DENVER--Last week over one thousand administrators from academia, private institutions, and industrial enterprises gathered in downtown Denver for the Society of Research Administrators meeting. They managed to cover everything from the latest in electronic commerce and federal research financing to the benefits of humor in the workplace.

One of the hottest sessions at the meeting focused on bioethics and privacy issues in clinical research.

Bioethics--To Serve And Protect

In today's research climate, the institutional review boards of universities and government agencies have to make sure researchers go about recruiting subjects for clinical studies and obtaining biological samples from storage banks or archived patient data in an ethical manner.

Despite such oversight, ethical research mistakes still occur, partly because many investigators fail to properly follow existing guidelines and partly because many investigators don't fully understand just how careful they have to be.

"It's a timely topic, because we are confronted with reports of research projects that often involve inadequate forms of consent," says Ruth Fischbach, a senior biomedical ethics advisor at the National Institutes of Health (NIH) who spoke at the meetings' session on bioethics.

The upshot of the session is that Fischbach and her NIH colleagues have put together a draft of a soon to be circulated NIH brief designed to help alleviate confusion about the protocols that scientists must follow when seeking out human subjects or human specimens for their research. The document is currently being revised and will be released in the near future.

In addition to this document, Fischbach and her NIH team presented a more detailed report--entitled NIH's "Points to Consider ." The report focuses on the participation of "decisionally impaired" persons in research projects. A person's decision-making capacities can sometimes be affected by stress or neurologic, psychiatric, or substance abuse, explains Fischbach, and so they may not be able to make properly informed choices when asked to participate in a research study.

"Points to Consider," which was released earlier this year, highlights the need to properly assess a person's capacity to fully understand a research project before agreeing to participate. It has been written to provide practical suggestions and guidelines and is currently available through NIH's Web site.

Fischbach stressed that the recommendations and suggestions in the new document were not designed exclusively for persons with mental disorders or psychiatric problems but for potentially all research subjects. "We are all at some point eligible to be fit into this category," she says.

The research administrators were asked to do their best to help researchers recognize that on the one hand they may be considered clinicians but that on the other, while conducting research, they should consider themselves investigators.

The "Points to Consider" document is currently under consideration by subcommittees within the White House's Office of Science and Technology Policy.

Ultimately, "Points to Consider" will be submitted to the National Science and Technology Council (NSTC), who will go on to decide if the suggestions should be incorporated into existing policies on human protection in research, universally applied, or only applicable to certain institutes.

For All Eyes Only

Pearl O' Rourke, deputy director in the Office of Science Policy at NIH, sketched out the current privacy laws which help to protect participants of research. The ability to identify someone from a coded specimen or a numbered sample is a technical and legal issue of privacy that many in Congress and bioethical committees are currently debating.

Human protection and privacy issues are major bones of contention in Congress and federal institutions, as well as with researchers and the public. The problem lies in determining whether research results are regarded in categories such as (1) health information, (2) health research information, or (3) pure research information: They each have their own privacy boundaries and levels of accessibility to the public.

Until clear recommendations are in place to ensure integrity and confidentiality, determining what constitutes confidential medical information and what represents freely accessible data remains a cloudy subject.

Will this issue be resolved? According to O'Rourke, coming up with a set of privacy standards means reaching a steady, but extremely delicate, balance between the protection of individuals and the protection of society. And, while everyone would like to say that no information will be disclosed without informed consent, certain public health issues, such as tracking the spread of disease, require full access to particular kinds of medical information.