This document is produced by the CEAL Inclusive Participation Group for investigators and trialists as best practices to maximize engagement, dispel misinformation and foster trust. The priority populations for these trials are minorities and the elderly.
The purpose of informed consent it to ensure that a volunteer can make an informed choice about
taking part, or continuing to take part, in a clinical study. It is a process that is required by the Federal
Code of Regulations and is described in both the FDA (Food and Drug Administration) regulations and
the Office of Human Research Protection (OHRP) regulations.
Informed consent begins with the recruitment and screening of a volunteer and the signing of the
consent document and continues throughout the volunteer’s involvement in the research and even
after the study ends.
To summarize, Informed consent process needs to include active listening, “teach back”, and use of
open-ending questions throughout the process in order to increase trust and retention. The consent
process culminates by creating rapport.
Tell Volunteers Upfront WHAT IS in the Consent?
· A statement that the study involves research, an explanation of the research’s purposes and the
expected duration of the volunteer’s participation, a description of the procedures to be
followed, and identification of any procedures that are experimental.
· A description of any reasonably foreseeable risks or discomforts to the volunteer.
· A description of any benefits to volunteers or to others.
· A disclosure of appropriate alternative procedures or courses of treatment.
· The study is VOLUNTARY and will NOT affect the medical care in any shape or form.
· A clear statement that this is voluntary “The main reason for you to do this is to help people like
you in the future prevent/treat COVID”.
· They can withdraw at anytime.
Building Rapport with Priority Population
· Let them know how much you appreciate them taking time to be part of the study/research
· Clear communication that this is research, and the purpose of the research (e.g., “We’re trying
to see if this helps prevent infection with the coronavirus”).
· Always remember that they are doing us a favor by being in the study and if you are sincere in
your intention, it will show in your conversations in them.
· Ask them open ended questions like what do you understand? Do you have any specific
· Using the “teach back” method: Have them repeat their understanding of the study back to you.
That will help you address any miscommunication.
· Address Tuskegee and other studies if they come up, by owning it and saying they are the
reason there are all the regulations and processes now to ensure their safety. We have come a
· Always leave them with the consent for at least 10-15 minutes after going over it so they can
process it on their own.
· Pause after your questions to give them time to formulate their responses.
· The consent process should be conducted in the language spoken by the volunteer and the
consent form should be translated into that language.
· Volunteers who are not literate in their language must have an interpreter present to explain
the study to the volunteer and translate questions and answers between the volunteer and the
person obtaining consent.
· Assessing volunteer’s literacy using REALM or similar instrument.
· Use videos for getting informed consent that show all the steps in detail.
· Addressing specific concerns as inclusion of various populations so vaccine/drug results are
focused on them.
· For elderly make sure to listen to all their concerns related to various medications and co-
· Give the volunteer multiple options to consent so that they can make informed decision with
their loved ones and family if so desired.
· Consent sent ahead of time so volunteer and family can familiarize themselves.
· Option to do zoom meeting or phone call with family if they are at different places.