Setting Up a Canine DNA Bank: Issues of Logistics, Potential Conflicts of Interest, Privacy Rights, and Bioethics
Stuart F. Eckmann1; Linda W. Bell2
The Tibetan Terrier DNA Bank and Registry was established as a research project under a grant from the AKC Canine Health Foundation, with co-sponsorship by the Orthopedic Foundation for Animals, through the University of Missouri School of Veterinary Medicine. The objective of this project was to: demonstrate the viability of the concept; provide a model for other breeds to use; collect an adequate repository of DNA and health and morphology information from breeders and pet owners for genetic marker research; and develop the framework for its ongoing, perpetual viability.
In the time the DNA Bank and Registry has been in existence, it has made considerable progress toward achieving its goals. There is considerable awareness among breeders and owners of its existence. Blood collections have been held at regional and national specialties, and requests for collection kits have come from the United States, Canada, England, and Europe. Since September 1998, we have collected DNA and information on about 550 dogs. We collected samples from about 100 dogs in 1999 and 200 dogs in 2000, with decreasing numbers in subsequent years. The later, smaller numbers represented more focused efforts, as those with affected dogs for specific genetic conditions made concerted efforts to collect DNA from entire families of specific dogs. To put these numbers in the perspective, the national breed club has about 500 U.S. and foreign members, and AKC dog registrations for Tibetan Terriers were 645 for 2002. The result is that the DNA Bank has been the catalyst for three research proposals, for three different conditions, which were submitted to and approved by the AKC Canine Health Foundations. With financial support of the national breed club, we are now planning the next round of collections, which will add one more generation to the DNA Bank.
Our next step is to develop the structure that will ensure its ongoing viability. We are in the process of turning the DNA Bank into a formal trust. The trust will be a separate and distinct entity from the breed club to avoid potential conflicts of interest. The trust will be managed by a board of trustees. Trustees will be responsible for: ensuring the ongoing storage of the DNA and health and morphology information; ensuring the financial solvency of the Trust; informing potential researchers of the existence of the DNA bank; reviewing research proposals from researchers interested in access to the DNA bank and registry; providing information on these research projects to contributors, for them to make informed decisions regarding use of the stored DNA; once genetic tests are commercially available, developing protocols for use of DNA in the bank for such tests to be performed; determination of appropriate access to information on individual dogs-whether obtained through research or commercial tests; establishing the protocols for and relationship with health registries for use of such information; and providing an annual reporting mechanism to the national breed clubs of all the contributors.
As we envision the trust, researchers interested in using the DNA samples and information will be expected to submit their proposals to the Board of Trustees. The researchers will be asked to indicate: how their research could potentially benefit the breed (either from information which could assist breeders in producing healthier dogs or from information which could improve the quality of life of dogs with specific genetic or health conditions); whether any invasive procedures or "colony" dogs will be used in their research and, if so, the university protocols which would be followed for these dogs; how the proposed research will be funded; if any of the funding will be used for capital expenditures; the relevance of their prior research or experience with the breed to the proposed research; and whether the complete outcome of the research will be published or accessible to other researchers, or whether all or portions of the outcome will be considered to be proprietary. For all research, researchers will be expected to share their results in the aggregate but, at the same time, protect the confidentiality of individual dogs and breeders participating in the research.
For any research to be considered, it shall first have gone through an independent peer review process by other researchers outside of the Principal Investigator's academic institution. The independent review processes used by the AKC Canine Health Foundation and the Morris Animal Foundation shall be used as such models, though proposals considered by the Trustees shall not be limited to those foundations. The Trustees will review any proposals submitted and make recommendations to contributors of the DNA for their evaluation. Any Trustee who is also Principal Investigator on a potential research project will need to recuse himself or herself from evaluation his or her own research project. Likewise, any Trustee must also recuse himself or herself from any research project from his or her own academic institution.
The Trustees shall also recognize the unique nature of the DNA and related data in its Trust, both on an individual basis and in the aggregate, and shall regard it as Real Property. Accordingly, the Trust shall convey to any prospective researchers that, unless there are any agreements specifically stating otherwise, it shall remain as Real Property of the Trust, for use by researcher without any conveyance of ownership. Researchers shall be expected to use the DNA and data for development of public-domain tests and published research, unless there are any agreements specifically stating otherwise. Researchers shall be permitted use of the DNA and data for development of any proprietary tests or intellectual properties derived thereof only after agreements have been specifically entered into with the Trust.
Our DNA is currently stored at the University of Missouri, a relationship that has worked well for us. Should that arrangement no longer be available to us, we need to evaluate, on an ongoing basis, the viability of other options. Properly structured and administered, the Orthopedic Foundation for Animals or the Canine Health Information Center (CHIC) has the potential to provide such conflict-free oversight. The OFA's profit from such involvement could be the registration of the genetic tests on its database, an area that is sure to grow as more tests become available. One critical component in the establishment of any new locus, as we see it, is that the organization be a non-profit with an arms-length relationship from any organization that could profit from access to or use of the archived DNA.
As we move forward in the development of a formal trust, we are doing so in consultation with a trust attorney and a bioethicist who is a Fellow at the Hastings Center for Bioethics. The issues we have had to address, which we feel are relevant to all breeds, are:
Does the breed's DNA bank have a structure in place which ensures its perpetuity in a manner responsible to those who have contributed the DNA and consistent with the long-term interests of the breed?
Who should have access to the DNA, and what is the best way to determine which projects merit use of that DNA? Is there a system of checks and balances in place to ensure that DNA use is limited to appropriate projects in the best interests of the breed?
Is there an adequate arms-length relationship between the organization storing the DNA and those who could profit from access to it?
Who owns the DNA in the DNA bank, and when it is provided to a researcher is the DNA bank allowing the researcher to use the DNA or is the DNA bank conveying ownership, too, and the intellectual property rights that go along with ownership?
Does the DNA bank have procedures in place to determine which research projects merit use of their DNA?
Does the DNA bank have procedures in place that address and ensure privacy rights in a way that balances the needs and benefits of research with the rights of breeders and owners?
Is the breed working with a trust attorney, bioethicist, veterinary geneticist, or other independent resource who can provide guidance and act as the breed's advocate in the establishment of their DNA bank?
There are several different interests involved in canine DNA banking: the breeds, researchers, funding sources, storage facilities, and organizations marketing genetic tests. As the different breeds move forward with their own DNA banks, all of the breeds can benefit from both shared information and a dialog independent of other interests. Perhaps this type of dialog will result in some common guidelines and a code of bioethics for canine DNA banking.