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If we don’t own our genes, what protects study subjects in genetic research?

This article was originally published on The Conversation. Read the original article. This article is also posted at Georgia State Law and the Center for Law, Health & Society.

Leslie E. Wolf, Georgia State University; Erin Fuse Brown, Georgia State University, and Laura Beskow, Duke University

On February 25, the White House hosted a forum on the National Institute of Health’s Precision Medicine Initiative. This is an ambitious research study that aims to develop targeted drugs and treatments that would vary from individual to individual.

To reach the goal of eventually being able to make specific recommendations for patients based on their own combination of genes, environment and lifestyle, researchers plan to collect that kind of information from one million Americans. The study is so large so results can account for diversity among Americans with respect to factors such as ancestry, geography, and social and economic circumstances.

At the forum, President Obama remarked “I would like to think that if somebody does a test on me or my genes, that that’s mine.”

Lots of people would make that same assumption – it seems sensible that we would each “own” our genetic information. But the legal reality is quite different. And that could turn out to be a problem, because research projects like the Precision Medicine Initiative rely on research participants trusting that their information is protected once they agree to share it.

As scholars with expertise in research ethics, informed consent and health law, we’re conducting research to clarify how different laws apply to information used for genomic research. We’ll identify gaps in those protections and suggest changes that may be necessary.

President Obama discussing the Precision Medicine Initiative.
Carlos Barria/Reuters

Do you own your genes?

Contrary to President Obama’s expectations, the few U.S. courts that have considered research participants’ claims of ownership of their biological materials have rejected them.

  • John Moore’s doctor used his cells without his knowledge to develop and patent a cell line (cells that could continue to reproduce indefinitely for research). In 1990, the California Supreme Court held that Mr. Moore did not own the cells that had been removed from his body.
  • The Greenbergs and other families affected by Canavan disease, an inherited, degenerative and fatal brain disease in children, provided a University of Miami researcher with tissue and blood samples, medical information and money to develop a genetic test. The researcher patented the associated gene sequence, limiting families’ access to it without payment. In 2003, a federal court rejected the parents’ claims that they owned their genetic samples.
  • About 6,000 research participants responded to a letter sent by Dr. William Catalona, the developer of the prostate specific antigen test, and asked that their research samples stored at Washington University be transferred to Northwestern University, where Dr. Catalona had a new job. But a court determined that the research participants had no control over who held their specimens after collection.

The courts that have looked at the question have consistently decided that once we give our biological materials to researchers, the materials and the genetic information they contain belong to the researchers or, more specifically, the institutions that employ them.

A few states have adopted statutes concerning ownership of genes, but they may not alter court decisions. A Florida statute certainly did not make a difference in the Greenbergs’ case.

Short of ownership, what protections exist?

So you don’t own your genes. But there are other protections for participants in the Precision Medicine Initiative and other research projects.

The primary one comes from the Federal Common Rule. It applies to research conducted or funded by 18 federal departments and agencies. Many universities and other institutions apply the Common Rule to their research too. And research on drugs and devices that must be approved by the Food and Drug Administration (FDA) must comply with very similar rules.

Under the Common Rule, with some exceptions, research studies must be reviewed and approved by an Institutional Review Board (IRB): a committee within the university or hospital, for instance, that scrutinizes proposed experiments involving human subjects. In approving a study, the IRB must evaluate, among other things, the adequacy of the consent process and confidentiality protections, whether risks are minimized and are reasonable in relation to the benefits, and whether the selection of subjects is equitable. The IRB provides a check on what researchers can do.

Once the Institutional Review Board approves a study, researchers can start recruiting people to participate. This is where another protection comes in – consent.

Study subjects should understand the potential risks and benefits of participating.
Form image via

The researchers must disclose the research’s purpose, procedures and any risks and benefits of participating. In a study like the Precision Medicine Initiative, the primary risks are informational, not physical. For example, if an insurer learned that a research participant had a gene that increases the risk of Alzheimer’s, it might refuse long-term care coverage.

Based on the risks and benefits (if any) discussed in the consent form, participants can decide whether they want to take part. They may decline to participate if they do not trust the researchers or do not want to share their information.

In some circumstances, the Common Rule doesn’t require participant consent. These exceptions are allowed when the study poses little risk to the participant, often because the information cannot be connected to the individual.

In recent years, these exceptions have been called into question as researchers have repeatedly demonstrated that it is possible to identify people whose information has been used in research, but were thought to be unidentifiable. However, such reidentification requires significant effort and technical skills, and, alone, is unlikely to result in harm to participants. Thus, it is not clear that we should forego the benefits of research conducted under these exceptions because of the theoretical threat to confidentiality.

Beyond these exceptions, some research – such as Facebook’s 2014 study that manipulated some 700,000 users’ newsfeeds to determine the effect of negative or positive words on their emotions – falls outside the Common Rule altogether.

In general, research that is not federally conducted or funded or subject to FDA regulations is not governed by federal research protections. Some states have adopted laws that apply similar protections to research not subject to either the Common Rule or the FDA regulations, but those laws vary considerably from state to state.

Additional protections for research participants

The Health Insurance Portability and Accountability Act’s (HIPAA) privacy rule provides a national standard for protecting the use and disclosure of identifiable health information. The corresponding security rule establishes standards for securing electronic health records which could include results of genetic research.

In addition, the Genetic Information Nondiscrimination Act (GINA) prohibits use of genetic information to discriminate against asymptomatic individuals in employment and health insurance decisions. Although it has recognized gaps, GINA provides some protections against discrimination, should genetic information from a research study be disclosed.

As with the Common Rule, state medical privacy and antidiscrimination laws may supplement these federal protections. Thus, the protections afforded to participants may depend greatly on where they live. Moreover, Institutional Review Boards may be unfamiliar with the myriad laws that could combine to protect research participants and their possible gaps.

Beyond these legal requirements, the Precision Medicine Initiative may provide participants additional controls over their data on a voluntary basis. For example, participants could reevaluate their preferences for how their data are shared or used, withdraw their consent for future use of their data at any time and control the types of communications they receive about their information.

While these types of protections may fall short of full legal ownership rights over your genetic information, they do go beyond current legal requirements and may be the types of controls to which President Obama was alluding.

The samples have been collected… now what happens?
Geir Mogen, NTNU, CC BY-NC

What is needed?

We think it is essential for all those involved in research – IRBs, researchers and study participants – to understand what protections are available and what their limitations are.

That’s why we’ve undertaken a comprehensive analysis of federal and state laws that combine to form what we call the “web of protections.” We want to be able to describe how the laws work together, to identify gaps, and to suggest ways to improve those protections, as well as how all this should be described to prospective research participants.

To the extent that the current laws fall short of the types of protections and controls expected by participants in research studies like the Precision Medicine Initiative, we may be able to propose ways that the laws can be updated or supplemented to address concerns like President Obama’s. In this way, we can maintain the public trust on which this research relies.

The Conversation

Leslie E. Wolf, Professor of Law and Director, Center for Law Health and Society, College of Law, Georgia State University; Erin Fuse Brown, Assistant Professor of Law, Georgia State University, and Laura Beskow, Director of the Program for Empirical Bioethics, Associate Professor of Medicine, Duke University



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Wolf to Represent Lawyers in Society of Scholars

wolf finalThis article was originally posted by the Center for Law, Health & Society and Georgia State University College of Law.

From doctors to historians, philosophers to engineers, the Johns Hopkins Society of Scholars comprises more than 600 of the most influential and pioneering minds in the world. But since its founding in 1969, the society has not included a single lawyer among its illustrious ranks—until now.

Leslie Wolf, professor of law and director of the Center for Law, Health & Society at Georgia State Law, will be inducted into the Society of Scholars this year. She and her fellow inductees will be presented with a certificate of membership and a medallion to be worn with their academic robes.

After earning a J.D. from Harvard Law School and practicing law for several years, Wolf earned her M.P.H. at Johns Hopkins Bloomberg School of Public Health in 1997 while a Greenwall Fellow at the school’s Berman Institute of Bioethics. She credits the program for her successful transition from private practice to academia and for this newest honor as well: Wolf was nominated for membership in the Society of Scholars by former leaders of the Greenwall Fellowship.

“Knowing the accomplishments of my distinguished colleagues and friends from the Greenwall Fellowship cohort and the Berman Institute of Bioethics, I am keenly aware of the honor of being the first to represent that group, as well as being the first lawyer, in the Society of Scholars,” Wolf said.

Though she will be the first of her kind in the society, Wolf will certainly be among equals. A leading expert in public health law and research ethics, Wolf has a distinguished record. She previously was on faculty at the University of California–San Francisco, has published extensively in the medical and legal literature, presented her research to government entities, and served on committees for the Centers for Disease Control and Prevention, the U.S. Department of Defense and the National Institutes of Health.

“This honor is well deserved and a tribute to the high quality and influence of Leslie’s interdisciplinary work,” said Steven J. Kaminshine, dean and professor of law.

Wolf will be inducted in an April 11 ceremony at the Peabody Institute of Johns Hopkins University.



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Prof. Wolf talks about role of law in HIV/AIDS epidemic

Reposted from Georgia State University College of Law and Center for Law, Health & Society websites:

The Role of Law in the HIV/AIDS Epidemic

By Leslie E. Wolfwolf final

World AIDS Day, Dec. 1, is a time to reflect on how far the United States and world populations have come since the disease was first identified in 1981, as well as what we still need to do to respond to the epidemic.

Others can talk about the scientific achievements that have helped stem the devastation wrought by the disease such as the introduction of the HIV test in 1985, the 076 protocol that dramatically reduced the risk of mother-to-child transmission, and the introduction of highly active antiretroviral therapy in 1996 that substantially improved the lives of those living with HIV. Instead, I wish to reflect on the role law in the epidemic.

In the early days, my former colleagues in San Francisco watched estranged families take control over their sons’ medical decision-making, often in violation of the patients’ and their partners’ wishes. The law came to the rescue with advance directives and health care proxies. These tools allowed dying patients to specify what care they would accept and who they wanted to make decisions when they could not and gave authority to physicians to honor those wishes.

The adoption of strict confidentiality laws at the time the HIV test became available provided reassurance in a time when disclosure of an HIV infection could result in loss of employment, housing, even medical care. While some question whether such special protections are needed today, there is little doubt that they were instrumental in encouraging people to discover their HIV status.

The Ryan White Comprehensive AIDS Resources Emergency Act of 1990 ensured essential services were provided to those in need. The Supreme Court extended the protection of the Americans with Disabilities Act to those living with HIV in the 1998 decision of Bragdon v. Abbott. The President’s Emergency Plan for AIDS Relief has played a significant role in addressing the global AIDS burden.

Unfortunately, while the law often has had a positive impact on the epidemic, sometimes it runs counter to public health efforts at combatting the disease. Possession of syringes remains illegal in most states, despite evidence that access to clean syringes reduces HIV infection, without increasing drug use. And many states have laws that criminalize exposure to HIV through sexual activity, without taking into account current science regarding prevention measures that reduce the likelihood of transmission to practically zero. Globally, a number of countries have adopted criminal exposure laws in the last decade, just as federal support for them has waned.

So on World AIDS Day 2015, we rejoice in the various ways that law has helped in the response to the HIV/AIDS epidemic during the last 34 years. But we must also recognize where the law needs to change to support public health efforts and make an AIDS-free generation possible.

 Leslie E. Wolf, professor of law and the director for the Center for Law, Health & Society at Georgia State University College of Law, conducts research in a variety of areas in health and public health law and ethics, with a particular focus on research ethics. From 1998-2007, she was on faculty at University of California San Francisco in the Program in Medical Ethics and the Center for AIDS Prevention Studies. 

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Georgia State College of Law and School of Public Health professors quoted on the legal and ethical issues surrounding vaccines

Director of the Center for Law, Health & Society and Professor Leslie Wolf, Professor Jessica Gabel Cino, and Associate Director Stacie Kershner from the College of Law, along with Professor Rich Rothenberg at the School of Public Health are quote in a 2-part series on vaccines on Georgia State’s website: “States Tighten School Vaccination Requirements” and “Exploring Moral, Ethical, and Legal Implications of Vaccines”.

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New blog post by Prof. Leslie Wolf: “Time to support syringe exchange programs”

20140403_CLHS_005Indiana is in the midst of “one of the worst documented outbreaks of HIV among IV users in the past two decades,” said Dr. Jonathan Mermin, director of the National Center for HIV/AIDs, Viral Hepatitis, STD and TB Prevention at the U.S. Centers for Disease Control and Prevention. Since December, more than 140 cases have been reported in an area that previously reported no more than five cases a year.. The outbreak is tied to intravenous injection of the prescription opioid, oxymorphone (brand name: Opana).

To combat the epidemic, Mike Pence, governor of Indiana, declared a state of emergency and temporarily authorized a needle exchange program.

Gov. Pence should be commended for listening to public health officials, despite his own reservations about needle exchange programs. While stopping injection drug use is the best way to reduce a user’s risk of HIV infection, addiction may prevent many from taking this step. Accordingly, providing clean needles and syringes through syringe exchange programs is the next best option.  Because most programs provide other health services, they can also help some addicts stop using.

Numerous studies have shown the effectives of syringe exchange programs in reducing HIV risk behaviors and infection. Nevertheless, SEPs have been controversial. Critics fear that making injection equipment easy to get will increase drug use.  They are also concerned that the programs will increase crime and discarded needles and syringes in surrounding neighborhoods.

However, studies have shown that syringe exchange programs neither increase drug use among existing users or new users, nor increase crime or discarded injection equipment where they operate.  With evidence of significant benefit, and few harmful effects, public health organizations, from the CDC to the World Health Organization, recommend syringe exchange programs as an essential component to HIV prevention programs.

Despite the evidence supporting the effectiveness of SEPs for HIV prevention, they remain illegal in most states because of drug paraphernalia laws and the long-standing federal ban on funding. Drug paraphernalia laws were adopted as part of Nixon’s “War on Drugs’ (before the AIDS epidemic) and prohibit possession or distribution of injection equipment.

Although some state and local governments and nongovernmental organizations have funded syringe exchange programs, these entities lack the financial stability that federal programs have, and some groups have been reluctant to support them given the federal government’s perceived disapproval.

The Indiana outbreak has brought renewed attention to the need to use the best-proven methods for HIV prevention, which includes syringe exchange programs, even if politically unpalatable. States should adopt laws that permit the programs, and the federal government should affirmatively support funding of them as part of its prevention efforts. If governments do not act, Indiana will not be alone in facing HIV outbreaks.

Leslie Wolf is the director of the Center for Law, Health & Society and a professor of law at Georgia State University College of Law. She conducts research in a variety of areas in health and public health law and ethics, including law and policy related to HIV/Aids.

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“FDA delivers an early Christmas gift” – new blog post by Professor Leslie Wolf

20140403_CLHS_005The timing of the announcement may have caused many to overlook it, but on Tuesday, December 23, the FDA delivered an early Christmas gift in announcing that it would lift the lifetime ban on blood donation by men who have sex with men.

Up to now, the FDA’s policy has been to permanently ban men who have had sex with other men, even once, since 1977 from donating blood. The ban has been in place since 1985, shortly after the HIV test first became available. There are strong reasons for the original policy. After all, the likelihood of transmission through blood is high – around 90%, and men who have sex with other men (MSM) were – and continue to be – at high risk of HIV infection.

However, things have also changed since the early years of the epidemic. An important one has been the development of more sensitive testing, which can test the presence of HIV at much lower levels, making it much more unlikely that a pint of infected blood will enter the blood supply. (We do not rely only on donors’ self-reports, because it is possible they may be infected, but not know it.) Moreover, antiretroviral treatment (first available in 1996) can reduce the HIV virus to undetectable levels, significantly reducing the likelihood of transmission. Effective treatment also has dramatically changed the outlook of someone infected with HIV, transforming a death sentence into a chronic disease with undiminished life expectancy.

Things have also changed for the blood supply. Shortages are chronic, in part, because fewer Americans are eligible to donate than previously and even fewer of those who are eligible donate. For almost a decade, representatives of the blood industry have sought to have the FDA’s lifetime ban lifted. The FDA has reconsidered the ban at least twice over the last decade, and, until now, has voted to retain the ban.

The ban has not been fully lifted. Rather, the FDA will adopt a 12-month deferral (i.e., men who have had sex with another man in the last 12 months will be deferred). This is consistent with other nations, such as Australia, the United Kingdom, Argentina, Japan, and Hungary, as well as the FDA policy on women who have had sex with men who have sex with other men. Nevertheless, the removal of the ban is significant; it eliminates a policy that many felt perpetuated outdated stereotypes about HIV while maintaining the safety of the blood supply. In this respect, it is a gift.

Leslie Wolf is the director of the Center for Law, Health & Society and a professor of law at Georgia State University College of Law. She conducts research in a variety of areas in health and public health law and ethics, including law and policy related to HIV/Aids.