|NIH Guidance on Informed Consent
For Gene Transfer Research
NIH GUIDELINES: "The subjects should be provided with specific information about any financial costs associated with their participation in the protocol and in the long-term follow-up to the protocol that are not covered by the investigators or the institution involved. Subjects should be provided an explanation about the extent to which they will be responsible for any costs for medical treatment required as a result of research-related injury."
Participant Costs: Costs associated with participation in the study and long-term follow-up that will be the responsibility of the participant should be enumerated. Such costs may include:
Bulleted lists of the costs that will be incurred may be helpful to potential participants, including:
Research-Related Injury: Institutions and sponsors are not required to compensate or provide free treatment to participants for research-related injuries. However, institutions and sponsors may adopt individual policies regarding compensation and provision of treatment for research-related injuries. Investigators should consult with their sponsors, Institutional Review Board and Institutional Biosafety Committee for their policy and model language. Investigators should provide information about the study's policy on research-related injuries, including whom to contact if a research-related injury should occur, regardless of whether compensation or treatment will be provided.
Financial Counseling: An increasing number of institutions make financial counseling available to potential research participants. Such counseling can help determine what is likely to be covered by the participant's health insurance and can help identify sources of supplemental support, such as uncompensated care funds, special arrangements and discounts from institutions and sponsors, subsidization for travel and living expenses for participants and families, and the like. Financial information and counseling may be particularly helpful for gene transfer trial participants. Although insurance coverage for participation in clinical trials has broadened considerably in recent years, coverage for early-phase trials, like most gene transfer, is far from certain because of the low likelihood of direct benefit from the experimental intervention. The investigator should provide information about financial counseling available to potential study participants.
The following items will not be charged to you or to your insurance company:
Health care costs not related to this study are billed to your health insurance company. Because this is a research study, insurance companies or government health care programs may not pay for the experimental interventions, research-related tests, or treatment of research-related injuries. You must pay all charges related to the medical care you receive for treatment of your disease except for those listed above. This includes charges your insurance company refuses to pay because of the connection with an experimental procedure. You will not be paid for being in this study.
There will be no costs to you for any research-related laboratory tests, investigator's time, or the [gene transfer agent]. You or your insurance company will be billed for tests and treatments that are considered standard care. Medical treatment for physical injuries directly resulting from research procedures that are not covered by your insurance will be provided free of charge at [study site] by the [study sponsor].
Comments: Although this sample language is common, it is insufficiently helpful. It does not allow potential participants to reasonably foresee the costs they will be expected to pay as a result of their participation in the study, since these are merely described as "standard care".