SFU

MEMORANDUM

OFFICE OP THE VTCE-PRESIDENT, ACADEMIC AND PROVOST

University Drive,

Burnaby,

Canada \'5.\ IS6

TEL: 778.782.3925

FAX: 778.782.5876

S.13-6

vpacati@sfu.ca

www.sfu.ca/vpacadetnic

attention

Senate

DATE

December 12,2012

from

Jon Driver, Vice-President, Academic and

pages

1/1

Provost, and Chair, SCUP

Revised Policy R20.01 - Ethics Review of Research Involving Human Subjects (SCUP 12-50)

RE:

At its December 5, 2012 meeting SCUP reviewed and approved the revised Policy R20.01 - Ethics

Review of Research Involving Human Subjects.

Motion:

That Senate approve and recommend to the Board of Governors the revised Policy R20.01 - Ethics

Review of Research Involving Human Subjects.

end.

c: M. Pinto

SIMON

FRASEE

UNIVERSITY

ENGAGING THE WORLD

SFU

OFFICE OF THE VICE-PRESIDENT, RESEARCH

MEMORANDUM

Strand Hall 3195

8888 University Drive, Burnaby, BC

Canada V5A 1S6

ATTENTION

Jon Driver

Vice-President, Academic and Provost

Chair, SCUP

FROM

B. Mario Pinto

Vice-President, Research

RE:

Revised Policy R20.01 for SCUP's Approval

TEL 778.782.4152

FAX 778.782.4860

DATE

November 26, 2012

PAGES

1/21

SCUP 12-50

vpres@sfu.ca

www.sfu.ca/vprcsearch

In Fall 2011, an external review of SFU's Research Ethics Board (REB) and Office of Research Ethics

(ORE) was undertaken. The External Reviewers submitted a final report in January 2012 with the ORE

Director (DORE) and REB Chair submitting responses in February and March 2012 respectively.

After reviewing the

report and its recommendations, the REB Chair, DORJE, and Vice-President,

Research undertook a Senate-mandated review of Policy R20.01 (Ethics Review of Research Involving

Human Subjects), starting in Spring 2012. The draft policy was scrutinized by the Vice-Presidents and

Deans in Fall 2012

and presented to the SFU community for feedback through in-person community

consultations and email comments. Following the community consultations, Policy R20.01 was revised to

incorporate the community comments with the final policy submitted to SCUP for approval.

To this end, the revised Policy R20.01 is attached and the following motion is submitted to SCUP:

Motion:

That SCUP approve the revised Policy R20.01 and forward the Policy to Senate for final approval.

Attachment (1)

SIMON PHASER UNIVERSITY

Dr. B. Mario Pinto

Vice-President, Research

ENGAGING THE WORLD

SIMON FRASER UNIVERSITY

POLICIES AND PROCEDURES

SIMON FRASER UNIVERSITY

Policies

and Procedures

Date

Number

October 1, 1992

R 20.01

Revision

Revision No

November 2012

Ethics Review of Research Involving Human Participants

(Proposed Revision, November 2012)

Preamble:

Simon Fraser University is committed to ensuring the highest level of ethical conduct for research

involving human participants and to following the guidelines outlined in the Tri-Council Policy

Statement,

Ethical Conduct for Research Involving Humans,

(the TCPS-2).

University

researchers enjoy special freedoms and privileges, which include freedom of inquiry and

the right to disseminate the results thereof, freedom to challenge conventional thoughts, freedom from

institutional censorship,

and the privilege of conducting research on human participants with the trust

and support of the general public, often with public funding. With these freedoms come responsibilities

ensure that research involving human subjects meets high scholarly and ethical standards, is

honest and thoughtful inquiry, involves rigorous analysis and complies with professional and

disciplinary standards for the protection of privacy and for methodological approaches. Review of

research proposals by a Research Ethics Board takes into account these freedoms and

responsibilities and provides accountability and quality assurance both to colleagues and to society.

Click here for instructions on accessing the electronic Ethics Applications.

Policy:

This Policy provides a mechanism for ethics review of research involving human participants to protect

those participants, researchers, support staff, students, and third parties, and to educate those

involved in this type of research. Its procedures are consistent with the educational and research

mandates of Simon Fraser University and respect the academic freedom and responsibilities of faculty

members and the principle of informed consent with respect to potential participants. No more than

three years after the implementation of this Policy, and no more than every five years thereafter,

Senate will undertake a review of the Policy and Procedures for Ethics Review of Research Involving

Human Participants, and make amendments should they be deemed necessary.

Definitions:

"embryo" means a human organism during the first 56 days of its development following

fertilization or creation, excluding any time during which its development

has been suspended,

and includes any cell derived from such an organism that is used for the purpose of creating a

human being;

"fetal tissue" includes membranes, placenta, umbilical cord, amniotic fluid and other tissue that

contains genetic information about the fetus;

"fetus" means a human organism during the period of its development beginning on the 57th day

following fertilization or creation, excluding any time during which its development has been

suspended, and ending at birth;

"human biological materials" means tissues, organs, blood, plasma, serum, DNA, RNA, proteins,

cells, skin, hair, nail clippings, urine, saliva,

and other body fluids. Materials related to human

reproduction include embryos, fetuses, fetal tissues, and human reproductive materials;

"human reproductive materials" mean a sperm, ovum or other human cell, or a human gene, as

well as a part of any of them;

"human biological materials" includes materials related to human reproduction;

"human participants"

means those individuals whose data, or responses to interventions, stimuli,

or questions by the researcher, are relevant to answering the research question;

"publicly available information" means existing stored documentary material, records or

publications, which may or may not include identifiable information and includes 'all information

that is available under FOI (Freedom of Information) legislation in British Columbia and Canada,

whether or not the information has been exposed to the public;

"research" means an undertaking intended to extend knowledge through a disciplined inquiry or

systematic investigation;

PART I - PRINCIPLES

Proportionate Approach to Ethics Review

A proportionate approach to research ethics review shall be adopted such that, as a preliminary

step, the level of review is determined by the level of risk presented by the research: the lower

the level of risk, the lower the level of scrutiny (delegated review); the higher the level of risk, the

higher the level of scrutiny (full board review). A proportionate approach to assessing the ethical

acceptability of the research, at either level of review, involves consideration of the foreseeable

risks, the potential benefits, and the ethical implications of the research.

Risk Analysis

3.1

As research is a step intothe unknown, its undertaking can involve harms to participants and

to others. Harm is anything that has a negative effect on the welfare of participants, and the

nature of the harm may be social, behavioural, psychological, physical, or economic.

Risk is a function of the magnitude or seriousness of the harm, and the probability that it will

occur, whether to participants or to third parties.

A proper ethical analysis of

research should consider both the foreseeable risk and the available

methods of eliminating or mitigating the risk.

3.2 Researchers should assess all reasonably foreseeable risks involved in, and benefits

expected to arise from, research projects. Researchers involved in greater-than-minimal risk

projects should be prepared to

fully document the reasonably foreseeable risks and benefits of

their proposed research.

3.3 Researchers should employ methods that avoid or reduce possible risks, and maximize

benefits in keeping with disciplinary and epistemological norms and standards.

3.4 To facilitate risk-assessment and mitigation, researchers must complete the analysis-of-risk

checklist in their online application.

3.5 Researchers should consider not only the likelihood of a given risk, but also variables such

as its duration and the likely reversibility of its impact should it materialize.

3.6 Benefits include specific advantages to participants, to third parties, or to society or a

segment thereof, and any general increase in human knowledge. Benefits may arise from

advantages or increases in knowledge that are actively sought by the researcher or as by

products of the research (e.g. serendipitous events).

3.7 In projects involving greater-than-minimal risk, it is the responsibility of both researchers and

the Research Ethics Board (REB) to balance risks and benefits. Projected benefits should

outweigh reasonably foreseeable risks. With regard to greater-than-minimal risk, the more

incalculable the risks or the less tangible the benefits, researchers and the REB must be more

cautious.

3.8 In a project involving greater-than-minimal risk the REB should be satisfied that the research

design and proposed implementation procedures are consistent with sound research standards

and with accepted standards of disciplinary conduct and practice.

3.9 In the conduct of their approved research, should unanticipated issues arise that may

increase the level of risk or have other ethical implications, researchers shall report them to the

Office of Research Ethics in a timely manner. Researchers shall also submit to the Office of

Research Ethics in a timely manner requests for changes to their approved research.

3.10

The REB must always be conscious of the importance of academic freedom for

researchers, particularly where risks are the subject of informed consent, or will devolve upon

the researchers personally. Nothing in Policy R20.01 is intended to inhibit the rights of

researchers to engage in critical inquiry and disseminate that information.

Risks to Researchers

Risks in research are not limited to participants. In their conduct of research, researchers

themselves may be exposed to risks that may take many forms (e.g. injury, incarceration). Risks

to researchers may become a safety concern, especially for student researchers who are at a

learning stage regarding the conduct of research. While it is not a formal part of its

responsibilities, the REB may raise concerns about the safety of student researchers as part of

its communication to the student researchers, and to their supervisors. Based on the level of

risk, the REB may consider referring these concerns for review by the Office of Risk

Management.

Obtaining Informed Consent

5.1

Individuals who participate in research should do so voluntarily, understanding the purpose

of the research, and its risksand potential benefits, as fully as reasonably possible.

5.2 Under no circumstances may researchers proceed to conduct research with anyone who has

refused to participate.

5.3 Those who lack the capacity to decide for themselves should nevertheless have the

opportunity to participate in research that may be of benefit to themselves or others. Authorized

third

parties acting on behalf of these individuals may decide whether participation would be

appropriate. For the purposes of this Policy, the term "authorized third party" (also known as

"authorized third party decision makers") refers to any person with the necessary legal authority

make decisions on behalf of an individual who lacks the capacity to consent to participate or

to continue to participate in a particular research project.

5.4 Where it is appropriate to do so, the REB may permit certain elements of the consent

process to be adapted to the requirements of a particular research project. However, such

adaptation must conform to the requirements specified in Chapter 3 of TCPS-2.

5.5 The principal investigator in a research team is responsible for ensuring that the consent

process is followed. This person is also responsible for the actions of any member of the

research team involved in the consent process.

5.6 In addition to this Policy and TCPS-2, researchers are responsible for ensuring that all

applicable legal and regulatory requirements with respect to consent are met.

5.7 With respect to consent:

a. Consent shall be given voluntarily.

b. Consent can be withdrawn at any time.

c. If a participant withdraws consent, the participant can also request the withdrawal of

their data or human biological materials. Withdrawal of data does not apply to Health

Canada-regulated or U.S. Food and Drug Administration-regulated research.

Withdrawal of data or human biological materials does not apply when the data or

human biological materials were collected anonymously and there is no way of re

linking

the data or human biological materials to a participant's identity.

5.8 Researchers shall provide to prospective participants, or authorized third parties, full

disclosure of all information

necessary for making an informed decision to participate in a

research project.

5.9 Consent shall be maintained throughout the research project. Researchers have an ongoing

duty to provide participants with all information relevant to their ongoing consent to participate in

the research.

5.10 Researchers have an obligation to disclose to the participant any material incidental

findings discovered in the course of research.

"Incidental findings" is a term that describes unanticipated discoveries made in the course of

research but that are outside the scope of the research. Material incidental findings are findings

that have been interpreted as having important welfare implications for the participant, whether

health-related, psychological, or social.

5.11 Research shall begin only after the participants, or their authorized third parties, have

provided their consent.

5.12 Permission is not required from an organization to conduct research on that organization. If

a researcher engages the participation of members of an organization without the organization's

permission, the researcher shall inform participants of any foreseeable risk that may be posed

by their participation

5.13 The REB may approve research without requiring that the researcher obtain the

participant's consent in accordance with paragraphs 5.7 to 5.11 where the REB is satisfied, and

documents, that all of the following apply:

a. the research involves no more than minimal risk to the participants;

b. the lack of the participant'sconsent is unlikely to adversely affect the welfare of the

participant;

c. it is impossible or impracticable to carry out the research and to answer the

research question properly, given the research design, if the prior consent of the

participant is required;

d. whenever possible and appropriate, after participation, or at a later time during the

study, participants will be debriefed and provided with additional pertinent

information in accordance with paragraphs 5.7 to 5.10, at which point they will have

the opportunity to refuse consent in accordance with paragraph 5.7; and

e. the research does not involve a therapeutic intervention, or other clinical or

diagnostic interventions.

5.14 For research involving individuals who lack the capacity, either permanently or temporarily,

to decide for themselves whether to participate, the REB shall ensure that, as a minimum, the

following conditions are met:

a. the researcher involves participants who lack the capacity to consent on their own

behalf to

the greatest extent possible in the decision-making process;

b. the researcher seeks and maintains consent from authorized third parties in

accordance with the best interests of the persons concerned;

c. the authorized third party is not the researcher or any other member of the research

team;

d. the researcher demonstrates that the research is being carried out for the

participant's direct benefit, or for the benefit of other persons in the same category.

If the research does not have the potential for direct benefit to the participant but

only for

the benefit of the other persons in the same category, the researcher shall

demonstrate that the research will expose the participant to only a minimal risk and

minimal burden, and demonstrate how the participant's welfare will be protected

throughout the participation in research; and

e. when authorization for participation was granted by an authorized third party, and a

participant acquires or regains capacity during the course of the research, the

researcher shall promptly seek the participant'sconsent as a condition of continuing

participation.

5.15 Where an authorized third party has consented on behalf of an individual who lacks legal

capacity, but that person has some ability to understand the importance of the research, the

researcher shall ascertain the wishes of that individual with respect to participation. Prospective

participants' dissent will preclude their participation.

5.16

Where individuals have signed a research directive indicating their preferences about future

participation in research in the event that they lose capacity or upon death, these directives

should guide researchers and authorized third parties during the consent process.

5.17

Evidence of consent shall be contained either in a signed consent form or in documentation

by the researcher of another appropriate means of consent. In certain types of research and for

particular participants or groups of participants, written consent may be inappropriate: in these

cases, there are other means of obtaining consent that are ethically acceptable (e.g. oral

consent, a verbal agreement, or a handshake). In the case of gathering oral evidence, informed

consent is distinct from providing the researcher with consent to publish and archive the data.

Where consent is not documented in a signed consent form, researchers may use a range of

consent procedures, including oral consent, field notes, and other strategies, for documenting

the consent process. Consent may also be demonstrated solely by the actions of the participant

(e.g. through

the return of a completed questionnaire). Where there are valid reasons for not

recording consent in writing, the procedures used to seek consent must be documented.

5.18

The age of majority in British Columbia is 19 years and parental consent is required for

subjects younger than 19. Written consent from parents or legal guardians (as well as

authorization from appropriate school authorities) is normally required for research in the public

schools. An opportunity

must be given to the individual to refuse to participate or withdraw at any

time. A copy of what is written or said to the individual must be included for review by the REB.

The REB considers minors attending University, who are 17 to 18 years of age, to be

emancipated adults for the purposes of minimal-risk research. Parent or legal guardian consent

will generally only be required if the research study is deemed greater-than-minimal risk or

represents an invasion of the family's right to privacy. In either case, justification must be

provided in the application for ethics review. The REB may make an exception to these

requirements on a case-by-case basis, but the investigator must provide adequate justification in

the application for ethics review (e.g. the child no longer lives with parent or guardian, there is no

invasion of privacy or sensitive issue involved, etc.).

Privacy and Confidentiality

6.1

Individuals have privacy interests in relation to their bodies, personal information, expressed

thoughts and opinions, personal communications with others, and spaces they occupy.

Research affects these various domains of privacy in different ways, depending on its objectives

and methods. An important aspect of privacy is the right to control information about oneself.

The concept of consent is related to the right to privacy. Privacy is respected if an individual has

an opportunity to exercise control over personal information by consenting to, or withholding

consent for, the collection, use, and/or disclosure of information.

The ethical duty of confidentiality refers to the obligation of an individual or organization to

safeguard entrusted information. The ethical duty of confidentiality includes obligations to protect

information from unauthorized access, use, disclosure, modification, loss, or theft. Fulfilling the

ethical duty of confidentiality is essential to the trust relationship between researcher and

participant, and to the integrity of the research project.

6.2 Researchers shall safeguard information entrusted to them and not misuse or wrongfully

disclose it.

6.3 Researchers shall describe measures for meeting confidentiality obligations and explain any

reasonably foreseeable disclosure requirements:

in application materials they submit to the REB; and

during the consent process with prospective participants.

6.4 Researchers shall familiarize themselves with Chapter 5 of TCPS-2 and indicate in their

applications how they are meeting the privacy and confidentiality requirements of that chapter

that pertain to their projects.

PART II - SCOPE

Scope of Requirement for Ethics Review

7.1

The following types of research require ethics approval:

a. research involving living human participants;

b. research involving human biological materials (from both living and deceased

individuals), as well as human embryos, fetuses, fetal tissue, reproductive materials,

and

stem cells. An individual whose data and/or biological materials are used in

research becomes a participant.

This requirement applies to research conducted by any employee or student of Simon Fraser

University, or Adjunct faculty member of any Department, School, or non-Departmentalized

Faculty of

Simon Fraser University. Where external agencies or non-SFU researchers are

involved, the applicant should seek advice from the Director of the Office of Research Ethics

(DORE) regarding the potential need for ethics review.

Research that utilizes human biological materials as well as research involving human embryos,

fetuses, fetal tissue, reproductive materials, and

stem cells requires review and approval by the

REB before research is started, except as stipulated in 7.5 below. In addition, such research

must first be reviewed by the Bio-Safety Committee who will provide the REB with a statement

as to the nature of any risk(s) that may be posed to those who may come into contact with the

human biological materials, etc. The Chair or Deputy Chair of the REB will decide whether the

approval of an application involving such research should be delegated or should be subject to a

full Board review.

Distinctions with respect to human biological materials that are relevant to REB review include:

Primary Tissue Cultures,

which are the mixture of cells that grow out of or from tissue

samples taken from participants placed into culture;

Secondary Tissue Cultures

which are derived from cells in Primary Tissue Culture by

serial

passages and dilution, often leading to clonally derived lines of cells having

relatively uniform properties that have

adapted to growth in tissue culture. Once

characterized and described in the public domain, these cultures may be considered

Established Cell Lines that can be maintained or stored indefinitely. Established Cell

Lines can normally be obtained commercially or as a gift, but identifying information

about the donor is not provided with the cells. REB approval is not required for the use

of human secondary tissue cultures (providing appropriate ethical approval was

obtained for creation of the primary culture), nor for the use of established cell lines.

7.2 Research involving living human participants occurs when data are derived from:

a. information that is collected through intervention or interaction with a living

individual (e.g. interviews, questionnaires, observations taken that are noticeable by

the individual);

b. secondary sources/non-public sources (e.g. interviews about a living individual,

company personnel records, student records collected by an educational

institution); or

c. identifiable private information about a living individual.

7.3 Research that relies exclusively on publicly available information does not require ethics

review when:

a. the information is legally accessible to the public and appropriately protected by

law; or

b. the information is publicly accessible and there is no reasonable expectation of

privacy.

7.4 Ethics review is not required for research involving the observation of people in public places

where:

a. it does not involve any intervention staged by the researcher, or direct interaction

with the individuals or groups;

b. individuals or groups targeted for observation have no reasonable expectation of

privacy;

and

c. any dissemination of research results does not allow identification of specific

individuals.

7.5 Quality assurance and quality improvement studies, program evaluation activities, and

performance reviews, or testing within normal educational requirements when used exclusively

for assessment, management or improvement purposes, do not constitute research for the

purposes of this Policy. These studies involve assessments of the performance of an

organization or its employees or students, within the mandate of the organization, or according

to the terms and conditions of employment or training.

7.6 All course-based research assignments involving living human participants, including

Directed Studies require ethics review.

7.7 Certain classes of research involving human participants are excluded from the requirement

of ethics review:

a. research conducted by a member of the academic staff as an

Outside

Professional Activity (see Policy A30.04),

or by other employees or students, as

long as the research data are not collected by asserting connection or affiliation with

Simon Fraser University, and the results are not disseminated in the public domain

indicating association with Simon Fraser University, and the research is not

conducted at Simon Fraser University or using Simon Fraser University resources;

b. research undertaken by students outside the auspices of Simon Fraser University

and/or its academic programs (e.g. students on co-op or work terms outside the

University) that does not require Simon Fraser University resources and is not

directly supervised by Simon Fraser University faculty;

research undertaken by Adjunct Faculty outside the auspices of Simon Fraser

University and/or its academic programs that does not require Simon Fraser

University resources;

d. REB review is not required for research that relies exclusively on secondary use of

anonymous information, or anonymous human biological materials, so long as the

process of data linkage or recording or dissemination of results does not generate

identifiable information.

Secondary use refers to the use in research of information or human biological materials

originally collected for a purpose other than the current research purpose. Anonymous

information and human biological materials are distinct from those that have been coded, and

also from those that have been anonymized.

7.8 Research on public policy issues, public institutions, and other matters that in a free and

democratic society can properly be considered as part of the public domain is not required to

undergo ethics review, even when interviews with individuals occupying positions connected to

such matters are involved, provided there is no reasonable expectation of privacy. Public policy

is defined as follows:

a. Research protocols that require contact with human participants as part of the study

and whose regular occupational duties involve communicating with the public on

behalf of their organizations (such as public relations officers, official

spokespersons, diplomatic officials, freedom of information officers, archivists, etc.,

or the Chief Executive of an organization) do not require ethics review, to the

degree that answering questions posed by the public is within the ordinary duties of

the participant and are within the acceptable limits of disclosure defined by the

participants'employers;

b. Research protocols in which inquiries are referred to other members of an

organization by a public-relations officer, official spokesperson, etc., of the

organization, do not require ethics review, to the degree that their inquiries are in

keeping with the initial protocol and the substance of the interviews are attributable.

7.9 The opinion of the DORE or Associate DORE should be sought whenever there is doubt

whether or not a particular research project requires ethics review.

PART III - RESPONSIBILITIES

Researchers' Responsibilities in Relation to Ethics Review

8.1

In supervised research, the term "researcher" includes both the supervisor and the

individual(s) being supervised. When a graduate student is shown as the principal investigator

an application, the supervisor of the student must be the co-investigator. When an

undergraduate student's research project is submitted for ethics review, the supervisor must

submit the application and be designated as the principal investigator and the student as the co-

investigator. Before submitting their first ethics application, graduate students are required to

submit a certificate of completion of the graduate student tutorial, which is designed to familiarize

them with the process of online submission (the tutorial is available at: ore.code.sfu.ca).

8.2 It is the responsibility of researchers to obtain ethical approval as described in this policy for

any project, funded or not, involving human participants before commencing the research.

8.3 It is the responsibility of researchers to ensure that there is adequate lead time available for

ethical review in relation to other deadlines.

8.4 Project funds will not be released by the University to the project principals until ethics

approval for the project has been obtained and a copy of the approval is on file in the Office of

Research Ethics.

Research Involving the First Nations, Inuit and Metis Peoples of Canada

Researchers who propose to conduct research involving the First Nations, Inuit, and Metis

Peoples of Canada should familiarize themselves with community customs and codes of

practice, including the traditional and contemporary cultural and political protocols of the

Aboriginal groups involved in the research. Researchers will also familiarize themselves with

Chapter 9 of TCPS-2 and indicate in their applications how they are meeting the requirements of

that chapter that pertain to their projects.

9.1 Community Engagement and Consent

Researchers collecting primary data will obtain informed consent from individuals, communities,

and/or governing bodies, as appropriate to the research project. The researchers and

participants should be apprised of the project's research design and the potential research risks.

Researchers are ethically bound to respect the First Nations, Inuit, and Metis Peoples' cultures,

customs, languages, governance structures, and codes when engaging communities prior to,

during, and following the conclusion of research involving these groups.

Secondary use of data and human biological materials that are publicly available or legally

accessible does not require informed consent. If an Aboriginal group, community, or segment

can be identified by the secondary use of data or human biological materials, researchers will

engage with the group, community, or segment in question to identify the research risks and

potential benefits.

9.2 Intellectual Property and Products of Research

The First Nations, Inuit, or Metis individual or community owns their intellectual property,

including intellectual

and cultural property rights and traditional knowledge (IP). A distinction will

be made between the ownership of IP and the ownership of the products of research in the form

of research analysis data. The latter is subject to Policy R30.03 (Intellectual Property Policy).

Researchers should respect and endeavour to accommodate all participants regarding

ownership of the research results generally and the various attributes of ownership specifically,

including title, attribution, access and usage rights (e.g. scholarly & academic consideration and

publication, internal research, and individual, community, public and commercial purposes);

control, possession, economic rights (e.g. commercialization including protection, development,

and marketing); and risk. These accommodations will be made in accordance with applicable

federal, provincial,

and territorial privacy legislation, with due regard to complying with Policy

R30.03, and in keeping with the cultural protocols of the Aboriginal individual, community, or

organization in question.

Resolution of the issues regarding the research results, generated from primary data collection,

will be determined by consensus between the researcher and the First Nations, Inuit, or Metis

individuals and/or community, and, where practicable, documented in a research agreement.

9.3 Use and Storage of Data

A research agreement between the researcher and the Aboriginal individual, community, and/or

organization should specify details for the use of primary data and research analysis data

including: timelines for the retention of data, the arrangement for secure storage and retrieval,

potential

and actual secondary uses of data, and limits on data disclosure. The research

agreement may include provisions for the storage of data on behalf of an Aboriginal individual,

community, and/or organization without disclosure of the data to a third-party, as permitted by

applicable federal, provincial, and territorial privacy legislation. The research agreement should

be in keeping with the cultural protocols of the Aboriginal individual, community, or organization

in question and should be established before the commencement of research.

10. Qualitative Research

10.1

Qualitative research aims to understand how people think about the world and how they act

and behave in it. This approach requires researchers to understand phenomena based on

discourse, actions and documents, and how and why individuals interpret and ascribe meaning

to what they say and do, and to other aspects of the world (including other people) they

encounter.

10.2

Researchers who propose to conduct qualitative research will familiarize themselves with

Chapter 10 of TCPS-2 and indicate in their applications how they are meeting those

requirements of that chapter that pertain to their projects.

11. Clinical Trials

11.1

A clinical trial is any investigation involving participants that evaluates the effects of one or

more health-related interventions on health outcomes.

11.2

Researchers who propose to conduct a clinical trial will familiarize themselves with Chapter

11 of TCPS-2 and indicate in their applications how they are meeting those requirements of that

chapter that pertain to their projects.

12. Human Biological Materials, Including Materials Related to Human Reproduction.

12.1 Human biological materials

include tissues, organs, blood, plasma, skin, serum, DNA,

RNA, proteins, cells, hair, nail clippings, urine, saliva, and other body fluids. The term also

includes materials related to human reproduction, including embryos, fetuses, fetal tissues, and

human reproductive materials.

12.2

Researchers who propose to conduct research with human biological materials will

familiarize themselves with Chapter 12 of TCPS-2 and indicate in their applications how they are

meeting those requirements of that chapter that pertain to their projects.

13. Human Genetic Research

13.1

Human genetic research involves the study of genetic factors responsible for human traits

and the interaction of those factors with each other, and with the environment.

13.2

Researchers who propose to conduct human genetic research will familiarize themselves

with Chapter 13 of TCPS-2 and indicate in their applications how they are meeting those

requirements of that chapter that pertain to their projects.

PART IV - ADMINISTRATION

Research Ethics Administration

14. Research Ethics Board (REB)

14.1

The REB is a committee of Senate. It is responsible for the timely review of all research

protocols or projects covered by this Policy to ensure that they meet acceptable ethical

standards.

14.2

The REB is administratively independent in its decision-making and is accountable to

Senate.

14.3

The REB has the authority to approve a protocol or project, approve a protocol or project

subject to modifications, or reject a protocol or project. In the latter two cases, detailed written

reasons will be provided to assist researchers in the preparation of revised applications for

ethics approval.

14.4

The REB has the responsibility to monitor ongoing research and to terminate any project

that does not conform to ethical standards.

14.5

The REB is responsible for responding to inquiries from external agencies with

responsibility to monitor ethics review procedures at universities.

14.6

The REB is responsible for ensuring that the research community at Simon Fraser

University is aware of the principles and practices of ethical conduct of research and for

publicizing

issues that will lead to changes in its current review process.

14.7

The REB shall provide an annual report of its activities in the previous year to Senate at its

September meeting.

14.8

At least once a semester, the entire membership of the REB will meet in open session to

discuss and approve the internal policies of the Board.

14.9

The REB has the authority to establish its own procedures and internal policies that do not

conflict with those established by Senate or TCPS-2 and to make recommendations to Senate

for revisions to the Policy.

15. REB Membership

15.1

The REB shall consist of 20 voting members, endeavouring to represent each gender, plus

the DORE and the Associate DORE, who will be ex

officio

(non-voting) members, and one of

whom will serve as Secretary. The membership will be constituted as follows:

One faculty member to be elected by and from each of the following Faculties: Applied

Sciences, Business Administration, Communication Arts and Technology, Education,

and Environment;

b. Two faculty members to be elected by and from each of the following Faculties: Health

Sciences and Sciences (at least one of whom will be from the Department of

Biomedical Physiology and Kinesiology);

Three faculty members to be elected by and from the Faculty of Arts and Social

Sciences;

d. Three graduate students to be elected by Senate; and

e. Five members to be elected by Senate from the SFU community (at least one of whom

will be an undergraduate student).

15.2 The REB will be divided into subcommittees for a) Biomedical and Health Research, b)

Clinical Trials, and c) Social and Behavioural

Sciences. When the Principal Investigator is not

affiliated with SFU,

the REB may choose to have proposals evaluated by external REBs through

reciprocal arrangements.

In addition to the Chair or Deputy Chair, each subcommittee will consist of the following

members, endeavouring to represent each gender:

a. at least

two members who have expertise in relevant research disciplines, fields, and

methodologies covered by the subcommittee ofthe REB;

b. at least one member who is knowledgeable in ethics;

c. at

least one member who is knowledgeable in the relevant law;

d. at least one community member;

e. one graduate student;

for biomedical and health research and clinical trials: a member with a medical degree

and a member with experience in statistics (if not already included in (a) above).

15.3 Every two years, Senate will approve a list of individuals with medical degrees and/or law

degrees qualified to serve on the REB.

15.4 In the event that there is no member elected who has a law degree and is familiar with the

law related to ethics review,

the Chair of the REB will select the next available person from the

approved list to serve on the relevant subcommittees as required.

15.5 In the event that there is no member elected who has a medical degree, the Chair of the

REB will select the next available person from the Senate list to serve on the relevant

subcommittees as required.

15.6 Even ifthere is an elected REB member with a law or medical degree, the Chair may select

the next available person from the Senate list in the case of absence of the elected member or in

order to maintain a reasonable workload for the elected member.

15.7 Every two years, Senate will approve a list of individualswith expertise in ethics.

15.8

In the event that there is no member elected with expertise in ethics, the Chair of the REB

will select the next available person from the Senate list to serve on the relevant subcommittees

as required.

15.9 Even if there is an elected REB member with expertise in ethics, the Chair may select the

next available person from the Senate list in the case of absence of the elected member or in

order to maintain a reasonable workload for the elected member.

15.10

Membership of the subcommittees will be determined in accordance with 15.2 above and

on the basis of the research expertise of the elected members from the Faculties. The members

not elected from Faculties will be selected by rotation and on the basis of availability.

15.11

The subcommittees of the REB will operate in closed session.

15.12

The term of office for voting members of the REB will be three years except for the

graduate student and undergraduate student member who shall be elected for a two-year term.

15.13

the event that a member of the REB is unable to attend a meeting of a subcommittee

and her or his presence is necessary to fulfil the requirements of 15.2 above, the Chair of the

REB has the authority to appoint a temporary replacement to act in place of the regular member

until that member returns or until an election can be held.

15.14

Prior to serving, all members of the REB will attend a workshop or orientation session,

organized by the DORE or Associate DORE, to ensure that they have an understanding of the

principles and practices of ethical review. The workshop requirement may be substituted by the

on-line tutorial accessed at http://www.pre.ethics.gc.ca/english/tutorial or a similar tutorial

approved by the REB.

15.15

On an annual basis, in open session, the full membership of the REB will elect a Chair

and a Deputy Chair who will act in the absence of the Chair. These persons will be faculty

members of Simon Fraser University who have served on the REB previously, normally for at

least two years.

15.16

Unless there is no business to transact, the subcommittees of the REB will normally meet

at least once per month, with no more than six weeks between meetings. The full membership of

the REB will meet at least once a semester in open session to discuss and approve the internal

policies of the Board.

15.17

The

quorum

for the subcommittees for meetings, at which applications involving greater-

than-minimal risk will be considered, is the Chair or Deputy Chair plus a minimum of six or seven

members, depending on the subcommittee, required to participate in accordance with 15.2

above.

15.18

The

quorum

for the full REB meetings in open session is the Chair or Deputy Chair plus

10 of the elected members.

16. Research Ethics Appeal Board

16.1

Researchers have the right to a reconsideration of a negative decision on any of the

grounds enumerated in paragraph 16.3. Researchers may appeal decisions of the REB to the

Research Ethics Appeal Board (REAB) within 15 working days.

16.2

The REAB will be the University of Victoria's Human Research Ethics Committee. The

decisions of the REAB shall be final and binding in all respects for any appeal lodged against a

decision of the REB.

16.3

Appeals may only be heard on the basis of a procedural error that materially and adversely

influenced the decision of the REB, including real or reasonably apprehended bias, including

epistemological bias, or undeclared conflict-of-interest on the part of one or more members of

the REB. The REAB will first determine whether a procedural error, bias or a conflict of interest

(as described above) occurred, and if so, refer the matter back to the REB. The REB will then

determine whether to amend the procedures used based on the recommendations of the appeal

body and make a final determination on the research proposal.

17. Director of the Office of Research Ethics (DORE)

17.1

The DORE reports administratively to the Vice-President (Research).

17.2

The appointment of the DORE will be made by the Vice-President (Research), in

accordance with Policy AD10.03, after receiving advice from a search committee that includes

the Chair of the REB and four additional REB members, selected by the REB. The DORE will

have experience in research involving human participants and will normally hold a doctoral

degree.

17.3

The duties and responsibilities of the DORE are stated in the job description for the

position. The DORE will work in consultation with the REB to perform duties that include, but are

not limited to:

a. reviewing all applications submitted to the REB for the completeness of these

applications and their compliance with this Policy;

approving applications that are minimal-risk, and providing written summaries of the

reasons for such approvals to the REB;

acting in an ex

officio,

non-voting capacity as Secretary to the REB;

managing the Office of Research Ethics;

e. monitoring,

data collection, and communication with other universities and granting

councils;

f. liaising on behalf of REB with external boards and sponsors, and internal University

committees concerning ethics matters. Responds to requests for information or reports

from such boards and external sponsors;

g. completing activity reports concerning human subject ethics review and ethical

research conduct required by national boards and granting agencies;

h. conducting workshops and seminars focusing on ethical issues in the conduct of

research. Reference is made to research integrity issues as well as human subject

research ethics. Develops corresponding educational reference materials;

i. receiving and investigating any concerns or complaints from research participants

about their involvement in SFU research;

j. regularly attending and participating in educational workshops and conferences

concerned with the field of ethical conduct in research.

18.

Associate Director, Office of Research Ethics (Associate DORE)

18.1

The appointment of the Associate DORE will be made by the Vice-President (Research),

in accordance with Policy AD10.03, after receiving advice from a search committee that

includes the Chair of the REB and four additional REB members, selected by the REB. The

Associate DORE will have experience in research involving human participants and will

normally hold a doctoral degree.

18.2

The duties and responsibilities of the Associate DORE are stated in the job description for

the position. The Associate DORE will work in consultation with the DORE and REB to perform

duties that include, but are not limited to:

a. reviewing applications submitted to the REB for the completeness of these applications

and their compliance with this Policy;

b. assisting researchers in the preparation of research and course approval applications

prior to submission to the REB;

communicating to applicants any requirements of the REB to arising from REB's review

of expedited or non-expedited applications, in consultation with the DORE;

implementing and delivering educational workshops and seminars developed in

consultation with the DORE;

e. approving applications that are minimal-risk, and providing written summaries of the

reasons for such approvals to the REB; and

f. assisting in managing the Office of Research Ethics.

PART V - PROCESS

19. Research Ethics Review Process

19.1

Applications to the REB may be placed in one of three categories. These categories are:

Minimal-risk,

which is defined as research in which the probability and magnitude of

possible harms implied by participation in the research is no greater than those

encountered by participants in those aspects of their everyday life that relate to the

research.

Greater-than-minimal-risk,

which applies to applications not covered by a) above;

Course,

which applies to undergraduate and graduate courses that require or allow

students to participate in research projects as part of their training or for the purpose of

assessment.

19.2

When the DORE or Associate DORE considers that an application might appropriately be

designated greater-than-minimal risk, the DORE or Associate DORE will consult with the Chair

of the REB who will decide whether the application should be forwarded to the REB for review

by the appropriate subcommittee. The relevant subcommittee of the REB has the sole authority

to designate an application as "greater-than-minimal risk."

19.3 The REB may delegate its authority to approve minimal-risk applications to the DORE and

Associate DORE. The DORE or Associate DORE shall approve minimal-risk applications on

behalf of the Board, if the DORE or Associate DORE is satisfied that the applications conform to

the definition of minimal-risk stated in 19.1(a) above. If the DORE or Associate DORE is not

satisfied that the application conforms to this definition of minimal-risk or is incomplete, the

application may be returned to the applicant for revisions and/or forwarded to the Chair of the

REB, who will decide whether to refer it to the appropriate subcommittee for review. Upon a

request by the DORE or Associate DORE, the Chair or Deputy Chair of the REB may approve

an application as minimal-risk without a meeting of the appropriate subcommittee of the REB.

Written Summaries of the reasons for all approvals by the DORE, Associate DORE, Chair or

Deputy Chair will

be brought to the next regular meeting of the appropriate subcommittee of the

REB. The subcommittee of the REB may review and amend any decisions made independently

by the DORE, Associate DORE, Chair or Deputy Chair with respect to minimal-risk applications.

Normally, any

amendments made by the subcommittee will be only minor in nature.

19.4 If

the relevant subcommittee of the REB designates a project as greater-than-minimal risk,

it shall inform

the applicant(s) in writing of its reasons and shall also give the applicant the

opportunity to ask the REB to reconsider the designation of the project as greater-than-minimal

risk and propose a process, in consultation with the REB, that might assist the REB in its

reconsideration. If

the Chair of the REB considers that it is possible that the relevant

subcommittee of the REB

may designate an application as greater-than-minimal risk, the Chair

may invite the applicant(s) to meet with the members of the subcommittee at its regular monthly

meeting to answer questions and to make any presentation(s) that might assist the

subcommittee in reaching a decision as to the appropriate designation of the application.

19.5 When deciding whether or not to approve research proposals designated as greater-than-

minimal risk, the relevant subcommittee of the REB must adopt the "proportionate approach to

review." An important element in this approach is the consideration of the scholarly merit of the

proposal. The primary test of scholarly merit is the application of scholarly standards and

methodological approaches appropriate to the discipline(s) of the researcher(s).

Proposed research that has been submitted to a recognized granting agency (e.g. SSHRC,

CIHR, NSERC) for funding under peer review will be considered to have scholarly merit if the

work is funded by that agency. Ifthe proposed research has not been approved

for funding, or if

the proposed research is funded by an independent external contract, the appropriate REB

subcommittee will either determine scholarly merit itself, if the members of the subcommittee

have the necessary research expertise in the area(s) in question, or it may decide to refer the

project for external review by experts who have the appropriate qualifications with respect to the

project. The DORE will send a description of the project to two external reviewers. These

experts will be external to Simon Fraser University (they shall be neither faculty members nor

adjunct

faculty members and there should be no appearance of a conflict of interest).

One reviewerwill be chosen by the applicant(s) and the other by the Chair or Deputy Chair of

the REB

in consultation with members of the REB who have experience in the discipline of the

applicants) or the methodologies associated with the project. Ifthe decision of the two reviewers

is not unanimous, the Chair of the REB will consider the views of the two reviewers and cast the

deciding vote. The reviews by external experts must be completed no later than three weeks

from the date of the requests made by the REB. The application will then be brought to the next

meeting of the relevant subcommittee of the REB.

19.6 When a project has been determined to have scholarly merit, it will be reviewed by the

REB. Normal outcomes of the review process are:

when a majority of the relevant subcommittee of the REB votes to approve the research

protocol, approval will be granted and the research may be initiated;

when the relevant subcommittee of the REB identifies problems such that ethical

approval

cannot be granted, the problems will be communicated to the applicant(s) in

writing;

when a majority of the relevant subcommittee of the REB does not vote to approve the

research protocol, and attempts to address ethical problems have been unsuccessful,

the Chair or Deputy Chair will disallow the research on ethical grounds;

d. if the application has not been completed after one year of being sent an access code

to on-line ethics application forms, the application will be closed by the DORE.

19.7 An academic unit wishing to offer an undergraduate or graduate course that requires or

allows

students, as part of their academic training, to participate in research projects involving

human participants will submit to the DORE:

a. a description of the course;

b. the course outline;

c. a general description of the type(s) of research projects that are likely to be part of the

course;

d. an undertaking that the only type of research to be conducted is minimal-risk (see

19.1(a) above);

e. the means by which the students in the course are made familiar with the appropriate

ethical standards articulated by this Policy and TCPS-2, with copies of printed

materials;

f. the means by which students submit their research plans to the instructors);

g. the means by which those plans are assessed and approved by the instructors);

h. the means by which the conduct of the in-course student research projects is

monitored; and

i. other relevant information.

19.8 The application for course approval shall be submitted by the current instructor of the

course with the approval by the Chair, Director or Dean of the academic unit.

When the DORE is

satisfied that this course poses only minimal-risk to research participants and student

participants and otherwise meets the standards established in this policy, she/he will grant

approval for the course to be designated as a "Research Ethics Board approved course." If the

course is designated minimal-risk a written summary of the reasons for such approvals will be

forwarded to the next meeting of the relevant subcommittee of the REB. This designation will

remain with the course as long as the course description and the general method of teaching the

course do not change (i.e. there is no need forthe course to be approved each time it is offered

if it does not change). However, the Chair, Director, or Dean of the academic unit is responsible

for ensuring the maintenance of the agreement for the course when the instructor(s) of that

course change(s).

19.9 If a course may involve greater-than-minimal risk projects, each project must be submitted

for ethics approval to the DORE and will be considered on a case-by-case basis by the relevant

subcommittee of the REB. If approval is not given, the application will be returned to the

department with an explanation and appropriate suggestions or contingencies. In order for a

course to be offered as a designated "Research Ethics Board approved course," the instructor of

the course must sign a statement to the effect that he/she undertakes to include ethical issues

related to the research projects in the subject matter of the course. The instructor will also take

all reasonable efforts to ensure that his/her students comply with the terms of the approval in

carrying out the research. If the instructor or the DORE deems a research project to involve an

element of greater-than-minimal risk, it is the responsibility of the instructor to ensure that the

project be changed to conform with minimal-risk requirements or to be submitted to the Office of

Research Ethics as an individual application for ethics approval.

19.10 Any discussion of course applications shall take place in closed meetings of the relevant

subcommittee of the REB. After approval, the course application and approval shall be in the

public domain.

19.11 If a student in an REB-approved course wishes to publish any element of a research

project, she or he must submit an application for ethics approval. The DORE, the Chair or

Deputy Chair of the REB, or the relevant subcommittee of the REB may grant retroactive

approval in appropriate cases.

19.12 Once a year, the Chair, Director, or Dean of the academic unit concerned will submit a

report to the DORE which affirms that, for each of the REB-approved courses offered in her or

his

academic unit, every instructor has provided an undertaking to apply the ethical principles

articulated in this Policy and in TCPS-2.

20.

Multi-Jurisdictional Research

Where research involving humans requires the involvement of multiple institutions and/or

multiple REBs, the REB at Simon Fraser University may accept reviews undertaken by an

external REB of

the ethical acceptability of research. The REB must satisfy itself that there is a

formal agreement between Simon Fraser University and the other institution(s) involved and

that this agreement includes a commitment to adhere to the requirements of TCPS-2.

21.

International Projects

When a protocol requires collaboration with universities, agencies, or individuals in other

countries:

a. The REB, in conjunction with the Office of Research Services, shall normally require

confirmation by the collaborating universities, agencies or individuals of compliance

with TCPS-2 as part of a contract between Simon Fraser University and the

collaborating university, agency, or individual;

b. The REB may review the protocols and responsibility of those international universities,

agencies, or individuals;

c. The REB may accept the decision of an international university, or agency as a

substitute for their own review if the procedures adopted by that university, agency, or

individual require compliance of protocols with the TCPS-2 or similar policy,

determined by the REB.