1. Tri-Council Guidelines

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

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)

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

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?

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

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

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

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

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

11. RisksBenefits