Chapter 15

History of Research Ethics

Tuskegee syphilis study Nuremberg Trials Milgram Study

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

Ethics Guidelines for Behavioural Research

In Canada: Canadian Psychological Association (CPA) Code of Ethics for Psychologists Federal Regulations: The Tri-Council Policy Statement, 2nd edition (TCPS2) In the U.S. (Leary textbook): American Psychological Association (APA) Ethical Principles of Psychologists and Code of Conduct Federal Regulations (the Common Rule)

Additional guidelines govern clinical research, animal research, genetic testing,

Researchers Obligations

Advance scientific knowledge for the greater good Protecting the rights and welfare of participants. Research ethics guidelines are utilitarian, focusing on the consequences (costs and benefits) of research.
Benefits of scientific knowledge
Risks to participants

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

much longer and more detailed. more restrictive with placebo controls.

more restrictive in terms of acceptable harm in

research with children.

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 be

equally distributed. Special care with vulnerable populations

Basic Ethical Guidelines

Potential Benefits Basic knowledge Improvement of research or assessment techniques Practical outcomes Benefits for researchers Benefits for research participants

Basic Ethical Guidelines

Potential Costs Time and effort of participants Participants mental and physical welfare Money Deception; creation of a climate of distrust

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.

Informed Consent

Inform participants of the nature of their participation in the study and obtain their explicit agreement to participate. Problems with obtaining informed consent:
Compromising the validity of the study Participants who are unable to give informed

consent

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 may refuse 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

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.

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, students must be given the option of an alternate activity for filling the requirement or earning credit.

Physical and Mental Stress

The focus of a study may require participants to experience pain, stress, failure, anxiety, or other negative emotions. Minimal risk risk that is no greater in probability and severity than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations of tests Any use of more than minimal risk requires strong justification.

Deception

Types of Deception
Presenting participants with a false purpose

of the study Using an experimental confederate who poses as another participant or a bystander Providing false feedback to participants Presenting two related studies as unrelated Giving incorrect information regarding stimulus materials

Ethical Guidelines on Deception

Only use when necessary Benefit must outweigh risks Cannot deceive on factors that might influence willingness to participate Debrief participants

Objections to Deception

Ethical objection: Lying and deceit are immoral Pragmatic objection: Participants may enter studies suspicious of what the researcher 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.

Confidentiality

Confidentiality a 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 that participants responses are anonymous.

Debriefing

Four Goals:

Clarify the nature of the study Remove any stress or negative consequence that the study may have induced Obtain participants reactions to the study Be sure that participants leave the study feeling good about their participation

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

Vulnerable Populations (2)

People who have impaired decisional capacity

If they are incapable of understanding the

research, a legal guardian must give consent.

People who are at risk for suicide Pregnant women, fetuses, and newborns

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.