This document provides background information and instructions for writing an op-ed on research ethics regulations. It discusses the historical development of regulations from the Belmont Report to the Common Rule. It also summarizes 5 key cases that raise ethical issues: the Tuskegee Syphilis Study, the Guatemala Syphilis Experiment, research on Huron-Wendat remains, debates around IRB oversight of fieldwork and social sciences, and genetic research with the Yanomami people. Students are asked to outline regulations for research involving human subjects, how much freedom researchers should have, and how to prevent abuse and ensure societal benefits.

1. You 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.

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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?

8. For Thursday, February 12, bring to class two copies of an
outline of the op-ed piece you will be writing. The outline
should state your position on the regulations and procedures
related to the research on human subjects and answer the two
questions posed in the “Background File.”
In supporting your position, you can draw on some or all of the
cases described in the "Background File” material (BBLearn=>
"content" => "Public Anthropology"). Think about a "hook,"
that is, an attention-grabbing way to start your op-ed piece.
There are 15 points available for this assignment.
For this assignment you are encouraged to collaborate with your
group members by asking their feedback on your outline. You
may want to use “file swap” tool on your group’s forum. Each
student has to write and bring to class their own individual
outline.
Your op-ed text (about 500-700 words long) will be due on line
at the Public Anthropology website, on Friday, February 13 by
11:59 PM, accessible by registration only.