Thursday, November 3, 2011

Debunking the Myth: You Need to Have Your Own IRB to Get Accredited

AAHRPP accredits Human Research Protection Programs (HRPPs). HRPPs include an Institutional Review Board (IRB), and an IRB is a key component of an HRPP, but organizations can have an HRPP even when they do not have their own IRB and, likewise, can earn accreditation. Not only is it a myth that an organization can’t get accredited without its own IRB; there are many reasons why it is important for such an organization to obtain accreditation.

What kinds of organizations are we talking about? They include hospitals that conduct research but rely completely on external IRBs or independent IRBs, contract research organizations that work with independent IRBs, and private research sites that conduct research and rely exclusively on independent IRBs.

Why should organizations seek accreditation if they don’t have their own IRBs? For the same reason that there are HRPPs, and not just IRBs: Protecting human research participants is a shared responsibility among the research site, the IRB, and the researchers and research staff. All have specific roles and responsibilities. Thus, there are important components within an organization that work individually or collectively to help protect participants enrolled in research. This includes individuals, like researchers, research staff, and research administrative staff, as well as units, such as compliance, education, quality improvement, sponsored programs, radiation and biosafety, and others specific to the structure of the organization.

In fact, of the 234 organizations that AAHRPP has accredited thus far, 47 do not have their own IRBs.  

Accreditation fosters communication among the units in an HRPP, which unifies efforts to protect human research participants. Enhanced education resulting from the accreditation process improves compliance with laws and regulations, as well as with the organization’s own policies and procedures. And increased knowledge and compliance lead to higher efficiency and effectiveness in conducting research. These are all good things that promote ethical research. But there is a practical side to accreditation. When your group gets accredited, you join an elite set of organizations that have voluntarily chosen to follow high standards with worldwide recognition, which strengthens the reputation of the organization. In addition, accreditation makes an organization more competitive for research grants and contracts. Sponsors and funders preferentially or exclusively favor accredited organizations, and simply trust them more to adequately protect participants. Accreditation is an important step toward demonstrating quality for any organization with or without its own IRB that conducts research involving human participants.

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