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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.

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.

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.

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.

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.

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.

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 Canadian Aboriginal populations.