AAHRPP, Single IRB Review

by Jessica Huening

HRPP Management Best Practices: New AAHRPP Standard for Single IRB Review

Many institutional clients I provide HRPP consulting services to are increasingly seeking guidance for concerns related to single IRB review. This includes, for example, how to coordinate review with other institutions, reliance relationships and agreements, managing local context, harmonizing technology considerations such as IRB management systems, sIRB budgeting, and managing other ancillary reviews relevant to the HRPP beyond the IRB such as radiation safety and finance.

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has released a new accreditation standard, and related resources, to address some of these concerns. The new standard I.9 is in response to the industry movement towards single IRB (sIRB) review largely instigated by the forthcoming NIH and common rule mandates.

A corresponding AAHRPP Tip Sheet 24 on Single IRB or EC Review has also been released, which provides great insights to consider for institutions tackling single IRB review.

Updated Tip Sheet 24 is notable in that it continues to underscore the importance of clearly defined HRPP roles and responsibilities of collaborating institutions, which includes the written agreement between organizations. But it also recommends the creation of other supportive materials for all the areas discussed below, including written procedures, work flows, checklists, templates, etc.

AAHRPP’s Take on Implementing sIRB

In preparing for sIRB, AAHRPP generally recommends policies and written procedures be developed that describe:

  • Required written agreements
  • Record maintenance and retention
  • Compliance with other components of the HRPP (radiation safety, biosafety, etc.)
  • Communication to researchers on sIRB process
  • Ensuring compliance with another IRB’s applicable policies and procedures

Reviewing IRBs must have processes in place to obtain information from the relying organization necessary to conduct IRB review. Forms, templates, and checklists should be developed to help assist relying organizations in navigating collaborative research. Additionally, various tools and methods are available to help collect and track information, as well as ensure quality. This may include the use of separate protocol-specific and site-specific applications, a coordinating center to manage IRB submissions, and tracking software to manage agreements and other site-specific information.

AAHRPP recommends reviewing IRBs have policies and written procedures in place to determine:

  • How general study information will be provided, updated and maintained (e.g., FWA details, relevant contacts, AAHRPP accreditation status, consent template language, local rules, and ancillary review management)
  • How and what study-specific information will be collected (e.g., applicable regulations, researcher qualifications, local facilities and resources, recruitment process and informed consent approach, local population and equitable selection, confidentiality of information, and management of investigational products)
  • Who is responsible to submit information to the IRB
  • What the IRB review process is for specific transactions (e.g., to add of study sites, unanticipated problems involving risks to subjects or others, noncompliance, continuing review, etc.)
  • How IRB findings will be communicated, and how a relying institution can communicate with the reviewing IRB to address questions and concerns

The updated Tip Sheet 24 also provides considerations for relying organizations, and provides general suggestions for tools that can be developed to assist the HRPP in their oversight responsibilities. For example, relying organizations may find it helpful to create an administrative study file and for each project being reviewed externally.

AAHRPP recommends relying organizations have policies and written procedures in place that describes:

  • The workflow and relevant contacts for relying on an external IRB
  • The circumstances and process for determining when it is appropriate to rely on an external IRB (which includes both when reliance is required as part of performing the research and when it is entirely elective), including:
    • Any conditions, restrictions, rules and other local considerations for external reliance
    • Key organization decision makers
  • Information that investigators and/or external IRB are required to report, and the related processes to provide that information. This may include notification of when studies are initiated, unanticipated problems, noncompliance, suspensions, terminations, and other information deemed relevant to the organization
  • The process to provide the reviewing IRB with relevant local information such as consent template language and local laws and rules relevant to humans subjects research

Finally, AAHRPP makes note that accredited organizations should seek to rely on external IRBs that are also AAHRPP-accredited. If a non-accredited IRB is relied upon additional steps must be taken to ensure research participants are adequately protected. These steps vary depending upon the individual study details and level of risk.

For example, the provision of reasonable assurances and an internal quality check using AAHRPP tools may be done by non-accredited IRBs for minimal risk research whereas additional oversight is required from the relying organization for greater than minimal risk research, such as reviewing IRB minutes, records, policies, procedures as well as observing/attending meetings and additional monitoring.

Institutions Responsible to Determine sIRB Details

The new AAHRP I.9 standard and related Tip Sheet 24 provide a great starting point in how to conceptualize sIRB at a high level. Execution of this standard is becoming an increasing reality for institutions, whether AAHRPP-accredited or not, particularly those with a research portfolio largely federally funded. For institutions navigating the accreditation requirements the new I.9 standard will need to be addressed as follows:

  • Organizations applying for new accreditation: written materials evidencing compliance after January 19, 2018
  • Organizations applying for reaccreditation: written materials evidencing compliance for those whose applications are due March 15, 2018 or later
  • Other organizations: description of plans to implement I.9 in your annual reports

Beyond these broad brush strokes, the details of executing effective sIRB at your institution and how it takes shape will be largely informed by institution-specific cultural, technological, and resource factors. While it may seem overwhelming, there are many benefits to realize in strengthening processes around reliance that streamline and enhance the research enterprise. Though there may be an uncomfortable adjustment period, have confidence: greener pastures lie ahead!

AAHRPP

Executive Insight

James Riddle, MCSE, CIP, CPIA, VP of Client Services

AAHRPP lays out a great framework for establishing reliance relationships, but turning these principles into practice can be challenging and resource-intensive. Implementing these principles is key to success as an sIRB, so proceed with caution and seek advice from trusted partners who can help you do it efficiently.