GLD 15

During a patient recruitment meeting, the researcher provides the consent form and briefly explains the study. The patient immediately agrees verbally but has not signed the form. What should the researcher do next?

• Obtain the patient’s written consent before enrollment, ensuring they fully understand the study.

• Ask the patient to sign the consent form only after they start participating in the research program.

• Proceed with enrolling the patient into the research program since verbal agreement indicates consent.

• Allow the patient’s family member to sign on their behalf, regardless of whether the patient can sign.

A 17-year-old potential participant arrives with their parent to discuss enrolling in a study. After the discussion, the minor expresses interest in participating, but their parent does not agree. What should the researcher do?

• Allow the minor to participate verbally while postponing the written consent process.

• Proceed with the minor’s participation since they are old enough to decide for themselves.

• Seek approval from the ethics committee to override the parent’s decision.

• Obtain written consent from the parent or legal guardian before enrolling the minor.

A participant interested in the study cannot read or write but is eager to join. The researcher explains the study, and the participant verbally agrees. What additional step is necessary to comply with ethical guidelines?

• Have an independent witness (e.g., nurse, doctor, or spouse) present to confirm the participant’s understanding and consent.

• Allow the participant’s family member to sign on their behalf without requiring further verification.

• Proceed with the verbal agreement, as written consent is unnecessary for illiterate participants.

• Skip the consent process since the participant has verbally agreed and understands the study.

A patient who speaks a language not covered by the available consent forms shows interest in participating. The researcher explains the study using simplified English, and the patient nods in agreement. What should the researcher do next?

• Use the available consent form in a different language and explain it to the patient in English.

• Continue with the consent process, as nodding indicates understanding and agreement.

• Allow the patient’s family member to translate and sign the form on the patient’s behalf.

• Provide the consent form in the patient’s native language or involve a translator to ensure comprehension.

A patient is unconscious and cannot provide consent for a study. The researcher consults the patient’s spouse, who is available and willing to sign on the patient’s behalf. What is the correct course of action?

• Proceed with the spouse’s signature as they are automatically the LAR.

• Verify that the spouse is the legally authorized representative (LAR) before proceeding with the signature.

• Skip the consent process and enroll the patient since the spouse verbally agreed.

• Wait until the patient regains consciousness to obtain their written consent.

A patient who is illiterate is accompanied by their friend to the consent meeting. After explaining the study, the patient indicates their understanding verbally and agrees to participate. The friend offers to sign as the witness. What should the researcher do?

• Allow the friend to sign as the witness since they are accompanying the patient.

• Proceed with the patient’s verbal consent and document the conversation without requiring a witness.

• Ensure the witness is an independent individual not related to the study or the patient, such as a nurse or another healthcare professional.

• Ask the patient’s friend to read the consent form aloud and sign on behalf of the patient.

A researcher is recruiting a patient who cannot give consent due to cognitive impairment. The patient’s Legally Authorized Representative (LAR) is also a co-investigator in the study. What is the correct action for the researcher?

• Require an independent third party to review and confirm the LAR’s decision to avoid a conflict of interest.

• Proceed with the LAR’s consent since they are legally authorized to provide consent for the patient.

• Allow the LAR to provide consent but document their dual role for ethical transparency.

• Exclude the patient from the study to avoid any appearance of conflict.

A patient whose first language is different from the researcher’s asks for clarification about a complex medical term in the consent form. The researcher simplifies the explanation but does not provide a translated form. The patient seems confused but signs the form. What should the researcher have done differently?

• Proceed with the consent process as the patient signed the form, indicating agreement.

• Provide the patient with a translated consent form or involve a qualified translator to ensure full comprehension.

• Explain the term again in simpler language and document the conversation.

• Delay enrolling the patient and contact a family member to confirm

A patient is presented with the consent form and asked to decide immediately because the study has a strict timeline. The patient hesitates but eventually agrees and signs the form. What ethical principle has been compromised?

• The researcher respected the patient’s autonomy by allowing them to decide.

• The researcher compromised ethical guidelines by not giving the patient adequate time to make an informed decision.

• The patient’s informed consent is valid since they signed the form voluntarily.

• None of the above; the process was handled correctly.

A patient provides verbal consent for a study but does not want to sign the consent form. How should the researcher handle this situation?

• Document the verbal consent in the patient’s medical record, including the name of the investigator, date, and signature, and proceed with enrollment.

• Proceed with enrollment without documenting the verbal consent, as it is considered informal.

• Record the verbal consent in the study report only and keep no further records in the medical file.

• Decline the patient’s participation since written consent is mandatory for all study participants.