Ethical Principles and Guidelines for Research Involving Human Subjects

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

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.

Citi course

Citiprogram

How to get Students in research course Ana Ruiz

Once you have signed in and done the steps outlined in Dr. Messinger’s powerpoint follow these steps to get the appropriate course

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.

Click on View/Update Learner Group

How to answer questions Question 1 Is this your first time taking a CITI course at the University of Miami? Yes, This is my first time using the CITI Program. Question 2 Do you serve the University as an IRB member or IRB staff member? NO I am NOT affiliated with the IRB. Question 3 Are you an investigator or staff member involved at the U of Miami /Jackson Hospital or an investigator at another institution collaborating with an investigator at the University of Miami? YES, My focus is Social or Behavioral research. I may have direct contact with subjects and /or their personal information. Question 4 Have you previously completed the CITI Basic Course at the University of Miami? I have NOT previously completed an approved CITI Basic Course. If this is your first time using the CITI Program, you must complete the Basic Course first. Go to question 2.Go to question 2 Question 5 If you have taken a CITI Basic course and would like to complete Good Clinical Practice (GCP), Health Information Privacy and Security (HIPS), and Students in Research, then please make your selection below: Make the above unavailble

Click on “Go back to learner’s main menu”

Click on Grade book link

Click on Introduction and begin

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”.

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.

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 ”

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. Privacy

No data may be removed from the lab under any condition

Counseling Center for UM students Office Hours: M-F 8:30-5pm Building 21-R counseling- (for information only)

Research Ethics Heather Henderson

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

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

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

History of Unethical Research with Human Populations (cont) Tuskegee Syphilis Study ( ): 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

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, 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? 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 Ethical Guidelines for Research with Humans (APA; 1973, 1982, 1992)

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, 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

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

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.