by Jessica Huening

HRPP Management Best Practices: How to Lay the Foundation for Smooth Operations

Tension is almost guaranteed between the research community and administrators of Human Research Protection Programs (HRPP) if the research enterprise is not operating effectively with clearly defined roles and responsibilities.

At Kinetiq, we have seen—many times over—the significance of having enough detail in HRPP written policies and procedures to ensure compliance with applicable regulations as well as to clearly delineate responsibilities and expectations. However, it is also important to remember that these documents should not be so narrowly construed as to unreasonably constrain the institution. This delicate balancing act is one that all HRPPs must take on.

 

Building and Maintaining an Efficient HRPP

Define the HRPP – Policy and Corresponding Written Procedures

A well-performing HRPP takes measures to clearly define its purpose and scope, as well as to clearly outline roles and responsibilities across its various elements.

This undertaking is often represented with both an overarching “program” or “plan” as well as detailed written procedures for the various HRPP elements. There are many HRPP elements which have independent, related functions that nonetheless must work together to carry out an ethical and compliant HRPP. Most programs will include at least the following elements:

  • Institutional officials and other leaders
  • Research community
  • Research compliance
  • Institutional review board
  • Privacy board
  • Conflicts of interest
  • Grants and contracts
  • Ancillary review committees
  • Institution-specific review or oversight offices or committees

The research community is in this equation because they are responsible for understanding their responsibilities in conducting human subject research, just as HRPP administrators are responsible for providing the tools necessary to facilitate that understanding.

 

Outline Stakeholders, Roles, and Responsibilities

The documented roles, responsibilities, and processes of the various HRPP elements should work together to streamline HRPP function, as well as reduce areas of re-work, redundancy, and bottleneck.

Beyond demonstrating compliance with applicable rules, regulations, accreditation standards, and institutional policy, this documentation should seek to increase transparency among stakeholders and relay institutional expectations. In so doing, administrators equip the HRPP with the foundation necessary to be consistent and reliable.

In my HRPP consulting work, I am often told by administrators, as well as leaders and front-line staff in the research community, that having documented expectations goes a very long way to reduce administrative back and forth and overall frustration. HRPP administrative staff feel more supported by having substantive writings to point to in carrying out their duties, and, because they have an accessible resource, they spend less time spinning their wheels when working to solve a problem. Likewise, research staff feel better prepared for HRPP requirements and that requests made by HRPP administration are more consistent and appear less arbitrary.

When consulting with institutions to assess their wants and needs during the policy and procedure development process, I first identify the compliance floor (the minimum documentation needed to ensure compliance), then thoroughly examine any remaining institutional practices beyond this threshold to ensure they remain only if value is added.

For example, institutions often struggle to decide whether they should “check the box” in their Federal-Wide Assurance (FWA).  Absent demonstrable benefit to the institution, applying constraints on the HRPP beyond those necessary for compliance may work to needlessly burden the institution and expose it to unnecessary audit risk.

The question of where to draw this line has no single right answer. The solution ultimately varies depending on the how the institution is organized, institutional culture, the research portfolio, and experience in human subject protection.

When conceptualizing all the moving pieces of your HRPP, it is also important to keep each element’s role and responsibilities in mind to the degree feasible. It is easy to lose sight of the foundational purpose of a given element in the face of convenience and short-sighted solutions.

Institutional IRBs, for example, are often inappropriately used as a gatekeeper to facilitate administrative functions associated with human subject research that go beyond the intended scope of the IRB’s function under the regulations. This occurs for a number of reasons, but I often see confusion about the intended scope and role of the IRB. The accumulation of administrative functions generally occurs organically, as the IRB and its staff tend to become the center of institutional knowledge related to research administration.

While pooling staff resources can make sense—depending on the size of an institution’s research portfolio, policy and practice should always ensure the operational lines of the various HRPP elements are clearly separated and defined. This not only clarifies roles, responsibilities, and process, but it also helps the research community better understand what requirements to meet in the conduct of ethical and compliant human subject research.

 

Built-In Optimization Leads to Success

Identifying, organizing, and documenting roles and responsibilities in your HRPP is a necessary first step to a well-functioning program.  Doing so will optimize the HRPP function to reduce waste, redundancy, and bottlenecks, in addition to enabling compliance with applicable rules, regulations, and policy. Laying this strong foundation will inevitably lead to smoother operations in the future, allowing your institution to focus on its research.

Executive Insight

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

 

Within all effective Human Research Protection Programs (HRPP) there is an element of community. And like all communities, each HRPP is unique. Leaders of effective HRPPs take time to understand their community’s constituents and develop programs, policies, and procedures to support its uniqueness while ensuring compliance—all with an overarching goal of supporting research and serving the human research participants within the community through the HRPP designed to protect them.

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