the required RSC language, which links to a pamphlet entitled: Introduction to Radiation for NIH Research “An Subjects: ARE THERE State potential direct benefits that may be associated with an BENEFITS TO There is no direct benefit to you from participating in this intervention being studied for the participant (if applicable) TAKING PART research. However, we hope to learn more about [disease and/or collateral benefit to participants (medical or genetic IN THE name] or [your or your family member’s illness]. counseling care). RESEARCH? Do not overstate benefits; be realistic. If a subject will not benefit from participation, clearly state so. (e.g., should not expect your condition to improve as a “You result of participating in this research.”) If the subject may benefit from the initial research but not secondary/future uses of their samples and data, this should be stated as well. State possible general benefit for science or for other subjects with similar diseases or for the population at large, if applicable. Ensure that the description of benefits is consistent with the benefits described in the protocol. Do not list financial compensation as a benefit in this section. WHAT ARE MY Explain realistic alternatives to participation. Specifically, Instead of being in this research study, you have these OTHER the treatment that would be recommended, offered, or options: OPTIONS? available to subjects if they decline to participate. (or) You do not have to participate in this study if you do not want to. WHAT IF I Explain that the subject may withdraw from the study at any You may stop participating in this research study at any CHANGE MY time, and specify what will happen to their samples and data time. If you choose, you may request to have your MIND? upon withdrawal. [data/biological materials/interview transcript] destroyed. Describe circumstances where data/biological materials may It may not be possible to withdraw samples or delete data not be removed or destroyed, such as iPS cells, data once they have been deposited in research databases and deposited into dbGaP and other repositories. shared with other researchers.
the required RSC language, which links to a pamphlet entitled: “An Introduction to Radiation for NIH Research Subjects: ARE THERE BENEFITS TO TAKING PART IN THE RESEARCH? State potential direct benefits that may be associated with an intervention being studied for the participant (if applicable) and/or collateral benefit to participants (medical or genetic counseling care). Do not overstate benefits; be realistic. If a subject will not benefit from participation, clearly state so. (e.g., “You should not expect your condition to improve as a result of participating in this research.”) If the subject may benefit from the initial research but not secondary/future uses of their samples and data, this should be stated as well. State possible general benefit for science or for other subjects with similar diseases or for the population at large, if applicable. Ensure that the description of benefits is consistent with the benefits described in the protocol. Do not list financial compensation as a benefit in this section. There is no direct benefit to you from participating in this research. However, we hope to learn more about [disease name] or [your or your family member’s illness]. WHAT ARE MY OTHER OPTIONS? Explain realistic alternatives to participation. Specifically, the treatment that would be recommended, offered, or available to subjects if they decline to participate. Instead of being in this research study, you have these options: (or) You do not have to participate in this study if you do not want to. WHAT IF I CHANGE MY MIND? Explain that the subject may withdraw from the study at any time, and specify what will happen to their samples and data upon withdrawal. Describe circumstances where data/biological materials may not be removed or destroyed, such as iPS cells, data deposited into dbGaP and other repositories. You may stop participating in this research study at any time. If you choose, you may request to have your [data/biological materials/interview transcript] destroyed. It may not be possible to withdraw samples or delete data once they have been deposited in research databases and shared with other researchers.
nhgri_irb_sample_consent_language_rev_nov_25_2015.docx