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General

Why Choose Alion HRPP Accreditation?

Alion’s unique HRPP Accreditation Services offering aligns a set of nationally-recognized subject matter experts in human subjects’ protection with a distinct vision for HRPP accreditation.  Alion’s standards strike the balance of rigor and comprehensiveness while being practical and less burdensome.  Our business model is anchored by full-time, dedicated staff committed to each client, and is not reliant on adjunct site visitors.  Utilizing this employment strategy preserves consistency in reviews and inspections, ensuring you deal with the same experienced staff member at each phase of the process.  Alion’s simple pricing model eliminates upfront costs, reducing the barrier to entry for many organizations and demonstrating cost competitive pricing relative to industry.

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What is HRPP Accreditation?

The Human Research Protection Program (HRPP) includes all individuals, committees, and entities within an organization that have responsibilities for the protection of human subjects in research conducted or reviewed by that organization.  The HRPP accreditation certifies that an organization is compliant with common accreditation standards.  This designation is achieved through independent assessment of the implementation of the accreditation-seeking organization’s written policies and procedures governing human subjects’ research.

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Can I just get my IRB accredited?

While the Institutional Review Board (IRB) is an extremely important entity within the human research protection program (HRPP), human subject protection in research requires the coordination and fulfillment of responsibilities of many people and committees within the organization.  The IRB cannot protect human subjects in research alone.  Thus, Alion accredits the entire HRPP within an organization including all of the relevant individuals and entities.

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Do Alion Standards include DHHS and FDA regulations?

The Alion standards are grounded in the Department of Health and Human Services and the Food and Drug Administration regulations.  Accredited organizations are more likely to include all relevant regulations in their policies and procedures and be more knowledgeable about the regulations.  Accreditation proactively addresses issues commonly found in audits, FDA warning letters, and Office for Human Research Protections compliance letters.

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Is Alion HRPP Accreditation recognized by industry sponsors?

Only a small number of industry sponsors have officially or unofficially considered accreditation when choosing performance sites for clinical trials.  Alion is reaching out to the top 20 pharmaceutical companies to inform and educate them about the Alion HRPP Accreditation Services and the value of accreditation in general.

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How long does it take to get accredited?

The Alion HRPP Accreditation process is designed to take 12 months to complete, from submission of an application to the decision by the Alion Council on Accreditation (COA).  The Council has the option of approving with minor revisions, which can be approved by the HRPP Program Director. This can alleviate the need to return the application to the Council and thus shorten the accreditation process.  If the COA decision is “Deferred approval pending corrective actions,” the response will go to the next COA meeting in 3 months.

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We are a small organization, why should we get accredited?

Regardless of the size of a research program, every research participant deserves respect and protection.  On an ethical level, accreditation demonstrates the commitment of your organization to protecting every individual involved in research under its auspices.  On a practical level, Alion HRPP Accreditation is designed to accommodate smaller organizations by reducing burden and offering cost-efficient fees.

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Is Alion HRPP Accreditation relevant to Social-Behavioral Research?

The Alion HRPP Accreditation Standards were specifically designed to be relevant to social-behavioral research (SBR).  Some of the standards are not relevant to SBR and thus do not need to be addressed by organizations that conduct only SBR.  Also, the key Alion staff is highly experienced in reviewing and evaluating SBR research and programs.

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How much does it cost to get accredited?

Alion HRPP Accreditation is designed to be cost-effective for all sizes of organizations.  Fees are based on the size of research programs (number of active protocols).  There is no application fee, but there are annual fees based on a five year accreditation cycle, complete listing of Fees and Schedules.

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Why should an organization without an IRB get accredited?

When organizations conduct human subjects’ research, even when relying on an external Institutional Review Board many individuals and entities within that organization have responsibilities to protect human subjects in their facilities.  HRPP accreditation ensures that organizations meet high standards, are knowledgeable about and perform those responsibilities.  Accreditation helps improve the reputation of the organization and can make the organization more competitive for grants and attractive to clinical trial sponsors.

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