Quiz 4 Informed Consent

1)Which of the following statements is true?

1. 1. Sponsor is respsonsible for properly administering and documenting the IC process
   2. IC document is a contract and the subject cannot withdraw from clinical research once they are enrolled
   3. Legally effective signature includes subjects signature only

1. 4. Legally effective signature includes subjects signature and date of signature

2. The elements of informed consent listed in ICH E6 guidelines require the informed consent document to state the reasonable expected benefits. Often, clinical research trials are not intended to provide clinical benefit to the subject. In this case, which of the following should be state in the informed consent document?
   1. Omit mention of expected benefits
   2. Informed Consent document should state participation in the trial is not intended to provide any clinical benefit
   3. Refer to www.clinicaltrials.gov
   4. List other potential benefits such as compensation for participation

3. Which of the following is true regarding the informed consent process?
   1. For each subject, a copy of the signed IC document must be stored and present at the sponsor
   2. For each subject, the original, signed IC document must be stored and present at the investigative site
   3. For each subject, the original, signed, IC document must be stored and present at the sponsor
   4. For each subject, a copy of the signed IC document must be stored and present at the investigative site

4. Prior to signing informed consent, how long does a potential subject have to consider their participation in a clinical research trial?
   1. 24 hrs
   2. 48 hrs
   3. 5 working days
   4. As long as the patient needs or until enrollment period is over

5. Informed consent must be obtained:
   1. Prior to a subjects participation in the trial including any study related tests/procedures
   2. Prior to any discussion on the aspects of protocol

1. 3. After investigational screening procedures have been completed to verify eligibility
   4. Within 48 hours of study enrollment

6. In addition to the informed consent document, what other documentation must be completed?
   1. IRB must document each subject that is enrolled in a clinical trial
   2. IRB must notify the FDA when informed consent is obtained
   3. Site must document in subjects medical record that proper IC was obtained from the subject
   4. Site must document the other family members involved in the subjects decision to sign IC
7. According to federal regulations, sites must ensure which of the following regulatory entities have approved the informed consent document prior to any attempts to enroll potential patients?
   1. FDA
   2. IRB
   3. ICH
   4. Sponsor
8. You are a clinical researcher coordinator at a site in the states conducting a pediatric asthma trial. You are delegated to the task of obtaining informed consent. Your study is following federal regulations. As a condition of approval the IRB requires written assents to be obtained on the consent form of all minors/pediatric subjects 10 years and older. Your first potential patient is a 13 y/o male. According to the scenario above which MOST accurately represents the individuals that will need to sign the informed consent document?
   1. Parent or legally authorized representative and the PI
   2. Parent or legally authorized rep and you as the person obtaining the IC
   3. Parent or legally authorized rep
   4. Parent or legally authorized rep and the subject

9. You are a PI about to begin enrolling subjects for a new clinical research trial. Which of the following should you consider in order to ensure your subjects receive them most appropriate informed consent?