Human Research Ethics Policy

Responsibility: Vice-President, Research 
Authorization: University Council
Approval Date: Jun 20, 2013

To set forth the requirements for ethical conduct of research with human participants for all those involved in any capacity in research under the auspices of the University of Saskatchewan.

When humans, human tissues or human data are used in the course of research or other comparable activities, it is the primary concern of the University that the rights of the participants are respected and protected and that the procedures followed comply with ethical, scientific, methodological, medical, and legal standards.

The University of Saskatchewan follows the national standards articulated in the current Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans.  The guiding principles of this policy statement are:

• Respect for persons, including the recognition of the intrinsic value of human beings and respect for the autonomy of research participants.  Respect for autonomy is normally reflected in the requirement to seek free and informed consent from participants both prior to and during their participation in a research project.
• Concern for welfare is broadly construed to mean all aspects of a person’s life, including their physical and mental health, spiritual well-being, and other elements of their life circumstances.  Concern for welfare includes respect for the person’s privacy and confidentiality and requires that Research Ethics Boards (REB) and researchers adopt an attitude that aims to protect the welfare of research participants, minimize foreseeable risks to those participants and their communities, and inform research participants of those risks.
• Justice requires that people be treated equitably and fairly. The principle of justice takes into account the vulnerability of the person, the difference in power between participant and researcher, and seeks to equitably distribute the risks and benefits of research participation.

For the purposes of this policy, research is defined as “an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation”.

This policy applies to all members of the University involved in research with human participants, tissues or data.  Members of the University of Saskatchewan include but are not limited to, faculty, professors emeriti, sessional lecturers, staff, trainees, clinical faculty, graduate and undergraduate students, adjunct professors, visiting professors, visiting scholars, professional affiliates, associate members, residents, and postdoctoral fellows (PDFs) at the University of Saskatchewan. 

This policy also applies to research with human participants, tissues or data undertaken by any person or Institute/Centre associated with the University of Saskatchewan, or using any University of Saskatchewan resources inclusive of persons (i.e., students, staff, faculty), or if funds for such purposes be accepted or accounts established.

In addition, this policy applies to those institutions that have entered into affiliation agreements with the University of Saskatchewan for purposes of ethics review of research with human participants.

Research at the University of Saskatchewan will be conducted under the highest standards of ethical integrity and in accordance with the following responsibilities:

a.  The University of Saskatchewan is responsible for establishing the Research Ethics Boards, defining their reporting relationships, ensuring the REBs have sufficient support to carry out their duties and supporting and promoting the independence of the REBs in their decision making. 

b.  University Council, through the Research, Scholarly and Artistic Work Committee of Council is responsible for receiving annual reports of the Research Ethics Boards, and for maintaining governance oversight over University research ethics policies.

c.  The University Committee for Ethics in Human Research (UCEHR) reports to the Vice-President, Research through the Director, Research Ethics and is responsible for adopting codes, guidelines, standards, and policies, with respect to research ethics review. In this adoption, the Committee must adhere to the Tri-Agency guidelines and other applicable policy and legislation. UCEHR is responsible for hearing appeals of REB decisions.

d.   The Research Ethics Office (REO) is responsible for supporting the University’s Human and Animal Research Protection Programs to ensure the rights of research participants and animals are protected and that the University is in compliance with funding agencies, national guidelines, and international standards.

e.   Research Ethics Boards (REB) are responsible for the review of the ethical acceptability of research under the auspices of or within the jurisdiction of the University of Saskatchewan, including approving, rejecting, proposing modification to, or terminating any proposed or ongoing research involving humans.  The University of Saskatchewan REBs will adhere to the Tri-Agency MOU, the Tri Council Policy Statement on the Ethical Conduct for Research Involving Humans and, where required, to provincial, national and international guidelines and regulations.

f.   Researchers are responsible for conducting their research according to the principles and procedures found in the relevant university, provincial, national and international guidelines including:. 

1. obtaining all the required approvals prior to the inclusion of human participants, tissues or data in the research.
   
   
2. ensuring that their research, scholarly, and artistic work is conducted in accordance with these approved protocols.
   
   
3. adhering to all reporting requirements.
   
   
4. ensuring that students and research staff are carefully trained and supervised in the conduct of research.
   
   
5. protecting the privacy of any individuals whose personal information has been obtained as part of any research activities as required under the University’s Freedom of Information and Protection of Privacy Policy, the Local Authority Freedom of Information and Protection of Privacy Act and the Health Information Protection Act and any other relevant legislation.
   
   
6. Adhering to the University of Saskatchewan Responsible Conduct of Research Policy and the Procedures on the Stewardship of Research Records at the University of Saskatchewan.

Failure to comply with pertinent federal, provincial, international, or University guidelines for the protection of human research participants and/or failure to conduct research in the manner in which it has been approved by the University’s Research Ethics Boards is defined as a breach of the Responsible Conduct of Research Policy and will be handled under the procedures of that policy.

Application guidelines, composition of the REB’s, review procedures, appeal procedures, activities requiring REB review, and information pertaining to all aspects of the review of research protocols are described in the Research Ethics Office Standard Operating Procedures (SOPs).  SOPs are issued and maintained by the Research Ethics Office.

Effective date July 1, 2013