Response

In [our Policy Forum][1], we proposed a trade-secret model that would enable greater autonomy for individuals who contribute to genomic biobanks by contesting elements of the informed consent regime. We thank Matsuura, Weil and Compton, and Dove, Joly, and Knoppers for their thoughts on the potential of this model.

Matsuura proposes that personal privacy rights could strengthen recognition of research participant autonomy. Personal privacy rights enable individuals to control public use of personal or private information or characteristics, and are thus a solution to the problem of unwanted public disclosure. Yet whether guided by current human subjects research protections or recent exemption guidelines, researchers generally promise not to make public any link between individuals and their DNA. Our proposal aims to enhance participant autonomy whether or not unwanted public disclosure becomes an issue.

Our model does not require that individuals understand their secret, as both Matsuura and Dove, Joly, and Knoppers suggest. The information qualifies as long as it “derives economic value, actual or potential, from not being generally known” ([ 1 ][2]).

We do not oppose the custodianship model advocated by Weil and Compton, although we find it legally complex and indeterminate. We do disagree, however, with several of their claims. We do not “submit that donating genetic samples for medical research is like selling a confidential commodity of potentially lucrative value.” Rather, we believe that prospective participants view their DNA as confidential property, and often consider the terms and conditions—which may include financial compensation—upon which they might permit its use. Likening a participant's DNA to a trade secret does not imply that its primary value is personal gain, nor does it preclude “widespread dissemination for use.” On the contrary, the licensing of trade secrets often encourages widespread dissemination. Researchers working on “approved studies” can, if inclined, include in their menu options a provision for open sharing.

With respect to practicalities, we do not propose recognizing the “diverse licensing preferences” of participants. We propose that biobanks offer participants a limited menu of licenses that differ, for example, in the nature of the compensation and the extent of the permitted use. Just as sharing biospecimens motivated creation of material transfer agreements, licensing needs can drive creative approaches to track permitted options. We also wish to clarify that although Weil and Compton (understandably) refer frequently to cancer research, we think that our model should be tested first among healthy volunteers.

Weil and Compton's claim that our model may “foment suspicion and distrust among research participants” seems inconsistent with their claim that research participants “are primarily motivated by altruistic, not compensatory, desires.” Our research suggests that participants are motivated by both altruism and money, with the respective contributions varying among individuals ([ 2 ][3])—a reality that our model recognizes. We feel that the current interpretation of human subjects regulation is more likely than our proposal to alienate many among the large populations necessary for biobanking, given that informed consent often serves as a quasilegal device to ensure that an institution retains rights to whatever is derived from a biospecimen yet absolves itself of liability. Our model, by contrast, offers a way for individuals to be actual partners, rather than simply “subjects,” in biobank research.

Dove, Joly, and Knoppers are concerned that we conflated “value” with “secret.” However, we described these terms as the two distinct elements of the legal definition of a trade secret: It must have economic value to its proprietor, and it must not be generally known. The avid interest of medical science in obtaining DNA samples seems to be conclusive evidence that a person's genetic information has economic value. Likewise, it seems self-evident that DNA information cannot be generally known unless and until the person chooses to make it available.

We do not see why a menu of options would in principle promote a power imbalance, as Dove, Joly, and Knoppers suggest, given that a menu could be developed in cooperation with likely participants. Such an imbalance seems more likely in the present system of informed consent. Currently, the prospective participant has two choices—take it or leave it—and all terms are dictated by the researcher, and are probably legally unenforceable by the participant ([ 3 ][4]).

The fact that “genetic information is financially worthless absent outsourced scientific interpretation” is not relevant. Many trade secrets cannot be exploited without third-party expertise and resources—that is why their proprietors license them out.

Finally, Dove, Joly, and Knoppers suggest that increasing contributor autonomy may run counter to “robust, transparent, and collaborative research models.” We disagree that autonomy and collaboration are opposed, given that true collaboration seems to require that each participant retain autonomy. The idea that the trade-secret model necessarily facilitates rampant individualism is a misunderstanding of the concept of intellectual property. Contrary to what Dove, Joly, and Knoppers contend, trade secrets—and intellectual property generally—can indeed be “instrumental legal tools to serve (bio)ethical ends.” Intellectual property owners use their rights to promote the public interest all the time; for example, PXE International holds and uses a patent (which could just as well be a trade secret) not for profit but to promote its health agenda.

If our proposal were given a trial among healthy volunteers, we suspect that many if not most of them would seek the same eleemosynary ends for which Dove, Joly, and Knoppers argue. However, our proposal would let participants make that choice, rather than deferring to scientific and academic elites who speak for them.

1. [↵][5] U.S. National Conference of Commissioners on Uniform State Laws, Uniform Trade Secrets Act, § 1(4).


2. [↵][6] 1. J. Kaye, 2. M. Stranger
1. R. J. Cadigan, 2. A. M. Davis
, in Governing Biobanks, J. Kaye, M. Stranger , Eds. (Ashgate Publishing, Farnham, UK, 2009), pp. 117–133.


3. [↵][7] Greenberg v. Miami Children's Hospital Research Institute, 264 F. Supp. 2d 1064 (S.D. Fla. 2003).

[1]: http://www.sciencemag.org/content/332/6027/309.full
[2]: #ref-1
[3]: #ref-2
[4]: #ref-3
[5]: #xref-ref-1-1 View reference 1 in text
[6]: #xref-ref-2-1 View reference 2 in text
[7]: #xref-ref-3-1 View reference 3 in text