Accreditation Standards & Requirements

Accreditation Standards & Requirements

HRA Canada’s accreditation program will soon follow national standards for human research currently in development by Human Research Standards Organization (HRSO). Until the publication of HRSO’s national standards, our program will remain based on the standards outlined below.

Our accreditation standards are built on Canada’s normative documents governing human research and embrace Canada’s unique cultures and diversity. Our standards also encompass the United States Code of Federal Regulations and related guidelines.

The standards for accreditation are grouped under the headings of Leadership, Knowledge, Oversight, Safety, Vigilance, Conduct, Independence and Engagement. Each heading embraces the standards for accreditation and the requirements inherent to each standard.

General Standards

[expand title=”+ Leadership Standards”]
L1 – The Organization has a written Mandate that describes the structure, leadership, culture and overall applicability of the HRPP.

L2 – The Organization has written operating procedures and demonstrates practices that determine what constitutes human research and is subject to the HRPP and whether the proposed research is scientifically valid.

L3 – The Organization has written operating procedures and demonstrates practices that ensure that proposed research attains all levels of approval prior to commencement of any research activities.
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[expand title=”+ Knowledge Standard”]
K1 – The Organization ensures that the HRPP is staffed with individuals trained in human research protection, that the individuals are adequately qualified, and that a program is in place for ongoing training.[/expand]
 
[expand title=”+ Oversight Standards”]
O1 – The Organization has written operating procedures and demonstrates practices for self-auditing its activities to ensure compliance with the HRPP and promote quality improvement.

O2 – The Organization has written operating procedures and demonstrates practices for selecting vendors and sub-contractors and auditing their activities to ensure compliance with the HRPP.

O3 – The Organization has written operating procedures and demonstrates practices for reviewing, managing and reporting incidents of non-compliance with HRPP requirements.[/expand]
 
[expand title=”+ Safety Standards”]
S1 – The Organization has written operating procedures and demonstrates practices for reviewing, handling and reporting adverse events.

S2 – The Organization has written operating procedures and demonstrates practices for reviewing, handling and reporting unanticipated problems involving risks to research participants and others.[/expand]
 
[expand title=”+ Vigilance Standards”]
V1 – The Organization has written operating procedures and demonstrates practices to ensure the security of any and all data pertaining to human research.

V2 – The Organization has written operating procedures to protect the privacy interests of research participants.

V3 – The Organization has written operating procedures and demonstrates practices to ensure confidentiality of any and all data pertaining to research participants.

V4 – The Organization has written operating procedures and demonstrates practices for operations during emergencies.[/expand]
 
[expand title=”+ Independence Standards”]
I1 – The Organization has written operating procedures and demonstrates practices to disclose, review and manage conflicts of interest of individuals subject to the HRPP.

I2 – The Organization has written operating procedures and demonstrates practices to ensure that individuals subject to the HRPP function independently and free from undue influence.

I3 – The Organization has written operating procedures and demonstrates practices to ensure that the results of human research are disseminated in a timely manner and without restrictions.[/expand]
 
[expand title=”+ Engagement Standards”]
E1 – The Organization has written operating procedures and demonstrates practices to ensure that inquiries and complaints of research participants are addressed in a timely manner.

E2 – The Organization has written operating procedures and demonstrates practices to identify and consider situations where research participants may be vulnerable.

E3 – The Organization has written operating procedures and demonstrates practices that respect the culture and the beliefs of the research participants, including those of Indigenous populations in Canada.
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Our program has unique Conduct standards tailored to the type of organization applying for accreditation:

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