Question 1

A nutritionist and a psychologist plan a study to evaluate the effects of a healthy, low fat, and low sugar diet on the ability to concentrate and perform complicated tasks. The researchers plan to first recruit volunteers and evaluate their performance under their regular diet. Then the researchers will provide the volunteers with the new diet and repeat the evaluation. Which of the following statements is false?

Accepted Answer

A) This study has only benefits; no risks are associated with it and Institutional Review Board approval is not required. 
B) Informed consent is not necessary, since the participants can only benefit from such a study. 
C) This is a social and behavioral science project and, as such, does not require Institutional Review Board approval. 
D) All of the answer options are correct. D

Question 2

In order to investigate treatments for morbid obesity, obese subjects satisfying fairly strict requirements were randomly assigned to one of three treatment groups: (1) gastric bypass surgery, (2) participation in a diet and exercise program, or (3) both gastric bypass surgery and participation in a diet and exercise program. This clinical trial is ethical because:

Accepted Answer

A) all subjects are likely to receive benefits. 
B) randomization is ethical if no treatment seems to work better than the others. 
C) the interests of the study subjects prevail. 
D) All of the answer options are correct. D

Question 3

A criminologist wishes to evaluate a new parolee release program that provides job skills. A person convicted of a felony is often referred to parole when first released from prison. While on parole, a parolee must meet with an parole agent at regular and frequent intervals, must undergo random drug tests and searches of the residence, and can be returned to prison for parole violations at the request of a parole agent. A parolee is not a free person. With respect to participation in this research study:

Accepted Answer

A) a parolee can provide informed consent and does not fall under the rules for prisoners because the person is no longer physically confined to a prison. 
B) a parolee can provide informed consent and does not fall under the rules for prisoners because the project provides job skills which are good to have. 
C) a parolee is not a free person and subject to return to prison, therefore, the same rules would apply as do for prisoners. 
D) None of the answer options is correct. C

Question 4

A randomized clinical trial is a type of study that:

Accepted Answer

A) studies the effectiveness of medical treatments on actual patients. 
B) compares two or more treatments by surveying subjects who were prescribed these treatments. 
C) is always a double-blind experiment. 
D) is always a block design.

Question 5

A randomized placebo-controlled clinical trial may be conducted:

Accepted Answer

A) if medical science will benefit and there is minimal harm to humans, even though there is no benefit to current patients. 
B) if there is reason to hope the treatment will help patients who are subjects in the trial. 
C) if there is strong evidence that the treatment works and the clinical trial will confirm it. 
D) All of the answer options are correct.

Question 6

When a felony convict is released from prison, the person is often placed on parole for some time. During parole, the person can be returned to prison by the supervising parole agent without a trial and conviction. A criminologist plans a randomized study comparing an intervention with a regular release from prison to study the effectiveness of the intervention in preventing re-incarceration. The criminologist prepares an informed consent form and plans to enroll parolees during the first meeting with the parole agent, who will introduce the study to the parolee. This procedure is appropriate because:

Accepted Answer

A) parolees are adults and are free to participate or not. 
B) there are no risks to the parolee, only potential benefits. 
C) the parole agent has the best interest of the parolee in mind and will advise accordingly. 
D) None of the answer options is correct.

Question 7

Which of the following groups are subject to coercion to participate in a clinical trial by other persons with the power to impose punishment for refusal to participate?

Accepted Answer

A) adults with a serious illness 
B) parents of a child, if the parents are against participation but the child is not 
C) prisoners 
D) All of the answer options are correct.

Question 8

A new surgical procedure is to be tested for effectiveness in saving limbs. The procedure is at a fairly early stage and little is known about it. The investigators wish to conduct a study to improve their surgical technique and to compare the new procedure with the established procedure, which has a 50% success rate. The study will assign 20 patients to either the established procedure or the new procedure in a systematic way. This study should:

Accepted Answer

A) be approved, because future patients will benefit from it. 
B) not be approved, because it is not an experiment. 
C) be approved, because comparing experimental and control subjects will provide valid conclusions. 
D) not be approved, because there is no benefit to current patients.

Question 9

Informed consent refers to:

Accepted Answer

A) asking the patient to sign a form stating that the patient agrees to participate in a clinical trial. 
B) outlining to the patient how the study will be conducted. 
C) providing the patient with a detailed description of the study, including all benefits and risks, and asking for written consent. 
D) None of the answer options is correct.

Question 10

Confidentiality in a randomized clinical trial of a new drug means that:

Accepted Answer

A) a patient can be confident the treating physician is knowledgeable about the new drug. 
B) the patient will be provided with all confidential information related to the trial. 
C) all data about the patient will be kept confidential even when study results are published. 
D) All of the answer options are correct.

Question 11

A veterinarian studying surgery to repair damaged colons in horses obtains 10 horses that have been relinquished by their owners and slated for euthanasia because of severe lameness. The horses will be randomized into two treatment groups. The control group will have blood flow interrupted to parts of the colon for five minutes before it is restored again. The experimental group will have blood flow interrupted for five minutes, then will be injected with a drug before blood flow is restored. At the end of the surgery the horses will be euthanized. The goal is to assess if the drug can slow cell death and allow recovery from interruptions in blood circulation. Does the veterinarian, who works for a major research university, need to obtain approval from the Institutional Review Board?

Accepted Answer

A) No, because the horses were slated for euthanasia anyway. 
B) Yes, because the study involves live animals. 
C) No, but informed consent from the previous owners needs to be obtained. 
D) None of the answer options is correct.

Question 12

Anonymity in a study means that:

Accepted Answer

A) the identity of participants is not revealed and identifiers are inaccessible to others. 
B) the patient is blinded to the treatment received. 
C) the investigators are blinded to the treatment the patient receives. 
D) both the patient and the investigators are blinded to the treatment.

Exam 9: Data Ethics