A. N. DIBA

Ethiconomics

Canada's Tri-Council Policy Statement:

Ethical Conduct




Involving Humans

To Address

Issues of

Fairness

AND

Equity

Identify possible


vulnerable circumstances


of participants

Panel on Research Ethics

TCPS 2: CORE, Module 6:


Fairness & Equity

Objectives

Upon completion of this module you will be able to:

-identify possible vulnerable circumstances of participants

-assess the appropriateness of inclusion and exclusion criteria to a research question

-address issues of fairness and equity in sample research designs [1]

Note: Some people may find the historical examples of unethical research in this module upsetting. These examples do not represent the vast majority of excellent research that is done today in compliance with our national ethical standards.[1]

The Fair Distribution of Potential Benefits & The Equitable Treatment of All Research Participants	In the Context of Research
How do we decide who may participate in a study and who may not? How do we ensure that participants are treated fairly and equitably? [2]	History has taught us that without adequate oversight, individuals and groups can be included in research without consideration of the ways in which they may be vulnerable. [2]

Society as a Whole

Suffers

 Because Inequitable


Participation

in Research

Compromises

The Reliability 

&

Usefulness of


Research Results

Good Research


Is


Ethical Research

When any individual or group is unfairly treated in the context of research, the entire research community suffers. Public trust in researchers and their institutions is broken.[2]

Introduction:

Fairness

AND

Equity

The fair distribution of potential benefits and the equitable treatment of all research participants is a matter of concern to all researchers

Panel on Research Ethics

TCPS 2:


CORE, Module 6:





Fairness & Equity

How do we decide who may participate in a study and who may not? How do we ensure that participants are treated fairly and equitably?[2]

History has taught us that without adequate oversight, individuals and groups can be included in research without consideration of the ways in which they may be vulnerable. [2]

Conversely, past research has also unfairly excluded participants, making it inappropriate or unsafe to apply the results to members of excluded groups.[2]

The fair distribution of potential benefits and the equitable treatment of all research participants is a matter of concern to all researchers, REBs, institutions and sponsors of research.[2]

When any individual or group is unfairly treated in the context of research, the entire research community suffers. Public trust in researchers and their institutions is broken. [2]

Society as a whole suffers because inequitable participation in research compromises the reliability and usefulness of research results. Good research is ethical research.[2]


In the evolution of research ethics policies, there has been a progression from a lack of adequate safeguards protecting participant safety and autonomy, to an emphasis on protecting those deemed to be vulnerable, to a more balanced approach to the overall application of fairness and equity to all research participants. [2]

Understanding

Vulnerable

Circumstances

Panel on Research Ethics

TCPS 2: CORE, Module 6:


Fairness & Equity

In applying the principle of Justice to research design and review, it is important for researchers and REB members to understand vulnerable circumstances from the perspective of the participant.[3]

This is particularly important when a study involves people whose ability to provide consent free of influence or coercion may be compromised.[3]

Click through the historical examples below to learn more about how the vulnerable circumstances of participants have been overlooked or abused in the past:




MKULTRA

The Yanomami

Dorothy Proctor

Tuskegee Syphilis Study


The MKULTRA Study









During the 1950s and early '60s, hundreds of people were given experimental treatment with electro-convulsive therapy (ECT) and LSD without informed consent under the supervision of Dr. [4]

Ewen Cameron, a professor at McGill University and head of the Allan Memorial Institute in Montreal.[4][10][11][12][13][14]

Many of the patients had come to the institute to be treated for depression (which was poorly understood then).[4]

Cameron was convinced that all forms of mental illness could be cured by wiping the mind clean of undesired thoughts and behaviours and inserting healthy thoughts. [4]

Patients were given ECT frequently and kept in a drug-induced coma while messages were played to them via tape recorders hidden in their beds. Cameron called this "Psychic Driving".[4]

The CIA (Central Intelligence Agency, U.S.) and the Canadian government funded Cameron's work for its possible military applications.[4]

The program was later found to have been ineffective and many of the patients experienced long-term memory loss.[4]

To see a CBC video about this program, code-named MKULTRA, click this button.[5][6]

MKULTRA

The Yanomami

Dorothy Proctor

Tuskegee Syphilis Study

Donald Ewen Cameron

Donald Ewen Cameron

(24 December 1901 – 8 September 1967)

Courtesy of Wikipedia

Donald Ewen Cameron (24 December 1901 – 8 September 1967)[7] — known as D. Ewen Cameron or Ewen Cameron — was a Scottish-born psychiatrist who served as President of the Canadian Psychiatric Association, American (1952–1953) and World Psychiatric Associations, the American Psychopathological Association and the Society of Biological Psychiatry during the 1950s.

Notwithstanding his high professional reputation, he has been criticized for his administration, without informed consent, of disproportionately-intense electroshock therapy and experimental drugs, including LSD, which rendered some patients permanently comatose. Some of this work took place in the context of the MKUltra mind control program.[8][9]

The Yanomami

Panel on Research Ethics

TCPS 2: CORE, Module 6:

Fairness & Equity

In 1966, anthropologist Napoleon Chagnon was interested in observing one of the last pre-industrial cultures of Brazil and Venezuela, the Yanomami tribe.[15]

He lived among the tribe and bartered weapons (axes and machetes) for information about their norms and history. [15]

The appeal of the weapons was strong enough to persuade the Yanomami to break their strongest taboo, the sharing of their ancestors' genealogical information.[15]

Though the ethnography Chagnon published about the Yanomami, “The Fierce People” was a popular text for anthropology students, it also attracted criticism. [15]

In this book, the Yanomami are described as chronically violent, infanticidal, and abusive to women.[15]

Critics have charged that this is not a true depiction of the tribe, that some observed events were staged to please the researchers, that Chagnon’s presence led to increased violent conflict, and that the book has been used by politicians and private interests to re-settle the Yanomami on reservations so that traditional lands could be opened to gold mining operations.[15]

Chagnon has stood by his work, charging that his critics are biased in favour of a romantic ideal of "the noble savage".[15]

The controversy over Chagnon’s interaction with the Yanomami still provokes heated debate among anthropologists. It has been the subject of numerous books and articles and, most recently, a documentary film entitled "Secrets of the Tribe".[15]

Certainly, the absence of informed consent and the trading of weapons for information would not meet the code of ethics for anthropological fieldwork developed in the 1970’s or the current TCPS.[15]

In Canada, a set of guidelines has been created in response to concerns about the conduct of research in our isolated Northern Communities. To learn more about these guidelines you can access the document, "Ethical Principles for Conduct of Research in the North" by clicking HERE.[15]

Dorothy Proctor

Panel on Research Ethics

TCPS 2: CORE, Module 6: Fairness & Equity

In 2001, Dorothy Proctor, a former inmate of the Kingston Prison for Women who said she was coerced into psychotropic drug experimentation during her incarceration, sued the Canadian government for negligence – and won.[16]

The federal documents unearthed by Proctor's case also revealed that a wide variety of research on prisoners was common during the 1950s and 60s in many prisons across Canada. [16]

Some research was focused on behavioural control and some was in aid of medical or pharmaceutical ventures. At this time there were no standard procedures for obtaining informed consent from prisoners and these practices differed from prison to prison. [16]

To hear a radio documentary about prison research including an interview with Dorothy Proctor


Dorothy Proctor's case was eventually settled out of court. Her allegations prompted a government inquiry that revealed at least 23 other inmates of the Prison for Women had been victims of involuntary experiments. To hear Dorothy Proctor tell her story click on the short excerpt button below. To hear more about research involving prisoners in both Canada and the U.S. listen to the complete report.[17][18][19][20][21][22]

The U.S Public


Health Service


Syphilis Study

Tuskegee, Alabama





Panel on Research Ethics

 The Tuskegee

Syphilis Study

TCPS2:CORE, Module 6: Fairness & Equity

From 1932 to 1973, physicians sought to trace the natural history of syphilis by observing 400 African-American men with syphilis in Tuskegee, Alabama.[23]

The subjects, poor share-croppers, were enticed into the study with offers of free medical examinations and special free treatments. [23]

These special treatments were actually diagnostic procedures such as lumbar punctures.[23]

The false belief that treatment was being administered prevented subjects from otherwise seeking medical treatment for their disease. [24]

Even after penicillin was discovered to be an effective treatment for syphilis in the 1940s, this information was withheld from the subjects until the study was exposed in the media.[23]

Creating Vulnerable Circumstances

Panel on Research Ethics

TCPS2: CORE, Module6: Fairness & Equity

With the development of modern research ethics guidance and education, the extreme instances of mistreatment of participants in vulnerable circumstances are largely a thing of the past.[24]

However, there are subtle ways in which a study can create conditions that make participants vulnerable – or worsen existing conditions.[24]

Even the most well-intentioned research designs can have inadvertent negative effects on these participants. Click on the examples below to learn more:

Watch your Language

Avoid Misunderstandings

Be Careful of Context

Watch Your Language

Panel on Research Ethics

TCPS2: CORE, Module 6: Fairness & Equity

A researcher is interviewing people in an area known for its poor access to education and low literacy levels.[25]

They are told that their stories about their experiences in the local school system will be heard by a government task force that wants to improve educational opportunities in their area. Before doing the interview, each participant is given a consent form that begins:

This study, an assessment of this region's level of educational disenfranchisement, will seek to establish each individual's intensity and longevity of engagement with the school system.[25]

Click HERE to see this sentence in clear and simple language. You may Click HERE to see the original version.

Using unsuitable language in recruitment, information, consent and debriefing documents is one of the most common mistakes researchers make. [25]

Aside from being difficult to understand, this sort of language can make participants feel too uncomfortable to admit they don't fully understand the study causing them to give uninformed consent.[25]

Conversely, a lack of understanding may cause people to refuse to participate in research that may be in their interests. This violates the principle of Respect for Persons.[25]

Avoid Misunderstandings

A team of researchers spend a week talking to elderly people in an assisted care home about their quality of life. [26]

They have permission from the administration to approach people and ask if they would like to do the study.[26]

Those who agree to be interviewed are taken to a room that has been set aside for the study for about an hour at a time.[26]

A few days later the daughter of a participant calls the researchers.[26]

She tells them that each person they interviewed is being treated differently by the staff and the other residents because of a rumour that each person taken into the study room has been diagnosed with senile dementia.[26]

 This is causing the participants a great deal of distress.[26]

How could this have been avoided.[26]

Be Careful of Context

A researcher is using a well-established intelligence test to assess the average intelligence of children in a cross-section of a large city's neighbourhoods. [27]

The results indicate that, on average, Black and Hispanic children scored lower on the intelligence test than Caucasian children, and Asian children scored higher than Caucasian children. [27]

The results, consistent with other studies, are used by some to speculate that intelligence is genetic and that some races are naturally more intelligent than others – igniting a storm of controversy.[27]

A closer look at IQ tests revealed them to be culturally biased, that is, the scenarios and question content are more familiar to people raised in a white middle-class family than to people from other cultural backgrounds. And, the "normative" scores were derived from the scores of people from white, middle-class families.[27]

Efforts have been made to create "culture free" IQ tests but there is still much controversy over the use and applications of IQ tests in general. [27]

If you are interested in exploring some examples of standard and alternative IQ tests click HERE.[27]

Varying Vulnerable Circumstances

As the pendulum swung away from inappropriate inclusion of participants in vulnerable circumstances to an emphasis on protection, research ethics policy reflected a concern for "vulnerable populations."[28]

Women, children, and the elderly, as well as mentally ill, institutionalized and impoverished people, were all considered to be vulnerable populations in need of special protection in the context of research.[28]

TCPS 2 takes the view that categorizing people in this manner fails to consider the nature and stability of each participant’s circumstances in the context of specific research. [28]

Anyone may be in vulnerable circumstances at some time in their lives. [28]

These circumstances may be long-term, short-term, or perhaps only in the context of a specific research project. Click on the examples below to learn more:

Minors

Brain Injury Survivors

Students

Students attending a research institution are often asked to take part in studies conducted by their instructors, advisors, and/or peers.[28]

If a student is approached to participate in a study by someone they view as having a position of authority or being able to influence their academic career, they may be in a vulnerable circumstance in the context of that particular study. [28]

In this case it is the relationship between the student and the researcher that creates a vulnerable circumstance.[28]

The REB may wish the researcher to indicate how the vulnerability of these participants in this context can be minimized or eliminated so as not to jeopardize the consent process.[28]


People who have suffered a brain injury and have been enrolled in a study by their authorized third party may be in vulnerable circumstances because the injury has affected their capacity to make decisions.[29]

This may be a short-term, long-term, or permanent situation. Researchers must be aware of any change in the cognitive status of these participants.[29]

Those whose injuries heal sufficiently to permit independent decision-making are no longer considered to be in vulnerable circumstances due to their brain injury.[29]

They must be asked for their consent to continue their participation in the study.[29]

Inappropriate Exclusion

Panel on Research Ethics

The consideration of participants' vulnerable circumstances in the context of research design and review should not lead to the inappropriate exclusion of individuals or groups.[30]

Historically, women, children, the elderly and those who lack capacity to consent have been routinely excluded from research (particularly health research).[30]

Sometimes these exclusions were due to an over-protective attitude on the part of researchers and REBs. [30]

Sometimes they were due to a desire for expediency and the assumption that results from one group (males aged 18 – 35) could be adapted to other groups.[30]

Exclusions that are not justified by the research question violate the principle of Justice by denying the excluded groups the benefits of research participation. [30]

TCPS 2 requires that individuals not be excluded from the opportunity to participate in research on the basis of attributes such as culture, language, religion, race, disability, sexual orientation, ethnicity, linguistic proficiency, gender or age -- unless there is a valid reason for the exclusion.[30]

The intent of this directive is a more inclusive practice of research leading to a more just distribution of research benefits across the whole of society.[30]

Out in the Cold

In 2007, the U.S. and Canadian governments called for all cold and cough medicines promoted for use in infants to be pulled from the market. [31]

This was in response to reports of children suffering side-effects (and several deaths) from the use of common over-the-counter cold medications.[31]

Physicians had long been concerned about the use of these drugs as they have never been tested on children. [31]

Rather than include children in the clinical trials, manufacturers of the medications decided to estimate dosages for children based on data from trials with adult participants.[31]

After having conducted a review of cough and cold medicines intended for children, Health Canada currently advises parents not to give these medications to children under the age of six and has required the manufacturers to label the products accordingly.[31]

Click HERE to read a news report on this issue.[31]

Expecting the Worst

For women who are pregnant and on medication for a pre-existing condition – or who develop a condition during pregnancy that requires medication – there is usually very little their doctor can tell them about how that medication is going to affect their child.[32]

The majority of clinical trials for medications do not include pregnant women among their participants. [32]

Researchers and REBs have traditionally shown a reluctance to include pregnant and/or nursing mothers in any research that may pose a risk to the fetus or infant.[32]

Some studies exclude women for fear that they may get pregnant during a study. [32]

The result is a lack of information about the safety of medications many pregnant and nursing women need (e.g. for epilepsy, anxiety, heart condition, thyroid disease).[32]

TCPS 2 recognizes that there are ways to safely conduct research with pregnant and nursing women that is consistent with the core principles. [32]

The Policy also requires that these prospective participants not be excluded from research solely on the basis of reproductive capacity, pregnancy, or breastfeeding.[32]

To learn more about this issue, click HERE.[32]

Including Incapacity

Research involving participants who lack capacity to consent is necessary to ensure that the results benefit those with the same source of incapacity.[33]

Here are some examples of research that could not be done without the participation of people lacking capacity to consent:

monitoring long-term effects of a new drug for Alzheimer's disease on people experiencing its early stages comparing different educational approaches to helping children with autism learn to express themselves assessing the effect of community employment on the well-being of intellectually disabled adults [33]

TCPS 2 recognizes the fairness and equity of the appropriate inclusion of people who lack cognitive capacity, and provides specific guidance to researchers and REBs.[33]

Missing the Mark

Sometimes, researchers exclude participants who represent the very population they are trying to help. [34]

Using exclusion criteria to maximize the success of the research – that is, accepting only participants whose behaviour, opinions, or mental or physical characteristics are likely to support a hypothesis – is a built-in bias of researchers and their support staff that needs to be addressed at the design, review, and recruitment stages of research.[34]

For example, an analysis of the inclusion and exclusion criteria of studies investigating the efficacy of psychiatric treatment for alcohol abuse, compared the participants who passed the recruitment screening with the real-world population of people in need of treatment for alcohol abuse.[34]

It was revealed that African-Americans, low-income earners, and individuals with more severe alcohol, drug, and psychiatric problems were disproportionately excluded from the research, while white, economically stable, high-functioning individuals were disproportionately included.[34]

The exclusion criteria effectively denied the potential benefits of the research to the populations in need of those benefits. Click HERE for a news report on the study.[34]

Who's In and Who's Out?

In the design stages of a study, researchers have to decide who to include and who to exclude in their recruitment of participants. [35]

They create a list of inclusion criteria and a list of exclusion criteria. These criteria are based upon the research question, the available participant population, and the goals of the research.[35]

At the review stage, it is the REB’s responsibility to examine the research proposal and determine if the inclusion and exclusion criteria are justified by the research question in accordance with the core principles of TCPS 2.[35]

Click on the examples below to try your hand at generating appropriate inclusion and exclusion criteria:

Work station Comparison

Learning Disability Assessment

Effects of Frequent Body Scans [35]

Work Station Comparison

Research Questions: Are there any measurable differences in user posture, alertness, fatigue, and subjective well-being between users assigned to the prototype, "WorkRite station" and users assigned to a standard work station?[36]

Method: Participants will be randomly assigned to work at either a standard work station or a WorkRite station for a two hour period each day for two weeks.[36]

 Participants will be assigned routine tasks and video-taped while they perform them to provide data for posture and alertness measures. [36]

After each session they will complete a well-being questionnaire.[36]

What are the appropriate inclusion and exclusion criteria for this study?[36]

Inclusion Criteria:

Exclusion Criteria

Work station Comparison

Learning Disability Assessment

Effects of Frequent Body Scans

FEEDBACK

Inclusion Criteria:

- adults between the ages of 18 and 65 (age range of majority of adults in the workforce)

- currently employed in a job requiring the use of a standard workstation

Exclusion Criteria:

- anyone requiring adjustments to the workstation beyond its physical limitations

- anyone who has no experience using a standard workstation [37]

Learning Disability Assessment Research Questions: Are assessments of learning disabilities (LD) currently in use in public schools correctly identifying children with LD? [38]

Is a new assessment method more accurate than the existing measure? Method:

 Three participating schools will allow:

Researchers to conduct LD assessments of primary school children on a one-to-one basis (with the consent of their parents).[38]

 The results of these assessments will be compared with previous standard assessment reports. [38]

What are the appropriate inclusion and exclusion criteria for this study? Inclusion Criteria Exclusion Criteria [38]

Learning Disability Assessment

Effects of Frequent Body Scans

FEEDBACK

Inclusion Criteria:

- Children in grades one, two, or three attending a participating school whose parents have provided consent Exclusion Criteria:

- Children whose parents have not provided consent

- Children who refuse to participate in the assessment

- Children with a severe learning disorder already sufficiently assessed [39]

Effects of Frequent Body Scans

Research Questions: What are the effects of frequent x-rays due to security procedures at airports and other international border checkpoints on the human body over time?[41]

Method: Pilots and people identified as frequent business travellers will be asked for their consent to be assessed for the effects of radiation on cell tissue over one year. [41]

Samples of hair, skin, urine, and blood will be taken before and after each trip.[41]

 After each trip participants will be asked to report whether or not they were exposed to an x-ray body scan.[41]

What are the appropriate inclusion and exclusion criteria for this study?[41]

Inclusion Criteria

Exclusion Criteria [41]

FEEDBACK [42]

Inclusion Criteria:

- adults who routinely encounter x-ray body scan technology at airports or other International border checkpoints

Exclusion Criteria:

- anyone currently undergoing any kind of radiation treatment

- anyone who has undergone radiation treatment within the last five years

- anyone who has been exposed to high levels of radiation in the last five years

- pregnant women or women who may be pregnant (due to potential harm to the fetus)[42]

Effects of Frequent Body Scans

Research Questions: What are the effects of frequent x-rays due to security procedures at airports and other international border checkpoints on the human body over time?[43]

Method: Pilots and people identified as frequent business travellers will be asked for their consent to be assessed for the effects of radiation on cell tissue over one year. [43]

Samples of hair, skin, urine, and blood will be taken before and after each trip. After each trip participants will be asked to report whether or not they were exposed to an x-ray body scan.[43]

What are the appropriate inclusion and exclusion criteria for this study?[43]

Inclusion Criteria

Exclusion Criteria

And Benefits for All

Participants may form expectations in regard to the potential benefits of their involvement in a study.[44]

It is important that the consent materials provide an accurate description of potential benefits and that researchers talk to prospective participants to ensure they have a clear understanding.[44]

Recall from Module 3 that benefits may be direct (e.g. participants learn new information relevant to their lives) or indirect (e.g. results from the study of the effects of a drug on one group of participants can be used to improve the safety and efficacy of the drug for others).[44]

Benefits may be specific to individuals (e.g. improved recovery from depression) or spread out within a community (e.g. access to training, establishment of services) or society in general (advancement of knowledge).[44]

To promote the equitable distribution of the potential benefits of their research, researchers are expected to:

Disseminate the results of the research in presentations and publications

Provide copies of publications or other reports resulting from the research to their institution, professional association or other recognized body to further the dissemination of new knowledge [44]

Provide information about the results of the research to participating individuals, groups, and communities in a language and format that is respectful of their needs [44]

Vulnerability and Inclusiveness

Click on ONE (or more) of the case studies below.[45]

 Each describes a study that may or may not be in conflict with the TCPS guidelines regarding participants in vulnerable circumstances and/or respect for justice and inclusiveness.[45]

 Your challenge is to identify any such conflicts.[45]

Vulnerability & Inclusiveness:

Health Sciences

A master's student in the School of Nursing is interested in the effect of shift timing and duration on nursing efficiency, error rate, fatigue, and morale.[46]

In collaboration with the administration of a major hospital he will have access to the scheduling details for nursing shifts in several departments (e.g. obstetrics, urology, cardiology, etc.) and the internal reports of errors on the floor. [46]

He also intends to interview nurses in each department about their job satisfaction, their energy levels, and their suggestions to improve efficiency and safety on their floor.[46]

He plans to send the following message to the active full-time nurses' listserv:

"How is your job working for you? [46]

 We are interested in interviewing nurses about what they like and don't like about their jobs and how it could be better.[46]

 If you are currently on the duty roster for City Hospital and wish to be interviewed, please email: nurseopinion@gmail.com."[46]

Vulnerability &
Inclusiveness: Health Sciences

Over 90% of the nursing workforce in Canada is female. [47]

As women still assume the larger burden of housework and childcare and eldercare even if they are working fulltime, the researcher may need to consider the ability of nurses with the most stressors to take the necessary time to participate in the study. [47]

One solution may be to offer mini-interview slots of 15 minutes at times chosen by the participants according to their schedules.[47]

In the context of the interview, these circumstances could be addressed by asking whether participants are having difficulty balancing the demands of family (e.g. childcare, eldercare, housework) with the demands of their profession - and asking for suggestions for how their work/life balance could be improved.[47]

As the researcher will be interviewing nurses regardless of their age, gender, or other non-related characteristics, there do not appear to be any relevant groups excluded from the study.[47]

Your Response:

Is the inclusion/exclusion criteria justified by the research question?

Correct answer: Yes

Your answer: Yes

Could the participants in this study be in vulnerable circumstances?[47]

Correct answer: Yes

Your answer: Yes

There are those nurses who are vulnerable and unwilling, They do not bear an unjust burden of research risks

Summary

Researchers and REBs must consider the possible vulnerable circumstances of participants in the context of specific research.[48]

Over-protectionist attitudes or built-in recruitment biases can lead to the inappropriate exclusion of individuals or groups from participation in research.[48]

Care must be taken to avoid inappropriate inclusion of particular populations or groups such that they bear a disproportionate burden of research participation without necessarily being able to enjoy its benefits. [48]

Researchers and REBs must navigate between the dangers of imposing unfair burdens on particular participants, groups and communities, and overprotecting them.[48]

Take the Quiz! Question 1 6-1. If your research involves people in vulnerable circumstances:

a. it will take significantly longer to complete your ethics application. [49]

b. you will need to justify why the research cannot be done without this population.[49]

c. you must demonstrate what measures will be taken to eliminate, reduce, or manage the vulnerable circumstances.[49]

Feedback for c: If it is possible to eliminate, reduce, or manage the vulnerable circumstances of participants, you must demonstrate how this will be done.[49]

 For example, if the source of vulnerability is the potential consequence of being seen to take part in the study, you can describe how the identify of participants will be protected throughout the study from consent to dissemination.[49]

Find the other correct answer[49][50]

 

Varying Vulnerable Circumstances

Panel on Research Ethics

As the pendulum swung away from inappropriate inclusion of participants in vulnerable circumstances to an emphasis on protection, research ethics policy reflected a concern for "vulnerable populations."[40]

Women, children, and the elderly, as well as mentally ill, institutionalized and impoverished people, were all considered to be vulnerable populations in need of special protection in the context of research.[40]

TCPS 2 takes the view that categorizing people in this manner fails to consider the nature and stability of each participant’s circumstances in the context of specific research.[40]

Anyone may be in vulnerable circumstances at some time in their lives. These circumstances may be long-term, short-term, or perhaps only in the context of a specific research project.[40]

Click on the examples below to learn more:

Minors

Brain Injury Survivors

Students


The term 'minor' is most often used to describe someone who has not reached 'the age of majority' – an age that legally separates childhood from adulthood (in the view of the government) and affects the ability of citizens to vote, to enter into contracts, and to make other types of decisions. [40]

This age varies among the provinces and territories. [40]

In most provinces and territories there is no legislation that governs how old one must be to consent to participate in research; Article 21 of the Quebec Civil Code sets out specific rules governing research involving minors. [40]

However, many institutions adopt the 'age of majority' benchmark out of concern that minors may not be cognitively mature enough to make decisions in their own best interests.[40]

TCPS 2 does not specify a minimum age of consent for participation in research.[40]

The Policy encourages researchers and REBs to consider participants' capacity to consent, which can be affected by factors other than age (see Chapter 3, Section [40]

Module 6: Take the Quiz

Panel on Research Ethics

TCPS2: CORE

Module 6:Fairness & Equity

Take the Quiz
Question 2

6-2. It is okay to exclude certain individuals or groups in your recruitment process if:

a. they seem as though they will have difficulty showing up on time or keeping to the study schedule.[51]

b. they have different cultural practices and/or language from those of the research team.[51]

c. they are unlikely to provide information of relevance [51]

Take the Quiz   Question 3

6-3. The advice provided in this unit to watch your language is meant to help you:

a. avoid offending the sensibilities of potential participants while recruiting for your study.[52]

b. provide information and gain consent in ways that preserve the integrity of participants and respects their need for information.[52]

c. complete the research ethics review application so that members of the REB will understand it.[52]

[1]https://tcps2core.ca/course/viewContainer/3uE0Iz-ay0hR


[2]https://tcps2core.ca/course/viewContainer/3txg9ca71uMj

[3]https://tcps2core.ca/course/viewContainer/3kpKIYiQKzFT

[4]https://tcps2core.ca/course/viewContainer/3vD7E5IH7Jrn

[5]https://tcps2core.ca/files/module6/MKULTRA_Psychic_Driving_Media_Transcription_EN.pdf

[6]http://www.ctka.net/pr300-mkultra.html

[7]Obituary Notices". British Medical Journal 3 (5568): 803–804

[8]Ross, Colin. Bluebird: Deliberate Creation of Multiple
Personality Disorder by Psychiatrists. Manitou Communications. ISBN 978-0-9704525-1-1.

[9]https://en.wikipedia.org/wiki/Donald_Ewen_Cameron

[10]http://www.mcgilldaily.com/2012/09/mk-ultraviolence/

[11]http://coat.ncf.ca/our_magazine/links/issue43/articles/1957_1961_canada.htm

[12]http://coat.ncf.ca/our_magazine/links/issue43/articles/1957_1961_canada.htm

[13]http://spartacus-educational.com/JFKcameronDE.htm

[14]http://www.cbc.ca/news/canada/montreal/
montreal-woman-seeks-compensation-in-50s-brainwashing-case-1.670151

[15]https://tcps2core.ca/course/viewContainer/3mZLEKCfeTnr

[16]https://tcps2core.ca/course/viewContainer/3sVyMwR8nwCP

[17]https://tcps2core.ca/course/viewContainer/3sVyMwR8nwCP#

[18]https://en.wikipedia.org/wiki/Dorothy_Proctor

[19]http://tcps2core.ca/files/module6/Dorothy_Proctor_radio_documentary_transcript_EN.pdf

[20]http://www.radio4all.net/index.php/program/7520

[21]http://www.oakridgeclassaction.ca/document/vol%201/Vol%201%20sec2E.pdf

[22]http://www.cefso.ca/public_html/OTD_spring_1999.pdf

[23]https://tcps2core.ca/course/viewContainer/3lO5JFLH7TrH

[24]https://tcps2core.ca/course/viewContainer/3umglI-jjM9Q

[25]https://tcps2core.ca/course/viewContainer/3n8pGx2IXrF2

[26]https://tcps2core.ca/course/viewContainer/3u64aqcsaeWl

[27]https://tcps2core.ca/course/viewContainer/3ngc5Hgb32mF

[28]https://tcps2core.ca/course/viewContainer/3sK0M1YHLNEO

[29]https://tcps2core.ca/course/viewContainer/3sK0M1YHLNEO#

[30]https://tcps2core.ca/course/viewContainer/3lTszLQu78nj

[31]https://tcps2core.ca/course/viewContainer/3vdVijGnYvST

[32]https://tcps2core.ca/course/viewContainer/3mEzlwEPwemY

[33]https://tcps2core.ca/course/viewContainer/3ts1jUNz9l-n

[34]https://tcps2core.ca/course/viewContainer/3k1edZ_CBHWT

[35]https://tcps2core.ca/course/viewContainer/3ri9_gUljuXK

[36]https://tcps2core.ca/course/viewContainer/3i52UHqj8-mt

[37]https://tcps2core.ca/course/viewContainer/3i52UHqj8-mt#

[38]https://tcps2core.ca/course/viewContainer/3pSxMO_o_1w_

[39]https://tcps2core.ca/course/viewContainer/3pSxMO_o_1w_#

[40]https://tcps2core.ca/course/viewContainer/3sK0M1YHLNEO#

[41]https://tcps2core.ca/course/viewContainer/3gLv-KqKsiRQ

[42]https://tcps2core.ca/course/viewContainer/3pSxMO_o_1w_#

[43]https://tcps2core.ca/course/viewContainer/3gLv-KqKsiRQ

[44]https://tcps2core.ca/course/viewContainer/3qHYp3SKzR3r

[45]https://tcps2core.ca/course/viewContainer/3jfeWQNWuNi1

[46]https://tcps2core.ca/course/viewContainer/3hvIZGXTYBmZ

[47]https://tcps2core.ca/course/viewContainer/3hvIZGXTYBmZ#

[48]https://tcps2core.ca/course/viewContainer/3hweXXlD-QAi

[49]https://tcps2core.ca/course/viewContainer/3qZUD8EXSASu

[50]https://tcps2core.ca/course/viewContainer/3qZUD8EXSASu#ans13

[51]https://tcps2core.ca/course/viewContainer/3jDEAayhBBtY
[52]https://tcps2core.ca/course/viewContainer/3pPS0oisK4_M

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