SOCRA - Society of Clinical Research Associates The Informed Consent Process Questions and Answers 1 — 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?
- Use a qualified interpreter to orally translate the English consent form for the participant, and document this process using a short form.
- Ask a bilingual staff member, who is not a certified interpreter, to translate the consent form during the discussion.
- Enroll the participant using the English consent form, as long as they seem to understand the verbal explanation.
- Delay the consent process until a fully translated Spanish version of the long-form consent is approved by the IRB. (Correct answer)
Correct answer: Delay the consent process until a fully translated Spanish version of the long-form consent is approved by the IRB.
According to regulatory guidelines (21 CFR 50.20), the information given to a subject must be in a language understandable to them. While a short form process with an interpreter is permissible, the preferred and most ethically sound method is to use a fully translated and IRB-approved consent form. This ensures the participant has a written document to refer to in their own language, maximizing comprehension and respecting their autonomy. Delaying until the proper form is available upholds the highest standard of the informed consent process.
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?
- Ask the participant, "Do you have any questions?" and if they say no, proceed with signing the form.
- Use a teach-back method, asking the participant to explain the study's purpose, risks, and procedures in their own words. (Correct answer)
- Provide the participant with a copy of the consent form and tell them to call later if they think of any questions.
- Document in the research record that the participant appeared to understand and agreed to participate.
Correct answer: Use a teach-back method, asking the participant to explain the study's purpose, risks, and procedures in their own words.
The informed consent process is more than a signature; it's about ensuring genuine comprehension. The teach-back method is an effective technique to assess and confirm a participant's understanding. It moves beyond simple yes/no questions and requires the participant to actively demonstrate their grasp of the key information, allowing the investigator to identify and clarify any areas of misunderstanding.
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?
- A statement that the participant's data may be inspected by regulatory authorities.
- Language that appears to waive any of the subject's legal rights or releases the investigator from liability for negligence. (Correct answer)
- A description of the compensation that will be provided to the participant for their time and travel.
- A statement that new information relevant to the participant's willingness to continue in the study will be provided in a timely manner.
Correct answer: Language that appears to waive any of the subject's legal rights or releases the investigator from liability for negligence.
Both FDA regulations (21 CFR 50.20) and ICH GCP guidelines explicitly forbid the use of exculpatory language in informed consent forms. This means the document cannot include any wording that makes the participant waive or appear to waive their legal rights, nor can it release the investigator, sponsor, or institution from liability for negligence. This is a critical protection for research subjects.
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?
- No action is needed as the participant already consented to the main trial.
- Send a letter to all participants informing them of the new optional procedure.
- Obtain re-consent from all active participants using an IRB-approved revised consent form that includes the new optional procedure. (Correct answer)
- Verbally inform the participant of the optional blood draw at their next visit and document their agreement in the progress notes.
Correct answer: Obtain re-consent from all active participants using an IRB-approved revised consent form that includes the new optional procedure.
When a protocol is amended with new information or procedures that might affect a participant's willingness to continue, such as an optional genetic research component, re-consent is required. The investigator must use a revised, IRB-approved informed consent form to explain the changes and document the participant's decision to agree to the new procedures or continue under the terms of the original consent.
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?
- A statement that the study involves research and an explanation of its purposes.
- A disclosure of appropriate alternative procedures or courses of treatment.
- A statement on whether the subject's de-identified biospecimens may be used for future research. (Correct answer)
- An explanation of whom to contact for answers to pertinent questions about the research.
Correct answer: A statement on whether the subject's de-identified biospecimens may be used for future research.
The Revised Common Rule (also known as the 2018 Requirements) introduced a new basic element of informed consent. For research involving the collection of identifiable private information or identifiable biospecimens, the consent form must include a statement that the identifiers might be removed and the information or biospecimens could be used for future research, or a statement that they will not be used for future 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)?
- When the subject is unconscious, and the family agrees over the phone.
- When the subject has a life-threatening condition, and a single investigator determines the product is the only option.
- 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. (Correct answer)
- Anytime a physician declares a medical emergency in a hospital that is an active research site.
Correct 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.
The FDA provides a very narrow exception from the general requirements for informed consent in life-threatening situations under 21 CFR 50.23. This exception requires that the subject has a life-threatening condition, cannot consent, there isn't enough time to get consent from their legally authorized representative, AND a physician who is not otherwise participating in the investigation certifies in writing that all of these conditions are met.
SOCRA - Society of Clinical Research Associates The Informed Consent Process Questions and Answers 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?