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Informed consent is an ongoing job
Don't completely rely on a template form
Tracy Arwood, MS, director of research compliance at Clemson University's office of research compliance in Clemson, SC, has dealt with a variety of consent issues over the years, including handling informed consent of college students and from community leaders. She offers this advice about how to improve the informed consent process to IRB Advisor readers:
IRB Advisor: How might institutions support continual informed consent?
Arwood: Every institution should have templates, a form, or script for obtaining the required informed consent elements. In addition, they should continually provide informed consent education.
Every single educational opportunity we offer, whether it's on-line or face-to-face, we stress that informed consent is a process, an ethical requirement, a part of the Belmont Report, and that informed consent is the ethical basis for responsible conduct of human research. We teach people that it's a process, and we use a form that conveys information about the study, but informed consent doesn't start with that form.
You tell investigators: "When you start a conversation with a subject you're recruiting, you begin the informed consent process at that point because you're giving them information they'll use to make a decision. And you have to be consistent, so the IRB will check your recruiting materials, script, flier, emails, or whatever you have along with the informed consent document."
So we touch on that with every opportunity we have and at every teachable moment.
IRB Advisor:What are the chief problems you see with principal investigators and the informed consent process?
Arwood: I think it's a challenge to many researchers, and this is true in both the biomedical and social-behavioral fields, to communicate to subjects about the study, using lay terms and using language that is meaningful and actually provides the information that's needed.
I think we're all used to writing in a certain way, based on what we do on a daily basis. We're trying to develop ways to communicate that information in a meaningful way, and this is challenging across the board.
First-time student researchers might have difficulty using lay language or really understanding how the elements of informed consent fit together, so their informed consent documents will seem somewhat choppy, or the recruiting materials won't match the consent document.
There is some flexibility in the regulations, and informed consent should be a meaningful process rather than having investigators completely rely on a template form and a standard procedure for doing something that's pretty complex and extremely important.