Protecting

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• Protecting
• Human Participantsin Research

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Contact Information

• Susanne Santi
• Senior Manager, Research Ethics
• 1027 Needles Hall
• 519-888-4567 extension 37163
• ssanti_at_uwaterloo.ca

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Overview

• Canadian Research Ethics Guidelines
• Architecture Research Methods
• Recruitment
• Informed Consent
• Data Collection, Storage and Retention
• ORE Review and Application Processes
• Responsibility of Researchers

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Canadian Research Ethics Guidelines

• Tri-Council Policy Statement
• Ethical Conduct for Research Involving Humans
• (TCPS)

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Context of Ethics Framework

• Need for Research advance knowledge to benefit
  groups and society
• Respect for Human Dignity ethic should include
  (1) morally acceptable ends, (2) morally
  acceptable means to those ends
• Subject-Centred Perspective participants usually
  central to a study not treated as objects
• Guiding Ethical Principles

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TCPS Guiding 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 benefits

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TCPS Article 1.1

• All research that involves living human subjects
  requires review and approval by an REB (research
  ethics board) in accordance with this Policy
  Statement, before the research is started

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Architecture Research Methods

• Research involving human participants may involve
• Observation
• Photography
• Interview
• Focus group
• Survey (questionnaire)

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Architecture Research Methods

• Usually, these procedures
• do not involve physical contact between
  researcher and participant
• do not involve interference with behaviours
• do not involve deception
• Risks due to procedures generally negligible, but
  may increase due to context, lack of
  confidentiality

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Participant Observation

• Public place no informed consent
• Not public place informed consent
• Observing behaviour does not involve recording
  conversations or video recording.

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Photographs

• Publicly accessible space
• People are not identifiable no consent to use
• People are identifiable obtain consent to use
  photo in research publications

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Interview, Focus Group, Survey

• Fully Inform participants about the study,
• and obtain written consent
• Unless it is an anonymous survey

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Interviews

• Key Informant
• Professionals in design, planning, etc.
• May be difficult to provide anonymity key
  agents can be traced
• Recognize expert opinion, contribution by
  identifying in publications, with permission
  provide opportunity to review quotations
• Obtain permission to audio record

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Interview

• Users or Citizen Participants in Design
• Anonymity should be provided
• Participant characteristics age, gender,
  ethnicity, etc. should not lead to
  identification
• Obtain permission to audio record

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Focus Group

• Anonymity of information reported
• Researcher guarantees confidentiality however
  cannot guarantee confidentiality by session
  participants
• Audio or video recording is for analysis
  purposes if wish to use for presentation or
  publication, obtain written consent from all
  session participants

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Survey (Questionnaire)

• Paper and pencil, web-based, in-person, telephone
• Usually, questions with multiple-choice
  responses, statements with likert scales, ranking
  of items, and/or short, open-ended response
  questions
• Fully inform no written consent for anonymous
  survey

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Recruitment in Organizations

• Obtain permission from organizations gatekeeper
  to conduct study in organization or recruit
  participants
• discuss project with gatekeeper
• work out a recruitment method while
  protecting privacy of potential participants
• script/letter for gatekeeper permission

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Recruitment

• Who is recruited justice and inclusiveness,
  credibility of findings
• Participation is voluntary no coercion or
  exercise of power or authority
• For minors, recruitment begins with parents
• Variety of routes telephone, email, paper,
  poster, flyer see samples on website
• http//iris.uwaterloo.ca/ethics/human/application/
  101samples.htm

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Informed Consent Process

• Informed consent process involves
• Participant-centered approach
• Full disclosure in lay language i.e. told exactly
  what is going to happen
• Interactive- between researcher participant
• Materials should be grammatically correct easy
  to read grade 8 level, sub-titles, QA format,
  white space

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Informed ConsentInformation-Consent Letter

• Elements of an Information Consent Letter
• ? Names, affiliation, and contact s for Faculty
  Supervisor and Student Investigator  
• ? Study purpose
• ? Lay language description of procedures  exampl
  es of the type of questions for interview or
  questionnaire
• ? Indicate participants may decline answering
  any question(s), if interview or questionnaire
• ? Describe all known or anticipated risks and
  benefits
• ? Details of time commitment required for
  participation

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Information-Consent Letter

• Elements of an Information Consent Letter,
  Contd
• ? Free not to participate, or subsequently
  withdraw consent, without jeopardizing any
  entitlements    
• ? Details about follow-up sessions or subsequent
  related project  
• ? Procedures to ensure confidentiality of data
  and anonymity of participants -- limitations on
  confidentiality should be noted    
• ? Financial or other remuneration for
  participation   
• ? Length of retention and security of data

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Information-Consent Letter

• Elements of an Information Consent Letter,
  Contd
• ? Opportunity to ask any related questions and
  receive answers to their satisfaction
• ? Statement This study has been reviewed and
  received ethics clearance through the Office of
  Research Ethics. However, the final decision
  about participation is yours. If you have any
  comments or concerns please contact the office at
  [phone] ext. 36005 or by email at
  ssykes_at_uwaterloo.ca

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Data Collection, Storage Retention

• Privacy and confidentiality while collecting data
• Data are kept secure from theft, interception,
  copying or perusal
• Personal identifiers removed from questionnaires,
  tapes, other documents
• No names/identifiers released without written
  consent
• Access to data with identifiers only by
  researchers

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Risks vs. Benefits of Procedures

• Potential benefits of research must outweigh any
  potential risks
• Researcher must determine both known and
  potential risks of procedures
• Risks of procedures can be physical,
  psychological, legal, economic and social
• Risks of procedures assessed within context

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UW Ethics Review Process

• What Research Requires Ethics Review?
• All research involving living
• human participants
• Research involves a systematic investigation to
  establish facts, principles or generalizable
  knowledge

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UW Ethics Review Process

• Two Ethics Review Routes
• ORE Ethics review by Director or a Manager,
  Office of Research Ethics
• HREC Ethics review by all members of Human
  Research Ethics Committee (or sub-committee)

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UW Ethics Review Process

• How is Ethics Review Route Determined?
• Most commonly, on the basis of identified level
• of risks to participants
• Applications that pose no more than minimal
  risk to participants are reviewed by Director or
  a Manager
• Applications that pose greater than minimal
  risk to participants are referred to the HREC

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UW Ethics Review Process

• What is Minimal Risk?
• .Participation in research activities in which
  the potential risk of harm is no greater than
  that which participants already experience in
  their everyday lives.

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UW Ethics Review Process

• Primary Considerations
• Study Details
• - Purpose, methodology, recruitment, participants
  
• Recruitment procedures
• Anonymity of participants and confidentiality of
  data
• Risks vs. benefits of procedures
• Informed consent process

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UW, Human Research Accountability

• Tri-Council Policy Statement Ethical Conduct for
  Research Involving Humans
• University of Waterloo Guidelines for Research
  with Human Participants
• Memorandum of Understanding between Federal
  Granting Agencies and Institutions

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ORE Application Process
 

• Form 101/101A

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Review Time

• ? 15 working days for review, may be less
• ? Obtain Ethics Review Feedback via email
  cannot begin project until ethics clearance
• ? Respond to comments and make revisions
• ? Responses and revisions returned to
• OHRAC_at_uwaterloo.ca
• ? Review Feedback emails will be sent until all
  comments addressed, then ethics clearance
• ? Once ethics clearance can begin project

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Researchers Responsibilities

• Researchers expected to design and implement
  research consistent with TCPS and with UWs
  Guidelines
• Researchers ensure all their research involving
  humans undergoes ethics review and receives
  ethics clearance prior to commencement of the
  project
• Researchers conduct research in accordance with
  their description in the application for which
  ethics clearance has been granted

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Researchers Responsibilities

• Researchers submit all subsequent modifications
  to the protocol for ethics review and clearance
  before changes are undertaken (ORE 104)
• Researchers responsible for submitting an annual
  Progress Report for all ongoing research projects
  (ORE 105)
• Researchers submit an adverse event form for any
  events related to the procedures used that
  adversely affect participants (ORE 106)