Ethical Conduct of Research Involving Humans

You are here

BACKGROUND

The policy and procedures outlined in this document are largely based on the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans. The Tri-Council Policy was created by Canada’s three federal granting agencies --the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council (NSERC), and the Social Sciences and Humanities Research Council (SSHRC). Their intent is to set h igh ethical standards for research involving human subjects that is conducted with their funding and, more generally, to promote high ethical standards for all research conducted in Canada.

The guiding ethical principles of the Tri-Council Policy are:
  • Respect for human dignity
  • Respect for free and informed consent
  • Respect for vulnerable persons
  • Respect for privacy and confidentiality
  • Respect for justice and inclusiveness
  • Balancing harms and benefits
  • Minimizing harm
  • Maximizing benefit
CCNM has adopted the Tri-Council Policy Statement (most recent version: TCPS2 2014) as the basis for ethical review of research conducted at the College. It provides guidelines for research that transcend the disciplinary boundaries of the three federal granting agencies but also highlights considerations that are particular to certain types of research conducted in the health sciences.

Definitions
The following terms and definitions, whether used in the singular or plural, will apply in this policy.

Members of the CCNM community: In this policy, refers to all students and staff, regardless of status. As it regards students, the term includes, but is not limited to full-time, part-time, and visiting students. As it regards staff, the term covers any employment or affiliation status that may be found at CCNM, which includes, but is not limited to full-time, part-time, and contract. As it specifically relates to faculty, the status covered by the term also includes, but is not limited to part-time and visiting faculty.

Primary Research: Information that is collected directly from participants/subjects, regardless of the method used to collect the information.

Secondary Research: The collection of information about human subjects from existing records.

Purpose: The purpose of this policy and specifically of ethical review is to ensure that the rights of human subjects participating in research are respected and that such research is conducted ethically. CCNM is committed to ethical conduct in all of its research activities, including research involving members of the CCNM community, whether as a researcher or participant/subject in primary or secondary research.

Scope: This policy applies to all research done by members of the CCNM community involving human subjects. This also includes research involving human remains, cadavers, tissues, biological fluids, embryos and fetuses.

POLICY STATEMENTS

1. In accordance with Tri-Council Policy, a Research Ethics Board has been established to provide ethical review at CCNM.

2. Role of the Research Ethics Board: The Research Ethics Board will review and make decisions about whether research that is to involve members of the CCNM community can be conducted. This decision will be based on the ethical considerations involved in each proposal according to the guidelines provided by the Tri-Council Policy.
As well as reviewing new research proposals, the Research Ethics Board will monitor the ethical and legal conduct of approved research activities involving CCNM through notices of change to research design, notices of research completion, and annual renewal of continuing research projects. (Refer to section 4, Monitoring the Status of Research, for more details.)

The Research Ethics Board may also recommend changes to the policy and procedures contained in this document, as required, and will provide the College with an annual summary of its activities.

3. Jurisdiction of the Research Ethics Board

The Research Ethics Board is responsible for conducting an ethical review of any research activity that will involve individuals categorized and functioning in the role of employee or student (i.e., members of the CCNM community). This applies regardless of where the research takes place and whether the involvement is as a researcher or participant/subject in primary or secondary research. The Chair of the Research Ethics Board reports to the President of CCNM and all reports from the Board are shared with the Audit Committee of the CCNM Board of Governors.

The Research Ethics Board must approve proposals before any research can begin or before funding can be received, if funded. The Research Ethics Board has the authority to approve, reject, propose modifications to, suspend or terminate any proposed or on-going research involving members of the CCNM community. Thus, any individual or group who wishes to conduct research involving members of the CCNM community must have their research proposal reviewed by CCNM’s Research Ethics Board.

The following list of individuals, groups, and research activities subject to ethical review is intended to be illustrative and not exhaustive.

A submission to CCNM’s Research Ethics Board should be made when:

  • the research is conducted by students for personal interest, as part of course work, or for other reasons;
  • the research is conducted by faculty independently or as part of a team of researchers for personal interest, academic, professional, or other reasons;
  • the research is new and conducted by CCNM staff and/or its partners with the intention of contributing to the management of CCNM, its programs and services, including joint initiatives;
  • the research is conducted by students who are not otherwise affiliated with CCNM;
  • the research is funded or not funded;
  • the funding is from internal or external sources;
  • the participants/subjects are from inside or outside CCNM;
  • the participants/subjects are paid or unpaid;
  • the research is conducted inside or outside Canada;
  • the research is conducted inside or outside CCNM;
  • the research is conducted by individuals not associated with CCNM;
  • the research is conducted in person or remotely (e.g., by mail, electronic mail, Website, fax, or telephone);
  • the information is collected directly from participants/subjects (primary research) or from existing records not in the public domain (secondary research);
  • the research is to be published or not published;
  • the focus of the research is the participant/subject;
  • the research is observational, experimental, correlational, or descriptive;
  • a similar project has been approved elsewhere or not;
  • the research is a pilot study or a fully developed project;
  • the intent of the research is to acquire basic or applied knowledge;
  • the intent of the research is to develop skills and/or advance practice;
  • the research is primarily for teaching or training purposes, or the primary purpose is the acquisition of knowledge.

    Exemptions from Ethical Review: See Articles 2.1 – 2.4 of the TCPS (2014)

    On-going research that is conducted to facilitate the management of the College, its programs and services as part of its normal operation--such as the student satisfaction survey, course evaluations, student evaluations and research mandated by the provincial government - such as Key Performance Indicator surveys do not require a review by the Research Ethics Board.

4.The Standard of Minimal Risk and Types of Ethical Review: Previous versions of the Tri-Council Policy Statement outlines the standard of minimal risk, which provided the basis for two primary types of ethical review: full review and expedited review. These definitions have been included here for information purposes. The Tri-Council Policy defined minimal risk as follows:

“If potential subjects can reasonably be expected to regard the probability and magnitude of possible harms implied by participation in the research to be no greater than those encountered by the subject in those aspects of his or her everyday life that relate to the research, then the research can be regarded as within the range of minimal risk. Above the threshold of minimal risk, the research warrants a higher degree of scrutiny and greater provision for the protection of the interests of prospective subjects.”(Section 1, C1, Tri-Council Policy Statement 2010)

Monitoring

The CCNM Legal Counsel in conjunction with the Director, Research is responsible for reviewing this policy.

For more information or inquiries about submitting an application to the CCNM Research Ethics Board, please contact REBChair@ccnm.edu.

Attachments

Appendix (PDF) - Application for Research Involving Human Subjects
]

Appendix A (PDF) - Procedures for Implementing This Policy

Attachment B (PDF) - Guidelines for Free and Informed Consent
Attachment C (PDF) - Sample Cover Letter – Full Review
Attachment D (PDF) - Sample Cover Letter – Expedited Review
Attachment E (PDF) - Guidelines for Determining Whether Ethical Review is Required for Course-Based Projects or Activities
Attachment F (PDF) - Guidelines and Procedures for Course-Based Activities Involving Human Participants
Attachment G - Sources

CCNM logo

CONNECT WITH US

Talk to a student services advisor today by emailing info@ccnm.edu

The Canadian College of Naturopathic Medicine

Educating naturopathic doctors in North America for over 40 years

1255 Sheppard Avenue East, Toronto, Ontario M2K 1E2

College: (416) 498-1255 I 1 (866) 241-2266 (toll-free)

Clinic: (416) 498-9763

AANMC
Member of the Association of
Accredited Naturopathic Medical Colleges