AAHRPP revises standards

By Nick Taylor

- Last updated on GMT

Related tags Institutional review board Government accountability office

The AAHRPP has issued a major revision of its standards, the first time it has done so, adding sections on transnational research and the separation of business interests from ethics review.

Since the Association for the Accreditation of Human Research Protection Program (AAHRPP) was formed in 2001 there have been numerous changes to the clinical trial field and the revisions are designed to reflect these.

In particular the globalisation of clinical trials has progressed quickly, leading to the AAHRPP adding a new standard for accreditation. This states that an organisation’s transnational trials must be consistent with the ethical principles detailed in its Human Research Protection Program.

Furthermore, overseas trials must have equivalent levels of participant protection as research conducted in its principal location, comply with local laws and take cultural context into account.

The revised standards also cover the structure and composition of institutional review boards (IRB) and ethics committees (EC). IRBs have come under increasing scrutiny in the wake of the US Government Accountability Office’s (GAO) sting operation and gaining the AAHRPP’s voluntary accreditation is a means for them to demonstrate commitment to high standards.

From March 1 2010, when the new standards come into force, IRBs and ECs will have to demonstrate they have and follow “written policies and procedures to separate competing business interests from ethics review functions​”.

A similar standard has been added for organisations conducting clinical trials. This states that financial conflicts of interest must be identified, managed and minimised or eliminated.

The AAHRPP has also added an element that re quires organisations to promote the involvement of community members in the design and implementation of research and the dissemination of results.

A copy of the revised standards can be viewed here and a comparison of the old and new versions is available here.

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