Accreditation: Get Accredited - Part 4: Evaluation of Practice

After the Review of Written Materials step is complete, AAHRPP will request a final set of written materials in the form of a Step 2 Application. AAHRPP staff will schedule your site visit, usually within three months of when the Step 2 application for accreditation or reaccreditation is submitted. The size and scope of your organization affects how long the site visit will last and the size of the site visit team.

Before the Site Visit

Six weeks before the site visit

AAHRPP will send an initial email with a draft agenda for the site visit and other information to help you get ready. This initial email helps establish contact between the Organization and AAHRPP staff who will work together to answer your questions relating to accreditation and the site visit. This email includes:

A list of members of your Organization who will be interviewed, along with a proposed schedule of interview times.
An explanation of the types of meetings that will occur during the site review: the introduction, program overview, interviews, record review and executive session, daily closeout, lead contact review, and final closeout.
A list of the individuals who will be members of your site visit team.
If the evaluation will be on-site, a request for logistical and travel information, such as the location of the nearest airport and recommendations for lodging and meals.
If the evaluation will be virtual, a request for a meeting to identify and test the technology that will be used for interviews and document sharing.

Approximately six weeks before the site visit, AAHRPP will provide a list of the records and documents you must have ready for the site visitors on the first day of the site visit. The list includes documentation, such as

Your Organization’s most recent periodic evaluation of resources allocated to the HRPP, key functions of the HRPP, and participant outreach plan;
Plan to assess HRPP compliance and quality, efficiency, and effectiveness of the HRPP;
Organizational conflict of interest management plans;
Copies of the last notification letters sent to a US federal agency (e.g., OHRP, FDA, or other agency) or other governmental agency reporting serious or continuing noncompliance, suspension and termination of IRB or ethics committee approval, and unanticipated problems involving risks to participants or others;
IRB or ethics committee meeting minutes;
IRB or ethics committee roster(s);
Curriculum vitae or resume for IRB or ethics committee members;
Performance evaluation of IRB or ethics committee members and chairs; and
Study files.

The number of requested documents varies depending on the size of your organization and whether you have an internal IRB or ethics committee.

Two weeks before the site visit
AAHRPP will send a final agenda and other logistical details.

During the visit

Some of the key meetings that will occur during the site visit are:

Introduction session

This typically includes the site visit team, the lead contact from your Organization, the Organizational Official, and other staff members that you would like to invite. Team members will describe the accreditation process. This is also an ideal time for representatives of your Organization to ask questions.

Program overview

The program overview is an opportunity for site visitors to ask questions about your organizational structure and how your Human Research Protection Program (HRPP) functions within your Organization. Invite the people who are most involved with the overall operation of the HRPP. Include the lead contact and key managers of the institutional review board, HRPP, and compliance oversight. Attendees should be able to answer questions and present overviews on how various components of your Organization interact.

Interviews

These are confidential and are limited to the individuals listed on the agenda, unless other arrangements have been made in advance.

Close out session

Site visitors will provide both a high-level overview and specific observations about each Standard. They will mention the types of issues that will be noted in the Draft Site Visit Report. Site visitors may provide suggestions, but these will not be included in the report. Senior leadership as well as individuals who are intimately involved in the operations of your HRPP should attend this session.

After the site visit

AAHRPP will provide a Draft Site Visit Report to you within 45 calendar days of the last day of the site visit. While waiting for the report, debrief everyone who was interviewed during the site visit. This can help you anticipate some of the comments you might see in the Draft Site Visit Report. Take a breather but remain focused on accreditation. Review the notes you took during the site visit and begin working on improvements that will address the observations that the site visitors reported.

Once you receive the report, study the observations and ask AAHRPP for clarifications. Your response is due to AAHRPP within 45 calendar days. Pay attention to the due date in the letter you receive along with the Draft Site Visit Report. This deadline is strictly observed. See Instructions to Prepare a Response to a Draft Site Visit Report.

Respond to any errors of fact. If you have made any changes to your HRPP since the site visit, make sure to note those changes in your response.

For some Organizations, the response and resulting corrections involve more work than expected. If the report includes a lot of observations, pick a few and respond well.

If you plan to send a response to AAHRPP, have staff available to assist you. Although a significant amount of the work in achieving accreditation is finished by the end of the site visit, your response to the Draft Site Visit Report is an integral part of your application. The application process does not end until you have submitted your response.