Box 2.2
Necessary Education Requirements for Organizational Leadership

President, Chancellor or CEO: The Association of American Medical Colleges (AAMC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), in concert with Public Responsibility in Medicine and Research (PRIM&R) and the Applied Research Ethics National Association (ARENA) should develop educational materials and programs for executive leadership positions in private industry and academic institutions. These could include knowledge of the federal regulatory structure, especially the assurance process; an overview of the federal regulations governing human research; the definition and function of each component of a program; an overview of the program accreditation process and specific knowledge of the accreditation standards at the level of the institution; continuing education on evolving issues in human participant protections.

Dean for Research or Industry Counterpart: AAMC and PhRMA, in concert with PRIM&R and ARENA should develop educational materials and programs for Deans, Vice Presidents, and Department Chairs. These would include knowledge of the federal regulatory structure, especially the assurance process; an overview of the federal regulations governing human research; the definition and function of each component of a program; an overview of the program accreditation process and specific knowledge of the accreditation standards for the institution; continuing education on evolving issues in participant protections.

Federal Research Assurance Signatory: In-depth knowledge of the federal regulatory structure, especially the assurance process; an overview of the federal regulations governing human research; the definition and function of each component of a program; an overview of the program accreditation process and specific knowledge of accreditation standards at all levels; continuing education on evolving issues in participant protections.

Institutional Compliance Officer: In-depth knowledge of the federal regulatory structure, especially the assurance process; an overview of the federal regulations governing human research; an understanding of the certification process for IRB professionals and investigators; the definition and function of each component of a program; an overview of the program accreditation process and specific knowledge of accreditation standards at all levels; continuing education on evolving issues in participant protections.

Academic or Unit Department Head/Scientific Merit Signatory: Certification as an investigator; overview of the federal regulatory structure and assurance process; overview of federal regulations governing human research; knowledge of professional codes of research ethics and conduct such as the Nuremberg Code and the Declaration of Helsinki; a working knowledge of the IRB process of ethics review; in-depth knowledge of the review process for scientific merit; specific knowledge of program accreditation standards for investigators; review of accreditation standards for other program components; continuing education on evolving issues in participant protections.

   

NOTE: Inclusion of accreditation elements within the requisite education content is dependent upon its applicability to an organization and contingent upon the determination that accreditation programs effectively contribute to participant protection, as discussed in Chapter 6.



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