Q&A: Informed Consent in Medical Research
new methods of obtaining consent are offering options that can bridge the geographic distances between researcher and participant, while making study information more easily accessible.
In most medical research, informed consent has been accepted as ethically essential, despite being a relatively new concept in the United States.1,2 Technological advances have permitted us to improve the process by which informed consent is obtained.
In addition, new methods of obtaining consent are offering options that can bridge the geographic distances between researcher and participant, while making study information more easily accessible.
Recently, these innovative approaches were highlighted in a review article, written by Christine Grady, RN, PhD, from the Department of Bioethics, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, Maryland, and colleagues, and published in the New England Journal of Medicine.1
Dr Grady spoke with Clinical Pain Advisor on the issue of informed consent, the advent of digital and electronic consent, and how the newer modalities are helping to bring the consent process into the 21st century.
Clinical Pain Advisor: Could you please describe the primary goal of informed consent in medical research?
Dr Grady: In my view, the main goal is to give people the information they need to make decisions as to whether or not to participate in medical research. In certain circumstances, the participant may have difficulty providing their own consent, which puts the responsibility on the investigators to find other ways to protect them. For instance, in some cases, a legally authorized representative can give permission for an individual to be part of a study if they are not able to consent for themselves.
Clinical Pain Advisor: Can you briefly explain the process for traditional paper informed consent?
Dr Grady: In most situations, informed consent is obtained before a study participant enters research. It usually involves face-to-face meetings with the participant, in which researchers explain the study and offer a written consent document to be read and signed once ready.
Part of the reason we wrote the review article was because in contemporary times, certain kinds of research are being conducted in which the investigator never meets the participant in person, and in some cases has little-to-no interaction with him or her. So the question is, how do you think about consent in those spaces? Part of what has also happened is we now have a lot of information technology, which creates interesting opportunities for exchanging information in creative ways that could potentially substitute for face-to-face consent.
Clinical Pain Advisor: In what ways does the traditional process impede medical research?
Dr Grady: One could argue that sometimes proximity is a problem. It takes time to get enough people to come to a particular location, or to find and recruit them in a way that allows for face-to-face interaction with the researcher. Certain models for doing internet-based research now exist in which participants themselves go on to a portal, find information about the study, read or watch a video about the study, and decide whether they want to participate. If they decide to get involved, they can do an e-consent and contribute their data periodically over the internet. This process allows for the inclusion of many more people from many different places. However, not every study could be conducted that way.