Conferences: Overcoming a failure to communicate
'Informed consent is not just a document, it's a process.'
The quote above is a familiar truism of human subjects protection. Nevertheless, many institutions still spend a lot of time grappling with the documentation of informed consent and precious little looking at how well the process of informed consent actually informs and prepares subjects for making a decision about research participation.
A Seattle team decided to look more closely at this problem, sitting in on dozens of informed consent conferences between investigators and parents who were considering enrolling their children in studies.1 They looked at how well those conferences informed parents about fundamental human subjects protection issues voluntariness, risks and benefits, the difference between research and treatment.
Mary Beth Foglia, RN, PhD, MA, an ethicist at the National Center for Ethics in Health Care of the U.S. Department of Veterans Affairs in Seattle, says the goal was to adapt quality improvement (QI) principles to informed consent practices.
"QI is an integral part of health care operations and should be for research, too," she says. "This study offers one approach to identifying and addressing ethics quality gaps in research activities."
Critical gaps uncovered
The 33 informed consent conferences included in the study all were conducted at Seattle Children's Hospital in 2006. They involved a range of studies, involving some children with life-threatening diseases and others with chronic medical conditions that were not life-threatening.
Each conference was observed by a research and family liaison (RFL) from Seattle Children's Hospital. The hospital developed the role of RFLs to help families navigate the informed consent process. The RFL development team also created a consent conference observation tool (CCOT) that allowed RFLs to rate each conference based on the degree to which the presenter verbally explained the necessary information for informed consent to the family.
The results showed that nearly all of the conferences included an explanation of the voluntary nature of participating in a study and the difference between research and treatment. But other elements were not as consistently explained in conferences:
- In more than a third of the conferences, RFLs believed the risks and potential discomfort associated with the research were not explained to families;
- In two-thirds of the conferences, the presenter did not explain steps that would be taken to protect confidentiality in the studies;
- More than 80% of the time, presenters did not provide an explanation of whether and how families would receive research results, who to contact with questions, what payment or incentive might be given or potential costs or expenses to families.
The RFL observers also assessed the communications skills of the presenters. Presenters overall got good marks for helping parents feel at ease, trying to use understandable language and encouraging families to take the time they needed to make a decision.
But the RFLs believed that most of the presenters did not assess parents' understanding of the information, either through asking them questions or a teach-back method of some kind.
Changing the environment
In addition, the RFLs' field notes raised issues about the environment in which the conferences were held. Often, they noted, conferences were held in patient rooms, sometimes with the other occupant (and the occupant's visitors) present, which potentially exposed personal information to others.
Presenters and families were frequently interrupted during the conferences either for care-giving activities for a patient or when the presenter or child's physician was paged. And families often were asked to enroll in a study while they were still processing the news about a life-threatening diagnosis.
"There is some evidence that the timing of the discussion can affect understanding and understanding is the job of the researcher to ensure, from an ethics point of view," Foglia says.
In cases where time is of the essence, there may be methods researchers can use to revisit the decision in 24 or 48 hours, she adds. Taken with other improvements, such as teach-back or moving the conference to a more private place, this might address some of the issues raised in the study, Foglia says.
Investigators have shown interest in the results from this study so RFLs have included it in their education programs aimed at helping researchers better communicate with families, notes Halle Showalter Salas, MPhil, one of the two RFLs at Seattle Children's Hospital who conducted the assessments.
"We had the oncology group [at the hospital] ask us to come to their meetings and review what we were learning as this went on," Salas says. "They were very interested to hear what we were finding with their group. The fact that they invited us gives you some idea that they did see value in what was being discovered."
She says the RFLs also presented the information to the hospital's IRB as part of a larger effort to raise IRB members' awareness of informed consent issues.
Research programs should look at developing internal quality improvement programs to continually assess and improve in the area of ethics practices, Foglia adds.
- Foglia MB, Salas HS, Diekema DS. A Quality Improvement Approach to Improving Informed Consent Practices in Pediatric Research. J Clin Ethics 2009;20(4):343-52.