Informed Consent Flashcards
informed consent
- The legal key protection of the subjects in clinical trials
- One of the primary ethical considerations (i.e. Respect and Autonomy) underlying research with human subjects.
- Subjects should feel that their participation is voluntary, and that their refusal to cooperate is free of consequence to them.
- It is an ongoing communication between researchers and subjects (supersedes the importance of any other part of the research).
Informed Consent Regulations
All Clinical trial involves obtaining informed consent based on
Nuremburg Code
Declaration of Helsinki
Belmont Report
ICH GCP
Local law and regulations (Clinical Trials Regulations)
Process of obtaining informed consent as a fundamental prerequisite for conducting research.
IRB role
Institutional Review Board (IRB) must consider informed consent when reviewing research proposal
IRB must be fully aware of regulations and guidelines in relation to obtaining informed consent from a subject
A balance must be struck in the application of guidelines for obtaining informed consent and hindering medical research
Principals of IC
More than a piece of paper to be signed, informed consent is an
ongoing communication between researchers and subjects, one
which at any point supersedes the importance of any other part
of the research.
Subjects should feel that their participation is voluntary, and that their refusal to cooperate is free of consequence to them.
Informed consent is one of the primary ethical considerations
(i.e. Respect and Autonomy) underlying research with human
subjects.
Mental Capacity
A person has capacity to make a decision for himself if he is able to do the following:
1. understand the information relevant to the decision;
2. retain that information;
3. use or weigh that information as part of the process of making the decision;
4. communicate his decision (whether by talking, using sign language or any other means).
- Non-technical
- Practical
- Understandable to the subject or the subject’s impartial witness, where applicable
IC record
- It is a process and not just a signature on a form.
- The investigator is responsible for ensuring that 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 this task. - Dated and witnessed
- A copy of the consent document must be provided to the subject and the original signed consent document should be retained in the study records.
- IRB must know who will conduct the consent interview. Those conducting consent procedures should be adequately trained.
Voluntary
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.
IC contents I
- That the trial involves research.
- The purpose of the trial.
- The trial treatment(s) and the probability for random assignment to each treatment.
- The trial procedures to be followed, including all invasive procedures.
- The subject’s responsibilities.
- Those aspects of the trial that are experimental.
- The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or nursing infant.
- The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should be made aware of this.
- The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important potential benefits and risks.
10.The compensation and/or treatment available to the subject in the event of trial-related injury.
Ic contents II
11.The anticipated prorated payment, if any, to the subject for participating in the trial.
12.The anticipated expenses, if any, to the subject for participating in the trial.
13.That the subject’s participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled.
14.That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will be granted direct access to the subject’s original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the subject,
15. That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the subject’s identity will remain confidential.
Ic contents III
- That the subject or the subject’s LAR will be informed in a timely manner if information becomes avalable that may be relevant to the subject’s willingness to continue participation in the trial.
- The person(s) to contact for further information regarding the trial and the rights of trial subjects, and whom to contact in the event of trial-related injury.
- The foreseeable circumstances and/or reasons under which the subject’s participation in the trial may be terminated.
- The expected duration of the subject’s participation in the trial.
- The approximate number of subjects involved in the trial.
Elements of IC I
- An explanation that the trial involves research, the aims and the expected duration of the subject’s participation, a description of the procedures.
- The trial treatment(s) and the probability for random assignment to each treatment or placebo
- The subject’s responsibilities.
- A description of any reasonably foreseeable risks or discomforts to the subject.
- A description of any benefits to the subject or to others which may reasonably be expected from the research.
Elements of IC II
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
- A statement describing the confidentiality of records identifying the subject will be maintained.
- 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.
- 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. - 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.
English Speaking Subjects with
Low Literacy
A person who can understand and comprehend spoken English, but is physically unable to talk or write, can be entered into a study if they are competent and able to indicate approval or disapproval by other means.
(1) the person retains the ability to understand the concepts of the study and evaluate the risks and benefits 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.
Non-English Speaking Participants
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.
Who obtains IC
It is the investigator full responsibility
for IC. Investigator can delegate to
others.
