1. Ethical research Dr. Yan Liu
Department of Biomedical, Industrial and Human Factors Engineering
Wright State University

2. Milgram’s Obedience Experiment
Overview
A series of social psychology experiments conducted by Stanley Milgram at Yale University to measure the willingness of study participants to obey an authority figure who instructed them to perform acts that conflicted with their personal conscience (Milgram, 1963,1974)
Participants
40 males between ages of 20 and 50
Ranging from elementary school dropout to those with doctoral degrees
Participants were recruited through newspaper ads and direct mail
The experiment was advertised as lasting one hour, for which the respondents would be paid $4.50 whether they completed the task or not

3. Milgram’s Obedience Experiment (Cont’d)
Procedure
The role of the experimenter was played by a stern, impassive biology teacher dressed in a technician's coat, and the victim was played by an Irish-American accountant trained to act for the role. The participant and confederate of the experimenter were told by the experimenter that they would be participating in an experiment to test the effects of punishment on learning. One person would be a “teacher” who would administer the punishment, and the other would be the “learner”. The confederate and the participant then drew slips of paper to determine who would be the “teacher” and who would be the “learner”. However, the drawing was rigged so that the confederate was always the “learner” and the participant was always the “teacher”.
The "teacher" was given a 45-volt electric shock from the electro-shock generator as a sample of the shock that the "learner" would probably receive during the experiment. The "teacher" was then given a list of word pairs which he was to teach the “learner”. The “teacher” began by reading the list of word pairs to the “learner”. The “teacher” would then read the first word of each pair and read four possible answers. The “learner” would press a button to indicate his response. If the answer was incorrect, the “learner” would receive a shock, with the voltage increasing with each wrong answer. The first level was labeled 15 volts, the second 30 volts, and so on up to 450 volts. The “learner” never actually received any shock, but the participant did not know that.

4. Milgram’s Obedience Experiment (Cont’d)
Results
Approximately 65 percent (26 out of 40) of participants administered the experiment's final 450-volt shock, though many were quite uncomfortable in doing so; everyone paused at some point and questioned the experiment, some even saying they would return the check for the money they were paid. No participant steadfastly refused to give further shocks before the 300-volt level
Discussion
The extreme willingness of adults to go to almost any lengths on the command of an authority constitutes the chief finding of the study
Implications for understanding obedience to authority in real life situations, e.g. the Holocaust
Ethical Issue
Participants suffered from extreme emotional stress

5. The Belmont Report Overview
Summarized the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (The Belmont Report: Ethical Principles and Guidelines for Protection of Human Subjects of Research, 1979)
Defined the principles and applications that have guided more detailed regulations and the APA Ethics Code
Ethical Principles
Beneficence
Respect for persons
Justice
Applications
Assessment of risks and benefits
Informed consent
Selection of subjects

6. Principle of Beneficence
The need for research to maximize benefits and minimize any possible harmful effects of participation
Risk-benefit analysis
Potential Risks
Psychological or physical harm
Loss of confidentiality
The cost of not conducting the study if in fact the proposed procedure is the only way to collect potentially valuable data
Benefits
Direct benefits (e.g. educational benefit, acquisition of a new skill, treatment for a psychological or medical problem)
Material befits (e.g. monetary payment, gift)
Less tangible benefits (e.g. satisfaction, potential beneficial applications of the research findings)

7. Potential Risks Physical Harm Psychological Stress Medical procedures
Administering drugs or alcohol
Depriving participants of sleep for an extended period of time
Psychological Stress
More common than physical stress
Fear and anxiety of failing in completing a task
Grief induced by being asked about past traumatic or unpleasant events
All safeguards should be taken to help participants deal with the stress
“Debriefing” session following the study that is designed in part to address potential problems

8. Potential Risks (Cont’d)
Loss of Privacy and Confidentiality
Care must be taken to protect the participant’s privacy
Keep all data locked in a secure place
Keep responses to sensitive questions confidential
Reponses are usually completely anonymous
Separate information of participants’ identity from the actual data
Concealed observation of behavior
Observing people in public places does not seem to present major ethical issues
Observing people’s behavior in private settings can violate their rights to privacy and confidentiality
Use role-playing to gather evidence about participants’ perception of a potential study

9. Principle of Respect for Persons
Principle of Respect for Persons (Autonomy)
Participants are treated as autonomous, capable of making deliberate decisions about whether to participate in a research
Informed Consent
Potential participants in a research should be provided with all information that might influence their decision of whether to participate
Purposes of the study (not the hypothesis to be tested)
Risks and benefits of participation
Rights to refuse or terminate participation in the study

10. Autonomy Issues Lack of Autonomy Coercion
Special populations such as minors, patients in psychiatric hospitals, and adults with cognitive impairments require special precautions
When a minor is asked to participate, a written consent form signed by a parent or guardian is usually required
The Division of Developmental Psychology of the APA and the Society for Research on Child Development have established their own guidelines for ethical research with children
Coercion
Any procedure that limits an individual’s freedom to consent is potentially coercive
A supervisor asks employees to fill out a survey during a staff meeting
A professor requires students in his class to participate in a study
Some benefits are so great that they become coercive
People may agree to participate in a study because of its high payment rate even if they realize the potential danger to them

11. Informed Consent Form Content
Contains the information that participants need to make their decision of whether to participate
It is important that participants understand the information in the form
Written in simple and straightforward language
Avoids jargon and technical terminology (generally a sixth- to eighth- grade reading level)
Information should be provided as if the researcher were simply having a conversation with the participant (using the “second person”)
If participants are non-English speakers, there should be a translated version of the form
The form might say:
Participation in this study is voluntary. You may decline to participate without penalty.
instead of
I understand that participation in this study is voluntary. I may decline to participate without penalty

12. Information Issues in Informed Consent
Withholding Information
Withhold information about the hypothesis of the study and the particular condition an individual is participating in
It is generally acceptable to withhold information when the information would not affect the decision to participate and when the information will later be provided
Make sure that you have good reasons not to have any informed consent
Deception
Active misrepresentation of information to participants

13. Alternatives to Deception
Role-Playing
The experimenter describes a situation to the participants and then asks them how they or others would respond to the situation
Problems
Simply reading a description of a situation does not involve the participants very deeply
Giving the participants a complete description of the situation (demand characteristics) may allow them to figure out the hypotheses, and they may try to behave in a way that is consistent with the hypotheses as a result
Results obtained in role-playing would be different from those obtained in the real situation
People are likely to underestimate their tendency of undesirable behavior yet overestimate their tendency of desirable behavior

14. Alternatives to Deception (Cont’d)
Simulation Studies
Variation of role-playing that involves simulation of a real world situation
Can create high personal involvement
Ethical issues
Participants can become so engaged in the simulated environment that they experience significant levels of stress
Honest Experiments
Participants are made completely aware of the purposes of the research
Many field experiments involve honest procedure

15. Debriefing Debriefing Importance
A short interview that takes place between the researcher and the participant after the completion of the study
Importance
An opportunity to deal with issues of withholding information, deception, and potential harmful effects of participation
Explain why deception was necessary
Make sure the participant has got over the stress and is comfortable with having participated
Provide access to additional resources if necessary
An opportunity to explain the purpose of the study and tell the participant what kinds of results are expected and their practical implications
Debriefing has both ethical and educational purposes

16. In Milgram’s experiment, Milgram went to great lengths to provide a thorough debriefing session. Participants who were obedient were told that their behavior was normal in that they had acted the same to most other participants. They were made aware of the strong situational pressure that was exerted on them, and efforts were made to reduce any tension they felt. Participants were assured that no shock was actually delivered, and there was a friendly reconciliation with the confederate.
Milgram mailed a report of his research findings to the participants and at the same time asked about their reactions to the experiment. The responses showed that 84% were glad that they had participated, and 74% said that they had benefited from the experience. Only 1% said they were sorry that they had participated. When a psychiatrist interviewed participants a year later, no ill effects of participation could be detected.

17. Justice and the Selection of Participants
Principle of Justice
Addresses issues of fairness in receiving the benefits of research as well as bearing the burdens of accepting risks
Any decisions to include or exclude certain people in a research study must be justified on scientific grounds
There must be a scientific rationale if age, ethnicity, gender, or other criteria are used to select participants

18. Researchers’ Commitments
Researchers’ commitments are important in maintaining trust between the researcher and participant
Punctuality
Being present at the appointed time
Deliver a summary of results to the participant as promised
Deliver the benefits to the participant promptly

19. Federal Regulations and the Institutional Review Board (IRB)
Rules and regulations for the protection of human research participants were issued by the U.S. Department of Health and Human Services (HHS, 2001)
IRB
Required for each institution that receives federal funds
Responsible for the review of research conducted within the institution
Consists of at least five individuals
At least one member must be from outside the institution
Categories of Research in Terms of Amount of Risk
Exempt research
Minimal risk research
Greater than minimal risk research

20. Exempt Research Research which involves no risk is exempt from review
Anonymous questionnaires, surveys, and educational tests
Naturalistic observation in public places when there is no threat to anonymity
Archival research in which the data being studied are publicly available or the participants cannot be identified
No informed consent is required
IRB formulates a procedure to allow researchers to apply for exempt status

21. Minimal Risk Research
Research which involves risk of harm that is no greater than risk encountered in daily life or routine physical or psychological tests
Recording routine physiological data from adult participants except recordings that might involve invasion of privacy
Moderate exercise by healthy volunteers
Research on individual or group behavior in which the researcher does not manipulate participants’ behavior and the research will not involve much stress to participants
Elaborate safeguards are less of a concern; approval by IRB is routine

22. Greater than Minimal Risk Research
Research that places participants at greater than risk encountered in daily life or routine physical or psychological tests
Requires complete informed consent and other safeguards
Requires a thorough review by the IRB
Description of risks and benefits
Procedures for minimizing risks
The exact wording of the informed consent form
How participants will be debriefed
Procedures for maintaining confidentiality

23. IRB Impact on Research Potential Issues
Review process can take a long time
Submissions often need to be revised or clarified
Little can be done to change the basic IRB structure
Researchers must plan carefully
Allowing time for the approval process
Submitting all materials required in the application to minimize the review duration

24. APA Ethnic Code Overview
The Ethical Principles of Psychologists and Code of Conduct (Ethic Code) was revised by APA in 2002 (
Five general principles
Beneficence
Responsibility
Integrity
Justice
Respect for rights and dignity of others
Ten ethical standards addressing issues concerning the conduct of psychologists
Teaching
Research
Therapy
Counseling
Testing
Other professional roles and responsibilities

25. Research with Human Participants
8.01 Institutional Approval
When institutional approval is required, psychologists provide accurate information about their research proposals and obtain approval prior to conducting the research. They conduct the research in accordance with the approved research protocol.
8.02 Informed Consent to Research
(a) When obtaining informed consent as required in Standard 3.10, Informed Consent, psychologists inform participants about (1) the purpose of the research, expected duration, and procedures; (2) their right to decline to participate and to withdraw from the research once participation has begun; (3) the foreseeable consequences of declining or withdrawing; (4) reasonably foreseeable factors that may be expected to influence their willingness to participate such as potential risks, discomfort, or adverse effects; (5) any prospective research benefits; (6) limits of confidentiality; (7) incentives for participation; and (8) whom to contact for questions about the research and research participants’ rights. They provide opportunity for the prospective participants to ask questions and receive answers.

26. Research with Human Participants (Cont’d)
8.03 Informed Consent for Recording Voices and Images in Research
Psychologists obtain informed consent from research participants prior to recording their voices or images for data collection unless (1) the research consists solely of naturalistic observations in public places, and it is not anticipated that the recording will be used in a manner that could cause personal identification or harm, or (2) the research design includes deception, and consent for the use of the recording is obtained during debriefing.
8.04 Client/Patient, Student, and Subordinate Research Participants
(a) When psychologists conduct research with clients/patients, students, or subordinates as participants, psychologists take steps to protect the prospective participants from adverse consequences of declining or withdrawing from participation.
(b) When research participation is a course requirement or an opportunity for extra credit, the prospective participant is given the choice of equitable alternative activities.

27. Research with Human Participants (Cont’d)
8.05 Dispensing With Informed Consent for Research
Psychologists may dispense with informed consent only (1) where research would not reasonably be assumed to create distress or harm and involves (a) the study of normal educational practices, curricula, or classroom management methods conducted in educational settings; (b) only anonymous questionnaires, naturalistic observations, or archival research for which disclosure of responses would not place participants at risk of criminal or civil liability or damage their financial standing, employability, or reputation, and confidentiality is protected; or (c) the study of factors related to job or organization effectiveness conducted in organizational settings for which there is no risk to participants’ employability, and confidentiality is protected or (2) where otherwise permitted by law or federal or institutional regulations.
8.06 Offering Inducements for Research Participation
(a) Psychologists make reasonable efforts to avoid offering excessive or inappropriate financial or other inducements for research participation when such inducements are likely to coerce participation.
(b) When offering professional services as an inducement for research participation, psychologists clarify the nature of the services, as well as the risks, obligations, and limitations.

28. Research with Human Participants (Cont’d)
8.07 Deception in Research
(a) Psychologists do not conduct a study involving deception unless they have determined that the use of deceptive techniques is justified by the study’s significant prospective scientific, educational, or applied value and that effective nondeceptive alternative procedures are not feasible.
(b) Psychologists do not deceive prospective participants about research that is reasonably expected to cause physical pain or severe emotional distress.
(c) Psychologists explain any deception that is an integral feature of the design and conduct of an experiment to participants as early as is feasible, preferably at the conclusion of their participation, but no later than at the conclusion of the data collection, and permit participants to withdraw their data.
8.08 Debriefing
(a) Psychologists provide a prompt opportunity for participants to obtain appropriate information about the nature, results, and conclusions of the research, and they take reasonable steps to correct any misconceptions that participants may have of which the psychologists are aware.
(b) If scientific or humane values justify delaying or withholding this information, psychologists take reasonable measures to reduce the risk of harm.
(c) When psychologists become aware that research procedures have harmed a participant, they take reasonable steps to minimize the harm.