Research Ethics
Dr. Dodge
1/17/06
Ethics Review
Morals: Rules that define what is right andwrong
Ethics-process of examining moralstandards and looking at how we shouldinterpret and apply such standards in realworld situations
Ethical Codes - AMA, APA, CRC. Knowyour codes!!!
Ethics Review
Ethical Principles
1.1.Autonomy
2.2.Beneficence
3.3.Non-malfeasance
4.4.Justice
5.5.Fidelity
Think for a moment … how might theseprinciples relate to research?
History of Unethical Research
Tuskegee Experiment (1932-1972)-American researcherspurposely withheld treatment for 399 African-American peoplewith syphilis for the sole purpose of studying the long termeffects of the disease.
Willowbrook Study (1963-1966)-Children withdevelopmental disabilities were deliberately infected withHepatitis (some were even fed fecal matter). Purpose of thestudy was to examine the course of the disease and to test apotential immunization
Human radiation experiments by the US Department ofDefense & Atomic Energy Commission.
Milgram’s Obedience Study-Researchers asked participantsto “Pseudo-shocking” confederates in order to examineobedience.
Zimbardo’s Stanford Prison Experiment (1971). Study hadto be ended prematurely because of abusive behaviorsgenerated participants who where assigned as guards overthose subjects that were assigned as prisoners.
Responses to Unethical Research
Nuremberg Code created as a result of cruelexperiments the Nazis conducted on humansduring WWII.
NIH Ethics Committee (1964)
Declaration of Helsinki (1964, ’75, ’83, ’89, ’00)
Beecher “Ethics & Clinical Research” (1966)[NEJM, 274, 1354-60].
1973 Congressional Hearings on Quality ofHeath Care and Human Experimentation.
National Research Act of 1974
Established the IRB system.
Responses to Unethical Research
National Research Act of 1974
The IRB system was established
May 1974 – 45 CFR 46 drafted
1975-1978 – National Commission forProtection of Human Subjects of Biomedicaland Behavioral Research
April 1979 – Belmont Report
1981 – 45 CFR 46 revised
1991 45 CFR 46 adopted as the CommonRule by 17 federal agencies
The Belmont Report
The National Commission for the Protectionof Human Subjects of Biomedical andBehavioral Research - April 18, 1979
1.1.Boundaries Between Practice and Research
2.2.Basic Ethical Principles
3.3.Applications (of Principles)
The Belmont Report (1979) is the majorethical statement guiding human research inthe United States.
The Belmont Report
1.1.Boundaries Between Practice andResearch
IRB must determine that the researcher (andthrough informed consent, the subject)distinguishes practice from experiment inboth social science and medical scienceresearch
The Belmont Report
2.2.Basic Ethical Principles
Respect for Persons
Individual autonomy Protection of individuals withreduced autonomy
Beneficence
Maximize benefits and minimize harms
Justice
Equitable distribution of research risks andbenefits
Respect for Persons
Treat individuals as autonomous agents
Do not use people as a means to an end
Allow people to make choices for themselves
Provide extra protection to those with limitedautonomy
Voluntary Participation
Informed Consent
Protection of Privacy & Confidentiality
Right to Withdraw without Penalty
Beneficence
Acts of kindness or charity that go beyond duty
Obligations derived from beneficence
Do no harm
Prevent harm
Prevent evil
Promote good
Risks are justified by the benefits
Risks are minimized
Conflicts of interest are managed to avoid bias
Justice
Treat people fairly
Fair sharing of burdens and benefits of research
Distinguish procedural justice from distributivejustice
Vulnerable subjects are not targeted for convenience
People are not selected as subjects because of theirease of availability or compromised position
People who are likely to benefit are not excluded
The Belmont Report
3.3.Application
All principles are essential to sound ethicalresearch
Principles carry equal moral weight
Ethical conduct is expected
Institutional Review Board
To provide standards of conducting ethicalresearch, and to protect human an animalsubjects, the National Research Act (lawin 1974) established the InstitutionalReview Board
Any research project that receives federalmoney must demonstrate that its methodsare ethical
Role of the IRB
The role of the IRB is to protect the rights andwelfare of individual research subjects. This isaccomplished by having the IRB assure that thefollowing requirements are satisfied:
1. risk to subjects are minimized
2. risk to subjects are reasonable in relation toanticipated benefits,
3. selection of subjects is equitable, i.e. fair
4. informed consent is sought form each subjector his/her legally authorized representative,
Role of the IRB
5. informed consent is appropriately documented,
6. when appropriate, the research plan makes provisionsfor monitoring data collection,
7. privacy and confidentiality of research subjects areappropriately protected, and
8. when some or all of the subjects are likely to bevulnerable to coercion or undue influence, additionalsafeguards have been included.
The IRB has to approve that these requirements arefollowed before they approve a research study and mustreview these documents on, at the least, an annualbasis.
IRB Levels of Risk
The IRB categorizes the risk associatedwith research into Exempt, Minimal, andGreater than Minimal:
Exempt
Experiment is without risk to the participant,the researcher, and the environment
Examples: Anonymous questionnaires,standardized education tests, and anonymousnaturalistic observations
IRB Levels of Risk
Minimal Risk
Although safeguards must be present, usually nomore risk than one would face in everyday life
Examples: Certain Medical Diagnostic tests, researchon individual or group behavior that involves nomanipulation of the subjects and is not stressful (i.e.,research on perception, cognition, motivation, identity,language, communication, cultural beliefs orpractices, social behavior), and research employingsurvey, interview, oral history, focus group, programevaluation, human factors evaluation, or qualityassurance methodologies
IRB Levels of Risk
Greater than Minimal Risk
Can cause stress, pain, injury, or even death. Aproject that involves greater than minimal riskrequires approval by an IRB panel composed ofmembers qualified to review research in that field.
Examples: Research with children and othervulnerable populations; research that involvesexperimental drugs or devices, invasive procedures;and any research involving deception.
HIPAA
The Health Insurance Portability andAccountability Act of 1996 (HIPAA) is acomprehensive Federal protection plan thatensures continuity of healthcare coverage forindividuals changing jobs; includes a provisionthat impacts on the management of healthinformation; seeks to simplify the administrationof health insurance; and aims to combat waste,fraud, and abuse in health insurance and healthcare.
Research Ethics: Areas of Focus
Harm
Informed Consent
Confidentiality
Deception
Reporting Results and Plagiarism
Harm
As mentioned before, researchers shouldtake every precaution to ensure thatparticipants are not subjected to undueharm or stress
Please visit IRB website for furtherinformation
Informed Consent
Voluntary Informed Consent is essential for researchinvolving human subjects
According to the APA, Informed Consent should include:
Description of the nature of the research
Statement that the research is voluntary andparticipants can withdraw at any time
Identification of Risks and Benefits
Description of how confidentiality will be protected
Description of compensation
Description of what info researchers will share withparticipants
Identification of who is responsible for research withcontact information
Confidentiality
All information collected in a researchproject should remain confidential
Participants should be assigned a HIPAAcompliant code
Data should be locked away in a securesetting
Electronic Databases should also beprotected
What do you do if you bump into a researchparticipant in Wal-Mart?
Deception
At times, researchers may choose to hidefrom participants the true nature of thestudy
Deception by Omission
Withholding important facts from theparticipants
Deception by Commission
Lie to or purposely mislead researchparticipants
Deception
Staged Manipulations
Also called Event Manipulations
Used for 2 reasons
The researcher may need to create some sort of psychological state(anxiety)
The researcher may need to stage a manipulation to recreate a real-world scenario
Having a participant do one task and then having them do more tasksat the same time
Staged manipulations usually employ a confederate
Also called an accomplice
A confederate is someone who appears to be another participantin an experiment but is really a part of the experiment
Example: Someone who purposely insults a participantin a study in order to provoke anger or frustration
Deception
Another example of the use of confederates:
Asch (1956) study on conformity
Which line is bigger?
1)---------------------
2)-----------------------------
3)-------------------
Right before a participant had to choose which linewas the longest, a confederate announced anincorrect answer
Repeatedly, Asch found that people conformed tothe confederate’s incorrect response
Deception
According to the APA, researchers can usdeception under certain conditions:
Participants must be provided with enoughinformation to consent voluntarily
Researchers must convince the IRB thatdeception is necessary to collect data andthat it will cause little or no harm
Researchers must arrange to fully inform thepatients of the true nature of the study in atimely manner
Reporting Research Results
Results of research studies should be reported in ahonest, accurate manner
Researchers cannot “massage” data to fit theirhypotheses
Researchers cannot make up or report false results
Researcher must report what they find, even if thedata does not support their initial hypotheses
Researchers should ensure that data is beingcollected consistently (do checks of researchassistants)
Researchers should give the proper credit(authorship) to those who have earned it
Plagiarism
Comes from the Latin word meaning “tokidnap”
Examples of plagiarism:
Copying someone else’s words without propercitation
Stealing someone else’s ideas
Stealing someone else’s intellectual property
Bottom Line: Cite sources properly andminimize quotations in research reports
Ethics Among Researchers
Authorship
Ownership of data
Consultants