Required Education on the Protection of Human Subjects: An NIH Initiative

On 23 May 2000, Department of Health and Human Services (DHHS) Secretary Donna Shalala announced several new initiatives to heighten government oversight of biomedical research and to reinforce to research institutions their responsibilities for overseeing their researchers and institutional review boards (IRBs). The announcement addressed five areas: (1) education and training; (2) informed consent; (3) improved monitoring; (4) conflict of interest; and (5) civil monetary penalties.

NIH has taken the lead role for three of the five areas, namely, education and training, improved monitoring, and conflict of interest. The Office of Human Research Protection (OHRP) will address informed consent issues. DHHS will pursue legislation to enable the Food and Drug Administration to levy civil monetary penalties for violation of informed consent and other important research practices.

NIH has recently announced its policy concerning required education. As of 1 October 2000, investigators, which are defined as key personnel responsible for the design or conduct of research involving human subjects, must be educated on the protection of human subjects. Key personnel include investigators of subcontracts, foreign awards or foreign subcontracts. Consultants on NIH awards are also included, regardless of whether they receive compensation from the award. The major features of this new policy along with issues raised by the research community are summarized below. (The text of the policy is available on the NIH website at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.)

Applicability of the Policy

In deciding the applicability of the education requirement, investigators must first determine if they are conducting research with human subjects. As defined in 45 CFR part 46, human subjects are living individuals about whom an investigator conducting research obtains data through intervention or interaction or from whom an investigator obtains any other identifiable private information. Human subjects research goes beyond clinical trials. It also includes research that collects data through surveys, interviews, and observations. Moreover, it includes private information that can be linked to individuals, such as medical or employment data or residual administrative records, such as earnings and treatment histories. In addition, it includes tissue specimens obtained for routine medical care that would have been discarded if not used for research. And it includes DNA samples and other samples or specimens that can be linked to a living individual.

It should be noted that investigators who conduct research that is exempt from Institutional Review Board (IRB) review and approval nevertheless must comply with this education requirement if the research uses data on human subjects. Exemption from IRB review and approval is determined on the basis of the risks associated with the study. (The six exempt categories of research are defined in 45 CFR part 46.) For example, research on the effectiveness of instructional strategies to promote reading would not expose school children to risk and thus is considered exempt from IRB review. However, it does not exempt the researcher from the NIH education requirement. Research using human specimens, tissues, or data that cannot be linked to an identifiable individual is not considered human subjects research, however, and thus does not invoke the education requirement.

The mandatory education policy applies to all projects involving human research subjects that are supported by grants or contracts that are funded in FY 2001 or later. It applies to both competing and noncompeting-i.e., multi-year-awards. Regarding training grants, the policy applies to individual fellowships that involve human subjects in research, but it does not apply to trainees in institutional training grants who are already required to comply with a program on the responsible conduct in research, which includes protection of human subjects as a topic. For individual fellowships, the funding Institute or Center will request the necessary information prior to issuing the award.

Educational Content

The required education policy allows flexibility for investigators and institutions to determine the content of the curriculum. It is expected, however...