ETHICAL CONDUCT FOR RESEARCH INVOLVING HUMANS

1. Tri-Council Guidelines ETHICAL CONDUCT FOR RESEARCH INVOLVING HUMANS

2. 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

3. 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

4. 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)

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

6. 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 Core Principles

7. 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 ROLE OF ETHICS REVIEW

8. 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 ETHICS REVIEW NOT NEEDED

9. 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

10. 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

11. Assessment of Risks and Benefits