Ethical Principles and Guidelines for Research Involving Human Subjects

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Ethical Principles and Guidelines for Research
Involving Human Subjects

• http//www.hhs.gov/ohrp/humansubjects/guidance/bel
  mont.htm

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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

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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.

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Citi course
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Citiprogram
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How to get Students in research course

• Ana Ruiz

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• Once you have signed in and done the steps
  outlined in Dr. Messingers powerpoint follow
  these steps to get the appropriate course

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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.

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Click on View/Update Learner Group
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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.
• 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

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Click on Go back to learners main menu
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Click on Grade book link
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Click on Introduction and begin
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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.

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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.

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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.

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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.

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No data may be removed from the lab under any
condition
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Counseling Center for UM students

• 305-284-5511
• Office Hours M-F 830-5pm
• Building 21-R
• Email counseling-center_at_miami.edu (for
  information only)

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Research EthicsHeather Henderson
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Research Ethics Scientific Fraud

• Plagiarism
• Carelessness
• see
• Holden, C. (2003). Party drug paper pulled.
  ScienceNow Daily News, 09/08/03.

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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

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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 pregnancybut later found that it caused
  severe deformities in fetus
• Many patients didnt 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

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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

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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.

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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., Milgrams obedience study
• Offering Inducements for Participants
• Targets the vulnerable?

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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

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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

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Research Ethics Scientific Fraud

• Other than being dishonest, why is scientific
  fraud harmful?
• Ways in which scientific fraud can be detected?

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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.