Directives

PURPOSE

To establish principles and guidelines for maintaining quality and ethical standards in conducting research at the College on human subjects, consistent with the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans 

SCOPE

All researchers engaged in any research activities, regardless of where the research is conducted, that include human subjects and involve the College through:
a)  its employees and/or students, either as researchers or participants;
b)  an affiliation between the College and other institutions; and/or
c)  non-college individuals or organizations using the College name or its resources to conduct research on College students and/or employees.

This policy does not apply to ongoing collection of data used to facilitate the management of the College as part of its normal operations and related directly to the normal administering, evaluating, or improving of an operation, program, service or activity within the College. These include quality assurance studies, first year student surveys, early-leaver surveys, course evaluations, student evaluations, key productivity indicator studies, and other similar activities.

DEFINITIONS

POLICY

1. The College is committed to safeguarding the rights and well-being of human subjects of research activities in which the College is involved by adhering to quality and ethical standards and principles for research involving human subjects.  Anyone working under the aegis of the College engaging in research, using College facilities, or seeking approval of the College for research involving human subjects must adhere to this policy.

 2.  All research conducted by the 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.  

3.  Guiding Ethical Principles

All research at the College involving human subjects shall be conducted in accord with the principles guiding ethical research conduct.

 3.1 Respect for Human Dignity

The cardinal principle of modern research ethics is respect for human dignity. This principle aspires to protecting the multiple and interdependent interests of the person from bodily to psychological to cultural integrity. This principle forms the basis of the ethical obligations in research.

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 means respecting the right of individuals to consent to participate in a research project.

3.3  Respect for Vulnerable Persons

Respect for human dignity entails high ethical obligations towards vulnerable persons, that is,   those whose diminished competence and/or decision-making capacity make them vulnerable. Ethical obligations to vulnerable individuals in the research enterprise will often translate into special procedures to protect their interests.

3.4  Respect for Privacy and Confidentiality

Respect for human dignity implies the principles of respect for privacy and confidentiality.   Standards of privacy and confidentiality protect the access, control and dissemination of personal information. 

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 protocols, and that the process be effectively independent. 

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, require favourable harms-benefit balance — that is, that the foreseeable harms should not outweigh anticipated benefits.

4.  Scope of Research Requiring Review 

4.1  All research involving living human subjects shall require the review and approval of the Research Ethics Board of the 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.

 4.2  For multi-centred research, all centers shall be involved in the ethical review process.  International projects with a research component involving human subjects must undergo the same review process.  The researcher in an international project shall submit to a review by a Research Ethics Board in another jurisdiction, as well as that of the College. 

4.3  The following kinds of research proposals shall be exempted from the need for ethical review:

a.  Quality assurance studies, performance reviews, questionnaires concerning employee performance or course content distributed to a class by instructors or others within normal educational requirements in which there is no research component to the activity.

b.  Research conducted by the College where such research is conducted to meet external reporting requirements or to facilitate the management of the institution.

c.  Research where data are in the public domain.

5.  Research Ethics Board

5.1  Authority of the Research Ethics Board

The College shall maintain a Research Ethics Board (REB). The President has mandated the REB to approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human subjects which is conducted within, or by members of the institution, using the considerations set forth in this Policy as the minimum standard.

As a formal cross-college committee, the President shall ensure that the Research Ethics Board has the appropriate and administrative independence to fulfill its primary duties.

5.2  Chair of the REB

The Chair of the REB is appointed by PEC and reports directly to the President. The Chair of the REB is selected from among nominations brought forward by the Director, Applied Research and Innovation.

5.3  Membership of the REB

The REB shall consist of at least five members, including the Chair, including both men and women, of whom:

a)  at least two members have broad expertise in the methods or in the areas of research that are covered by the REB; 

b)  at least one member is knowledgeable in ethics;

c)  for biomedical research, at least one member is knowledgeable in the relevant law; this is advisable but not mandatory for other areas of research;

d)  at least one member has no affiliation with the College, but is recruited from the community served by the College;

e)  membership may be added in order to ensure:

i.  an adequate and thorough review of research proposals;

ii.  adequately reflect the ethical views of society;

iii.  and address specific research disciplines or legal issues;

f)   the size of the REB increases beyond the minimum of five members, the number of community representatives shall also increase.

g)  from time to time it may be necessary to vary the membership of the REB to reflect specific research submissions

h)  under certain circumstances the College may wish to seek the assistance and cooperation of other local REBs in the region.

5.4  Terms of Office 

5.4.1  The term of appointment shall be for three years.

5.4.2  At the completion of a term of appointment, membership shall rotate among staff to ensure diversity of opinion and the opportunity to spread knowledge and experience gained from REB membership throughout the College.

5.4.3  Vacancies will be filled in accordance with 5.3 as new appointments to the REB.

5.5  Number of REBs within Algonquin

5.5.1  The College shall maintain a single Research Ethics Board covering as broad a range of research as is consistent with manageable workloads. Departmental REBs may be established for review of undergraduate research within course requirements. 

5.5.2  Departmental level review should not be used for research in which a student is carrying out research that is part of a professor’s own research program.  Such research should be reviewed under regular REB procedures.

5.6  Ethics Review

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

5.6.2  The extent of the ethics review for biomedical research that does not involve more than minimal risk will vary according to the research being carried out. 

5.6.3  Research in the humanities and the social sciences which poses, at most, minimal risks shall not normally be required by the REB to be peer reviewed.

5.6.4  Certain types of research, particularly in the social sciences and the humanities, may legitimately have a negative effect on public figures in politics, business, labour, the arts or other walks of life, or on organizations. Such research should not be blocked through the use of harms/benefits analysis or because of the potentially negative nature of the findings. The safeguard for those in the public arena is through public debate and discourse and, in extreme cases , through action in the courts for libel.

6.  Review Procedures

 6.1  A Proportionate Approach to Ethics Review

6.1.1  The REB shall adopt a proportionate approach based on the general principle that the more invasive the research, the greater should be the care in assessing the research.

6.1.2  The REB shall use three levels of review:

a)  full REB review;

b)  expedited REB review by an individual or sub-group of the REB; and

c)  departmental level review of student projects carried out within formal course requirements.

6.1.3  A full review by a REB shall be the default requirement for all research involving human subjects unless the following conditions are met:

a)   research protocols involve no more than minimal risk;

b)  annual renewals of approved projects in which there has been little or no change in the ongoing research;

c)  research involving review of patient records by hospital personnel, or

d)  affirmations that conditions laid down by the REB as a condition of approval have been met.

6.1.4  Expedited and departmental reviews must be reported to the full REB. 

6.2  Meetings 

6.2.1  The REB shall meet within 10 days of receipt of an application for ethics review or at the call of the Chair to discharge its responsibilities. 

6.2.2  The REB may also meet to take advantage of educational opportunities that may benefit the overall operation of the REB, discuss any general issues arising out of the REB’s activities or revise policies.

6.3  Submission of Applications for Ethics Review

Applications may be submitted at any time via the College website.

6.4  Record Keeping 

6.4.1  Minutes of all REB meetings shall be prepared and maintained by the REB. The minutes shall clearly document the REB’s decisions and any dissents, and the reasons for them.  The minutes must be accessible to authorized representatives of the College, researchers and funding agencies. 

6.4.2  The REB, and departmental REBs shall report decisions regarding all reviews, whether expedited or not, within five (5) working days of the decision to the Director, Applied Research and Innovation. 

6.4.3  The REB shall meet to review proposed research that is not delegated to expedited review. REB review shall be based upon fully detailed research proposals or, where applicable, progress reports. 

6.4.4  The REB shall function impartially, provide a fair hearing to those involved and provide reasoned and appropriately documented opinions and decisions. 

6.4.5  When meeting face-to-face to review a research proposal that is not delegated to expedited review, the REB shall maintain a quorum of at least 5 members including community members. Decisions requiring full view should be adopted only if the members attending the meeting possess the range of background and expertise identified in section 1.2.

6.4.6  The REB shall accommodate reasonable requests from researchers to participate in discussions about their proposals, but researchers will not be present when the REB is making its decision. When a REB is considering a negative decision, it shall provide the researcher with all the reasons for doing so and give the researcher an opportunity to reply before making a final decision. 

6.5  Reconsideration

Researchers have the right to request, and the REB has an obligation to provide, reconsideration of decisions affecting a research project.

6.6  Appeals

6.6.1  In cases when researchers and REBs cannot reach agreement through discussion and reconsideration, a Research Appeal Board will review the decision. 

6.6.2  The Research Appeal Board will be comprised of at least five members, appointed by the President’s Executive Committee,  including both men and women, of whom: 

a)  at least two members have broad expertise in the areas of research covered by the REB at the College;

b)  one member is knowledgeable in ethics;

c)  one is a lawyer, who is not the College legal counsel;

d)  one is community member with no affiliation with the College.

6.6.3  The term of appointment for Research Appeal Board members shall be three years. 

6.6.4  Current members of the REB may not serve on the Research Appeal Board. 

6.7  Conflict of Interest

If the REB is reviewing research in which a member of the REB has a personal interest in the research under review (e.g., as a researcher or as an entrepreneur), conflict of interest principles require that the member not be present when the REB is discussing or making its decision. The REB member may disclose and explain the conflict of interest and offer evidence to the REB provided the conflict is fully explained to the REB, and the proposer of the research has the right to hear the evidence and to offer a rebuttal. 

6.8  Review Procedures for Ongoing Research 

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

 6.8.2  As part of each research proposal submitted for REB review, the researcher shall propose to the REB the continuing review process deemed appropriate for that project.

6.8.3  Normally, continuing review should consist of at least the submission of a succinct annual status report to the REB. The REB shall be promptly notified when the project concludes.

6.9  Review of Multi-Centered Research

For multi-centered research, all centers shall be involved in the ethics review.  The REB may coordinate its review of multi-centered projects with other REBs reviewing the same project to better communicate any concerns that they may have with the project.  Researchers will indicate other REBs reviewing the project in their application to the REB.

6.10 Review of Research in Other Jurisdictions or Countries

Research to be performed outside the jurisdiction or country of the institution which employs the researcher shall undergo ethics review both by:

a)  the REB within the researcher’s institution; and

b) the REB, where such exists, with the legal responsibility and equivalent ethical and procedural safeguards in the country or jurisdiction where the research is to be done. 

7.  FREE AND INFORMED CONSENT 

7.1  Requirements for Free and Informed Consent

a)  Research governed by this Policy may begin only if:

i.  prospective subjects, or authorized third parties, have been given the opportunity to give free and informed consent about participation, and

ii.  the free and informed consent of prospective subjects has been given and is maintained throughout their participation in the research. 

b)  Evidence of free and informed consent by the subject or authorized third party should ordinarily be obtained in writing. 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 shall be documented. 

c)  The REB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent, provided that the REB finds and documents that: 

i.   The research involves no more than minimal risk to the subjects;

ii.  The waiver or alteration is unlikely to adversely affect the rights and welfare of the subjects;

iii. The research could not practicably be carried out without the waiver or alteration;

iv. Whenever possible and appropriate, the subjects will be provided with additional pertinent information after participation; and

v.   The waivered or altered consent does not involve a therapeutic intervention.

d)  In studies including randomization and blinding in clinical trials, neither the research subjects nor those responsible for their care know which treatment the subjects are receiving before the project commences. Such research is not regarded as a waiver or alteration of the requirements for consent if subjects are informed of the probability of being randomly assigned to one arm of the study or another.

 7.2  Voluntary Consent

7.2.1  Free and informed consent must be voluntarily given, without manipulation, undue influence or coercion. It is normally provided in writing. 

7.2.2  Researchers must take care to avoid problems when a special relationship between researcher and participant exists, so that such relationship does not unduly influence the participant’s free and informed consent.

7.2.3  When dealing with restricted or dependent subjects, consent may not be secured by the order of authorities or as a result of coercion or manipulation. The influence of power relationships on voluntary choice should be judged according to the particular context of prospective subjects. 

7.2.4  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.

7.3  Naturalistic Observation

REB review is normally required for research involving naturalistic observation. However, research involving observation of participants in, for example, political rallies, demonstrations or public meetings, should not require REB review since it can be expected that the participants are seeking public visibility.

7.4.  Informing Potential Subjects

Researchers shall provide, to prospective subjects or authorized third parties, full and frank disclosure of all information relevant to free and informed consent. Throughout the free and informed consent process, the researcher must ensure that prospective subjects are given adequate opportunities to discuss and contemplate their participation. When starting the process to obtain a free and informed consent, researchers or their designates, shall provide prospective subjects with the following: 

a)  Information that the individual is being invited to participate in a research project;

b)  A comprehensible statement of the research purpose, the identity of the researcher, the expected duration and nature of participation, and a description of research procedures;

c)  A comprehensible description of reasonably foreseeable harms and benefits that may arise from research participation, as well as the likely consequences of nonaction, particularly in research related to treatment, or where invasive methodologies are involved, or where there is a potential for physical or psychological harm;

d)  An assurance that prospective subjects are free not to participate, have the right to withdraw at any time without prejudice to pre-existing entitlements, and will be given continuing and meaningful opportunities for deciding whether or not to continue to participate;

e)  The possibility of commercialization of research findings, and the presence of any apparent or actual or potential conflict of interest on the part of researchers, their institutions or sponsors;

f)  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;

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

i.   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;

ii.   Information on the resources available outside the research team to contact regarding possible ethical issues in the research;

iii. 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;

iv.  An explanation of the responsibilities of the participant;

v. Information on the circumstances under which the researcher may terminate the individual’s participation in the research;

vi.  Information on any costs, payments, reimbursement for expenses, or compensation for injury;

vii. In the case of randomized trials, the probability of participant assignment to each of the options;

viii. The ways in which research results will be published, and how the participants will be informed of the results of the research. 

7.5  Competence

 7.5.1  Subject to applicable legal requirements, individuals who are not legally competent shall only be asked to become research subjects when:

a)  The research question can only be addressed using the identified group(s);

b)  Free and informed consent will be sought from their authorized representative(s); and

c) The research does not expose them to more than minimal risks without the potential for direct benefits for them.

7.6  Individuals Not Competent

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

a)  The researcher shall show how the free and informed consent will be sought from the authorized third party, and how the subjects’ best interests will be protected.

b)  The authorized third party may not be the researcher or any other member of the research team.

c)  The continued free and informed consent of an appropriately authorized third party will be required to continue the participation of a legally incompetent subject in research, so long as the subject remains incompetent.

d)  When a subject 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. 

7.7  Third Party Consent

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 researcher shall seek to ascertain the wishes of the individual concerning participation. The potential subject’s dissent will preclude his or her participation.

7.8  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 advance 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 subject or of his or her authorized third party if All of the following apply: 

a)  A serious threat to the prospective subject requires immediate intervention; and

b)  Either no standard efficacious care exists or the research offers a real possibility of direct benefit to the subject in comparison with standard care; and

c)  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

d)  The prospective subject is unconscious or lacks capacity to understand risks, methods and purposes of the research; and

e)  Third-party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so; and

f)  No relevant prior directive by the subject is known to exist; and

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

8.  PRIVACY AND CONFIDENTIALITY 

8.1  Privacy Legislation

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.

 8.2  Accessing Private Information: Personal Interviews

Researchers who intend to conduct interviews as part of their research with a human subject to secure identifiable personal information shall secure REB approval for the interview procedure used and shall ensure the free and informed consent of the interviewee.

8.3 Accessing Private Information: Surveys, Questionnaires and the Collection of Data

Researchers shall secure REB approval for obtaining identifiable personal information about subjects. Approval for such research shall include such considerations as:

8.3.1  The type of data to be collected;

8.3.2  The purpose for which the data will be used;

8.3.3  Limits on the use, disclosure, and retention of the data;

8.3.4  Appropriate safeguards for security and confidentiality;

8.3.5  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 subjects;

8.3.6  Any anticipated secondary uses of identifiable data from the research;

8.3.7  Any anticipated linkage of data gathered in the research with other data about subjects, whether those data are contained in public or personal records; and

8.3.8  Provisions for confidentiality of data resulting from the research.

8.4  Secondary Use of Data

If identifying information is involved, REB approval shall be sought for secondary uses of data. Researchers may gain access to identifying information if they have demonstrated to the satisfaction of the REB that:

8.4.1  The identifying information is essential to the research; and

8.4.2  The researchers will take appropriate measures to protect the privacy of the individuals, to ensure the confidentiality of the data, and to minimize harms to subjects;

8.4.3 The individuals to whom the data refer have not objected to secondary use.

8.5  Identifying Information

The REB may also require that a researcher’s access to secondary use of data involving identifying information be dependent on:

8.5.1  The informed consent of those who contributed data or of authorized third parties; or

8.5.2  An appropriate strategy for informing the subjects; or

8.5.3  Consultation with representatives of those who contributed data.

8.6  Contacting Individuals

Researchers who wish to contact individuals to whom data refer shall seek the authorization of the REB prior to contact.

8.7  Data linkage

The implications of approved data linkage in which research subjects may be identifiable shall be approved by the REB.

9.  CONFLICT OF INTEREST 

Researchers and REB members shall disclose actual, perceived or potential conflicts of interest to the REB. REBs should develop mechanisms to address and resolve conflicts of interest.

10.  INCLUSION IN RESEARCH 

10.1  Inclusion

10.1.1  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.

10.1.2  This section is 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).

10.2  Research Involving Women

Women shall not automatically be excluded from research solely on the basis of sex or reproductive capacity.

10.3 Research Involving Those Who Are Incompetent to Consent for Themselves

Those 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.

PROCEDURE 

SUPPORTING DOCUMENTATION
None

RELATED POLICIES
AD 02    Freedom of Information and Protection of Privacy
HR 12     Conflict of Interest
AA 16    Academic Dishonesty and Discipline
AA 35    Confidentiality of Student Records
SA 07     Student Conduct
RE 01     Research Administration
RE 02     Policy on Integrity in Research and Scholarly Activities
RE 04     Use of Animals in Research, Teaching and Other Activities
RE 06     Use of Biohazardous and Radioactive Materials in Research and Education

RELATED MATERIALS

TRI-Council Policy Statement: Ethical Conduct for Research Involving Humans