Protecting participants is the goal of ethics initiatives

APA and the U.S. and Canadian governments focus on the issue.

By Rebecca A. Clay

A glance at APA?s Ethical Principles in the Conduct of Research With Human Participants published in 1982 and the new ethics document now available for comment shows the enormous changes the research world has undergone.

'The new document is 160 pages single-spaced in 10-point type,' says Sangeeta Panicker, PhD, research ethics officer at APA. 'The 1982 document was a skinny little monograph.'

The heft of the new document?The Ethics of Research With Human Participants?suggests how complex ethical issues have become as behavioral and social science researchers have faced data sharing research and research involving children and people with AIDS.

The new document represents APA?s attempt to guide researchers through increasingly common ethical dilemmas, including the sometimes competing interests of researchers and research populations, the tension between the right to privacy and need for careful research and the potential dangers of electronic technologies used for gathering and storing data.

Psychologists aren?t the only scientists working on ethics issues: The Canadian government recently released new ethical guidelines for that nation?s scientists. And the U.S. government?embarrassed by recent revelations about unethical conduct in past human experiments?is thinking about how it can do a better job of protecting research participants in the future.

An educational document

The project began with the need to update the 1982 ethics booklet, which was based on the ethics code every APA member is held to. When that ethics code was revised in the early 1990s, the booklet no longer adhered to the structure of the newly revised code.

But while the original booklet elaborated on each of the ethics code?s research-related principles, the Board of Scientific Affairs task force responsible for the new project decided to take a completely different approach. (The American Psychological Society participated in the project?s early stages, but is not involved at this time.) The result is not an annotation of the new ethics code but instead a complete tutorial on conducting ethical research, says task force co-chair Bruce D. Sales, PhD, JD, a professor of psychology, psychiatry, sociology and law at the University of Arizona in Tucson.

'I hope the document will be used as an educational vehicle to sensitize researchers already working in the field as well as students at both the graduate and undergraduate level to the ethical implications of their work,' he says, emphasizing that the document is aspirational instead of prescriptive.

Serving as an ideal rather than a list of rules, the document begins by laying out the moral foundations of research using human participants. It then takes readers step by step through the entire research process, from planning an experiment to deciding whose name should appear on the final publication. The book also covers issues related to recruiting participants, gaining informed consent, protecting privacy, identifying conflicts of interest, resolving ethical dilemmas and educating research staff, participants and the general public about ethics.

The draft will be available for review until Sept. 1. (See box for more information.) According to Sales, he and co-chair Susan Folkman, PhD, are looking forward to comments from their peers. And there are sure to be plenty, says Christine R. Hartel, PhD, associate executive director for scientific affairs at APA.

'There are going to be lots of controversial elements, because ethical issues are always controversial,' she says. APA Books will publish the final document late next year, Hartel predicts.

Canadian guidelines

The Canadian government has also been wrestling with ethical matters. After four years of debate and dozens of drafts, Canada?s federal research funding agencies?the Medical Research Council, Natural Sciences and Engineering Research Council and Social Sciences and Humanities Research Council?released new human research guidelines in June. Although the guidelines aren?t a compulsory code of ethics, researchers must comply with them if they receive government funding.

Early drafts produced by the Tri-Council Working Group on Ethics revealed an overly medical orientation, says Jenel G. Gauthier, PhD, past president of the Canadian Psychological Association and a psychology professor at Laval University in Quebec.

The group originally wanted to prohibit the use of deception in research, for instance. While understandable in medical experimentation, Gauthier says, such a prohibition would severely limit social psychologists? ability to conduct research. After all, researchers studying prejudice can?t expect honest responses if they tell their participants what they?re up to.

With APA providing copies of its official ethics code and the U.S. government regulations pertaining to the protection of human research participants, Canadian psychologists launched a grassroots initiative that helped convince the Tri-Council Working Group to take the needs of behavioral researchers into account.

The group dropped the prohibition against deception research for instance, allowing researchers to use a waiver of consent in low-risk situations. The group deleted a provision that allowed research participants the right to withdraw their data or even edit researchers? publications. And it removed the requirement that researchers get both individual and group consent when studying 'collectivities' such as governments, corporations and ethnic, cultural or social groups, a provision that could embroil researchers in debate about who actually speaks for such groups and even endanger participants such as gang members or victims of domestic violence.

'The final draft may not be exactly the code we wanted to have, but we can live with it,' says Gauthier, adding that the guidelines will be implemented this fall. 'Given where we started, I?d say it was a success in terms of grassroots lobbying and explaining psychologists? perspective.'

Future directions

Behavioral and social scientists in the United States may find themselves fighting a similar battle in coming years. Recently, for example, families have criticized some clinical trials for involving patients who may not have been competent to give truly informed consent. And researchers have documented relapses and even suicides among participants whose medication was stopped or replaced by a placebo in tests of new medications. A recent report by the U.S. Health and Human Services Office of the Inspector General deemed the system for protecting human participants a failure.

As a result of such concerns, proposals to improve protections for human participants are already rumbling through the government. Rep. Christopher Shays (R-Conn.), chair of the House Reform and Oversight Committee on Human Resources, held a hearing in June to discuss the inspector general?s charges with officials from the National Institutes of Health (NIH). NIH is already studying ways of improving informed consent rules and enhancing the workings of the institutional review boards that oversee research. And the federal National Bioethics Advisory Commission has mandated reports outlining the pros and cons of creating an independent government office specifically designed to regulate the protection of human research participants.

'Although none of the research ethics bills in Congress are going anywhere, that?s not to say they won?t,' says APA Director of Science Policy Patricia Kobor, who works with Panicker to monitor research-related activities and alert psychologists when action is needed. 'It takes a while to build consensus that an issue is worth paying attention to, and the pace is picking up in this area.'

Rebecca A. Clay is a writer in Washington, D.C.

For a copy of the draft document The Ethics of Research With Human Participants, contact APA's Science Directorate by phone at (202) 336-6000 or by e-mail. Please provide a mailing address; an electronic version of the document is not available. The deadline for submission of comments is Sept. 1.