informed consent

Question 1

7) What are the key features of informed consent?

Answer 1

1. One of the primary ethical considerations (respect and autonomy) underlying research with human subjects
2. More than a piece of paper to be signed, informed consent is an ongoing communication between researchers and subjects (supersedes the importance of any other part of the research)
3. Subjects should feel that participation is voluntary, and that their refusal to cooperate is free of consequence to them.

Question 2

8) Why is informed consent necessary?

Answer 2

All clinical trial involves obtaining informed consent (Nuremberg code, declaration of Helsinki, Belmont report, ich gcp, local law and regulations). The process of obtaining informed consent as a fundamental prerequisite for conducting research.

Question 3

9) What are the principles of medical ethics?

Answer 3

1. Respect: Acknowledge a person’s right to make choices, hold views and take actions based on personal values and beliefs
2. Non-maleficence: obligation not to harm intentionally; in medical ethics, a physicians guiding maxim is “do no harm”
3. Justice: Treat others equitably, distribute benefits/burden fairly
4. Beneficence: Provide benefits to persons and contribute to their welfare. Refers to an action done for the benefit of others.

Question 4

10) What is the rules of obtaining consent?

Answer 4

1. It is a process that involves the IRB, clinical investigators and research sponsors. All share responsibility for ensuring the IC process is adequate
2. The investigator is responsible for ensuring the IC is obtained from each research subject before that subject participates in the research study. While the investigator is not required to personally conduct the consent interview, the investigator remains ultimately responsible, even when delegating the task.
3. Date
4. A copy of the consent document must be provided to the subject and the original signed copy should be retained in the study
5. IRB should be aware of who will conduct the consent interview. Those conducting consent procedures should be adequately trained.

Question 5

11) What are the 3 components of informed consent?

Answer 5

1. Capacity:
   - a person is unable to make a decision for himself if he is unable to do all or any one of the following:

o Understand the information relevant to the decision o Retain that information

o Use or weigh that information as part of the process of making the decision

o Communicate his decision (whether by talking, using sign language or any other means)

• A person is not to be regarded as unable to understand the information relevant to a decision

o if he is able to understand an explanation of it given to him in a way that is appropriate to his circumstances (using simple language, visual aids or any other means);

o is able to retain the information relevant to a decision for only a short period does not prevent him;

2. Voluntary (coercion or legal rights) - Neither the investigator, nor the trial staff, should coerce or unduly influence a subject to participate or to continue to participate in a trial. - None of the oral and written information concerning the trial, including the written informed consent form, should contain any language that waive or to appear to waive any legal rights, or that releases or appears to release the investigator, the institution, the sponsor, or their agents from liability for negligence.
3. Information

Before informed consent may be obtained, the investigator, or a person designated by the investigator, should provide the subject or the subject’s LAR ample time and opportunity to inquire about details of the trial and to decide whether or not to participate in the trial. All questions about the trial should be answered to the satisfaction of the subject or the subject’s LAR.

LAR: Legally Authorized Representative

Question 6

12) Who should obtain informed consent?

Answer 6

The investigator or an adequately trained individual delegated by the investigator. The person obtaining consent should pass CT certification that is verified by the IRB + CV.

Question 7

13) What should the language and choice of words be used?

Answer 7

Non-technical, practical and should be understandable to the subject or the subject’s impartial witness, where applicable

Question 8

14) To what extent are subjects/subjects LAR allowed for inquiry about the trial?

Answer 8

Before informed consent may be obtained, the investigator, or a person designated by the investigator, should provide the subject or the subject’s LAR ample time and opportunity to inquire about details of the trial and to decide whether or not to participate in the trial. All questions about the trial should be answered to the satisfaction of the subject or the subject’s LAR. (Legally Authorized Representative)

Question 9

15) What signature is required in the informed consent?

Answer 9

Prior to a subject’s participation in the trial, the written informed consent form should be signed and personally dated by the subject or by the subject’s LAR, and by the person who conducted the informed consent discussion.

Question 10

16) What is required in the event a subject/subject’s LAR is unable to read?

Answer 10

An impartial witness should be present during the entire informed consent discussion. After the written informed consent form and any other written information to be provided to subjects, is read and explained to the subject or the subject’s LAR, and after the subject or the subject’s LAR has orally consented to the subject’s participation in the trial and, if capable of doing so, has signed and personally dated the informed consent form, the witness should sign and personally date the consent form. By signing the consent form, the witness attests that the information in the consent form and any other written information was accurately explained to, and apparently understood by, the subject or the subject’s LAR, and that informed consent was freely given by the subject or the subject’s LAR.

Question 11

17) What should the contents of informed consent cover?

Answer 11

1. An explanation that the trial involves research, the purposes and the expected duration of the subject’s participation, a description of the procedures.
2. The trial treatment(s) and the probability for random assignment to each treatment or placebo
3. The subject’s responsibilities.
4. A description of any reasonably foreseeable risks or discomforts to the subject.
5. A description of any benefits to the subject or to others which may reasonably be expected from the research.
6. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
7. A statement describing the confidentiality of records identifying the subject will be maintained.
8. An explanation of any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
9. An explanation of whom to contact for answers to pertinent questions and the subjects’ rights, and whom to contact in the event of a research-related injury to the subject.
10. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Question 12

18) When is a waiver of informed consent required?

Answer 12

1. The research involves no more than minimal risk to the subjects.
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects.
3. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
4. The research could not practicably be carried out without the waiver or alteration. (Waiver of Documentation of Informed Consent (Only Verbal Consent obtained))

Question 13

19) What happens if a subject can understand and comprehend spoken English, but is physically unable to speak or write?

Answer 13

If

(1) the person retains the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally (still competent) and
(2) is able to indicate approval or disapproval to study entry, they may be entered into the study. An impartial third party should witness the entire consent process and sign the consent document.

Question 14

20) What happens if the subject is a non-english speaking participant?

Answer 14

IRB requires a translated consent document to be submitted. A copy of the consent document must be given to each subject. Translation is needed to facilitate conversation with a non-english speaking subject, but should not be substituted for a written translation.