Ethics of Research Involving Human Participants

Principle:

Memorial University of Newfoundland is committed to the promotion and support of excellence in research and scholarship. The conduct of research must be guided by ethical principles which will protect the rights and welfare of participants.

Purpose:

To ensure that those conducting research at Memorial University achieve a proper balance between respect for the dignity and welfare of the participants on the one hand, and the need for advancement of knowledge on the other.

Scope:

All research activities involving human participants undertaken by Memorial University faculty, staff and students regardless of the source of financial support and irrespective of the location of the research. Research carried out by external researchers or investigators who access resources or participants at the University is also covered by this policy

Definitions:

CIHR - the Canadian Institutes of Health Research

DRC - Departmental Review Committee

HIC - the Human Investigations Committee

ICEHR - the Interdisciplinary Committee on Ethics in Human Research

NSERC - the Natural Sciences and Engineering Research Council of Canada.

Participant- any person who is used as a source of data in the conduct of research.

Research - a systematic investigation or process to establish facts, principles, or generalizable knowledge.

Researcher or Investigator - any individual who is involved in the intellectual direction, control and/or conduct of the research activity. This individual may be a faculty member (including sessional appointments), visiting scholar, adjunct, emeritus, honorary research professor, or executive in residence. The individual could also be a student in an undergraduate, graduate or postgraduate program, staff member, or a community or industrial partner.

REB - research ethics board.

SSHRC - the Social Sciences and Humanities Research Council of Canada

SWGCREB - the Sir Wilfred Grenfell College Research Ethics Board.

TCPS - the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans

Policy:

1.0 RESEARCH INVOLVING HUMAN PARTICIPANTS

The University requires that research involving human participants is designed and carried out in an ethical and responsible manner. This policy requires those conducting research to achieve a proper balance between respect for the dignity and welfare of the participants on the one hand, and the need for advancement of knowledge on the other.

2.0 ADOPTION AND INCORPORATION OF ETHICAL PRINCIPLES AND ARTICLES OF THE TRI-COUNCIL POLICY STATEMENT

CIHR, NSERC and SSHRC have jointly adopted the TCPS.

The University endorses this Policy Statement and has mandated REBs to ensure that all research investigations involving human participants are in compliance with the Tri-Council Policy Statement. No research may proceed until ethics approval has been granted by the appropriate REB.

The University's Policy on Ethics of Research Involving Human Participants is deemed to be consistent with the policy and practices outlined in the TCPS and either meets or exceeds the required standards. It is recognized that the TCPS will be amended from time to time. Upon notification of such amendments, the University's policy will be reviewed to ensure continuing compliance with the TCPS.

3. GUIDING ETHICAL PRINCIPLES

3.1 Respect for Human Dignity
The cardinal principle of modern research ethics is respect for human dignity. Such respect requires that researchers protect the multiple and interdependent interests of the person - from bodily to psychological to cultural integrity - as they may be affected by the research. This principle forms the basis of the remaining ethical principles described in the following subsections.

Conflicts may sometimes arise from the application of these principles in isolation from one another. Researchers and Research Ethics Boards (REBs) must carefully weigh all the principles and circumstances involved to reach a reasoned and defensible conclusion.

3.2 Respect for Free and Informed Consent
Individuals are generally presumed to have the capacity and right to make free and informed decisions. Respect for persons thus means respecting the exercise of individual consent. In practical terms within the ethics review process, the principle of respect for persons translates into the dialogue, process, rights, duties and requirements for free and informed consent by the research participant.

3.3 Respect for Vulnerable Persons
Respect for human dignity entails high ethical obligations towards vulnerable persons - to those whose temporary or permanent lack of competence and/or decision-making capacity make them vulnerable. Children, institutionalized persons or others who are vulnerable are entitled, on grounds of human dignity, caring, solidarity and fairness, to special protection against abuse, exploitation or discrimination. Ethical obligations to vulnerable persons involved in research will require special procedures to protect their interests.

3.4 Respect for Privacy and Confidentiality
Respect for human dignity also implies the principles of respect for privacy and confidentiality. Standards of privacy and confidentiality are required to protect the access, control and dissemination of personal information. In doing so, such standards help to protect mental or psychological integrity. They are thus consonant with values underlying privacy, confidentiality and anonymity.

3.5 Respect for Justice and Inclusiveness
Justice connotes fairness and equity. Procedural justice requires that the ethics review process have fair methods, standards and procedures for reviewing research proposals, and that the process be effectively independent. Justice also concerns the distribution of benefits and burdens of research. On the one hand, distributive justice means that no segment of the population should be unfairly burdened with the harms of research. It thus imposes particular obligations toward individuals who are vulnerable and unable to protect their own interests in order to ensure that they are not exploited for the advancement of knowledge. On the other hand, distributive justice also imposes duties neither to neglect nor discriminate against individuals and groups who may benefit from advances in research.

3.6 Balancing Harms and Benefits
The analysis, balance and distribution of harms and benefits are critical to the ethics of human research. Modern research ethics, for instance, requires a favourable harms-benefits balance. Foreseeable harms should not outweigh anticipated benefits. Harms-benefits analysis thus affects the welfare and rights of research participants, the informed assumption of harms and benefits, and the ethical justification for competing research paths.

This is not to say that harm may not result from research. In some areas of research such as political science, economics or modern history, there may be occasions in which research ethically results in harm to the reputations of organizations or individuals in public life.

There is often uncertainty about the magnitude and kind of benefits or harms that may result from proposed research and a resultant uncertainty about the balance of benefits and harms. This uncertainty imposes an obligation to conduct research at a high level of competency in order to maximize the potential benefits of the research.

3.7 Minimizing Harm
A principle related to achieving a favorable harms-benefits balance is that of non-maleficence, or the duty to avoid, prevent or minimize harm. Research procedures which might cause serious or lasting harm to a participant must not be used unless their absence would expose the participant to a risk of even greater harm. Research participants must not be subjected to unnecessary risks of harm. Their participation must be essential to achieving scientifically and societally important aims that cannot otherwise be realized. Minimization of harm also requires that research involving the smallest number of human participants and the smallest number of tests, procedures or interventions shall ensure scientifically valid data. Should adverse effects result from research procedures, the researcher has an obligation to assist the participant in reducing or eliminating those effects.

3.8 Maximizing Benefits
Another principle related to the harms and benefits of research is beneficence. The principle of beneficence imposes a duty to benefit others and, in research ethics, a duty to maximize benefits. Benefits of research may accrue to the research participants themselves, to other individuals or to society as a whole, or to the advancement of knowledge. In most research, the primary benefits are for society and for the advancement of knowledge.

4.0 RESEARCH REQUIRING ETHICS REVIEW

4.1 Research Requiring Ethics Review
The following kinds of research require review and approval by a REB before the research begins:

• Research involving living human subjects.
• Research involving human remains, cadavers, tissues, biological fluids, embryos or foetuses.
• Research about a living individual in the public arena if the subject is to be interviewed and/or private papers accessed.
• Research involving secondary use of data (use of data not collected for that research purpose) - health records, employee records, student records, computer listings, banked tissue - if any form of identifier is involved and/or if private information pertaining to individuals is involved.
• Quality assurance studies, performance reviews or testing within normal educational requirements are not subject to REB review. However, when such studies, reviews, or evaluations address a research question or if these are to be presented or published outside of the boundaries of the program which is the focus of the study, review, or evaluation, then REB review is required.

4.2 Research not Requiring Ethics Review
The following kinds of studies do not require ethics review. However, if the investigator is in doubt, the relevant REB office should be contacted.

• Research about an individual(s) in the public arena using only publicly available or accessible records without contact with the individual(s).
• Research involving naturalistic observation in public venues.
• Research resulting in a case study of one patient with the expectation that written informed consent has been obtained from the relevant patient.
• Quality assurance studies, program evaluations, performance reviews, testing within normal educational requirements if there is no research question involved and if there is no intention to present or publish the results of the studies to persons outside the relevant program.
• Research based on review of the published/publicly report literature.
• Research involving secondary use of data which is provided without any identifier or group of identifiers which would allow attribution of private information to an individual.
• Consulting unless carried out under the auspices of the University.

5.0 AUTHORITY AND MEMBERSHIP OF RESEARCH ETHICS BOARDS (REBs)

5.1 Authority
The University endorses the ethical principles espoused in the TCPS and has mandated REBs to ensure that all research investigations involving human participants are in compliance with the statement. The terms of reference for REBs outlines in more detail the composition and operating procedures of the committees. No research involving human participants may proceed until ethics approval has been granted by the appropriate REB.

Three REBs are constituted at the University:

• The Human Investigations Committee (HIC) normally receives proposals for medical and bio-medical research, and related health research, originating at the St. John's campus, usually from researchers in the Faculty of Medicine; the Schools of Nursing and Pharmacy; the Health Care Corporation of St. John's; and the staff of the Newfoundland Cancer Treatment and Research Foundation.
• The Interdisciplinary Committee on Ethics in Human Research (ICEHR) normally receives proposals for research in the social sciences, humanities, sciences, and engineering, (including some health-related research in these areas) originating at the St. John's campus, usually from researchers in the Faculties of Arts, Business Administration, Education, Engineering and Applied Science, Science; the Schools of Continuing Education, Graduate Studies, Human Kinetics and Recreation, Music, Social Work; Institutes and Special Divisions (excluding the Health Research Unit and the Centre for Applied Health Research); and the University Library and Counselling Centre.
• The Sir Wilfred Grenfell College Research Ethics Board (SWGCREB) normally receives proposals in all fields originating at the Sir Wilfred Grenfell College campus.

In ICEHR and SWGCREB constituencies, departmental-level ethics committees review course-based research that requires students to collect information from human participants.

Generally researchers submit their proposals for ethics review to the appropriate REB according to the criteria listed above or as required to ensure review by a REB with the appropriate expertise. Persons conducting clinical trials, health intervention studies of greater than minimal risk (human kinetics) or health research in particularly vulnerable populations (abuse victims) normally submit to the HIC. REBs have the authority to transfer research proposals to another REB to ensure review by a REB with the appropriate expertise. In addition, research sometimes spans the criteria of more than one REB. In such cases, the appropriate REB is determined by agreement between the Chairs of the relevant REBs. The Chairs may decide that the research must be reviewed by both REBs.

REBs report to the Office of the President.

5.2 Mandate
University REBs are mandated to approve, reject, propose modifications to, or terminate any proposed or ongoing research which is subject to REB review. A decision of a REB to allow or disallow research on ethical grounds can be appealed only on the basis of an error in process. The appeal process is described in the PROCEDURE TO APPEAL A RESEARCH ETHICS BOARD DECISION.

Each REB shall suspend any ongoing research under its purview that it deems to pose an unacceptable risk of harm to participants. Chairs of REBs are authorized to act on behalf of their members in exigent circumstances.

Each REB is responsible for developing procedures for implementing the University's ethics policy that meet particular needs of the disciplines it reviews. Such procedures may be more stringent (but not less stringent) than those described in the University's Policy on Ethics of Research Involving Human Participants. All such procedures must be formalized in writing and made available to researchers, sponsors and funding agencies, and participants.

Research that has not been submitted to and approved by the appropriate REB cannot be undertaken. Non-compliance with this provision may constitute misconduct as defined by the current Collective Agreement between the University and Memorial University of Newfoundland Faculty Association (Article 19.32(f)).

5.3 Administrative Support
Memorial must provide adequate resources and an annual budget to support the administrative processes and educational activities required by the REBs so that the University as a whole remains in compliance with the TCPS.

The considerable time commitment of those faculty members who serve on Memorial's three REBs will be appropriately noted by the heads of their academic units. In the case of REB Chairs, the need for teaching release, stipendiary or research support will be taken into consideration in consultation with the appropriate academic unit heads at the time of appointment to the position of Chair.
Adequate administrative support must be provided by the University for the three REBs.

6.0 REB ASSESSMENT, DECISION-MAKING AND PROCEDURES

6.1 Proportionate Approach to Ethics Assessment
REBs employ a proportionate approach to ethics assessment as recommended in the TCPS. The principle of proportionate review as outlined in the TCPS dictates that the degree of scrutiny that an application for ethics approval receives is determined in relation to the degree of risk to which study participants may be exposed.

6.2 Research undertaken by faculty members

Ethics review by REBs entails a full review by the committee, with the exception of reviews of those studies which are judged to pose no more than minimal risk. Studies deemed to be of no more than minimal risk to participants may qualify for an expedited review process. The determination of whether a review is conducted by the full committee or through an expedited process is determined by the committee's assessment of the level of risk for participants in the study.

Regardless of the level of the review, the ethical requirements for approval do not change; these requirements are applicable to all research involving human participants.

Expedited review, where the research under consideration is deemed to pose no more than minimal risk to participants, can be undertaken by a committee of the REB designated by the Chair. REBs are authorized to undertake expedited review based primarily on an assessment of the risks posed to participants by the research.

6.3 Research undertaken by students
The University has delegated to the ICEHR and to the SWGCREB constituencies the responsibility for ethical review of undergraduate and graduate student research undertaken as part of course work when it is minimal risk. Such research is to be reviewed by the committees internal to the academic units that report regularly to ICEHR and SWGCREB. Academic units must adopt procedures by which such research will be reviewed. Any student research as part of course work that is beyond minimal risk to participants must be forwarded to the appropriate REB for full review. All undergraduate, graduate and postgraduate research in the constituencies for which the HIC is responsible is submitted under the student's name for review. Any student project deemed to be of greater than minimal risk will be sent for review by the full committee. Course projects are submitted in the regular application process and presented by the course chair to a subcommittee of the HIC.

6.4 Ethics Proposals and Determination of Review Level Required
REBs establish and publicize a regular schedule of meetings and notify researchers in their constituencies about submission dates for proposals prior to the meetings. Frequency of meetings should reasonably reflect the needs of researchers in the disciplines served by the committee.

Ethics review by REBs is based upon fully detailed research proposals. Researchers must submit their proposals for ethics assessment to the committee in the format prescribed by the relevant REB. Either the REB Chair or such person(s) designated by the Chair assesses the level of review required. The Chair or designate(s) determines whether the proposal poses greater than minimal risk and therefore must receive full REB review at a meeting of the REB, or poses no more than minimal risk and therefore may receive expedited review.

In the case of research undertaken as part of course work in an ICEHR or SWGCREB constituency, the academic unit assesses the level of risk and either undertakes an expedited review internally or forwards the proposal to the appropriate REB for full review, as necessary (see APPENDIX).

6.5 Scholarly Review
REBs must satisfy themselves that the research design and methods of projects are capable of addressing the questions being asked in the research. REBs must base their judgement about scholarly value on a global assessment of the degree to which the research might further the understanding of a problem, issue or phenomenon; it must not be based on methodological biases (intentional or unintentional) or a preference for particular procedures or on the judgement that another approach is possible. REBs must recognize that theoretical or methodological preferences are often open to debate and take this into account to ensure fair judgement. REBs may seek external scholarly review.

REB members must keep in mind that definitive studies are rare; the significance of any individual study, even when viewed in retrospect, is not always immediately apparent and can be trivialized. Accordingly, the benefit of a particular research project should often be judged within the context of a research program, taking into account the expertise and experience of the researchers. 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 pilot studies is often indirect and may be better evaluated in the broader context of a research program.

Research in the humanities and social sciences which poses minimal risk is not normally required by REBs to be peer reviewed in order to determine capacity to address the questions being asked.

Certain types of research, often from social science and humanities disciplines, may legitimately have negative effects on public figures or on organizations. Such research should not be disallowed automatically because of a negative imbalance of benefits and harms. The safeguard for those in the public arena is through public debate and discourse and through action in the courts.

6.6 Decision-Making Standards and Review Procedures
The University's Policy on Ethics of Research Involving Human Participants, in conjunction with the TCPS, shall form the basis of decision-making by REBs. REBs shall refer, where appropriate, to other external policies and commentaries (e.g., the Canadian Code of Ethics for Psychologists of the Canadian Psychological Association; Ethical Principles for the Conduct of Research in the North of the Association of Canadian Universities for Northern Studies): the Declaration of Helsinki; the Belmont Report (U.S.); the Code of Federal Regulations (CFR) Title 45, Part 46 (U.S.); Good Clinical Practice; and Health Canada Amendments, Division 5.

Quorum for REB meetings is, at the minimum, one half of the total number of regular members. Where alternate members are appointed to a REB and these members are present at a meeting, they count in determining whether quorum is met.

REB meetings at which full reviews of proposals are conducted must be face-to-face.
REBs must develop procedures to ensure the impartiality and fairness of both their full and expedited review processes and to avoid conflicts of interest. Members must not be present during REB discussions of research with which they are associated, whether the proposal is from a student, faculty member, or external researcher. Similarly, members must not be involved in the expedited review of research with which they are associated. Members must also not participate in the review of any proposal where the researcher is someone with whom they have or have had a close personal or financial relationship.

Decisions of REBs are reached by consensus wherever possible. If the committee cannot achieve consensus, however, the decision is based on majority vote of those present.

For expedited reviews, the decision to approve must be made by consensus if two or more members conduct the review. Lack of consensus in such cases automatically results in referral of the proposal for full REB assessment unless the applicant chooses to withdraw the proposal.

When a REB identifies factors that may jeopardize the well-being of human participants, such issues should be resolved cooperatively by the committee and the researcher. When review indicates significant problems with the proposal and subsequent correspondence and discussion between the REB Chair and the researcher has not alleviated the concerns of the REB, the researcher may be invited to meet with one or more members of the REB or to attend a meeting of the Committee for discussion of issues.

When a REB decides to deny an application or makes approval contingent on changes to the proposal, it must provide the researcher with written grounds for the decision. When a REB decides to deny an application or makes approval contingent on changes to the proposal, researchers have a right to request, and REBs have an obligation to provide, reconsideration based on the researcher's rebuttal to the concerns identified by the REB. The researcher may be invited to meet with one or more members of the REB or to attend a meeting of the Committee for discussion of issues before a final decision is made.

6.7 Record Keeping
Minutes of all REB meetings shall be prepared and maintained by REBs. The minutes shall clearly document the REB's decisions and any dissents, and the reasons for them. In order to assist internal and external audits or research monitoring, and to facilitate reconsideration or appeals, the minutes shall be accessible to authorized representatives of the University and funding agencies. Researchers shall have access to the portions of the minutes in which their own proposal are considered.

REBs shall maintain a file for each research proposal they consider, either during face-to-face meetings or through expedited review. The file shall contain at minimum one copy of the application form, the review proposal, consent documents, along with any additional documentation relevant to the proposal and/or revisions submitted, and formal correspondence with the researcher.

REBs may establish additional requirements for record-keeping relevant to the constituencies they represent, to granting and regulatory agency requirements, and to legislative requirements. The minimum amount of time that REB records shall be kept is five years beyond the closure of the file. Sponsors may require that records be kept for a longer period.

6.8 Ongoing Research
Ongoing research shall be subject to continuing ethics review. The rigour of the review shall be in accordance with the proportionate approach to ethics assessment.

REBs are guided by Tri-Council Policy recommendations for continuing review procedures but may develop other means of continuing ethics review as needed. REBs determine the nature of the continuing review process, including the intervals at which the researcher must submit materials, if any, for review. Normally, continuing review consists of at least the submission of a succinct annual status report to the REB documenting any changes in the study. The REB must be notified promptly when the project concludes.

Researchers are required to report to the REB any changes in research design, procedures, instruments, sample characteristics, and so forth that are contemplated after ethics approval has been granted. The REB, through full or expedited review, depending on the nature of the proposed changes, must approve the changes before the modified research can proceed or continue.

Researchers are required to notify the REB immediately if an untoward or adverse event occurs during their research or if data analysis or other review reveals undesirable outcomes for participants.

7.0 APPEALS OF REB DECISIONS

A decision of a REB to allow or disallow research on ethical grounds can be appealed only on the basis of an error in process in accordance with the PROCEDURE TO APPEAL A RESEARCH ETHICS BOARD DECISION

In the case of appeals against a decision of the HIC, the Appeals Board is a standing committee appointed by the President of the University in consultation with the Dean of the Faculty of Medicine, the Directors of the Schools of Nursing and Pharmacy, the Chief Executive Officer of the Health Care Corporation of St. John's, and the Chief Executive Officer of the Newfoundland Cancer Treatment and Research Foundation. The membership of the Appeals Board excludes current members of the HIC. The Board includes three representatives appointed from the jurisdictions noted above, in addition to one member knowledgeable in ethics, one lawyer, and one lay person. Terms of appointment are the same as those for the HIC. Investigators wishing to lodge an appeal against a decision of the HIC must submit a letter to the Dean of Medicine, acting for the President of the University, who will convene the Appeals Board. Current members of the HIC are informed that an appeal has been made and of its final disposition, but they will have no involvement in the appeals process. A description of the appeals process is outlined in the documentation of the HIC which is available on its website at www.med.mun.ca/hic

In the case of appeals against a decision of either the ICEHR or the SWGCREB, these two REBs will serve as an Appeals Board for each other. Researchers wishing to lodge an appeal against a decision of either of these two REBs must submit a letter to the Vice-President (Research), acting for the President of the University, who will advise the two REBs that an appeal has been made. The appropriate REB will consider the appeal and the other Board will have no involvement in the appeal process except to be advised of its final disposition.

8.0 REVIEW OF OFF-CAMPUS RESEARCH
Research conducted by any of the persons to which this policy applies outside the campuses of the University is subject to review by a REB of the University and by the REB, where such exists, with legal and ethical responsibility for research in the country or jurisdiction where the research is to be done.

9.0 FREE AND INFORMED CONSENT

9.1 Normal Requirements
Research, except as otherwise permitted in the Exceptions section may begin only if prospective participants, or authorized third parties, have been provided the opportunity to give free and informed consent about participation before the research begins and periodically throughout the study.

Free and informed consent must be voluntarily given, without manipulation, undue influence or coercion. Participants have given free and informed consent when they have freely agreed to serve in the study on the basis of their understanding of the objectives of the research. They must be fully informed of all risks and possible benefits of their participation. The participants must have an opportunity to evaluate the relative weight of any risks and benefits of the proposed research. Continuing voluntary participation requires that participants be assured that at any time their withdrawal from the research shall not result in penalty or harm or loss of promised benefits.

Participants must understand their respective obligations and responsibilities in deciding whether or not to participate. The researcher must inform the participant of all aspects of the research that could reasonably be expected to influence the participant's willingness to participate, including aspects that involve financial gain.
Any incentive offered to participants must not be so large as to become an undue inducement that would undermine the voluntariness of their participation. Captive populations such as prisoners and those involuntarily committed to mental institutions must not be offered inducements that would unduly improve their situation or influence their relation to others. If the participants are students and are involved in research as part of their education, they must be given the opportunity to obtain equivalent experiences through alternative procedures. All monetary reimbursements and other incentives used to solicit participation must be clearly agreed to in writing. The investigator must honour all promises and commitments included in the agreement.

Special problems of consent and voluntariness arise when, in addition to being a research participant, there is a second relationship between research participant and a researcher. This may be of the nature of relationship between patient and physician, between student and teacher, between prison administrator and inmate, between employer and employee, and other like relationships. Researchers must evaluate these potential problems and take steps to eliminate them before the research can be undertaken. Consent must be obtained under conditions that do not involve explicit or implicit coercion which would limit the freedom and voluntariness of participation.

9.2 Documentation of Consent
Evidence of free and informed consent by the participant or authorized third party should ordinarily be obtained in writing. Where written consent is not possible for the participant or is culturally unacceptable, or where there are good reasons for not recording consent in writing, such as a telephone survey, researchers must document the procedures used to seek and obtain free and informed consent.

9.3 Exceptions
A REB may approve a consent procedure which does not include, or which alters some or all of the elements of the normal requirements for informed consent, or waive the requirement to obtain informed consent, provided that the REB documents that:

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

In studies including randomization and blinding, normally neither the research participants nor researchers may know to which condition participants have been assigned. Such methods are not regarded as a waiver or alteration of the requirements for consent if participants are informed of the probability of being randomly assigned to one condition of the study or another and the responsibility of the researcher to unblind if circumstances warrant.

If the methodological requirements of a study make concealment of the goals of the study or the risk involved necessary, the investigator and the REBs have a special responsibility to determine whether the use of these techniques is justified by the study's prospective scientific, educational, or applied value. The investigator must indicate why the objectives necessitate such concealment, and whether alternative procedures are available that do no use concealment. Studies involving concealment normally must not be conducted if there is greater than minimal risk involved because meaningful prior consent is not possible. Particularly in cases of concealment, it is necessary to advise participants that they can withdraw from the study at any time without penalty and without losing anonymity. In the case of behavioural and questionnaire research where full disclosure about the nature and objectives of the research could bias and invalidate results (for example, in communications intended to change attitudes or in studies in incidental learning), the explanation must be given immediately after data collection or as soon as is consistent with the research design and methods. Participants must be fully informed as soon as possible of the purposes and aims of the research, and any uncertainties must be removed. The investigator must remove any misconceptions that may have been fostered and must attempt to re-establish any trust in the research community which may have been lost, assuring the participant during post-briefing that the research procedures were neither arbitrary nor capricious, but necessary for scientifically valid findings.

Even when fully informed consent has not been obtained for participation, participants can sometimes exercise their consent at the conclusion of the study, following post-briefing. In cases where the participant expresses concerns about the study, the researcher may be able to give the participant the option of withdrawing his or her data (See PROCEDURE FOR OBTAINING INFORMED CONSENT FOR RESEARCH ON HUMANS)

9.4 Participation in Research by Persons who are Not Legally Competent
Competence refers to the ability of prospective participants to give informed consent in accord with their own fundamental values. It involves the ability to understand information presented, to appreciate the potential consequences of a decision, and to provide free and informed consent. This ability may vary according to the choice being made, the circumstances surrounding the decision, or the time in question. Competence to give consent, then, is not an all-or-nothing condition. It does not require prospective participants to have the capacity to make every kind of decision. It does require that they be competent to make an informed decision about participation in particular research. Competence is neither a global condition nor a static one; it may be temporary or permanent.

Researchers must comply with all applicable legislative requirements of the jurisdiction in which participation takes place.

Individuals who are not legally competent must only be asked to become research participants when:

• the research question can only be addressed using the identified group(s); and
• free and informed consent must be sought from their authorized representative(s); and
• the research does not expose them to more than minimal risks without the potential for direct benefits for them.

9.5 Consent Requirements for Persons who are Not Legally Competent
For research involving incompetent individuals, the REB must ensure that, as a minimum, the following conditions are met:

• the researcher must show how the free and informed consent shall be sought from the authorized third party, and how the participant's best interests shall be protected;
• the authorized third party shall not be the researcher or any other member of the research team;
• the continued free and informed consent of an appropriately authorized third party shall be required to continue the participation of a legally incompetent participant in research, so long as the subject remains incompetent;
• when a participant who was entered into a research project through third-party authorization becomes competent during the project, his or her informed consent shall be sought as a condition of continuing participation;
• where free and informed consent has been obtained from an authorized third party, and in those circumstances where the legally incompetent individual understands the nature and consequences of the research, the principle of supported decision making is required. The researcher shall seek to ascertain the wishes of the individuals and those supporting them concerning participation. The potential participant's dissent shall preclude his or her participation. If a legally incompetent participant expresses a desire to cease participation after the research procedure has commenced, such indication shall be deemed dissent, and the procedure shall be terminated.

9.6 Emergency Health Situations
Subject to all applicable legislative and regulatory requirements of the jurisdiction where participation takes place, research involving emergency health situations shall be conducted only if it addresses the emergency needs of the eligible participants and the criteria established by the TCPS and the HIC have been met. Normally HIC requires that a participant be provided with information on the objective of the study, how treatment under the research study differs from standard treatment and any significant risks in a brief consent process prior to treatment or that an authorized third party provide free and informed consent. Where the potential participant cannot be informed and there is no authorized person to third party consent, the individual may not be entered into the study. However, in exceptional circumstances where there is no standard efficacious treatment or the risk of harm is no greater than that of standard treatment, treatment without consent can be considered. Any study involving patients presenting in emergent conditions must be rigorously reviewed by the REB.
When a previously incapacitated person regains capacity, full free and informed consent shall be sought for continuation in the study including subsequent examinations or tests related to the study.

10.0 PRIVACY AND CONFIDENTIALITY

Researchers must comply with all applicable privacy legislation of the jurisdiction in which information [collection] takes place. Information regarding the federal Personal Information Protection and Electronic Documents Act (PIPEDA) and the provincial Access to Information and Protection of Privacy Act (AIPPA) can be found at the following websites: www.parl.gc.ca/36/2/parlbus/chambus/house/bills/government/C-6/C-6_4/C-6_cover-E.html and www.gov.nf.ca/hoa/statutes/a01-1.htm.

Where possible, participants must be guaranteed privacy and anonymity and their information must be treated as confidential. If these cannot be assured or granted, potential participants must be made aware of the limitations of privacy protection and of the possible consequences of breach of confidentiality as part of the consent process.

10.1 Primary Collection
Personal information may be obtained through interviews, focus groups, observation, questionnaires and individual paper or electronic administrative, health, and research records.

Subject to the exceptions in Section 4, researchers who intend to interview participants to obtain personal information shall obtain REB approval for the consent and for the interview procedures and instruments. They shall ensure the free and informed consent of participants. Interview includes face-to-face, telephone or other electronic encounters and individualized questionnaires administered in person, by telephone, electronically or by mail. As noted in Section 4, REB approval is not required for research involving access to publicly available information or materials (including archival documents) and records of public interviews or performances.
Subject to the exception in Section 4, researchers shall require REB approval for obtaining identifiable personal information about participants through interview, questionnaire, direct or indirect observation and through access to records or materials containing personal information. REB approval for such research shall include such considerations as:

• the type of data to be collected;
• the purpose for which the data shall be used;
• limits on the use, disclosure and retention of data;
• appropriate safeguards for security and confidentiality;
• any modes of observation (e.g., photographs or videos) or access to information (e.g., sound recordings) in the research that allow identification of particular participants;
• anticipated secondary uses of identifiable data;
• anticipated linkage of data gathered in the research with other data about subjects, whether or not those data are contained in public or personal records; and
• provisions of confidentiality of data resulting from the research.

10.2 Secondary Use
Secondary use of data refers to the use in research of data collected for a purpose other than the proposed research. Common examples are patient, employee and student records and records of birth and death. These records were originally obtained or produced for a variety of purposes other than research. Such data also include those obtained for one REB approved project but proposed for use in new research. Secondary use of data is of concern when data can be linked to individuals (particularly when it may be possible to identify individuals in published research).
REB approval is required for secondary use of data in research. These data may be anonymous (e.g., information obtained from a cancer registry about each patient diagnosed with colon cancer in a particular year). Researchers may gain access to identifying information if they have demonstrated to the satisfaction of the REB that:

• identifying information is essential to the research;
• the researchers will take appropriate measures to protect the privacy of individuals;
• individuals to whom the data refer have not objected in a written consent to secondary use.

Depending on the perceived risk of a breach of confidentiality, a REB may also require that a researcher's access to data involving identifying information be dependent on:

• the informed consent of those who contributed data or of authorized third parties or the designated guardian of the data;
• an appropriate strategy for informing the subjects and/or the subject community;
• consultation with representatives of those who contributed data.

Researchers who wish to contact individuals to whom the secondary data refer shall seek the approval of the REB prior to contact. The REB shall ensure the original confidentiality guarantees are respected in making such contacts. Normally the data guardian or a member of the research team collecting the data shall make the first contact.

Linkage of data in which research participants may be identifiable shall be approved by the REB. These techniques provide opportunity for addressing previously unanswerable questions but may also create new threats to privacy. REBs must exercise caution in the creation and use of linked data.

10.3 Safeguards in the Protection of Privacy
A number of safeguards are available to researchers for the protection of the information of research participants:

• organizational safeguards such as limited access to data, security clearances, use of study numbers, confidentiality agreements, undertakings/oaths of confidentiality;
• physical safeguards such as locked filing cabinets, locked rooms;
• technological safeguards such as data encryption, special algorithms, access and password codes, tracking features, firewalls.

REBs shall ensure that the means taken to protect the privacy of research participants is thoroughly documented by the researcher. Privacy protection shall be a priority of continuing ethical review.

11.0 CONFLICT OF INTEREST
Researchers hold trust relationships with research participants, research sponsors, institutions, professional bodies, and society. These trust relationships can be put at risk by conflicts of interest that may compromise independence, objectivity, or ethical duties.

Potential conflicts of interest between researchers and participants include but may not be limited to:

• individual financial interest in the research by a researcher;
• existing or potential professional or personal relationships with participants, especially when a participant may perceive the researcher to have power to influence outcomes for the participant (e.g., instructor-student relationships, current or past physician-patient relationships, current or past social worker-client relationships, friendship between the researcher and participant);
• past professional or personal relationships with participants that may lead the participant to feel obligated to participate (e.g, felt debt of gratitude to the researcher for help previously received, felt threat of disclosure of sensitive information about the participant).

REB members may also have conflicts of interest with researchers or with the research project. Potential conflict of interest include but may not be limited to:

• previous experience with the researcher that could positively or negatively bias the member's evaluation of the proposal;
• close personal relationships with the researchers;
• individual financial interest in the research project.
  Researchers and REB members shall disclose actual, perceived or potential conflicts of interest to the REB. REBs shall develop mechanisms to address and resolve conflicts of interest (ref Section 6.4).

12.0 INCLUSION IN RESEARCH

An important aspect of the principle of justice is the fair distribution of benefits and burdens. Members of society should neither bear an unfair share of the direct burdens of participating in research, nor should they be unfairly excluded from potential benefits of research participation.

Where research is designed to survey a number of living research subjects because of their involvement in generic activities (e.g., in many areas of health research or in some social science research such as studies of child poverty or of access to legal clinics) that are not specific to particular identifiable groups, researchers shall not exclude prospective or actual research subjects on the basis of such attributes as culture, religion, race, mental or physical disability, sexual orientation, ethnicity, sex or age, unless there is a valid reason for doing so. Neither women nor men shall be automatically excluded from research solely on the basis of sex or reproductive capacity. These statements are not intended to preclude research focused on a single living individual (such as in a biography) or on a group of individuals who share a specific characteristic (as in a study of an identifiable group of painters who happen to be all of one sex, colour or religion , or of a religious order which is restricted to one sex).

Subject to the provisions in Section 9.4, people who are not competent to consent for themselves shall not be automatically excluded from research which is potentially beneficial to them as individuals, or to the group that they represent.

13.0 RESEARCH INVOLVING ABORIGINAL PEOPLES

Research involving aboriginal communities may raise difficult ethical issues, including overstudying. The investigator must describe in detail to the REB any ethical issues relevant to the particular project proposed. Research begins with community or band consultation, often before the design of the research has been finalized. As well, the community must be given opportunity to learn of, and to respond to, the research results before publication. Disagreements in interpretation among community members, and between the community and the research team must be included in any published report.

14.0 CLINICAL TRIALS

14.1 Clinical Equipoise
Clinical equipoise provides the foundation to the requirement that the health care of participants not be disadvantaged by research participation. Clinical equipoise is present when uncertainty exists on the part of the expert health sciences community about the comparative therapeutic merits of each arm, or condition, of a clinical trial.

14.2 Special Requirements for REB Review of Clinical Trials
All phases of clinical trials but, particularly Phase I and Phase II trials, require both stringent review and continuous monitoring by the HIC independent of the clinical trials sponsor. Researchers and the HIC must carefully examine the integrity of the free and informed consent process.

In Phase I and II trials the HIC must be satisfied that the appropriate hospital and clinical resources are available for safe conduct of the trial and will require assurance by the relevant hospital ethics/resource committees that such resources are available before approving the protocols.

The HIC requests investigators to identify real or perceived conflicts of interest as part of the application process. The budgets of clinical trials are examined to assure that ethical duties concerning conflict of interest are respected. In keeping with the TCPS, finders fees are prohibited. Physicians' fees for services rendered as part of a clinical trial or for prescreening potential participants by the referring physician are limited to the standard rates authorized by the Medical Care Plan (MCP).

14.3 Placebo Controls in Clinical Trials
The use of placebo controls in clinical trials is generally unacceptable when standard therapies or interventions are available for a particular patient population. Consistent with clinical equipoise, a placebo may be used as the control treatment in a clinical trial in the following circumstances:

• there is no standard treatment;
• standard therapy has been shown to be no better than placebo;
• evidence has arisen creating substantial doubt regarding the net therapeutic advantage of standard therapy;
• effective treatment is not available to patients due to cost constraints or short supply. (This may only be applied when background conditions of justice prevail within the health care system in question; for example, a placebo-controlled trial is not permissible when effective but costly treatment is made available to the rich but remains unavailable to the poor or uninsured.);
• in a population of patients refractory to standard treatment and for whom no standard second-line treatment exists;
• testing add-on treatment to standard therapy when all participants in the trial receive all treatments that would normally be prescribed;
• in trials where a substantial placebo response is expected, requiring comparison to a placebo arm to establish efficacy, and when withholding such therapy shall not lead to undue suffering or the possibility or irreversible harm of any magnitude.

When a clinical trial involving a placebo control is undertaken, the consent form must indicate that standard therapy is being withdrawn or withheld for purposes of the research, the anticipated consequences of the withdrawing or withholding of the therapy, the type of rescue, e.g, alternative medication or study withdrawal, and the reasons why the investigator deems a placebo-controlled trial to be necessary.

15.0 HUMAN GENETIC RESEARCH

The ability to identify human genes and their mutations has profound social implications. Misunderstanding or misuse of the results of genetic testing has the potential to interfere with an individual's self-identity and sense of self-worth, and to stigmatize the entire group to which that individual belongs. Researchers and HIC shall exercise care in identifying risks to individuals and groups posed by genetic research.

The genetics researcher must seek free and informed consent from the individual and report results to that individual if the individual so desires. Where appropriate, free and informed consent must also involve the family and/or relevant social structures as far as practical and possible. Researchers retain the right not to perform the genetic analysis if the patient/participant does not want to know the result.

The researcher and the HIC must ensure that the results of genetic testing and genetic counseling records are protected from access by third parties, unless free and informed consent is given by the participant. Family information in databanks shall be coded so as to remove the possibility of identification of subjects within the bank itself.

Researchers and genetic counsellors who involve families and groups in genetic research studies must reveal potential harms to the HIC and outline how such harms shall be dealt with as part of the research project.

Genetics researchers and the HIC must ensure that the research protocol makes provision for access to genetic counselling for the participants, where appropriate.
Gene alteration (including "gene therapy") that involves human germ-line cells or human embryos is not ethically acceptable. Gene alteration for therapeutic purposes and involving human somatic cells may be considered for approval.

Though the banking of genetic material is expected to yield benefits, it may also pose potential harms to individuals, their families and the groups to which they may belong. Accordingly, researchers who propose research involving the banking of genetic material have a duty to satisfy the HIC and prospective research participants that they have addressed the associated ethical issues, including confidentiality, privacy, storage, use of the data and results, withdrawal by the subject, future contact of participants, families and groups, and the requirement for further ethics approval.

At the outset of a research project, the researcher must disclose to the HIC and the research participant the possibility and/or probability that the genetic material and the information derived from its use may have potential commercial uses.

16.0 RESEARCH WITH HUMAN GAMETES, EMBRYOS OR FOETUSES

16.1 Research Involving Human Gametes
Researchers shall obtain free and informed consent from the individual whose gametes are to be used in research.

It is not ethical to use in research ova or sperm that have been obtained through commercial transactions, including exchange for service.

It is not ethically acceptable to create, or intend to create, hybrid individuals by such means as mixing human and animal gametes, or transferring somatic or germ cell nuclei between cells of humans and other species.

16.2 Research Involving Human Embryos
It is not ethically acceptable to create human embryos specifically for research purposes. However, in those cases where human embryos are created for reproductive purposes, and subsequently are no longer required for such purposes, research involving human embryos may be considered to be ethically acceptable, but only if all of the following apply:

• the ova and sperm from which they were formed are obtained in accordance with Section 16.1;
• the research does not involve the genetic alteration of human gametes or embryos;
• embryos exposed to manipulations not directed specifically to their ongoing normal development shall not be transferred for continuing pregnancy; and
• research involving human embryos takes place only during the first 14 days after their formation by combination of the gametes.

It is not ethically acceptable to undertake research that involves ectogenesis, cloning human beings by any means including somatic cell nuclear transfer, formation of animal/human hybrids, or the transfer of embryos between humans and other species.

16.3 Research Involving Foetuses
Research may be undertaken on methods to treat, in utero, a foetus that is suffering from genetic or congenital disorders. Because the foetus and the woman cannot be treated separately, any intervention on one involves an intervention on the other. Accordingly, research involving a human foetus requires the free and informed consent of the women.

Research involving the use of foetal tissue must be guided by respect for the woman's dignity and integrity. Researchers must thus obtain the free and informed consent of the woman whose foetal tissue is to be used for research.

17.0 HUMAN TISSUE

17.1 Requirements for Ethics Review

Research proposing the collection and use of human tissues requires ethics review by the HIC. Amongst other things required by the HIC, the researcher shall demonstrate the following:

• that the collection and use of human tissues for research purposes shall be undertaken with the free and informed consent of competent donors;
• in the case of incompetent donors, free and informed consent shall be by an authorized third party;
• in the case of deceased donors, free and informed consent shall be expressed in a prior directive or through the exercise of free and informed consent by an authorized third party.

17.2 Requirements for Informed Consent

For the purpose of obtaining free and informed consent, researchers who seek to collect human tissue for research must, as a minimum, provide potential donors or authorized third parties information about:

• the purpose of the research;
• the type and amount of tissue to be taken, as well as the location where the tissue is to be taken, and where any tissue remaining after the research is to be stored;
• the manner in which tissue shall be taken, the safety and invasiveness of acquisition, and the duration and conditions of preservation;
• the potential uses for the tissue including any commercial uses;
• the safeguards to protect the individual's privacy and confidentiality;
• any identifying information to be attached to specific tissue, and its potential traceability;
• how the use of the tissue could affect privacy;
• the ability and timeline, if any, for the withdrawal of consent and tissue destruction.

17.3 Previously Collected Tissue

When identification is possible, researchers shall seek to obtain free and informed consent from individuals, or from an authorized third party, for the use of their previously collected tissue. The provisions of Section 17.2 may also apply here.
When collected tissue has been provided by persons who are not individually identifiable (anonymous and anonymized tissue), and when there are no potential harms to them, there is no need to seek donors' permission to use their tissue for research purposes, unless an applicable law so requires. The REB will require documentation of both application to access such tissue and the approval provided by the designated guardian of the banked tissue.

18.0 RESPONSIBILITIES OF RESEARCHERS

Researchers are primarily and ultimately responsible for the protection of human research participants. In order to fulfill this responsibility, researchers must be competent in their area of inquiry. They must be familiar and comply with this policy and with other ethics guidelines relevant to their disciplines. Researchers must ensure that all individuals under their supervision have the training and competence needed to carry out their responsibilities. Principal investigators must ensure that all research personnel are familiar with and comply with this policy and other applicable ethics guidelines. Similarly, instructors who include research components in their courses must ensure that their students are competent to conduct the assigned research and that they are familiar with and comply with this policy and other applicable ethics guidelines. Adequate supervision of student research must be ensured, with greater care required as risk of harm to participants increases. Assistants, students, and others who conduct research under the supervision of others should understand that they are themselves researchers and therefore also bear personal responsibility for the ethical conduct of research with human participants.

Researchers have an ethical obligation to protect the welfare of their assistants, employees, and students by not exposing them to unsafe equipment, materials, and environments during the course of research.

19.0 EDUCATION AND DISSEMINATION

The REBs, through information provided on their respective websites, in conjunction with the Office of Research and the Office of the Vice-President (Research) have the primary responsibility for providing education for researchers about the ethical treatment of human research participants in general and about this policy.
The President or his/her designate will convene a meeting of the three REBs on a semi-annual basis to discuss institutional ethics matters and on-going or emerging issues of a general ethics nature.

The President or his/her designate will also convene an annual meeting of academic heads to discuss institutional ethics matters and on-going or emerging issues of a general ethics nature.

The School of Graduate Studies will continue to offer its Graduate Research Integrity Programme (GRIP) on at least an annual basis. This programme is a requirement for all graduate students at the University and is designed to provide graduate students with the knowledge to make informed decisions on integrity issues commonly encountered in the research process. It is an initiative offered in direct response to the TCPS.

Related Documents:

Appendix - Ethics of Research Involving Human Participants

Human Investigations Committee (HIC) http://www.med.mun.ca/hic/

Interdisciplinary Committee on Ethics in Human Research (ICEHR) www.mun.ca/research/researchers/ethics_committee.php

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS)http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/

Sir Wilfred Grenfell College Research Ethics Board (SWGCREB)http://www.swgc.mun.ca/research/Pages/ethics.aspx

Procedures

• Procedure To Appeal A Research Ethics Board Decision
• Procedure For Obtaining Informed Consent For Research On Humans