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Responsible Research: A Systems Approach to Protecting Research Participants
cally, perhaps every three years. In order to be effective, rewards and sanctions should be concrete and consistent, and educational and behavioral endeavors promoting the safety of human research should be closely linked to the institution’s program promoting research integrity.
As a measure to demonstrate competence in the design and conduct of ethically sound research, the National Bioethics Advisory Commission (NBAC) recommends that all investigators, Institutional Review Board (IRB) members, and IRB staff should be certified prior to conducting or reviewing research involving humans. Certification requirements should be appropriate to research roles and to the area of study. The federal government should encourage organizations, sponsors, and institutions to develop certification programs and mechanisms to evaluate their effectiveness. Federal policy should set standards for determining whether institutions and sponsors have an effective process of certification in place (NBAC, 2001b, p.48-49). The committee concurs that it is the responsibility of the research organization to establish the level of initial and continuing instruction appropriate for individuals with different responsibilities.
This committee’s previous report, Preserving Public Trust: Accreditation and Human Research Participant Protection Programs, addressed the utility and potential value of an accreditation program for Human Research Participant Protection Programs (IOM, 2001a). Similar arguments regarding a move toward quality improvement (QI) and stimulating attention to weaknesses can be made for the certification of individual investigators. Certification would increase the likelihood that program principles would be followed by
systematizing the body of knowledge that any investigator would be expected to have,
providing an external mechanism to attest to the investigator’s knowledge and understanding,
stimulating periodic re-review and updates by investigators seeking recertification,
reassuring stakeholders and potential participants that research is conducted appropriately, and
recognizing the skilled research practitioner and screening out the unprepared investigator.
Investigators would be more likely to seek certification if offered an incentive, such as an increased likelihood of qualifying as a study site in multisite studies, or a disincentive, such as exclusion from federally funded or regulated investigations. The committee believes that certification of investigators is a promising approach that deserves immediate and careful