Response of the Department of Health and Human Services to NBAC's Report 'Research Involving Human Biological Materials: Ethical Issues and Policy Guidance'. Recommendations Regarding Professional Education and Responsibilities

05/01/2001

Recommendation 21. The National Institutes of Health, professional societies, and health care organizations should continue and expand their efforts to train investigators about the ethical issues and regulations regarding research on human biological materials and to develop exemplary practices for resolving such issues.

Discussion

The Working Group supports NBAC’s goal but feels that Recommendation 21 is too narrowly focused, both with respect to identification of those responsible for providing education and training and with respect to those in need of education.

Recommendation 21 identifies the NIH as having a responsibility to train investigators about ethical issues and regulations that are relevant to research on human biologic materials. Other DHHS agencies, including CDC, FDA, HRSA and IHS, also conduct, support or regulate research on human biologic materials and engage in activities relevant to implementation of NBAC’s recommendation. In fact, several of these DHHS agencies are already implementing programs and policies that are consistent with the intent of NBAC’s recommendation. Furthermore, there are other federal departments, for example USDA, DoD and DoE, that also conduct and support research involving human participants. These departments should also be partners in the educational efforts that NBAC describes.

As part of the DHHS initiative to further enhance protections for human research subjects, as of October 1, 2000, NIH requires that all NIH-sponsored clinical investigators working with human subjects receive appropriate research bioethics and human subjects research training as a condition of their NIH grant award40 . To assist researchers in determining whether the research they are conducting with human specimens is human subjects research, the NIH has developed a user-friendly brochure to help investigators understand how 45 CFR Part 46 applies to their research.41

Proposed Action

The Working Group proposes that, in addition to ongoing and separate endeavors by DHHS agencies and offices, efforts be made to coordinate education and training related to research with human biological materials in order to avoid duplication of efforts and to maximize the impact of available resources.

Recommendation 22. Compliance with the recommendations set forth in this report will require additional resources. All research sponsors (government, private sector enterprises, and academic institutions) should work together to make these resources available.

Discussion

Recent attention to instances of inadequate protections for human research subjects and several reports prepared by the DHHS Inspector General have spotlighted weaknesses in the infrastructure for protection of human subjects in federally supported research. Some of these weaknesses have been attributed to the lack of adequate resources. NBAC recognizes that implementation of the recommendations in its report on research involving human biological materials will require additional resources – for enhanced federal oversight, for development of appropriate guidance materials, for institutions and IRBs, for researchers, for convening of workshops, and for educational efforts. The Working Group recognizes the merit of Recommendation 22 and notes not only the need for new resources but also the need to ensure appropriate utilization of existing resources.

Proposed Action

The Working Group proposes that DHHS continue to work with awardee institutions to highlight the importance of adequate support for IRBs and for other appropriate human subjects protection measures.

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