SOCRA - Society of Clinical Research Associates The Informed Consent Process Questions and Answers

Question 1

A clinical research coordinator is consenting a potential participant for a study involving a new investigational drug.
The participant is fluent in Spanish, but the IRB-approved informed consent form is only available in English.
Which of the following is the most appropriate action to take?

Accepted Answer

Delay the consent process until a fully translated Spanish version of the long-form consent is approved by the IRB.

Answer

Use a qualified interpreter to orally translate the English consent form for the participant, and document this process using a short form.

Answer

Ask a bilingual staff member, who is not a certified interpreter, to translate the consent form during the discussion.

Answer

Enroll the participant using the English consent form, as long as they seem to understand the verbal explanation.

Question 2

During an informed consent discussion for a complex oncology trial, the investigator notices the potential participant is nodding along but seems overwhelmed and is not asking any questions. What is the best practice for the investigator to ensure adequate understanding?

Accepted Answer

Use a teach-back method, asking the participant to explain the study's purpose, risks, and procedures in their own words.

Answer

Ask the participant, "Do you have any questions?" and if they say no, proceed with signing the form.

Answer

Provide the participant with a copy of the consent form and tell them to call later if they think of any questions.

Answer

Document in the research record that the participant appeared to understand and agreed to participate.

Question 3

Which of the following statements is strictly prohibited from being included in an informed consent form, according to both FDA regulations (21 CFR 50.20) and ICH GCP?

Accepted Answer

Language that appears to waive any of the subject's legal rights or releases the investigator from liability for negligence.

Answer

A statement that the participant's data may be inspected by regulatory authorities.

Answer

A description of the compensation that will be provided to the participant for their time and travel.

Answer

A statement that new information relevant to the participant's willingness to continue in the study will be provided in a timely manner.

Question 4

A participant signed an informed consent form for a clinical trial a year ago. The protocol has now been amended to include a new, optional blood draw for future genetic research. Which of the following actions is required?

Accepted Answer

Obtain re-consent from all active participants using an IRB-approved revised consent form that includes the new optional procedure.

Answer

No action is needed as the participant already consented to the main trial.

Answer

Send a letter to all participants informing them of the new optional procedure.

Answer

Verbally inform the participant of the optional blood draw at their next visit and document their agreement in the progress notes.

Question 5

An investigator is conducting a trial that involves collecting identifiable biospecimens. According to the Revised Common Rule (45 CFR 46), which of the following is a new required element that must be included in the informed consent form?

Accepted Answer

A statement on whether the subject's de-identified biospecimens may be used for future research.

Answer

A statement that the study involves research and an explanation of its purposes.

Answer

A disclosure of appropriate alternative procedures or courses of treatment.

Answer

An explanation of whom to contact for answers to pertinent questions about the research.

Question 6

In which of the following emergency situations can an investigational product be administered to a subject without obtaining prospective informed consent, according to FDA regulations (21 CFR 50.23)?

Accepted Answer

When the subject is confronted by a life-threatening situation, cannot communicate, there is no time to obtain consent from a legal representative, and a second, uninvolved physician concurs in writing.

Answer

When the subject is unconscious, and the family agrees over the phone.

Answer

When the subject has a life-threatening condition, and a single investigator determines the product is the only option.

Answer

Anytime a physician declares a medical emergency in a hospital that is an active research site.