accomplished through a variety of approaches and which approach is best, will depend on the nature of the research.

 

Key considerations

First and foremost, in consideration of your consent process (remote or otherwise), it helpful to think of consent documentation as a separate, yet related, component of your consent process. The consent process generally includes assessing a subject’s interest in a study, disclosing the necessary information about the research to the subject, ensuring the subject understands the information, and obtaining the subject’s decision on whether or not to participate in the research. Whereas the consent document is only meant to act as a foundation for that exchange of information (providing a written version of the information that needs to be disclosed) and affords a place to document the subject’s agreement to participate in the research. The document is a part of the process, and is not the process in and of itself.

So, when considering remote consent for a study there are two key, processes to determine:

  1. How will information be exchanged between the potential subject and the study team (inclusive of the consent discussion and verification of the subject’s understanding); and
  2. How will the subject’s consent be documented?

Information exchange strategies

Remote consent discussions can take place over the telephone or via remote video conferencing (e.g., Zoom). Additional written or multi-media materials, including the use of an e-consent platform, may be used to further supplement or facilitate the consent discussion. Under limited circumstances (e.g., when the research involves only minimal risk and no subject interaction), written or multi-media materials may be used in lieu of the formal consent discussion.

Ultimately, whichever strategy is employed, it is critical to understand that the same consent requirements set forth in the federal regulations (45 CFR 46; 21 CFR 50) that apply to in-person consent discussions, still apply when the consent process is conducted remotely. This includes:

  • Obtaining consent prior to participation in the research;
  • Providing sufficient detail about the research (i.e., the information needed for a reasonable personal to make a decision about participation), including basic and additional (as applicable) consent elements and excluding any exculpatory language;
  • Providing information in a language that is understandable to the subject; and
  • Providing sufficient opportunity to consider participation, including reading the consent form, discussing the subject’s participation, and answering any questions.

It is critical to note the use of the word ‘discussion’ in this context. For a consent process to be successful, regardless of the media used to disclose information about the research, study teams need to ensure they are able to provide an opportunity for a back-and-forth conversation with the potential subject. Certainly this can be accomplished when consent discussions take place over the telephone or via remote video conferencing. But care must be taken in circumstances where there is little (or no) interaction with the potential subject (e.g., online surveys).

More specifically, study teams must ensure that potential subjects are provided the opportunity to ask questions to the study team about the research prior to providing consent.  In other words, subjects should be instructed to contact the study team with questions and direct contact information must be provided.

Interacting with study subjects via Zoom

When using Zoom to interact with study subjects (or potential subjects) precautions must be taken to ensure adequate protections are in place to protect the privacy of the subject and the confidentiality of any data collected during the Zoom session.

Keep the following points in mind:

  • Only use your University of Rochester (UR) Zoom account (as opposed to a personal account) to create and log into study-related meetings. If the research is being conducted under the University of Rochester Medical Center (URMC) and Affiliates covered entity, the URMC HIPAA-compliant log-in must be utilized.
  • To secure the session, at a minimum, it should be locked once all attendees have joined the meeting to prevent uninvited attendees from joining. To lock the session, the host can click ‘Participants’ in the meeting toolbar and then select ‘More’ and ‘Lock Meeting’.
  • If the session requires recording, be aware of what folder the recording will download into on your computer following completion of the meeting. Recordings must be stored in the manner described in your IRB-approved study protocol and in compliance with University of Rochester IT requirements. Based on the computer used for the Zoom meeting (e.g., personal vs. UR computer) and your Zoom settings, the recording may automatically download to your desktop. Recordings that download to a location inconsistent with your IRB-approved protocol, must be moved to a location that aligns with your IRB-approved protocol immediately. All files remaining on the desktop must be subsequently deleted (including permanently deleting the files from your computer’s recycle bin).

Additional information regarding University Zoom access and security is available on the University IT website.

Want to use a different video conferencing platform? Utilizing a video conferencing platform other than Zoom is permitted provided the platform undergoes review, and receives approval, in accordance with the University’s Guideline for Human Subject Research Data Security Requirements.

Documentation strategies

When conducting consent remotely, consider the following options for documenting consent.

Waiver of Documentation of Consent

Federal regulations (45 CFR 46; 21 CFR 56) permit Institutional Reviews Boards to waive the requirement to obtain a signed consent under specific circumstances. To clarify, this waiver applies only to the documentation (e.g., signature) component of the consent process; it does not waive the requirement to obtain consent entirely. In remote consenting scenarios, this is often applied when/if verbal consent will be obtained from a study subject (e.g., via telephone or video conferencing) or when there is no direct with potential subjects (e.g., online surveys). To qualify for the waiver, the study protocol must clearly indicate that the waiver is requested and provide adequate justification for how the research meets waiver requirements. The Reviewing IRB will also likely require that written information about the research be provided to the subject (e.g., via an information sheet). Reference OHSP Policy 701: Informed Consent for additional information.

E-Consent

Generically, e-consent provides a mechanism to share written or interactive information, evaluate subject comprehension, and ultimately document consent electronically. It can be used in a variety of manners, as well in both in-person and remote consent scenarios. Based on the platform utilized, subjects can document their consent to participate by typing or ‘signing’ their name into a signature field using a mouse, stylus or finger. Of note, in addition to consent-related regulations, research utilizing e-consent is further subject to:

For information on how to use REDCap for e-consent, reference the University’s Guideline for Using REDCap for Electronic Informed Consent. Note: REDCap is not compliance with 21 CFR 11 and therefore cannot be used to obtain consent for studies subject to FDA regulations.

Posted Mail/E-Mail/Fax

Consent forms may be mailed, e-mailed or faxed to subjects for ‘traditional’ handwritten signatures and then returned back to the study team for signature by the person obtaining consent. Careful consideration and forethought must be paid to how subjects will be instructed to complete and return the form and what resources they may need in order to do so (e.g., a printer for emailed consent forms and self-addressed stamped envelopes for returning the completed document). Lack of (or unclear) instructions commonly result in consent documentation errors (e.g., incomplete checkbox options, missing signature dates).

Federal requirements

As with the information exchange strategies identified above, federal regulations (45 CFR 46; 21 CFR 50) also set forth documentation-related requirements that apply when informed consent needs to be documented (i.e., when the research does not qualify for a waiver of documentation of consent and consent is obtained in-person, electronically or via posted mail/e-mail/fax). These requirements specify that consent documentation must include the handwritten or electronic signature of the subject and a copy of the form must be provided to the subject.

FDA and HIPAA regulations and guidance, as applicable, further require the subject to date the form and for the person obtaining consent to sign and date the form (similarly, OHSP Policy 701: Informed Consent indicates that the Research Subjects Review Board will consider when the signature of the person obtaining consent is required).

Customizing your strategy

Once you’ve weighed your information exchange and documentation options, customize your overall remote consent strategy by selecting the options that will best meet the needs of your research. When doing so, consider:

  • What methods will be most accessible and feasible for your study population (e.g., utilizing e-consent and/or remote video conferencing requires a computer or smart device and internet access, as well as a certain level of computing skills)?
  • What is an appropriate level of interaction is with a potential subject, based on the nature of the research, to assess and ensure their understanding of the research (e.g., greater than minimal risk and more complicated minimal risk research may require multiple conversations, through multiple mediums, over time to ensure understanding)?
  • What level of identity verification might be necessary in order to confirm that consent is obtained from the appropriate individual and ensure the validity of the data? E-consent platforms, as supported by FDA guidance, will generally require subject identity verification prior to consent. Internet-based research (e.g., online surveys) may similarly need to consider subject authentications strategies in order to minimize misrepresentation (reference OHSP’s Guideline for Computer and Internet Based Research for additional information).
  • For research that does not require the collection of identifiable information, consider requesting a waiver of documentation of consent over written or e-consent. Written or e-consent minimally requires the documentation of the subject’s name, signature, and IP address (for e-consent) and therefore negates that anonymity of the data.

As a final step, ensure that your consent process, inclusive of the information exchange and documentation strategy is clearly detailed in your study protocol. As a reminder, all consent processes must be approved by your Reviewing IRB prior to implementation (including modifications or additions to already approved consent processes).

Related resources

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