Belmont Report and Its Principles

The NBAC looks at characteristics individuals might have that would prevent them from being able to provide voluntary informed consent. The traits may be thought of as falling into six broad areas: cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a: A. Cognitive or communicative vulnerability B. Economic or social vulnerability C. Institutional vulnerability D. Physical vulnerability

A. Cognitive or communicative vulnerability

Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? A. Determining that the study has a maximization of benefits and a minimization of risks. B. Ensuring that persons with diminished autonomy are protected. C. Ensuring that the selection of subjects includes people from all segments of the population. D. Providing detailed information about the study and obtaining the subject's consent to participate.

A. Determining that the study has a maximization of benefits and a minimization of risks.

The National Research Act of 1974 A. Established the National Commission. B. Identified the basic ethical principles of human subjects research. C. Identified guidelines to ensure the ethical conduct of research. D. Required that all federal agencies have the same regulations governing human subjects research.

A. Established the National Commission.

How long is an investigator required to keep consent documents, IRB correspondence, and research records? A. For a minimum of three years after completion of the study B. As long as the investigator is at that institution C. Until the study is closed D. Until data analysis is complete

A. For a minimum of three years after completion of the study

Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following is an example of exculpatory language? A. I waive any possibility of compensation for injuries that I may receive as a result of participation in this research. B. In the event of any injury you may have related to this research, you will be given medical treatment. C. Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with your doctor or your right to health care or other services that you may be eligible for. D. The investigator may stop you from participating in this research without your consent if you experience side effects that make your condition worse.

A. I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.

A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? A. Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. B. Do not report the adverse drug experience to the IRB since it is a common adverse experience. C. Report the adverse drug experience as part of the continuing review report. D. Report the adverse drug experience to the IRB only if there are several other occurrences.

A. Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.

An investigational biologic administered to the first two subjects in a Phase II clinical trial was not appropriately screened for two viral contaminants, HIV and Hepatitis B, due to human error in the screening process. Follow-up testing indicated that the subjects and their partners were not infected. The subjects and others were notified of the increased risk. A. This is an unanticipated problem requiring notification to the IRB and FDA. B. There was no need to inform the IRB because this was a screening procedure. C. This is neither an unanticipated problem, nor an adverse event. D. This is an adverse event, which is also an unanticipated problem.

A. This is an unanticipated problem requiring notification to the IRB and FDA.

The purpose of informed consent is: A. To provide a potential subject with appropriate information in an appropriate manner and allow that person to make an informed decision about participation in research. B. To document the investigator's participation in the consent process. C. To obtain a signature from a study subject in order to document his or her agreement to participate in research. D. To obtain a signature from a study subject in order to protect the investigator, the study staff and the institution.

A. To provide a potential subject with appropriate information in an appropriate manner and allow that person to make an informed decision about participation in research.

Which of the following brought increased public attention to the problems with the IRB system? A. HHS Inspector General Report of 1998 B. "Shut Downs" by OHRP C. Death of Research Subject (Jesse Gelsinger) D. 1983 Presidential Commission Report

C. Death of Research Subject (Jesse Gelsinger)

The use of prisoners in research is a concern under the Belmont principle of Justice because: A. Prisoners are less educated that the general population and have difficulty understanding research B. Prisoners are not free to say no C. Prisoners are not a representative sample of the general population D. Prisoners may not be used to conduct research that only benefits the larger society

D. Prisoners may not be used to conduct research that only benefits the larger society

IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must: A. Occur only when the level of risk changes. B. Occur at least annually. C. Include copies of all signed consent forms. D. Be conducted by an expedited review.

B. Occur at least annually.

According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four? A. Physical control, coercion, undue influence, and neglect B. Physical control, coercion, undue influence, and manipulation C. Coercion, undue influence, neglect, and disrespect D. Prejudice, physical control, manipulation, and coercion

B. Physical control, coercion, undue influence, and manipulation

Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C, and D with additional protections: A. Prisoners, children, and elderly B. Pregnant women, prisoners, children C. Children, prisoners, and terminally ill D. Pregnant women, prisoners, and mentally disabled

B. Pregnant women, prisoners, children

Informed consent is considered an application of which Belmont principle? A. Justice B. Respect for Persons C. Beneficence D. Non-maleficence

B. Respect for Persons

Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if: A. They are eligible for review using expedited procedures. B. The changes must be immediately implemented for the health and well-being of the subject. C. The investigator keeps careful records of all changes and includes them in the final report. D. They only involve changes to the consent form.

B. The changes must be immediately implemented for the health and well-being of the subject.

Which of the following was the result of the Beecher article? A. Multiple Congressional hearings B. An identification of basic ethical principles C. Additional FDA regulations D. Realization that ethical abuses are not limited to the Nazi regime

D. Realization that ethical abuses are not limited to the Nazi regime

Which of the following are the three principles discussed in the Belmont Report? A. Privacy, Confidentiality, Equitable Selection of Subjects B. IRB Review, Federal Regulations, Declaration of Helsinki C. Informed Consent, Institutional Assurance, Researcher Responsibility D. Respect for Persons, Beneficence, Justice

D. Respect for Persons, Beneficence, Justice

An investigator is confronted w/ a life-threatening situation that necessitates using a test article in a human subject who can't give informed consent and there is no time to obtain consent from the individual's LAR Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator: A. Use the test article without obtaining consent from the subject or the LAR then notify the IRB. B. The investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later. C. Do not use the test article until either the subject or the subject's LAR can give consent. D. Submit a research protocol to the IRB and justify an expedited review approval of the consent document so test article can be used immediately.

B. The investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later.

A study requires that each subject be given two study drugs. The first study drug is given on Day 1. A second study drug is given on Day 7 to counteract the toxicity of Drug 1. Subject # 4-706 is given Drug 1 on Day 1. Due to a snowstorm, Subject 4-706 is delayed for several days before returning to the site for Drug 2. Missing the administration of Drug 2 on Day 7 placed the subject at risk of significant toxicity. This event required the subject be notified of the increased risk and required close monitoring of the subject by phone. A. This is an adverse event, which does not require notification to the IRB. B. This is an unanticipated problem that does not include an adverse event. C. This is not an unanticipated problem because the subject was required to return on Day 7. D. This is not an unanticipated problem because adverse weather is a possibility in the area where the site is located.

B. This is an unanticipated problem that does not include an adverse event.

A subject received the wrong study drug resulting in severe nausea and vomiting, and a visit to the emergency room for treatment. The subject notified the study coordinator the day after the emergency room visit. The study coordinator reviewed the subject's study records and discovered the error. The coordinator notified the subject of the study drug error, which caused the nausea and vomiting. The investigator notified the IRB and the IRB approved a revision of the standard pharmacy procedure for administering investigational drugs. A. The IRB does not have authorization to require changes in the pharmacy procedures. B. This is an unanticipated problem, which resulted in an adverse event. C. This is an adverse event that was anticipated because there is always a possibility of a pharmaceutical mistake. D. The subject should have contacted the study site for authorization before going to the emergency room.

B. This is an unanticipated problem, which resulted in an adverse event.

A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on-going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following? A. Withhold this new information to avoid confusing the subject with other treatment options or alternatives. B. Do not tell the subject about the new drug because physicians have the right to try out new treatments with their patients. C. Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug. D. Tell the subject about the new drug but discourage him from switching treatments until the study is completed.

C. Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.

Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA) protects individuals from: A. Long-term care insurance and religious discrimination B. Disability insurance and mortgage insurance C. Health insurance and employment discrimination D. Gender discrimination

C. Health insurance and employment discrimination

Which of the following is considered a SBR data collection method? A. Physical exams B. Hearing/audiological screenings C. Interviews D. Blood draws

C. Interviews

The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that... A. Persons involved in research cannot financially benefit. B. Persons with diminished autonomy should be excluded from research. C. Persons with diminished autonomy are entitled to protection. D. Persons with diminished autonomy should only participate in no more than minimal risk research.

C. Persons with diminished autonomy are entitled to protection.

An elderly man, whose wife is his legally authorized representative (LAR) since his strokes several years ago, was recently diagnosed with lung cancer. He is eligible for a clinical trial using a new investigational drug that aims to treat lung cancer. He is able to express interest, shows a basic understanding of the nature of the trial, and gives his assent to participation. The subject's wife is out of town on a business trip. Which of the following is the most appropriate action to take for the investigator? A. The investigator can go ahead and enroll the man without a signed consent. B. Exclude the man from the study. C. Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back. D. Consult a colleague about his opinion. If the colleague agrees, enroll the man without a signed consent.

C. Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back.

A Data Safety Monitoring Board report for an investigator-initiated investigational drug study indicates a significantly higher than anticipated rate of an expected adverse event. This event required revision of the informed consent form to disclose the higher rate. A change in the eligibility criteria of the protocol to reduce the risk was implemented. Current subjects would be reconsented. A. Current subjects should never be reconsented. B. This is not an unanticipated problem because the adverse event was acknowledged in the consent form. C. This is an unanticipated problem. D. This study was an investigator-initiated study. There is no need to report to the IRB or any federal agency.

C. This is an unanticipated problem.

Which is an example of a situation where deferential vulnerability might be a factor? A. A college professor recruiting among their students B. An employer recruiting among persons who directly report to them C. An army medical officer recruiting subjects among lower ranks D. A physician recruiting patients to be subjects

D. A physician recruiting patients to be subjects

A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of: A. Institutional vulnerability B. Communicative vulnerability C. Social vulnerability D. Economic vulnerability

D. Economic vulnerability

Under which of the following conditions is it appropriate to re-contact the individuals who provided biological specimens? A. Biological specimens need to be replenished B. Subjects received financial compensation for participation in the study C. Discovery of related clinical information requires contacting subjects for follow-up D. Original signed consent documents include provisions for recontacting subjects

D. Original signed consent documents include provisions for recontacting subjects

According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB? A. The study does not require informed consent or survey instruments. B. The study is required for a student research project C. The study includes only research subjects that are healthy volunteers. D. The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations

D. The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations

Housekeeping employees of the medical center were recruited for a federally funded study of BP, blood count levels, infectious disease history, and job stress. The interviews and blood tests were conducted in a private location. The study coordinator stopped at the cafeteria on her way to the study office after the 2nd study visit for the last 3 study subjects and lost the 3 files. One subject had a history of a STD and another had been treated for TB. The subjects were notified. Following this, the IRB approved a protocol change that all records be transmitted electronically. A. Not an unanticipated problem nor an adverse event b/c it's not a clinical trial. B. The coordinator should assume that housekeeping staff will locate the files and return them to her at the end of the day. C. Not an unanticipated problem b/c employees' medical records are on file. D. This is an unanticipated problem and not an adverse eve

D. This is an unanticipated problem and not an adverse event.