Informed Consent

Question 1

What is Informed Consent?

Answer 1

. IC is a process through which you learn details about the trial before deciding to take part in it.

. The trial’s purpose, possible risk, and benefits are learned. It’s a critical part of ensuring patient safety in research.

. It gives potential participants all the info needed to understand what they are volunteering for otherwise subject may not fully understand what they are participating in.

Question 2

Informed Consent Process

Answer 2

A potential research subject must have an opportunity to:

. Ask questions about any part of the study
. Take time and opp to read and understand the ICD
. Discuss w/Fam & Friends about enrollment
. Have docs and info presented in a language they can read and understand.

They must be informed that:

. There are risks involved in CT participation
. Benefits aren’t guaranteed by the research team
. They can exit CT at anytime
. Study may not follow standard medical procedures

Ongoing interaction btwn subject and research personnel

. Begins w/ the first contact and exchange of info
. Each contact is an opp to reiterate info and ensure that participation continues to be fully informed and voluntary

Continues beyond study termination

Question 3

ICD - Informed Consent Document

Answer 3

Describe:

. Requirements of the protocol
. Responsibility of the subject
. Risk/benefits of participation

Documentation of consent is only the first step

. Docs voluntary and IC, prior to any study procedures

Question 4

Who Can Consent?

Answer 4

PI - Principal Investigator

Designated study personnel

. Appropriately qualified (CITI trained)
. Appropriately trained and intimately familiar w/protocol
. Adequate medical knowledge and understanding of potential AE
. Ability to communicate effectively

The ultimate responsibility for ensuring IC is obtained, and all questions are answered. PI must be satisfied with subject knowledge of the study.

If anyone other than the PI is conducting the interview, then PI or Co-I must be reachable by phone is subject have questions that can’t be answered in the interview.

Question 5

Who can give consent?

Answer 5

.The subject or subject LAR
. Adults (18 or older) or the person has married, has been pregnant, or has been graduated from HS may give effective consent and the consent of no other person shall be necessary

Question 6

ICFD - Informed Consent Form Document

Answer 6

.Doc that requires a participant’s signature upon participating in a clinical research study

. Gives detailed info about the study the participant is considering, and ensures the health care provider has given complete info, including the risks and benefits of the study

Be sure to use the current, IRB approved version

Question 7

ICF review

Answer 7

Confirm that ICF

. Most current, IRB approved version
. All pages are present 
. Req dates initials and/or signatures are present
. Date doesn’t precede study activity
. Stored in ISF

Question 8

Reconsent

Answer 8

Reconsent should occur if:

. Protocol amendment

. New findings that change the risk/benefit profile including the identification of new risks, an increase in the magnitude of known risks, or a decrease in the expected benefit

. Study procedures have been added, modified, or removed

. IRB will advise as to who requires reconsent, i.e. active study participants

. Will be consented at next study visit

. If ICF expires, patient does not need to be reconsented.