Series helps IRBs wrestle with tough ethical issues

Program focuses on the gray areas

Some of the thorniest questions that IRBs face are those for which there are no clear-cut answers — opinions may vary, arguments on both sides may be compelling, regulatory guidance may be scanty.

It's those types of questions that Washington University in St. Louis tackles on a regular basis through its Ethics Series, a free series of discussions open to researchers, IRB members and anyone else who is interested.

The series, which has run since 2004, uses faculty members to explore human subjects protection issues such as payments for research participation, vulnerability in research, therapeutic misconception and research with human biological materials. It recently was honored by the Health Improvement Institute as a best practice in human subjects protection.

Sarah Fowler-Dixon, PhD, an education specialist in the Human Research Protection Office (HRPO) at Washington University, says the idea first was proposed by Ira Kodner, MD, an ethicist and professor of surgery at the university.

"He thought it would be a good idea to have more ethical offerings at the university," Fowler-Dixon says. "There was a need, not just in what he was seeing clinically, but also from research people who would come and ask these questions and there were no straightforward answers."

She says that at the same time, IRB members were asking for a forum at which they could have more ethical debates — not just determining what the regulations said, but expounding on them.

At first, the HRPO collaborated with the university's newly formed Center for the Study of Ethics and Human Values to come up with speakers and topics for the series. Early topics included sham surgeries, gene therapy, organ transplantation and pre-IRB scientific review. Some sessions were offered as lecture-type forums, while others featured panel discussions.

In the past few years, the HRPO has been working with the Center for Clinical Research Ethics of the Institute for Clinical and Translational Sciences (ICTS), a joint effort between Washington University and St. Louis University. Speakers now are identified through the ICTS and matched with topics in their areas of expertise. The 2008-2009 series included five sessions; four sessions are scheduled during the 2009-2010 year.

Audience demand

Fowler-Dixon says topics are chosen based on demand.

"We solicit topics that people want to see selected," she says. "We always monitor what's out there currently in the literature, and we see what topics are coming up in the questions that we're receiving over and over again."

She says that so far in the series, they haven't needed to repeat a topic.

Sessions are advertised not just at Washington University, but at 10 other institutions affiliated through the St. Louis IRB consortium. Sessions are free, but participants are asked to sign up in advance, so organizers know how big a room to book, Fowler-Dixon says. Most sessions draw about 50 people, but on occasion, she's had to find a larger venue for more heavily attended sessions.

"Fifty is very good for Wash U, because we have a lot of events competing," she says. "It's not just faculty and staff but also people who are training."

She says the university has been able to

operate the series fairly inexpensively. From its inception in 2004 until spring of last year, it was run on one $2,300 grant, and since then

has used departmental funds. Speakers volunteer their time and materials are posted on the IRB Web site, eliminating the cost of copying them.

"We had no room rental, we did have refreshments, we videotaped some sessions and money went to that," she says. "The personnel are already on staff, although they will have to allocate preparation time.

"I'm not going to say there are no costs, but other than resources that are already available at your institution, you don't have to have additional costs."

She says the project does require a fair amount of time to coordinate, and occasionally, speakers need to be prepared ahead of time if they're not familiar with the format being used. She expects the forum to continue in about the same form through 2010.

A broader context

Fowler-Dixon says she's seen a real impact the series has had on ethical discussions within the research community at the university.

"If nothing else, it brings an awareness that causes people to start thinking about topics differently," she says. "For instance, because of some of the presentations of the ethics series, people realize now that there might be a difference between cognitively impaired and decisionally impaired people and it was a much broader topic than they originally thought."

She says the session on sham surgery caused some people to realize that there were types of study interventions that they might not identify as sham surgeries that carried the same types of ethical risks.

"The ethics series takes a topic that people might think of only in isolation and puts it in a broader context," Fowler-Dixon says. "People start to realize that it's not just an isolated issue relating only to certain people or a certain type of study – it's an issue that can cross several disciplines and types of studies."

She says one important step in creating this type of discussion series is to make it clear to the audience ahead of time that the topics won't have set answers.

"You want to prepare your audience first in the way you advertise it, to let them know that you're not going to give them yes-or-no type answers. You don't want them to think they will come out an hour later knowing exactly what to do in a given situation. It just doesn't work that way."