Thursday, December 1, 2011

Be Better Than Minimal: A Case for Maximizing HRPP Quality and Efficiency

Reports, articles, and comments over the past few years have criticized organizations that go beyond the regulations in their human research protection program (HRPP).  

Do you really want to have a “just good enough” HRPP? Do you want to tell a mother and father who are trying to enroll their 5-year-old daughter in a clinical trial that you plan to do the minimum to protect her from harm? Even in an ethnographic study that involves no greater than minimal risk, would you tell the people in the community under study that you plan on doing the least possible to protect their privacy interests and maintain confidentiality of their data? These are rhetorical questions. A quality research protocol goes hand in hand with a quality participant protection plan, and a quality research program goes hand in hand with a quality HRPP. Respecting the rights and welfare of all participants, no matter the level of risk involved in the research, is the ethical and smart thing to do.

AAHRPP is all about maintaining a quality HRPP. How does AAHRPP exceed the regulations? Standard I-2 requires that HRPPs have adequate resources and that organizations evaluate resources, personnel, number of IRBs, and other components of the HRPP periodically to ensure they are performing properly. If there is evidence that the HRPP or IRB is not conforming to the accreditation standards, AAHRPP mandates improvements. AAHRPP publishes benchmarking metrics that allow organizations to assess their own metrics.  

The AAHRPP Standards also require organizations to have quality improvement programs related to compliance with the regulations (Element I.5.A.) as well as quality, efficiency, and effectiveness of the HRPP (Element I.5.B.). This helps ensure not only that programs are doing the right thing but also that they are doing it right and doing it efficiently.  

Research organizations are dynamic; they are constantly changing. Organizations need a strong quality assessment component to measure what they are doing and what they need to improve. Without that, it is impossible to know the condition of their HRPPs. 

Requiring that organizations have education programs to improve the knowledge of IRB staff, IRB members and chairs, and researchers and research staff also exceeds the regulations. IRBs that know the regulations have greater confidence in making decisions, including using the flexibility in the regulations such as granting waivers of consent or waivers of documentation of consent. The AAHRPP Standards require HRPPs to have mechanisms to inform researchers and research staff of the HRPP’s policies and procedures and when any changes occur. As researchers become knowledgeable about the expectations of the HRPP and aware of changes, they are not surprised by altered requirements when they submit an application to the IRB, for example. Some organizations have observed a decrease in protocol deviations, which they attribute to accreditation because researchers know their roles and responsibilities.

Element II.2.A. includes the process for making determinations about whether research meets the criteria for exemption. One of the most common findings on AAHRPP site visits is that projects do not meet the definition of research or that they involve human participants and are erroneously classified as exempt. When this situation occurs, AAHRPP requires revision of definitions and monitoring of exempt determinations to make sure they are accurate. All these AAHRPP requirements, which go beyond the regulations, in fact reduce burdens on researchers and IRBs and promote high-quality research.

Senior research administrators face tough decisions about where to put their resources. They can choose the path of minimal investment into their HRPP and deal with remediation of noncompliant investigators and IRBs and defending adverse findings from FDA and OHRP inspections. Cutting corners often results in doing less than the minimal. They can hope that nothing goes really wrong. Or they can put resources into developing a quality HRPP with strong education and quality improvement activities—one that is less likely to get inspected by regulatory authorities, and when it is inspected, senior administrators and staff are confident that no deficiencies will be found because they have built capacity in researchers and IRBs. An organization is only as strong as its weakest link. Patients and research participants know that, which is the reason they seek out research and treatment programs that have a reputation for excellence in research.

AAHRPP promotes quality research programs. The Standards that go beyond the regulations contribute to developing not only a compliant but also a superior HRPP. AAHRPP accreditation requires organizations to apply the regulations correctly, use flexibility in the regulations when appropriate, and conduct the HRPP effectively and efficiently. No organization wants a minimal HRPP. Organizations want a program that follows the rules, but does so with quality and efficiency.

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