Ethics consultation services answer faculty questions
Ethics consultation services answer faculty questions
Be creative in finding funding
Research enterprises rarely offer staff ethics consultation services, although a clinical ethics consultation service commonly is offered in hospitals to physicians.1
At least one IRB sought to change this.
"My colleague Nancy Kass and I were asked by our IRB at the School of Public Health of Johns Hopkins University in Baltimore, MD, to help them identify ways to engage the faculty in what we loosely called continuing education around research ethics," says Holly Taylor, PhD, MPH, an assistant professor in the department of health policy and management and a core faculty member of Berman Institute of Bioethics.
"We did a needs assessment and went to faculty meetings of the departments that do the most human subjects research," Taylor says. "We said, 'We've been tasked by the IRB to identify ways in which you the faculty would like to receive additional information around human subjects research."
It became clear from these conversations that the faculty wanted to have a place where they could go to ask about specific challenges they were encountering, Taylor notes.
"The reason why this was put together was there was an identified need among faculty to have a place to talk about the ethical challenges they were facing in their own work," Taylor says.
"We developed a proposal for our IRB, and they said they'd support some of our time and support us in developing a Web-based system in which consults can be submitted and addressed," she explains. "We receive a message when a consult is requested, and we address it."
The consults take place by email, telephone, or in person, depending on the needs and whether the request comes from an off-site location. An evaluation of the consultation service found that 11% of the consultations were conducted by telephone, 31% were resolved by email, and 46% were conducted in meetings in person.1
"Our preference is to do it in person," Taylor says. "We do the consult on the telephone if it's not logistically possible to do it in person."
In 91% of the cases, a consultant responded to a request within 24 hours of receiving the initial request.1
The in-person consultations took more than a day and had a median resolution time of seven days. One in-person consultation even took 49 days because of an email glitch.1
The consultation service was designed to deal with ethical issues, not regulatory questions, and most of the consultation questions were about ethical challenges.1
"We don't respond to regulatory questions," Taylor says. "We leave that to the IRB."
Still, 18 of 108 total consultation questions involved regulatory issues.1
"We can say, 'We think the IRB may agree that this is exempt from documentation from consent,' but we make it clear that it's up to them and the IRB has the final say on regulatory issues," she adds.
Johns Hopkins' general counsel approved a legal disclaimer regarding any advice the consultants provided to investigators. It states in part:
"An ethics consultation is an advisory service to assist Johns Hopkins University Bloomberg School of Public Health faculty, staff, and students in considering ethical challenges that arise in the design and conduct of human subjects research. The information provided is intended to be educational and helpful in decision-making processes. However, the ethics consultants will not make decisions for the investigators…"1
The funding initially was part of the IRB's mission.
"We purposely acknowledged that we were funded by the IRB, but we also made a commitment to those who came to us for a consult that it'd be confidential," Taylor says.
Although the initial consultation service was part of the School of Public Health and supported by the office of research and IRB within that school, it's since changed.
Johns Hopkins received funding to establish a Clinical and Translational Science Awards (CTSA) site. As part of this funding, Hopkins committed to expanding the consulting service to faculty in the schools of public health, nursing, medicine, and arts and sciences, Taylor says.
"So we now serve a much broader population of faculty and students," she adds. "The consulting service never closed, but it was transitioned [to CTSA]."
In the period between April, 2005, and December, 2007, there were 76 consultation requests with 67% coming from faculty, 25% from students, and 6% from study staff.1
The study found that nearly a third of the studies involved in consultation were community/clinical trials, with one quarter of the studies involved being survey/interview types. Other types were secondary data analysis, longitudinal studies, case-control studies, and record reviews.1
Also, the consultations came while the study was still in development for 35% of the studies. For 25% of the studies, the consultation occurred during the data collection preparation stage.1
One example of a consultation involved a cancer screening study in a rural, South Asian area where women participants refused to accept the standard therapy and wanted a riskier, clinically nonindicated procedure instead.1
Another example was a case in which investigators wanted to conduct in-depth interviews with immigrant parents of young adolescents, and they needed advice on how to maximize confidentiality for participants who might be illegal immigrants.1
The consultation service proved to be a success, based on its use.
"People are very satisfied with it," Taylor says. "We have a number of people who have used the service many times."
Reference
- Taylor HA, Kass NE. Research ethics consultation at the Johns Hopkins Bloomberg School of Public Health. Ethics & Human Research. 2009;31(2):9-14.
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