Ethical Studies of Research Ethics--NIH Program Announcement


We all know that the participation of human subjects and the use of human specimens are crucial to many types of basic, applied, pharmaceutical, and clinical research. And we also know that experimental procedures must abide by ethical guidelines. In particular, participants in clinical trials, drug tests, or familial analysis must fully understand their involvement if the resulting research is to be ethically sound.

But many projects come under public and federal scrutiny--the recent fracas over gene therapy trials is a case in point ( Science, 24 March, p. 2163), often because the manner in which they were conducted led to concerns over the safety of the recruited participants or the protection of their confidentiality.

To promote better understanding of the ethics of research and the inclusion of individuals in research experiments, the National Institutes of Health (NIH) announced last year a new funding initiative: Research on Ethical Issues in Human Studies. The NIH program is "one of the steps the NIH is taking to develop an ongoing, multiagency, comprehensive program in research ethics," officials state in the program announcement of the grant award.

Ruth Fischbach, NIH's senior adviser for biomedical ethics, was instrumental in designing and creating the program. Fischbach says in the announcement that "more empirical work is needed to guide researchers ... toward selecting optimal ways that promote appropriate protections to research participants." Few studies, she says, offer any assessment of the methods researchers use or the effects of their recruitment strategies.

But only a handful of applications have been submitted since last March, causing concern among NIH officials about how bioethics is perceived among the scientific community. "We're very anxious to get scientists involved and into the field of bioethics," says Fischbach.

What Types of Research Projects Will Be Funded?

"This is a promising time for research, because the prospect for advancing generalizable knowledge is so great," Fischbach says. The focus of research applications can be on "potential, current, or former" research participants and investigators. Research topics include:

  • Evaluating the ability of human participants to comprehend, appreciate, and reason before they consent to specific experimental procedures and risks.

  • Identifying ways in which researchers can obtain input from community representatives.

  • Researching the social harms that might accrue following participation in research--such as discrimination by insurance companies.

  • Researching ethical issues within the context of a specific disease or disorder.

Of special interest, Fischbach notes, is the need for research into the challenges encountered when designing and conducting cross-cultural studies. Potential topics for investigation in this area include translating ethical procedures to local environments, informed consent, and privacy and confidentiality.

How Can I Improve My Chances of Winning a Grant?

Fischbach believes the grantsmanship of the applications currently under consideration could be better. Many proposals do not address all the required NIH criteria--significance, approach, innovation, investigator, and environment--and others fail to make a compelling case as to why their work should be funded or how it relates to the ethics of research. Fischbach adds that it is "not a major drawback" if you do not include much preliminary data, but your application must adequately address NIH's review criteria.

"It seems to be advantageous," begins Fischbach, "to include a multidisciplinary approach." A biologist, for example, needn't feel disqualified from applying for the award to address an "intriguing ethical question" just because he or she doesn't have the appropriate background. Fischbach suggests "assembling a team that has expertise in different fields"--sociology or statistics, for example--and gather together people who can contribute to skills you need for the project. It's a worthwhile endeavor because--as Fischbach points out--the members of the reviewing panel themselves are multidisciplinary in nature.

Who Can Apply?

This international program is open to principal investigators who work in a wide range of organizations, including public and private labs, universities, hospitals, and colleges, and in state and local governments.

What Is the Mechanism of Support?

Applications for up to $250,000 should follow NIH's recently imposed modular grants system, which involves constructing a budget around $25,000 increments. Support for 3 to 5 years can be requested.

When Are the Deadlines?

There are three receipt dates for this program announcement: 1 June 2000, 1 October 2000, and 1 February 2001.

Fischbach encourages investigators to contact her at

Although the NIH program announcement represents a new initiative for the federal funding agency, it is not the only attempt to better promote ethics among public and scientific communities. The Open Society Institute, for example, is a private grantmaking foundation established to "foster the development of open society around the world." Their Individual Project Fellowships Program has awarded grants to projects that include making the medical profession "more visible and active on behalf of drug policy reform," and also evaluating how pure and practical research is controlled.

The Robert Wood Johnson Foundation makes "about $360 million a year in awards" to improve the health care of all Americans. This foundation funds a variety of projects, including those that gather and monitor health-related statistics, training and fellowship programs, policy analysis, and health services research. Check out their rules for applying for a grant for more information.

The NIH's National Human Genome Research Institute (NHGRI) awards similar grants through their Ethical, Legal, and Social Implications of Human Genetics Research program announcement. These grants support more focused research and educational activities than do those described in Fischbach's announcement, addressing issues that arise "from the use of the knowledge and technologies resulting from human genetics research." As he indicates in an interview with Next Wave, Francis Collins, director of the NHGRI, is outspoken on the need for scientists to address the ethical implications of their research, and he speaks to the importance of the ELSI program. The next deadline for NHGRI grant applications is 1 June, with others at 1 October and 1 February next year.

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