New journal focuses on evidence-based ethics

Empirical evidence helps to interpret regulations

There is a new research journal in town, and it's likely to create a stir in the clinical trials research industry and the IRB world.

The Journal of Empirical Research on Human Research Ethics (JERHRE, pronounced "Jerry") dives right into the issue of research misbehavior in its first issue, published March 2006.

An inaugural article and study, titled, "Scientists' Perceptions of Organizational Justice and Self-Reported Misbehavior," discusses the link between investigators perceiving injustice in the way they are treated by their institution or some other organization in science that exerts control over their career and "leveling the playing field" by engaging in scientific misbehavior that will give them some advantage.

Published quarterly, JERHRE will feature articles that are useful for educational purposes, says Joan Sieber, PhD, editor of JERHRE. Sieber also is a professor in the department of psychology at California State University, East Bay, of Hayward.

JERHRE is a nonprofit journal published by the University of California Press.

"When I started talking seriously about creating this journal three years ago, a lot of people said, 'Yeah, but is there going to be enough research to fill a journal?'" Sieber recalls. "I said, 'I think so, but I don't know.'"

As it turns out, finding research articles has not been a problem for JERHRE, Sieber says. "We're getting some wonderful unsolicited manuscripts," she says. "Also, now that people know about the journal they're coming forward with ideas that they would not have researched otherwise."

Any net income from the journal will be returned to educational purposes, such as funding conferences and workshops, Sieber says. For example, JERHRE is sponsoring its first conference on July 28, 2006 at the California State University, East Bay Conference Center in Oakland, with some funding from NIH, since JERHRE does not yet have a positive cash flow.

The conference is called Creative Ethical Problem Solving in Human Research: Challenges and Solutions for Researchers and IRBs, and the keynote speaker is Greg Koski, MD, a senior scientist with the Institute for Health Policy, Massachusetts General Hospital, Partners HealthCare System in Boston. Koski also is an associate professor of anesthesia at Harvard Medical School, and he is the former director of OHRP.

JERHRE also will encourage new researchers to study human subjects research ethics.

"We hope to give prizes to early career investigators who do outstanding research on human research ethics," Sieber says.

JERHRE also is expected to create collaborations among researchers around the world who share an interest in a particular problem.

One such problem is the risk of emotional or physical harm to researchers, such as social workers or trauma researchers, who work in field settings.

"How do you debrief research assistants about the terrible traumas people have experienced, their terrible life situations, and murders?" Sieber asks. "How do you anticipate and protect researchers who go into harm's way?" Several investigators are interested in doing this research and creating a cross-cultural study, Sieber says.

"By creating collaborations across research sites and, ideally, across countries, we can evaluate the generalizability of our research findings," she says.

"JERHRE is applied and intended to be practically useful," she notes. "Each article will discuss the best practices and educational implications that can be derived from it."

JERHRE will provide educational curriculum material for researcher and IRB training, Sieber notes.

"I expect JERHRE will improve the quality of ethical decision-making," she says. "In addition to generating information that will foster better ethical decision-making, JERHRE will enable investigators and IRBs to become more collaborative and collegial."

Sieber says she has long thought the research world was relying too heavily on regulatory compliance without delving into deeper ethical considerations.

"One of the things I fear and I think when people are talking about a culture of compliance is that we are winding up with compliant researchers who will do what the regulations say irrespective of what they really think is ethical," Sieber says.

"It's not that the regulations promote unethical behavior, but like any other regulations, they're written for the general case," Sieber explains. "So people wind up doing very foolish things like having a 20-page consent form that subjects can't understand."

This isn't what the regulations recommend, of course, but without a culture in which clear thinking and intelligent interpretations of the regulations are encouraged it's easy for investigators and IRBs to mindlessly comply with what they believe are the regulations' intent, Sieber says.

Federal regulations need to be interpreted, and sometimes the regulations are specific on points that can lead one into ethical conflicts, Sieber says.

"For example, the federal regulations in the United States state that when you do research on identified individuals, in most contexts, you should get their informed consent and document the consent by having them sign a consent form," Sieber says. "The federal regulations allow waiver of the signature under certain circumstances, but many times IRBs are very hesitant to waive the signing of informed consent forms because they may be unclear on how to document in their minutes why they made that decision or why that decision is the correct one."

However, there are many cultures in which people do not want to sign consent documents, Sieber notes.

"Another problem is that informed consent documents are often quite long and complicated, and many people justifiably feel suspicious of having to sign something so long and incomprehensible," Sieber adds.

"They may be quite pleased to participate in the research, but not if they have to sign something they're not sure they understand; this is particularly true in non-Western cultures."

Alternately, some people will sign a long informed consent document without reading it, which is hardly informed consent, Sieber says.

There are many other issues involved in fulfilling ethical requirements regarding being respectful of people and protecting their rights and their own perception of their rights, she says.

Without fully understanding those problems, IRBs are hesitant to vary from the default position in interpreting regulations, Sieber says.

But when investigators are able to demonstrate the ethical and scientific advantages of innovative procedures and publish those findings in a reputable peer-reviewed journal, then other investigators and their IRBs can feel comfortable with those nontraditional procedures, Sieber explains.

The solution is evidence-based ethical problem solving, she says. "What evidence-based ethical problem solving means is conducting and publishing research that shows how to be ethical in a given circumstance," Sieber says.

"For instance, an important ethical principle is to respect people," she adds. "Evidence-based ethics isn't about whether people should be respected, but it is about how to respect people in ways that are appropriate to the culture and context."

In one culture, investigators would handle it one way, and in another culture, they'd have a different approach, Sieber says.

If investigators were to do evidence-based ethical research on how people feel about signing a consent form, it might involve discovering some of the circumstances in which people don't want to sign consent forms and the alternative ways in which those people would be willing to signify their willingness to participate, Sieber says.

"With the publication of such information in a peer reviewed journal, an investigator could go to the IRB and say, 'Here is research that shows that I am in a circumstance where people typically would like to participate in research, but typically do not want to sign a document,'" Sieber says. "The investigator would add, 'This should qualify for a waiver of informed consent, which is permissible in the regulations if the research is minimal risk research.'"

Another example might be interviewing people about medical matters. In the U.S., it would be considered disrespectful to interview people about medical matters in a nonprivate setting, but in Sri Lanka, medical matters are never discussed in private, and people would be very uncomfortable discussing them in private, Sieber explains.

"While we can agree on general ethical principles, the how to of being ethical typically is context-specific, and that's an empirical matter," Sieber says.

When Sieber discussed evidence-based ethical research at the 2005 Annual HRPP Conference, held by the Public Responsibility in Medicine & Research (PRIM&R) and the Applied Research Ethics National Association (ARENA), held Dec. 3-6, 2005, in Boston, she had an interesting response from the audience during the open-microphone session.

"One IRB administrator said, 'This is wonderful — at last a voice for the IRB,' and investigators said, 'At last a voice for me,'" Sieber recalls. "What this seemed to mean was that empirical evidence gathered objectively and published in a peer reviewed journal has standing with both investigators and an IRB."

Instead of IRBs and investigators having frequent clashes over the interpretation of regulations, based on hunch and anecdote, they could point to objective evidence that supports their position, she adds.

Evidence-based ethical research provides an objective way to evaluate the pros and cons of a particular research procedure, Sieber says.

At JERHRE's first conference about evidence-based ethical problem solving, which will be held July 28 in Oakland, CA, investigators and IRBs will present cases of research ideas that seem good in the context in which they are proposed, but that are nontraditional in approach and raise questions with the IRB, Sieber says.

"The authors of the cases will suggest ways to empirically evaluate the pros and cons of the proposed research procedures to a panel of experts," she says.

"The panel of experts will have examined and evaluated the proposals ahead of time and will probably suggest additional ways one might evaluate those pros and cons," Sieber adds.

"What we expect will come out of that process is that the proposed research will be done and published, and, we hope, resolve some of the questions."

[Editor's note: The Journal of Empirical Research on Human Research Ethics' first issue, dated March 2006, is being made available to subscribers of Clinical Trials Administrator as a free sample on-line. To view the journal, visit the web site: http://caliber.ucpress.net/loi/jer.

Also, information about the conference on Creative Ethical Problem Solving in Human Research: Challenges and Solutions for Researchers and IRBs, held July 28, 2006, at the California State University, East Bay Conference Center, 1000 Broadway, Oakland, CA, is available at the web site: www.csueastbay.edu/JERHRE/conference/index.html.]