The primary purpose of providing Informed Consent to a subject enrolled in a clinical trial is to give him/her the right to know about the experimental drug and to understand what will occur during a clinical trial. The informed consent process should not be taken lightly by the participant or the responsible investigator. However, that being said, in my opinion, the informed consent process is often times a compliance issue or concern because standard elements may be missing or the informed consent is not appropriately given to the participant by the investigator responsible for the clinical trial. Elements 1-8 identified below should be in every informed consent; I have also noted additional elements that are commonly found in the form. The elements listed below were taken directly from the Code of Federal Regulations Title 21, Part 50, Subpart B section 50.25
(1) “A 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) A description 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 the research.
(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 and that notes the possibility that the Food and Drug Administration may inspect the records.
(6) For research involving more than minimal risk, an explanation as to whether 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.
(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject.
(8) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
(b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
(1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
(2) Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent.
(3) Any additional costs to the subject that may result from participation in the research.
(4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.
(5) A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject.
(6) The approximate number of subjects involved in the study”
“The following questions will be helpful for the participant to discuss with the investigator if they are not already addressed in the informed consent document in a clear and understandable fashion.
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
- What kinds of tests and experimental treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- What type of long-term followup care is part of this study?
- How will I know that the experimental treatment is working? Will results of the trials be provided to me?
- Who will be in charge of my care?”
As you are aware, the informed consent must be given before any clinical trial-related procedures are conducted; I often hear from the health provider team that some procedures are a matter of good healthcare practice and not necessarily a part of the clinical trial. However, if the clinical protocol defines a time period (within 30 days of study start) and the procedure is outlined as an event per the protocol and is performed in an effort to meet the protocol eligibility it is a part of the clinical trial.
In my opinion, ethics over research has to play a pivotal role in effective communication between the clinical trial participant and the physician/investigator. It is unfortunate that we are still hearing of incidents where full disclosure regarding the clinical trial was not embraced and apparently in some cases research over ethics is still the philosophy..