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Chapter 15

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History of Research Ethics

Tuskegee syphilis study

Nuremberg Trials

Milgram Study

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Early Ethical Guidelines

Nuremberg Code (1947)

Declaration of Helsinki(1964)

The Tuskegee study led to:

Belmont Report (1979)

Federal regulations requiring Institutional

Review Boards (IRBs)

Early Canadian guidelines

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Ethics Guidelines for Behavioural

Research

In Canada:

Canadian Psychological

Association (CPA) Code

of Ethics for Psychologists Federal Regulations: The

Tri-Council Policy

Statement, 2ndedition

(TCPS2)

In the U.S. (Leary textbook):

American Psychological

Association (APA) Ethical

Principles of Psychologistsand Code of Conduct

Federal Regulations (the

Common Rule)

Additional guidelines govern clinical research,

animal research, genetic testing,

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Researchers Obligations

Advance scientific knowledge for the greatergood

Protecting the rights and welfare of

participants. Research ethics guidelines are utilitarian,

focusing on the consequences (costs and

benefits) of research.

Benefitsof scientific knowledge

Risksto participants

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TCPS2 vs. the Common

Rule The Leary textbook focuses on the context

of research ethics in the U.S.

The foundational principles underlying

these guidelines are very similar.Among other differences, the TCPS2 is

muchlonger and more detailed.

more restrictive with placebo controls. more restrictive in terms of acceptable harm in

research with children.

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Core Principles of Research

Ethics Respect for Persons

Participants deserve respect and consideration

Respect and promote autonomy

Protect those with diminished autonomy

Concern for Welfare Minimize risks

Benefits should outweigh risks

Justice

Benefits and burden of research should beequally distributed.

Special care with vulnerable populations

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Basic Ethical Guidelines

Potential Benefits

Basic knowledge

Improvement of research or

assessment techniques

Practical outcomes

Benefits for researchers

Benefits for research participants

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Basic Ethical Guidelines

Potential Costs

Time and effort of participants

Participants mental and physical welfare

Money

Deception; creation of a climate of

distrust

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Research Ethics Board (REB)

Institutional Review Board (IRB)

Members are from scientific and nonscientific

disciplines; the community.

Researchers submit a written proposal

describing the purpose, procedures, and

potential risks of the study.

REB must approve the proposal before the

study may be conducted.

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Informed Consent

Inform participants of the nature of their

participation in the study and obtain their

explicit agreement to participate.

Problems with obtaining informedconsent:

Compromising the validity of the study

Participants who are unable to give informedconsent

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Elements of an

Informed Consent Form

Description of why the study is being conducted

List of activities that participant will do

Description of possible risks

Statement informing participants that they mayrefuse to participate with no penalty

Confidentiality statement

Encouragement for participants to ask questions

Instructions on how to contact the researcher

Signature lines for the researcher and the

participant

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Invasion of Privacy

Participants have the right to decide when,

where, to whom, and to what extent their

responses will be revealed.

Research involving observation of people in

public places does not constitute an invasion

of privacy.

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Coercion to Participate

Coercion to participate occurs when participants

agree to participate in a research study because

of real or implied pressure from some individual

who has authority or influence over them.

When research participation is a course

requirement or given as extra credit, studentsmust be given the option of an alternate activity

for filling the requirement or earning credit.

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Physical and Mental Stress

The focus of a study may requireparticipants to experience pain, stress,failure, anxiety, or other negative emotions.

Minimal riskrisk that is no greater inprobability and severity than that ordinarilyencountered in daily life or during theperformance of routine physical orpsychological examinations of tests

Any use of more than minimal risk requiresstrong justification.

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Deception

Types of Deception

Presenting participants with a false purpose

of the study

Using an experimental confederate whoposes as another participant or a bystander

Providing false feedback to participants

Presenting two related studies as unrelated

Giving incorrect information regarding

stimulus materials

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Ethical Guidelines on Deception

Only use when necessary

Benefit must outweigh risks

Cannot deceive on factors that might

influence willingness to participate

Debrief participants

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Objections to Deception

Ethical objection: Lying and deceit are

immoral

Pragmatic objection: Participants may

enter studies suspicious of what theresearcher tells them and come to distrust

scientists and the research process

Researchers are not justified in deceiving

participants about aspects of the study that

might affect their willingness to participate.

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Confidentiality

Confidentialitya participants data

may be used only for purposes of the

research and may not be divulged to

others

The easiest way to maintain

confidentiality is to ensure thatparticipants responses are anonymous.

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Debriefing

Four Goals:

Clarify the nature of the study

Remove any stress or negative

consequence that the study may haveinduced

Obtain participants reactions to the study

Be sure that participants leave the study

feeling good about their participation

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Vulnerable Populations (1)

Children

Require parental consent

Children aged 12-17 require parental consent and

personal assent

Prisoners

Must be protected from being forced to participate

Small inducements to participate may lead them to

participate even when they would rather not.

Must ensure that prisoners do not believe that study

participation will affect their treatment in prison

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Vulnerable Populations (2)

People who have impaired decisionalcapacity If they are incapable of understanding the

research, a legal guardian must giveconsent.

People who are at risk for suicide

Pregnant women, fetuses, andnewborns

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Ethical Principles in

Research with Animals

Research involving non-human animals must be

monitored by a person who is experienced in the

care and use of laboratory animals, and a

veterinarian must be available for consultation.Animals must be housed under healthy and

humane conditions.

Experimental procedures must minimize

discomfort.