Informed Consent

Question 1

Definition of Informed Consent

Answer 1

a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form

Question 2

the Common Rule (45 CFR 46)

Answer 2

Informed consent should begin with a concise and focused presentation of the key information

Question 3

essential elements of informed consent form (20)

Answer 3

1) involves research, 2) research purpose, 3) treatments and randomization, 4) experimental aspects of the study, 5) procedures, 6) subject responsibility and time commitment, 7) risks and inconveniences, 8) benefits, 9) alternative treatments, 10) compensation and treatment for study-related injuries, 11) prorated payment for participation, if any, 12) anticipated expenses, 13) voluntariness, 14) access to medical records, 15) confidentiality of records, 16) new information, 17) contact information 18) withdrawal and termination, 19) duration of study participation, 20) number of subjects

Question 4

components of the informed consent process (6)

Answer 4

1) the form, 2) the dialogue, 3) adequate time, 4) understanding, 5) signatures, 6) re-consenting if necessary

Question 5

3 things that make the ICF the correct form

Answer 5

1) contains all essential elements, 2) it is IRB-approved, 3) it is the correct version

Question 6

When is re-consent necessary

Answer 6

increased risk, new risks, new side effect identified, decrease in expected benefit, new SOC alternative, changes to medical treatment choices if subject injured due to study, change in drug dosage or device application, change in exposure to drug/device, change in trial duration, significant increase in number of research subjects, change in use of samples taken (i.e. blood now used for genetic testing)

Question 7

LAR

Answer 7

legally acceptable representative

Question 8

According to ICH E6, for a clinical trial in which there are no expected benefits to subjects (that is, a non-therapeutic trial), which of the following must apply in regards to informed consent for subjects unable to give their consent personally and must use a legally acceptable representative (LAR)?

Answer 8

The objectives of the trial cannot be met by means of a trial in subjects who can give informed consent personally.

Question 9

A healthy volunteer is considering participating in a research study testing a new vaccine for Ebola. He has left his glasses at home and he is unable to read the informed consent form. According to ICH E6, who must be present during the discussion of informed consent?

Answer 9

an impartial witness