Research Ethics: Policy, Processes and Procedures

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Research EthicsPolicy, Processes and Procedures

• Prepared by Alison Collins-Mrakas M.Sc., LLM
• Manager, Office of Research Ethics
• Presented by Daphne Winland (Chair- HPRC),
  Alison Collins-Mrakas,
• Susan Warwick, and Judith Codd, FGS
• Presentation to the Faculty of Graduate Studies
• December 4th, 2007

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York University Senate Policy on the Ethics
Review Process of Research Involving Human
Participants

• Universities across Canada have signed
  Memoranda of Understanding to implement the
  Ethics Code as outlined by the Tri-Council Policy
  Statement (TCPS). York Senate Policy closely
  adheres to the tenets outlined in the TCPS. And
  FGS requires all graduate students, prior to
  conducting research, to complete and pass the
  Tri-Council online Tutorial
• TCPS tutorial http//www.pre.ethics.gc.ca/english
  /tutorial/
• The Senate of York University affirms that
  researchers must respect the safety, welfare, and
  dignity of human participants in their research
  and treat them equally and fairly.
• York Senate policy is intended to serve as
  joint protection for the researcher, the study
  participant and the University in order to ensure
  attention to various rights and responsibilities
  of the respective parties to the research
  endeavour.

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Why is human research ethics review necessary?

• To ensure responsible conduct in research
• To protect research subjects
• To protect researchers

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When is research ethics review required?

• Review is required for ALL research involving
  human subjects, animals and biohazardous
  materials including
• Funded or non-funded or contract
• conducted by faculty, staff or students
• Includes adjunct, contract, visiting fellows
• Research that is undertaken off-campus
• Research that is undertaken by a member of
  the York research community or under the
  aegis of York University but conducted
  off-site is still subject to ethics review

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Example(s) of research that ARE subject to Ethics
Review

• Collection of information through any
  interaction with a living person
• Secondary use of data previously collected from
  human subjects
• Use of identifiable private information about an
  individual
• Research involving human remains, cadavers,
  human organs, tissues and biological fluids,
  embryos or fetuses

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Examples of Research NOT subject to review

• Research about a living individual involved in
  the public arena, based on publicly available
  materials
• Quality assurance studies, performance reviews or
  testing within normal educational requirements
  are not subject to ethics review.
• Practica are generally not subject to ethics
  review.
• Research conducted using secondary analysis of
  datasets or coded samples - identity of subjects
  unknown

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Ethics Review Processes

• Review
• Approval
• Renewal
• Amendment
• Incident(s)
• End of Project

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Graduate Student Research and Ethics Review

• Graduate student research two ethics review
  processes
• Both start the same completing and passing the
• TCPS tutorial http//www.pre.ethics.gc.ca/english
  /tutorial/
• 1. FGS review
• Theses
• Dissertations
• 2. Program/Departmental/Faculty review
• MRPs
• Course-related research
• (undergraduate research)
• unless the research is funded and/or more than
  minimal risk, then it is subject to full review
  by the HPRC

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FGS Website

• www.yorku.ca/grads/
• RESEARCH ETHICS FORMS AT
• www.yorku.ca/grads/policies/ethics.htm

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How are Graduate Student Protocols
Reviewed?Theses and Dissertations

• Student completes Thesis/Dissertation Research
  Proposal Submission (TD1) and FGS ethics review
  protocol form (TD2)
• Student submits the protocol package to
  Graduate Program Office (protocol package
  includes TD1, protocol form, informed consent
  document, TCPS tutorial/certificate and other
  relevant documents such as survey instruments if
  applicable) 1 original 1COPY OF COMPLETE
  PACKAGE
• GPA/GPD reviews package for completeness,
  document is signed, and forwarded to FGS
• FGS Associate Dean reviews submission, then
  forwards (along with any comments) to the Office
  of Research Ethics for circulation to the Chair,
  HPRC
• Protocol is then reviewed by the Sub-committee
  of the HPRC (Associate Dean, FGS Chair, HPRC)
• Decision of committee forwarded to student, FGS
  and GPA
• 20 working days to process

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How are Graduate Student Protocols
Reviewed?MRPS, Course-Related Research

• Student completes appropriate
  Faculty/Department/Programme ethics protocol
  form(s)
• Student submits the protocol package to
  Graduate Programme office for circulation to
  Faculty/Department/Programme ethics committee
• (protocol package includes protocol form,
  informed consent document and other relevant
  documents such as survey instruments if
  applicable)
• GPA reviews package for completeness and
  forwards it to the appropriate Faculty/Department/
  Program review committee
• Committee reviews protocol and communicates
  decision to Student Graduate Program office
• Graduate Program office records the approval
  (for reporting to the HPRC re the annual report)

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Committee Decisions Important Points

• Committee decisions
• Approved
• Approved pending minor revisions
• Approved pending major revisions
• Not approved (decision can be appealed to YEAC)
• Approvals are granted for a 3 year period,
  subject to annual renewals
• Ethics approval certificates MUST be renewed
  annually
• Notification of committee decisions electronic
• Responses to committee concerns electronic
• Hard copy responses are also accepted however
  this can increase the response time
• Research funds cannot be administered and/or
  research accounts cannot be created while a
  protocol/file is pending
• No research activities may be undertaken until
  ethics approval is in place

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Ethics Approval and Researcher Responsibilities

• To ensure continued compliance with the TCPS,
  once ethics approval is in place, the Principal
  Investigator/Researcher is responsible for the
  following
• Annual Renewals multi year projects
• Amendment approval(s)
• Incident reports
• Security and Maintenance of research
  materials
• ICF
• data

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Ethics Review Research Involving Animals and/or
Biohazardous Materials

• Research Involving Animals
• Student completes TD1 and TD4
• Faculty supervisor signs TD4 and provides
  required documents
• Submit, to FGS
• completed, signed TD1 and TD4 with required
  documents
• copy of faculty members certificate of ethics
  approval
• FGS will submit material to Dr. Barry Loughton,
  Chair, ACC c/o Julie Panakos,
• Vivaria Supervisor room 338 BSB
• Research Involving Biohazardous Materials
• Student completes TD1 and TD4
• Faculty supervisor signs TD4 and provides
  required documents
• Submit, to FGS
• completed, signed TD1 and TD4 with required
  documents
• FGS will submit material to Dr. Katalin Hudak,
  Chair, ACoBS room 208 FQ
• TD1 and TD4 Forms are available on the FGS
  website at www.yorku.ca/grads/policies/ethics.h
  tm

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The Research Website

• The York Research website (www.research.yorku.ca)
  has everything you need to complete the ethics
  review and approval process. For your reference
  and use, the following ethics related documents
  and/or forms are available
• HPRC protocol the ethics review protocol
• Informed Consent Form Template
• Checklist for the Informed Consent Form to
  assist researchers in developing their Informed
  Consent Form
• On-line tutorial
• Application for Renewal of Approval
• Application for Approval of Amendment to
  Protocol

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What is Research Ethics?

• Definition
• An ethic of research involving human subjects
  should include two essential components (1)
  the selection and achievement of morally
  acceptable ends, and (2) the morally acceptable
  means to those ends.
• (TCPS 2002)

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Why Research Ethics is Important Cardinal
Principles of Research Ethics

• Research involving human subjects is premised on
  a fundamental moral commitment to advancing human
  welfare, knowledge and understanding, and to
  examining cultural dynamics. Goals and principles
  of human participant protection (TCPS 20002002)
• Governing Principles
• Respect for human dignity
• Respect for free and informed consent
• Respect for vulnerable persons
• Respect for privacy and confidentiality
• Respect for justice and inclusiveness
• Balancing Harms and benefits
• Minimizing harm
• Maximizing Benefit

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The need for Research Ethics Historical Cases
of Ethics Abuse

• Historical
• Nazi experiments and the Nuremberg Code
• Jewish Chronic Disease Hospital Study
• The Willowbrook Study
• Tuskegee Syphilis Study
• Cold War Radiation Experiments
• The monster Study
• Recent
• Rakai Aids Study
• Nuu-Chah-Nulth blood collection
• Emerging
• The Government of Iceland and deCODE

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Ethics Codes and the Protection of Human
Participants in Research

• Nuremberg Code 1948
• Response to Nazi atrocities
• First international document to advocate
  voluntary participation and informed consent
• The voluntary consent of the human subject is
  absolutely essential
• Declaration of Helsinki 1964
• Guidance document for doctors developed by the
  World Medical Association
• Governs international research ethics and defines
  rules for research involving both therapeutic and
  non-therapeutic care
• It is the basis for good clinical practices used
  today
• National Research Act (US 1974) (also known as
  the Belmont Report 1979)
• As a result of the Tuskegee study, created the
  National Commission for the protection of Human
  Subjects of Biomedical Behavioural Research
• Belmont Report development of standard
  principles for research conducted with human
  participants

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Office of Research Ethics

• Should you have any questions about matters
  relating to research ethics, please contact
• Alison Collins-Mrakas M.Sc., LLM
• Manager, Office of Research Ethics
• Room 309 York LanesTel [phone] Fax
  [phone] acollins_at_yorku.ca