Table 3.

Text of Problematic Language

Topic	Problematic Language
Withdrawal	Example 1: If you withdraw any tissue or blood samples that were collected from you, they either will be destroyed or stored without any information that identifies you. Example 2: For withdrawal of samples: If you agree to allow your tissue/blood/cells to be kept for research, you are free to change your mind at any time. We ask that you contact [researcher name] in writing and let him know you are withdrawing your permission for your blood to be used for research…. Any unused blood will have all identifying information removed that would link the sample to you. The sample may then be used for other research, but no one will be able to relate those research results to you. Example 3: If in the future you decide you no longer want to participate in this research, we will remove your name and any other identifiers from your blood samples/genetic information, but the material will not be destroyed, and we will continue to use it for research.
Exculpatory language	Example 4: By agreeing to allow your samples to be stored and used in future research, you agree to give up all ownership and rights to the samples, and to DNA/cells extracted from those samples, including any potential profit from commercial development from your samples. Your DNA/cells become the property of [the institution]. (emphasis added) Example 5: By agreeing to participate in this study, you agree to waive any claim that you might have to the body tissues and fluids that you donate. It is possible that samples you have donated, which are used in research, may result in new products, tests, or discoveries. In some instances, these may have value and may be developed and owned by the study sponsor or others. Participation in this research means that you waive the right to any new material or process developed through this research. (emphasis added) Example 6: This is being done for our research purposes only. Researchers would like to know about your family’s history of diabetes and other diseases. You will not learn anything through this research about yourself or your family members and, should you participate in this study, you agree to waive access to or review of your information related to the study indefinitely. (emphasis added)

Topic

Problematic Language

Withdrawal

Example 1: If you withdraw any tissue or blood samples that were collected from you, they either will be destroyed or stored without any information that identifies you.
Example 2: For withdrawal of samples: If you agree to allow your tissue/blood/cells to be kept for research, you are free to change your mind at any time. We ask that you contact [researcher name] in writing and let him know you are withdrawing your permission for your blood to be used for research…. Any unused blood will have all identifying information removed that would link the sample to you. The sample may then be used for other research, but no one will be able to relate those research results to you.
Example 3: If in the future you decide you no longer want to participate in this research, we will remove your name and any other identifiers from your blood samples/genetic information, but the material will not be destroyed, and we will continue to use it for research.

Exculpatory language

Example 4: By agreeing to allow your samples to be stored and used in future research, you agree to give up all ownership and rights to the samples, and to DNA/cells extracted from those samples, including any potential profit from commercial development from your samples. Your DNA/cells become the property of [the institution]. (emphasis added)
Example 5: By agreeing to participate in this study, you agree to waive any claim that you might have to the body tissues and fluids that you donate. It is possible that samples you have donated, which are used in research, may result in new products, tests, or discoveries. In some instances, these may have value and may be developed and owned by the study sponsor or others. Participation in this research means that you waive the right to any new material or process developed through this research. (emphasis added)
Example 6: This is being done for our research purposes only. Researchers would like to know about your family’s history of diabetes and other diseases. You will not learn anything through this research about yourself or your family members and, should you participate in this study, you agree to waive access to or review of your information related to the study indefinitely. (emphasis added)