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.