At the heart of the accreditation process is a comprehensive self-assessmentApril 15 2009 at 8:39 AM
Response to Nigeria state, TROVAN - Pfizer to settle out of court
How to Conduct a Self-Assessment
At the heart of the accreditation process is a comprehensive self-assessment during which an Organization reviews its Human Research Protection Program and evaluates its compliance with 20 AAHRPP standards and 77 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.
- Read, read, and read some more. Start with the AAHRPP Web site and newsletter, AAHRPP Advance. Read institutional review board (IRB) journals, and check the Web sites 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 Web site, under Apply, pay particular attention to the sections on How to apply and this section - How to conduct a self-assessment. Information on the AAHRPP Web site is available to all 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 Human Research Protection Program fit together.
- Strive for protection, not perfection. The goal is to have an effective Human Research Protection Program, 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.
- Gather all written policies and procedures, and organize them by topic. Remember to think in terms of the entire Human Research Protection Program, 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 Human Research Protection Program 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.
- Save the first Element, I.1.A, for last. This Element is global in nature and cannot adequately be addressed until you have completed the entire self-assessment.
- Start with Domain II: Research Review Unit, including the IRB. 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 Human Research Protection Program 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.
- Dont 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, Web sites, 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 Organizations human research protection practices. When you find a gap, design a policy, procedure, or practice that makes sense for your Human Research Protection Program and then use the AAHRPP Standards to refine what you have developed. Communicate the new policy, procedure, or practice throughout your Human Research Protection Program.
- 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.)
- Dont 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 Human Research Protection Program
- AAHRPP's Board of Directors is responsible for overseeing the accreditation process - Anonymous on Apr 15, 8:45 AM
- Naturally Pfizer have a place person on the Board of AAHRP - Cathryn M. Clary, M.D., M.B.A - Anonymous on Apr 15, 8:47 AM
- I've seen that name before... - admin on Apr 15, 12:49 PM