One area that trips up many organizations in the AAHRPP accreditation process is consistency. While no one expects perfect consistency within a human research protection program, AAHRPP expects a reasonable amount of consistency within the program. Inconsistency can creep into a program in a number of ways:
1) Inconsistency within documentation. One common area of inconsistency occurs when something is described a certain way in one part of the documentation, but another way somewhere else. For example, a minor change is defined one way in the procedures for expedited review and another in the procedures for an amendment. In looking to avoid this, one way is to only describe or define something once and then reference it when discussed later. Another area of inconsistency in documentation occurs when forms or documents are referred to by name in one area of the documentation but the actual name is different. For example, the written policies and procedures refer to the “Initial Review Application Form” and the name of the form is “Application for IRB Approval.” Written policies and procedures should be reviewed on a regular basis to ensure consistency with other forms and documents.
2) Inconsistency between documentation and practice. Practice and documentation often diverge over time. When written procedures are developed they describe the practice in place at that point. However, over time, practice changes and written procedures are not updated. An important part of the self-evaluation phase of the accreditation process is ensuring consistency between documentation and practice.
3) Inconsistency in IRB review. When reviewing IRB protocols and minutes, AAHRPP often finds inconsistency in IRB review. For example, an IRB may waive documentation of consent in one study and require documentation in another similar study. While every study is different, IRBs should be reasonably consistent in applying review criteria. Consistency in IRB review is accomplished through good guidance and training of IRB members.
Maintaining consistency within an organization’s human research protections program is not just important for AAHRPP accreditation, but is essential for an effective human research protections program. Organizations should review their documentation and practices on a regular basis to ensure consistency.