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Protecting
Human Participantsin Research
Research with Humans2
Contact Information
Susanne Santi
Senior Manager, Research Ethics
1027 Needles Hall
519-888-4567 extension 37163
Research with Humans3
Overview
Canadian Research Ethics Guidelines Architecture Research Methods Recruitment Informed Consent Data Collection, Storage and Retention ORE Review and Application Processes Responsibility of Researchers
Canadian Research Ethics Guidelines
Tri-Council Policy Statement:
Ethical Conduct for Research Involving Humans
(TCPS)
Research with Humans4
Research with Humans5
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
Research with Humans6
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
Research with Humans7
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…
Architecture Research Methods
Research involving human participants may involveObservationPhotographyInterviewFocus groupSurvey (questionnaire)
Research with Humans8
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
Research with Humans9
Participant Observation
Public place – no informed consent Not public place – informed consent
Observing behaviour does not involve recording conversations or video recording.
Research with Humans10
Photographs
Publicly accessible space People are not identifiable – no consent to
use People are identifiable – obtain consent to
use photo in research publications
Research with Humans11
Research with Humans12
Interview, Focus Group, Survey
Fully Inform participants about the study,
and obtain written consent
Unless it is an anonymous survey
Research with Humans13
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
Research with Humans14
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
Research with Humans15
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
Research with Humans16
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
Research with Humans17
Recruitment in Organizations
Obtain permission from organization’s 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
Research with Humans18
Research with Humans19
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
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, Q&A format, white space
Research with Humans20
Research with Humans21
Informed Consent:Information-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: examples
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
Research with Humans22
Information-Consent Letter
Elements of an Information Consent Letter, Cont’d:
● 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
Research with Humans23
Information-Consent Letter
Elements of an Information Consent Letter, Cont’d:
● 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 (519) 888-4567 ext. 36005 or by email at [email protected]
Research with Humans24
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
Research with Humans25
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
Research with Humans26
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
Research with Humans27
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)
Research with Humans28
UW Ethics Review Process
How is Ethics Review Route Determined?
Most commonly, on the basis of identified levelof 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
Research with Humans29
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.
Research with Humans30
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
Research with Humans31
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
Research with Humans32
ORE Application Process
Form 101/101A
Research with Humans33
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
● Review Feedback emails will be sent until all comments addressed, then ethics clearance
● Once ethics clearance can begin project
Research with Humans34
Researcher’s Responsibilities
Researchers expected to design and implement research consistent with TCPS and with UW’s 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
Research with Humans35
Researcher’s 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)