Accreditation: Center's critical competitive edge

Hutchinson Center remains the only research institution in Washington state to achieve and maintain accreditation for human research subject protection

January 3, 2012 • By Galen Motin Goff

Institutional Review Office Director Karen Hansen said, "I am very proud of the ongoing commitment of the IRO staff, the IRB committee members and IRB chairs." Their contributions help make continued accreditation possible. Center News file photo

The Hutchinson Center has received reaccreditation by the Association for Accreditation of Human Research Protection Programs (AAHRPP), making it the only research institution in the state of Washington to lay claim to an industry gold standard for human research subject protection.

"The accreditation process involves the Center's entire Human Research Protection Program. It reflects the Center's commitment to human protections, and provides numerous advantages," said Karen Hansen, director of the Institutional Review Office (IRO).

Among the advantages, accreditation:

Enhances opportunities for collaboration — Other organizations can rely on the Center's Institutional Review Board for multisite trials and coordinating center activities (e.g., Women's Health Initiative, HIV Vaccine Trials Network and the Cancer Immunotherapy Trials Network). Reliance on a single IRB avoids the complexities of multiple IRB reviews at various performance sites. The use of a single lead IRB can also reduce the time to first accrual for clinical trials.

Provides an extra measure of quality assurance — The AAHRPP seal indicates the institution safeguards research participants and is committed to quality improvement.

Leads to improved efficiency, effectiveness — Streamlined policies and procedures are documented and put into reliable practices, which supports the ethical conduct of research and a regulatory compliant program.

Offers a competitive edge — Sponsors, drug companies and other funding agencies recognize that accredited organizations are committed to efficient operations, provide comprehensive protections and have compliant human research protection programs.

"Achieving and maintaining accreditation requires an institution to examine human research protection programs closely, to identify and address any weaknesses, and to build upon strengths," Hansen said. During more than 36 years at the Center, Hansen gained firsthand knowledge of the process by serving as a member of the AAHRPP's Council on Accreditation and conducting site visits at other institutions.

The Center first achieved AAHRPP accreditation in 2008. The reaccreditation process, conducted three years after initial accreditation and scheduled for every five years thereafter, involves:

Gathering information, filing an annual report documenting the quality of the Center's human research program, and completing an application consisting of more than 3,500 pages of supporting materials.

Submitting 1,400 protocols, from which AAHRPP picks 10 percent to closely review.

AAHRPP interviews that start with the Center's president and director and include affiliated and unaffiliated members of the IRB, IRO staff, and representatives from the Research Trials Office, Clinical Trials Office staff, Technology Transfer and Industry Relations, the Office of General Counsel, and key collaborators from the University of Washington and Seattle Children’s.

The role of institutional review

The Institutional Review Office plays a critical role in Center science because it works to ensure that all research activities involving human and animal subjects comply with ethical standards, applicable regulations and established Center policies relating to the care and protection of such subjects.

The office coordinates the activities of three Institutional Review Boards. These committees are responsible for the human subject protocols research review. Approximately 50 individuals from across the Center and community volunteers serve on an IRB. Hansen’s team is responsible for making sure IRB committee members receive all the proper materials, conduct ethical review, and consider all regulations for the protection of human subjects.

"I am very proud of the ongoing commitment of the IRO staff, the IRB committee members and IRB chairs,” Hansen said. “Collectively they make an enormous contribution to the Center's human research protection program, which helps make continued accreditation possible."

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