Season 1 – Episode 25 – Governance of Genetic Information
Discusses ethical issues and governance considerations associated with the collection, analysis, and sharing of genetic material and information.
Podcast Chapters
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- Shelly’s Background (00:01:04) Shelly discusses her role at Boston College Law School and her research interests in bioethics and law.
- Defining Genetic Material and Information (00:02:34) Shelly explains what genetic material and information are, emphasizing their interconnectedness.
- Uses of Genetic Material by Entities (00:06:15) Discussion on how biotech companies, biobanks, and research institutions utilize genetic material for research and treatment.
- Key Ethical Issues in Genetic Material Collection (00:09:17) Shelly highlights ethical concerns, including property rights, exploitation, and privacy issues in genetic research.
- Inadequacies of Current Laws (00:15:58) Shelly critiques existing laws for failing to protect individuals against exploitative practices in genetic material usage.
- Proposed Solutions for Legal Framework (00:20:55) Suggestions for comprehensive federal legislation and better governance to protect individual rights in genetic research.
- Importance of Comprehension Over Consent (00:23:14) Shelly advocates for ensuring individuals understand how their genetic information will be used rather than just seeking consent.
- Prohibiting Surreptitious Collection (00:24:36) Discussion on the need for oversight mechanisms to prevent unauthorized collection of genetic material.
- Privacy Protections for Genetic Information (00:25:30) Call for updated laws to extend privacy protections to both identifiable and de-identified genetic information.
- Benefit Sharing for Genetic Material Use (00:26:14) Shelly suggests that individuals should financially benefit from the use of their genetic material in research and commercial contexts.
- Research Articles and Scholars (00:26:52) Shelly discusses her published articles and recommends various scholars working on related topics.
- Educational Resources on Genetic Research (00:27:23) Information about the National Human Genome Research Institute and webinars on ethical implications of genomic research.
- Final Thoughts on Collaboration (00:28:16) Emphasis on the need for a multidisciplinary approach to address complex ethical issues in genetics.
- Adapting Legal Frameworks (00:28:44) The importance of flexible laws that can adapt to rapid advancements in technology and science.
- Fostering Public Trust (00:29:24) Highlighting the need for transparent communication and public engagement to build trust in genetic information handling.
- Conclusion and Further Learning (00:29:53) Wrapping up the conversation and inviting listeners to explore additional resources on technology ethics and bioethics.
Episode Transcript
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Daniel Smith: Welcome to On Tech Ethics with CITI Program. Our guest today is Shelly Simana, who is an assistant professor at Boston College Law School. Shelly’s research focuses on the intersection between bioethics and laws and addresses questions resulting from genetics, reproductive technologies, and biotechnology. Today, we are going to discuss some ethical issues and governance considerations associated with the collection, analysis, and sharing of genetic material and information.
Before we get started, I want to quickly note that this podcast is for educational purposes only. It is not designed to provide legal advice or legal guidance. You should consult with your organization’s attorneys if you have questions or concerns about the relevant laws and regulations that may be discussed in this podcast. In addition, the views expressed in this podcast are solely those of our guests. And on that note, welcome to the podcast, Shelly.
Shelly Simana: Hi, how are you?
Daniel Smith: Good. It’s great to have you. So to get started, can you tell us more about yourself and your work at Boston College Law School?
Shelly Simana: Of course. And thanks again for having me. So I’ve recently actually began my position as an assistant professor at Boston College Law School. And there I’ll be teaching torts, health law, and a seminar on the legal and ethical issues related to reproductive technology and genetics. And prior to Boston College, I was a postdoctoral fellow at the Center for the Law and the Biosciences at Stanford Law School and a doctoral candidate at Harvard Law School.
And as you mentioned before, and this relates to your question, what I’m doing at Boston College is that my scholarship is really situated at the intersection of law, bioethics, and medicine with a primary focus on genetics and reproduction. And I also explore other health-related issues such as the regulation of biotechnology. And in my research I ask, I would say two main questions like how advances in genetics, reproduction, biotechnology, affect people and society, and then how laws shape these impacts. And I feel that technologies can revolutionize our health and well-being, but that’s when the right legal frameworks are in place for that.
Daniel Smith: Now, just to help lay the groundwork for our discussion today, can you briefly describe what exactly genetic material and information entails?
Shelly Simana: Sure. And before I delve into this, I just want to emphasize that I think scholars and scientists might define these terms differently. And also many tend to speak about material and information separately. And while this is true in some cases, often I think once we collect the material, we can also access the information. And that’s why in my own research, I always prefer to speak about them together as one resource.
And I define genetic material as the physical substance that contains genetic information. And so genetic material can be specimens. These are samples such as hair, saliva, skin cells, and even DNA that is left behind on surfaces. And these are the sources from which genetic information is extracted. And in my own research when I speak about these specimens, I exclude gametes because they have reproductive potential. And so for the others we don’t. So that’s why it’s important for me to just focus on those without the reproductive potential for now.
There’s also DNA samples, and these are more refined forms of genetic material obtained through various extraction techniques, and they can include entire genomes or specific gene segments. We can also have manipulated genetic material, and this includes genetically modified cells like cell lines that can grow indefinitely. For example, I’m sure many of the listeners have heard about the HeLa cells, which were taken from Henrietta Lacks and continue to be used in scientific research. And synthetic DNA is another example for a manipulated genetic material.
And then we have the genetic information and this is actually the encoded within genetic material, and we can analyze it at different levels. So we can have single location in the DNA sequence. We can have short sequences of DNA that repeat multiple times. We can have information about a single gene, we can have information about chromosomes, and of course we can have information about the whole genome. And I do want to note that understanding genetic material and information also involves appreciating their personal, familial, and collective dimensions.
So genetic material and information are intimately tied to an individual’s identity. They provide some insights on health risks, traits, conditions, but genetic material and information are also shared with family members. So that means that an individual’s genetic material and information can really reveal information about the relatives. And on a broader scale, genetic material and information also contribute to our understanding of human genetics. So it’s important to recognize that we share 99.9% of our DNA with each other. And that underscores, I think, our common humanity and the actually societal benefits that can be gained from the fields of genetics and genomics.
Daniel Smith: That gives us a really good base understanding of both genetic material and information. And you mentioned the HeLa cells, which is one use of such material, but how do entities currently, so entities like biotech companies and biobanks and research institutions, how do they use genetic material and information? And also as a follow-up question of that, why is it valuable to them?
Shelly Simana: Sure. So different entities and like you mentioned, biotech companies, biobank research institutions use genetic material and information in various ways. So biotech companies, for instance, use them for developing new drugs and therapies. And so by understanding the genetic roots of diseases, they can create treatments that are more effective and specifically targeted to individual patients. And this is where personalized medicine comes into play. So instead of having the one-size-fits-all approach, now we are moving towards more treatment that would be tailored based on individual’s genetic profile, and that hopefully will lead to better outcomes and fewer side effects.
Biotech companies also engage in genetic engineering and developing genetically modified organisms and gene therapies. Of course, the value for them is immense because it drives innovation, it makes drug development more efficient and also opens up significant marketing opportunities for them.
As you also mentioned, biobanks play a crucial role in this, and they store vast amounts of genetic material and information. And ultimately, I feel that genetic material and information are kind of a goldmine for a researcher because they enable them to study genetic factors on a larger scale. And biobanks basically support long-term studies and they allow researchers to track genetic changes over time and understand how diseases progress.
Similarly, research institution use these resources to advance our understanding of genetic material and information, and they conduct studies to uncover the genetic bases of diseases. They also use it for educational purposes. And of course the value of all of these, I feel entities is also aside from obviously financial gains, it’s also scientific, to advance scientific knowledge, to foster innovation.
And of course, I’ll just note that these are not the only ones who are interested in collecting genetic material and information. Law enforcement agencies, you didn’t mention them. They also want these resources and they use them to solve crimes. Direct-to-consumer genetic testing companies are also interested in them because they want to generate profit, but they also want to build massive databases and offering services like ancestry tracking or health risk assessments. Then finally, individuals, you and I are also interested because we can use these resources for paternity testing for instance, or other personal issues like to explore genetic heritage or understand our health risks.
Daniel Smith: You mentioned a lot of potential implications and a lot of different uses by these different entities. So when it comes to the collection and analysis and sharing of genetic material and information, what are some of the key ethical issues that we should be thinking about?
Shelly Simana: I think we could easily spend an entire hour on this question, but let me maybe highlight a few issues that I find particularly troubling and I work on them in my own research. When discussing the collection, analysis, and sharing of these resources, I feel that some of the key ethical and legal issues are implication of exclusive property rights, which is how we currently govern these resources. And I’ll, in a minute, explain what I mean by exclusive property rights.
Other issues are exploitation, lack of transparency, and really also managing, I feel the hard task of balancing individual interests like privacy with collective interests, going back to what I’ve just said about the personal, familial, and collective interests that are related to genetic material and information.
So one critical issue that I see in the governance of these resources is exclusive property rights over these resources. So currently legal frameworks like the one in the US grant property rights to a single entity. So it could be either the individual who provided that material and information or perhaps an institution or another entity like a biotech company or even a research institution. And this exclusive ownership regime I feel is problematic because it may not adequately reflect the interests of all the stakeholders who are involved.
So just to illustrate, there is a case called Moore versus Regents of the University of California, which is one of the most debated and studied cases related to the ownership of genetic material. And there, the court ruled that the genetic material was the researcher’s property and rejected the person, Moore’s claim of ownership. And the court emphasized that Moore could not claim property rights over his cells and the genetic code within them. And as a result, while the court refused to protect the interest of the person, Moore from whom the genetic information were extracted, it did recognize the property interest of their researchers.
So that’s one issue. Another important issue in genome governance is the exploitation and power asymmetries. So individuals are often required to waive property rates over their genetic material and information. And these waivers are often embedded in complex consent forms that they have to sign. And these individuals may not fully understand these waivers. And I feel that this practice can exploit the informational and power asymmetries between individuals and organizations and companies and really leaving individuals with little control over their genetic material and information.
And another way the power asymmetries manifest in this context is through surreptitious collection of genetic material and information. And this can happen through discarded genetic materials such as hair, saliva on a coffee cup or skin cells left on different surfaces. And so for example, police have collected genetic material from discarded napkins, water items without individual’s knowledge. And this raises I feel serious concerns because individuals are often unaware that their genetic material and information are being collected and analyzed.
The lack of transparency in the use of these resources is also another indication for the exploitation in power symmetries in this space. So for example, genetic material and information are frequently used for secondary purposes that were not disclosed at the time of collection. So a DNA sample provided, for instance for ancestry testing might later be used in pharmaceutical research or sold to third parties for different studies. And there is a case of the Havasupai tribe here in the US which is a great example for this because their blood samples were collected for diabetes research and later were used for other studies without the tribe members’ consent. This is what the members claim violated their expectations and trust. And so I feel this lack of transparency can lead to individuals feeling deceived.
And a third issue is also related to privacy. So genetic material and information can, as I said before, reveal personal details about a person’s health, traits, even family history. And there is really a need to balance the individual’s right to privacy with the benefits of sharing genetic material and information in order to achieve important public benefits. So for example, genetic material and information might be used to identify predisposition to certain diseases, which is valuable for preventive health measures, but also raises concerns about genetic discrimination and the misuse of personal data.
And finally, I think there is another issue, which is the collective and familial implications of the use of genetic material and information. As I said, these resources not only pertain to individuals, but also have implications for their family members and the broader communities. And if one person’s genetic information reveals certain genetic disease, it might affect their relatives who share similar genetic traits. And this interconnected nature I feel requires from us to consider the broader rights and interests of families and communities when we think about the governance of genetic material and information.
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Daniel Smith: So when it comes to addressing these issues, how well do our current laws and regulations do that?
Shelly Simana: So actually, I feel that our current laws and regulations are significantly inadequate in addressing these issues surrounding genetic material and information. At least the legal framework in the US is really fragmented. It’s very narrow and I would say also very inconsistent. And therefore it fails to provide comprehensive protection against the exploitative practices by genetic testing, biotech companies, biobank research institutions and government agencies, all the practices that I just mentioned to you. The request to waive the property rights issues of privacy, lack of transparency, and other important issues. And all of these entities exploit the power and information asymmetries to maximize their own benefits from genetic material and information. And this of course undermines individual property and privacy interests.
So for instance, current laws in the US, again, this is what I research, the laws do not effectively safeguard individuals from being required to waive their property right over genetic material and information. And so these practices common among many entities who use the waivers without ensuring that individuals fully comprehend the implications. And so existing federal and state laws largely ignore this troubling practice. Also, the current laws fail to address secondary uses of genetic material and information adequately. They do address some concerns, but I feel that a comprehensive solution is needed.
So entities, as I mentioned, frequently engage in secondary uses without individuals’ knowledge or understanding of the potential outcomes. So this lack of transparency is facilitated by laws, for instance, like the Common Rule or HIPAA. So Common Rule is the law that governs human subject research in the United States. And the Common Rule allows for broad consent. So this means that individuals can give permission for their genetic material and information to be used in a wide range of future research without being informed of specific details about each use.
HIPAA, which is the Health Insurance Portability and Accountability Act, and it focuses on protecting patient health information, this act doesn’t cover de-identified genetic information. So as a result, once genetic data is stripped from personal identifiers, it can actually be used and shared without the individual’s knowledge or consent.
When it comes to surreptitious collection of genetic material and information, this is another area where current laws fall short. There are no comprehensive federal protections against this practice, and state laws where they exist often contain several exemptions, particularly for law enforcement. So at the federal level, for instance, there are limited protections against surreptitious collection, the Genetic Information Nondiscrimination Act, which many might know as GINA. It provides some safeguards against the misuse of genetic information in employment and health insurance contexts, but it doesn’t broadly address surreptitious collection.
Some states have enacted laws to restrict the collection of genetic material and information without consent. For instance, Alaska and Florida have laws prohibiting the collection and use of DNA samples without informed consent, except in circumstances like law enforcement or paternity testing. So these laws vary widely and they often contain significant exemptions that undermine the effectiveness.
Overall, I would say that the structural limitations of the legal framework in the US further exacerbate these issues. As I said before, the laws are sector-specific. As I mentioned, HIPAA is employment and insurance. So they apply only to certain types of entities and certain uses of genetic material and information. And that’s why they lead to kind of a patchwork of inconsistent regulation across different state. And this fragmented approach leaves, I feel, significant gaps in protection and allowing many entities to engage in several exploitative practices without really facing legal repercussion.
Daniel Smith: So from your perspective, what could be done moving forward to better address these issues and fill in some of those gaps and create a more comprehensive approach to addressing these issues?
Shelly Simana: So moving forward, I think several steps can be taken to better address some of the issues I just mentioned and others related to the governance of these resources. So for instance, one of the things that I suggest is a comprehensive federal legislation that will also establish a new statutory category of what I call gene stewards. So this law would impose quasi-fiduciary duties and by quasi-fiduciary duties, I mean duties of loyalty and care. And these duties will be imposed on all entities that collect, analyze, and share genetic material and information regardless whether of whether they are public or private, because we tend to make this distinction between private and public.
And the duties, I hope, would ensure that entities act ethically and responsibly. And this gene stewards framework would ultimately require the powerful entities in this space to act in the best interest of individuals whose genetic material and information they use. It would also include avoiding conflict of interest and using genetic material and information in ways that do not respect individual’s interest. And I hope that we might be able in the future to create trust-based system that would mitigate the power and information and symmetries that I mentioned.
And also I think that the current legal framework allows, as I said, for extensive secondary uses of genetic material and information without adequate oversight. So to address that, I think we need stricter regulation that govern how genetic material and information can be used beyond the initial purpose. And that could include mandatory review and approval by oversight bodies to ensure that secondary uses are justified and do not exploit individuals.
And now I realize that I didn’t say something that I feel is important to this conversation, which is I don’t think that informed consent is something that is practically necessary for every single use of genetic material and information. And while informed consent is a critical aspect of ethical governance, I do think that we should emphasize more on ensuring individual’s comprehension of how their genetic material and information will be used rather than seeking consent before every time we want to use these resources. So that means that we need to provide clear accessible information that would enable individuals to understand the implication of their participation and the potential uses of their resources. And I feel that by focusing on comprehension, rather than just seeking consent, we can empower individuals to make more informed decision, but while still facilitating the appropriate flow of genetic material and information in the genetic space.
And something in addition that we need to do is to keep individuals informed about how their genetic material and information are being used. I think it’s important to keep them in the loop and perhaps create an app that people can actually track how their genetic material and information is being used. So I think it’s important for people to know rather than just to provide the consent.
And perhaps another step going back to some of the things that we should do moving forward, I think also that we should prohibit this surreptitious collection of genetic material and information without individual’s knowledge. And so in situation where genetic material and information are critical for achieving public benefits, as I said, in some cases it’s important for us to collect these resources without individual’s knowledge like in the case of law enforcement. But in those cases we should implement oversight mechanisms. And this might include, for instance, requiring law enforcement and other entities to obtain judicial authorization or perhaps authorization from another agency before collecting genetic samples surreptitiously.
I also think that privacy protection must be extended to cover both identifiable and de-identified genetic material and information. As I mentioned, both the Common Rule and HIPAA only applies to de-identified genetic material and information. And so we need to update the existing laws to ensure comprehensive coverage and protection.
And finally, this is something that I hope will develop with some recent lawsuits by the Lacks family. I think individuals whose genetic material and information are used for research and commercial purposes should financially benefit from their contributions. And this can be achieved through benefit-sharing arrangements that provide individuals with share of the profits or other forms of compensation that derive from the use of their genetic material and information. So I think I provided many measures, but even if some of them will be implemented, I think we can establish a stronger legal framework for the governance of these resources that will better protect both individual’s interest, but also promote scientific and medical advances and achieve other important public benefits.
Daniel Smith: So I want to include a few resources in our show notes for our listeners so that they can explore more on these issues. So do you have any of your own work that you’d like to highlight and also any other additional resources that you think would be helpful for our listeners?
Shelly Simana: Yeah, so as you said, I work on these issues. So there are two articles. One is already out, one is about to publish. If people want to read them, I’m happy to provide. So just send me an email. There are several other interesting scholars who are working in this space like Natalie Ramm, Jessica Roberts, Anya Prince, Sonia Sutter. I don’t know if people have access, but Google Scholar and PubMed, these are excellent platforms to also a wide range of academic papers on these topics.
There’s also the National Human Genome Research Institute website, which offers educational resources and information on genetic research and different ethical consideration. Something that I would highly recommend is a webinar hosted by ELSIhub. Their webinars cover various topics related to the ethical, legal, and social implication of genomic research. So if people are interested, they can subscribe to the ELSIhub newsletter and so they can stay updated on different discussions and developments in the field.
Daniel Smith: I’ll certainly include links to some of those in our show notes so that folks can get started on exploring more. So on that note as our final question for today, do you have any final thoughts that we have not already touched on?
Shelly Simana: One point that I would like to emphasize is I think the importance of collaborative and multidisciplinary approach to address some of the issues that I raised today. I think the complexities of this field require kind of input from a wide range of stakeholders like legal expert myself, but also ethicists, scientists, policymakers, and the public, of course.
Another important aspect I think that I haven’t touched is that really need also to adapt and be responsive in our legal framework. As technology and science advance rapidly, our laws and regulations should be flexible and forward-thinking and try to anticipate some of the future challenges and opportunities with genetic material and information, but more broadly with technologies. And so we should take a more proactive approach to some of these issues.
And finally, I think fostering public trust is essential in this space. So transparent communication, public engagement, education, I feel are key to build a foundation of trust between individuals and the entities that handle their genetic material and information. This trust currently does not exist, and I feel that perhaps by involving public in the conversation and even decision-making processes, maybe we can create a more inclusive and just framework that respects and protects everyone’s interests.
Daniel Smith: I think that is a wonderful place to leave our conversation for today. So thank you again, Shelly.
Shelly Simana: Thank you so much.
Daniel Smith: I also invite everyone to visit CITIprogram.org to learn more about our courses, webinars, and other podcasts. Of note, I encourage you to check out our Technology Ethics and Regulations course, which covers various technologies and their associated ethical issues and governance approaches. You may also be interested in our Bioethics course, which discusses genetics and ethics, among other topics. And with that, I look forward to bringing you all more conversations on all things tech ethics.
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Meet the Guest
Shelly Simana, SJD – Boston College Law School
Shelly Simana is an Assistant Professor at Boston College Law School. Prior to joining BC, she was a fellow at Stanford Law School’s Center for Law and the Biosciences and a doctoral candidate at Harvard Law School. Her scholarship lies at the intersection of law and bioethics.
Meet the Host
Daniel Smith, Associate Director of Content and Education and Host of On Tech Ethics Podcast – CITI Program
As Associate Director of Content and Education at CITI Program, Daniel focuses on developing educational content in areas such as the responsible use of technologies, humane care and use of animals, and environmental health and safety. He received a BA in journalism and technical communication from Colorado State University.