Informed Consent (MEDRADSC 3Y03)

What is the primary goal of clinical settings?

To treat the patient

What is the primary goal of research settings?

To gain further knowledge

What historical event prompted the creation of the Nuremberg Code?

Nazi medical experiments.

What does the Nuremberg Code establish?

- Guidelines to protect the human rights of test subjects

- 10 principles that guide ethical research done on human subjects

What is the first principle of the Nuremberg Code?

The voluntary consent of the human subject is absolutely essential

What are the four conditions for informed consent in a clinical environment?

For consent to be morally and legally meaningful, patients must be:

- competent

- given relevant information about tx or condition

- informed about alternatives

- free from coercion.

What additional requirements does informed consent in research settings include compared to clinical settings?

- Subject should understand diff b/w trial and clinical tx

- Requires disclosing the nature, duration, purpose, methods and means, hazards, and effects on health or person of the experiment

- Subjects should be at liberty to bring experiment to an end if they have reached physical/mental state where continuing seems impossible to them

What is the significance of the Tri-Council Policy Statement (TCPS2) in research?

It provides certification guidelines for ethical research involving human subjects.

What is meant by 'capacity' in the context of informed consent?

The legal ability to give consent and exercise free power of choice.

What does 'freedom from coercion' mean for research clinical subjects?

Subjects should be able to exercise free power of choice w/o intervention of an element of force, fraud, decit, duress, overreaching, or other ulterior form of constraint/coercion

TRUE or FALSE: In a clinical environment, an MRT should only talk to the parents to gain informed consent.

FALSE: In a clinical environment, an MRT should talk to the parents AND CHILD to gain informed consent.