Ethics and Research

Karina McInnis, Executive Director, Research Services Dr. Andrew Winterborn, University Veterinarian &

Director of Compliance

September 25, 2013 Expanding Horizons Student Workshop

Agenda

Review principles, applicable policies, standards and supports for the ethical conduct of research

1) Research Integrity (& publications)

2) Conflict of Interests

3) Intellectual Property

4) Human Research Ethics

5) Animal Research Ethics

Research Integrity

Research & Academic Integrity

"Rather fail with honor than succeed by fraud."

Sophocles

(www.queensu.ca/academicintegrity/index.html)

Senate Policy on Integrity in Research

• Access on the Senate Website at queensu.ca/secretariat/policies/senateandtrustees/research_integrity_policy.pdf

• Applies to faculty, staff, students*, post docs

• Members of the Queen’s community are responsible for:

– Fulfilling integrity expectations of the policy

– Reporting suspected cases of misconduct

• Compliant with Tri-Council requirements – National Standard

• Policy outlines expectations, definitions, processes for reporting and investigating potential misconduct

*except when an integrity issue relates to research associated with a course

Expectations Senate Policy on Integrity in Research

• Deal fairly with colleagues and students

• Carry out research in an honest search for knowledge

• Base findings upon a critical appraisal and interpretation according to scientific, scholarly and/or creative principles

• Make results of work accessible

• Indicate affiliation with Queen’s and properly attribute significant contributions of others.

• Retain research records within personal control for a minimum of 5 years – normally in lab or department of PI

Misconduct in Research or Scholarly Activity Senate Policy on Integrity in Research

Examples:

• Fabrication of data (making up data)

• Falsification (manipulating data/equipment/processes so results inaccurately presented)

• Plagiarism

• Financial misconduct

Misconduct Definitions cont’d Senate Policy on Integrity in Research

Examples:

• Failure to disclose conflict of interests

• Failure to inform co-workers in a timely way of experimental findings or developments

• Failure to recognize contributions of others

Misconduct Definitions cont’d Senate Policy on Integrity in Research

Examples

• Using unpublished material of others without permission

• Attribution of authorship to persons other than those who have contributed sufficiently to take responsibility for intellectual content

• Submitting for publication articles published elsewhere excepted where clearly indicated to be a republication

Other expectations: Tri-Council

• Tri-Council funding agencies :

– Acknowledge funders and sponsors

– Funding applications and progress reports provide true, complete and accurate information

– PIs must ensure all individuals listed on application have agreed to be included

Tri-Agency Framework: Responsible Conduct of Research

www.rcr.ethics.gc.ca/eng/policy-politique/framework-cadre/

Misconduct – Academic Integrity Policy, Queen’s School of Graduate Studies

www.queensu.ca/calendars/sgsr/Academic_Integrity_Policy.html

• Adherence to the values expressed through academic integrity forms a foundation for the "freedom of inquiry and exchange of ideas" essential to the intellectual life of the University

• Academic integrity is constituted by the five core fundamental values of honesty, trust, fairness, respect and responsibility

Misconduct – Academic Integrity Policy, Queens’s School of Graduate Studies

www.queensu.ca/calendars/sgsr/Academic_Integrity_Policy.html

• Use of unauthorized materials (e.g., copying on test, using a calculator)

– unauthorized removal of materials from the library, or deliberate concealment of library materials.

• Facilitation (deliberately enabling another’s breach)

• Forgery (e.g. Creating/altering a transcript)

• Falsification (e.g. Impersonating someone on a test)

Publications – Additional Information; Guide for Graduate Supervision

• Overriding objective – research results are made available through publication/dissemination

• Authors should be able to vouch for quality and integrity of their contribution

• Discuss with supervisor and have a written agreement re issues surrounding publication – template provided

• Publications co-authored by supervisor must be discussed with supervisor first

• Students must respect a supervisor’s request to review any original data associated with the submission

Research Integrity Advice Column

Advice

• Familiarize yourself with policies – internal and external

• Key role in mentoring/training other students:

– Model exemplary behavior

– Ensure they understand policies

– Expect high levels of integrity

• Establish clear understanding re: data, publications etc. when you enter collaborations

• Grant reviewers are smart and careful

• Protect yourself: keep good records (see PARTEQ guide), document key conversations

• Report research misconduct

Other Advice….

Relationship Advice

• Communicate, communicate, communicate

• share information and seek clarity with your supervisor, collaborators etc.

• discuss your future (who will publish what, where and when; how data will be stored/shared; what will you do if one of you chooses not to publish?)

• Ask questions

• Get advice o Advisor SGPS / Supervisor

o Graduate Studies

o VP Research Office (Research Integrity Advisor)

Conflict of Interest

Conflict of Interests

• Two competing interests

• TCPS2 - research involving human subjects

• when research activities and other activities conflict

• Real, potential or perceived conflict between duties/responsibilities related to research AND personal interests

• COIs create divided loyalties, distract researchers from concern for research participants

• Compromised independence, objectivity or ethical duties of loyalty

Conflict of Interests

Examples from Chapter 7, TCPS2:

• Pressure to withhold publications

• Inappropriate recruitment strategies

• Interpersonal relationships (family, community)

• Financial partnerships or other economic interests

• Academic interests

Conflicts of Interests: Advice

• Avoid real, perceived or potential conflicts • Bring forward potential conflicts, yours or others, for

discussion early • Cannot always avoid so consider other ways to minimize or

manage conflicts • University policy requires faculty/staff to declare conflicts (to one-up, e.g., Dept Head) • Policies at Queen’s for faculty: – QUFA Collective agreement, Section 18 – Senate Policy: Conflict of Interest and Conflict of

Commitment

Intellectual Property (IP)

• Intellectual property (IP) is defined as any result of intellectual or artistic activity that can be owned by a person.

• Includes inventions, publications, computer software, works of art, industrial and artistic designs, as well as other creations that can be protected under patent, copyright, or trademark laws.

Intellectual Property

• Typically owned by both graduate student and supervisor if both are creators – collaborative research

• University retains royalty-free irrevocable right to use IP for educational and research purposes

• Senate policy on IP states the overriding objective is to make research results accessible to society through publication for wide utilization and scrutiny

queensu.ca/secretariat/policies/senateandtrustees/intellectualproperty.html

Research Involving Human Subjects

Core Principles of the Ethical Conduct of Research (TCPS2)

• Three core principles - express the value of human dignity

1. Respect for persons

– Autonomy – freedom to choose participation; adequate information

2. Concern for Welfare

– Ensure participants not exposed to unnecessary risks

3. Justice

– Treat people fairly – ensure no segment of the population is unduly burdened with risks of research or denied benefits of the knowledge generated from it

Core Principles of the Ethical Conduct of Research (TCPS2)

• Ethical Balance between providing the necessary protection of participants and serving the legitimate requirements of research

• The core principles provide the compass for navigating between these two main goals

– Maintain free, informed and ongoing consent throughout the research process

Human Research Ethics Review

Research involving human subjects: • Requires ethics board approval

• Must comply with applicable external standards

• Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans

• Eg. Health Canada Regulations, US Regs

• Proportionate approach: – balance potential benefits and risks – Level of scrutiny by boards increases as risk increases

Research Ethics Boards at Queen’s

Two Main Boards at Queen’s:

Health Sciences Research Ethics Board (HSREB)

Chair – Dr. Albert Clark (clarka@queensu.ca)

Coordinator – Kathy Reed (ext 77000; reedk@queensu.ca)

General Research Ethics Board (GREB)

Chair – Dr. Joan Stevenson (stevensj@queensu.ca)

Coordinator – Gail Irving (ext 78281; irvingg@queensu.ca)

http://www.queensu.ca/ors/researchethics.html

Unit REBs - GREB

• Review and may approve course-based research unless it is medium or high risk – then it is forwarded to GREB

• Faculty research and graduate theses – reviewed by the Unit REB if one exists – once approved sent to the GREB with a recommendation for expedited or full review

• GREB Chair reviews recommendation – based on evaluation of risk/ethics concerns recommends expedited or full review

• Expedited: two reviewers; Full: board meeting

Departments with Unit REBS (for GREB)

• Cultural Studies

• Faculty of Education

• Geography

• Gender Studies

• Music

• Political Studies

• Psychology

• School of Business

• School of Kinesiology and Health Studies

• School of Policy Studies

• School of Urban and Regional Planning

• Sociology

Human Research Ethics Education at Queen’s

• Human ethics training required for all graduate students (and recommended for all)

• Online “CORE” (Course on Research Ethics) developed at Queen’s

• Available on Research Services website or www.tcps2core.ca

Human Research Ethics “Advice Column”

• Conduct your study as it was approved (or submit an amendment)

• Ensure consent reflects clearly the expectations for participants, what will happen, risks, voluntary nature of participation etc.

• Ensure records/data are safe and secure; control access; do not violate access rules

• Provisions for confidentiality of subjects – must be specified in study application

• When you submit for approval, don’t despair! Questions really are questions

• Get prior advice for complicated issues

Research Involving Animals

Animal Based Research - The 3 R’s

• Replacement refers to methods which avoid or replace the use of animals in an area where animals would otherwise have been used

• Reduction refers to any strategy that will result in fewer animals being used

• Refinement refers to the modification of husbandry or experimental procedures to minimize pain and distress

• Source: CCAC website http://www.ccac.ca/en_/threer

Research Involving Animals

University Animal Care Committee: Chair – Dr. Chris Ward (uacc@queensu.ca) http://www.queensu.ca/uvet/about/uacc.html University Veterinarian – Dr. Andrew Winterborn (andrew.winterborn@queensu.ca) • Must review and approval all research and teaching activities involving

animals • Primary purpose:

– Minimize harms to animals – Balance harms/use vs. benefits – Ensure compliance with Animals for Research Act and Canadian Council

on Animal Care – Public input – Educate / promote best practices

Animal Research Ethics “Advice Column”

• Don’t start experiments before your protocol is submitted and approved

• Complete animal ethics/handling course

• When you submit for approval, don’t despair! Questions really are questions

• Get prior advice for complicated issues

Thanks for your time!

Questions???