Two Questions for Marjorie Speers of AAHRPP

IRB accreditation rules explained

IRB Advisor: Dr. Marjorie Speers, would you please explain how AAHRPP accreditation requirements work with regard to institutions that are seeking accreditation and have plans to use foreign IRBs for a multi-site study that includes clinical trials located in other countries? Foreign countries hosting clinical trials often require a local board to review the study. So how does this work with accreditation requirements: do the U.S. institutions need to use a centralized and accredited IRB in the U.S. and/or require these foreign IRBs to be accredited?

Speers: This is a complicated question and the answer depends on the type of research organization seeking accreditation. If the organization seeking accreditation is a university, for example, AAHRPP expects the university to meet all the accreditation standards for its human research protection program but does not hold the university to ensure that its collaborating partners meet the standards. The exception is when the university uses an external IRB to review its research. In this case, AAHRPP expects the university to ensure that the external IRB meets the accreditation standards. The simplest way for this to occur is for the university to use AAHRPP-accredited external IRBs. Another way is for the university to put procedures in place to ensure the external IRB meets the standards.

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Let's say, that the research organization seeking accreditation is a CRO. In this case, the CRO must meet all the accreditation standards. For those standards pertaining to the IRB, the CRO needs to ensure that the primary IRB for each study (generally the one the sponsor or the CRO selects for the multi-site study) meets the accreditation standards. This ensures that the study is reviewed appropriately and meets the higher standards set by accreditation. The CRO can use AAHRPP-accredited central IRBs or must have procedures in place to ensure that the standards are met. If the CRO were conducting a study outside the U.S. and engaging a foreign commercial IRB, the foreign commercial IRB would need to meet the accreditation standards or be AAHRPP-accredited.

Another way to think about this complex research enterprise and accreditation is AAHRPP looks at each institution as an individual entity that has a human research protection program. A human research protection program can be comprised of components internal to the institution and also external. When there are external components, such as a central IRB, the external components must meet the accreditation standards in order for the institution to achieve accreditation.

IRB Advisor: What kind of flexibility is there in the requirement that accredited research institutions use only accredited IRBs?

Speers: The IRB component is an essential part of the human research protection program. It is the entity that determines whether a study is ethically sound. From AAHRPP's perspective, an organization cannot have a high-quality human research protection program without using IRBs that meet the accreditation standards. AAHRPP expects research institutions to use accredited IRBs. And now, there are options: Nine independent IRBs are accredited by AAHRPP. If a research institution does not wish to commit to using an accredited IRB then it must have a process in place to evaluate and ensure that the IRB meets the accreditation standards. Those research institutions that are currently accredited and use an external IRB have chosen to use AAHRPP-accredited IRBs. It's the smart thing to do.