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

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Tri council guidelines l.jpg

Tri-Council Guidelines

ETHICAL CONDUCT FOR RESEARCH INVOLVING HUMANS


Tuskegee study of untreated syphilis us public health service l.jpg

  • 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

Tuskegee Study of Untreated SyphilisUS Public Health Service


The willowbrook study 19663 1966 l.jpg

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 Willowbrook Study: 19663-1966


The humphrey study 1965 l.jpg

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

The Humphrey Study (1965)


Maternal fetal hiv transmission prevention trials in africa 1990 s l.jpg

1998: US ends support for placebo-controlled trials of in tearoom sex (fellatio in public restrooms)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?

Maternal Fetal HIV transmission Prevention Trials in Africa (1990’s)


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  • Concern for Welfare in tearoom sex (fellatio in public restrooms)

    • 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

Core Principles


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Minimize risk to subjects in tearoom sex (fellatio in public restrooms)

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

ROLE OF ETHICS REVIEW


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Self-study in tearoom sex (fellatio in public restrooms)

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

ETHICS REVIEW NOT NEEDED


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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

Inclusion in research


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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

Privacy and Confidentiality


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Assessment of Risks information (address)and Benefits


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