March 2000

Advances in biomedical research create challenging bioethical dilemmas. Within and beyond the scientific community, there is a range of ethical questions being debated. For example: What are the best means to safeguard confidential information generated during genetic screening? Should persons of limited mental capacity be involved in research that will not provide direct benefit to them? What is appropriate compensation for research participation? What role should the NIH play in supporting embryonic stem cell research? These questions and others highlight complex ethical issues that are difficult to answer. As a result, OER has developed several sources of information to help researchers, participants in research studies, and the general public to think through ethical issues and problems.

In collaboration with the NIH Bioethics Interest Group, OER has recently developed a comprehensive web site, Bioethics Resources on the Web. (See http://www.nih.gov/sigs/bioethics) Bioethics Resources on the Web is designed to facilitate research, scholarly activities, and training. The web site provides information about bioethics initiatives at NIH Institutes and Centers, OPRR, and other government offices and programs, publications, reports, guidelines, and regulations related to bioethics. The web site contains a new bibliography of 4,650 items as well as information on educational and funding opportunities. There is a wealth of information and excellent sources on topics as diverse as human subject and animal research, IRBs, genetics and medical ethics, international research, and teaching material, such as case studies and course curricula. The web site also links to related sites, such as university ethics programs, medical and biotech sites, the Federal Register, and ethics journals. For people who are just being introduced to biomedical ethics, this web site serves as a useful point of departure. For people with more experience in the area, it also serves as a quick method for locating key documents and references.

Bioethics Resources on the Web is maintained by Drs. Ruth Fischbach of OER and Miriam Kelty of NIA, who is the chair of the NIH inter-institute Bioethics Interest Group. Because this resource is still evolving, Drs. Fischbach and Kelty welcome your suggestions for links to other useful web sites and comments on your experience using this site.

NIH also produces documents to provide guidance for researchers and IRB members who have an obligation to safeguard the rights and welfare of research participants. An upcoming report, Research Involving Individuals with Questionable Capacity to Consent: Points to Consider (Interim), offers guidance on the appropriate selection of subjects, the evaluation of research risks and benefits, the assessment of decision making capacity subjects, the use of advance directives, and the development of educational materials. (See http://grants.nih.gov/grants/policy/questionablecapacity.htm ) The authors of this report have also developed a sliding scale of protections to be put in place as the risk to subjects increases while their capacity for making decisions decreases. The report's guidance emphasizes that decisional impairment can occur in different circumstances, including times of great stress (e.g., serious injury, illness, or loss.) Impairment is not limited to individuals with neurologic, psychiatric, or substance abuse problems. Indeed, the report also cautions that individuals with neurologic, psychiatric, or substance abuse problems should not be presumed to be decisionally impaired.

In addition, NIH recently produced a brochure to answer perplexing questions that arise from the use of human tissues from living persons in research. (See http://www-cdp.ims.nci.nih.gov/policy.html) Some of these questions include: Does research on tissue specimens from living human beings constitute research on human subjects? Do studies involving such tissue need IRB approval or is the research exempt? When specimens are obtained from a collaborator, do IRB regulations apply? The brochure answers these and other questions. It also covers other important issues for researchers to consider, including identifiers that link tissue to individuals and the use of specimens from tissue banks.

NIH is committed to the ethical conduct of research and the protection of human subjects. We would like to expand the empirical base of knowledge and have developed several initiatives related to research and training. Last year, NIH issued a Program Announcement (PA) to support Research on Ethical Issues in Human Studies. (See http://grants.nih.gov/grants/guide/pa-files/PA-99-079.html ) Applications on a broad range of topics related to biomedical ethics are encouraged. The PA is available for two more years and is an excellent opportunity to support much-needed research. In addition, K awards are available to support researchers who want to develop expertise in biomedical ethics, and support for the development of short courses in biomedical ethics is also available. For further information on training, see Dr. Milton Hernandez at NIAID and information on the NIH web site at http://grants.nih.gov/grants/guide/pa-files/PAR-98-005.html and http://grants.nih.gov/grants/guide/pa-files/PAR-98-006.html

The NIH Bioethics Interest Group meets from 3 p.m. to 5 p.m. on the first Monday of the month. Timely and provocative topics are presented in an informal forum that is open to all. Information on the Bioethics Interest Group is available on NIH's Bioethics Resources on the Web. This web site also lists the offices and programs at NIH that are concerned with bioethics-related issues. If you have questions or concerns about a specific issue, you may contact a representative of the appropriate office or program. The contact person for OER is Dr. Ruth Fischbach. Dr. Fischbach may be reached by calling: 301-496-1414, or by email at: rlfisch@nih.gov.

Previous OER Connection Documents

• January 2000 - New Roles/New Faces At OER
• November 1999 - NIH Introduces Modular Grant Applications