• Comment on Draft National Standard

CAN/HRSO – 100.01 – 2020 (D7 2020-07-31)
National Standard of Canada
Draft Standard - DS1
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DEVELOPMENT OF A HUMAN RESEARCH PROTECTION PROGRAM (HRPP)

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4  Technical Requirements

4.1 HRPP Mandate

The Organization shall have a written Mandate that describes the structure, leadership, culture, and overall applicability of the Human Research Protection Program (HRPP).
The Mandate shall:
  • 4.1.1 describe it origins, and the processes for its approval, updates, and revisions.
  • 4.1.2 outline the structure of the HRPP and its reporting relationship(s), if any, within the Organization and outside the Organization.
  • 4.1.3 outline the individuals and groups that play a role in the HRPP including, but not limited to, the REB, Investigators/Researchers, and administrative staff.
  • 4.1.4 list the relevant regulations, guidelines, policies, and standards governing the HRPP.
  • 4.1.5 outline the function, responsibility, jurisdiction and authority of the HRPP.
  • 4.1.6 describe the culture of the HRPP, particularly the core organizational values with respect to the ethical conduct of its human research, and its adherence to regulations, guidelines, policies, and standards listed in the Mandate.
  • 4.1.7 describe how the HRPP will operate in a multi-centre and multi-jurisdictional research environment.
  • 4.1.8 outline the process that ensures that the deliberations and decision making of the REB are free from any outside influences or biases.
  • 4.1.9 outline the process for ensuring responsible conduct of research by the HRPP’s Investigators/Researchers.
  • 4.1.10 be available in the working languages of the individuals that play a role in the HRPP.
  • 4.1.11 ensure that individuals that play a role in the HRPP are aware of who the HRPP Leader or Leadership is and have direct access to the HRPP Leader or Leadership.
  • 4.1.12 appoint a Leader or Leadership of the HRPP that is responsible for its oversight and has the legal authority to represent it.
  • 4.1.13 outline the Leader or Leadership’s authority and responsibilities, including the following:
  • (a) The Leader or Leadership should have training in human research protection.
  • (b) The Leader or Leadership shall foster a culture that supports the ethical conduct of all human research and adherence to relevant regulations, guidelines, policies, and standards listed in the Mandate.
  • (c) The Leader or Leadership shall ensure that the HRPP has resources to support the size and complexity of the research conducted, such as qualified staff, space, equipment, materials and technology.
  • (d) The Leader or Leadership should ensure that the HRPP is insured to fulfill its mandate and has access to independent legal counsel.
  • (e) The Leader or Leadership may delegate parts of its authority to other qualified individuals that play a role in the HRPP but shall be solely responsible for their conduct.
  • (f) The Leader or Leadership shall ensure that the HRPP has sufficient resources for internal compliance auditing, and that activities of the HRPP are audited on a regular basis.
  • (g) The Leader or Leadership shall ensure that findings stemming from internal or external compliance auditing are addressed in a timely manner, including corrective and preventative actions, and effectiveness verification, as required.
  • (h) On an annual basis, the Leader or Leadership shall conduct a formal and documented review of the HRPP and make adjustments, as required. The scope of the review can be found in Annex A.
  • (i) The Leader or Leadership shall ensure that the procedural documents of the HRPP will be reviewed at least every two years and revised where necessary.
Comment on 4.1 HRPP Mandate
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