The informed consent process is taken very seriously. All informed consent documents for any new clinical trial must first be reviewed and approved by the IRB before the research may start. Furthermore, if substantial changes are desired after the trial is started, the changes must first be approved by the IRB, and all Research Subjects must be informed and agree.
In this section we will cover only the major circumstances of informed consent. There are other complex circumstances-such as for children, prisoners, unborn children, emotionally disturbed or severely injured unconscious persons for which there are special rules. The informed consent process must be carried out by the PI or by a trained associate. When you reach the end of the consent process and are about to sign the consent document, you should have considered each of the following questions:
- Are you under any pressure to participate in this trial against your will?
- Do you know who the PI is?
- Do you understand what the PI is trying to learn from this research?
- Do you know who the sponsor is?
- Is the language in the informed consent document clear to you?
- What overall benefits are possible from this research?
- Do you expect any personal benefits from this trial?
- What alternative treatments are available to you outside of this trial?
- Do you know what tests or procedures will be performed on you?
- Which of these tests are different from those you might have otherwise?
- What medications must you take?
- Do you know what discomforts or risks might occur with these medications?
- Have you been given instructions as to your responsibilities?
- What medical costs will the sponsor pay for?
- What medical costs will your insurance pay for?
- What medical costs will you have to pay for?
- What medications, foods or activities must you avoid?
- How often must you come to the CTSI?
- How long must you stay in the CTSI?
- How long will the study go on?
- If you are to receive payment has the amount and method been explained?
- If you are to receive payment is it clear that you must receive partial payment even if you discontinue?
- Was it explained that you can leave the trial at any time you wish?
- Are you aware the PI can discontinue you from the trial at any time?
- Is it clear that leaving the trial will not affect your future care with NYU/Bellevue/VAH/HJD?
- Is it clear that you keep all your legal rights even if you sign the consent?
- Do you know what will be done with any blood or tissue taken from you?
- Is it clear as to who will or will not have access to your information?
- Do you know if there is a plan to present or publish the findings?
- Do you know if there is a possible commercial value to the results?
- Will you be given the results of the study?
- If the trial discovers a new treatment important to you, will you get it?
- Have you been given a copy of the informed consent document to keep?
- Have you been given adequate opportunity to ask questions?
You can see from the length of this list that every effort is made to be thorough. If you understand the answers to these questions then you are well informed. If you have decided to be a volunteer and have addressed these questions, you may sign the consent form and become a full-fledged Research Subject!
What if you change your mind later? Remember that as part of the informed consent process you are advised that you may discontinue your participation at any time without any penalty. Your resignation from a clinical trial will not cast a shadow on your continued care as a patient outside of the research program.
