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

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

2 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 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 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 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 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 7 Potential Risks Physical Harm  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 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 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 10 Autonomy Issues Lack of Autonomy  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 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 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 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 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 15 Debriefing  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 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 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 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 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 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 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 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 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 24 APA Ethnic Code Overview  The Ethical Principles of Psychologists and Code of Conduct (Ethic Code) was revised by APA in 2002 (http://www.apa.org/ethics)http://www.apa.org/ethics  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 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 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 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 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 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 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 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 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.


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