At the heart of the accreditation process is a comprehensive self-assessment during which an Organization reviews its Human Research Protection Program (HRPP) and evaluates its compliance with the AAHRPP Accreditation Standards and Elements. Given the scope of these Standards and Elements, it is not surprising that one of the most frequent questions that AAHRPP receives is “Where do we begin?”

Following are some tips designed to answer that question. As you move forward with accreditation, keep in mind that the process is meant to be rigorous, not overwhelming.

First of all, and throughout the accreditation process, you should:

Read, read, and read some more. Start with the AAHRPP website and newsletter, AAHRPP Advance. Read institutional review board (IRB) journals, and check the websites of other accredited organizations and relevant federal agencies or offices, such as the Food and Drug Administration and the Office for Human Research Protections. On the AAHRPP website, under “Apply,” pay particular attention to the sections on “Preparing the Application” and to this section—“How to Conduct a Self-assessment.” Information on the AAHRPP website is available at no charge. Work at your own pace. You can start the self-assessment whenever you are ready, and work on it as long as necessary.

Get commitment from the highest level. Accreditation is attainable only if your entire Organization fosters a culture of accountability and makes human research protection a priority. When you begin the process, obtain organizational commitment, backed by budgetary support.

Establish an accreditation team. Identify key individuals who can help with accreditation, and invite them to join the team. Be clear about the responsibilities of each team member, and set realistic deadlines for meeting those responsibilities. To oversee the accreditation process, choose a team leader who is organized and has an organizational perspective with an understanding of how all the components of your HRPP fit together.

Strive for protection, not perfection. The goal is to have an effective HRPP whose activities achieve the desired outcome: to protect research participants. If practices and policies meet the AAHRPP Element and Standard, do not spend time revising them further. Instead, focus your energy on identifying and correcting gaps.

Check for inconsistencies. Do your procedures match your forms and checklists? Are your procedures an accurate reflection of how your Organization oversees its research activities and protects research participants?

Create and maintain an accreditation intranet site. If you have the resources, this is a convenient way to keep everyone in your Organization up to date on issues, news, schedules, and other accreditation-related information.

Getting ready

 Download the Evaluation Instrument for Accreditation. Read through the entire document before tackling any of the steps in earnest. Familiarize yourself with the Standards and Elements.

Gather all written policies and procedures, and organize them by topic. Remember to think in terms of the entire HRPP, and, if applicable, include policies and procedures for areas such as human resources, budgeting, counseling services, pharmacy, student orientation, corporate ethics, and corporate compliance. In most cases, your HRPP will have a policy, procedure, or practice to demonstrate that you meet the Element and the Standard.

Share the load. As you read over the self-assessment, identify experts for each Domain and even for each Standard within a Domain. Then, enlist their help.
Use the AAHRPP Tip Sheets. These are available here. They also are referenced in the Evaluation Instrument for Accreditation.

Specific tips

Start with Domain II. This Domain will be most familiar to you and, therefore, easiest to complete.

Tackle the Evaluation Instrument Element by Element. For each Element, identify the policies and procedures that spell out how your HRPP meets the Element. If someone in your Organization is an expert in the requirements covered by a particular Element, assign the Element to that expert. If an Element does not apply to your Organization, just indicate that it is not applicable.

Don’t write. Instead, list. Most Elements can be addressed by your existing documents. Examples include policy statements, procedures, checklists, guidelines, educational materials, job descriptions, bylaws, memoranda, forms, templates, strategic plans, slide presentations, websites, charters, and mission statements. Find the appropriate document, and cite the name and relevant section.

If you must write, do it for your Organization – not for AAHRPP. If you find yourself writing a detailed explanation in response to an Element, chances are you need to create a document for your own Organization. Once you have done that, reference the document for the applicable Element.

Some Elements do not require documentation. These Elements are evaluated during the site visit, through interviews with members of your Organization. For these Elements, provide a brief description of your practice.

Identify and fill in the gaps. Most self-assessments identify a number of gaps between the AAHRPP Standards and your Organization’s human research protection practices. When you find a gap, design a policy, procedure, or practice that makes sense for your HRPP, and then use the AAHRPP Standards to refine what you have developed. Communicate the new policy, procedure, or practice throughout your HRPP.

Construct an Element-by-Element index of your supporting documents. For each Element, list the supporting document, assign it a number, and provide a very brief explanation. Use page numbers, paragraph numbers, item numbers, titles, and headings to pinpoint the information. (This index becomes Section C of your accreditation application.)

Copy your documents. Provide one copy of each document cited in your Element-by-Element index. Do not include non-organizational documents. Cross-reference and cite each document as many times as necessary, but include only one copy. (These copies become Section D of your accreditation application.)

Don’t be afraid to ask. AAHRPP is available as a resource throughout the accreditation process. If you have questions or need help, just ask.

Once you start the self-assessment, you will be surprised at how quickly everything falls into place—and how valuable the self-assessment proves in strengthening your HRPP.