L10: Informed Consent

Question 1

what is the purpose of giving informed consent?

Answer 1

protect subjects by giving them respect and autonomy through ongoing communication.

Question 2

who reviews informed consent for a clinical study?

Answer 2

IRB

Question 3

Under respect for human subjects, what must be upheld?

Answer 3

• person’s right to make choices eg. when to exit trial
• confidentiality of personal info

Question 4

State the 3 principles of Informed Consent

Answer 4

1. Respect and Autonomy
2. ongoing communication
3. subjects should feel that their participation is voluntary

Question 5

During Consent process, investigator is responsible for ____

Answer 5

• obtaining IC from subject before subject participates in study
• dont have to be the one to conduct consent interview but is the person responsible for this process, even when delegating task

Question 6

copy of consent is provided to participant only when they request for it. T/F?

Answer 6

false. copy of consent MUST be provided to subject

Question 7

____ must know who will conduct the consent interview

Answer 7

IRB

Question 8

What constitutes to a person to be incapable of making a decision for himself? [4]

Answer 8

1. understand info relevant to decision
2. retain info
3. use or weigh info as part of process of making decision
4. communicate his decision through any means

Question 9

language and choice of words in IC should be: [3]

Answer 9

1. non-technical
2. practical
3. understandable to subject or subject’s impartial witness

Question 10

Content of Informed Consent [10]

Answer 10

1. trial involves RESEARCH+ purpose and duration of trial
2. trial treatment and probability of random assignment + trial procedures + duration
3. subject’s responsibilities
4. foreseeable risk/inconveniences
5. benefits
6. disclosure of appropriate alternative
7. compensation in the event of trial-related injury or anticipated prorated payment or expenses (if any)
8. mention that participation is VOLUNTARY
9. specific people have direct access to subject’s medical records + their contacts
10. identity will be kept confidential

Question 11

impartial third party should witness entire consent process and sign consent document when ____

Answer 11

1. person can understand but cannot talk or write [as long as can indicate approval/disapproval]
2. subjects have low literacy but can understand concepts explained + can indicate approval

Question 12

for non-english speaking participants, what must be done for IC?

Answer 12

IRB require a translated consent document. copy must be given to each subject

Question 13

who should obtain informed consent from subjects?

Answer 13

INVESTIGATOR. fully responsible, even if he is delegating task for others to conduct IC interviews

Question 14

IC should be obtained 1 day before study starts. T/F?

Answer 14

False. ample time has to be provided for subject or subject’s legally authorised representative (LAR) to inquire about details