Week 5 Flashcards
(21 cards)
Tuskegee syphilis experiment
600 poor African American sharecroppers, 399 had syphilis (but didn’t know).
- Began in 1932 studied the progression of the disease.
- No cure initially. Penicillin became a
standardized cure for syphilis in 1945-1947. - Treatment was withheld to study the progression and full effects of the disease.
- The study was terminated 1972, when a
whistleblower leaked information to the press. - “The longer the study, the better the ultimate information we would derive.“ Dr. John Heller, Director of the U.S. Public Health Service.
Henrietta Lacks and the immortalized HeLa cell line.
Was treated for cervical cancer at Johns Hopkins Hospital in 1951. She died that year.
- Tumor cells were biopsied without her knowledge or permission.
- A medical researcher, George Otto Gey, noted that her cells could be induced to multiply continuously.
- The cell line was used for the polio vaccine, cancer research, and is still used today (cited in more than 75,000 scientific articles).
- The family was unaware of this until 1975. An agreement was reached in August of 2013 regarding use of the cells and related genetic data
Project MKUltra
Research sponsored by the CIA to study human behavior modification through clandestine means.
- Began in the 1950s and halted in 1973. Formally investigated in 1975, but most of the files had been destroyed.
- Drugs (e.g. LSD) and behavioral control techniques were surreptitiously given to individuals at 44 universities, 3 prisons, and 12 hospitals.
- Subjects often ‘participated’ without consent or knowledge.
After World War II (1947), the _______ established the first protocols for working with human subjects.
- In response to horrific tests run by Germany in concentration camps during the Holocaust.
- 10 principles centered around informed consent, absence of coercion, and benefit to society.
Nuremberg Code
The _______ (1964) refined the elements of the Nuremberg Code and is used as the basis for human subjects treatment in European countries (and the US).
Declaration of Helsinki
Milgram obedience experiments (1963)
A series of experiments examining willingness to obey authority figures.
- Participants were ‘teachers’ told to give increasing levels of an electric shock to ‘learners’ (confederates who were part of the experiment) when they made mistakes on a memory task.
- Deception was critical to the experiment.
- If the ‘teacher’ protested, they were told
they needed to continue. - 25 of 40 participants complied to the final
450 volt shock
Stanford prison experiment (1971)
Purpose was to study how people would act in a simulated prison environment when randomly assigned to different roles. Do roles and situational factors drive behavior?
- 11 participants were randomly assigned as guards, 10 as prisoners. Prof. Phil Zimbardo (PI) served as superintendent. Planned 14 day experiment. Prisoners were kept in a simulated prison.
- ‘Guards’ began mistreating ‘prisoners’, using humiliation, threats, and isolation to control them.
- 5 participants had to be released early due to “ extreme emotional depression, crying, rage, and acute anxiety.” The entire experiment was terminated within 6 days
The _____ ____ ___of 1974 created a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the United States.
National Research Act
Belmont report
- Respect for persons: Informed voluntary consent and protection for those needing protection.
- Beneficence: Humans should not be harmed. Aim is to maximize benefit and minimize any potential harm.
- Justice: Participant selection should be fair and benefits should accrue to everyone.
Respect for persons
- All participation in human studies must be voluntary and free from coercion (also called free consent). In an academic setting, alternatives must be provided. You also can’t pay too much, such that the participant’s judgment is clouded.
- Adequate information must be provided so that
the participant can provide informed consent. - Individual rights, such as privacy and confidentiality, must be maintained. Any potential violations of this must be made clear.
- Participants who cannot make decisions for themselves (e.g. children or psychiatric patients) must be protected by a responsible party.
- A participant can stop the experiment at any time.
- Deception is to be avoided, as it conflicts with the principle of informed consent. Deception may never be used to induce a participant to volunteer or act in ways they would have otherwise avoided.
- If deception is used, it must be justified by the nature of the experiment and explained clearly
during the debriefing.
Beneficence
- Actual or potential risks must be kept to a minimum. If any risk is present, then the benefit to society must greatly outweigh that risk.
- Minimal risk: The risk or discomfort must be comparable to what would be experienced in ordinary life.
- Appropriate care and steps must be taken to mitigate risks as much as possible.
- This can be very subjective and is often open to interpretation.
- Who must benefit and how much?
Justice
- Participants should be recruited fairly and equally to any study.
- Risks and benefits should apply equally to all participants or potential participants. (You can’t experiment on one group, for the benefit of a different group.)
- This mainly applies to the selection of participants.
Institutional Review Boards
The general goal of this independent committee is to protect human participants from physical or psychological harm
- They review all proposed research protocols at the institution and approve, approve with changes, or reject each submission
All IRBs must have at least __ members.
5
They must be of mixed gender and have at least one scientist, one non-scientist, and one community member.
t or f: All facilities receiving federal research funding must have an IRB or its equivalent.
true
At UCSD, the IRB operates under
The Human Research Protections Program (HRPP), which ensures that it follows all federal, state, and University policies.
Institutional Animal Care and Use Committee (IACUC).
This group oversees all proposed research protocols for animal research on campus.
Goal: minimize animal pain and distress, or propose alternative methods when possible.
- Ensures compliance with federally mandated regulations through reviews of procedures and on-site inspections.
- Because the Belmont principles can’t be applied, this remains controversial.
Scientific misconduct
a violation of the regulatory or scholarly codes of ethical behavior in scientific research
Scientific misconduct examples
- Falsifying data.
- Reporting/manipulating data that to inaccurately reflect the results of an experiment.
- Excluding or suppressing data that do not support the research hypothesis.
- Plagiarizing another persons work without giving appropriate credit.
- Including (or excluding) authors on a paper in a way inconsistent with their contribution to the work.
Scientific misconduct damages the reputation of all science, making the public less likely to trust scientific results. It has contributed to the ___ ____ in the sciences.
replication crisis
