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ETHICAL CONDUCT FOR RESEARCH INVOLVING HUMANS
Tri-Council Guidelines
TUSKEGEE STUDY OF UNTREATED SYPHILISUS PUBLIC HEALTH SERVICE
Between 1932 and 1972, 412 men with untreated syphilis compared with 204 disease-free men to study the natural course of the disease
When study started no effective treatment available, but study continued after penicillin known to be effective
Reporter discovered study and publicized ethical breaches : no informed consent, denied best known treatment at the time, and study continued even after effective treatment available
+ Scientists argued that this poor community would not have obtained treatment anyway, once in a lifetime opportunity, and results most relevant to the poor
THE WILLOWBROOK STUDY: 19663-1966 Investigated natural history of hepatitis, and
effectiveness of gamma globulin treatment Conducted at Willowbrook State Hospital in a
group of children with mental retardation Children were deliberately infected with virus
by being fed stools of infected children, and later by injecting purified virus
Parents asked to enroll their child in exchange for hospital admission (space shortage)
THE HUMPHREY STUDY (1965)
Sociologist studying characteristics of individuals engaging in tearoom sex (fellatio in public restrooms)
Method: participant observation (offered to be watchqueen for police) and structured interviews about the subjects and motivation
Bias reduction approach: secretly followed men, recorded their license plates, appeared at their homes and claimed to be a health survey interviewer and collected information on marital status, race, job
Results: dispelled many stereotypes—most men were successful businessmen, only 14% part of the gay community
Academic community rejected his research as unethical and violation of privacy
MATERNAL FETAL HIV TRANSMISSION PREVENTION TRIALS IN AFRICA (1990’S)
1998: US ends support for placebo-controlled trials of zidovudine to prevent perinatal transmission of HIV
Issues: when is placebo control valid? If optimal treatment “not available/ accessible” in third world country is it valid to conduct placebo-control trial in these circumstances?
CORE PRINCIPLES
Concern for Welfare Welfare=individual’s physical, mental, social, economic, and
cultural environment and significant others Research risks are proportionate to expected benefit from
scientific study Respect for Autonomy
Participation should be voluntary Choice should be informed (purpose of research, risks and
benefits) Respect for Equal Moral Status
Not discriminatory on the recruitment of subjects Selection criteria for inclusion relevant to the research question Protection for vulnerable groups not so onerous as to prevent
opportunity to participate
ROLE OF ETHICS REVIEW
Minimize risk to subjects Risks to subjects reasonable relative to anticipated
benefits Subject selection is equitable (fair) Informed consent from individual or legal representative Research plan (when appropriate) makes provision for
monitoring data collection Privacy and confidentiality of research subjects is
appropriately protected If vulnerable to coercion, appropriate safeguards
included Annual/ periodic review
ETHICS REVIEW NOT NEEDED
Self-study Research on organizations, policies,
procedures (humans may provide info but are not the subject of the research)
Program evaluation, quality assurance/improvement
Public health surveillance that is legally mandated
INCLUSION IN RESEARCH
Researchers should not exclude individuals on the basis of culture, religion, race, ethnicity, sexual orientation, sex, age, disability, sexual orientation unless there is a valid reason for exclusion
Individuals not proficient in the language used by researchers should not automatically be excluded
Vulnerable groups—institutionalized, children, should not automatically excluded
Inability to provide consent (comatose, cognitively impaired): research question cannot be addressed without their inclusion; and if there are risks, can provide direct benefits to group to which they belong
PRIVACY AND CONFIDENTIALITY
Refers to identifying (name, birth-date) and identifiable information (address)
Privacy: right to control personal information about yourself (informed consent, all intended uses of personal information, any planned linkage)
Confidentiality: duty of the researchers to safeguard information of participants
Security: measures used to protect information (limits on use, disclosure, retention)
Secondary use: REB approval required and justified based on: identifying information needed for research, individuals to whom data refer do not object, any legal permission is obtained, privacy and confidentiality protection, impracticable to obtain consent
ASSESSMENT OF RISKS AND BENEFITSRisks Benefits