protecting human participants in research: living with evolving guidelines
DESCRIPTION
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]. - PowerPoint PPT PresentationTRANSCRIPT
Office ofResearch Ethics
University of Waterloo
Protecting Human Participantsin Research: Living with Evolving
Guidelines
Office of Research Ethics
University of Waterloo
Office ofResearch Ethics
University of Waterloo
Contact Information
Susan Sykes, Ph.D., C.Psych.Director,
Office of Research Ethics and GrantsNeedles Hall 1026
888-4567 extension 6005
Office ofResearch Ethics
University of Waterloo
Evolution of Codes of Ethics Canadian and UW Guidelines UW Ethics Review Process ORE Application Process Samples Researcher Safety Responsibility of Researchers
OverviewProtecting Human Participants
Office ofResearch Ethics
University of Waterloo
Evolution of Codes of Ethics
Prior to World War II, little concern for the treatment of humans in research
- no formal protections existed
Office ofResearch Ethics
University of Waterloo
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 participationof subjects are essential to all ethical biomedical
research’
Office ofResearch Ethics
University of Waterloo
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
Office ofResearch Ethics
University of Waterloo
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
Office ofResearch Ethics
University of Waterloo
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
Office ofResearch Ethics
University of Waterloo
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
Office ofResearch Ethics
University of Waterloo
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
Office ofResearch Ethics
University of Waterloo
Evolution of Codes of Research EthicsBelmont 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
Office ofResearch Ethics
University of Waterloo
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
Office ofResearch Ethics
University of Waterloo
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
Office ofResearch Ethics
University of Waterloo
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
Office ofResearch Ethics
University of Waterloo
UW Ethics Review Process
What Research Requires Ethics Review?
All research that involves…..data collected from humans
Office ofResearch Ethics
University of Waterloo
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
Office ofResearch Ethics
University of Waterloo
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)
Office ofResearch Ethics
University of Waterloo
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
Office ofResearch Ethics
University of Waterloo
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.
Office ofResearch Ethics
University of Waterloo
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
Office ofResearch Ethics
University of Waterloo
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
Office ofResearch Ethics
University of Waterloo
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.
Office ofResearch Ethics
University of Waterloo
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
Office ofResearch Ethics
University of Waterloo
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
Office ofResearch Ethics
University of Waterloo
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
Office ofResearch Ethics
University of Waterloo
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
Office ofResearch Ethics
University of Waterloo
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
Office ofResearch Ethics
University of Waterloo
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
Office ofResearch Ethics
University of Waterloo
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.
Office ofResearch Ethics
University of Waterloo
Informed Consent Process
Exceptions to Written Consent Anonymous survey research
Research with individuals from particular cultures
Provision for obtaining written informed consent is normally made in human research
Office ofResearch Ethics
University of Waterloo
ORE Application Process
Form Description All Forms Copyright © 2000-03 University of Waterloo
WordW
Online
Form 101 - 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
W
101A
W
Must
Be
Done
Form 105 - Annual Progress ReportSee description of Annual progress report. W
Office ofResearch Ethics
University of Waterloo
Samples
Sample recruitment materials, information letters, consent forms, and feedback letters
http://www.research.uwaterloo.ca/ethics/human/
informed_consent.asp
Copy and modify sample materials for your project
Office ofResearch Ethics
University of Waterloo
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
Office ofResearch Ethics
University of Waterloo
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
Office ofResearch Ethics
University of Waterloo
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)