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The Clinical Research Ethics Consultation, a group of 40 bioethicists at 30 institutions, helps investigators resolve ethical issues that arise during research.
• Investigators want help in real time with ethical issues they’re confronting.
• Some participants are willing to consult with investigators from other institutions.
• Bioethicists use conference calls to present a range of opinions.
Institutional review boards (IRBs) typically give guidance to researchers only during the pre-study regulatory review process, but investigators also struggle with ethical questions that arise during research. “For years, this has been done informally,” says Benjamin Wilfond, MD, director of the Treuman Katz Center for Pediatric Bioethics at Seattle Children’s Research Institute.
When facing an unexpected ethical issue, researchers sometimes seek advice from ethics consultants at their institutions; the final recommendation is often to discuss any proposed change in protocol with the IRB. “IRBs have varying degrees of expertise and comfort with more complex ethical issues,” notes Wilfond. “Some of these are hard cases.”
Increasingly, investigators are anticipating ethical issues in advance of conducting their projects and seeking advice, says Mildred Cho, PhD, associate director at the Stanford (CA) Center for Biomedical Ethics. “In addition, investigators also have been working with ethicists to publish co-authored articles about ethical issues they identified, and strategies they developed to address the issues,” she notes.
Wilfond founded the Clinical Research Ethics Consultation Collaborative, a group of 40 bioethicists at 30 institutions, as a resource to help investigators resolve ethical issues that arise during research.1
“In building this collaborative, we want to be very clear that we need to supplement, not replace, the IRB,” he says. Wilfond co-authored a 2009 paper that examined how a research ethics consultation service may differ from and complement the role of an IRB.2
“Ethics consult services have varying degrees of success,” adds Wilfond. “Often, it’s a combination of the overall institutional enthusiasm and the people running the program.”
Many ethical issues confronted by researchers involve communication of findings to study participants. “There may not necessarily be a plan to return the findings of laboratory or clinical evaluations to individual participants. But suddenly, the information seems important to convey,” says Wilfond.
This issue arose during a study in which participants were given the option of knowing results of genetic testing, Wilfond says. Two siblings participated; one was sick and one was healthy. The healthy sibling said he didn’t want to know the results.
“The researchers ended up having findings that suggested he had the same condition as the sibling, but decided not to tell him because those were his wishes,” says Wilfond. However, the investigators then learned that the man was scheduled to be a bone marrow donor for his sibling. “This raised the question of whether the researchers should tell him against his stated wishes,” says Wilfond. The group considered that he was also committed to the health of his sister, and the information was disclosed.
In another study, a member of a family tested positive for the BRCA1 gene, but wanted to keep it confidential; in fact, the man lied about the result to his relatives, which had implications for their own health. “He told all his family members he was negative, including his adult children, in front of the investigators,” says Wilfond. The group considered that maintaining a therapeutic relationship with the subject was the best way to encourage him to tell the truth.
Another frequent ethical issue involves incidental findings. For example, investigators donated a DNA sample so other researchers could study a rare disease, Cho says. As part of the analysis, the researchers found in one of the samples from the normal healthy control population a variant in one of the genes they were studying that is associated with that disease. “People with this disease are often asymptomatic until they die suddenly,” says Cho, a member of the Clinical Research Ethics Consultation Collaborative.
The question was whether the researchers had an obligation to tell this individual about their finding, even if the consent form said that no such results would be returned. The researchers were advised to first confirm the finding in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. “As it turned out, the presence of a disease-associated variant was not confirmed,” says Cho. “This highlighted the need for clinical-grade tests for any results that are reported to individuals.”
The Clinical Research Ethics Consultation Collaborative is currently developing a website to allow investigators to learn about the members and the service. “Some are willing to do consults for people who are from other institutions,” notes Wilfond. “Not everybody has access to groups like this.”
Recently, a dozen ethicists participated on a conference call with an investigator faced with a difficult ethical issue. “This consult focused on research studies that provide more frequent standard clinical data for which the clinical meaning is not clear, and could result in unnecessary subsequent clinical interventions,” says Wilfond.
This allowed the investigator to hear a wide range of views. Some thought disclosure was necessary, while others thought it was problematic. “There were a number of people throwing out ideas that I hadn’t thought of,” says Wilfond. “We’ve only done this twice now, but I think it’s a new, interesting way of trying to help investigators.”
Since 2012, the group has recorded the cases from 10 institutions in a database. “Our fantasy at the time was for people to use the database to get immediate advice. It turns out that people would rather have a listserv,” says Wilfond. Researchers prefer to consult with someone who can tell them right away what they think about the particular issue the researcher is dealing with, he says.
“We are in the process of creating opportunities, when we do a complicated consult, to get input from other people,” says Wilfond. Another possibility is for a group of ethicists to be invited to call in at a certain time, if available, to address a particular question.
“People often try to resolve this on their own. Most things never get to an outside consultant for advice — it’s only when people are really, really stuck,” says Wilfond. “We can provide greater clarity of thinking.”