Ethical, Legal, and Policy Best Practices

Inventions and data arising from research using annotated biospecimens may have commercial value. As researchers and industry sponsors have sharply increased their demand for properly prepared and clinically annotated biospecimens, some institutions have begun to assert control over biospecimens, associated data, and research findings. The current variability in intellectual property (IP) policies at institutions hosting research and biospecimen resources may ultimately lead to problems in biospecimen and data access, timely and open publication, sharing of research findings, and establishment of new biospecimen resources. Sharing of research data obtained through use of biospecimens and associated research materials (e.g., derivatives) is essential for the advancement of science. Accordingly, research data and tools generated through the use of biospecimens should be shared in a timely manner and, to the greatest extent possible, in a manner consistent with applicable NIH sharing policies (for example, see http://sharing.nih.gov) .

C.5.1. Material Transfer Agreements

An agreement (e.g., MTA or contract) with terms consistent, as applicable, with the NIH Research Tools Policy, the NIH Data Sharing Policy, and other applicable NIH sharing policies should be used for the transfer of materials among academic, nonprofit, and/or industrial organizations (see Appendix 4 for a sample MTA) . Clinical protocols are not designed to document material transfers and are usually inappropriate for this purpose. Examples of agreements that capture the basic principles of the NIH policies above are the NIH Simple Letter of Agreement and the Uniform Biological Material Transfer Agreement. However, these agreements are insufficient for the transfer of human specimens without appropriate modification. Desirable terms in an MTA for the transfer of biospecimens include the following:

• Clear descriptions of the biospecimens and/or unmodified functional derivatives thereof (e.g., DNA and RNA) and identification of the institutions involved;
• Clear identification of the human subjects status of the biospecimens and associated obligations;
• Specific assurance that the biospecimen source site obtained appropriate informed consent and IRB approval;
• Agreement to abide by appropriate laws, rules, and regulations associated with human subjects research and private information;
• Acknowledgement of the recipient’s right, or lack thereof, to further distribute the biospecimens;
• Assurances of the end user’s academic freedom and the right to publish research results will not be hindered by the biospecimen resource; IP terms consistent with, as applicable and permissible, the basic principles of the NIH Research Tools Policy and other applicable NIH sharing policies, such as no reach-through by the biospecimen resource to end users’ IP and the sharing of research resources and data by the end-user with the research community;
• Description of any expectations regarding the dissemination of research data; and
• Conditions, or limitations, on commercial use, if any.

The following Web pages are relevant to this issue:

• http://sharing.nih.gov
• http://ott.od.nih.gov/policy/research_tool.html
• http://tinyurl.com/AUTM-UMBTA
• http://grants.nih.gov/grants/policy/data_sharing/
• http://cabig-ut.nci.nih.gov/working_groups/DSIC_SLWG