Academic Operational Policies

Subject: Integrity in Research and Scholarship Number:  AOP 220
Issued by: Vice-President Academic Date Issued:  October 2008
Supersedes: N/A Page:  1 of 1
Links:

Academic Integrity – AOP 216

Academic Freedom – AOP 218

Academic Freedom Statement

Intellectual Property – AOP 235

Appendix A: Misconduct and Disciplinary Review

Revision
Date:
 September 2016

Integrity in Research and Scholarship

Purpose

Loyalist College supports and encourages the highest standard of conduct in research and scholarship. The primary responsibility for maintaining integrity and ethical conduct rests with all individuals involved in such activities.

The purpose of this policy is to ensure academic research and scholarship by members of the College community are conducted with academic integrity, scientific rigour, honesty and transparency.

All members of the College engaged in academic research are expected to adhere to the standards outlined in the Tri-Agency Framework: “Responsible Conduct of Research (2014)” issued jointly by the Canadian Institute for health Research (CIHR); the Natural Sciences and Engineering Research Council (NSERC); and the Social Sciences and Humanities Research Council (SSHRC).  The policy may be found at:

http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/

Scope

Loyalist College expects faculty, staff, and students conducting research within the college, on behalf of the college, or using College resources, to adhere to the principles detailed in this policy. All members of the College community are expected to:

  1. Inform themselves of, and comply with, the regulations detailed in the “Tri-Agency Framework: Responsible Conduct of Research”. [Web links above]
  2. Inform themselves of, and adhere to, all College policies relevant to the research process, including: intellectual property rights, privacy, confidentiality, disciplinary measures.
  3. Share responsibility for ensuring integrity in research and scholarship
  4. Support approved procedures if there is any suspicion of misconduct in research or scholarship as per Appendix A: Misconduct and Disciplinary Review. Misconduct in academic research and scholarship is a serious offence. If misconduct is suspected or proven, researchers may face disciplinary measures such as: i) a ban on conducting research, ii) suspension or ban from the College, and even iii) charges of fraud, based on the rules of the relevant Collective Bargaining Agreement, the policies and procedures set forth by the College’s Research Ethics Board, and the Criminal Code of Canada (R.S.C., 1985, c. C-46, s. 380).

All members of the College engaged in academic research involving human participants are expected to adhere to the ethical standards detailed in Part 2 of this policy.

Responsibilities

Loyalist College will actively foster an environment that supports responsible research. The College will promote integrity in research and scholarship by offering workshops, seminars, professional development and the dissemination of relevant written material.

to ensure consistently high standards of integrity in research and scholarship, Loyalist College will appoint and maintain a Research Ethics Board (REB) that will:

  1. Function and make decisions independently from the College
  2. Review all matters concerning research involving human participants within the College, or from outside the College, that involve College resources or personnel

Part 1: Ethical Research and Academic Integrity

Principles

  • Notwithstanding the Tri-Agency Framework, all members of the College community involved in research and scholarship are expected to adhere to ethical standards including, but not limited to, the following:
    • Apply scholarly and scientific rigour and integrity when proposing, conducting, recording, analyzing, transporting and story data, and when reporting and publishing results
    • Recognize the substantive contributions of all collaborators; use unpublished work of other researchers and scholars only with permission and due acknowledgment; and use archival material in accordance with the rules of archival source
    • Ensure authorship of published work includes only individuals who have substantively contributed to, and share responsibility for, the contents of the publication
    • Obtain written permission of the author before using information, ideas or concepts, or data obtained through access to confidential manuscripts, or through applications for funds for research or training, seen as a result of processes such as peer review
    • Reference and, if applicable, obtain permission for the use of any published and unpublished work
    • Comply with the College policy on intellectual property as it relates to the operational and financial terms of research grands and/or contracts awarded to the College researcher
    • Acknowledge in writing in a timely manner any actual, potential or perceived conflict of interest which may compromise the integrity of proposed research or scholarship
    • Acknowledge in writing in a timely manner any material financial interest in a company that contracts with the College to undertake research. (These may include ownership, substantial stock holding, directorship, significant honoraria or consulting fees. It does not include minor stock holding in a large, publicly-traded company.)
    • Reveal in writing in a timely manner to sponsors, the College, and other relevant universities/colleges, journals, or funding agencies, any material conflict of interest that may influence a decision on whether an individual should be asked to review manuscripts or applications, or be permitted to undertake work sponsored from outside sources
    • Maintain transparency in all aspects of research

Procedures

It is the responsibility of any member of the College community who embarks on academic research to:

  • Inform themselves of all Academic Operating Policies relevant to the research process
  • Submit the necessary applications and obtain permissions from all relevant governing bodies before data collection in research involving human participants
  • Submit the necessary application and supporting documents to the College Research Ethics Board (REB) and obtain approval from the REB before beginning any research study involving human participants

Part 2: Research Involving Human Participants

Preamble

Loyalist College adheres to the principles and guidelines of the Tri-Council Policy Statement on Ethical Conduct for Research Involving Human Participants, 2014 (TCPS2).

TCPS2 is issued jointly by the Canadian Institutes of Health Research (CIHR); Natural Sciences and Engineering Research Council of Canada (NSERC); and the Social Sciences and Humanities Research Council of Canada (SSHRC).

These agencies seek to promote research conducted using the highest ethical standards. As a condition of funding, researchers and their institutions are expected to adhere to the ethical principles and articles of TCPS2.

Loyalist College requires employees and students conducting research within the college, or on behalf of the College, to adhere to TCPS2 principles. The policy may be found at:

http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/

Purpose

The purpose of this policy is to ensure research involving human participants is conducted in a manner which ensures human dignity and respect. This includes a clear understanding of:

  • What constitutes research involving human participants
  • The principles, practices, and procedures to ensure the processes and procedures of research involving human participants meets, at a minimum, the ethical standards set forth in TCPS2
  • The College’s Research Ethics Board, an independent standing committee that reviews research proposals involving human participants

Scope of Policy

This policy applies to all research activities involving human participants or human biological materials:

  • Conducted within the College or outside the College using College personnel and/or resources
  • Who are College employees, staff or students either as a researcher or participant

Definitions

Human Participants

The TCPS2 defines human participants as:

  • An individual whose data, or responses to interventions, stimuli, or questions by a researcher are relevant to answering a research question; also referred to as “human participant,” and in other policies/guidance as “subject” or “research subject.”

The TCPS2 defines human biological materials as:

  • 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.

Research Proposals Subject to Research Ethics Board (REB) review

The following require ethical review and approval from the REB before any research commences:

  1. Studies involving human participants (living individuals and/or groups of individuals such as social, ethnic, religious or economic group
  2. Research involving humans includes gathering of information from or about human subjects. This includes physical, sociological, or psychological tests and measurements, surveys, non-intrusive

observation, and the study of recorded data from previous studies, databases and archives, in which it is possible to identify individuals.

  1. Studies involving human biological materials from living or deceased individuals, including tissues, biological fluids, human embryos, fetuses, fetal tissue, reproductive materials and stem cells, human remains or cadavers
  2. Identifiable private information about individuals
  3. Information collected through naturalistic observation of humans (except as stipulated below in section on exemptions)
  4. Student- and course-based research involving human participants
  5. Projects involving secondary use of data on human participants gathered in earlier research projects
  6. Research conducted as part of formal course requirements may, in some instances, require REB review and approval. It is incumbent on the instructor to check with the College Research Services Office to determine if REB approval is required.

Research exempt from Research Ethics Board (REB) review

Some research is exempt from REB review if protections are available by other means, including:

  1. Evaluations that are part of regular college business (Student tests/exams, employee performance review)
  2. Quality assurance studies/surveys (Key Performance Indicators; student performance rates)
  3. Usage/service surveys (e.g. a library or cafeteria survey on usage/feedback)
  4. Data collected for college decision-making (program reviews, student course evaluations)
  5. Research collected by a college to meet external reporting requirements or to facilitate management of the facility
  6. Research based on information that is legally accessible to the public and appropriately protected by law
  7. Research based on information that is publicly accessible and there is no reasonable expectation of privacy

Research involving observation of people in public places does not require REB review when:

  1. It does not involve any intervention staged by the researcher, or any direct interaction with the individuals or groups
  2. Individuals or groups under observation have no reasonable expectation of privacy
  3. Dissemination of research results does not allow identification of any individuals or groups under observation

Principles

Respect for human dignity has been a fundamental principle of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans since the inception of the TCPS2.

5.1 Respect for Human Dignity

Respect for human dignity is central to research ethics. Research involving human participants must be conducted in a manner sensitive to the inherent worth of all humans. As set forth in the TCPS2 (2014), three core principles must guide all research:

5.2 Respect for persons

Respect for persons recognizes the intrinsic value of human beings and the requirement to treat all persons with respect and due consideration.

Researchers have a moral obligation to respect the autonomy of human participants and respect their right to make choices without interference.

Researchers also have a moral obligation to protect human participants with compromised or diminished autonomy. Research participants must have free, informed, and ongoing consent without coercion.

5.3 Concern for welfare

Researchers have an obligation to protect the welfare of research participants.

They must provide participants with clear information about the nature of the research, and the potential risks and benefits, to enable participants to make an informed decision about whether or not to provide consent.

Researchers must attempt to minimize risks and ensure participants are not exposed to undue risks.

Concern for welfare includes the potential impact on participants’ physical, mental and spiritual health and their physical, economic, and social circumstances.

Concern for welfare also includes steps that must be taken by researchers to protect the privacy and confidentiality of information about the person, and the treatment of human biological materials.

5.4 Justice

Research must be conducted in a manner that ensures people are treated fairly and equitably. All people must be treated with respect. The benefits and burdens of research participation must be balanced equitably. No segment of the participants should be unduly harmed or denied benefits from potential knowledge generated by the research.

Special attention may need to be afforded to vulnerable or marginalized people to ensure just treatment in research. Consideration must be given to address the imbalance of power that may exist in the relationship between the researcher and participant(s).

Research Ethics Board (REB)

Authority

The REB is a standing committee of the Research Services Office at Loyalist College that is independent from the College administration and the Board of Governors.

All other entities and offices at the College shall respect the independence, accountability, and authority delegated to the REB and may not over-ride an REB decision to approve or reject a research proposal.

The mandate of the REB is to review, approve, reject, propose modifications to, or terminate, any proposed or ongoing research involving human participants conducted within the College, or by members of the College.

The REB conducts its review process using the consideration set forth in the Tri-Council Policy (TCPS2) as a minimum standard. The REB website is located at:

http://www.loyalistcollege.com/about-loyalist/research-services/research-ethics-board/

Procedures

All individuals intending to conduct research involving human participants at Loyalist College must submit an application to the College’s Research Ethics Board (REB). Approval of the REB is required before an individual may begin data collection.

It is the responsibility of the researcher and principle investigator (PI) to adhere to all relevant research policies and to apply for and receive appropriate permission before conducting any data collection. Researchers are expected to follow any conditions and/or recommendations set forth by the REB.

All individuals who submit an application to the Loyalist College REB to conduct research involving human participants within the College, using College resources, or on behalf of the College, are expected to submit proof they have successfully completed the TCPS2 on-line tutorial training course.

REB Membership and Terms of Reference

  • Members of the REB are appointed by senior administration at the College.
  • Members have a range of experience and expertise in relevant research disciplines, fields and methodologies (relevant in research content methodology, ethics, and relevant law)
  • The REB shall of consist of at least five members, including both men and women, and at least one of whom is a community member with no affiliation to Loyalist College
  • To ensure independence of REB decision-making, no senior administrators at the College may sit on the REB
  • The REB has the authority to consult ad hoc advisors if members feel specific expertise or knowledge is necessary to review the acceptability of a research application
  • REB members are appointed for a three-year term, renewable
  • A chair (or co-chairs) shall be appointed by REB members for a one-year term, renewable
  • No member may sit on the REB for more than 12 years
  • All members must complete the TCPS2 CORE tutorial before sitting on the REB
  • Members are expected to attend and particulate in all REB meetings
  • REB meetings will be held monthly from September to June
  • Members are expected to maintain strict confidentiality regarding applications, reviews and decisions
  • Quorum for meetings shall be 70% of the REB membership; motions and decisions shall be carried with a majority (50%+1) in agreement

Applications

  • Researchers seeking REB approval shall submit their proposals using the current application form posted on the REB website and available from the College Research Services Office.
  • Applications must be accompanied by all necessary supporting documentation.
  • Researchers are expected to include with their application documentation proving they have completed the TCPS2 CORE tutorial.
  • Researchers who wish to conduct research at more than one college must submit a multi-site application to the REB of each institution and receive approval from each college before commencing data collection

Types of REB reviews

Applications may be submitted to the College Research Services Office at any time. The Research Services Office, in collaboration with the REB, determines if an application requires a full board review or a delegated review.

Delegated Review

A delegated review of an application is acceptable if the proposed research involves minimal risk to participants (e.g. potential harm to participants is less than (s)he would likely encounter in daily life.) A delegated review will be done by the chair (or one of the co-chairs) and one other REB member. It will not require a face-to-face meeting and a decision is typically rendered within two weeks of the submission of an application.

Full Board Review

An application requiring review by the full REB membership will be reviewed at a regularly-scheduled monthly meeting. The REB is required to do a full board review if the proposed research:

  1. Is deemed to pose a greater than minimal risk to participants (e.g. the potential harm to participants would be greater than (s)he would likely encounter in everyday life)
  2. Involves deception or incomplete disclosure as part of the research methodology

REB decisions

Following the REB review of your application, the REB will deliver one of the following decisions:

  1. Approved (You may begin data collection)
  2. Recommended for Approval (Questions from the REB need to be addressed. You must submit a revised application for review by the REB chair/co-chair and Research Coordinator.)
  3. Pending Approval (Significant issues/questions from the REB need to be addressed. A revised application must be resubmitted for REB review.)
  4. Not approved (Approval is not granted by the REB. Applicant may file an appeal to the Loyalist College REB appeal board.)

Appeal Board Process

Durham College’s Research Ethics Board will receive, review and respond to any researcher who Loyalist College’s REB has refused approval, with the following conditions:

  1. The researcher has formally requested the initiation of the appeal process to the Loyalist College REB
  2. The researcher must re-submit an application to the Durham REB and adhere to their pre-determined timelines for review
  3. Loyalist College will provide Durham REB with their final decision letter for documentation purposes.

 Durham College will have the authority to review negative decisions made by Loyalist College REB and in doing so, may confirm Loyalist College’s decision, modify the decision, impose specific conditions for approval, or reverse the decision entirely. Durham College REB’s final decision on behalf of Loyalist College will be final and binding

Renewal/Amendment Requests to the REB

Renewal

The REB approves projects for one year. If you require an extension, you must re-submit the entire application to the REB.

Amendment to original application

An applicant must submit an amendment request form to the REB:

  1. To make minor changes or amendments to the protocol of a project already approved by the REB
  2. To appoint a new principal investigator (PI), or add new co-investigator(s)
  3. To change the project title, the name of the funding agency, or sponsor

Adverse events

The principal investigator or faculty supervisor (in the case of student research) is responsible for reporting in writing to the REB any injury or detrimental incident experienced by a research participant or researcher related to the research procedures.

Any undesirable experience or response is considered an adverse event. An adverse event may be emotional, psychological, or physiological in nature.

Reporting to REB filing end-of-study documents

The principal investigator is required to submit to the REB a project completion or termination form. Researchers are required to provide the following information:

  1. A summary of research results
  2. Details about any problems encountered during the research
  3. Publications and dissemination of research findings
  4. Assurance the study was conducted in accordance with the TCPS2 policies

Part 3: Integrity Involving Non-Human Research

Research conducted with non-human participants can benefit our understanding of human health, the environment, conservation of species, population and community ecology, and the interactions between human and non-human populations. Research conducted at Loyalist College, and research conducted by Loyalist College staff or faculty with collaborators at other institutions, will show respect for all life, human and non-human alike. We acknowledge the vulnerability of non-human life in our care, and our responsibility to abide by the four Rs (replacement, reduction, refinement, and review) of research with non-human subjects.

Research at the College will also abide by the relevant, established standards and principles set out in provincial, federal, and international documents concerned with research on non-human subjects.  Such documents include, but are not limited to, the Province of Ontario’s Animals for Research Act (R.S.O. 1990, Chapter A.22), and the Canadian Council on Animal Care (CCAC).

Offices and Committees Responsible for Monitoring the Care and Use of Non-human Subjects

  1. Research Services Office (RSO)
  • Has executive responsibility for the Animal Care and Use Program;
  • Hears and decides appeals of the REB and Animal Care Committee actions and/or decisions.
  • Works closely with the College Animal Care Committee (CACC) for establishing institutional policies on the care and use of animals;
  • Assists investigators, research staff, students, veterinary and animal care staff, the CACC, and administrators in remaining compliant with animal care and use regulations, policies and guidelines;
  • Promotes College-wide understanding of the requirements for the ethical conduct of research, teaching, and testing involving animals.

b. Research Ethics Board (REB)

  • Reviews, and decides on, proposals for research using non-human subjects at the College, and planned by College staff with collaborators elsewhere.
  • Works closely with the ROS for establishing institutional policies on the care and use of non-human subjects;
  • The Board’s specific composition and function will accord with the requirements of its Terms of Reference.

c. College Animal Care Committee (CACC)

  • Is the institutional body responsible for ensuring the humane care and use of animals in research, teaching and testing, and has final authority to suspend any activity involving animals, which does not comply with applicable laws, regulations, policies, and guidelines.
  • Has the right to investigate any area where animals are housed or used. When such inspections are deemed necessary by the CACC, efforts will be made to minimize the risks of compromising ongoing scientific investigations, and whenever possible, a collaborative approach will prevail;
  • The Committee works closely with the RSO;
  • The Committee’s specific composition and function will be detailed in its Terms of Reference, but its membership must include a Veterinarian(s), and a member(s) of the College’s Facilities department.

The responsibility for ensuring compliance with all relevant standards is shared with all the offices and committees mentioned above.

Training of Researchers and Staff

All members of the Loyalist College community involved in research with non-human subjects will be expected to be trained in any methods necessary to ensure the proper care and handling of the organisms in their care, according to the training expectations outlined by the CCAC4, including members of the Facilities department, whose understanding of the needs of the non-human subjects should help to ensure the ideal living environment for the same.

Animal Housing and Care Facilities

Loyalist College will engineer its Animal Housing and Care Facilities in a manner that meets, at a minimum, the standards written by the International Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)5.  The College will be transparent in allowing inspection of their animal care facilities, even at short notice.  All efforts will be made to minimize the risks of compromising ongoing scientific investigations, and whenever possible, a collaborative approach will prevail with the AAALAC.

Veterinary Oversight and Involvement

The College recognizes that the use of non-human subjects in research at the college may result in stress and mortality of subjects under some circumstances.  The College, and all associated committees and offices, will always strive to minimize the likelihood of such events.  Involvement of a veterinarian(s) will help to ensure animals in our care are treated well, and as comfortable and stress-free as possible, as long as they are in our care.  Veterinary services involved with the research program will maintain all relevant standards of their profession, and those of the Canadian Association for Laboratory Animal Medicine (CALAM) Standards of Veterinary Care6.  Should there be instances where subjects must be euthanized, this task will fall to the veterinary services associated with the College.  The veterinary services have the right to halt research at any time it is determined that the care of non-human subjects is not at a standard that meets the expectations of the organizations previously listed.

Glossary

Autonomy – One’s ability to understand information and use one’s own judgment to make decisions (e.g. whether or not to participate in a research study).

Concern for welfare – Researchers and REBs are expected to promote the welfare of participants and protect them from undue risks or harm.

Confidentiality – Researchers and REBs have a legal and ethical duty to safeguard information collected during research. Precautions must be taken to prevent identifiable information from being lost, accessed by unauthorized persons, altered, or stolen.

Conflict of interest – Individuals must ensure there is no real, or perceived, conflict between their duties as researchers and REB members. Any professional or personal interests that may compromise a person’s ability to conduct ethical research or make ethical decisions must be declared.

Consent – Before an individual becomes a participant in a research project, (s)he must indicate their permission or agreement. Ethical research requires free, informed and ongoing consent of participants.

Ethics – Principles of values used to define acceptable conduct. Ethical guidelines help distinguish between good and bad, right or wrong.

Minimal risk research – Research in which there is an expectation the possible harm to participants will be no greater than that encountered in daily life.

Participant – An individual who has freely consented to be involved in a research study whereby data or responses to stimuli or questions are collected by a researcher.

Research – A discipline inquiry or investigation with the goal of gaining or extending knowledge.

Research Ethics – The application of sound moral principles when conducting scientific inquiry.