Ethical Conduct for Research Involving Humans Policy

Effective Date: July 5, 2012
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Purpose/Rationale:

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. 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, and which the Research Ethics Board (REB) can use to judge the ethical merit of a given research study involving humans.

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: Ethical Conduct for Research Involving Human Subjects, 2nd edition (TCPS 2).

Humber supports research that consistently meets the highest ethical standards. Research can require 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. The purpose of this policy and the accompanying procedure document is to articulate the principles and framework underlying the establishment of the REB as well as the methodology for reviewing the ethical acceptability of research proposals. Together, the two documents ensure the preservation of human dignity and respect when humans are involved in research activities. Research conducted under the auspices of the college will be in accordance with the policy and procedures developed to ensure proper ethical review and accountability.

Scope:

All individuals associated with Humber in any capacity and conducting research involving humans must comply with this policy and the accompanying procedural document. This includes individuals not associated with Humber who approach faculty, staff or students or seek approval or endorsement from the college, or use college facilities for research involving humans, including at multiple sites that include Humber.

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, and incorporate these principles into the research design and implementation of the project.

REB approval is not required for access to publically available information or materials, including archival documents and records of public interviews or performances.

Definitions:

Conflict of interest: A conflict of interest can arise when activities or situations place a person or the college in a real, potential or perceived conflict between their duties or responsibilities related to research and their personal, institutional or other interests. Conflict of interests may occur 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.

Human participants: Individuals whose data or responses to interventions, stimuli or questions by the research are relevant to answering the research question. Under a broad definition, the 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.

Research: An undertaking designed to extend knowledge through a disciplined inquiry or systematic investigation. It is the advancement of knowledge through scholarly, scientific and creative activity. 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) oversees ethical screening and conducts a full review of research projects involving human participants. One REB will be established to evaluate all research and ensure the research is conducted in a manner that is consistent with this policy. (See Procedure, 1.).

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 REB cannot reach agreement through discussion and reconsideration.

Policy:

1. Principles of Research

 1.1 Respect for human dignity is an underlying value of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS), 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 2nd Edition of the TCPS through three core principles: Respect for Persons; Concern for Welfare; and Justice. These principles transcend disciplinary boundaries. [1]

 1.2 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 protecting from harm.

 1.3 To maximize the benefits of research, researchers will have the freedom of inquiry and the right to disseminate the results of that inquiry, freedom to challenge conventional thought and freedom from institutional censorship.

 2. Research Review and Approval

 2.1 Humber will establish and maintain one Research Ethics Board (REB) to provide ethical review and approval of research involving humans, prior to the start of the research. (See procedure, 1.)

2.2 The REB ensures that ethical procedures are implemented and regularly reviewed in the college. The REB may select advisors to address the particular ethical review that may arise with certain types of research.

2.3 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 II).

2.4 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.

2.5 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.

2.6 The REB shall function impartially, provide a fair hearing to those involved, and provide reasoned and appropriately documented opinions and decisions of its review of the research. (See Procedure, 1.2. 1.3)

2.7 The REB shall use a proportionate approach to ethics assessment based on the general principle that the more invasive the procedure in the research, 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 an Expedited Review. (See Procedure, 1.2. or 1.3).
 

3. Exemptions from Ethical Review

Research exempt or not normally requiring a review by the REB, includes research involving:

  • 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 which 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 and could include:
  • Conducting interviews, administering standard tests or collecting information to provide advice, diagnosis or as the basis for intervention for a client;
  • 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).

Where there is uncertainty about whether or not the research requires a review, the principal investigator will contact the Chair of the REB as to the need for an ethics review and approval.

 4. Research Ethics Appeals Board (REAB)

Humber will establish and maintain one REAB to provide an appeal mechanism in cases where the principal investigator and REB cannot reach agreement through discussion and reconsideration. (See Procedure, 1.2.9)

 5.  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.

 


[1] Ethics Framework. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd edition can be accessed at: http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf

 

Appendices:

 Appendix A

Authority of the Research Ethics Board (REB)

Purpose

The REB is accountable to the President of Humber and is vested with the authority to review and 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 through notices of change to research protocol, annual renewal of research projects and notices of research completion. It will suspend or terminate ongoing research that does not comply with this policy and with the TCPS.

Responsibilities

The Humber Research Ethics Board is responsible for the following:

  • Ensuring that all research proposals involving human participants meet the highest standards of scientific rigor 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, p. 3);
  • Rendering reasoned decisions, maintaining records of the process and documenting the opinions expressed (See procedure, p. 7);
  • 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, p. 7);
  • 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 chair will monitor the REB’s decisions for consistency.

Independence

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 Humber’s Research Department. The REB must have independence to conduct ethics reviews, free of inappropriate influence, including situations of real, potential or perceived conflict of interests.

Composition

The membership requirements 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 shall consist of at least five members of whom:

  • At least two have broad expertise in the methods or areas of scientific methodology and research;
  • At least one is knowledgeable in ethics to assist with ethical issues and options;
  • At least one is from the community and has no affiliation to Humber. This will broaden the perspective and value base of the board; and
  • At least one knowledgeable in relevant law so he or she can alert the board to possible legal issues and their implications. He or she must not be the college’s legal counsel.

In addition to the above, the REB will have adequate gender 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, based on the guidelines in the Tri-council Policy Statement. Where possible, former research participants will be appointed to the REB to provide an experiential perspective.

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. Attendance at REB meetings is directly attributable to the success of the review procedure; therefore, failure to attend two-thirds of the REB meetings will result in loss of membership.

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 faculty and administration
  • Commitment to ethics and willingness to expand knowledge;
  • Regular attendance at meetings and able to contribute to sound decisions;
  • Adherence to ethical practice in research;
  • Desire to foster ethical research practice within the college; and
  • Adherence to college policies and procedures.

Terms

Members of the REB will be nominated by the 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.

New members will receive orientation and training on ethics review including: principles; policies; legal and regulatory requirements to understand their role and responsibility on the REB. The REB will determine areas for improvement and schedule periodic educational opportunities as required.

The Chair of the REB shall be appointed by the VP Academic for two years, renewable.

 Meetings

Meetings will be held at least three times per year and as required to review research applications. REBs shall normally meet face-to-face 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.

A quorum for a full review shall consist of at least 60% of members .

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 a rebuttal. The REB member may not be present for the discussion where there is the perception she/he has a vested interest and she/he may not participate in the decision process.