Investigators are responsible to discuss the research with subjects, and to document the subjects’ consent to participate. The consent process must be adapted to the decision-making needs of the subject. Different studies--depending on degree of therapeutic benefit and risk--require different emphasis during the consent discussion. The consent form is an important part of this process and is intended to guide the investigator and subject in the consent process.
• Federal regulations describe the required elements of consent.
- A statement that the study involves research, an explanation of the purposes and the expected duration of the subject’s participation, and a description of the procedures, noting any procedures which are experimental;
- A description of reasonably foreseeable risks or discomforts;
- A description of benefits to the subject or others that may reasonably be expected;
- Disclosure of appropriate alternative procedures or courses of treatment;
- A statement of the degree to which confidentiality of records identifying the subject will be maintained;
- For studies involving more than minimal risk, a description of any compensation that will be provided, and of medical treatments that are available in case of injury;
- Who to contact for answers to questions about the research, about research subjects’ rights, and about research-related injury;
- A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject would otherwise be entitled
• There are additional elements that must be included if appropriate.
- A statement that there may be unforeseeable risks to the subject (or the embryo or fetus) if the subject is or may be pregnant;
- Anticipated circumstances under which the subject’s participation may be terminated without the subject’s consent;
- Additional costs that may accrue to the subject as a result of participation;
- Consequences of early withdrawal from the research, and procedures for orderly termination of participation in such an event;
- A statement that any significant new findings that may relate to the subject’s willingness to continue will be provided;
- The approximate number of subjects involved in the study.
• The requirement to obtain informed consent can be altered or waived if all of the following conditions pertain:
- The research involves no more than minimal risk to subjects;
- The waiver or alteration will not adversely affect the rights and welfare of subjects;
- The research could not practicably be carried out without the waiver or alteration; and
- When appropriate, subjects will be provided with additional pertinent information after participation.
PET template language (radiotracer risk language)
- Consent Form Template Language: Risks and Inconveniences
For studies using PET, the following language is an example of what should be included:
Radiation Risk: Everyone is exposed to natural background radiation daily from sources such as radon, food, water and the sun's rays. The average exposure of people in the U.S. each year is estimated to be 360 mrem (units for measuring radiation). As a very rough comparison, the amount of radiation you will receive in one PET scan is in the same range as what you would be exposed to in one year from natural background sources. There are no known risks associated with this level of radiation; however, radiation adds up throughout a person's lifetime. It is not possible to tell whether the small additional radiation you will be exposed to by participating in this study will increase your long-term risk for diseases such as cancer.
The following language is required in consent forms for PET studies that include the insertion of an intra-arterial catheter:
Risks of Intra-arterial Catheters: The placement of a catheter in your artery may cause discomfort. There is a very small chance of complications from this catheter such as bleeding, infection, or blood clot. There is an extremely low risk (0.09%) of cutting off circulation to your hand, which could result in a need for surgical repair, or in rare instances, could result in the loss of use of part or all of the hand. These complications are rare and usually occur in medically ill patients who have catheters in their wrists for several days. In contrast, the catheter will remain in your arm for about eight hours for this study. If you have a history of a bleeding disorder or are taking certain medications that affect blood clotting, you will not be asked to participate in this study.