Informed Consent

1. Informed Consent Dr Vina Vaswani

2. Definition • A Process by which subject voluntarily confirms his or her willingness to participate in a particular trial after having been informed of all aspects of trial that are relevant to the subjects decision to participate. • Documented as written, signed and dated IC form. ICH-CGP

3. Why? • Research done the wrong way • Example

4. Tuskgee Syphilis study • Nazi Prisoner research in world war II • Nuremberg code

5. Necessity • Research • Therapy/Treatment

6. Emerged from respect for human persons • Every individual treated as capable of taking decisions (autonomy) and self determination • Necessity to protect autonomy of those with diminished autonomy.

7. What is informed consent? • Process.. • Involves Providing the informaation • Patient understands the information • Makes a decision to volunteer for the process.

8. Five elements of consent 1. Disclosure • Patient must be given sufficient info. In a way he can understand. • Legal terms it refers to disclosure of significant risks or substancial risks of grave adverse consequences

9. 2. Comprehension • Patient comprehension enhanced by simple language, everyday analogies, explanation of risk factors • May be pictorial, time should be given for reflection

10. 3. Voluntariness • Consent process should not be controlled by factors that engineer the outcome, such as persuation by family members.

11. 4. Competence • Every adult is presumed to be competent to give consent on his/her behalf. • Individuals ability to make a choice -depending on his level of understanding, retention of the information and ability to apply the information to their own circumstances and come to a decision

12. 5. Agreement • Consent by exercising choice, by giving permission for intervention. • It is a right given to a patient whether or not to undergo a procedure, whether the refusal may result in harm or death yet freedom to exercise his right • Ability to withdraw at any time

13. Doctrine of Informed consent • Difference between the ethical ideal and the reality • Patient substantially understands the nature of the procedure he is authorizing. (He has a choice in the matter) • Legal use of the term discloses how consent is obtained • Reality, simply presented with a form to sign.

14. Communication skills • Steps must be taken to see what patient wants, and information depends of information seeking behaviour of the patient. • Every condition and patient are different.

15. Information for patients • Information patient wants to/ought to know • Details of the Diagnosis, Prognosis and sequelae if untreated • Uncertainities of the treatment and outcome • Other methods to treat as well as not treat • Whether present treatment is experimental

16. Patient info contd… • Name of the doctors, who will have overall responsibility. • Reminder to patient of his right to change mind and right to seek second opinion. • Details of charges, length of stay etc.

17. Consent in emergency • If there is no one to give consent in emergency, in good faith, to save the life of the patient emergency treatment can be instituted. • Once the patient comes to conciousness, consent has to be taken.