Ch. 4
What did Dr. Chester M. Southam do?
-1963: injected live cancer cells into 22 elderly patients at Jewish Chronic Disease Hospital (New York) -Patients not told about cancer cells in injections -3 doctors at the hospital objected, reported --Southam to NY State Board of Regents -Temporarily lost medical license (i.e., 1 year probation) -Ironically, 2 years later, he became President of the American Cancer Society
Tuskegee Syphilis Experiment
-At the beginning of the study in 1932, syphilis was rampant in the southern U.S. -Started with 600 black men, 400 of which had syphilis -Participants recruited via flyers: promised free medical treatment for "bad blood", not syphilis -Study conducted to examine the effects of untreated syphilis on the body as the disease progressed -In the beginning of the study participants told they were being treated when they actually were not
What is the type of information collected from individuals who participate in studies?
-Attitudes & opinions e.g., prejudices, politics, team preference -Measures of performance e.g., reaction time, manual dexterity, memory -Demographic characteristics e.g., age, income, sexual orientation -APA requires all info kept confidential and anonymous.
What is category 1 research proposals are classified into?
-Category 1 - Exempt Review No possible/foreseeable risk to adult participants Exempt from informed consent requirements Proposal viewed by IRB chair only Ex. Anonymous, mailed surveys on innocuous topics or public observation of behavior
What is category 2 research proposals are classified into?
-Category 2 - Expedited Review Research presents no more than minimal risk Typically includes research on individual or group behavior Normal adult participants, no psychological intervention or deception involved At least oral (if not written) consent required Reviewed by several IRB board members
What is category 3 research proposals are classified into?
-Category 3 - Full Review If study involves any questionable elements ex. vulnerable populations, deception, special equipment, interventions, invasive measures Researcher meets with all IRB board members in person to discuss, explain, and answer questions about the research
What is Clinical Equipoise?
-Clinician must provide best possible treatment. -Research comparing treatments in which one treatment is believed to be superior violates no harm principle -One group of participants isn't getting the known superior treatment
Informed Consent form should?
-Describe all elements of project. -State right to withdraw at any time without penalty.
General guidelines for debriefing?
-Do not rush. -Attempt to return participants to the way they were before. -Repeat all guarantees of confidentiality & anonymity. -For maximum effectiveness, conduct immediately after experiment.
Who brought attention to ethical misconduct?
-Dr. Henry K. Beecher published an article describing 22 examples of published research studies with questionable ethics. -Concluded "unethical or questionably ethical procedures are not uncommon." -Heightened the awareness of researchers, public, & media to problems of unethical research. -"Until this article we assumed that unethical research could only occur in a depraved regime like the Nazis."- Robert J. Levine, MD
Another concern is whether research involves vulnerable populations, which can be detected by?
-Health, age, & ability to understand -Special protections given to any sensitive/vulnerable populations
What are 2 general strategies to ensure confidentiality?
-No identifying info appears on data records Used when no need to link individual participant to their data -Coding system to connect participant names with data Used when data must be connected to person
The effectiveness of a debriefing can be influenced by?
-Participant suspicions (how likely they are to think they are still being deceived) -Nature of deception (passive vs. active; debriefing is less effective with active deception) -Sincerity of experimenter (last thing participant needs is a condescending experimenter telling them they were misled) -Time between study & debriefing (long vs. short; sooner the better)
How does confidentiality beneficial to researcher and participant?
-Participants protected from embarrassment or emotional stress that could result from public exposure -Researchers are more likely to obtain willing and honest participants
What are the unethical portions of the Laud Humphreys "tearoom trade" study?
-Real problems = disguising himself and violating participants' private lives, posing as a health-service worker to gain private information. -Violates no harm principle - if anyone had identified Humphreys or his participants, their lives would undoubtedly be destroyed -No consent (violation of APA principle 6) -No one other than Humphreys' dissertation committee knew about the research, until it was complete -When other faculty in the department found out, it caused an uproar -Some faculty petitioned university president to rescind Humphreys' Ph.D. -Fist fight between some faculty members -Half the department resigned and went to other universities
What are the 2 categories of ethical responsibility?
-Responsibility to ensure welfare & dignity of participants -Responsibility to ensure that public reports are accurate & honest
What is the nuremburg code?
-Set of 10 guidelines for ethical treatment of human research participants -Groundwork for modern ethical principles/practices -Similar to Declaration of Helsinki adopted by World Medical Association in 1964
Only where research would not reasonably be expected to cause distress or harm & the research involves 1 + of...?
-Study of normal educational practices, curricula, or classroom management methods, conducted in educational settings -Only anonymous questions, naturalistic observations, or archival research (i.e., no risk involved) -Study of job/organization effectiveness conducted in organizational settings with no risk to participants' employability and confidentiality is protected
What are the famous instances that caused concern for research ethics?
-The medical atrocities of World War II (The Nuremburg Code) -The Tuskegee syphilis project -The Willowbrook hepatitis project -Stanley Milgram's 1960's obedience studies -Humphreys' "tearoom trade" study -The Zimbardo Prison study
What is research ethics?
-The responsibility of researchers to be honest and respectful to all affected by their research studies or their reports of their studies. -Researchers are governed by a set of ethical guidelines that assist them in making proper decisions and choosing proper actions. -e.g., American Psychological Association (2002) Not an issue of morality, but with acceptable conduct.
What is deception?
-purposefully withholding information or misleading participants Goal: to produce "normal" behavior
What is Institutional Review Board (IRB)?
-review panel for human research. -Required at each institution or agency -Cross-section of individuals NOT affiliated with study. -Usually board members are from a variety of departments (e.g., history, biology, education, economics...), + 1 or 2 community members. -Ensures ethical guidelines are followed.
What are the 3 areas of ethical guidelines?
1. Relationship between society & science Extent to which societal concerns & cultural values should direct scientific investigation 2. Professional issues Scientific misconduct Competence, accuracy, honesty 3. Treatment of research participants Mostly the focus of this chapter
What are 3 specific areas of responsibility to protect participants that researchers have?
1.Deception justified (benefit > risk) Must consider all non-deceptive alternatives and justify why they were rejected 2.Cannot conceal information about any risk of physical pain or severe emotional distress Must debrief participants ASAP! 3.Debriefing - post-experimental explanation of the true purpose of the study, including the use and purpose of deception
What are the 7 Basic IRB Criteria for evaluating research proposal?
1.Minimization of risk to participants 2.Reasonable risk in relation to expected benefits of study 3.Equitable selection of participants Participant selection does not discriminate 4. Informed consent Basic element of all ethical codes Must state somewhere "participants can withdraw at any time without penalty" 5.How to document informed consent Written, verbal, or none required 6.Data monitoring (by researcher) -Monitor data during study to determine whether unexpected risks or harm have developed 7.Privacy & confidentiality
What are 2 categories of research to identify before discussing APA Principles?
1.Participants at Risk Are those placed under emotional or physical risk by participating If any possible participant risk, informed consent is mandatory -Minimal Risk No harmful effects expected. Certain studies may not require informed consent
What are the first 5 guidelines of the nurermburg code?
1.Participants should voluntarily consent to participate in research. No coercion; participants must be aware of what participation entails & any potential harms. 2.Experiment should yield fruitful results for good of society. Results unable to be obtained by other means, and not random and unnecessary in nature. 3.Experiment should be based on animal experimentation & knowledge of the natural history of the disease or problem - anticipated results will justify the experiment. 4. Avoid all unnecessary physical & mental suffering & injury. 5.No experiment with an expectation of death or disabling injury should be conducted.
What are two types of deception?
1.Passive Deception/Omission Withholding information about the study Ex. Participants shown words & asked to state whether the words are in capital or lower case letters. Researchers do not tell participants there will be a memory test for their recall of the words afterwards. 2.Active Deception/Commission Deliberately present false or misleading information Researcher can state an explicit lie about study, give false information about stimulus materials, give false feedback about a participant's performance, or use confederates Confederates - people who pretend to be participants in a research study but actually work for the researcher
What are the 3 basic principals of the Belmont Report?
1.Respect for persons Requires that individuals should consent to participate in studies and those who cannot give their consent (ex. Children, people with diminished mental capacity, prisoners, etc.) need to be protected. 2.Beneficence Do no harm, minimize risk, maximize benefits. 3.Justice Fairness in procedures for selecting participants. Forms the foundation for federal regulations protecting participants to this day
What are the 7 things principals dictate?
1.What measurement techniques can be used for certain individuals and behaviors 2.How participants are selected, recruited, compensated 3.Research strategies that can be used with certain populations and behaviors 4.Research designs that can be used with certain populations and behaviors 5.Research procedure 6.Data analysis 7.How results are reported
What are the remaining 6 guidelines of the nuremburg code?
6.Risk, where necessary, should not exceed the humanitarian importance of the study and the problem it aims to solve. 7.Proper preparation & adequate facilities should be used to protect participants from even remote chances of harm. 8.Experiment should be conducted by scientifically qualified personnel only. 9.Participants have the right to discontinue participation at any time. 10.Experimenter must be prepared to terminate experiment at any stage if necessary. If any potential harm to participants is likely if study continues
Research involving human participants must be reviewed and approved by a group of individuals who?
Are not directly affiliated with the study Purpose: ensure compliance with The Common Rule
Observing public behavior: not considered to be what?
a violation of privacy -When a person is in "public", it is assumed that others are able to observe them
What is the goal of the APA Ethics Code: 10 ethical guidelines?
Goal: Welfare & protection
What is the first component of informed consent and the problems they present?
Information If participants are aware of all information about a study could results be biased by participant reactivity?
What must one do before starting any research study?
Must apply to IRB (& other boards if applicable) for approval before starting any research study
What happened in 1979?
National Commission published The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
What was the major turning point, shifting from individualized ethics to formalized ethical guidelines?
Nazi experimentation on prisoners in concentration camps
What is the second component of informed consent and the problems they present?
Understanding Simply telling participants about the study doesn't guarantee they are informed, especially when participants may not be competent enough to understand
What is the third component of informed consent and the problems they present?
Voluntary participation Sometimes participants may feel coerced to participate or perceive they have a limited choice
What happened in 1950 with Joseph Stokes?
deliberately infected 200 female prisoners with viral hepatitis. -Prisoners never consented -Some of them died
US government enacted National Research Act in 1974, what is this?
formal guidelines and regulations for research with human participants
What is Anonymity?
practice of ensuring that person's identity not directly associated with their information.
What is Confidentiality?
practice of keeping information obtained from research participants secret & private.
What is Informed consent?
requires the researcher to provide all available information about a study so that an individual can make a rational, informed decision to participate in the study
