Ethical Principles and Guidelines for Research Involving Human Subjects

1. Ethical Principles and Guidelines for Research Involving Human Subjects http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

2. 1. Respect for Persons 2. Beneficence 3. Justice 1. Informed Consent 2. Assessment of Risk and Benefits 3. Selection of Subjects Basic Ethical Principles & Applications

3. CITI Program • It is the policy of the University that all personnel involved in the design or conduct of human subjects research receive "certification" in human subjects protections.

4. Citi course

5. Citiprogram

6. How to get Students in research course Ana Ruiz

17. Due Tuesday March 12, 2013 • Complete The Students In Research Course for Tuesday • The Basic Course and Informed Consent modules may be completed for extra credit but must be completed by Tuesday.

19. Elements of Consent Form • 28. Standard language for child abuse: • “If information is revealed concerning child abuse, it is required by law that this be reported to the appropriate authorities.” • 29. Standard language for other abuse: • ”The only exception is if information is revealed concerning harm to yourself or others, child abuse, neglect, or other forms of abuse that is required by law to be reported to the appropriate authorities”.

20. Indicate • I will submit the results of my research to my instructor, Daniel Messinger, Ph.D. and present it to my class (PSY341 or PSY344). I will not present any identifying details in my research.

21. Standard signature line: • “You may ask and will receive answers to any questions during the course of the study. If you have any questions about this study, please contact [your name and phone #] If you have questions about your rights as a research participant you may contact Daniel Messinger, my Professor at 305-284-8443.”

22. Privacy • Participants being rated rely on the discretion of the student for their confidentiality in the remote case they recognize a Participant. Raters will be asked to communicate their recognition of a Participant to the Investigators but to no one else.

23. No data may be removed from the lab under any condition

24. Counseling Center for UM students • 305-284-5511 • Office Hours: M-F 8:30-5pm • Building 21-R • Email: counseling-center@miami.edu (for information only)

25. Research EthicsHeather Henderson

26. Research Ethics: Scientific Fraud • Plagiarism • Carelessness • see • Holden, C. (2003). Party drug paper pulled. ScienceNow Daily News, 09/08/03.

27. History of Unethical Research with Human Populations • World War II: Nuremberg Code (1948) • German physicians and administrators faced criminal charges for participation in war crimes and crimes against humanity • Medical experiments on concentration camp prisoners without consent resulting in death or permanent disability • Result = Nuremberg Code was first international document advocating voluntary participation and informed consent

28. History of Unethical Research with Human Populations (cont) • Late 1950s: Thalidomide • Approved as sedative in Europe but no FDA approval in USA • Prescribed in US to control sleep and nausea during pregnancy…but later found that it caused severe deformities in fetus • Many patients didn’t know they were taking an experimental drug nor did they give informed consent • Result = new regulations from FDA requiring drug manufacturers to prove effectiveness prior to marketing

29. History of Unethical Research with Human Populations (cont) • Tuskegee Syphilis Study (1932-1972): • US Public Health Service research study • 600 low-income African-American males in Alabama monitored for 40 years • 400 infected with syphilis • Told they were being treated for “bad blood”; free medical examinations but not told about syphilis diagnosis • In 1950s proven cure (penicillin) discovered but study continued until 1972 with participants being denied treatment

30. Ethical Guidelines for Research with Humans (APA; 1973, 1982, 1992) • Planning the Study • Balance the need to discover the basic laws of behavior with the need to protect participants • Defining degree of “risk” for participants • Are the situations similar to “those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” ??? • Especially important consideration with special populations See Marshall, E. (2000). Enforcers halt NIH study called less risky than outdoor play. Science, 290, 1281.

31. Ethical Guidelines for Research with Humans (APA; 1973, 1982, 1992) • Ensuring that participants are volunteers • Getting informed consent • must give enough meaningful information for participants to volunteer • Consent must be documented • Exceptions = anonymous surveys, naturalistic observations • see Fig 2.3 for sample consent form • Read Box 2.2 “Historical Problems with Informed Consent” • Withholding information about the true purpose of a study at the beginning of the experiment • E.g., Milgram’s obedience study • Offering Inducements for Participants • Targets the vulnerable?

32. Ethical Guidelines for Research with Humans (APA; 1973, 1982, 1992) • Treating participants well • Full debriefing, “dehoaxing”, desensitizing • Provide appropriate feedback after the study • Summary of results, follow-up contact, contact info for them to reach you • Maintaining confidentiality • Identity of participants not to be revealed • Exception = when researcher compelled by law to report certain disclosures e.g., child abuse

33. Research Ethics: Scientific Fraud • Data Falsification • not collecting any data at all but reporting results • See Holden, C. (2001). Psychologist made up sex bias results. Science, 294, 2457. • Altering or omitting collected data to make overall results look better • Missing data are guessed at and created in order to have a complete set of information • Suppressing results of a study because results fail to come out as expected

34. Research Ethics: Scientific Fraud • Other than being dishonest, why is scientific fraud harmful? • Ways in which scientific fraud can be detected?

35. Research Ethics: Scientific Fraud • Current thoughts on the issue of scientific fraud • See article posted in Blackboard • Kennedy, D. (2002). More questions about research misconduct. Science, 297, 12.