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Data on consent for research with biological samples: toward a uniform approach

Data on consent for research with biological samples: toward a uniform approach The views and opinions expressed in this talk are my own. They do not reflect any position or policy of the NIH, or U.S. government. Informed Consent.

aurelia-hensley
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Data on consent for research with biological samples: toward a uniform approach

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  1. Data on consent for research with biological samples: toward a uniform approach The views and opinions expressed in this talk are my own. They do not reflect any position or policy of the NIH, or U.S. government.

  2. Informed Consent • Much of the debate over informed consent for research with biological samples has focused on what information individuals should be provided, and choices they should be asked to make.

  3. Consent for New Samples • Most endorse offering a variety of choices: What diseases can be studied? Will the samples be shared? Can they be used in commercial research? • However, there is disagreement regarding which choices should be offered.

  4. Range of Ethical Approaches • General ethical considerations seem consistent with several options. • Respect for autonomy and protection from risks do not determine whether individuals should consent to research on all diseases, or consent specifically to research on their disease and research on other diseases.

  5. Need for Data • When general considerations do not support one approach, data on individuals’ views can help identify a best approach. • In particular, data on individuals’ views can provide evidence of what individuals care about, the views of the ‘reasonable’ person, and which approaches have the broadest social support.

  6. Identified Studies • Literature search identified 30 studies published in English which provide empirical data on the views of over 33,000 individuals. • The studies were from England, France, India, Japan, Singapore, Sweden, Uganda, UK, and the US.

  7. Views of Subject Donors

  8. Patient/Public Donors and Patient non-Donors

  9. Public non-Donors

  10. NIH Subjects

  11. Ugandan Parents

  12. Swedes • 93% (1311/1409) gave consent for samples to be used for future “academic genetic research” provided ethics committee approved the project. • A significant percentage wanted to be contacted concerning each new project.

  13. English Patients Oct 1998-Aug 2002: Only 1.2% (38/3140) refused to donate a sample, with 2 citing commercial involvement as the main reason for refusal.

  14. Willingness to Donate • Of the 20 studies that assessed willingness, 17 found that at least 80% of respondents were willing to donate their samples. • Most unwilling respondents were appear to concerned with factors other than research use, especially the method of obtaining the samples. In Wong 2004, 38% of those who were unwilling to donate cited as their reason a fear of needles or injections.

  15. Choices • The majority of individuals asked were willing to provide one-time general consent and rely on IRBs to determine when their samples would be used in future research projects (Hoeyer 2005 85.9%; Wendler 2005 95%; McQuillan 2003 85.3%; Stegmayr 2004 93%; Malone 2002 93.7%; Hoeyer 2004 79.4%).

  16. Findings • The data yield consistent findings, despite being conducted around the world, over a 10 year period, in different groups, using different methods. • The studies reveal that the vast majority of individuals want to decide whether their biological samples are used for research purposes.

  17. Findings II • The studies also reveal that, when asked, the vast majority of individuals are willing to donate a sample for research purposes.

  18. Preferences to Policy? • Current data suggest, in addition to risks, most individuals care whether their samples are used for research, but not what diseases will be studied nor who will use them.

  19. Consent for New Samples • The data suggest that consent forms need not detail all the different diseases that might be studied. • Instead, subjects should be offered a binary choice of allowing all future research or not, with the provision that future studies will be approved by an IRB.

  20. Six Elements of Consent 1) Request to obtain samples 2) Risks, if any 3) Absence of direct benefits 4) Information, if any, to be provided 5) Reliance on IRB to review and approve future research provided research is important and ethical, and risks are minimal 6) Solicitation of individual concerns/questions

  21. Example Wording • We would like to use your blood (tissue) sample in future studies to learn how to improve people’s health. The researchers conducting these studies will not contact you for more information. Your sample will be used only when an independent group, called an IRB (REC), determines that the research is important and ethical, and poses no more than minimal risk to you. These future research projects will not benefit you personally, and are not needed for your medical care. All information you provide will be kept confidential as far as possible. However, there is always a very small chance that some information may be released.

  22. Additional Considerations When Relevant • Optional provision: The choice of whether you provide a sample is up to you. No matter what you decide, it will not affect how we treat you. • Individual information: We will provide you with any information from future studies that may have an impact on your health. • Study information: Information on the nature (findings) of future research projects will be posted on our website (provided in some other way). • Future removal: If you decide in the future that you longer want to allow your sample to be used for research, please contact the study doctors and any remaining sample will be removed.

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