Ethical Conduct of Research Involving Humans Policy

Policy Number: AS-2101-2006
Policy Title: Ethical Conduct of Research Involving Humans
Policy Owner: Vice President, Academic
Effective Date: July 15, 2013

1. 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 and in compliance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, December, 2010. The Tri-Council Policy Statement 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).

The Tri-Council Policy Statement sets high ethical standards for research involving humans that is conducted with granting agencies funding and, more generally, to promote high ethical standards for all research conducted in Canada.

Mohawk College has adopted the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, December 2010 as the basis for ethical review of research conducted at the College.

 

2. Application and Scope

This policy applies to all research involving human subjects undertaken by members of the Mohawk community or research conducted under the auspices of Mohawk College.

The REB is responsible for conducting an ethical review of any research that will involve individuals categorized and functioning in the role of employee or student. This applies regardless of where the research takes place and whether the involvement is as a researcher or participant in primary or secondary research.

The REB must approve research applications before research can begin or before research funding can be received, if funded.

The REB has the authority to approve, reject, propose modifications to, or terminate any propose or ongoing research involving human participants at Mohawk College. Thus any individual or group who wishes to conduct research involving human participants of the Mohawk community must have their research proposal reviewed by Mohawk’s REB.

The policy excludes program review and quality improvement research conducted by the college, which has been sanctioned by MEG.

 

3. Definitions (sources from TCPS2, December 2010)

  1. Members of the Mohawk 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 all three classifications of staff (administration, faculty and support) and any employment or affiliation status that may not be found at Mohawk, 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 sessional and visiting faculty.
  2. Appeal: a process that allows a researcher to request a review of a research ethics board (REB) decision when, after reconsideration, the REB has refused ethics approval of the research
  3. Collaborative research: research that involves the cooperation of researchers, institutions, organizations and/or communities, each bringing distinct expertise to a project, and that is characterized by respectful relationships.
  4. Concern for welfare: a core principle of the TCPS2 policy statement that requires researchers and research ethics boards to aim to protect the welfare of participants, and, in some circumstances, to promote that welfare in view of any foreseeable risks associated with the research.
  5. Confidentiality: an ethical and/or legal responsibility of individuals or organizations to safeguard information entrusted to them, from unauthorized access, use, disclosure, modification, loss or theft.
  6. Conflict of interest  the incompatibility of two or more duties, responsibilities, or interests (personal or professional) of an individual or institution as they relate to the ethical conduct of research, such that one cannot be fulfilled without compromising another
  7. Consent: an indication of agreement by an individual to become a participant in a research project. The term “consent” means “free (also referred to as voluntary), informed and ongoing consent”.
  8. Core principles: the three core principles of the TCPS2 December, 2010policy statement that together express the overarching value of respect for human
  9. Delegated research ethics board (REB) review: the level of REB review assigned to minimal risk research projects. Delegated reviewers are selected from among the REB membership, with the exception of the ethics review of student course-based research which can be reviewed by delegates from the student’s department, faculty, or an equivalent level.
  10. Emergency preparedness plans: plans that detail an institution’s policies and procedures for addressing research ethics review during public health outbreaks, natural disasters, and other publicly declared emergencies.
  11. Full research ethics board (REB) review: the level of REB review assigned to above minimal risk research projects. Conducted by the full membership of the research ethics board, it is the default requirement for the ethics review of research involving humans.
  12. Harm: anything that has a negative effect on participants’ welfare, broadly construed. The nature of the harm may be social, behavioural, psychological, physical or economic.
  13. Institutional conflicts of interest: an incompatibility between two or more substantial institutional obligations that cannot be adequately fulfilled without compromising one or another of the obligations.
  14. Minimal risk research: research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in the aspects of their everyday life that relate to the research.
  15. Multi-jurisdictional research: research involving multiple institutions and/or multiple REBs. It is not intended to apply to ethics review mechanisms for research involving multiple REBs within the jurisdiction or under the auspices of a single institution.
  16. Observational research: the study of behaviour in a natural environment in which people involved in their normal activities are observed whether with or without their knowledge. This term does not include observational methods used in epidemiological research.
  17. Participant: an individual whose data, ore responses to interventions, stimuli, or questions by a researcher are relevant to answering a research question; also referred to as “human participant”, and in other policies/guidance as a “subject” or “research subject”.
  18. Principal investigator: leader of a research team who is responsible for the conduct of the research, and for the actions of any member of the research team.
  19. Privacy: an individual’s right to be free from intrusion or interference by others.
  20. Reciprocal research ethics board (REB) review: an official agreement between two or more institutions in which they accept, with an agreed level of oversight, the research ethics reviews of each other’s REBs.
  21. Research: an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation.
  22. Research ethics board (REB): a body of researchers, community members, and others with specific expertise established by an institution to review the ethical acceptability of all research involving humans conducted within the institution’s jurisdiction or under its auspices.
  23. Research ethics education and training: provision of materials corresponding instruction by an institution to research ethics board (REB) members or researchers with regard to the core principles and understanding of the TCPS2 Policy Statement, December, 2010.
  24. Respect for Persons:  a core principle of the TCPS2 Policy Statement, December, 2010 that recognizes the intrinsic value of human beings and the respect and consideration that they are due. It incorporates the dual moral obligations to respect autonomy and to protect those with developing, impaired, or diminished autonomy.
  25. Risk: the possibility of the occurrence of harm. The level of foreseeable risk posed to participants by their involvement in research is assessed by considering the magnitude or seriousness of the harm and the probability that it will occur, whether to participants or to third parties.
  26. Welfare: the quality of a person’s experience of life in all its aspects. Welfare consists of the impact on individuals and/or groups of factors such as their physical, mental and spiritual health, as well as their physical, economic and social circumstances.

 

4. Principles

In accordance with Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, December, 2010, Mohawk College will establish an independent Research Ethics Board (REB) to conduct the ethical review of research involving humans undertaken at the College. The three guiding principles for research involving humans are: Respect for Persons, Concern for Welfare, and, Justice.

 

5. Accountability and Compliance

5.1 Accountability Framework

This policy has been approved by the Senior Management Team.

5.2 Compliance

Mohawk College Research Ethics Board (MCREB) is accountable for compliance with TCPS2 and this policy.

Updating and ownership of this policy is shared by the MCREB and Vice President, Academic.

 

6. Rules

6.1 The Research Ethics Review Process

Research Requiring REB Review (TCPS2; Article 2.1)

The following requires ethics review and approval by an REB before the research commences:

  1. research involving living human participants;
  2. research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals.

6.2 Risk - Concepts of Risks and Potential Benefits (TCPS2; Article 2.9)

The REB shall adopt a proportionate approach to research ethics review such that, as a preliminary step, the level of review is determined by the level of risk presented by the research: the lower the level of risk, the lower the level of scrutiny (delegated review); the higher the level of risk, the higher the level of scrutiny (full board review). A proportionate approach to assessing the ethical acceptability of the research, at either level of review, involves consideration of the foreseeable risks, the potential benefits and the ethical implications of the research.

6.3 Consent (TCPS2; Chapter 3)

Free and Informed (TCPS2; Article 3.1, 3.2)

  1. Consent shall be given voluntarily.
  2. Consent can be withdrawn at any time.
  3. If a participant withdraws consent, the participant can also request the withdrawal of their data or human biological materials.

Researchers shall provide to prospective participants, or authorized third parties, full disclosure of all information necessary for making an informed decision to participate in a research project.

Ongoing (TCPS2; Article 3.3)

Consent shall be maintained throughout the research project. Researchers have an ongoing duty to provide participants with all information relevant to their ongoing consent to participate in the research.

Consent Shall Precede Collection of, or Access to, Research Data (TCPS2; Article 3.5)

Research shall begin only after the participants, or their authorized third parties, have provided their consent.

Documented Consent (TCPS2; Article 3.12)

Evidence of consent shall be contained either in a signed consent form or in documentation by the researcher of another appropriate means of consent.

6.4 Initial Research Ethics Review (TCPS2; Article 6.11)

Researchers shall submit their research proposals, including  pilot studies, for REB review and approval of its ethical acceptability prior to the start of recruitment of participants, access to data, or collection of human biological materials. REB review is not required for the initial exploratory phase, which may involve contact with individuals or communities intended to establish research partnerships or to inform the design of a research proposal.

Determining the Level of Research Ethics Review (TCPS2; Article 6.12)

In keeping with a proportionate approach to research ethics review, the selection of the level of REB review shall be determined by the level of foreseeable risks to participants: the lower the level of risk, the lower the level of scrutiny (delegated review); the higher the level of risk, the higher the level of scrutiny (full board review).

Two levels of research ethics review may apply:

  1. Full REB review

    Research ethics review by the full REB should be the default requirement for research involving humans.
  2. Delegated REB review of minimal risk research

    The REB delegates’ research ethics review to an individual or individuals. Delegates shall be selected from among the REB membership with the exception of the ethics review of student course-based research. This can be delegated to the department, faculty or equivalent level as indicated below.

6.5 Record Keeping of REB Documents (TCPS2; Article 6.17)

REBs shall prepare and maintain comprehensive records, including all documentation related to the projects submitted to the REB for review, attendance at all REB meetings, and accurate minutes reflecting REB decisions. Where the REB denies ethics approval for a research proposal, the minutes shall include the reasons for this decision.

6.6 Conflicts of Interest (TCPS2; Chapter 7)

(See also CR 904 – Conflict of Interest in Research Activity, 2007)

Conflicts of interest must be assessed when conducting research as they may jeopardize the integrity of the research and the protection offered to participants. Conflicts that create divided loyalties may distract researchers, research ethics boards (REBs), and institutions from concern for the welfare of participants and are contrary to the core principles on which this Policy is based. Failure to disclose and manage conflicts may impede the informed and autonomous choices of individuals to participate in research. Prospective participants need to know about real, potential or perceived conflicts of interest in order to make an informed decision about whether or not to participate. Conflicts of interest may also undermine the respect for participants that is fundamental to the principle of Justice.

Institutional Conflict of Interest (TCPS2; 7.1)

Institutions shall develop and implement conflict of interest policies including procedures to identify, eliminate, minimize or otherwise manage conflicts of interest that may affect research. Institutions should make their written conflict of interest policies and procedures publicly…including participants, REBs, researchers, administrators and research sponsors.

REB Member Conflict of Interest (TCPS2; Article 7.3)

REB members shall disclose real, perceived conflicts of interest to the REB. When necessary, the REB may decide that some of its members must withdraw from REB deliberations and decisions.

Researcher Conflict of Interest (TCPS2; Article 7.4)

Researchers shall disclose in research proposals they submit to the REB any real, potential or perceived individual conflicts of interest, as well as any institutional conflicts of interest of which they are aware that may have an impact on their research. Upon discussion with the researcher, the REB shall determine the appropriate steps to manage the conflict of interest.

6.7 Research Ethics Review during Publicly Declared Emergencies (TCPS2; Article 6.22)

Subject to all applicable legislative and regulatory requirements, research ethics policies and procedures take effect in a publicly declared emergency, declared by an authorized public official.

6.8 Multi-Jurisdictional Research Review Mechanisms for Research Involving Multiple Institutions and/or Multiple REBs (TCPS2; Chapter 8)

This section primarily addresses the ethics review mechanisms for research involving multiple institutions and/or multiple REBs. It is not intended to apply to ethics review mechanisms for research involving multiple REBs within the jurisdiction or under the auspices of a single institution.

Research involving humans that may require the involvement of multiple institutions and/or multiple REBs includes, but is not limited to, the following situations:

  1. a research project conducted by a team of researchers affiliated with different institutions;
  2. several research projects independently conducted by researchers affiliated with different institutions, with data combined at some point to form one overall research project;
  3. a research project conducted by a researcher affiliated with one institution, but that involves collecting data or recruiting participants at different institutions;
  4. a research project conducted by a researcher who has multiple institutional affiliations (e.g., two universities, a university and a college, or a university and a hospital;
  5. a research project conducted by a researcher at one institution that requires the limited collaboration of individuals affiliated with different institutions or organizations (e.g., statisticians, lab or X-ray technicians, social workers and school teachers); or
  6. a research project that researcher(s) working under the auspices of a Canadian research institution conduct in another province, territory or country.

6.9 Research Involving the First Nations, Inuit and Métis peoples of Canada

The TCPS2 includes a new chapter on the ethical conduct and interpretation of ethics policies in relation to First Nations, Inuit and Métis peoples. Researchers conducting studies in collaboration with these communities are required to show they are aware and sensitive to the issues of conducting research with these communities and follow the guidelines outlined in TCPS2;Chapter 9.

Requirement of Community Engagement in Aboriginal Research (TCPS2; Article 9.1)

Where the research is likely to affect the welfare of an Aboriginal community, or communities, to which prospective participants belong, researchers shall seek engagement with the relevant community. The conditions under which engagement is required include, but are not limited to:

  1. research conducted on First Nations, Inuit or Métis lands;
  2. recruitment criteria that include Aboriginal identity as a factor for the entire study or for a subgroup in the study;
  3. research that seeks input from participants regarding a community’s cultural heritage, artefacts, traditional knowledge or unique characteristics;
  4. research in which Aboriginal identity or membership in an Aboriginal community is used as a variable for the purpose of analysis of the research data; and
  5. interpretation of research results that will refer to Aboriginal communities, peoples, language, history or culture.

6.10 Ontario Community College Multi-Site Research

Ontario Community Colleges Multi-site Ethics Application Form and Policy

The MCREB, working in collaboration with other college REBs in Ontario accepts a multi-site application form.

The multi-site research ethics application form is for researchers who are planning to conduct a study at more than one college in Ontario. This common application form, developed and launched in February 2012, has been adopted by 17 colleges and more are expected to approve the form. The researcher completes just one application form rather than a separate form for each college which he/she then submits to each college where the application undergoes ethics review. It is the researcher’s responsibility to contact the Research Ethics Coordinator at each site to determine where and how to submit the form.   

6.11 McMaster / Mohawk / Conestoga (MMC) Coordinated Review Ethics Process

Ethics review for multi-center research presents many challenges to researchers and REBs. In order to minimize the duplication of effort and the time delays associated with concurrent or serial ethics review, McMaster University, Conestoga College and Mohawk College shall co-ordinate a coordinated ethics review process.

6.12 Scholarly Review (TCPS2; Article 2.7)

As part of research ethics review, the REB shall review the ethical implications of the methods and design of the research.

As part of their assessment, the REB will satisfy themselves that the design and methods of research projects that pose more than minimal risks are capable of addressing the questions asked in the research. The REB may assume responsibility for assessing scholarly merit themselves, provided that the appropriate expertise is resident within the membership, or establish an ‘ad hoc’ independent external peer review, or establish a permanent peer review committee reporting directly to the REB. The REB may also determine that the proposed research has already passed appropriate peer review, for example by a funding agency. Generally, previous professional peer-review assessments will not be duplicated without clearly defined justification for doing so. However, the REB may require access to the full documentation of those reviews.

The REB will base their judgment about scholarly value based on a global assessment of the degree to which the research might further the understanding of a problem, issue or phenomenon; the judgment will not be based on methodological biases or a preference for particular procedures or on the judgment that another approach is possible. The REB will recognize that theoretical or methodological preferences are often open to debate and take this into account to ensure fair judgment. Ethical probity and high scientific and scholarly standards will serve as the primary assessment criteria.

The benefit of a particular research study may need to be judged within the context of a particular research program, taking into account the expertise and experience of the faculty. An integral part of some research programs is the pilot study, the results of which may be only suggestive but which can provide important indications of how to proceed with the research. The value of a pilot study is often indirect, and may be more appropriately evaluated in the broader context of a research program; otherwise, pilot studies will be evaluated under the normal ethical guidelines. The extent of the review for scholarly standards required for biomedical research that poses no more than minimal risk will vary according to the nature of the research being carried out.  
The REB will not normally require peer review for humanities and social science research projects that pose, at most, minimal risk.

 

7.  Policy Revision Date

Reviewed every three (3) years.

Reviewed by Vice President, Academic

 

8. Attachments

Appendix A - Guidelines and Procedures for Course-Based Research Activities Involving Human Participants

 

9.  Specific Links

This policy has been revised in accordance with the Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans, December, 2010.

https://ethics.gc.ca/eng/index/

http://www.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf

In addition, Research Ethics Board policies from other institutions including, but not limited to: Centennial College, Conestoga College, Sheridan College, McMaster University – Hamilton Health Sciences Integrated Research Ethics Board, and Mount Allison University.

Mohawk College Associated Policies:

  • CR902 Academic Freedom in Research
  • CR903 Administration of Research Grants and Contracts
  • CR904 Conflict of Interest in Research Activities
  • CR905 Ethical Conduct of Research Involving Animals
  • CR906 Integrity in Research and Scholarship
  • CR908 Research Involving Biohazardous and Radioactive Materials
  • GC-4100-2013 Intellectual Property Policy
  • GC-4010-2013 Copyright Policy
  • McMaster/Mohawk/Conestoga (MMC) Coordinated Review

 

Appendix A - Guidelines and Procedures for Course-Based Research Activities Involving Human Participants (CR901 – December 5, 2008)

Some Mohawk courses include class projects or activities designed to develop research skills, which might be carried out by individual students, small groups, or as a single class project. These class projects or activities might not fit the standard definition of research in the sense that the results are not intended for publication or for generalization to other situations. However, if the potential exists for risk to humans who participate in these course-based projects or activities, these projects or activities should undergo ethical review.

Course-based research projects or activities vary in scope but may include:

  • having students conduct interviews, administer standard tests, or distribute questionnaires to develop interview or questionnaire design skills;
  • conducting mini research projects where students pose research questions, gather data from human participants, and analyse the data for presentation; or
  • other activities that would be considered research within the disciplinary traditions in which the course is taught.

A. Distinguishing Research from Professional Practice/Skill Development

Students engaged in professional practice are not considered to be engaged in research. A student is engaged in professional practice when learning or doing the work of the profession. In general, professional practice for students involves the development of skills, which are considered standard practice within a profession or field, and includes information-gathering processes that are typically a part of the normal relationship between a student in a field and the people with whom the student interacts in that context. Examples of this include clinical practice in nursing, the collection of information for journalistic purposes, marketing surveys, the provision of advice to a client, and the process of evaluating or auditing in conjunction with professional course work or field placement. Activities considered to be professional practice should follow the ethical standards and guidelines found within the profession.

Not withstanding the above, ethical review will be required for course research projects involving humans where research is part of professional practice and ethical review is standard practice in the profession or field.

McMaster University and Ryerson University are the sources for the guidelines upon which appendix A is based.

The following criteria can be used to assess whether information-gathering activities within a Mohawk course are part of a research project or are intended for the teaching of professional skills (i.e., for pedagogical purposes) alone.

Information gathering activities are classified as research when:

  • the intent is to educate students on research processes used to explore and expand existing theories and conceptual knowledge;
  • students compare new techniques, practices, programs with standard approaches to determine which are more effective;
  • the results or findings are written in a format that would be acceptable for a research journal or academic conference presentation; or
  • primary data is collected and organized for analysis and distribution or dissemination/publication.

Information gathering activities are classified as professional development and not research when:

  • the intent is to use the information to provide advice, diagnosis, identification of appropriate interventions, or general advice for a client;
  • the intent is to develop skills which are considered standard practice within a profession (e.g., observation, assessment, intervention, evaluation, auditing); or
  • the information gathering processes are part of the normal relationship between the student and participants (e.g., classroom teacher and students, nurse and patient, lawyer and client).

Instructors who are uncertain if their classroom project or activity falls within the category of research, according to the criteria outlined above, should contact the Vice President, Academic.

B. Criteria for Student Research

If a class project falls under the definition of research described in section A above, the following guidelines and procedures may be applied.

The instructor may oversee the conduct of his or her individual student’s research by requesting a Department Level Review and completing the Application for Research Involving Humans. The completed application is submitted to the ethical review officer within the instructor’s academic department.

Requests for approval of course-based research projects must comply with the following criteria.

  • The research project must involve no more than minimal risk. The standard of minimal risk is defined in TCPS2; Chapter 2, p. 23.

If potential participants 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.

  • The research participants must be drawn from the general adult population, capable of giving free and informed consent, and may not include vulnerable subjects such as children, persons who are not legally competent to consent, mentally incompetent persons, legal wards or the therapeutically dependent.
  • The student project must not involve any personal, sensitive or incriminating topics or questions that could place participants or researchers at risk.
  • The student project must not manipulate behaviour of participants beyond the range of “normal” classroom activity or daily life.
  • The student project must not involve physically invasive contact with research participants.
  • The student project must not involve deception.

If the class project falls under the definition of research described in section A above and any of the preceding criteria are not met, Mohawk’s Research Ethics Board must review the project or activity.

C. The Application Process – For A Single or Uniform Class Project

  1. The course instructor assumes the role of principal researcher and submits Mohawk’s Application for Research Involving Humans on behalf of his/her class.
  2. The course instructor signs the application form and includes samples of free and informed consent forms, information letters for participants, questionnaires/surveys or other research instruments that might be used in the research project.
  3. The application is submitted to the ethical review officer within the instructor’s academic department.

D. The Application Process – For Different Projects within a Class

  1. A separate application should be submitted for each unique research project conducted in the class. Instructors should have their students complete and submit Mohawk’s Application for Research Involving Humans.
  2. The instructor should review each of these applications and ensure that they have been completed appropriately and include samples of free and informed consent.
  3. The applications are submitted to the ethical review officer within the instructor’s academic department.

E. Considerations for a Single Class Project and Different Projects within a Class

  1. If a student project is to be carried out at another institution or agency (such as school, hospital, government agency, etc.), students should be aware that approval or permission to access the premises or obtain private information from another institution might be required. Such approval should be obtained in advance, where appropriate, for a submission for ethical review at Mohawk.
  2. Ethical review approval for single or uniform class projects can be maintained for three years, provided that there are no changes to the course assignments. If changes are made, a new ethical review application must be submitted. New applications for course-based research must be re-submitted every four years. All sections of the course, whether on campus or not, must follow the procedures and all instructors must ensure that these policies are followed.