Protecting Human Participants in Research. Research with Humans 2 Contact Information Susanne Santi...

Protecting

Human Participantsin Research

Research with Humans2

Contact Information

Susanne Santi

Senior Manager, Research Ethics

1027 Needles Hall

519-888-4567 extension 37163

[email protected]


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)



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


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


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)


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


Participant Observation

Public place – no informed consent Not public place – informed consent

Observing behaviour does not involve recording conversations or video recording.


Photographs

Publicly accessible space People are not identifiable – no consent to

use People are identifiable – obtain consent to

use photo in research publications


Interview, Focus Group, Survey

Fully Inform participants about the study,

and obtain written consent

Unless it is an anonymous survey


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


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


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


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


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



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



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


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


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]


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


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


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



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)



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



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.



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


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


ORE Application Process

Form 101/101A


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

[email protected]

● Review Feedback emails will be sent until all comments addressed, then ethics clearance

● Once ethics clearance can begin project


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


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)

Protecting Human Participants in Research. Research with Humans 2 Contact Information Susanne Santi...

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