MEDRADSC 3Y03 - Informed Consent NEW

What is the primary goal of the clinical setting in the context of informed consent?

To treat the patient.

What is the primary goal of the research setting in the context of informed consent?

To gain further knowledge.

The Nuremberg Code was established in _ in response to Nazi medical experiments.

1947

What is the fundamental purpose of the Nuremberg Code?

To provide a set of guidelines to protect the human rights of test subjects.

What kind of limits does the Nuremberg Code place on medical research?

Ethical limits.

What concept is described as being central to the Nuremberg Code?

Human rights.

How many principles does the Nuremberg Code contain to guide ethical research on human subjects?

Ten principles.

What is described as the 'absolutely essential' first principle of the Nuremberg Code?

The voluntary consent of the human subject.

For consent to be meaningful in a clinical environment, what is the first condition a patient must meet?

The patient must be competent.

In a clinical setting, what kind of information must a competent patient be given regarding their own situation?

Relevant information about their condition and treatment.

Besides their primary treatment, what other information about options must be given to a patient for valid clinical consent?

Information about alternate treatments as well as the option of no treatment.

What is the final condition for morally and legally meaningful consent in a clinical environment?

The patient must be free from coercion.

In a research setting, what key distinction must a subject understand for their consent to be informed?

The difference between a research trial and standard clinical treatment.

How does informed consent in a research setting relate to the conditions required in a clinical setting?

It includes all four clinical conditions plus additional requirements from the Nuremberg Code.

According to the Nuremberg Code, a research subject must be able to exercise free power of choice, without the intervention of any element of _, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion.

force

For informed consent in research, the subject must possess the _ to give consent.

legal capacity

To give an 'understanding and enlightened decision' in a research setting, what must the subject possess?

Sufficient knowledge and comprehension of the elements of the subject matter involved.

What three aspects of an experiment must be disclosed for research consent?

The nature, duration, and purpose of the experiment.

What information about the execution of an experiment must be disclosed for research consent?

The method and means by which it is to be conducted.

What potential negative outcomes must be disclosed to a research participant for informed consent?

All inconveniences and hazards reasonably to be expected.

What must be disclosed regarding the potential personal impact on a research participant?

The effects upon their health or person which may possibly come from their participation.

Under what condition should a human subject in an experiment be at liberty to bring it to an end?

If they have reached a physical or mental state where continuation seems impossible to them.

What Canadian policy statement for ethical research is mentioned in the material?

Tri-Council Policy Statement (TCPS2 certification).

List the four summary points of conditions required for informed consent.

Capacity, relevant information, information about options/no treatment, and freedom from coercion.

The Nuremberg Code's guidelines apply specifically to which setting: clinical or research?

The research setting.