Protecting Human Participants in Research: Living with Evolving Guidelines

Office ofResearch Ethics

University of Waterloo

Protecting Human Participantsin Research: Living with Evolving

Guidelines

Office of Research Ethics




Contact Information

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

Office of Research Ethics and GrantsNeedles Hall 1026

888-4567 extension 6005

[email protected]



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



Evolution of Codes of Ethics

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

- no formal protections existed




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’




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

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

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

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

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 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



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 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

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

What Research Requires Ethics Review?

All research that involves…..data collected from humans




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




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)




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




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.




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

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

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 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 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

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 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




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




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




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.




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



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



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



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 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’ 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: Living with Evolving Guidelines

Documents

Transcript of Protecting Human Participants in Research: Living with Evolving Guidelines