Considering the frequency of this practice, it is critical that the mechanisms for independent scientific review are defined and can be audited.
Academic departments have a responsibility to establish and cultivate the highest standards in scientific conduct, including the treatment of those who participate in human studies. There are few, if any, investigators who are so senior and experienced that their proposed research cannot benefit from scientific review. In large institutions, departmental committees may already vet proposals before they are submitted to the IRB, perhaps serving as the formal scientific review mechanism. In smaller institutions, an inter-departmental review may occur. And in the case of graduate level research, the mentor or thesis committee may assume this responsibility.
Secondary gains from the use of this particular scientific review mechanism include an additional level of mentoring for new and junior investigators, continuing education of reviewers, a mechanism for monitoring and developing departmental research programs, and departmental investment in and responsibility for its research program and the consequent human participant protection needs. The organization’s standards should become an integral component of the mentoring that senior investigators provide to less experienced investigators and reviewers. Furthermore, the departmental responsibility for fostering quality research among its members is representative of the accountability for research conduct and behavior at the highest levels of a research organization (Recommendation 2.2). In this way, the local leadership provided by a department facilitates the realization of an ethically rich and robust research culture.
If the targeted scientific review mechanism, in whatever form it may take, is to be optimally utilized, a summary of the results of the scientific review must be reported to the Research ERB before the focused ethics consideration occurs, and it should be reported in a manner that is understandable to nonmedical, nonscientific members. A written, signed report might include the following items:
A determination that the importance of the scientific question is sufficient to merit the inclusion of human participants and the risks imposed upon them;
Comments on the strength of the scientific design and methodology;
An assessment of the practical feasibility of the research design;
An estimate of the probability of meeting the goals of enrollment;