IRB Accreditation and Human Subject Protection

Whether formally accrediting IRBs will benefit research subjectsor simply create more paperworkremains to be seen.

Just as there is no one perfect way to train for a marathon, neither is there one perfect way to run an institutional review board or ethics committee that oversees the rights and welfare of volunteer research participants. Runners preparing for a marathon may consult various books and Web sites to get help toward achieving their marathon goals. IRBs in the United States consult the

Code of Federal Regulations

on Protection of Human Subjects (21 CFR 50), Institutional Review Boards (21 CFR 56), and the Common Rule (codified at 45 CFR 46).

¹³

Although these regulations set the foundation for protecting subjects, they do not address particular study designs, drugs, or devices to be studied or the attitudes in a given community.

New directions in human subjects protection include a call for voluntary accreditation of IRBs. Why accreditation? Each IRB is located in a community that has its own attitudes and perceptions and a state (and/or nation) that has its own regulations. On top of this, each IRB reviews different types and volumes of research that pose varying degrees of risk to research subjects. Hence, effectively overseeing the rights and welfare of research subjects shares a characteristic common to reaching a marathon runners goal. Although there are many ways of going about the task, ultimately the goals are the same: for the runner, making it 26.2 miles; for the IRB, ensuring that each research participant is effectively protected.

This level of diversity requires a set of standards that allows each IRB to individualize to its specific environment, while adhering to regulations and maximizing oversight of research volunteers. This is what accreditation sets out to do, and it is a commendable objective. But some controversy surrounds proposed standards, with some of those involved asking whether increased regulation of IRBs will cause them to worry more about paperwork than about the rights and welfare of human subjects.This article summarizes the events that led to the current move toward accreditation and discusses the standards being developed by two organizations seeking to accredit IRBs. Our critique of those standards is designed to help you decide whether accreditation will simply add another layer of bureaucracy to IRB responsibilitiesor whether it will enhance the beneficence experienced by research participants.

From the OIG report to OHRP
In June 1998, the Office of the Inspector General published a report titled IRBs: A Time for Reform.⁴ This report outlines several obstacles to effective IRB functioning.

• They must review too many protocols, too quickly, with too little expertise.
• The continued growth of industry-sponsored studies puts an increased burden on IRB review and oversight.
• They conduct only minimal continuing review of investigations.
• Conflicts of interest are developing that can threaten IRB independence.
• IRBs are failing to evaluate their own performance and effectiveness.

On 2 June 2001, the death of Ellen Roche at Johns Hopkins sparked an immediate suspension of all research activities at the institution and prompted the Office for Human Research Protections (OHRP) to issue statements questioning the adequacy of oversight by the investigator and the IRB.⁵

In response to a request from the Secretary of Health and Human Services, the Institute of Medicine formed a Committee on Assessing the System for Protecting Human Research Subjects to determine how to improve human subjects protection in clinical research. The committee conducted a two-phase study, and has released the first phase of its findings in a report titled Preserving Public Trust: Accreditation and Human Research Participant Programs (HRPP).⁶

• Review proposed standards for accreditation of programs.
• Further develop accreditation standards.
• Develop an evaluation process.

The second phase of the IOMs work will focus on how to make accreditation work for the industry.

But is accreditation the answer? In a statement to CenterWatch, the president of an independent review board said, Some people say that some of the things theyre suggesting for accreditation may fall under policing.⁷ After examining the organizations that are piloting accreditation programs, we attempt to discern whether these standards will only add to institutional bureaucracy or truly enhance the protections that participants deserve when consenting to research participation.

Two accrediting organizations
Websters defines accreditation as to make authoritative, creditable, or reputable.⁸ That is the basic premise for accrediting IRBs. Before we proceed, it is important to note that broad accreditation standards are being written to apply to all human research protection programs (HRPP) for the global research communitywhich includes sponsors, investigators, and IRBs. Here, we address accreditation standards as they pertain specifically to IRBs, not to the broad HRPP community. Two bodies have developed accreditation standardsthe National Committee for Quality Assurance (NCQA) and the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

National Committee for Quality Assurance. In the spring of 2000, the Department of Veterans Affairs (VA) contracted with NCQA to develop an accreditation program for VA medical centers. The pilot phase of the VA accreditation program is complete. Data gathered from that program is being used to develop more broad-based accreditation standards that will apply to HRPPs. According to the IOM report, the NCQA standards are the strongest basis for accreditation of other research institutions, such as academic medical centers (AMCs), independent IRBs, and other research institutions. The purpose of the VA Human Research Protection Accreditation Program is to provide independent validation that HRPPs are in place, functioning properly, and effectively protecting human subjects.⁹ Of special note, according to Sandra Sanford, RN, MSN, CCRC, CIP, of the NCQA,

NCQA is in the process of developing an accreditation program for Human Research Protection Programs (HRPP) outside the VA system. The new HRPP will utilize the current VA HRPP standards as a basis and will incorporate the recommendations of the IOM. The program will be composed of two modulesHRPP accreditation designed for academic institutions and other large research programs and IRB accreditation designed for independent IRBs and smaller programs without formal human research protection programs.¹⁰

The NCQA HRPP Accreditation will begin pilot surveys in spring 2002. Because the current VA HRPP standards are specifically composed for VA institutions, further analysis will be needed when NCQA posts interim standards for the new HRPP Accreditation.

The Association for the Accreditation of Human Research Protection Programs is the other accrediting organization. The AAHRPP interim standards, published September 2001, are the culmination of years of effort, which began under the guidance of Public Responsibility in Medicine and Research (PRIM&R) and an IOM grant.¹¹ Because the AAHRPP interim standards are geared toward the broad research spectrum, not specific VA institutions, we review them in greater detail.

The main purpose of the interim standards is to improve the systems that protect the rights and welfare of individuals who participate in research. This is a noble goal, but how does AAHRPP intend to establish criteria to accomplish the feat? The Guiding Principles box summarizes nine principles the organization developed to help guide the accreditation standards.

The model underlying AAHRPPs approach to accreditation lists five different structural domains of a highly developed human research program. These domains refer to the areas of responsibility that an HRPP must address:

• Organization
• IRB
• Investigators
• Sponsor
• Subjects.

The organization is the entity responsible for the human research program and the one that applies for accreditation. This may be a university, hospital, an independent IRB, contract research organization (CRO), or a biopharmaceutical company. In short, it is the entity seeking accreditation and wishing to help protect the rights and welfare of research subjects.

The IRB is part of the HRPP, and its primary responsibility is to protect the rights and welfare of human research participants. The organization must have mechanisms to ensure that the IRB has independent decision-making power. Whatever the arena of research, the IRB is the organizations safeguard, its agent to ensure the rights and welfare of research subjects.

Investigators are those persons contracted by the organization to oversee or conduct the research according to the protocol in a specific location or facility. Investigators are the people who interact directly with research subjects. The organization has the responsibility to choose these important representatives of its research program and to ensure that they understand their responsibilities.

The sponsor is the entity that has a relationship with the organization, and funds the research. The sponsor may be the federal government, a pharmaceutical company, a university, or any other entity that finances the research study. Multiple sponsors may collaborate on a single research program. Whatever the case, it is the responsibility of the organization to identify all sponsors, and address all issues relevant to the human subjects participating in the research study.

Subjects are the human beings who participate as subjects under research protocols. The main goal of an HRPP in this domain is to enhance the involvement of research subjects at every stage of the research programand to ensure that the informed consent process helps to minimize risk to participants.

The organization needs to be mindful off all aspects of subjects well-being, including their social, psychological, and physical needs. To do this, the organization has to give the rights and welfare of research subjects top priority by giving them access to all of the appropriate resources.

The AAHRPP believes there is no one right way to integrate the five domains into every HRPP, but that each entity seeking accreditation must demonstrate its own unique approach to meeting the 22 standards for the five domains. Each standard then has elements to help guide the organization toward compliance with the standard. The entity seeking accreditation (the organization) must meet all the requirements or, as the standards state, make arrangements with the other domains to obtain accreditation according to those standards. These arrangements make the organization seeking accreditation responsible for remaining independent from the other domains. This puts the organization in charge of its compliance, and allows it to make its own policies and procedures, in relation to the other domains, to protect subjects rights.

Those involved in clinical research need to ask themselves and their organizations two questions about accreditation.

• Will it help protect the rights and welfare of the participant?
• Will it simply add more paperwork and bureaucracy to the organization with minimal or no impact on subject rights and welfare?

Below, we further examine two domainsIRBs and subjectsand critique scenarios for each set of standards. (The standards are subdivided into elements in the published interim accreditation standards and procedures document.) Thus we seek to determine whether meeting the standards will improve protection of the rights and welfare of research participants.