country. Unfortunately, this particular mechanism does not provide for ongoing support to stabilize the enhanced operations of most programs. The committee encourages NIH and other research sponsors to continue working with research institutions to bridge the gap between resource needs and the availability of funding mechanisms to meet them.
Recommendation 2.4: Research organizations should ensure that investigators, Institutional Review Board members, and other individuals substantively involved in research with humans are adequately educated to perform their respective duties. The Office for Human Research Protections, with input from a variety of scholars in science and ethics, should coordinate the development and dissemination of core education elements and practices for human research ethics among those conducting and overseeing research.
Education regarding the research process and the ethical issues intrinsic to research involving human participants is essential at every level of accountability in the program. Investigators, key research personnel, IRB members, and institutional officials should all possess a core body of knowledge relating to the ethical design and conduct of a research protocol.
The research organization is responsible for ensuring that program personnel are educated about their responsibilities and proper conduct. The research sponsor also shares responsibility for ensuring that a research organization has the qualified personnel and resources needed to carry out a study—and the adequate education of personnel is part of this responsibility. If an investigator is not part of an institution, the sponsors themselves must provide sufficient education in order to enlist an investigator in a particular project. For example, CROs enlisting private practice clinicians to carry out a study should ensure that they are appropriately trained in ethical research practice, good clinical practices, and the specific protocol (Wyn Davies, 2001). Therefore, both entities must provide adequate resources for initial and continuing education.
One-time education modules do not ensure that these individuals fully appreciate the complex issues involved in human research. Education and consultative services should be ongoing in order to create a rich culture of ethical research. Continuing education options might include activities at annual professional meetings focused on various aspects of ethical research design and conduct, tuition reimbursement for participation in formal education courses, formal mentoring programs to facilitate the training of new investigators, “brown bag” sessions on particularly complex topics or new information, seminars, Web-based tutorials, or in-house research consulta-