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Protecting Human Participants in Research: Living with Evolving Guidelines. Office of Research Ethics University of Waterloo. Contact Information. Susan Sykes, Ph.D., C.Psych. Director, Office of Research Ethics and Grants Needles Hall 1026 888-4567 extension 6005 [email protected]

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Protecting human participants in research living with evolving guidelines

Protecting Human Participantsin Research: Living with Evolving Guidelines

Office of Research Ethics

University of Waterloo

Contact information
Contact Information

Susan Sykes, Ph.D., C.Psych.


Office of Research Ethics and Grants

Needles Hall 1026

888-4567 extension 6005

[email protected]


Protecting Human Participants

  • Evolution of Codes of Ethics

  • Canadian and UW Guidelines

  • UW Ethics Review Process

  • ORE Application Process

  • Samples

  • Researcher Safety

  • Responsibility of Researchers

Evolution of Codes of Ethics

  • Prior to World War II, little concern for the treatment of humans in research

    - no formal protections existed

Evolution of codes of ethics
Evolution of Codes of Ethics

  • Nuremberg Code, 1947

    ▪ 10 standards for researchers/physicians

    ▪ result of an American war crimes tribunal

  • Declaration of Helsinki, 1964

  • ▪ developed by World Medical Association

  • ▪ individual patient interests before those of society

  • ‘Informed consent and voluntary participation

  • of subjects are essential to all ethical biomedical research’

Evolution of Codes of Ethics

  • Post-Nuremberg Code: abuses and exploitations of humans in research continued; for example

  • ▪ Tuskegee Syphilis Study, 1932-1972

  • ▪ Willowbrook School Study, 1957-1963

  • ▪ Jewish Chronic Disease Hospital Study, 1963

  • ▪ Milgram Obedience Study, early 1960s

  • ▪ Tearoom Trade Study, mid 1960s

Tuskegee syphilis study
Tuskegee Syphilis Study

  • 600 low-income African-American males recruited: 399 infected with syphilis

  • Participants given free medical exams and meals, and burial insurance, but not told about disease

  • Physicians told participants being treated for “bad blood’

  • Physicians deliberately denied men treatment for syphilis, and prevented treatment from other sources

Milgram obedience study
Milgram Obedience Study

  • Recruited participants for learning and memory study; really studying obedience and disobedience to authority; interest stemmed from Nuremberg Trials

  • Naïve participants believed they were applying escalating electric shock to a “learner” for incorrect answers

  • “learner” was confederate and not shocked

  • Study criticized for extreme psychological stress

Tearoom trade study
Tearoom Trade Study

  • Laud Humphreys conducted a sociology PhD study; it involved a study of homosexual encounters in public washrooms and determining personal characteristics of the men

  • Befriended men by acting as “lookout”

  • Recorded their licence-plate numbers

  • A police officer traced licence #s to provide identifying information

  • Humphreys, altered appearance, contacted the men, and interviewed them in their home for a study concerning health issues

  • Study criticized for using deception upon deception and the lack of informed consent

Bad blood
Bad Blood

  • Richard Ward, head of Institute of Biological Anthropology, University of Oxford studied the Nuu-chah-nulth Indians of Vancouver Island

  • 2/3 of Nuu-chah-nulth Indians have arthritis

  • In 1985, collected 833 vials of blood; subjects signed consent form for screening for arthritis biomarkers

  • Ward did not find the gene he was looking for; used samples in study identifying the people as a distinct indigenous pop. dating back nearly 70,000 years

  • Nuu-chah-nulth claim Ward should have given samples back after arthritis study; Ward has provided some of the blood for other genetic studies

Evolution of codes of research ethics
Evolution of Codes of Research Ethics

  • Belmont Report U.S. 1979:

  • Three Basic Ethical Principals

  • Respect for Persons

    ▪ Individuals treated as autonomous agents

    ▪ Protection of individuals with reduced autonomy

  • Beneficence

    ▪ Respect persons’ decision, protect from harm

    ▪ Maximize benefits and minimize harms

  • Justice

    ▪ Benefits and risks of research must be distributed fairly

Canadian guidelines
Canadian Guidelines

  • MRC Guidelines - 1978, 1987

  • SSHRC Guidelines - 1981

  • Tri-Council Code of Conduct - 1994-1996 (draft)

  • Tri-Council Policy Statement (TCPS): Ethical Conduct for Research Involving Humans - 1998

  • Tri-Agency Advisory Panel on Research

    Ethics- 2001-2006

Canadian guidelines1
Canadian Guidelines

  • 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

Uw accountability research with humans
UW Accountability: Research with Humans

  • 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

Uw ethics review process
UW Ethics Review Process

What Research Requires Ethics Review?

All research that involves…..

data collected from humans

Uw ethics review process1
UW Ethics Review Process

  • Office of Research Ethics Infrastructure

  • Established as Office of Human Research -1971

  • Mandates evolved and expanded during 1990s to present Office of Research Ethics

    • ▪ Director, Research Ethics

    • ▪ Manager, Research Ethics

    • ▪ Research Ethics Coordinator

    • ▪ Animal Research Coordinator

Uw ethics review process2
UW Ethics Review Process

  • Two Ethics Review Routes:

  • ORE: Ethics review by Director or Manager, Office of Research Ethics

  • HREC: Ethics review by all members of Human Research Ethics Committee (or sub-committee)

Uw ethics review process3
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 Manager

    ▪ Applications that pose greater than minimal risk to participants are referred to the HREC

Uw ethics review process4
UW Ethics Review Process

What is Minimal Risk?

….Participants reasonably expect to participate in research activities in which the potential risk of harm is no greater than that which they already experience in their everyday lives.

Uw ethics review process5
UW Ethics Review Process

  • Primary Considerations of Ethics

  • Review Process:

  • Recruitment procedures

  • Anonymity of participants and confidentiality of data

  • Risks vs. benefits of procedures

  • Informed consent process

Recruitment procedures
Recruitment Procedures

  • Variety of routes: telephone, email, paper, radio, poster, flyer

  • Recruitment materials undergo ethics review

  • Script for telephone recruitment necessary

  • For minors, recruitment begins with parents

  • Standard ethics review and clearance statement included in all recruitment materials

  • Sample recruitment scripts on ORE website

Recruitment script
Recruitment Script

Hello, my name is (insert name)and I am a 2nd year student conducting a course project under the supervision of Dr. (name) of Environmental and Resources Studies. I am studying how...

This research will hopefully…

If you volunteer as a participant in this study, you will be asked to…

The session should take approximately (X minutes) of your time.

I would like to assure you that this study has been reviewed and received ethics clearance through the Office of Research Ethics.

If you are interested in participating, please fill out one of the individual confidential recruitment cards* and I will be in touch with you.  Alternatively, you can come to (insert location) and see me.  Thank you.

Anonymity and confidentiality
Anonymity and Confidentiality

  • Anonymity gives best protection for confidentiality of data

  • Access to data only by research team

  • 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

Anonymity and confidentiality1
Anonymity and Confidentiality

  • For some types of research, attribution is preferred over anonymity, by both researcher and participants

  • Participant gives consent for attribution or anonymity of information provided

  • Participant has opportunity to review transcript, or relevant text of report

Risks vs benefits of procedures
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

  • Details on risks and benefits are included in information-consent letter and ORE application; must agree

Informed consent process
Informed Consent Process

Informed consent is

  • Not a single event in time and is not just a form to be signed

  • An educational process

    Informed consent includes

  • Full disclosure of researcher’s and participant’s role

  • Adequate comprehension for person to voluntarily decide to participate

Informed consent process1
Informed Consent Process

  • Elements of an Information Consent Letter

  • Names of the Faculty Supervisor and Student Investigator conducting the project along with departmental affiliation and contact numbers  

  • The study purpose

  • Description in lay language of all procedures:  For questionnaires or interviews, examples of the type of questions are to be included

  • For studies involving questionnaires or interviews, a statement indicating participants may decline answering any question(s)

  • Description of all known or anticipated risks and benefits

  • Details of time commitment required for participation in the project

Informed consent process2
Informed Consent Process

Elements of an Information Consent Letter cont’d

  • Assurance participants free not to participate, or t to subsequently withdraw their consent, without jeopardizing any entitlements   

  • Details about follow-up sessions or subsequent related project  

  • Procedures to ensure confidentiality of data and anonymity of participants -- any limitations on confidentiality should be noted   

  • Details concerning financial or other remuneration of participants  

  • Information on length of retention and security of data 

Informed consent process3
Informed Consent Process

  • Elements of an Information Consent Letter cont’d

  • Opportunity to ask any related questions and receive answers to their satisfaction

  • A statement that indicates that the project has been reviewed and received ethics clearance through the Office of Research Ethics (ORE), and that participants who have comments or concerns resulting from their involvement in the project may contact the Director, ORE. The telephone number for the ORE (519-888-4567, Ext. 6005) must be provided.

Informed consent process4
Informed Consent Process

Provision for obtaining written informed consent is normally made in human research

  • Exceptions to Written Consent

  • Anonymous survey research

  • Research with individuals from particular cultures


  • Sample recruitment materials, information letters, consent forms, and feedback letters


  • Copy and modify sample materials for your project

Researcher safety
Researcher Safety

  • May be risks to researcher while conducting a study; these may translate into risks to participants

  • Review methods of collecting data from the perspective of what could pose possible risks to the researcher

  • Door-to-door surveys or data collection in semi-secluded areas; consider

  • ▪ Work in pairs

  • ▪ Check in and out

  • ▪ Carry a cell-phone

Researchers responsibilities
Researchers’ 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

Researchers responsibilities1
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)