chapter 4

In therapeutic research, patient-subjects are themselves expected (or at least hoped) to benefit medically from the new drug, vaccine, treatment, or diagnostic procedure under investigation. a) true b) false

true

Incomplete replacement of live animals refers to the use of some biological materials derived from living or humanely killed animals. a) True b) False P. 311

true

Is it true that duty of physicians who participate in medical research is to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. true false pg.255

true

Most of the literature on the ethics of human research is concerned with specifying the conditions under which research involving human subjects is ethically acceptable. a) True b) False pg.246

true

Non-therapeutic research is often characterized as research whose sole aim is to furnish data that contributes to generalizable knowledge. a) True b) False Pg. 244

true

Randomized clinical trials cause difficulties and ethical issues due to doctors having to play roles as both physicians and scientists at the same time. A. True B. False p. 260

true

Research and experimentation refers to a set of scientific activities whose primary purpose is to contribute to generalizable knowledge about the chemical, physiological, or psychological processes involved in human functioning. True False pg. 243/244

true

The Declaration of Helsinki was the 1st major code of research ethics to address the participation of incompetent subjects. a) true b) false

true

The Nuremberg Code and Declaration of Helsinki are similar because they both require informed consent for human experimental purposes. a) True b) False pg. 246

true

The OTA (Office of Technology Assessment) suggests teaching by demonstration instead of by individual students use of animals. a) True b) False p. 303

true

The OTA study presents numerous suggestions involving the replacement, reduction, and refinement of the use of animals. True False pg. 303

true

The access model stress that participation in research can, in the absence of effective therapies for some illnesses, benefit subjects. a) True b) False Pg. 245

true

The conflicting moral demands arising from the use of RCT dismisses the standard conflict between rights-based moral and utilitarian theories. A) False B) True (pg 260)

true

The dilemma about enrolling patients in randomized clinical trials is generated by the claim that physician has a strict therapeutic obligation t inform the patients of the physician's treatment preference, even when the preference is based on evidence that is not of the highest quality. True False P. 265

true

The term 'alternatives' is often used to refer to the replacement of live animal use with non animal techniques. a) True b) False p. 311

true

There are 10 ethical codes to The Nuremberg Code. True False Page 253

true

True or false Respect for patients values is the central purpose of informed consent. True False pg266

true

While participating in RCTs, promotion of the patient's best interests would ruin a study. a)True b)False

true

the Declaration of Helsinki states that the first major code of research ethics is to address the participation of incompetent subjects. Determine the difference of how benifical/ gains it will in research for some circumstances. A)true b) false pg. 248

true

The NBC identifies which morally relevant features: a. sentience b. higher cognitive capacities c.sociability d. possession of a life. e. all of the above

. all of the above

According to Paul Litton and Franklin G. Miller, the essential purpose of clinical research is to produce generalizable medical knowledge that will improve medical care for future patients. a) True b) False p. 269

true

According to the "no-status view," animals' interests have no moral importance except where our treatment of animals affects human interests. 1)T 2)F pg. 307

true

Alternative methods to using animals for testing could include in vitro experimentation and computer simulation. a) false b) true page 296

true

Animals do not have rights because they are incapable of responding to moral claims and/or moral judgment. a.) True b.) False p. 293

true

Apparent ethical dilemmas arise when physicians consider enrolling their patients in randomized clinical trials. a) true b) false pg. 265

true

Background information is important and makes a difference in studies. a) true b) False Pg. 249

true

Carl Cohen defends the use of animals in research because, in his opinion, only humans can have rights. a) True b) False

true

DeGrazia distinguishes between four views on the moral status of animals: no-status, equal consideration, unequal consideration, and animal rights. a) True b) False pgs. 307-308

true

Discussions of whether or not individuals hace a duty to serve as research subjects sometimes reflect what may be called the the protection model. True False pg 245

true

In the biomedical context, therapy ordinarily refers to a set of activities whose primary purpose is to relieve suffering, restore or maintain health, or prolong life. True False

true

In the biomedical context, therapy ordinarily refers to a set of activities whose primary purpose is to relieve suffering, restore or maintain health, or prolong life. a) true b) false

true

Two noteworthy differences between the Nuremberg Code and the Declaration of Helsinki are that the Declaration of Helsinki addresses informed consent from incompetent subjects, and sets out guidelines for the treatment of animals. a) True b) False

false

Activists often aset that patient with AIDS have a right to participate in promising studies. This would be an example of: A) The protection model of participation B) The access model of participation C) Both A and B D) Neither A or B Page 245

B) The access model of participation

When a patient is involved in therapeutic research they will never be asked to undergo additional procedures unrelated to their own therapy. a) True b) False

false

When participating in a randomized clinical trial, signing an informed-consent form waives the rights implicit in the doctor-patient relationship. a) True b) False pg. 262

false

the benefits to participants during research are.. A. Heightened medical attention during the study B. Improvements to health and health care C. More one on one time with a physician D. Collateral health services unnecessary for research study E. Both B and C. pg 291

Both B and C.

Paul Ramsey, holds that informed consent is the _____. a) Chief canon of loyalty b) Consent where appropriate of a proxy c) Dependence on others to protect their interest. pg.246

Chief canon of loyalty

______ argued that only human beings can have rights. a. Brody b. Bouvia c. Cohen d. Andrew page 299

Cohen

Who advocates animal interests being comparable to human interests? A) Don Marquis B) Peter Singer C) Baruch Brody D) Carol Cohen (pg 251)

Peter Singer

The sliding-scale model of moral status for animals is where humans deserve full, equal consideration and other sentient beings deserve trivial, but less-than-equal consideration. a) True b) False p. 308

false

David DeGrazia suggests all but one of the following when it comes to identifying a palatable compromise in regards to animal research where consensus is unavailable . . . a) Great apes should not be used in research unless their participation is voluntary/compatible with the best interests of the individual research subjects. b) Wild animals should never be captured for laboratory research. c) Toxicity testing on live animals should not be banned because we have yet to make enough significant progress in alternative testing. d) Where animal research is permitted, housing conditions must meet the basic needs including physical, psychological, and social of the animal subjects. p. 311,312

Toxicity testing on live animals should not be banned because we have yet to make

According to the OTA report on alternatives to animal research, which of the below is not an alternative? A. Using human and animal cadavers B. Using brain-dead humans C. Sharing information D. Using plants instead of animals Pg. 303

Using brain-dead humans

The _________________ Conclusion is that human experimentation is not just morally permissible, but morally required, because its future benefits and prevention of harm to many will far outweigh its harmful consequences to some research subjects. a. Therapeutic b. Utilitarian c. Psychiatric d. Non-therapeutic

Utilitarian

Who establish the three R's ( refinement of techniques to reduce suffering, reduction of numbers of animal subjects, and replacement of live animals wherever possible) ? 1.William Russel and Rex Burch 2. Jeremy Bentham 3. Jhon Stuart Mill pg. 307

William Russel and Rex Burch

The _____ model stresses that participation in research can, in the absence of effective therapies for some illness, benefit subjects. a.) access b.) paternalistic c.) protection d) fair pg. 245

a.) access

As part of the Fair Benefits Framework for developing countries, which is included as benefits to the population during research a) health services unnecessary for the research study b) employment and economic activity c) public health measures d) all of the above p. 291

all of the above

Which of the following can be used as substitute techniques in the current biomedical use of of animals? a) cold-blooded for warm-blooded animals b) invertebrates for vertebrates c) plants for animals d) all of the above e) none of these

all of the above

The purpose of randomized clinical trials is to: A) free medication B) avoid the problems of observer bias and patient selection C) get more money D) improve health care Page 263

avoid the problems of observer bias and patient selection

____________ refers to a set of scientific activities whose primary purpose is to contribute to generalizable knowledge about the chemical, physiological, or psychological processes involved in human functioning. a) Therapy b) Research c) The protection model d) The access model p. 243-244

b) Research

________________ say "that physicians, even when acting as researchers, have the same duty of fidelity to subjects as they do to their patients". a) Hellmans b) Marquis c) Paul Litton and Franklin Miller d) both A and B e) none of the above p248

both A and B

What is the main central theme emphasized in The Nuremberg Code? a) suffering should be minimized b) only doctors should perform experiments c) voluntary consent is absolutely essential d) subjects may leave an experiment

c) voluntary consent is absolutely essential

In 1992, the Council for International Organizations of Medical Sciences (CIOMS) a.) Emphasized the centrality of voluntary consent b.) Adopted an ethical code to guide physician and other investigators who conduct medical research involving human subjects. c.) Published guidelines for the appropriate use of research subjects from underdeveloped communities." d.)Argued that one need not be a moral agent to possess rights, as suggested by the examples of human infants and severely retarded humans.

c.) Published guidelines for the appropriate use of research subjects from underdeveloped communities."

the protection model includes which of the following: a) emphasis the participation that involves the risks the subjects are going to take b) individuals have to right to participate in promising studies c)states some treatments might actually benefit d) none of the above

emphasis the participation that involves the risks the subjects are going to take

An Act utilitarian would say that no matter how many patients are cured from AIDS, animal testing is immoral. a) True b) False pg. 302

false

Carl Cohen believes we should reduce the use of animals in biomedical research. a) True b) False pg 297

false

Kantian deonologists who oppose animal research, feel this way because they think the overall good resulting from these experiments is not sufficient to justify the negative consequences. a) True b) False pg 302

false

T/F According to Paul Ramsey, only individuals who are capable of knowingly involving themselves in a common cause with the researcher have given their informed consent. true false Pg 246

false

The Declaration of Helsinki's paragraphs are intended to be read individually and to separate each paragraph from one another. True False Page 254

false

The Nuremberg Code states that once the human subject is enrolled in the experiment, he or she must stay enrolled until the experiment has come to an end. a) True b) False

false

The Nuremberg code, which was developed after the second world war, points out that voluntary consent can ruin an experiment an is not desirable. a) True b) False

false

The goal of the AZT studies was to see if lower doses of the drug AZT, than those used in the US, could reduce the rate of all transmission forms of HIC. a) True b) False p.280

false

The meaning of human research ordinarily refers to a set of activities whose primary purpose is to relieve suffering, restore or maintain health, or prolong life. a) True b) False

false

The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists? a) True b) False PG. 257

false