1. Office of Research Ethics University of Waterloo
Protecting Human Participants in Research: Living with Evolving Guidelines
Office of Research Ethics
University of Waterloo

2. Office of Research Ethics and Grants
Contact Information
Susan Sykes, Ph.D., C.Psych.
Director,
Office of Research Ethics and Grants
Needles Hall 1026
extension 6005

3. Overview
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

4. Evolution of Codes of Ethics
Prior to World War II, little concern for the treatment of humans in research
- no formal protections existed

5. 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’

6. Evolution of Codes of Ethics
Post-Nuremberg Code: abuses and exploitations of humans in research continued; for example
▪ Tuskegee Syphilis Study,
▪ Willowbrook School Study,
▪ Jewish Chronic Disease Hospital Study,
▪ Milgram Obedience Study, early 1960s
▪ Tearoom Trade Study, mid 1960s

7. 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

8. 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

9. 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

10. 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

11. 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

12. Canadian Guidelines MRC Guidelines - 1978, 1987
SSHRC Guidelines
Tri-Council Code of Conduct (draft)
Tri-Council Policy Statement (TCPS): Ethical Conduct for Research Involving Humans
Tri-Agency Advisory Panel on Research
Ethics

13. 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

14. 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

15. UW Ethics Review Process
What Research Requires Ethics Review?
All research that involves…..
data collected from humans

16. 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

17. 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)

18. 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

19. 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.

20. 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

21. Recruitment Procedures
Variety of routes: telephone, , 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

22. 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.

23. 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

24. 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

25. 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

26. 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

27. 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

28. 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   

29. 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 ( , Ext. 6005) must be provided.

30. 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

31. ORE Application Process
Form Description   All Forms Copyright ©  University of Waterloo
Word W
Online
Form Application for Ethics Review of Research with Human Participants.
Form 101A - Application for Ethics Review of Research with Human Participants, for non-thesis course projects. *ORE 101A is done through the  Form 101 online application.
Note: **Form 101 and Form 101A must be completed ON-LINE. TWO signed, paper copies with attachments also must be submitted to the ORE, NH 1024**
For assistance, see Guide to Application Form, Standard Operating Procedures, and sections Ethics Review and Informed Consent and Samples.
101
101A
Must Be
Done
Form Annual Progress Report
See description of Annual progress report.

32. Samples
Sample recruitment materials, information letters, consent forms, and feedback letters
informed_consent.asp
Copy and modify sample materials for your project

33. 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

34. 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

35. 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)