Ethical Conduct for Research Involving Humans Policy
|Effective Date:||October 15, 2021|
|Downloadable Version:||Ethical Conduct for Research Involving Humans Policy|
|Related Procedure(s):||Ethical Conduct For Research Involving Humans Procedure|
|This document is available in alternate format on request.|
The Humber College Institute of Technology & Advanced Learning (hereafter referred to as "Humber'' or ''the College") is committed to advancing and safeguarding high-quality academic and ethical standards in all its activities.
The purpose of this policy and the accompanying procedure is to ensure the preservation of human dignity and respect when humans are involved in research activities.
Attention to the ethical and legal implications of research is an accepted and inherent part of good research practice and will be conducted at Humber in accordance with the Tri- Council Policy Statement: Ethnical Conduct for Research involving Humans -- TCPS 2 (2018).
Research may involve collaboration between human participants and researchers and may require active involvement of participants. Therefore, the interests of both researchers and participants are central to the research and there is an overriding premise that participants must not be treated simply as objects or a means to an end. Researchers are required to conduct their research studies with accuracy, candor, objectivity and sensitivity.
It is understood that research can entail risk. Establishing research ethical standards involves identifying, promoting and adopting a clearly understood set of principles and procedures that will guide the actions of researchers, which the Research Ethics Board (REB) can use to judge the ethical merit of a research study involving humans.
All individuals associated with Humber in any capacity and regardless of the location (i.e. on or off campus), must comply with this policy and its accompanying procedure. This includes the University of Guelph-Humber faculty hired by Humber College. In addition, this includes individuals external to Humber who approach staff or students or seek approval or endorsement from the College. It also covers use of institutional data or College facilities.
All College employees involved in research involving humans must ensure that they are familiar with the principles in this policy, and those of the Tri-Council Policy Statement on ethical research. These principles must be incorporated into the research design and implementation of any project.
Ethics review and approval by the Humber REB is required for all research involving human participants that is conducted under the auspices of the College. REB approval is not required for access to publicly available information or materials, including archival documents and records of public interviews or performances.
Conflict of interest: A conflict of interest can arise when individuals' judgments and actions or the College's actions in relation to research are, or could be, affected by personal, institutional or other interests. Conflict of interest may also occur when individuals’ judgments and actions or the College’s actions are, or could be, affected by personal, institutional or other interests.
Human participants: Individuals (living or deceased) whose data or responses to interventions, stimuli or questions are relevant to answering the research question. Under a broad definition, research may include human participation:
- Directly through physical participation; may include both active and/or passive involvement;
- Indirectly through the provision for or access to personal data and/or biological material;
- On behalf of others (parents/legal guardians for those without the capacity to give informed consent and supervisors of individuals under controlled environments (e.g. prisoners, students).
The nature of human participation in research will vary from one project to the next depending on the degree of involvement and an individual's consent. It is recognized that data collected about characteristics and responses may have identifiable private information, which is confidential and must be protected by the researcher.
Principal Investigator: Person designated as the primary representative of a research project and bears the responsibility for research design, conduct of research and reporting of findings.
Research: Any internally or externally funded initiative that the College and the academic community in general, consider to be research, including:
- Finding solutions to practical problems through the application of knowledge;
- Experimental discovery;
- Activities leading to the publication of books, monographs and contributions to edited books;
- Unpublished research, including work in progress;
- Consulting and contract work under the auspices of the College, and other professional activities involving research.
Research involving humans is driven by the desire for new knowledge, for benefit to the participants, or for the benefit of society.
Research Ethics Board (REB): The Humber Research Ethics Board (REB) is an arm’s- length body, which oversees ethical screening and conducts a full review of research projects involving human participants. The REB endorses, and takes as its guide, the Tri- Council Policy Statement: Ethnical Conduct for Research involving Humans -- TCPS 2 (2018).
The REB evaluates all research involving humans and ensures it is conducted in a manner that is consistent with this policy and its aligned procedure.
Research Ethics Appeal Board (REAB): The Humber Research Ethics Appeal Board (REAB) is responsible for receiving and responding to requests for appeals in cases where the principal investigator and the REB cannot reach agreement through discussion and reconsideration.
1. Fundamental Principles
All research involving human participants carried out by College staff, students, or under the auspices of the College should be consistent with the following principles:
- Protection of academic freedom.
- Respect for persons; adequately informing participants of their right to choose voluntarily what shall happen to them.
- Fair and appropriate selection and treatment of human subjects.
- Expected benefits outweigh risks of research; reasonable efforts are made to minimize potential risks of the research.
- Principle Investigator is competent to both conduct research and to safeguard the welfare of research subjects.
2. Principles of Research
2.1. Respect for human dignity is an underlying value of the Tri-Council Policy Statement: Ethnical Conduct for Research involving Humans -- TCPS 2 (2018) and requires that research involving human participants be conducted in a manner sensitive to the inherent worth of all human beings, and the respect and consideration that they are due. Respect for human dignity is expressed in the TCPS through three core principles: Respect for Persons; Concern for Welfare; and Justice. These principles transcend disciplinary boundaries.
2.2. Research that benefits society and advances knowledge will be guided by ethical principles of conduct. These include respect for human dignity, including respect for vulnerable persons; respect for privacy and confidentiality; respect for fairness and equity; respect for free and informed consent; and, a balance of harms and benefits, maximizing benefits and protection from harm.
2.3. To maximize the benefits of research, researchers will have the freedom of inquiry, the right to disseminate the results of that inquiry, freedom to challenge conventional thought and, freedom from institutional censorship.
3. Research Review and Approval
3.1. Humber will establish and maintain a Research Ethics Board (REB) to provide ethical review and approval of research involving humans, prior to the start of the research.
3.2. The REB ensures that College ethical procedures are regularly implemented. The REB may select advisors to address the particular ethical review that may arise with certain types of research.
3.3. All research projects under the auspices of the College involving human participants, regardless of where the research is conducted or funding source, requires a review by and approval from the REB prior to the start of the research (See TCPS 2 ).
3.4. All research conducted under the auspices of Humber that involves human participation must be approved in writing by the REB, prior to beginning such research.
3.5. While it is not necessary for the REB to review a research proposal before it is submitted to a funding agency, REB approval must be obtained prior to commencing the research, and prior to releasing funding.
3.6. The REB shall function impartially, provide a fair hearing to those involved, and provide reasoned and appropriately documented opinions and decisions of its review (see Procedure Manual).
3.7. The REB shall use a proportionate approach to ethics assessment based on the general principle that the more invasive the research procedure, the greater the care and due diligence required in assessing the risks of the research to the human participant. The REB will review the application by assessing the character, magnitude and probability of potential harms of the research from the view of the human participant. Based on the initial assessment, the application will undergo a Full Review (default) or Delegated Review (see Procedure Manual).
3.8. Members of the REB will be provided 2 hours per week for duties related to this work. The Chair of REB will be provided 6 hours per week. These hours will be reflected on the SWF or through a contract for non-fulltime employees.
4. Exemptions from Ethical Review
Research exempt or not normally requiring a review by the REB, may include:
- Quality assurance studies assessing the performance of the College; staff performance reviews; nationally or provincially mandated studies such as Key Performance Indicators; primary data collection designed and administered by the College to facilitate the management of the institution (e.g. for review and renewal of programs) or continuous improvement to quality of services and student success (e.g. first-year student surveys; course evaluations; or testing done within normal educational requirements);
- A living individual in the public arena who is not being approached directly but where the research is based exclusively on publicly available information, documents, records, works, performances, archival materials or third-party interviews;
- Naturalistic observation of participants who seek public visibility such as in a political rally, demonstrations or public meetings;
- Practicums, field placements or on-the-job training where students are integrated into an organization for the purposes of learning and development of competencies;
- Class projects or student information gathering activities that are either not classified as research or where the research is conducted by students on other members of the class as an exercise on learning how to conduct research. These activities are part of the learning compendium for the purpose of skill development;
- Developing a competency to learn a professional standard of practice;
- Conducting projects where students pose questions, gather data and analyze the results;
- Information exchange as part of the relationship between students and participants (e.g. student and teacher, health professional and client);
- Research that relies exclusively on the secondary use of anonymous information, or anonymous human biological materials, so long as no identifiable information is generated through data linkage or dissemination of results.
5. Research Ethics Review during Publicly Declared Emergencies
As per Article 6.21 of the TCPS 2, the research ethics review process may follow modified procedures and practices during publicly declared emergencies. The Humber Research Ethics board will consider time constraints and logistical challenges when modifying procedures to ensure that quality, timely and appropriate research ethics review continues. A public health emergency may warrant an adjustment to the expertise, form and scope of research ethics review. When holding REB meetings during emergencies, consideration will be given to the security and privacy of software or services used. Modifications to procedures and practices should cease as soon as is feasible after the end of the publicly declared emergency.
6. Research Ethics Appeals Board (REAB)
Humber will establish and maintain a REAB to provide an appeal mechanism in cases where the Principal Investigator and REB cannot reach agreement through discussion and reconsideration (See Procedure Manual).
7. Non-compliance Implications
Failure to comply with this policy may result in damage to internal and external relationships, financial loss, property damage, reputational harm, and/or legal action.
University of Toronto
George Brown College
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans TCPS 2 (2018)
Appendix A: Authority of the Research Ethics Board (REB)
Authority of the Research Ethics Board (REB)
The REB is accountable to the President of Humber and is vested with the authority to review and to decide whether to approve, reject or recommend modifications to any proposed or ongoing research involving human participants conducted at Humber. The REB will also monitor all research involving human participants, including course-based research, through notices of change to research protocol, annual renewal of research projects and notices of research completion. It has the authority to suspend or to terminate ongoing research that does not comply with this policy and with the TCPS.
Responsibilities (for more details, refer to the Procedure Manual)
The Humber Research Ethics Board is responsible for the following:
- Ensuring that all research proposals involving human participants meet the highest standards of scientific rigour and ethics;
- Developing procedures regarding ethical issues related to the use of human participants in research;
- Assessing the design of research projects that pose more than minimal risk to ensure it is capable of addressing the questions being asked;
- Reviewing protocols involving human participants to verify there is a favourable risk/benefit ratio, that it is respectful of the rights, dignity and autonomy of human participants, and that it equally distributes the benefits and burdens of research;
- Reviewing annually all research policies regarding ethical issues relating to the use of human participants to ensure they reflect current changes in an evolving ethics environment;
- Ensuring that all applications that involve human participants, regardless of funding source, receive a thorough review and fair hearing in a timely fashion (see Procedure Manual);
- Rendering reasoned decisions, maintaining records of the process and documenting the opinions expressed (see procedure);
- Monitoring approved projects in an appropriate manner to ensure ethical standards and protocols are maintained throughout the course of the investigation;
- Ensuring there is a mechanism in place for reporting and reviewing all adverse events associated with research projects (see Procedure Manual);
- Preparing an annual report for submission to the President; and
- Acting as a resource and participating in professional development on matters relating to research ethics and the use of human participants.
The REB Chair will monitor the REB's decisions for consistency.
The REB must have independence to conduct ethics reviews, free of inappropriate influence, including situations of real, potential or perceived conflict of interests. The REB shall make decisions independently and be accountable for the process of ethics review as identified in the Humber Ethical Conduct for Research Involving Humans Procedure. In order to maintain its independence and operate at arm's length from administrative and programmatic research structures, the REB shall be provided with appropriate administrative and financial resources and will be supported by a Humber administrative area.
Membership criteria are designed to ensure the REB has the necessary basic background, expertise, perspectives and independence to conduct informed independent reflection and competent research ethics review. The REB should consist of at least five members, including both men and women, of whom:
- two members have expertise in relevant research disciplines, fields and methodologies covered by the REB;
- one member is knowledgeable in ethics;
- one member is knowledgeable in the relevant law. That member should not be the institution’s legal counsel or risk manager. This is mandatory for biomedical research and is advisable, but not mandatory, for other areas of research; and
- one community member who has no affiliation with the institution.
It is advisable that each member be appointed to formally fulfill the requirements of only one of the above categories.
To ensure the independence of REB decision making, institutional senior administrators shall not serve on the REB.
In addition to the above, the REB will have adequate Equity, Diversity and Inclusion (EDI) representation and may be expanded to include a lawyer with expertise in biomedicine, if required, to specifically provide insight into biomedical research issues. Should additional representation be added to the REB for the purpose of an adequate and thorough review, the community representation will also be increased to maintain a 20 per cent representation.Where possible, former research participants will be appointed to the REB. Their experience as participants provides the REB with a vital perspective and an important contribution to the research ethics review process. It is advisable that members are not currently engaged in research or legal work as their principal activities.
Substitute REB members may be nominated to replace a standing member in case of absence or unforeseen circumstances to maintain the composition of the membership for the duration of the review. Substitute members should have the appropriate knowledge, expertise and training to contribute to the research ethics review process.
Ad hoc appointments by the Chair may be made to provide specific expertise and knowledge not present on the REB; however, these appointees do not have voting privilege, nor can they be counted to establish quorum.
Members for the REB will be selected based on the following criteria:
- Representation from both teaching staff and administration but not senior administration;
- Management support of participation;
- Commitment to ethics and willingness to expand knowledge;
- Regular attendance at meetings (virtually or in person) and ability to contribute to sound decisions;
- Adherence to ethical practice in research;
- Appropriate academic credentials (e.g. doctorate) reflecting knowledge of research
- Desire to foster ethical research practice within the College; and
- Adherence to College policies and procedures.
Members of the REB will be nominated by the Senior Vice-President, Academic and appointed by the President for a period of two years, renewable with staggered appointments of no more than one-third being replaced each year to maintain continuity.
To understand their REB roles and responsibilities, new members will receive orientation and training on ethics review, including: principles; policies; legal and regulatory requirements. The REB will determine areas for improvement and schedule periodic educational opportunities as required.
The Chair of the REB shall be appointed by the Senior Vice-President Academic for two years, renewable.
Members of the REB may serve up to a maximum of 6 years.
Meetings will be held monthly, as required, to carry out a full review of research applications. The REB shall normally meet to review proposed research that is not assigned to delegated review, for adequate discussion and decision-making.
The Chair will provide leadership for the REB, call and preside over meetings, oversee the minutes and monitor all decisions, dissents and reasons. A schedule of regularly scheduled meetings will be made publicly available (e.g. website).
A quorum for a full review shall consist of at least 60% of members. Ad hoc advisors, observers, research ethics administration staff and others attending REB meetings are not counted in the quorum and are not allowed to vote on REB decisions. Decisions without a quorum are not valid or binding. To maintain quorum when REB members are geographically dispersed or in unexpected circumstances (e.g., emergencies), input from member(s) is allowed by other means, such as the use of technology.
Research Ethics Board Meetings and Attendance
Members of the REB must disclose any real or apparent conflict of interest regarding a proposal under review. They may explain the conflict of interest and offer evidence to the REB and the proposer of the research who has the right to hear the evidence and offer rebuttal. The REB member may not be present for the discussion where there is a perception they have a vested interest, and they may not participate in the decision process.