Thursday, January 5, 2012

Make Changes Permanently, Not Just for AAHRPP Site Visits

The Step 2 process for accreditation calls for a site visit to evaluate HRPP function and ensure that the organization’s policies and procedures have been implemented effectively. A site visit occurs during initial accreditation, three years later at reaccreditation, and again at subsequent reaccreditations. The site visit covers extensive review of records and interviews of people ranging from IRB chairs, members, and staff to senior administrators, researchers, and research staff.

Sometimes organizations prepare interviewees for the site visits. Some educate IRB members and researchers and research staff prior to the visit. Education of anyone involved in human participants research and protection is always good. Ideally, the education provided in preparation of the site visit is part of an ongoing and comprehensive education program.

Some organizations scour the records from the list that AAHRPP provides the organization five days prior to the site visit and try to find and correct deficiencies. Altering records can be problematic. For example, IRB meeting minutes should not be revised to add missing determinations that the IRB did not make. Edits or changes can be made that accurately reflect IRB decisions and determinations, but the deficiency of not documenting the IRB’s determinations should be recognized as such and corrected in all records, not just those selected for the site visit. Changing records for the site visit is counterproductive if the deficiency in practice is not corrected permanently and comprehensively.

After the completion of the Step 1 review of application materials (review of written policies and procedures) the organization has about 90 days prior to the site visit to implement any changes identified during the Step 1 application process. Changes required as a result of the entire accreditation process (Step 1 and Step 2) should be implemented permanently upon obtaining accreditation. For example, documenting protocol-specific findings to justify certain IRB determinations should begin when the Step 1 application process is completed and certainly by the time of the site visit, not two or three years later in preparation for the next site visit. In fact, AAHRPP looks at records that span all of the years of the accreditation period to make sure that the organization has put functioning policies and procedures in place since the most recent accreditation was obtained.

This discussion leads to one key point: Make changes permanently, not just for AAHRPP site visits. The purpose of accreditation is to identify problems and implement changes so the organization can become a high-functioning, quality HRPP. The organization should perform at this high level continuously, not just for or during AAHRPP site visits. Another reason for making the changes permanent is that inspectors from the Office of Human Research Protection, the Food and Drug Administration, or the Office of Research Oversight of the Department of Veterans Affairs may visit most organizations at any time.

As Mr. Bradley Olsen, administrative officer at the Durham Veterans Affairs Medical Center, put it, his VA facility “wants to be ready for a site visit by anyone every day. We want to be able to succeed every day, not just ramp up every five years.” That is the hallmark of an excellent HRPP, and should be every organization’s goal.

No comments:

Post a Comment