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ETHICAL CONDUCT FOR RESEARCH INVOLVING HUMANS Tri-Council Guidelines

Tri-Council Guidelines. Between 1932 and 1972, 412 men with untreated syphilis compared with 204 disease-free men to study the natural course of the

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Page 1: Tri-Council Guidelines.  Between 1932 and 1972, 412 men with untreated syphilis compared with 204 disease-free men to study the natural course of the

ETHICAL CONDUCT FOR RESEARCH INVOLVING HUMANS

Tri-Council Guidelines

Page 2: Tri-Council Guidelines.  Between 1932 and 1972, 412 men with untreated syphilis compared with 204 disease-free men to study the natural course of the

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

Page 3: Tri-Council Guidelines.  Between 1932 and 1972, 412 men with untreated syphilis compared with 204 disease-free men to study the natural course of the

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)

Page 4: Tri-Council Guidelines.  Between 1932 and 1972, 412 men with untreated syphilis compared with 204 disease-free men to study the natural course of the

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

Page 5: Tri-Council Guidelines.  Between 1932 and 1972, 412 men with untreated syphilis compared with 204 disease-free men to study the natural course of the

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?

Page 6: Tri-Council Guidelines.  Between 1932 and 1972, 412 men with untreated syphilis compared with 204 disease-free men to study the natural course of the

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

Page 7: Tri-Council Guidelines.  Between 1932 and 1972, 412 men with untreated syphilis compared with 204 disease-free men to study the natural course of the

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

Page 8: Tri-Council Guidelines.  Between 1932 and 1972, 412 men with untreated syphilis compared with 204 disease-free men to study the natural course of the

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

Page 9: Tri-Council Guidelines.  Between 1932 and 1972, 412 men with untreated syphilis compared with 204 disease-free men to study the natural course of the

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

Page 10: Tri-Council Guidelines.  Between 1932 and 1972, 412 men with untreated syphilis compared with 204 disease-free men to study the natural course of the

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

Page 11: Tri-Council Guidelines.  Between 1932 and 1972, 412 men with untreated syphilis compared with 204 disease-free men to study the natural course of the

ASSESSMENT OF RISKS AND BENEFITSRisks Benefits