Research Involving Human Subjects

1. Purpose and Application

   The purpose of this practice is to ensure that the rights of human subjects participating in research are respected, and to ensure that such research is conducted ethically.

   This practice applies to all research involving human subjects conducted by faculty, staff, and students of Niagara College, regardless of where the research is conducted. For multi-centred research, all centers should be involved in the ethical review process. International projects with a research component involving human subjects must undergo the same review process. The researcher shall be required to acquire permits or review are required by an REB in another jurisdiction in addition to the Niagara College review.

   This practice also applies to research conducted on Niagara College premises by researchers who are not members of the Niagara College community.

   Research in this context is defined as systematic investigation to establish facts, principles or generalizable knowledge.

2. Compliance with Tri-Council Policy Statement

   All research conducted by Niagara College that involves human subjects shall comply with the standards established by the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council, and the Social Sciences and Humanities Research Council, known as the Tri-Council, and stipulated in its policy statement on the Ethical Conduct for Research Involving Humans. All research involving human subjects will be subject to review by the Research Ethics Board (REB). (The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans should be consulted for guidance. It may be found at http://www.pre.ethics.gc.ca/english/policystatement/ policystatement.cfm)

3. Scope of Research Requiring Review

   All research involving living human subjects requires the review and approval of the Research Ethics Board of Niagara College prior to the start of the research. In this context, research involving living human subjects refers to research where humans are participating in studies over which the College has the responsibility to regulate legal or ethical aspects, or where databases will be used containing specific information about the human subjects.

   Research involving human remains, cadavers, tissues, biological fluids, embryos, or fetuses must also be reviewed by the REB. However, such research is not permitted at the College at this time. In addition, the College may develop policies and procedures for the ethical review of research involving clinical trials at such time as both researchers and the College wish to conduct such research. Until that time, such research is not permitted at Niagara College.

   Research that does not normally require a review by the REB includes research involving public policy issues, the writing of modern history or literary or artistic criticism. REB reviews are not normally required for research about a living person involved in the public arena, or about an artist, if such research is exclusively based on publicly available information, documents, records, works, performances, archival materials, or third party interviews. However, if the subject is to be approached directly for interviews or for access to private papers, then REB review is required to ensure that such approaches are conducted following professional interview protocols.

   Quality assurance studies assessing the performance of the College, staff performance reviews, or testing that occurs within normal educational requirements should not be subject to REB reviews. However, if such studies are conducted in the context of a research framework, they may require review by the REB. If there is any question about the applicability of this practice to a particular research project, the advice of the REB, through its Chair, must be sought.

4. Guiding Principles

   The Tri-Council policy statement describes the principles that must guide research involving human subjects. These principles are:

   Respect for Human Dignity. This cardinal principle of research protects the multiple interests of the person from bodily to psychological to cultural integrity. This principle forms the basis of the ethical obligations in research involving human subjects.

   Respect for Free and Informed Consent. Individuals are generally presumed to have the capacity and the right to make free and informed decisions. This principle translates in practice into the dialogue, process, rights, duties and requirements for free and informed consent by the research participant.

   Respect for Vulnerable Persons. Vulnerable persons, including children and institutionalized persons, are entitled to special protection against exploitation, discrimination or abuse. Special procedures may be required to protect these persons.

   Respect for Privacy and Confidentiality. This standard protects the access, control and dissemination of personal information and materials. This principle is fundamental to the principle of respect for human dignity.

   Respect for Justice and Inclusiveness. Justice means fairness and equity. The ethics review process must have fair methods, standards and procedures. Justice also balances benefits and potential harms and protects vulnerable segments of the population.

   Balancing Harms and Benefits. The analysis and balance of harms and benefits are critical to the ethics of research involving human subjects. Foreseeable harms should not outweigh anticipated benefits. The balance must respect human dignity and impose strict ethical obligations on the validity, design, and conduct of research.

   Minimizing Harm. It is the duty of those conducting research involving human subjects to avoid, prevent, or minimize harm to others. Research participants must be fully aware of any potential for harm at any stage of the research.

   Maximizing Benefit. This principle imposes a duty to benefit the participants, and to maximize benefit to society as a whole.

5. Research Ethics Board (REB)

   1. The Research Ethics Board is mandated by the President of the College to accept, reject, propose modifications to, or terminate any proposed or ongoing research that is subject to REB review which is conducted within, or by members of, the College. The President will ensure that appropriate financial and administrative independence is provided to the REB to enable it to fulfill its mandate.

   2. A decision of the REB to disallow research on ethical grounds, unless reversed on reconsideration by the REB, may only be reversed through the appeal process.

   3. The REB shall consist of at least 5 members, including both men and women, of whom:

      1. at least two members have broad experience in the areas of research covered by the REB at the College
      2. at least one member is knowledgeable in ethics
      3. one is a lawyer, who is not the College legal counsel. For biomedical research, the member should be knowledgeable in the relevant law.
      4. one is a community member with no affiliation with the College

      Members normally serve for a two year term, and may be re-appointed. The term of appointments of REB members should be balanced to ensure both continuity and appropriate diversity of membership. The Chair is elected by the REB on a two year appointment.

   4. The REB will meet face-to-face every other month, unless there is a need to meet at an earlier date than the next scheduled meeting. A schedule of REB meetings should be made available to all College researchers.

   5. A quorum for the REB is 50% plus one of the membership present. Decisions requiring a full review should be adopted only if the members in attendance have sufficient background and expertise present to conduct the review(s) required.

   6. The REB will endeavour to reach consensus on decisions, and may wish to request external advice and/or representation in person from a researcher prior to decision-making. If a consensus cannot be reached, a decision will be made by majority vote, and the vote details will be made available to the researcher if requested.

   7. All records and documents of meetings, research applications, decisions and the reasons for them, as well as dissents and the reasons for them must be maintained in the REB committee files. The files are maintained in the office of Research and Innovation. Minutes are accessible to authorized personnel of the College, researchers, and funding agencies.

   The membership and terms of reference for the REB are contained in the Niagara College practice on Research Ethics Boards.

6. Procedure for the Ethical Review of Research Involving Human Subjects

   1. If a research activity is proposed that will involve human subjects, the REB must satisfy itself that the design of the research project involves a minimal risk, or that if it poses more than a minimal risk that the research plan is capable of addressing the questions being asked in the research. For any activity involving human subjects that falls within the scope of this practice, an “Application for Research Involving Human Subjects” form must be completed and signed by the Principal Researcher and submitted to the Office of Research and Innovation. Research carried out by undergraduate students that falls within the scope of this practice is also required to follow the procedure outlined in 6.1. The Director, Research and Innovation will request the Chair of the Research Ethics Board (REB) to review the proposed research plan and determine the nature of the ethical review by the REB according to a “proportional approach” that is based on the principle that the more invasive the research, the greater should be the care in assessing that research.

      Based on a proportional approach, the ethical review at Niagara College shall be either an “Expedited Review” or a “Full Review”. No research is permitted to begin until the review process has been completed. Ongoing research is also subject to an ethics review based on the proportional approach to assessment.

      Expedited Review. If the Chair of the REB determines that the proposed research will involve a minimal risk to the research subjects, and if the applicant has not indicated a preference for a full review, a sub-committee of the REB consisting of the Chair and one other member will determine whether the proposed research is a) acceptable as submitted, or b) acceptable with minor modifications, in which case it shall be returned to the applicant with a request for modification. The sub-committee may also determine that the proposed research must undergo a full ethical review. The applicant will be notified in writing of the decision of the review normally within 10 to 14 working days of the submission of the application. Approvals of expedited research proposals will be reported to the REB at its next scheduled meeting. An application cannot be rejected without a consideration by the full REB. “Minimal risk” is defined as the probable level of risk that potential subjects can reasonably expect to be no greater than those aspects of everyday life, encountered by the subject, that relate to the research.

      Full Review. If the Chair determines that an expedited review is not appropriate, or if the applicant elects a full review, the application will be copied and distributed to the members of the REB for consideration at its next scheduled meeting. A full REB review must take place in a face-to-face meeting of the REB. The applicant may be present to discuss the proposed research and answer questions the REB may have about the research, but may not be present when the REB is making its decision.

      Scholarly Review. The REB should satisfy itself that the design of the research project that poses more than a minimal risk is capable of addressing the questions being asked in the research.

      Research in the humanities and social sciences which poses minimal risk to participants will not normally be required by the REB to be peer-reviewed. However, the REB may require such a review.

      The REB will determine the method of scholarly review of the proposed research. It may accept a peer review from a funding agency; it may establish an ad hoc independent external peer review; it may establish a permanent peer review committee that reports directly to the REB; or it may assume the responsibility of the peer review of the research questions and methodologies itself if it has the necessary scholarly expertise in the research discipline area.

   2. The REB may determine that the proposed research is a) acceptable as submitted, in which case approval will be granted and the Chair of the REB will sign the application form; b) acceptable with modifications, in which case the application will be returned to the applicant with a request for modification, or c) unacceptable, in which case the applicant will be advised in writing with reasons for the rejection, and in which case the applicant will have the right to reconsideration of the application.

   3. On-going research is subject to an ethics review at the level consistent with the level of risk in the research. As part of the research proposal submitted for review by the REB, the researcher(s) will proposed a process for on-going review of the research. At minimum, the researchers must submit a brief report annually and at the conclusion of their research. Where there is more than minimal risk, the Chair of the REB and one other member (i.e. the expedited review sub-committee) may require a more stringent review process.

      Researchers must report to the REB any significant change or modification in research design or procedures. The Expedited Review Committee will assess the modification and may require a full review. The REB must be notified immediately of any adverse event that occurs during the research.

   4. Any request by the REB for modification of proposed research shall include an explanation of the reason for the modification request. The REB should consult with the researcher to assist him or her in planning research that meets ethical requirements. Once the research plan has been modified to comply with the REB requests, and reviewed by the Chair of the REB and one other member, the Chair will issue approval and notify the members of the REB. If the modifications do not meet REB requests, the applicant will be invited to the next REB meeting for assistance in amending the application.
   5. Upon approval of the REB, the principal investigator must ensure that all participants are informed of the nature of the research and their participation, understand the risks and benefits of the research, and provide their consent to participate in writing by signing the “Informed Consent Form for Research Participants”. Where written consent is culturally unacceptable or where there are good reasons for not recording consent in writing, the procedures used to seek free and informed consent must be clearly documented and reviewed by the REB Chair prior to the start of the research. Original consent forms must be kept by the department responsible for the research.
   6. Reports on the research program must be submitted annually at a minimum to the department responsible, with a copy to the office of Research and Innovation. Funded programs of research must follow the reporting requirements of the funding agency.
   7. If the research is being conducted at more than one centre or site, there may be more than one REB involved. All REBs with jurisdiction over the research project must approve the planned research. The researcher should distinguish between core elements of the research (those that cannot be altered without invalidating the combined data from the participating institutions or centres) and those elements that may be altered to comply with local requirements without invalidating the research project. The participating REBs may choose to coordinate their review of multi-centred projects through an agreed on coordination method.
7. Reconsideration of REB Decisions

   An applicant has the right to have a negative REB decision reconsidered by the REB. The reconsideration is guided by the principles of natural and procedural justice including a reasonable opportunity to be heard, an explanation of the reasons for opinions and decisions and the opportunity for rebuttal, fair and impartial judgement, and consideration in a timely manner. The applicant will be invited to be present to discuss the application with the REB prior to decision making. The decision of the REB will be made in writing to the applicant, with reasons for the decision, and will be issued in a timely manner. If the decision of the REB, on reconsideration, remains negative, the applicant may appeal the decision to the Research Ethics Appeal Board.

8. Appeal of REB Decisions

   If the applicant wishes to appeal a negative decision of the REB following a reconsideration, he or she must do so within 30 days of receipt of the written decision of the REB. The appeal must be made in writing to the Chair of the Research Ethics Appeal Board (REAB), and include all supporting documents. The applicant has the right to appear before the REAB, although he or she may not be present for the decision-making by the Board.

   The Research Ethics Appeal Board may sustain, modify or reverse a decision of the REB. The decision of the Research Ethics Appeal Board is final, and will be communicated in writing promptly to the applicant.

   The membership of the Research Ethics Appeal Board shall be similar to that of the Research Ethics Board, and should operate under the same reporting and administrative practices as the REB. Current members of the REB shall not be eligible for membership on the REAB.

   Note: The terms of reference of the Appeal Board are contained in the Niagara College practice on Research Ethics Boards.

9. Conflict of Interest

   Researchers hold a relationship of trust with research participants, sponsors, professional bodies and society. Trust relationships must not be put at risk by a conflict of interest. Researchers, REB members, and REAB members must disclose any actual, perceived, or potential conflict of interest to the REB. If the REB or REAB is reviewing research in which a member has a personal interest, conflict of interest principles require that he or she not be present during the discussion or decision regarding the research.

10. Free & Informed Consent

    1. Research that is governed by this practice may begin only if prospective participants, or authorized third parties, have been provided with the opportunity to give free and informed consent about participation, and their free and informed consent has been given and maintained throughout their participation in the research.

       Participants must have freely agreed to serve in the research study on the basis of well-understood information about the objectives of the research and the nature of their participation. Participants must be fully informed of any and all risks associated with the research, as well as possible benefits of their participation. They must have the opportunity to evaluate the relative weight of any risks and benefits.

    2. Fee and informed consent must be voluntarily given, without manipulation, undue influence, or coercion. There shall not be incentives offered that are so large as to become an undue influence and undermine the voluntary nature of their participation. Researchers must take care to avoid problems of informed consent based on a special relationship between researcher and participant, so that such relationship does not unduly influence the participant’s free and informed consent.

    3. Participants may withdraw their consent at any time during the research program, and such withdrawal shall not result in penalty or harm or loss of promised benefits that are not inherently dependent on completion of their participation.

    4. Free and informed consent should normally be provided in writing, following section 6.5 of this practice document. If written consent is not culturally acceptable, or where there are good reasons for not recording consent in writing, the procedures used to seek free and informed consent must be documented for review by the REB.

    5. The REB may approve a consent procedure that does not include, or alters some or all of the elements of informed consent as noted above, or waives the informed consent, provided that the REB documents that:

       1. the research involves no more than minimal risk to the participants;
       2. the waiver or alteration is unlikely to adversely affect the rights and welfare of the subjects;
       3. the research could not practicably be carried out without the waiver or alteration;
       4. whenever possible and appropriate, the subjects will be provided with additional pertinent information after participation; and
       5. the waiver or altered consent does not involve a therapeutic intervention.

       In studies that include randomized consent or blinding in clinical trials, neither the research subjects nor those responsible for their care know which treatment the subjects are receiving before the project begins. Such research is not regarded as a waiver or alteration of the requirements for consent if the subjects are informed of the probability of being randomly assigned to one part of the study or another.

    6. Where any research participants express significant concern about the nature of the informed consent or the use of the research, the researcher should report the concerns to the REB.

    7. REB review is normally required for research involving naturalistic observation, except for observation of participants in public meetings, demonstrations, political rallies or like activities where participants are expected to be seeking or are aware of public visibility. Naturalistic observation is used to study behaviour in a natural environment. If the naturalistic observation does not allow for the identification of the subjects, and is not staged, then the research will normally be considered as of minimal risk. However, naturalistic observation still raises the concerns of privacy and the dignity of those being observed. Accordingly, REB review is required, and free and informed consent should be obtained from the participants following this practice.

11. Procedures for Free & Informed Consent

    1. Researchers shall provide to prospective participants, or to authorized third parties, full and frank disclosure of all information relevant to their free and informed consent. Throughout this process, the researcher must ensure that prospective participants are given adequate opportunities to discuss and contemplate their participation.

    2. Researchers shall provide at a minimum the following information:

       1. information that the person is being invited to participate in a research project;
       2. a comprehensible statement of the research purpose, the identity of the researcher and College, the expected duration and nature of participation, and a description of the research procedures;
       3. a comprehensible description of reasonably foreseeable risks and benefits that may arise from participation in the research, as well as any consequences of non-action, particularly related to research involving treatment, or where invasive methods are involved, or where there is a potential for physical or psychological harm;
       4. assurance that the prospective participants are free not to participate, and are able to withdraw at any time without prejudice;
       5. assurance that the participants have ongoing opportunities to decide whether or not to continue to participate during the course of the research;
       6. the potential of commercialization of research findings, and the presence of any apparent, actual, or potential conflict of interest on the part of the researchers, sponsors, or institutions.
       7. The name, and contact information for a person who may be contacted for information on the nature of the research, or in the case of concerns, complaints, or consequences.

       Additional information may be required, depending on the nature of the research project, including:

       1. assurance that new information will be provided to the participants in a timely manner whenever such information is relevant to the participant’s decision to continue or withdraw from the research;
       2. information on the resources available outside the research team to contact regarding possible ethical issues in the research;
       3. an indication as to who will have access to the information collected on the identity of participants, descriptions of how confidentiality will be protected, and the anticipated uses of the data;
       4. an explanation of the responsibilities of the participant;
       5. information on the circumstances under which the researcher may terminate the individual’s participation in the research;
       6. information on any costs, payments, reimbursement for expenses, or compensation for injury;
       7. in the case of randomized trials, the probability of participant assignment to each of the options;
       8. the ways in which research results will be published, and how the participants will be informed of the results of the research.

    3. Written consent must normally be obtained and properly filed, following 6.5 of this practice.

    4. The competence of the potential participants to provide free and informed consent is an important factor in the validity of the consent. Competence refers to the ability to understand the information presented about the research, to appreciate the potential consequences of a decision, and to provide free and informed consent to participate in a specific research project. Competence is not an all or nothing condition. The prospective participants do not need to have the capacity to make every kind of decision, only the informed decision about participation in the specific research.

       Researchers must ensure that they comply with all applicable federal and provincial legislative requirements and the legislative requirements of the jurisdiction in which participation takes place.

       Individuals who are not legally competent to participate in the proposed research shall only be asked to become research subjects when:

       1. the research question can only be addressed using the identified group(s); and
       2. free and informed consent is sought from their authorized representatives, such as parents or legal guardians; and
       3. the research does not expose them to more than minimal risk without the potential for direct benefits to them.

    5. For research involving individuals who are not competent, the REB shall ensure that, as a minimum, the following conditions are met:

       1. the researcher shall show how the free and informed consent will be sought from the authorized third party, and how the participant’s best interests will be protected;
       2. the authorized third party is not the researcher or any other member of the research team;
       3. the continued free and informed consent of the authorized third party is required in order for the continuation of the participation of the legally incompetent person in the research project, as long as the person remains incompetent;
       4. if the incompetent participant becomes competent during the research project, his or her informed consent will be sought as a condition of continuing participation.

       If the free and informed consent has been obtained from an authorized third party, and the legally incompetent participant understands the nature and consequences of the research, the researcher must seek to determine the wishes of the participant. Should the potential participant not agree, the research must terminate for that participant.

12. Research in Emergency Health Situations

    Subject to all applicable legislative and regulatory requirements, research involving emergency health situations shall be conducted only if it addresses the emergency needs of individuals involved, and then only in accordance with criteria established in advanced of such research by the REB. The REB may allow research that involves health emergencies to be carried out without the free and informed consent of the participant or of his or her authorized third party if ALL of the following apply:

    1. a serious threat to the prospective subject requires immediate intervention; and
    2. no standard efficacious care exists or the research offers a real possibility of direct benefit to the subject in comparison to the standard of care; and
    3. either the risk of harm is not greater than that involved in standard efficacious care, or it is clearly justified by the direct benefits to the subject; and
    4. the prospective subject is unconscious or lacks capacity to understand risks, methods and purposes of the research; and
    5. third party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so; and
    6. no relevant prior directive by the subject is known to exist.

    If a previously incapacitated subject regains capacity, or when an authorized third party is found, the free and informed consent of the subject or authorized third party shall be sought promptly for the subject’s continuation in the project and for subsequent examinations or tests related to the study to be conducted.

13. Privacy & Confidentiality
    1. Researchers shall comply with all applicable privacy legislation of the jurisdiction in which the research takes place. Wherever possible, participants must be guaranteed privacy and anonymity, and their responses must be treated with confidentiality. If anonymity and confidentiality cannot be assured or guaranteed, potential participants must be made aware of the limitations and possible consequences before they are asked for their consent to participate.

    2. Researchers who plan to interview a participant to secure identifiable personal information must obtain REB approval for the consent and the interview procedures used, and shall ensure the free and informed consent of the participant as required within this practice. An interview may be face-to-face, by telephone, electronic media, or through individualized questionnaires. REB approval is not required for access to publicly available information or materials, including archival documents and records of public interviews or performances. REB considerations shall include such elements as:

       1. type of data to be collected
       2. purpose for which the data shall be used
       3. limits on the use, disclosure, and retention of data
       4. appropriate safeguards for security and confidentiality
       5. modes of observation or access to information that allows for identification of particular participants
       6. anticipated secondary uses of identifiable data from the research
       7. anticipated linkage of data gathered in the research with other data about participants
       8. provisions for confidentiality of data resulting from the research.
    3. The primary researcher has the exclusive right to use the data collected in any study for the approved period of time that is required for the completion of the approved research. Following this period, the researcher is encouraged to make such data available to other researchers. Secondary use of the data will not normally include access to any personal identifiers. REB approval is required for any secondary use of the data.