Tuesday, July 15, 2014

Intellectual Property from Clinical Research on Neuropsychiatric Disorders: What Constitutes Informed Consent?

By Elaine F. Walker, Ph.D. & Arthur T. Ryan, M.A.

Elaine Walker is a Professor of Psychology and Neuroscience in the Department of Psychology at Emory University and is the Director of the Development and Mental Health Research Program, which is supported by the National Institute of Mental Health. Her research is focused on child and adolescent development and the brain changes that are associated with adolescence. She is also a member of the AJOB Neuroscience editorial board.

The pace of advances in biomedical research has accelerated in conjunction with new technologies for studying cellular processes. While this progress holds promise for relieving human suffering from a range of illnesses, it also poses significant and thorny questions about the ownership of new knowledge. In June of 2013, the Supreme Court issued a unanimous ruling on the Association for Molecular Pathology v Myriad Genetics, Inc.; all justices agreed that naturally occurring DNA sequences cannot be patented1. This ruling was precipitated by a patent owned by Myriad genetics on the DNA sequences for the human BRCA1 and BRCA2 genes, which are associated with human variation in susceptibility to cancer. The ruling concluded that genes are products of nature and, therefore, cannot be claimed as the intellectual property (IP) of any individual or commercial entity. Within hours after this ruling, other companies announced that they would offer genetic testing for BRCA1 and BRCA2 at a significantly lower cost than Myriad had been charging for years.

While the Supreme Court's ruling on the patentability of naturally occurring human genetic sequences had broad and immediate implications, it represents only the tip of the iceberg with respect to the contentious issues that will confront intellectual property (IP) rights for future biomedical advances. We can anticipate more ethical and legal debates regarding commercialization in the fields of proteomics (the study of protein structure and function), epigenetics (changes in gene expression mediated by RNA, as opposed to changes in the DNA code), stem cells, and the study of the human connectome (the map of neural connections in the brain). The implications of the pursuit of patents in these areas will extend to all fields of medicine, but they present some particularly complex problems with regard to the brain disorders that are the province of neurology and psychiatry.

By way of background, most consent forms approved by institutional review boards (IRBs) do not explicitly inform prospective participants that IP may be generated using the biospecimens they provide during their participation. Some have argued that researchers are ethically obligated to inform participants that the investigator may benefit financially from the research, whereas the participant will not2. On the other hand, it has been argued that individuals who are capable of providing informed consent would be expected to be aware that patents might be obtained on marketable biomedical products that result from scientific advances3.

Can the same assumptions be made for all prospective participants? Clinical research aimed at elucidating the causes and effective treatments for neuropsychiatric disorders are dependent on the participation of volunteers who are either at risk for, or diagnosed with, such a disorder. This includes studies of individuals at risk for psychotic and mood disorders, and dementia and other neurodegenerative illnesses. As a result, these research volunteers may be suffering from symptoms that impair their cognitive capacities. Such impairments have the potential to diminish their ability to comprehend the information provided during the consenting process, as well as their comprehension of the broader implications of their property rights to their biospecimens and the knowledge that might be generated with them4. Nonetheless, informed consent procedures are used with these clinical research populations, albeit with extra consideration given to assure their understanding of the procedures. Ruling out informed consent by individuals who may be suffering from, or at risk for, a brain disorder would severely compromise scientific progress on these illnesses. At the same time, the ethical complexities of patents on the IP generated by such research cannot be ignored.

Concerns about risk status are a motivator for many participants in clinical research. Most IRBs require that consent forms include a ‘disclaimer’ statement concerning the likely absence of direct benefit to the participant. Yet, it is not clear that most prospective participants, especially those at risk for neuropsychiatric disorders, are aware that they may not have access to any advances in risk prediction that accrue from the research in which they participate. Thus, if a diagnostic test that enhances risk prediction and/or informs effective treatment results from the research, participants may assume that their access to it is assured. Yet this may not be the case if the ‘discovery’ becomes IP and the investigator applies for a patent.

Several scenarios may ensue and these are unlikely to be anticipated by most participants. For example, the pursuit of a patent may delay the public disclosure of the research findings, and in the interim the individual may succumb to an illness that might have been prevented if the discovery had been more promptly revealed. Further, the cost of the patented diagnostic test may be prohibitive for the individual, despite the fact that the participant contributed biospecimens that were used for the test's development. While such concerns are not unique to neuropsychiatric research, the ethical concerns are amplified in the case of individuals with cognitive impairments.

If participants were informed, as is the case in some European nations, that the researchers may benefit financially from discoveries made using their biospecimens, would that affect their willingness to participate? Although we are not aware of any research directly addressing this question, the results of studies of the general population indicate that many would be disinclined to consent to research participation if they were so informed 3,5.

It is clear that research advances in biomedical risk assessment, combined with trends toward commercialization, raise serious questions that are likely to become even more salient. Perhaps the most important question we must address is what information should be conveyed while obtaining the informed consent of prospective clinical research participants who provide biospecimens that might be used for commercial purposes. The ethical issues in this arena are especially noteworthy when the study population is characterized by limited cognitive capacity and when individual participants may be motivated by the desire for illness prevention or treatment access.


1. Ass’n for Molecular Pathology v. Myriad. Ct 133, 2107 (2013).

2. Godard, B., Schmidtke, J., Cassiman, J.-J. & Aymé, S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A professional perspective. Eur. J. Hum. Genet. 11, S88–S122 (2003).

3. Steinsbekk, K. S., Ursin, L. Ø., Skolbekken, J.-A. & Solberg, B. We’re not in it for the money—lay people’s moral intuitions on commercial use of ‘their’biobank. Med. Health Care Philos. 16, 151–162 (2013).

4. Caplan, A. L. & Arp, R. Contemporary Debates in Bioethics. (John Wiley & Sons, 2013).

5. Sterckx, S., Cockbain, J., Howard, H., Huys, I. & Borry, P. ‘Trust is not something you can reclaim easily’: patenting in the field of direct-to-consumer genetic testing. Genet. Med. 15, 382–387 (2013).

Other Relevant Articles 

Andrews, L. B., & Paradise, J. (2005). Gene patents: the need for bioethics scrutiny and legal change. Yale J. Health Pol'y L. & Ethics, 5, 403.

DuBois, J. M., Beskow, L., Campbell, J., Dugosh, K., Festinger, D., Hartz, S., ... & Lidz, C. (2012). Restoring balance: a consensus statement on the protection of vulnerable research participants. American journal of public health, 102(12), 2220-2225.

Kim, S. Y., Caine, E. D., Currier, G. W., Leibovici, A., & Ryan, J. M. (2001). Assessing the competence of persons with Alzheimer’s disease in providing informed consent for participation in research. American Journal of Psychiatry, 158(5), 712-717.

Klein, R. D. (2013). AMP v Myriad: The Supreme Court Gives a Win to Personalized Medicine. The Journal of Molecular Diagnostics, 15(6), 731-732.

Rojahn, Susan Y. Cheaper Genetic Tests for Breast Cancer Risks in 2014? MIT Technology Review, December 31, 2013.

Want to cite this post?

Walker, E., Ryan, A. (2014). Intellectual Property from Clinical Research on Neuropsychiatric Disorders: What Constitutes Informed Consent? The Neuroethics Blog. Retrieved on , from http://www.theneuroethicsblog.com/2014/07/intellectual-property-from-clinical.html

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