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Week 3

Terms in this set (47)

smallpox, swallowed 17 drugs, germ warfare testing,
1749 to 1823 - Edward Jenner first tested ____ vaccines on his son and on neighborhood children
1779 to 1856 - Johann Jorg ____ in various doses to record their properties
1822 to 1895 - Louis Pasteur "agonized over treating humans," even though he was confident of the results obtained through animal trials. He finally did so only when he was convinced the death of the child, the first test subject, "appeared inevitable."
1942 to 1945 - Researchers in the Japanese military killed Chinese civilians in ____
1941 to 1945 - Medical researchers in Nazi Germany conducted a wide range of dangerous and often fatal experiments on prisoners of concentration camps
could not convict, 1947
At the end of World War II, 23 Nazi doctors and scientists were put on trial for the inhumane treatment and murder of concentration camp inmates who were used as research subjects

The court _______ on the grounds of violating the rights of human subjects because there were no accepted standards

___ - Nuremberg Code was created
Informed consent, prior, qualified, Physical, mental
Nuremberg Code:
____ is essential.
Research should be based on ____ animal work.
The risks should be justified by the anticipated benefits.
Only ___ scientists must conduct research.
___ and ___ suffering must be avoided.
Research in which death or disabling injury is expected should not be conducted.
Nuremberg Code
Had little impact on researchers in the United States
Many thought that the principles in the code were already implicit in their work
Researchers assumed that unethical research could only occur under a depraved regime like the Nazis
1947, penicillin
In __, ____ became a standard and effective cure for the congenital syphilis disease
National Research Act (1974)
Mandated that institutions conducting research with human subjects establish Institutional Review Boards (IRBs)
National Research Act (1974)
This act now requires that investigators obtain "informed consent" from all subjects prior to enrollment in a research protocol
National Research Act (1974)
Established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Responsible for identifying the key components of ethical research involving human subjects and developing guidelines to ensure that human research is conducted in accordance with those principles
1979
In ___, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research published the Belmont Report
Belmont Report
a statement of the basic ethical principles and guidelines to be used to resolve the ethical problems that surround the conduct of research with human subjects
Research
Federal regulations define ____ as:
"a systematic investigation designed to develop or contribute to generalizable knowledge."
DHHS defines Human Subjects
"a living individual about whom an investigator (whether professional or student) conducting research obtains:
Data through intervention or interaction with the individual or identifiable private information
Private Information
______ includes:
Information about behavior that occurs in a setting in which the individual can reasonably expect that no observation or recording is taking place.
and
Information that has been provided for specific purposes, other than research, where the individual can reasonably expect that it will not be made public (e.g., a medical record.)
Respect for Persons, Beneficence, Justice
The Belmont Report identifies three basic ethical principles that underlie all human subject research. These principles are commonly called the Belmont Principles:
Respect
Belmont Report:
initial and continuing informed consent
Beneficence
Belmont Report:
evaluate the social and scientific value of the research, the scientific validity of the research, and determine whether the research has a favorable risk/ benefit ratio.
Justice
Belmont Report:
Whether there is fair subject selection is called...
Respect
Belmont Report:
We need to evaluate whether the research allows subjects to withdraw from the research
Maintains the welfare of each subject
Autonomy, vulnerability
Justice
Belmont Report:
We also need to evaluate the inclusion and exclusion criteria and the methods of recruitment.
Respect for Persons Ethical Principles
Belmont Report:
Individuals should be treated as autonomous agents
"An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation." (The Belmont Report, 1979)
Persons with diminished autonomy are entitled to protection
Vulnerable
___ subjects are those subjects with diminished autonomy.
Mental Capacity and Voluntariness
Autonomy is generally broken down into two general elements in the bioethics literature:
Mental Capacity
the ability to understand and process information.
Voluntariness
freedom from the control or influence of others
capacity, freedom
Therefore, subjects have full autonomy when they have the...
____ to understand and process information and ____ to volunteer for research
Physical Control
Vulnerability:
A dentist keeps someone under anesthesia to perform research after clinically-required surgery, despite the subject's prior refusal to participate in the research.
Coercion
Vulnerability:
The use of a credible threat of harm or force to control another person. An example of coercion is a nursing home resident who was forced to choose between participating in a research study or leaving the nursing home.
Undue Influence
Vulnerability:
The misuse of a position of confidence or power to lead another to make a decision (s)he would not otherwise have made. An example would be a physician's affirmative response to a patient's inquiry of whether the patient should enter a research study, when in fact the physician knows that participation in the study is not in the patient's best interest.
manipulation
Vulnerability:
Deliberate management of conditions or information in such a way as to lead another to make a decision he would not otherwise have made. Examples of information _____ include lying, withholding information, and exaggeration.
Law of Respect
Individuals' considered judgments are rejected
Their ability to act on their judgments is denied
Information is withheld that is necessary to make a thoughtful, considered judgment when there is no compelling reason to do so
Investigator-Subject Relationship
The investigator must place the subject's rights, welfare, and safety above all other personal and scientific concerns.
Informed consent, discretion
Differences between Investigator-Subject relationship and Patient-Physician:
Investigators should be sensitive to power relationships
____ is required for participation in research
Withdrawal from a study is at the ___ of the subject
IRB
is a review committee established to help protect the rights and welfare of human research subjects.
research involving human subjects
Regulations require IRB review and approval for ___ if it is funded or regulated by the federal government.
proposals
Reviews research ____ to ensure there is no harm to participants, that appropriate procedures will be followed to obtain informed consent and that the privacy and anonymity of participants will be respected.
Internal review Board:
The ____ may apply an exempt from review to some research.
Expedited review
Internal review Board:
research that involves no more than minimal risk or for review of minor changes to previously approved research projects and protocols
Full review
Internal review Board:
all research involving greater than minimal risk to subjects or any protected subject population (i.e., fetuses, pregnant women, prisoners, children, elderly, psychiatric patients)
five, both sexes, nonscientific, scientific, the institution
The Composition Of the IRB:
at least ___ members;
members of ___;
members that come from varied professions;
at least one member whose primary concerns are in ____ areas;
at least one member whose primary concerns are in ____ areas;
at least one member who is not otherwise affiliated with ____.
Information that the study involves Research
Consists of:
1.An explanation of the purposes of the research
2.The expected duration of the subject's participation
3.A description of the procedures to be followed
4.Identification of any procedures that are experimental
A clear description of the risks or discomforts to the subject
Be accurate and reasonable;
Review any risks related to procedures and tests relating solely to research and any tests that carry a risk of morbidity/mortality;
Inform the subject of previously reported adverse events.
alternative procedures
A disclosure of any ____ or treatments that may be advantageous to the subject. When appropriate, a statement that supportive care with no additional disease specific treatment is an alternative
confidentiality of records
A description explaining how the institution/investigator will maintain _____. Statement should include full disclosure and description of approved agencies and/or other designated parties that may access the records
Language Issues
Special Challenges:
The consent process should be conducted in the language spoken by the subject, and the consent form should be translated into that language.
Literacy
Special Challenges:
Cultural Issues
Special Challenges:
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