Theory on Accreditation (for a Term Paper

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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.

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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.

All standards should be based on existing federal regulations for the protection of human research participants. However, if the accreditation standards are identical to federal regulatory standards, this will lead to performing redundant tasks, both by the institution and the accreditation organism. Also, if standards are inconsistent with federal regulations, this will lead to confusion.

Accreditation organizations should use their power on the applicants in order to orient them towards the process of self-study, evaluation, and continuous quality improvement.

The accreditation process, along with accreditation standards and HRPPP operations must directly involve research participants. More research participants should be included in the review and oversight process and in other additional activities. Focus groups, consent monitors, and participant representatives should be directly involved in the accreditation process.

Reference List

Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001). Committee on Assessing the System for Protecting Human Research Subjects, Board on Health Sciences Policy, Institute of Medicine.

Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001). Committee on Assessing the System for Protecting Human Research Subjects, Board on Health Sciences, Policy, Institute….....

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