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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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Hospitals rationing drugs behind closed doors: a civil rights issue

This article was originally published on The Conversation. Read the original article.

by Wendy F. Hensel, Georgia State University and Leslie E. Wolf, Georgia State University

The United States is facing a shortage of prescription drugs, ranging from antibiotics to cancer treatments. These shortages are putting the medical profession in the frequent position of deciding who will get the drugs that are in short supply and, more importantly, who will not.

Physicians and hospitals always have had to make rationing decisions in times of shortage. But these decisions usually are made behind the scenes. A recent New York Times article about the drug shortages shines a light on the rationing that is occurring.

According to the article, the decision-making process varies considerably across institutions. For instance, in some hospitals formal ethics committees make these decisions. At others, these decisions are made by individual physicians, pharmacists or even drug company executives.

And, as the article also reports, patients typically are not told of the shortage and have no idea that their choice of treatment has been limited, even though the decision may delay their recovery, increase their pain or, in some cases, potentially accelerate their death.

As legal experts in medical ethics and disability law who have conducted research on the allocation of medical resources, we were struck by the general lack of awareness of the law evident in the article. The fact is, there are civil rights laws and state laws governing informed consent that apply to such decisions, even in times of public health emergencies and medical shortages.

These laws constrain physician decision-making and must be taken into account on the front end in making treatment or distribution decisions for all patients and in particular, we would argue, for patients with disabilities.

Bias against people with disabilities

In 1990, Congress passed the Americans with Disabilities Act (ADA) to provide protection to people with disabilities and assure equal opportunity, access and participation in all areas of public life. The ADA applies to both public and private hospitals, as well as physicians providing care to patients.

The ADA prohibits the use of any eligibility criteria that would screen out people with disabilities from receiving necessary services, including medical care.

But, in the past, drug and treatment allocation protocols or distribution plans created by medical professionals in times of shortage have failed to acknowledge that the ADA limits their discretion.

In 2013, we reviewed the allocation protocols developed by public health and medical organizations in providing critical care, such as ventilators, to guide medical decision-making in the event of shortages during an H1NI flu pandemic.

Some of these groups have made recommendations that physicians restrict access to treatment based on patients’ diagnosed disability, their anticipated quality of life, the duration or intensity of their need for care and the treatment effectiveness.

All of these criteria to varying degrees raise the troubling potential for disability bias to play a role.

For example, categorically preventing all individuals with severe mental retardation from all access to ventilators clearly violates the ADA. Likewise, refusing to treat an individual with cystic fibrosis for swine flu because he will still have cystic fibrosis after treatment, and thus a “poor quality of life,” is unlawful.

Quality of life assessments allow the prejudices of health professionals and laypeople, who systematically underestimate the quality of life experienced by people with disabilities, to result in the denial of treatment.

Patients need to know how shortages affect their care.
Doctor and patient image via

To stop bias, decisions should be made in the open

Given this background, there is little reason to believe that allocation decisions in other situations where medicine or equipment is in short supply will be free from bias against people with disabilities.

The New York Times article coincided with the publication of an ethical framework for allocating pediatric cancer drugs in the Journal of the National Cancer Institute. The authors bring attention both to a persistent problem of drug shortages and to the need for a more transparent and inclusive process for deciding who should get rationed drugs.

Although this particular decision framework laudably rejects consideration of disability, it fails to recognize or discuss the fact that such consideration is legally impermissible under the ADA. As to the kinds of ad hoc decision-making described in the New York Times article, they are even less likely to appreciate what the ADA requires.

Secrecy prevents informed consent

The secrecy surrounding allocation decisions is also in conflict with state laws concerning informed consent.

Patients have a right to know when and why their physicians restrict their access to viable treatment options. State tort law governs when a physician must give this information to her patients. Indeed, state courts explicitly lay out when a physician must give this information to her patients.

Just over half the states have adopted a physician-centered standard that allows the profession to determine when disclosure is desirable. Other states have adopted the more liberal patient-centered standard, which requires physicians to disclose information that most patients would find relevant to their treatment. Under either standard, physicians have a legal obligation to inform patients of shortages when the shortages affect their care, the risks they face, or their prognosis.

Patients have the right to make informed decisions about their treatment options. This includes knowing when they are being denied effective and otherwise recommended treatment because there is a drug shortage.

The drug shortages are not likely to go away any time soon. Although the medical profession must make hard choices about how to allocate care, these decisions need not and should not be shrouded in mystery.

We need to acknowledge that rationing decisions are being made in the U.S. health system. The limitations on care, the reasons for them and how care will be dispensed should be debated openly.

And those discussions must include the voices of people with disabilities, who so often have been impacted by such decisions. They should also include civil rights experts who can ensure that any allocation protocol incorporates the legal protections society already has put in place.

It is neither fair for physicians to bear this burden alone nor right for people with disabilities unknowingly to be affected at the most fundamental level by decisions made behind closed doors.

Wendy F. Hensel, Associate Dean for Research and Faculty Development and Professor of Law, College of Law, Georgia State University and Leslie E. Wolf, Professor of Law and Director, Center for Law Health and Society, College of Law, Georgia State 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.