Exam 9: Data Ethics

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?

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:

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:

A randomized clinical trial is a type of study that:

A randomized placebo-controlled clinical trial may be conducted:

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:

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?

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:

Informed consent refers to:

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

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?

Anonymity in a study means that: