3. Informed Consent

Question 1

What is informed consent?

Answer 1

-Ongoing process of communication and understanding
-Voluntary agreement between subject and investigator (abscess of pressures/coersion)

Question 2

What is informed consent is NOT

Answer 2

-A piece of paper
-A one time conversation

Question 3

What are the 9 elements of informed consent?

Answer 3

1. Statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental
2. Descriptions of any reasonably foreseeable RISKS or discomforts to the subject
3. A description of any BENEFITS to the subject or to others which may reasonably be expected from research (NOT including monetary)
4. A disclosure of appropriate ALTERNATIVE procedures or courses of treatment, if any, that might be advantageous to the subject
5. A statement describing the extent, if any, to which CONFIDENTIALITY of records identifying the subject will be maintained
6. Research involving more than minimal risk, an explanation as to whether any COMPENSATION and an explanation as to whether any medical treatments are available of injury occurs and, if so, what they consist of, or where further information may be obtained
7. An explanation of whom to CONTACT FOR ANSWERS to pertinent questions about the research and research subjects rights, and whom to contact re research related injuries
8. Statement that participation is voluntary, may discontinue participation any time
9. Statement about research that involves identifiable PRIVATE information. Identifiers might be removed, or that information was collected as part of the research and will not be used or distributed for future research studies

Question 4

What are the 5 principles of documentation of informed consent?

Answer 4

1. Valid ethics review committee approved consent form
2. Sign and date (research subject and person obtaining consent)
3. Retain original
4. Prove subject with a copy (unless waived by IRB)
5. Approved oral script, if applicable

Question 5

When to obtain consent?

Answer 5

1. Prior to any study procedure
2. After sufficient time allowed for prospective subjects to discuss with family, friends, other physicians
3. Throughout individuals participation in the study

Question 6

Who can obtain informed consent?

Answer 6

1. PI or Co-investigator
   -qualified by training and experience
   -knowledgeable about informed consent process
   -knowledgeable about protocol
   -knowledgeable about local culture and customs

If others persons must be approved by ERC

Question 7

Whose responsibility is it to ensure informed consent is obtained and documented?

Answer 7

PI

Question 8

What are the 5 criteria required to waive INFORMED CONSENT?

Answer 8

1. No more than minimal risk research
2. Could not practically be carried out without the waiver or alteration
3. If research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format
4. The waiver or alteration will not adversely affect the rights and welfare of the subjects
5. Whenever appropriate, the subjects will be provided with additional pertinent information after participation

Question 9

What are the 3 scenarios where you can have waiver of documentation of informed consent

Answer 9

1. Only record linking subject/research would be the consent and the principal risk would be harm resulting from a breach of confidentiality
2. The research is minimal risk and involves no procedures for which written consent is normally required
3. If the subjects are members of a distinct cultural group or community in which signing forms is not the norm, that the research IS MINIMAL RISK, and provided there is appropriate ALTERNATIVE mechanism for documenting that informed consent was obtained