Questions and Answers
Under FDA regulations for using test articles, which of the following describes the best course of action for the investigator in a life-threatening situation?
What is the purpose of informed consent?
To provide a potential subject with appropriate information and allow that person to make an informed decision about participation in research.
Which of the following statements is an example of exculpatory language in a consent form?
What should the investigator do when an elderly gentleman's wife is out of town but he has expressed interest in a clinical trial?
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What should the investigator do if a new drug becomes available while a subject is enrolled in a Phase 2 study for severe diabetic neuropathy?
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Study Notes
Informed Consent Overview
- Informed consent is crucial for ethical research involving human subjects, allowing individuals to make informed decisions about participation.
Emergency Situations and Consent
- In urgent life-threatening scenarios where a subject cannot consent, the investigator may utilize a test article without informed consent if:
- An independent physician agrees to the necessity of the test article.
- The IRB will be notified post-incident.
Purpose of Informed Consent
- The primary aim is to provide potential subjects with sufficient information and a clear understanding, facilitating an informed decision regarding research participation.
Exculpatory Language in Consent Forms
- Informed consent forms must not contain exculpatory language, which:
- Waives or appears to waive legal rights of the subject.
- Releases researchers from liability for negligence.
- Example of exculpatory language: A statement waiving compensation for injuries incurred during research participation.
Handling Consent for Legally Authorized Representatives
- In scenarios where a subject has a legally authorized representative (LAR) unable to provide consent immediately:
- If the subject is capable of understanding the trial and expresses interest, the investigator can send the consent form to the LAR via fax after the subject’s assent.
New Treatment Availability During Ongoing Studies
- When a new treatment becomes available during a study:
- Investigators must inform enrolled subjects thoroughly about the new treatment and its potential benefits versus risks.
- Subjects should have the option to withdraw from the study if they choose to pursue the new medication.
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Description
These flashcards focus on the concept of informed consent, particularly in life-threatening situations where immediate action is required. The content is designed to help you understand the ethical and regulatory frameworks surrounding informed consent in clinical investigations.
