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A patient has been selected as a potential recipient of an experimental drug for multiple sclerosis. The nurse knows that when informed consent has been obtained, it indicates which of these?
- A. The patient has been informed that he or she will need to stay in the study until it ends.
- B. The patient will be informed of the details of the study as the research continues.
- C. The patient will receive the actual drug during the experiment.
- D. The patient has had the study's purpose, procedures, and possible benefits as well as risks involved explained to him.
Correct Answer: D
Rationale: Informed consent involves the careful explanation of the purpose of the study, the procedures to be used, and the risks involved. The other options do not describe informed consent. Participation in studies is voluntary and patients have the right to end participation at any time.
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For which cultural group must the health care provider respect the value placed on preserving harmony with nature and the belief that disease is a result of ill spirits?
- A. Hispanics
- B. Asian Americans
- C. Native Americans
- D. African Americans
Correct Answer: C
Rationale: Some Native Americans believe in preserving harmony with nature and that disease is a result of ill spirits. The groups listed in the other options do not typically reflect these practices.
The nurse is reviewing the concept of drug polymorphism. Which factors contribute to drug polymorphism?
- A. The number of drugs ordered by the physician
- B. Inherited factors
- C. The patient's diet and nutritional status
- D. Different dosage forms of the same drug
- E. The patient's cultural practices
- F. The patient's drug history
- G. The various available forms of a drug
Correct Answer: B,C,E
Rationale: Inherited factors, diet and nutritional status, and cultural practices are some of the factors that contribute to drug polymorphism. The other options are not factors that contribute to drug polymorphism.
During the development of a new drug, which would be included in the study by the researcher to prevent any bias or unrealistic expectations of the new drug's usefulness?
- A. A placebo
- B. FDA approval
- C. Informed consent
- D. Safety information
Correct Answer: A
Rationale: To prevent bias that may occur as a result of unrealistic expectations of an investigational new drug, a placebo is incorporated into the study. The other options are incorrect. FDA approval, if given, does not occur until after phase III. Informed consent is required in all drug studies. Safety information is not determined until the study is under way.
A member of an investigational drug study team is working with healthy volunteers whose participation will help to determine the optimal dosage range and pharmacokinetics of the drug. The team member is participating in what type of study?
- A. Phase I
- B. Phase II
- C. Phase III
- D. Phase IV
Correct Answer: A
Rationale: Phase I studies involve small numbers of healthy volunteers to determine optimal dosage range and the pharmacokinetics of the drug. The other phases progressively involve volunteers who have the disease or ailment that the drug is designed to diagnose or treat.
When reviewing the various schedules of controlled drugs, the nurse knows that which description correctly planting describes Schedule II drugs?
- A. Drugs with high potential for abuse that have accepted medical use
- B. Drugs with high potential for abuse that do not have accepted medical use
- C. Medically accepted drugs that may cause moderate physical or psychologic dependence
- D. Medically accepted drugs with limited potential for causing physical or psychologic dependence
Correct Answer: A
Rationale: Schedule II drugs are those with high potential for abuse but that have accepted medical use. Drugs that have high potential for abuse but do not have accepted medical use are Schedule I drugs. Medically accepted drugs that have moderate physical or high psychologic dependence potential are Schedule III drugs. Medically accepted drugs with limited potential for causing physical or psychologic dependence are Schedule IV and V drugs.