Clinical Trials and Research Ethics
1. What is the difference between an observational study and an experimental study?
2. Define confounding by indication.
3. How does randomization attempt to protect against confounding?
4. What are the ethical concerns related to the use of placebo treatment for the control group?
5. What is the difference between a treatment trial, a prevention trial, and a screening trial?
6. What does it mean for a clinical trial to be double-blinded?
7. What is the difference between health outcomes research and more traditional clinical trials?
8. What is the purpose of an informed consent document?
9. What information should be included in an informed consent document?
10. Why does the CDC not consider the collection of data to evaluate and improve a particular program to research?
1. Difference between an observational study and an experimental study.
Observational study | Experimental study |
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Clinical Trials and Research Ethics 1. What is the difference between an observational study and an...
Which of the following is NOT correct about randomization in clinical trials a.Randomization of subjects in a clinical trial helps to prevent some investigator-induced bias b.Randomization effectively removes placebo effects c.Randomization minimizes confounding by disrupting the association between the confounder and the treatment d.Randomization without blinding in a study of a treatment on anxiety may be useless
Which of the following is NOT correct about randomization in clinical trials a.Randomization of subjects in a clinical trial helps to prevent some investigator-induced bias b.Randomization effectively removes placebo effects c.Randomization minimizes confounding by disrupting the association between the confounder and the treatment
What is the difference between interventional studies and observational studies? Provide an example of a clinical trial. Explain what makes your example an interventional study or an observational study
Post, an explanation of how informed consent for medical research (clinical trials) differs from the patient's consent to treat used in health care practice (e.g., medical treatment or surgery). Explain why you think this difference exists? Provide at least one clear example of how informed consent could be used in medical research and one example of how it is used in health care practice. Then provide an example of each of the four ethical principals in action in research. Use...
Clinical research trials are being conducted on children being treated for a rare type of leukemia at a children's hospital. What is necessary for families to know when considering entering their child into a research study? a. The patient or legal representative must be given the choice to participate or not. b. The patient or legal representative must know that he or she cannot terminate participation in the study. c. Informed consent is not mandatory in clinical research trials. d....
7. What is the difference between health outcomes research and more traditional clinical trials?
Clinical trial The design of the clinical trial for this study represented a single centered, double blind, placebo-controlled trial that utilized randomization to target patients for the trial. The eligible patients for the study were aged 21-90 years and after receiving a biopsy, these patients had confirmed colorectal adenocarcinoma and were deemed eligible for receiving treatment for the surgery to remove their adenocarcinoma, but were instead given an opportunity to participate in this research trial with written informed consent. Potential...
5. What is the difference between a treatment trial, a prevention trial, and a screening trial?
61 2.2 Waived Consent in a Breast Cancer Trial In the case below, British researchers persuaded an ethics committee that a particular trial should not involve informed consent because the information to be comveyed in that process would be hurtful to the subjects. However, a subject learned later that she had been involved in the trial without her knowledge or consent. This disclo sure opens the question of whether informed consent should ever be waived and, if so, whether justifications...
In late February, the US National Institutes of Health (NIH) announced that a new study to evaluate the safety and efficacy of the antiviral drug remdesivir in hospitalized adults diagnosed with COVID-19 had begun at the University of Nebraska Medical Center (UNMC) in Omaha. Participants in the NIH-sponsored study must be hospitalized for lab-confirmed COVID-19, provide informed consent to participate in the study, and undergo a baseline physical exam before receiving treatment. They will then be randomly assigned either to...