Ethical Principles and Guidelines for Research

Involving Human Subjects

http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

Basic Ethical Principles & Applications

• 1. Respect for Persons

• 2. Beneficence • 3. Justice

• 1. Informed Consent • 2. Assessment of

Risk and Benefits • 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

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.

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 305-284-8443.”

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

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

Research EthicsHeather 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 (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

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.

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, 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

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.