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Standards

The Alion Human Research Protection Program (HRPP) Accreditation Standards set the tone of benchmark quality for protection of research participants.  Alion’s standards emphasize the welfare of the research participant first, outlining a model for comprehensive research oversight in the 21st century.  The standards are designed to be grounded in regulations yet elevated to reflect prevailing ethos and practices.  Demonstrating that an HRPP meets these standards reflects that organization’s commitment to strengthen the research enterprise.

Alion’s parent-level 36 standards are outlined below. For a comprehensive file containing our more detailed sub-requirements, please Contact Us.

# Alion HRPP Accreditation Standards
1 Standard 1 - The Organization has policies, procedures and practices to ensure the fulfillment of all responsibilities of the Institutional Official in human research protection.
2 Standard 2 - The Organization has policies, procedures and practices to determine whether a study meets the definition of human subjects research and falls under the auspices of the Organization’s HRPP.
3 Standard 3 – The Organization has policies, procedures and practices to ensure that all research protocols receive all required institutional approvals before the research can commence.
4 Standard 4 – The Organization has policies, procedures and practices to ensure that all research protocols are scientifically sound and reviewed for scientific validity and the reviews are provided to the IRB.
5 Standard 5 - The Organization has an education program for IRB staff, IRB members, investigators, and research staff to ensure adequate training in human research protection and qualifications and credentialing of all staff.
6 Standard 6 – The Organization has policies, procedures and practices that grant authority to the IRB to function independently and to approve, modify, disapprove, and suspend or terminate all human subjects research proposed or conducted at the facility.
7 Standard 7 - The Organization has policies, procedures and practices to ensure fulfillment of the HIPAA privacy rule including HIPAA authorization and waiver of HIPAA authorization, and other regulations or laws related to the privacy of research subjects.
8 Standard 8 - The Organization has policies, procedures and practices to ensure fulfillment of all responsibilities, policies and regulations concerning information security in all research reviewed or conducted at or by the Organization.
9 Standard 9 – The Organization has policies, procedures and practices to disclose, review and manage when appropriate, conflicts of interests of investigators and research staff and IRB members and staff and appropriate administrators.
10 Standard 10 – The Organization has policies, procedures and practices to ensure the fulfillment of all responsibilities of the investigators and research staff in human research protection.
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Standard 11- The Organization has policies, procedures and practices for monitoring and auditing functions of the IRB and other organizational entities to ensure compliance and promote quality assessment and improvement.
12 Standard 12– The Organization has policies, procedures and practices to ensure that the IRB has an appropriate composition and qualified members and leadership.
13 Standard 13 – The Organization has policies, procedures and practices for investigators to request whether research qualifies as exempt and for an experienced person to make exempt determinations.
14 Standard 14– The Organization has policies, procedures and practices to conduct review of research by the expedited procedure, including initial review, continuing review and review of modifications.
15 Standard 15 – The Organization has policies, procedures and practices to prepare for and conduct meetings of the convened IRB.
16 Standard 16 – The Organization has policies, procedures and practices to conduct review of research by the convened IRB, including initial review, continuing review and review of modifications.
17 Standard 17 - The Organization has policies, procedures and practices for the IRB to satisfy the regulatory criteria for approval of research.
18 Standard 18 – The Organization has policies, procedures and practices for investigators to submit and the IRB to review recruitment methods and materials including advertisements and payment arrangements.
19 Standard 19 - The Organization has policies, procedures and practices for the review and conduct of research involving investigational drugs and devices.
20 Standard 20 - The Organization has policies, procedures and practices for the emergency use of test articles.
21 Standard 21 - The Organization has policies, procedures and practices for investigators to submit and the IRB to approve an exception from informed consent requirements for planned emergency research. 
22 Standard 22 - The Organization has policies, procedures and practices for the development, submission, review, approval and conduct of the consent process according to regulatory requirements and ethical standards, and considerate of the rights and welfare of subjects.
23 Standard 23 - The Organization has policies, procedures and practices to ensure that consent documents are developed, submitted, reviewed, utilized and retained according to regulatory requirements and ethical standards, and considerate of the rights and welfare of subjects.
24 Standard 24 - The Organization has policies, procedures and practices for the IRB to grant waivers or alteration of the consent process.
25 Standard 25 - The Organization has policies, procedures and practices for the IRB to grant waivers of documentation of consent.
26 Standard 26 - The Organization has policies, procedures and practices for the investigators to provide additional protections and for the IRB to review research with participants that have diminished or no capacity to consent.
27 Standard 27 - The Organization has policies, procedures and practices for the investigators to provide and for the IRB to review added safeguards for research involving children, prisoners, pregnant women or other vulnerable participants.
28 Standard 28 – The Organization has policies, procedures and practices for the review and conduct of research involving human biological specimens, including specimen repositories, and human data including data repositories.
29 Standard 29 - The Organization has policies, procedures and practices for the conduct of multi-site research including defining responsibilities of all parties related to human research protections including facility approvals, coordination of IRB approvals, and data and reporting coordination.
30 Standard 30 - The Organization has policies, procedures and practices to review and conduct international research according to relevant US regulations and local laws, regulations and customs.
31 Standard 31 - The Organization has policies, procedures and practices for the IRB to review, take appropriate action, and report serious adverse events.
32 Standard 32 - The Organization has policies, procedures and practices to review, take appropriate action, and report unanticipated problems involving risks to participants or others.
33 Standard 33 - The Organization has policies, procedures and practices to report and for the IRB to review, manage, and report non-compliance with HRPP requirements.
34 Standard 34 - The Organization has policies, procedures and practices to suspend or terminate research and report decisions.
35 Standard 35 - The Organization has policies, procedures and practices for the IRB to create, maintain, and store IRB records and study files according to all legal, regulatory and sponsor requirements.
36 Standard 36 - The Organization has policies, procedures and practices for the IRB to create, maintain, and store minutes of convened IRB meetings according to all legal, regulatory and sponsor requirements.

 

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