Accreditation

PNNL is the first Department of Energy Laboratory and the first Battelle Human Research Protection Program to achieve accreditation with the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). AAHRPP, a nonprofit organization headquartered in Washington, D.C., was founded in 2001 by the following nationally recognized organizations:

Association of American Medical Colleges
Association of American Universities
Consortium of Social Science Associations
Federation of American Societies for Experimental Biology
National Association of State Universities and Land-Grant Colleges
National Health Council
Public Responsibility in Medicine and Research

AAHRPP is governed by a 23-person Board of Directors and utilizes the services of over 70 volunteer site visitors, including researchers, IRB professionals, institutional officials, and public representatives. AAHRPP's Council on Accreditation, comprised of 11 members, makes all accreditation determinations.

Accreditation is a visible way of demonstrating that PNNL values research protections for human subjects and that it is worthy of our clients' confidence and collaboration in research. It was important that our Laboratory take its place alongside the other 107 institutions that have earned this prestigious distinction, including Cedars-Sinai Medical Center, Harvard University Faculty of Medicine, The University of California at San Francisco, Vanderbilt University, and the only other major institution in Washington State to achieve accreditation, the Fred Hutchinson Cancer Research Center in Seattle. The decision to seek accreditation came at the urging of DOE and the PNNL Laboratory Director and was supported at all levels by management, researchers, and IRB members and support staff.

To qualify for accreditation, the PNNL HRPP had to meet 77 standards and principles established by AAHRPP for five specific domains which include the Institution, the IRB, investigators, research sponsors, subjects and the community.

Institutions that obtain accreditation with AAHRPP are able to:

Demonstrate to sponsors that their organization values research protections, follows regulatory requirements, and has an efficient, streamlined human research protection system.
Demonstrate to potential human subjects that their organization is committed to protecting the rights and welfare of subjects.
Attract high-quality investigators who can have confidence in the IRB and in an organization that supports human subject research.
Increase their efficiency and reduce costs by streamlining operations and eliminating duplicative efforts.
Foster alliances with other accredited and like-minded organizations.

Laboratory management and staff involved in the conduct or oversight of human subject research contributed to this effort. For additional information regarding the accreditation process, see the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP).

Maintaining Accreditation

In order to maintain AAHRPP accreditation, an organization must be revisited every three years. In between, organizations must meet the AAHRPP reporting requirements described below. For the majority of organizations this is all that will be necessary to maintain their accreditation. Some organizations, however, may be required to participate in a mandatory revisit. Others may make an appeal or request an an oral hearing before the Council on Accreditation regarding their accreditation status.

Annual and Other Reporting

During the intervening years between triennial site visits, AAHRPP requires accredited organizations to submit annual reports. The purpose of the annual report is to inform AAHRPP of major changes or problems related to the Organization's Human Research Protection Program. Organizations must submit a standard form that includes the following information:

A summary or table of major problems or deficiencies identified in the last 12 months, and how they were resolved.
A brief description of all programmatic changes that positively or negatively influenced the Human Research Protection Program.
The results of any federal or accrediting review of its Human Research Protection Program.

In addition to the annual report, organizations must notify AAHRPP as soon as possible, preferably within 72 hours, of any:

Inquiries from a government oversight office, such as the Office of Human Research Protections or the Food and Drug Administration when the inquiry could result in a for-cause investigation.
Any findings or changes concerning your Human Research Protection Program that might affect your ability to continue to meet AAHRPP standards.

Organizations must report to AAHRPP within 24 hours of:

Any sanctions taken by a government oversight office.

The purpose of these prompt reporting requirements is to ensure that AAHRPP is fully informed of compliance-related activities at accredited organizations between regular triennial site visits. Through the acquisition of such information AAHRPP may be able to work with accredited organizations in dealing with these situations.

AAHRPP does not comment publicly on ongoing investigations. AAHRPP's policy is to maintain accreditation of the organization until the ongoing investigation is complete and the results of the investigation have been evaluated. Organizations that fail to report government sanctions or who fail to provide requested information may be placed in the Pending Category or have accreditation revoked.

For additional information regarding AAHRPP requirements, refer to the AAHRPP website.