Pfizer awarded for human rights in research

06-Apr-2009 - Last updated on 07-Apr-2009 at 10:29 GMT

Pfizer has become the first drugmaker to win accreditation for protecting the human rights of subjects enrolled into early-stage clinical trials under a scheme operated by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

The AAHRPP accreditation was awarded to Pfizer's clinical research units in New Haven, Connecticut in the US, Brussels in Belgium and Singapore. The company conducts most of its Phase I clinical research at these three centres.

To gain accreditation, organisations have to show tangible evidence of a commitment to scientifically and ethically sound research based on “policies, procedures and practices,” according to the AAHRPP.

The independent, non-profit accrediting body was established in April 2001 and started receiving applications in 2002. The path to winning accreditation involves carrying out a self-assessment and submission of an application, followed by an onsite evaluation and review by the AAHRPP Council. Once awarded, accreditation is valid for three years.

Fees range from $6,400 to around $80,000 based on the number of active clinical trial protocols, according to the AAHRPP’s website.

To earn its accreditation, Pfizer underwent a 15-month examination of the clinical research practices at its Phase I units and submitted an application of more than 1,000 pages to AAHRPP.

The company said it sought accreditation because it wanted to show “commitment to integrity in research and .. be among more than 150 of the world's best universities, hospitals, institutional review boards (IRBs) contract research organizations (CROs), and other organizations that are AAHRPP-accredited.”

Pfizer has implemented a number of other initiatives recently to shore up its clinical research policies, and in November 2008 adopted a requirement that it would only use institutional review bodies (IRBs) for its US trials that are themselves AAHRPP-accredited.