essay + outline
BigMo
public_anthropology_project15.pptxYou should address the following questions in writing your Op-Ed: 1. Based on the information presented above in the five case studies, you are to voice your view on how Institutional Review Boards (in the U.S.) and/or Review Ethics Boards (in Canada) should enforce a set of common rules regarding research. A. How much freedom should researchers be allowed in conducting their research? B. What regulations should be enforced to: -- prevent the abuse of research subjects and -- ensure, more generally, that the research strives to promote positive benefits for the larger society sponsoring it?
ESSAY TOPIC
1. Taking a Position 2. Persuasive 3. Hook and Structure 4. Writing and Clarity 5. Tone
GRADING CRITERIA-Guidelines from “Background file”
The National Research Act - 1974
Created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles
Three principles of Belmont report 1979
1. respect for persons
2. beneficence
3. justice
Respect for persons
a. treat persons as autonomous agents
b. persons with diminished autonomy entitled to special protection
Beneficence
1. do not harm
2. maximize possible benefits
3. minimize possible harms
justice
Who ought to receive the benefits of research?
Who should bear its burdens?
The “Common Rule” 1991
Department of Health and Human Services established the Office for Human Research Protection to oversee the implementation of Belmont Report.
This has included the establishment and supervision of the Institutional Review Boards
The criteria for IRB approval include:
1. risks to subjects are minimized
2. risks reasonable in relation to expected benefits
3. equitable selection of subjects
4. informed consent requirement
5. informed consent must be documented
6. provisions for data monitoring
7. protection of subjects’ privacy and confidentiality
The key cases
0. The Tuskagee Syphilis Experiment (1946-1948)
1. Guatemala Syphilis experiment
2. Huron-Wendat: Studying Old Bones
3. The IRB and the future of fieldwork
4. IRB overreach– Behind closed door
5.) The Yanomami
Case 0: The Tuskagee experiment (US Public Health Department) 1932-72
1. subjects not informed of the diagnosis
2. no informed consent or its equivalent
3. no treatment offered when penicillin became available in 1947
4. no measures to prevent further infections
5. preventing patients from seeking treatment elsewhere
Case 1 Guatemalan Syphilis Experiment
US Public Health Service- John Cutler
Deliberately infected healthy people to study penicillin effect
76% patients prescribed the therapy, 26% completion
Case 2. Huron-Wendat Ossuary
The Huron-Wendat Nation is demanding that Louisiana State University return the “stolen” remains of about 200 people. They say researchers improperly gathered the bones from an Ontario ossuary to use for unauthorized student research. . . .
The dispute raises questions about the best way for academics to be culturally sensitive
Archaeologist Heather McKillop is the LSU professor who oversaw the excavation and export of bones from the Poole-Rose ossuary near Cobourg to Baton Rouge, La., where she teaches.
She was given permission to do so by the native community geographically closest to the ossuary, the Alderville First Nation, which is not Huron-Wendat.
For remains deemed very old and aboriginal, there are two choices under the Ontario Cemeteries Act: One is to contact the closest First Nations group, which in this case was the Alderville First Nation. The second option is to
consult with the most likely people descended from the dead.
To the Huron-Wendat buried bones are sacred because a person’s soul rests with the remains, while
a second soul soars skyward
Case 3. IRB and the future of fieldwork
Should talking to people, and collecting stories, the research activities that anthropologists and many other scholars typically do, be subject to the same restrictions as biomedicine and experimental research? Why yes? Why not?
Who should be deciding whether a population is a “vulnerable” one?
Case 4. Irb overreach?
Issues of due process
Case 5: The yanomami (James Neel and Napoleon Chagnon)
Issue 1.
a. Neel collects blood samples for genetic research
b. Samples never returned
Issue 2.
a. Neel attempts to help control the spread of measles
b. Gives half of the vaccine to Venezuelan Govt. including all his immune gamma globuline (MIG) (prevents anaphylactic shock)
continued
c. measles outbreak among the Yanomami
d. Neel carries out vaccinations
e. numbers of people die, most likely due to the reaction to the vaccine
Issue 3. Neel never consulted the Yanomami about his genetic research, procedures, and ways to give back to the community
Chagnon
Unfavorable, possibly partially staged representations of the Yanomami? We’ll be viewing some this material in class.
What to do?
Now the US Department of Health and Human Services is reconsidering the rules and regulations while allowing researchers and publics to weigh in. It is your turn…
IN Your OP-Ed
Based on the information presented in the five case studies (“Background File”) you are to voice your view on:
How Institutional Review Boards (in the U.S.) and/or Review Ethics Boards (in Canada) should enforce a set of common rules regarding research.
2. How much freedom should researchers be allowed in conducting their research?
3. What regulations should be enforced to prevent the abuse of research subjects and ensure that the research strives to promote positive benefits for the larger society sponsoring it?
