Listening to the voices of research in the New Year

By Elisa Hurley, PhD, education director

As we begin the New Year, I continue to reflect on themes that emerged during the 2010 Advancing Ethical Research Conference in early December. There is one theme in particular that I keep coming back to: listening to the voices of research participants. As well-meaning as we are in the human subject protections field, when we are faced with the mounting pressures to push research forward, to adhere to increasingly complex regulations and guidelines, and to manage overloaded IRB dockets, we may forget to listen to those we are tasked to protect. We were reminded again and again at the 2010 AER Conference the true value of the voices of research participants.

During the panel Hot off the Presses: Selected Abstracts on Innovative HRPP Programs and Research on Research Ethics, Susan Trinidad of the University of Washington gave a presentation titled Informed Consent in High-Throughput Genomic Research: Views of Health Plan Members. She and colleagues conducted focus groups asking people what they would like to see covered in consent forms for genome-wide association studies (GWAs). Many of us in the session were surprised to learn that, while information about the study purpose was important to respondents, information about risks—primarily risks concerning disclosure of identifying information—was not of particular interest or importance to them. In fact, they were more concerned about the risk of disclosure of their private banking information from routine financial transactions.

This finding is striking in the context of informed consent. From the conference’s first debate, Be it Resolved that Consent Forms are an Obstacle to Informed Consent and Should be Abolished onward we heard repeatedly that the current process for obtaining and documenting informed consent is in need of a major overhaul. Consent forms get longer and more complicated every year, and yet, as Dr. Ezekiel Emanuel pointed out in his plenary, the forms do not get any better at disclosing information relevant ito making an informed decision about participating in research. Part of the problem, it seems, is that consent forms contain information investigators think participants ought to know, rather than the information that potential research participants want and need to know. The work of Ms. Trinidad and her colleagues suggests that the research protections community’s ongoing struggle to develop meaningful informed consent would benefit from conducting more empirical research on what is truly important to potential participants; in other words, from listening to the voices of those whose consent is required.

The most common sentiment Ms. Trinidad and her colleagues heard in their focus groups was “we just want to be asked.” Participants were less concerned with the details of a study then with the idea of being asked, and thereby being shown basic respect and appreciation for their willingness to participate. How would the lives of Henrietta Lacks and her family have been different if she, or they, had just been asked their permission for keeping , replicating, and distributing Ms. Lacks’ tumor cells? How different would the Havasupai tribe’s relationship with medical researchers be if they had been asked to specify the kinds of DNA research for which they would allow their blood samples to be used? Listening seems like such a simple thing; perhaps, every once in a while, we just need to be reminded of its concrete value.