Theory of accreditation in human research protection programs

Theory on Accreditation (for a Human Research Protection Program)

Theory of accreditation proposed by the Institute of Medicine

The accreditation of the HRPP proposed by the IOM is recommended to follow the next approaches: pursuing accreditation through pilot testing; establishing a nongovernmental accreditation organization; articulating sound goals within accreditation standards; establishing flexible, ethics-based, and meaningful standards; accommodating distinct research methods and models within accreditation models; basing standards on existing regulations; incorporating continuous quality improvement mechanisms into standards; directly involving research participants in accreditation programs; using modified NCQA standards to initiate pilot programs; starting collecting data and assessing impacts of accreditation now; initiating federal studies evaluating accreditation.

Accreditation standards should be able to ensure that the knowledge contributed by the proposed research justifies human research; that the perspectives of the participants are represented on IRBs, research monitoring bodies; that the participants are managed responsibly by research institutions; that risks are kept to the minimum necessary; it also has to ensure transparency.

In the United States accreditation efforts "followed one of two models, although a third model can also be observed." The first of these models consists in supplementing government regulation through accreditation. In this case, accreditation would be considered a mark of excellence held by organizations already regulated by the government. Only a fraction of these entities are accredited. This model was illustrated by the NCQA program (NCQA 2001a). In the United States the organizations are regulated by state insurance departments, state health departments, or DHHS. Accreditation is perceived as an indicator of performance higher than the required minimum.

The second model is clearly different, as "accreditation substitutes private regulation for public regulation." On the one hand, institutions of higher education with no formal government regulation are accredited, which means that accreditation represents the only oversight system. On the other hand, nongovernmental accreditation is considered to be an alternative to state certification. This approach has important advantages, as it reduces costs of oversight to government (being paid for by user fees); also, nongovernmental accreditation programs are more flexible and responsive to change, compared to governmental certification. However, this type of accreditation has its costs, and it is not directly accountable to the public.

The third accreditation model does not consist in creating its own standards, but in ensuring compliance with standards based on interpreting the regulatory standards established by the government. The AAALAC is using this accreditation model.

However, despite the difference between these three models, they also have several common elements, like: the accreditation process must be mediated by a national organization; the eligibility for applying for the accreditation has a set of threshold criteria; a process of self-evaluation; also, an external evaluation process is necessary; an appeals process for accreditation determinations; the self-evaluation and external evaluation are part of a repetitive cycle; and also, a set of standards by which HRPPPs can be measured is necessary.

In the committee's opinion, the accreditation bodies must be national independent organizations with high credibility among the stakeholders on the one hand, but independent of any interest group among them on the other hand. Therefore, any accreditation body should be characterized by independence, credibility, and familiarity with stakeholders' needs.

The accreditation body should establish who can be accredited, it should also establish the fees that can cover the costs of accreditation, and also the application process. In order to be accredited, the applying organization must present relevant information for the future to be used standards. Self-evaluation is considered to be the most important element of the entire accreditation process. The accreditation body then performs the external evaluation through visiting sites, by reviewing the self-evaluation and the documentation, performing necessary interviews. After the external evaluation is performed, the accreditation body's staff must decide whether they accredit the applicant, give it a probationary status, or reject the application.

The appeals process is needed by those institutions that were rejected by the accreditation body after the external evaluation. PRIM&R standards do not include such a step in the accreditation process.

The accreditation is only valid for 3 to 5 years, after which it must be repeated.

Despite accreditation's numerous advantages, it cannot totally replace federal regulation. The accreditation body is not responsible for uncovering, investigating and sanctioning any violations committed by the applicant.

Regarding the standards for accreditation, their primary features should be flexibility, which would allow them to be applicable to various institutions, and rigorousness, which would ensure that their enactment would enhance protection of human research participants. Also, "they must be clearly written, relatively straightforward to execute, consistently applicable, and measurable."

The three ethical principals discussed in The Belmont Report represent the basis for ethical requirements human research. These principles are: respect for persons, beneficence, and justice. The respect for persons principle establishes that individuals should be treated as autonomous agents and their decisions must be respected, and that individuals with diminished autonomy should be protected. The beneficence principle indicates that no harm must be done and that any possible harm must be diminished as much as possible. The justice principle recommends that all he benefits and burdens should be fairly and ethically distributed, and that the election of participants must be fair. However, along with these ethical principals, procedural requirements are necessary, in order to establish the foundation of the standards.

Standards must be accompanied by measures for evaluating an organization's level of compliance. These measures should be designed for areas in which performance influences in a significant manner the protection of human research population. Standards should generally help HRPPPs and accreditation bodies to identify exemplary performance and best practices of the organizations applying for accreditation.

In Understanding Accreditation (Young et. al., 1983) the accreditation process is discussed as having four trends regarding accreditation standards: the system of assessment has become more qualitative, since the standards are more general rather than specific; institutions' individuality should be recognized and encouraged; the system is based more on self-evaluation and self-regulation; the focus is on encouraging and assisting the organization regarding quality improvement.

Standards must be able to apply to various types of organizations, including research institutions, educational institutions, independent IRBs, academic medical centers, nongovernmental organizations, and private interests. Therefore, the scope of institutions to which standards apply can be made clear by explicitly stating the intended focus of the standards, by including flexible language, or by organizing the standards for each institution to ascertain which sections apply to them.