Beginner’s Guide to Human Research Protection Programs

Human research protection programs (HRPPs) play a critical role in protecting the rights, safety, and welfare of research participants. A popular misconception amongst research administrators, investigators, and research team members is HRPPs are the same as an institutional review board (IRB) or ethics committee (EC)—that is, an IRB or EC is the only entity or program making up an HRPP. A robust HRPP is comprised of many individuals and programs throughout an organization, and everyone works together toward the common goal of protecting research participants. This blog highlights the fundamental components of an effective HRPP.

What is an HRPP?

We can trace the framework for HRPPs to the ethical principles established in the Belmont Report: respect for persons, beneficence, and justice. Together, these three principles form the foundation upon which HRPPs were established and provide the basis for laws, regulations, guidelines, and policies governing human subjects research.

HRPPs vary widely in structure, size, and component programs and offices. At large organizations, HRPPs often include offices and programs such as:

• Investigational drug pharmacies
• Radiation safety
• Biosafety
• Research data security
• HIPAA officers
• Numerous research governance committees in addition to the IRB

In smaller organizations, HRPPs often consist of far fewer offices and programs, many of which have research and non-research related responsibilities.

Regardless of size or structure, every HRPP’s goal is to collaborate and communicate to ensure research participant protection. Large and small HRPPs alike should include certain fundamental components to adequately protect participants:

• An institutional official
• Conflict of interest policies and procedures
• Contracting office
• Researchers and research support staff
• The IRB or EC

Fundamental Components of a HRPP

Institutional Official

The institutional official (IO) is responsible for guaranteeing an organization’s HRPP functions effectively. They also ensure the organization provides sufficient resources to support the HRPP and conduct compliant human subject research. The IO must be of sufficient rank and responsibility in an organization to be able to authorize administrative or, if necessary, legal action to protect research participants’ rights, safety, and welfare. At large academic medical centers, the IO is typically the vice president or chancellor of research. At smaller organizations, the IO may be the chief medical officer or the chief compliance officer.

The IRB or Ethics Committee

The IRB or EC is often viewed as the central coordinating component of the HRPP. This committee is responsible for ensuring all parts of the HRPP work together effectively and research participants are protected.

With the implementation of federal policies requiring the use of a single IRB for multi-site research, many HRPPs have shifted from only utilizing their internal IRB to relying on external IRBs. This can include independent IRBs or those at other academic medical centers or hospitals.

Regardless of whether an organization’s internal or external IRB or EC is providing research oversight, the committee must have the independence and authority to review and approve research. They also must have sufficient resources – including expertise and support staff – to carry out necessary responsibilities. The IRB or EC should have mechanisms in place to communicate with other parts of the HRPP and confirm it has the information necessary to conduct its reviews in accordance with applicable regulations.

Conflict of Interest Policies and Procedures

HRPPs should maintain and enforce policies regarding disclosure and management of research-related individual investigator conflicts of interest (COIs). Such policies serve to identify interests – financial and otherwise – potentially introducing bias into a study. They also typically specify the ways in which such COIs can be managed to protect research participants and the integrity of the research.

Often, organizations have a COI program or office part of the HRPP. There are staff dedicated to developing, implementing, and enforcing the organization’s COI policies. However, some organizations don’t have the resources to maintain dedicated COI staff, and instead, delegate COI-related responsibilities to staff who have multiple roles.

The person(s) or office responsible for oversight of COI disclosure and management, including related policies, should maintain clear lines of communication with other HRPP components. This includes the IRB or EC, sponsored research, and the clinical trials office – when a COI is identified, HRPP staff can collaborate to determine appropriate management.

Contracting Office

A contracting office is another critical component of an effective HRPP. Typically, this is the office of sponsored programs or a clinical trials office. However, at smaller institutions, in-house or outside legal counsel usually reviews research agreements.

The contracting office is typically responsible for submitting grant applications, negotiating clinical trial agreements, and reviewing other research-related agreements (e.g., material transfer agreements and data use agreements) and study budgets. Important participant protections issues often arise when negotiating research agreements, such as who owns research data and how to utilize it when a study is completed, how participants’ confidentiality will be protected, who will pay for research-related injuries, and whether participants will be compensated. Every HRPP should have contract support from individuals with expertise in negotiating agreements who also understand regulatory requirements related to human subject research.

Researchers and Research Support Staff

An integral but often forgotten part of every HRPP is its researchers and research team members. Researchers and their team members are in regular, direct contact with research participants and are well-positioned to protect participants. They must ensure research is conducted in compliance with the protocol and applicable policies and regulations. Organizations should support researchers and their support staff (e.g., coordinators, research nurses) by providing ongoing education related to human subject protections. They also should ensure researchers’ experience and training qualifies them to conduct human subject research.

Collaboration and Communication are Essential to an Effective HRPP

Each HRPP is unique in its form depending on the size of the organization and resources available to support research. Having fundamental programs and functions in place to support the review and approval of research at an organization is critical – all parts of the HRPP must work collaboratively together to protect participants’ rights, safety, and welfare.

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