BME 213 Ethics Final, BME 213 Midterm
Which statement best describes information that must be included in a consent form:
A description of the research's potential benefits and risks.
Which of following protocols is the one that is most likely to require IRB review:
A study to evaluate a newly designed wheelchair by asking elderly individuals to use it.
length of life
According to Iona Heath, the preeminent outcome measure of healthcare now is
Four biomedical principles
Autonomy - The right for an individual to make his or her own choice. Beneficence - The principle of acting with the best interest of the other in mind. Non-maleficence - The principle that "above all, do no harm," as stated in the Hippocratic Oath. Justice - A concept that emphasizes fairness and equality among individuals.
Professional, Health Care, Research, Training
BMES code of ethics four areas of obligations
Which statement best describes the role of an IRB:
Committee that reviews all biomedical research
What are the three main goals of data lifecycle management?
Confidentiality, availability, and integrity
The main reason that the Royal Society of London developed the modern form of peer review was to:
Control the quality of published papers.
Which of the following is true regarding data acquisition?
Data acquisition should follow a detailed collection plan that is set in advance.
Profit
Deming's first theorem says: "Nobody gives a hoot about_______
Which of the following statements most clearly illustrates the principle of beneficence:
Determining whether the benefits of a study outweigh the risks.
T or F? Human subjects research regulations and policies ensure that the subjects' risks outweigh the benefits:
False
The main focus of NIH's conflict of interest policy is:
Financial conflicts of interest
Michael McFarland argues that proximity is one reason why researchers have an obligation to help the public. Which of following most accurately describes what McFarland means by proximity?
Having the specialized expertise to reduce technical risks
Which of the following set of shared values are the four components of RCR:
Honesty, accuracy, efficiency, objectivity
Pharmaceutical treatments
How did Iona Heath complete this sentence? "To date, the vast majority of the clinical measures have been of process rather than of outcomes relevant to patients and a disturbingly large number of the measures assess the adherence to _______
Conflict of conscience
If researchers allow their moral or other personal beliefs to influence their objectivity, this is most likely an example of:
Belmont Report
In the CITI Undergraduate RCR module there are nine customary topics in the Responsible Conduct of Research. In addition, there is an ASU-specific module which is added to its required Undergraduate RCR content. That ASU-specific module is
Which of the following is true regarding industry-sponsored research?
Industry sponsors of research may seek to place restrictions on the disclosure of research results
Nuremberg Code
Informed, voluntary consent. Improve public good. Avoids unnecessary suffering. Done by experts. Must be stopped if it threatens subjects well being
The numbers of biometric measurement
Iona Heath wrote that across the whole of medicine, we are witnessing an extraordinary process within which the definition of disease is shifting away from patients' subjective experience of symptoms, distress and suffering and towards __________________
What is the main function of the Bayh-Dole Act of 1980 as it relates academic institutions?
It allows institutions to have control over the intellectual property from federally-funded research.
Which of the following most accurately describes the Green Revolution?
It involved mobilizing a technological system to improve food production.
Which of the following most accurately describes technological momentum?
It is the belief that technology is neither morally good nor bad
Which of the following most accurately describes an institutional conflict of interest?
It occurs when an institution's financial interests could interfere with its research activities.
Which of the following most accurately describes a conflict of commitment?
It occurs when outside activities interfere with obligations to one's primary employer.
Which of the following most accurately describes data lifecycle management (DLM)?
It refers to the tools and processes for handling data during a research study and after it concludes.
What is the most appropriate process for determining which journal a collaborative research team should submit their work to?
It should be discussed early on in the collaboration by the members of the research team.
What best describes "objectivity" in the Responsible Conduct of Research
Letting the facts speak for themselves and avoiding bias.
According to the U.S. Federal Research Misconduct Policy, falsification involves:
Manipulating research materials, equipment, or processes, or changing or omitting data.
You work in Dr. May's biology laboratory to study the effects of pollution on deceased persons human lung tissue Is this an example of human subjects research?
No
Nuremburg Code
One of the war crimes trials that was conducted after World War II, which became known as the "Doctors' Trial," tried the German physicians responsible for conducting unethical medical procedures on humans during the war. During this trial ten points defining legitimate medical research were adopted and became known as the
According to U.S. Federal Research Misconduct Policy, which of the following is considered to be research misconduct?
Plagairism
Definition of research misconduct
Plagiarism, Fabrication, Falsification
Reviewers have a responsibility to promote ethical peer review by
Preserving the confidentiality of the submission.
The main way in which the organization Doctors Without Borders acts on social responsibilities is by:
Providing medical care in emergency situations.
Which statement best describes what an IRB is responsible for reviewing:
Research involving a human subject
Social responsibility is usually expressed in professional codes of ethics by stating that:
Researchers have an obligation to the public
Which of the following is true regarding data sharing and stewardship?
Researchers who receive federal funding may have to adhere to a data sharing requirement.
Which of the following statements is true regarding the responsibilities of reviewers?
Reviewers should identify the positive and negative aspects of a manuscript, and indicate where improvements are needed.
Helsinki
Set of ethical principles regarding human experimentation developed for medical communication developed by world medical association. Concern for interests of subject must always prevail over interests of science/society
Plagiarism is considered a serious problem facing academia Examples of plagiarism include:
Students taking and using materials from internet sources without proper attribution or proper citation.
Principle of beneficence
That health care providers have a duty to be of a benefit to the patient, as well as take positive steps to prevent and to remove harm from the patient
Pavlov
The 1904 Nobel Prize was awarded to which of the following individuals for his discoveries about the nervous control of digestion using dogs as his research test subjects?
USDA, APHIS, and Animal Care agency
The Animal Welfare Act created in 1966 is enforced by
Office of Public Health and Science
The Office for Human Research Protections (OHRP) is a part of
1932-1972
The Tuskegee Syphilis Study was conducted
Health Insurance Portability and Accountability Act (HIPAA)
The U.S. agency responsible for protection of your identifiable health information is
17.10%, 9.40%
The U.S. currently spends about _____% of its gross domestic product on healthcare costs and Australia currently spends about ______% of its gross domestic product on healthcare costs
Justice
The biomedical ethical principle that applies to the following statement: "a form of fairness or as Aristotle once said, 'giving to each that which is his due.'"
benificence
The biomedical ethical principle that applies to the following statement: "taking actions that serve the best interests of patients"
Autonomy
The biomedical ethical principle that applies to the following statement: "the patient has the right to refuse or choose their treatment"
nonmaleficence
The biomedical ethical principle that applies to the following statement: "this concept is embodied by the phrase, 'first, do no harm,'"
Institutional Animal Care and Use Committee (IACUC)
The committee that oversees animal care for research institutions is it the
Which of the following is true regarding academic-industry collaborations?
The industry sponsor typically owns the data from research that it funds.
Rene Descartes
The notion that animals are unfeeling robots that cannot reason and do not feel pain was a belief widely held by scientists into the 20th century and beyond is in large part predicated on the notions espoused by
Which of the following best describes when a protocol may be eligible for expedited review by the IRB:
The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified by the federal government.
Which of following is true about conflicts of interest?
They increase the likelihood of bias
What is the primary responsibility of oversight bodies such as an IRB or an IACUC?
To detect compliance with regulatory requirements, including those relating to protecting research subjects
T or F? Data "ownership" generally refers to both the possession of and responsibility for information with respect to a data collection:
True
T or F? Peer review can directly affect public policy:
True
T or F? Students should generally not assume that it will be permissible to take "their data" when they leave:
True
Which of the following most directly contributed to the establishment of the National Research Act and the creation of the Belmont Report:
Tuskegee study
This level of ASU's RCR training fulfills the training requirements for:
Undergraduate students
To treat, rather than cure
What result is the current U.S. healthcare system (consciously or unconsciously) designed to produce?
July of 1965
When Medicare and Medicaid programs were signed into law
Anthropomorphism
Which of the following words means "attribution of human characteristics or behavior to an animal"?
The credit derived from publications is used to determine a researcher's:
Worth
To find out which laboratory safety practices are used in a specific laboratory setting you should contact
Your principal investigator
Ethics, Morality
____ refers to rules provided by an external source (for example, professional codes of conduct) while_____refers socially agreed upon ideas regarding right and wrong
Principle of Justice
a form of fairness, fair distribution of goods in society and requires that we look at the role of entitlemenT
Principle of respect of autonomy
any notion of moral-decision making assumes that rational agents are involved in making informed and voluntary decisions
Law
concrete duties established by governments that are necessary for maintaining social order and resolving disputes,
Politician taking money from a company he is supposed to regulate
ethical problem
Falsification
intentionally removes data points from the data set in order to generate a deceptive conclusion
Which statement most accurately describes the process leading to the development of the Nuremberg Code:
it was created in response to the harms caused by Nazi researchers around the time of the Second World War.
Principle of nonmaleficence
requires that we not intentionally create harm or injury to the patient, either through acts of commission or omission
single blind review
reviewer knows author
Morals
set of deeply held, widely shared, and relatively stable values within a community (based on person's judgment of right and wrong)
Ethics
study of values, and the justification for right and good actions(principle of right conduct)
As a first step, what must be done before enrolling a young child in a research protocol:
the risks and benefits must be explained to the child's parents or legally authorized representative.
