Jessica Huening

by Jessica Huening

HRPP Management Best Practices: How to Build Effective External IRB Reliance Relationships

Relationships have the potential to synergistically complement us or weigh us down. As with any new relationship, institutional leaders and administrators should seek to enhance their human research protection program’s (HRPP) function (and, consequently, the research within their organization) when entering into relationships with external IRBs.

 

How to Ensure Effective Reliance Relationships with External IRBs

HRPP administrators I consult for often tell me they are tentative about entering into reliance agreements with external IRBs, be it independent IRBs or other institutions. There are a variety of reasons for this, but one prevailing theme is uncertainty about the reliance process and fear of being in the dark.

Not all reliance agreements are the same—they have different names, functions, and obligations depending upon how the research is funded, what regulatory oversight is required, intended scope of the agreement, and who other collaborators are. Further, the ultimate aim of an effective reliance is to let go of some traditionally held institutional responsibilities relating to IRB review. This can be an uncomfortable adjustment.

Below are some dos and don’ts I present to clients, specifically when developing procedures and practices for effective reliance relationships.

DO understand whom you are partnering with

A reliance relationship is more than establishing and executing a written agreement—it’s an exercise in trust. When ceding IRB review, an institution entrusts its reputation, and most importantly, the protection of its human subjects to the appointed external IRB.

Due diligence is required to understand the IRB you are partnering with to ensure it is appropriately qualified for the responsibility. Ask the following preliminary questions when evaluating potential IRB partners:

DON’T be afraid to draft and negotiate in your HRPP’s best interest

Leaders and administrators have a responsibility to ensure agreements with external IRBs maximize benefits to the HRPP and the institution. This involves the inclusion of terms that work with your HRPP’s processes, as ceding IRB review does not extinguish HRPP responsibilities.

Indeed, the IRB is just one of the many elements your HRPP is responsible to coordinate to maintain an ethical and responsible research program that operates smoothly. Terms should be avoided that unnecessarily restrict the institution or curtail its control over the review process.

To that end, consider these general practice recommendations when drafting or reviewing the terms of the reliance agreement:

  • Include language that allows for the inspection of IRB minutes, meetings, records, IRB member rosters, and IRB standard operating procedures.
  • Include language that allows for a mandatory review period prior to the IRB of Record sending reporting letters to federal agencies.
  • Avoid exclusivity clauses that prevent reliance on other external IRBs. This kind of restriction may place your institution in a weaker position to engage with a sponsor seeking to rely on a different IRB.
  • Avoid language that indemnifies the external IRB.

DO evaluate internal processes to appropriately designate roles and responsibilities

Institutions should carefully consider the scope and nature of reliance on external IRBs, which largely depends upon an institution’s experience, research portfolio, and unique HRPP processes.

For example, will the institution allow reliance on a study-by-study basis, or for multiple protocols? Are certain kinds of research eligible or prioritized for reliance on external IRBs over others (such as industry-sponsored research vs. an investigator-initiated study where the investigator holds an IND)?

To help you conduct this evaluation, ask the following questions:

  • Is the designation of responsibilities in the written agreement clear and appropriate? (i.e., responsibilities around conflicts of interest, radiation safety review, etc.)
  • Is the reliance relationship conducive to the HRPP and institutional processes? For example, is institutionally required language for billing, injury, or HIPAA permitted in the informed consent?
  • What categories of research should the institution prioritize for external review? What should remain in-house?

 

 

Processes, Procedures, and Templates—Oh My!

The HRPP, institution, and research community overall can realize many gains from reliance on external IRBs. External reliance, however, takes effort, time, and coordination. Clearly written processes, procedures, and templates are essential to engendering HRPP staff and research community understanding of the responsibilities, expectations, and process flow of research reviewed by an external IRB.

When working with external IRBs, the HRPP will be confronted with new methods of research administration operations. While diligence is important to ensure the HRPP and institution is best positioned in the reliance relationship, it’s also important to keep an open mind to find areas of gain. Efficient interfaces with external IRBs are designed to optimize human subject protections while avoiding unnecessary redundancies in the review and other administrative processes.

 

Where Does Single IRB Review Fit In?

These considerations are particularly germane as institutions seek to develop best practices to address the NIH and Common Rule mandate for single IRB review. Change and transition is hard, as it brings novel questions and challenges; but it also brings new opportunity. In the clichéd but on-point words of Alexander Graham Bell, preparation is the key to success.

This is just the starting point. Each HRPP seeking to develop reliance relationships has its own nuanced decisions to make. But HRPPs that take deliberate steps to organize and structure practices around reliance agreements and relationships stand to reap the benefits, as does the research enterprise as a whole.

 


James Riddle

Executive Insight

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

Research organizations must be prepared to use multiple Central IRBs for industry and federally funded research.  Now is the time when institutions should be proactively establishing relationships with the major accredited independent IRBs.

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