Clinical Pain Advisor: In addition to internet-based consent, how else has the process of informed consent changed with the technological developments of the 21st century?

Dr Grady: In general, recent advances are giving us the opportunity for more creative ways of exchanging information. The limitations of a piece of paper with a lot of words on it are fairly obvious. However, if you take that same information and put it in an interactive format that allows the participant to read it in pieces and answer questions along the way, the possibility of engaging with and absorbing that information, at least in theory, goes up. So this creates opportunities that might help people understand the information better than they have in the past with written forms.


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One example is app-based consent, which is really interesting and promising, particularly for certain age groups and people who regularly use their smartphones. This modality offers a great way to engage these individuals, and, for researchers, provides a new tool for our toolbox.

Clinical Pain Advisor: What do you believe is the most promising alternative to paper-based informed consent?

Dr Grady: It depends on the circumstances of the study, including what the study is about, how many people are needed in it, and what kind of participants are appropriate. So age matters, computer or technological literacy matters, and culture matters, among other things. For me, the electronic and digital alternatives provide different tools for investigators that allow them to tailor the approach and information to a particular participant pool, which is a good thing. Nevertheless, I do not believe there is just 1 modality that everyone should use.

Clinical Pain Advisor: Is there still a debate about which of the modalities are the most effective?

Dr Grady: One of the major points I tried to make in the part of the article I wrote was that we need evidence to know what modalities work best in what setting. For example, there are some data on strategies to improve understanding in the context of informed consent. Some of the older data suggest that videotapes and interactive computers do not make a difference.3,4 There are some newer data that suggest study information comprehension is improved using certain engaging methods, but the time it takes to do the consent process is increased.5 Ultimately, what we need are data to say in what circumstance does the interactive approach to providing information increase comprehension and satisfaction, and is therefore worth the cost and time, and in what settings does it seem to make less of a difference or no difference.

Clinical Pain Advisor: Going forward, what steps should be taken to improve the informed consent process?

Dr Grady: If we believe it is important for people to understand study information to give consent to participating in research, then we need to find strategies that will enhance understanding. Data suggest that understanding of study information is at best variable and is often quite limited,6 so we need to do better. One possible direction for future research is to test these new technologies and ways of obtaining informed consent to see whether they, in fact, have the capacity to increase understanding among participants. Personally, I think some of them will, while some might be dependent on the population and culture.

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References

  1. Grady C, Cummings SR, Rowbotham MC, McConnell MV, Ashley EA, Kang G. Informed consent. N Engl J Med. 2017; 376:856-867. doi: 10.1056/nejmra1603773
  2. Faden RR, Beauchamp TL. A history and theory of informed consent. New York, Oxford: Oxford University Press, 1986.
  3. Flory J, Emanuel E. Interventions to improve research participants’ understanding in informed consent for research: a systematic review. JAMA. 2004;292(13):1593-1601.
  4. Nishimura A, Carey J, Erwin PJ, Tilburt JC, Murad MH, McCormick JB. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. BMC Med Ethics. 2013;14:28. doi: 10.1186/1472-6939-14-28
  5. Rowbotham MC, Astin J, Greene K, Cummings SR. Interactive informed consent: randomized comparison with paper consents. PLoS One. 2013;8(3):e58603.
  6. Mandava A, Pace C, Campbell B, Emanuel E, Grady C. The quality of informed consent: mapping the landscape. A review of empirical data from developing and developed countries. J Med Ethics. 2012; 38(6):356-365. doi: 10.1136/medethics-2011-100178

This article originally appeared on Clinical Pain Advisor