DOE Human Subjects Resources
Self Assessment and Accreditation
DOE Interim Policy Statement. (Note: a broader, more comprehensive Policy Statement is in preparation and will be issued in the near future.) The Department of Energy requires that all research conducted at DOE institutions, supported with DOE funds, or performed by DOE employees, including research that is classified and proprietary, whether done domestically or in an international environment, must comply with all federal regulations and DOE requirements that address the protection of human subjects. DOE supports the concept of self-assessment and accreditation to assure that all the applicable regulations for the protection of human subjects in research is properly and consistently applied. With the DOE operating over 25 research laboratories and other facilities across the country, identification of projects with human participants and ensuring protection of those participants is compounded by the variety of communities in which these facilities are located and the spectrum of research done across these sites. Because of this diversity of projects in number and variety at each site, DOE has adopted the “graded-approach” to self-assessment and accreditation whereby each facility may use an accepted assessment plan to validate the implementation of their own protection program. The currently accepted assessment plans are:
- The Office of Human Research Protections (OHRP) self-assessment program - A Guided Self-Assessment for Human Research Protection Programs
- The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) accreditation program and self-assessment process
OHRP Self-Assessment Program. Over the past several years, institutions and IRBs have faced increasing scrutiny and/or criticism from the public, media, and the federal government’s Office of the Inspector General (OIG) and the General Accounting Office (GAO). Such criticism includes the failure to obtain prospective IRB approval, minimize risks for subjects, obtain legally effective informed consent, provide oversight or adequate continuing review of human subjects research, and eliminate or minimize conflicts of interest. To strengthen individual institutional human subjects protection programs, the OHRP has developed a new Quality Improvement Program (QIP) to offer consultation and support. It is intended to benefit human subjects protection programs at institutions that conduct biomedical, social, or behavioral research, as well as independent IRBs.
The primary purpose of the QI Program is to increase the quality, performance, and efficiency of an institution’s human subjects protection program. Secondarily, the QI Program is designed to help institutions ensure compliance with federal regulations for the protection of human subjects in research. OHRP further intends this program to help institutions prepare to achieve accreditation of their human research protection programs by private-sector accrediting entities such as Association for the Accreditation of Human Research Protection Programs (AAHRPP). OHRP believes that such accreditation is an important complementary process for strengthening and improving the performance of the national system for protection of human subjects in research.
Institutions that wish use OHRP's Quality Improvement Program may do so by completing one or both of the following procedures:
- Conduct a guided self-assessment of the human research protections program at the Institution’s site by using the OHRP QA Self-Assessment Tool and Instructions
- Contact OHRP to request an OHRP QA consultation of your human research protections program
AAHRPP Accreditation Program. The Association for the Accreditation of Human Research Protection Programs (AAHRPP) is a nonprofit organization based in Washington D.C. dedicated to protecting the rights and welfare of people who participate in research.
In December 2003, the Department of Energy encouraged its more research-intensive laboratories to seek accreditation for their human research protection programs (see the press release on the AAHRPP Web site). Responding to increased public concern for protecting research participants, AAHRPP seeks not only to ensure compliance with the federal regulations, but to raise the bar in human research protection by helping organizations reach performance standards that surpass the threshold of local and federal requirements.
AAHRPP has established an internationally recognized "gold seal" accreditation program that signifies an organization is committed to the most comprehensive protections for research participants and the highest quality research.
The AAHRPP standards are divided into five domains of responsibility: organization, Institutional Review Board, investigators and research staff, sponsored research, and participant outreach. The accreditation program involves an intensive self-assessment conducted by the applicant organization followed by a peer-review site visit.
Organizations can receive accreditation for a three-year period at the end of which they reapply for accreditation.
Content reviewed: November 12, 2013