Prospective clients interested in InfoEd’s Human Subjects module often ask questions related to AAHRPP accreditation. For those who aren’t familiar with the work of AAHRPP, its full name is the Association for the Accreditation of Human Research Protection Programs, and its mission is to improve human research protections through standards-based accreditation. Any eligible organization that engages in human research can seek to become accredited as long as it can demonstrate that all standards applicable to its operations are met. Accreditation is extended to the HRPP as a whole, not to individual components (such as IRBs). Currently, the initial period of full accreditation is 3 years, which can be extended to 5 years after re-accreditation.
The AAHRPP standards are organized into three domains that address the responsibilities of the organization, IRB/EC and research community to protect – and establish a culture of respect for – the rights, safety and welfare of human subjects. The InfoEd system helps organizations coordinate departmental, scientific, safety, FCOI and other reviews with IRB review, as required by Domain I. This domain also includes the HRPP’s education program. Training and education related to human research can be tracked as certifications in one particular module, or shared across modules to increase transparency and reduce duplicative effort. Implementing InfoEd as an enterprise solution allows virtually all data needed to prepare future applications to be captured within one system.
Domain II focuses on IRB operations. InfoEd Human Subjects, whether used on its own or as part of an integrated solution, can help the IRB document that it meets AAHRPP’s standards for membership, meeting attendance, reviews, regulatory determinations and records. The module enables the provision of protocol documentation to all members of the committee, eliminating the need for costly and time-consuming paper review packets. It facilitates prompt notification to investigators, organizational officials and others of the IRB’s review activities and findings following each meeting.
In this context, the term “policies and procedures” encompasses many different types of written materials that guide the work of the IRB. While AAHRPP does not dictate any specific format or verbiage, it does require that these materials be consistent with actual practice. Updates will likely be needed to reflect the use of the Human Subjects module for protocol tracking, submissions, distribution of review materials to IRB members and/or online reviews. If other recordkeeping systems or databases will continue to be used, it’s important to document which specific functions the InfoEd system will be used for, and whether it is considered the primary system of record for those functions. For example, if approved meeting minutes will continue to be stored in hard copy, the paper files would be primary for this function, even if the Human Subjects module is used to generate the minutes. If the organization has a pending Step 2 application for accreditation or reaccreditation, process changes should be held at least until the site visit has been completed.
Module configurations should be based on current business process documentation. Ideally, the Human Subjects module administrator will be someone who has sufficient understanding of the IRB’s processes to interpret and apply written procedures as the basis for configuration of appropriate submission types, review methods, statuses, etc. In the same vein, the content of batch communications and eForms will come from the IRB’s existing templates and forms.
The InfoEd system provides a wide variety of options for capturing and tracking the data necessary to address the Domain III standards for investigators and research staff. Application forms with branching logic can elicit detailed information on processes for obtaining consent, addressing participant concerns, safety monitoring/reporting and other essential components of research plans. At the same time, they can take much of the guesswork out of determining which federal, state, local and institutional requirements apply to a given protocol. Investigators can easily access their current and previously approved protocols.
These are just a few of the ways the InfoEd system can support an organization’s efforts to obtain or maintain AAHRPP accreditation. If you would like more information, please submit an information request form.