Ethical Conduct for Research Involving Human Subjects Policy

Seneca has a responsibility to safeguard the rights and well-being of students, employees and other members of the Seneca community by ensuring the rights and interests of all human subjects involved in research are respected. 

This policy applies to all research conducted within or associated with the Seneca community domestically or internationally that involves the participation of human subjects or databases of information used within a study about them, and/or Seneca equipment and facilities. 

An undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation. Research activities include but are not limited to observations, surveys, interviews, focus groups, and interventions. Pilot studies also fall within the definition of research requiring Research Ethics Board (REB) review.

A person who is a source of primary data or information by their involvement in a data-gathering situation or activity.

Research in which the probability and magnitude of possible harms implied by participation in the research are no greater than those encountered by participants in those aspects of their everyday life that relate to the research.

Those with developing, impaired, or diminished autonomy because of youth, cognitive impairment, other mental health issues or illness, or those with limited access to social goods, such as rights, opportunities, and power.

Providing clear disclosure of the nature of the research study, its potential impact on the participant(s), voluntary participation, and the right to withdraw from participation or refrain from answering any question(s) that the participant(s) considers being intrusive, without explanation or penalty. “Some people may be incapable of exercising autonomy because of youth, cognitive impairment, other mental health issues or illness”. A high ethical obligation is required to protect vulnerable persons by ensuring procedures requiring a legally responsible adult’s written consent to protect their interests is in place prior beginning the research.  “Respect for Persons requires involving individuals in circumstances of vulnerability in decision making where possible. This may include asking about their feelings regarding participation and/or for their assent”.

Participants should not be subject to unnecessary risks or harm.  Measures should be taken to avoid, prevent or minimize harm to research subjects.

The recruitment process should ensure participants are selected based on inclusionary criteria justified by the research question and not by unfair or inequitable practices.

A research methodology involving observation of participants in their normal environment, without manipulation. 

*The above definitions are sourced from the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2018)

1. Any individuals wishing to conduct research involving human participants within the context of, or associated with, Seneca, whether locally or in other jurisdictions, or countries are required to submit to the REB a completed Application for Ethics Review form and obtain approval in writing by the Seneca REB before beginning any such research.
2. There is no requirement that the intention is to publish the findings to be considered research.
3. Research-type activities conducted for pedagogical purposes such as learning about observation, survey, or interview techniques, etc., are also required to be reviewed and approved by the Seneca REB to ensure alignment with ethical participant treatment guidelines.
4. Seneca does not currently engage in any research involving human remains, cadavers, tissues, biological fluids, embryos, fetuses, or similar biological elements or biomedical research. If research of this nature is required, researchers must obtain written approval from the REB before beginning.

1. Naturalistic Observation requires ethics review except if the subjects are publicly visible, there is no expectation of privacy, and the dissemination of information will not allow identification of specific individuals.
2. Research about events or living individuals involved in the public arena or based exclusively on publicly available information and materials is not required to undergo ethics review, unless the individual is to be contacted directly for interview or access to private documents is needed, in which case ethics review is required.
3. Data gathering practices related to normal educational program processes and requirements, such as evaluation of student learning, quality assurance and performance reviews, do not require ethics review.
4. Data gathering related to discipline-specific practices conducted as part of the regular activities within that discipline does not require research ethics review (e.g. observing students to develop or modify the curriculum; interviewing individuals for news gathering; measuring or collecting health data as part of a clinical assessment). Pedagogical activities related to learning these techniques are also exempt from ethics review. 

1. Seneca’s President mandates the REB to approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human subjects based on their assessment of the compliance with this policy and Tri-Council standards of any research conducted under the auspices of Seneca.
2. The REB will have the appropriate administrative and financial independence to enable it to fulfil its mandate.
3. A decision of the REB to prohibit research on ethical grounds, unless reversed on reconsideration by the REB itself, may only be reversed through the appeals process.
4. Initially Seneca will have only one REB but as research activity increases, additional REB's may be added whose membership will be as stated in paragraph 4.7 will not be specific to any one school or department and whose mandates will be as defined by the research domain. Once additional REBs are set up, processes will be put in place to ensure that lines of communication are opened in order that each REB is kept aware of the research under review and of the decisions made by the respective REBs. Should researchers conduct biomedical research at or within the Seneca community, the REB will have a member knowledgeable in the relevant law.
5. The members of the REB will be appointed by the Dean, Applied Research, in consultation with relevant administrative staff.
6. Membership will be gender-inclusive and will consist of a minimum of six members per REB as follows:
   • none will be administrators
   • two will have broad research expertise
   • at least one will be knowledgeable in ethics
   • at least one external community member who has no affiliation with Seneca and is not currently engaged in research or legal work as their principal activity
   • each faculty at Seneca will have at least one representative.
7. The primary role of the external community members is to reflect the perspective of the participant. As the size of the REB becomes more extensive than the minimum, additional community representation should correspond with the size of the REB.
8. Members will serve for three years and may be re-appointed.
9. The term of appointments of REB members will be staggered to ensure continuity and representation of the membership as defined within this policy.
10. Of the minimum six members of the REB, one will serve as chair and one will serve as vice-chair. The chair and vice-chair are elected by the members of the REB and serve for three years.
11. The REB will normally meet face-to-face at least once per month to review applications received and more frequently (e.g., if the applicants respond to previous input from the REB) at the discretion of the Dean, Applied Research.
12. Members of the REB may elect to participate in face-to-face meetings by teleconference or video conference if necessary.
13. Research proposals that are not assigned to delegated or expedited review must be reviewed in face-to-face REB meetings.
14. Schedules of the REB meetings will be available to all researchers
15. Frequent absences of members from regularly scheduled REB meetings will be deemed a notice of resignation, and the Dean, Applied Research, will seek an appropriate replacement for that member.
16. Quorum for meetings and full REB reviews shall be 70 per cent of the REB membership.
17. Motions and decisions shall be carried with a majority; being 50 per cent plus one in agreement
18. A member of the REB with a conflict of interest may not participate in or be present during the discussion and/or decision related to the research application where the REB member has a conflict of interest.
19. The chair of the REB will ensure that the minutes of each meeting and decisions reached are recorded and ensure all documentation is stored securely but accessible to authorized representatives of the institution, researchers, and funding agencies/sponsors.
20. The members of the REB will engage in discussion and professional development opportunities related to their role and responsibilities as appropriate.

1. Any individual(s) wishing to conduct research involving human participants will submit to the Seneca REB one of the Applications for Ethics Review forms.
2. The REB will take a balanced approach to the ethical review. The greater the possible risk of harm to participants, the more thorough the scrutiny in a review.
3. Full review is always the default type of review.
4. Where there is any doubt about the potential risk to human participants, a full review will be conducted.
5. In the event that the researcher or the chair of the REB determines that the research has the potential to pose more than minimal risk to potential participants, involves a vulnerable population, involves physically invasive contact or involves deception, a full review is appropriate, and the full REB will review the application. 
6. Members of the REB and/or the researcher(s) may request informal meetings to discuss and clarify the application before or during the official meeting of the REB on that researcher's application for ethics review.
7. The applicant may elect to be present to discuss or explain the proposed research but may not be present when the REB makes its decision.
8. If the researcher(s) and the chair of the REB determine that there is no foreseeable harm or only minimal risk to participants, the application may be assigned to delegated review
9. A delegated review can be assigned to one or two REB members, one of which could be the chair of the REB.
10. Applications assigned for delegated review must have research participants who are drawn from the general adult population, capable of giving free and informed consent, and may not include vulnerable subjects (e.g., children, persons who are not legally competent to consent, mentally incompetent persons, prisoners, legal wards, or the therapeutically dependent).
11. The research assigned for a delegated review should not involve highly personal, sensitive, or incriminating topics or questions that could place participants at risk or cause embarrassment, should not involve physically invasive contact with the research participants and should not involve deception.
12. A researcher may apply for expedited review if the researcher and the chair of the REB determine that there is no foreseeable harm or minimal risk to participants (i.e., where the probable level of risk is reasonably anticipated to be no greater than potential subjects encounter in everyday life), and the research has been formally approved (in writing) by a constituted REB under the TCPS 2 of another institution (e.g., college or university).
13. Expedited review will usually be conducted by the chair or one or two members of the REB.
14. Course-based research review occurs with minimal-risk research involving collecting data from human participants conducted for pedagogical purposes only as partial fulfillment of course requirements.
15. Instructors of courses that include research projects will apply for approval of that project using the Application for Course-Based Research Approval Form.
16. Course-based research review will be conducted by the chair of the REB or one or two other members of the REB.
17. Once a course research project is approved, the course instructor can be delegated to review and monitor the individual student research activities related to that course assignment.
18. Course-Based Research review does not apply to student-initiated research projects conducted to fulfill a capstone or thesis research requirement in a degree program.
19. The Seneca REB may delegate the ethics review of research entailing no more than minimal risk to be carried out by undergraduate students as part of their course work to a faculty/divisional level process, which complies with this policy and TCPS2.
20. Research carried out within formal course requirements, including course-based research and student-initiated capstone or thesis research requirements in a degree program, which poses no more than minimal risk, may be reviewed by a faculty/school or department REB subcommittee.
21. The subcommittee should include no less than three individuals with knowledge and expertise in research and ethics, one of whom should be a member of the Seneca REB.
22. The faculty/school or departmental level process should be reviewed and approved by the Seneca REB. The faculty/school or departmental level applications and decisions should be reported to the Seneca REB.

1. REB members will ensure that all applications receive a fair hearing, decisions are made impartially, and the researcher(s) is provided with a reasonable and complete explanation of the REB's decision in a written Decision Letter that includes the reasons for the decision(s) made and any dissents (to facilitate any reconsideration and/or appeal).
2. The REB may, at its discretion, invite individuals with expertise in particular areas to help review issues that require knowledge beyond or in addition to that available on the REB. These individuals will not vote with the REB on any decisions.
3. The REB will notify the applicant(s) in writing within two weeks of the review meeting of any issues that need to be addressed, if the application is denied or when approval is granted to proceed.
4. The chair of the REB will submit to the Dean, Applied Research, for safekeeping, a record of the application received, and the REB’s decision.
5. No research activities may begin until the applicant receives written approval from the REB.
6. If the researcher is not satisfied with the decision of the REB, the researcher or the Dean, Applied Research, may ask the REB to reconsider their decision. If the issues cannot be resolved, the researcher can appeal the decision.

1. The decision of the REB may be appealed by the principal investigator(s) through one of two mechanisms at the discretion of the Dean, Applied Research:
   • An ad hoc Research Ethics Appeals Committee (REAC), whose membership consists of a minimum of five members who are not members of the REB, two of which have broad expertise in research, at least one knowledgeable in ethics and at least one member external to Seneca and none of whom are administrators. selected for their expertise in the research process and ethics
   • External review by another institutional REB in Ontario that is fully compliant with the TCPS2 and has a formal written agreement in connection with REB appeals in place with Seneca in advance of any appeal process.

1. All ongoing research is subject to continuing ethics review, which at minimum consists of an annual report submitted by the principal investigator to the REB chair.
2. Where the REB perceives there to be more than minimal risk to participants, they may request more frequent reporting consistent with the nature of the research.
3. The principal investigator is responsible for notifying the REB immediately if any significant changes in the research methodology and procedures are anticipated and explaining how they will safeguard the rights of human subjects. The research may not continue until approval to do so is granted by the REB.
4. The principal investigator is responsible for notifying the REB immediately if participants encounter any adverse effects.
5. If the research is supported financially by external sources (e.g., CFI, OCI, Tri-Council granting agencies), the principal investigator is responsible for approving the use of these funds for specific research activities and for reporting the use of these funds so that Seneca can meet the granting agency's reporting requirements.

• None

• Responsible Conduct of Research Policy

• Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2018)

Approval Date: August 2021

Last Revision:  August 2021