Research Ethics: Policy, Processes and Procedures

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Research EthicsPolicy, Processes and Procedures

• Alison Collins-Mrakas, Manager
• Office of Research Ethics
• October 10th, 2006

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Ethical Conduct in Research and the Tri-Council
Policy Statement (TCPS)

• Universities across Canada have signed
  Memoranda of Understanding to implement the
  Ethics Code as outlined by the TCPS. York Senate
  Policy closely adheres to the tenets outlined in
  the TCPS.
• 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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York University Senate Policy on the Ethics
Review Process of Research Involving Human
Participants

• A brief summary of the policy
• What does it mean for researchers?
• What does it mean for administrators?
• What does it mean for student research?

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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 Ethics Review Required?

• All University-based research involving human
  participants whether funded or non-funded,
  faculty or student, scholarly, commercial or
  consultative is subject to the ethics review
  process. Research that is subject to review
  includes, but is not limited to surveys,
  questionnaires interviews and participant
  observation (TCPS, 1998)

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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
• 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
• 1. FGS review
• Theses
• Dissertations
• 2. Program/Departmental/Faculty review
• MRPs
• Course-related research
• (undergraduate research)

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How are Graduate Student Protocols
Reviewed?Theses and Dissertations

• Student completes FGS ethics review protocol
  form (TD2)
• Student submits the protocol package to
  Graduate Program Office (protocol package
  includes protocol form, informed consent
  document, TCPS tutorial/certificate and other
  relevant documents such as survey instruments if
  applicable)
• GPA reviews package for completeness, signs the
  document and forwards it to FGS
• FGS forwards one copy of the package to the
  Associate Dean, Research and another copy 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/Program ethics protocol
  form(s)
• Student submits the protocol package to
  Graduate Program office for circulation to
  Faculty/Department/Program 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

• Approvals are granted for a 3 year period,
  subject to annual renewals
• No research activities may be undertaken until
  ethics approval is in place
• Thesis defences will not be scheduled without
  appropriate approvals 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
• Notification of end of project
• Security and Maintenance of research
  materials
• ICF
• data

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Renewal Process

• At the end of each year of a multi-year
  project, the PI/researcher is required to
• Complete and submit an Application for Renewal
  Form to the Manager, Research Ethics
• Receive renewed approval prior to continuing
  research activities
• Renewal of approval - one-year period
• Copy of the renewal of approval kept on file by
  PI/researcher
• Renewal of approval process - 5 working days
• Please consider this when submitting renewal of
  approval applications

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Amendment Process

• The Manager Research Ethics must be notified and
  approve of any change to a protocol
• Researchers must
• Ensure that the protocol for which ethics
  approval has been granted is adhered to
• For example must utilize the final version of
  ICF, recruitment procedures as outlined on the
  protocol
• Complete and submit an Application for Approval
  of an Amendment to a Protocol
• Form should be submitted to the HPRC c/o
• Manager, Research Ethics, 309 York Lanes
• Receive approval of the amendment prior to
  continuing research activities

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Researcher Responsibilities Other

• The Manager Research Ethics must be notified in
  writing of any adverse impacts or incidents
  related to an approved protocol
• PI/Researchers are responsible for
• Storing completed ICFs
• Secure storage of data collected
• Ensuring all ethics related documents renewals,
  amendment approvals are kept on file
• Notification of end of project
• PE/Researcher shall notify the Manager, Research
  ethics that the project has ended

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Common Problems

• Incomplete/inadequate protocols
• informed consent form missing
• survey instruments missing
• illegible protocols
• Inadequate consent documents
• missing elements of consent document
• informed consent form template
• Administrative issues
• submission lag times
• contact information

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Office of Research Ethics

• Should you have any questions about matters
  relating to research ethics, please contact
• Alison Collins-Mrakas, Manager Office of
  Research Ethics (ORE) 309 York Lanes
• Tel [phone] Fax [phone]
  acollins_at_yorku.ca