BME 213 Midterm

Morals

set of deeply held, widely shared, and relatively stable values within a community (based on person’s judgment of right and wrong)

Law

concrete duties established by governments that are necessary for maintaining social order and resolving disputes,

Ethics

study of values, and the justification for right and good actions(principle of right conduct)

Politician taking money from a company he is supposed to regulate

ethical problem

sex scandal

moral problem

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.

What best describes "objectivity" in the Responsible Conduct of Research

Letting the facts speak for themselves and avoiding bias.

T or F? Peer review can directly affect public policy:

True

T or F? Human subjects research regulations and policies ensure that the subjects’ risks outweigh the benefits:

False

The credit derived from publications is used to determine a researcher’s:

Worth

This level of ASU’s RCR training fulfills the training requirements for:

Undergraduate students

T or F? Students should generally not assume that it will be permissible to take "their data" when they leave:

True

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

T or F? Data "ownership" generally refers to both the possession of and responsibility for information with respect to a data collection:

True

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.

Definition of research misconduct

Plagiarism, Fabrication, Falsification

To find out which laboratory safety practices are used in a specific laboratory setting you should contact

Your principal investigator

Which of the following set of shared values are the four components of RCR:

Honesty, accuracy, efficiency, objectivity

Which statement best describes what an IRB is responsible for reviewing:

Research involving a human subject

Which of the following most directly contributed to the establishment of the National Research Act and the creation of the Belmont Report:

Tuskegee study

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.

Which statement best describes the role of an IRB:

Committee that reviews all biomedical research

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.

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.

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 the following statements most clearly illustrates the principle of beneficence:

Determining whether the benefits of a study outweigh the risks.

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 the following is true regarding academic-industry collaborations?

The industry sponsor typically owns the data from research that it funds.

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

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 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 a conflict of commitment?

It occurs when outside activities interfere with obligations to one’s primary employer.

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.

The main focus of NIH’s conflict of interest policy is:

Financial conflicts of interest

Conflict of conscience

If researchers allow their moral or other personal beliefs to influence their objectivity, this is most likely an example of:

Which of following is true about conflicts of interest?

They increase the likelihood of bias

What are the three main goals of data lifecycle management?

Confidentiality, availability, and integrity

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.

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

Which of the following is true regarding data acquisition?

Data acquisition should follow a detailed collection plan that is set in advance.

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.

The main reason that the Royal Society of London developed the modern form of peer review was to:

Control the quality of published papers.

Reviewers have a responsibility to promote ethical peer review by

Preserving the confidentiality of the submission.

single blind review

reviewer knows author

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.

According to the U.S. Federal Research Misconduct Policy, falsification involves:

Manipulating research materials, equipment, or processes, or changing or omitting data.

Falsification

intentionally removes data points from the data set in order to generate a deceptive conclusion

According to U.S. Federal Research Misconduct Policy, which of the following is considered to be research misconduct?

Plagairism

Social responsibility is usually expressed in professional codes of ethics by stating that:

Researchers have an obligation to the public

Which of the following most accurately describes the Green Revolution?

It involved mobilizing a technological system to improve food production.

The main way in which the organization Doctors Without Borders acts on social responsibilities is by:

Providing medical care in emergency situations.

Which of the following most accurately describes technological momentum?

It is the belief that technology is neither morally good nor bad

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

Nuremberg Code

Informed, voluntary consent. Improve public good. Avoids unnecessary suffering. Done by experts. Must be stopped if it threatens subjects well being

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