Alternate Consent Processes

The FDA has provided guidance on Alternative Methods of Obtaining Informed Consent (see section E.2). “Methods other than a face-to-face consent interview may be acceptable if those methods allow for an adequate exchange of information and documentation, and a method to ensure that the signer of the consent form is the person who plans to enroll as a subject in the clinical investigation or is the legally authorized representative of the subject. For example, the consent form may be sent to the subject or the subject's legally authorized representative by facsimile or e-mail, and the consent interview may then be conducted by telephone when the subject or subject's legally authorized representative can read the consent form during the discussion. After the consent discussion, the subject or the subject's legally authorized representative can sign and date the consent form and return the document to the clinical investigator by facsimile, scanning the consent form and returning it through a secure e-mail account, or by posting it to a secure internet address."

The IRB also applies this FDA guidance to non-FDA-regulated research.

Before you obtain consent from participants remotely (for example, by phone, video call, or another online platform), you must describe your process in the protocol and get IRB approval. If your protocol doesn’t already mention remote consent, or if you want to switch from one remote method (like phone) to another (like video), you need to update your protocol. If participants will come to the NIH for screening or research, you must also explain why you want to use remote consent. If you only need remote consent for a short time and for a few people (such as during a pandemic), you can use a single patient planned deviation form instead of changing the protocol.

Try to make the remote consent process as similar as possible to in-person consent. This means you should have a real-time conversation with the participant to explain everything and answer questions. If you plan to let participants read the consent form on their own and only contact you if they have questions, you must explain why this won’t affect their understanding of the study.

Remote consent must follow the same rules and policies as in-person consent. This guide gives you an overview of what the IRB wants in your protocol, but it doesn’t cover every rule.

NIH Policy 301 describes all the requirements for obtaining informed consent.

In your protocol, clearly explain:

• If you will give the consent form to the participant before you talk to them about it
• Whether you will send the form electronically or on paper
• Where the participant will be during the consent process
• How you will protect the participant’s privacy during the process
• How much time participants will have to decide if they want to join the study
• If you will allow participants to talk with others (like family, friends, or their doctor) before they agree
• Which method or online platform you will use for remote consent (for example, phone, Zoom, etc.)
• If you use video or another online platform, make sure it meets NIH security requirements (ask your IT Security Officer for help)

If you plan to use a telehealth platform to obtain consent, review the NIH Intramural Telehealth requirements first.

Unless the IRB says otherwise, you must get a signed consent form from the participant before you start any research activities. You need to check that the participant has signed and dated the form before you do anything else. There is one exception: If the IRB has approved you to collect information or samples (like a survey, blood, or cheek swab) by mail or online and the consent form comes back with them, you still can’t use or look at the data or samples until you get and check the signed consent form.

If you do all consent steps remotely, you may need to get consent electronically. Not all electronic consent methods use an e-signature. “Electronic consent” means you give the consent form to the participant in an electronic way. “Electronic signature” means the participant signs the form by clicking a field, and the system creates a digital signature. Using electronic signatures can mean you have to follow extra rules.

If your study is FDA-regulated, your electronic system must meet 21 CFR, Part 11 rules. For more information, see the FDA guidance on electronic systems, electronic records, and electronic signatures in clinical investigations.

If the participant signs by writing their name with a finger, stylus, or mouse, this is fine and not considered an electronic signature. But it is NOT okay for the participant to just type their name in the signature field. If you want to use true electronic signatures for an FDA-regulated study, your system MUST meet 21 CFR, Part 11 standards.

If you use an electronic system for signatures, you need to describe all of this in your protocol:

• Name the electronic platform you will use (for example, iMed, DocuSign, Adobe), and whether it meets 21 CFR, Part 11 requirements
• Explain how you will get signatures from both the participant and the investigator (for example, will you both be looking at the same screen? Will you sign at the same time or separately?)
• Say whether you will use a true electronic signature or a signature with a finger, stylus, or mouse
• If you plan to use a true electronic signature, explain how you will check the participant’s identity before they sign. Part 11 rules say you must confirm who the person is before you accept their electronic signature.