|NIH Guidance on Informed Consent
For Gene Transfer Research
NIH GUIDELINES: "The Informed Consent document should indicate the availability of therapies and the possibility of other investigational interventions and approaches."
Disease-appropriate alternatives include:
There may be no alternatives that have been shown to have significant success in individuals with certain diseases or conditions. Researchers should discuss this situation with potential participants, as appropriate.
In the consent process, investigators should recognize that some potential participants may consider themselves to have no real choice other than to participate in research. Investigators should take extra care in explaining and discussing alternatives with these potential participants. In contrast, very ill potential participants, whom investigators may be tempted to characterize as having no options, may view themselves as having a range of choices. Investigators should be sure to give these potential participants complete information about alternatives to participation.
Sample 1 - Standard Treatment Alternatives
Instead of being in this study, you may choose to have treatment with one or more standard chemotherapy drugs, alone or in combination. Some individuals have responded to standard treatments. The drugs used for your type of cancer include: [drug listing]. Or you may choose to have radiation treatment to control symptoms of your disease
Sample 2 - Experimental alternatives
It is not known whether any of the other experimental agents being studied are effective in your disease. If you decide not to be in this study, you can still join other studies, here or at other medical centers, if you wish.
Sample 3 - Palliative care alternatives
You may decline life-prolonging interventions for your disease. If you did, you would receive palliative care. This is supportive care that will not help you live longer, but will make you as comfortable as possible for as long as you live.
Sample 4 - Combination of alternatives
You do not have to participate in this study. You may want to be in a different study. You can choose not to participate in this study and continue to be cared for regularly here at [hospital]. You may choose at any time to stop being in this study and maintain all other aspects of your care by your doctors at [hospital]. [INCLUDE WHEN APPLICABLE: Getting the gene transfer in this study should not prevent future treatment with standard therapy. Getting the gene transfer in this study should not make you ineligible for participation in other studies either.]
Sample 5 - Combination of alternatives
You may choose not to participate in this study. If you choose not to, your decision will not affect your care at [study site]. Alternatives to being in this study include:
You can receive these treatments during and after the study. Since this study will not directly treat your [disease], a decision not to participate will not affect your health.
Sample 6 - Randomization to Experimental or Control Arm
Standard treatment cannot cure your disease. You may be in other studies that may improve your quality of life and help you live longer even though they will not cure your cancer. A variety of research studies for your cancer are going on in medical centers around the world. The effectiveness of these approaches is unknown. [New treatment X] has recently shown longer survival in some patients. Other treatments may also be available. You can also decline further life-prolonging treatment for your disease, and receive palliative care to manage your symptoms. If you decide not to participate in this research study, we will discuss all appropriate treatments with you and help you decide what to do next.