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Ethics In Research
- 1. Ethics in Research and Publication Grant Heller, Ph.D.
- 2. Ethical Responsibilities of Researchers • Each individual scientist has the ethical responsibility to seek knowledge and to strive to improve the quality of life (Shaughnessy, Zechmeister, & Zechmeister, 2003) • Requirements of scientists (Diener & Crandall, 1978): – Competence – Report results accurately – Manage resources honestly – Acknowledge others – Consider the consequences – Speak out on societal concerns related to are of expertise
- 3. Approaches to Ethical Decisions • Balancing obligations to science & society with protecting rights & welfare of participants. • 3 General approaches to resolving ethical issues: – 1.) Deontology • Universal moral code – 2.) Ethical Skepticism • Individual conscience – 3.) Utilitarianism • Costs vs. Benefits
- 4. Need for ethical guidelines • Little Albert (1920) • Nuremberg code (1947) – Principles of informed consent, absence of coercion, properly formulated experimentation, beneficence to participants. • Milgram’s (1963) obedience study • Tuskeegee syphilis study (1932-1972) • Humphreys’s (1970) “tearoom study” • Stanford Prison Experiment (1971)
- 5. Tuskegee Syphilis study (1932-1972)
- 7. The Belmont Report • 3 overarching principles 1.) Respect for persons – Informed consent – Coercion is unethical 2.) Beneficence – Ethical decision making (cost-benefit analysis) 3.) Justice – Equitable distribution of risks & benefits
- 8. APA Ethics Code (2002) • General Principles – Principle A: Beneficence & Nonmaleficence – Principle B: Fidelity & Responsibility – Principle C: Integrity – Principle D: Justice – Principle E: Respect for People’s Rights & Dignity
- 9. APA Ethics Code Standard 8: Research & Publication • 8.01 Institutional Approval • 8.02 Informed Consent to Research • 8.03 Informed Consent for Recording Voices & Images • 8.04 Client/Patient, Student, & Subordinate Research Participants • 8.05 Dispensing with Informed Consent • 8.06 Offering Inducements for Research Participation
- 10. APA Ethics Code Standard 8: Research & Publication • 8.07 Deception in Research • 8.08 Debriefing • 8.09 Humane Care & Use of Animals in Research • 8.10 Reporting Research Results • 8.11 Plagiarism • 8.12 Publication Credit • 8.13 Duplicate Publication of Data • 8.14 Sharing Research for Verification • 8.15 Reviewers
- 11. The Institutional Review Board • Required by all institutions receiving federal funding • Consists of members from both scientific and unscientific disciplines • At least one member must be a local community member not associated with the institution • Research cannot be conducted without prior approval of the board
- 12. IRB criteria for reviewing & approving research 45 CFR 46.111 • Risks to subjects (Ss) minimized • Risks reasonable in relation to anticipated benefits • Selection of Ss equitable • Data monitored for Ss safety • Ss privacy protected & confidentiality of data maintained • UDM’s IRB
- 14. IACUC • Institutional Animal Care And Use Committee (IACUC) • Review board for animal research, study, and teaching • UDM’s IACUC
- 15. Cost-Benefit Model Cost/Risk: High Cost/Risk: High Benefit: Low Benefit: High Cost/Risk: Low Cost/Risk: Low Benefit: Low Benefit: High
- 17. A pain scale for psychological research in animals (Orlans, 1993)
- 18. Costs of Research • Time & effort • Participants’ welfare – Physical risk – Psychological risk (anxiety, depression, altered self concept, loss of confidence in others, boredom) – Confidentiality (social, legal, and economic risks of participating) • Financial issues…research is expensive • Negative stereotypes for the profession
- 19. Potential Benefits • Basic Knowledge • Improvement of research or assessment techniques • Practical outcomes • Benefits for researchers • Benefits for research participants
- 20. Experimental Tx isn’t always better Tx • Tell participants about assignment to conditions, along with potential risks and benefits of experimental treatment • Offer the new Tx free of charge to control condition participants if it proves efficacious
- 21. Ethical considerations • Informed consent – Provide information about the study – Obtaining informed consent • Informed consent form • Elements to be included – Purpose of study (brief) – Activities involved – Risks/benefits – Right to refuse/withdraw without penalty – How confidentiality will be handled – Primary investigator contact info – Signature lines for participant & researcher
- 22. Problems with attaining informed consent • Compromising the validity of a study • Participants who are unable to give informed consent – e.g., children • Consent from parent/guardian • Assent from participant • Ludicrous cases of informed consent – No more than minimal risk – Waiver will not adversely affect rights/welfare – Research could not be feasibly carried out otherwise
- 23. Ethical considerations, cont. • Invasion of privacy • Coercion to participate • Physical and mental stress – Minimal risk • Deception • Debriefing – 4 goals • 1.) clarification • 2.) remove stress • 3.) obtain reactions • 4.) should feel good about participating • Confidentiality
- 24. Margin of support for animal research (Plous, 1996)
- 25. Animal research, cont. 4000000 3500000 3000000 2500000 2000000 1500000 1000000 500000 0 Dogs & Cats Dogs & Cats in Primates in Euthananized by Research Research HS Series1 3500000 88572 54998
- 27. 3 R’s of Animal Research • Reduction • Replacement • Refinement
- 29. Misconduct Damages our Credibility
- 30. Normal Misbehavior (de Vries, Anderson, & Martinson, 2006) • Serious (but rare) scientific infractions – F.F.P. • Falsification • Fabrication • Plagiarism • Misconduct is generally more mundane… – 4 categories • The meaning of data • The rules of science • Life with colleagues • The pressures of production
- 31. Normal Misbehavior (de Vries, Anderson, & Martinson, 2006)
- 32. “Scientists Behaving Badly” (Martinson, Anderson, & de Vries, 2005)
- 33. Steps for ethical decision making (Shaughnessy, Zechmeister, & Zechmeister, 2003) 1.) Know the facts 2.) Identify the relevant ethical issues 3.) Determine what is at stake 4.) Identify alternative methods or procedures 5.) Decide on the action to be taken
- 34. Case Study: Stanley Milgram’s study of obedience (1963)
- 35. Ethical issues of the Milgram study • Participants were mislead as to the purpose of the study • A confederate posed as another participant • Participants were led to believe they were shocking another person…this was likely disturbing to them • Participants experienced considerable stress as the experiment continued: They sweated, trembled, stuttered, swore, and laughed nervously as they delivered increasingly intense shocks • Participants’ attempts to withdraw from the study were discouraged by the experimenter’s insistence that they continue.
- 36. Milgram’s Obedience Study: Follow-up • 92% responded to the survey – Attitudes about volunteering • 84% positive • 15% neutral • 1% regretful
- 37. Common Courtesy (Leary, 2004) • Chief complaints of research participants – The researcher: • Failed to show up or was late • Was not adequately prepared • Was cold, abrupt, or downright rude • Failed to show appreciation for the participant
Notas do Editor
- Most ethical issues in research occur because behavioral scientists have two sets of obligations that can sometimes conflict. On the one hand, behavioral researcher’s job is to provide information that enhances our understanding of behavioral processes and leads to improvement of human or animal welfare. This obligation requires that scientists pursue research they believe will be useful in extending knowledge or solving problems. ON THE OTHER HAND, behavioral scientists also have an obligation to protect the rights and welfare of the human and nonhuman participants they study. When these two obligations coincide, few ethical issues arise. However, when the researcher’s obligations to science and society conflict with obligations to protect the rights and welfare of research participants, the researcher faces an ethical dilemma. It is important to understand that well meaning people may strongly disagree about the ethics of particular research procedures. Not only do people disagree about the ethics of particular research procedures, but also they often disagree about the fundamental ethical principles that should be used to make ethical decisions. People often tend to hold one of three general approaches to resolving ethical issues about research. These approaches differ in terms of the criteria people use to decide what is right and what is wrong.1.) DEONTOLOGY maintains that ethics must be judged in light of a universal moral code. Certain actions are inherently unethical and should never be performed regardless of the circumstances. A researcher who operates from this perspective might argue that lying is immoral in all situations regardless of the consequences, and thus deception in research is always unethical.2.) ETHICAL SKEPTICISM asserts that concrete and inviolate moral codes such as those proclaimed by deontology cannot be formulated. Given the diversity of opinions regarding ethical issues and the absence of consensus regarding ethical standards, skeptics resist those who claim to have an inside route to moral truth. Skepticism does not deny that ethical principles are important but rather insists that ethical rules are arbitrary and relative to culture and time. According to ethical skepticism, ethical decisions must be a matter of the individuals conscience: One should do what one thinks is right and refrain from doing what one thinks is wrong. The final arbiters of ethical questions are individuals themselves. Thus, a skeptic would claim that research ethics cannot be imposed from the outside, but rather are a matter of the individual researcher’s conscience.3.) UTILITARIANISM maintains that judgments regarding the ethics of a particular action depend on the CONSEQUENCES of the action. There is the belief that that the potential benefits of a particular action should be weighed against the potential costs. The official guidelines for research enforced by the federal government and most professional organizations, including the APA, are essentially utilitarian.Jeremy Bentham & John Stuart Mill
- The Tuskeegee syphilis study was conducted from 1932 through 1972 by the U.S. Public Health Service to study the progression of untreated syphilis. Nearly 400 African American men from Macon County Alabama with syphilis were offered free medical exams, free meals, and burial insurance for participating in the study. They were told they were being treated for “bad blood” which was a local term used to describe several illnesses including anemia, fatigue, and syphilis, but were never informed that they actually had syphilis.By 1947 penicillin became the treatment of choice for syphilis. The researchers had the choice of discontinuing the study and offering treatment to participants, offering treatment to some participants to compare with no treatment, or continue the study as planned. The researchers chose to deny treatment to all participants and did not inform them they had the disease in order to continue to study the natural untreated progression of the fatal disease.Not only were the original participants affected, but their wives (or other sexual partners) and children born with congenital syphilis.The study only ended when someone leaked information on the study to the media. It was not until 1997 that the government issued an official apology.
- http://www.youtube.com/watch?v=HwqNP9HRy7Y
- General Principles, as opposed to Ethical Standards, are aspirational in nature. Their intent is to guide and inspire psychologists toward the very highest ethical ideals of the profession. General Principles, in contrast to Ethical Standards, do not represent obligations and should not form the basis for imposing sanctions. Relying upon General Principles for either of these reasons distorts both their meaning and purpose.Principle A: Beneficence and NonmaleficencePsychologists strive to benefit those with whom they work and take care to do no harm. In their professional actions, psychologists seek to safeguard the welfare and rights of those with whom they interact professionally and other affected persons, and the welfare of animal subjects of research. When conflicts occur among psychologists' obligations or concerns, they attempt to resolve these conflicts in a responsible fashion that avoids or minimizes harm. Because psychologists' scientific and professional judgments and actions may affect the lives of others, they are alert to and guard against personal, financial, social, organizational, or political factors that might lead to misuse of their influence. Psychologists strive to be aware of the possible effect of their own physical and mental health on their ability to help those with whom they work.Principle B: Fidelity and ResponsibilityPsychologists establish relationships of trust with those with whom they work. They are aware of their professional and scientific responsibilities to society and to the specific communities in which they work. Psychologists uphold professional standards of conduct, clarify their professional roles and obligations, accept appropriate responsibility for their behavior, and seek to manage conflicts of interest that could lead to exploitation or harm. Psychologists consult with, refer to, or cooperate with other professionals and institutions to the extent needed to serve the best interests of those with whom they work. They are concerned about the ethical compliance of their colleagues' scientific and professional conduct. Psychologists strive to contribute a portion of their professional time for little or no compensation or personal advantage.Principle C: IntegrityPsychologists seek to promote accuracy, honesty, and truthfulness in the science, teaching, and practice of psychology. In these activities psychologists do not steal, cheat, or engage in fraud, subterfuge, or intentional misrepresentation of fact. Psychologists strive to keep their promises and to avoid unwise or unclear commitments. In situations in which deception may be ethically justifiable to maximize benefits and minimize harm, psychologists have a serious obligation to consider the need for, the possible consequences of, and their responsibility to correct any resulting mistrust or other harmful effects that arise from the use of such techniques.Principle D: JusticePsychologists recognize that fairness and justice entitle all persons to access to and benefit from the contributions of psychology and to equal quality in the processes, procedures, and services being conducted by psychologists. Psychologists exercise reasonable judgment and take precautions to ensure that their potential biases, the boundaries of their competence, and the limitations of their expertise do not lead to or condone unjust practices.Principle E: Respect for People's Rights and DignityPsychologists respect the dignity and worth of all people, and the rights of individuals to privacy, confidentiality, and self-determination. Psychologists are aware that special safeguards may be necessary to protect the rights and welfare of persons or communities whose vulnerabilities impair autonomous decision making. Psychologists are aware of and respect cultural, individual, and role differences, including those based on age, gender, gender identity, race, ethnicity, culture, national origin, religion, sexual orientation, disability, language, and socioeconomic status and consider these factors when working with members of such groups. Psychologists try to eliminate the effect on their work of biases based on those factors, and they do not knowingly participate in or condone activities of others based upon such prejudices.
- 8.01 Institutional ApprovalWhen 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. (See also Standards 8.03, Informed Consent for Recording Voices and Images in Research; 8.05, Dispensing with Informed Consent for Research; and 8.07, Deception in Research.)(b) Psychologists conducting intervention research involving the use of experimental treatments clarify to participants at the outset of the research (1) the experimental nature of the treatment; (2) the services that will or will not be available to the control group(s) if appropriate; (3) the means by which assignment to treatment and control groups will be made; (4) available treatment alternatives if an individual does not wish to participate in the research or wishes to withdraw once a study has begun; and (5) compensation for or monetary costs of participating including, if appropriate, whether reimbursement from the participant or a third-party payor will be sought. (See also Standard 8.02a, Informed Consent to Research.)8.03 Informed Consent for Recording Voices and Images in ResearchPsychologists 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. (See also Standard 8.07, Deception in Research.)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.8.05 Dispensing with Informed Consent for ResearchPsychologists 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. (See also Standard 6.05, Barter with Clients/Patients.)
- 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. (See also Standard 8.08, Debriefing.)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.8.09 Humane Care and Use of Animals in Research(a) Psychologists acquire, care for, use, and dispose of animals in compliance with current federal, state, and local laws and regulations, and with professional standards.(b) Psychologists trained in research methods and experienced in the care of laboratory animals supervise all procedures involving animals and are responsible for ensuring appropriate consideration of their comfort, health, and humane treatment.(c) Psychologists ensure that all individuals under their supervision who are using animals have received instruction in research methods and in the care, maintenance, and handling of the species being used, to the extent appropriate to their role. (See also Standard 2.05, Delegation of Work to Others.)(d) Psychologists make reasonable efforts to minimize the discomfort, infection, illness, and pain of animal subjects.(e) Psychologists use a procedure subjecting animals to pain, stress, or privation only when an alternative procedure is unavailable and the goal is justified by its prospective scientific, educational, or applied value.(f) Psychologists perform surgical procedures under appropriate anesthesia and follow techniques to avoid infection and minimize pain during and after surgery.(g) When it is appropriate that an animal's life be terminated, psychologists proceed rapidly, with an effort to minimize pain and in accordance with accepted procedures.8.10 Reporting Research Results(a) Psychologists do not fabricate data. (See also Standard 5.01a, Avoidance of False or Deceptive Statements.)(b) If psychologists discover significant errors in their published data, they take reasonable steps to correct such errors in a correction, retraction, erratum, or other appropriate publication means.8.11 PlagiarismPsychologists do not present portions of another's work or data as their own, even if the other work or data source is cited occasionally.8.12 Publication Credit(a) Psychologists take responsibility and credit, including authorship credit, only for work they have actually performed or to which they have substantially contributed. (See also Standard 8.12b, Publication Credit.)(b) Principal authorship and other publication credits accurately reflect the relative scientific or professional contributions of the individuals involved, regardless of their relative status. Mere possession of an institutional position, such as department chair, does not justify authorship credit. Minor contributions to the research or to the writing for publications are acknowledged appropriately, such as in footnotes or in an introductory statement.(c) Except under exceptional circumstances, a student is listed as principal author on any multiple-authored article that is substantially based on the student's doctoral dissertation. Faculty advisors discuss publication credit with students as early as feasible and throughout the research and publication process as appropriate. (See also Standard 8.12b, Publication Credit.)8.13 Duplicate Publication of DataPsychologists do not publish, as original data, data that have been previously published. This does not preclude republishing data when they are accompanied by proper acknowledgment.8.14 Sharing Research Data for Verification(a) After research results are published, psychologists do not withhold the data on which their conclusions are based from other competent professionals who seek to verify the substantive claims through reanalysis and who intend to use such data only for that purpose, provided that the confidentiality of the participants can be protected and unless legal rights concerning proprietary data preclude their release. This does not preclude psychologists from requiring that such individuals or groups be responsible for costs associated with the provision of such information.(b) Psychologists who request data from other psychologists to verify the substantive claims through reanalysis may use shared data only for the declared purpose. Requesting psychologists obtain prior written agreement for all other uses of the data.8.15 ReviewersPsychologists who review material submitted for presentation, publication, grant, or research proposal review respect the confidentiality of and the proprietary rights in such information of those who submitted it.
- Federal regulations specify specific criteria that the IRB must use in reviewing and approving research (45 CFR 46.111). Whether or not the IRB uses an expedited or full review process, the research must satisfy the following requirements.1.) the risks to subjects are minimized by using procedures which are consistent with sound research design and which do not unecessisarily expose subjects to risk, and whenever appropriate, by using procedures already being performed for diagnostic or treatment purposes.2.) risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.3.) The selection of subjects is equitable – 4.) when appropriate, there are adequate provisions for monitoring the data collection to ensure the safety of subjects5.) when appropriate, there are adequate provisions to protect the privacy of subjects and maintain the confidentiality of data.
- http://www.youtube.com/watch?v=8fNlyCB3foc
- All UDM faculty, staff and students who use live vertebrate animals in teaching, study, or research must have the written approval of the University's Institutional Animal Care and Use Committee (IACUC) prior to their acquiring these animals. This applies also to other individuals who plan to house these animals anywhere on the campuses of the University. Strict regulations regarding the care and use of animals is mandated by the federal government; it is the duty of the IACUC to see that all projects which involve the care and use of animals are in compliance with these regulations. Note that animals may not be brought on any of the University campuses before IACUC approval has been obtained. That is, animals may not be brought on campus to be held while awaiting the approval of the Protocol procedures.Those preparing the Protocol are urged to contact the IACUC Chair as often as necessary in order to assure that the forms are completed properly.For copies of Protocol forms and supplements, and for additional information about the IACUC, please contact the IACUC Chair:Fr. R. Gerard Albright, SJalbrigrg@udmercy.edu
- Headlines of scientific misconduct such as this often grab our attention and make many think that the majority of those who commit ethical violations in research are apprehended and punished, the reality is that the majority of transgressions are much more mundane and banal, and the majority slip through the cracks and are not noticed or punished.