Accredited Organizations renew their accreditations three years after the initial accreditation and every five years thereafter, by performing the same self-assessment and gap analysis required for the initial accreditation application. You do not need to pay a new application fee to renew your accreditation; annual fees cover the costs of reaccreditation.
This time around should be easier. You know the AAHRPP Domains, Accreditation Standards, and Elements. Depending on your Organization’s approach to accreditation, though, you could already be falling behind in the reaccreditation process. The following tips can help you put together your renewal application.
Keep your application current. Your Organization earned accreditation, in part, because of its commitment to continuous improvement. It is only natural, then, that some of your practices, policies, and procedures will change in the three years after you submit your original accreditation application. Each time a change is approved, update the application immediately. Treat it as a “live document,” and you will always have an accurate record of your Organization’s efforts to safeguard research participants. You also will spare yourself the time and frustration of researching three years’ worth of changes just before the application is due to AAHRPP. Check the AAHRPP website periodically, attend conferences, and network with other accredited organizations to stay abreast of accreditation updates and innovative practices.
Have a backup. This applies to people as well as to paperwork. Staff changes and unforeseen events can derail reaccreditation efforts. If possible, have one or two staff members who are familiar with the application, are comfortable maintaining it, and know exactly where you stand in the reaccreditation process. As always, back up the electronic version of the document, and have a current hard copy on file.
Start your reassessment in plenty of time to meet the deadline for renewal. Your reaccreditation application is due 12 months before the regularly scheduled Council on Accreditation meeting. Use this meeting date to establish the time frame for your self-evaluation, which is an integral component of reaccreditation. Three to six months before your application submission deadline, start the same detailed self-assessment that you conducted for your original accreditation. Typically, this should occur at approximately the same time that you are preparing your second annual report. The self-assessment will help you evaluate your Human Research Protection Program and ensure that you’re up to date on AAHRPP’s interpretation of the accreditation Standards. (If your Organization is planning a major change, if possible, delay it until after reaccreditation, so you can give accreditation—and the organizational change—the attention that each deserves.)
Communicate constantly and effectively. Maintain the relationships that you built during the original accreditation process. Involve others, and ask for help. Continue to emphasize the value of accreditation, and keep organizational officials and co-workers informed of your progress. Make sure that procedural and policy changes are communicated and adopted throughout the Organization. Remember: Documentation alone is not enough; policies and procedures must be put into practice.
Save time for formatting. The application for reaccreditation is submitted as a PDF, with links to supporting documents. Allow one to two weeks to convert your application from word-processing format to PDF. Prepare for your site visit. Reaccreditation involves the same comprehensive, on-site evaluation that is required for accreditation. See Preparing for Your Site Visit for more information.
An Organization that is renewing its accreditation conducts a new self-assessment. The results of this internal review are submitted to AAHRPP in the form of a Step 1 application. Next, AAHRPP staff review the application and determine whether the written documents meet the accreditation Standards. Staff will communicate required changes to the Organization.
Once staff determines that the written documents are satisfactory, a site visit is scheduled, and the Organization submits its Step 2 application for reaccreditation. AAHRPP site visitors review the application and conduct an on-site evaluation. AAHRPP must have sufficient information to evaluate adequately an Organization's program.
In general, this requires that site visitors be permitted to enter all facilities and have access to all relevant records, policies, procedures, minutes, audits, sample protocols, consent forms, and other materials. To perform these tasks, the site visitors must sign confidentiality agreements with AAHRPP prior to the visit. AAHRPP will not accredit an Organization that cannot be thoroughly evaluated.
The Organization’s application and results of the on-site evaluation form the basis of a site visit report. AAHRPP provides a Draft Site Visit Report to the Organization shortly after the site visit and no later than 45 calendar days of completion of the site visit unless the site visitors make no observations that warrant a response from the Organization.
Within 45 calendar days of receipt of the report, an Organization has the opportunity to respond in writing to AAHRPP to identify any errors of fact and to describe any corrective actions it has taken since the site visit. The site visit team leader then reviews the Organization’s response and writes an evaluation of the response. The Council on Accreditation reviews the Draft Site Visit Report, the Organization’s response, and the evaluation of the response. The Council then makes a determination regarding accreditation. Then the decision of the Council is communicated to the Organization.
When an accredited organization has a substantive change to its Human Research Protection Program (e.g., a merger of another entity), it must notify the AAHRPP office when the change occurs. AAHRPP will assess along with the Organization whether an individual consultation might be needed prior to submitting a renewal application.
Timelines for Renewing Applicants
Each Organization is assigned to one of the Council on Accreditation quarterly meeting dates. The assignment is based on the Organization’s initial accreditation date.
Organizations must submit their applications 12 months in advance of the Council meeting. Refer to the letter that you received when you were accredited to find out when you must submit your application for reaccreditation.
Organizations that cannot submit by the deadline must notify the AAHRPP office at least 45 calendar days in advance. Extensions will be granted only under unusual or exceptional circumstances.
Organizations that submit renewal applications after the deadline date or fail to complete the Step 1 application in time to complete the accreditation process before the Council meeting at which it is to be reviewed will be placed in Reaccreditation-Pending, on Probation, or lose accreditation status. Organizations must provide justification to the Council on Accreditation to avoid being placed on Probation or losing accreditation status. Organizations that are placed in Reaccreditation-Pending or on Probation and eventually earn reaccreditation will have a reaccreditation period equal to five years minus the time spent in Reaccreditation-Pending or on Probation.