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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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Prof. Fuse Brown’s article on the ACA’s cost control policies published in the Annals of Internal Medicine

fuse brown finalProf. Erin Fuse Brown’s article”The Blind Spot in the Patient Protection and Affordable Care Act’s Cost Control Policies was published online ahead of print in the journal Annals of Internal Medicine. In the article, Fuse Brown describes how containing health care cost requires reduction of overtreatment and constraint of health care prices. Provisions in the ACA address health care prices for Medicare, but private insurance is largely ignored. However, other provisions promote integration, pushing health care entities to consolidate, and potentially drive prices higher.

Erin C. Fuse Brown, assistant professor of law, is a faculty member of the Center for Law, Health & Society. Her research interests are in the intersection of the business and regulation of health care delivery systems. Her recent scholarship has focused on policies affecting hospital prices for health care services and on the structural fragility of the right to health care in the Affordable Care Act.

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Prof. Fuse Brown’s article on unfair hospital billing practice featured in HealthLeaders Media

fuse brown final

Professor Erin Fuse Brown’s recent article in the AMA Journal of Ethics is featured in an August 28, 2015 news article “Variation Ripe in Hospital Charity Care Payment Rules” in HealthLeaders Media. The IRS rules linking non-profit status of hospitals to their financial assistance plans are vague leaving room for wide interpretation. Fuse Brown discusses the large variation between hospitals’ financial assistance policies, which can be “stingy to generous” and still comply with the rules.

Erin C. Fuse Brown, assistant professor of law, is a faculty member of the Center for Law, Health & Society. Her research interests are in the intersection of the business and regulation of health care delivery systems. Her recent scholarship has focused on policies affecting hospital prices for health care services and on the structural fragility of the right to health care in the Affordable Care Act.

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“How to fix our hospital pricing problem (and how not to)” – new blog post by Prof. Erin Fuse Brown

FuseBrown_headshot-300x300Last month, Slate columnist Reihan Salam wrote a provocative article about outrageous hospital prices that are driven, according to Salam, by greed, avarice, and market power. Salam gets a few things dead right, namely his diagnosis that we have a massive hospital pricing problem that is bleeding us dry and that the problem is largely caused by growing hospital market power. However, he misses the mark when laying out policy recommendations to curb monopoly-driven hospital prices.

The solutions

Antitrust:  Salam favors using antitrust enforcement to prevent health care consolidation and to reduce barriers to entry for competition. The biggest problem with antitrust enforcement is that it can do little to reverse or break up existing monopolies. Antitrust laws will be unable to help the vast majority of hospital markets that are already concentrated. Second, even with its improving success rate in court, the FTC simply cannot prevent or police the ongoing wave of hospital mergers, resulting in price increases up to 40% price increases in some areas. To be sure, increased antitrust enforcement is a necessary element of the strategy to control hospital prices to stem the tide of consolidation that is driving prices upward. But antitrust is no silver bullet, especially for hospital markets that have already become noncompetitive.

Market solutions: Market solutions such as price transparency, consumer-directed health care, reference pricing, or narrow networks are popular approaches to control prices among health policymakers. Market solutions to the hospital pricing problem are intuitively pleasing—they attempt to restore market forces to a failed market.  The biggest problem with market approaches is that they fundamentally will not work in concentrated markets where there is little choice or competition between hospitals. This is because all market solutions rely on consumers being able to exert competitive pressure on hospitals, a scenario impossible if there are few choices. Moreover, the stressful nature of most hospital encounters make it unlikely for patients to overcome the substantial cognitive and behavioral barriers to rational consumer-behavior in acute care contexts.

Rate regulation: There are two policy alternatives to counter monopolies: antitrust laws and rate regulation. As noted above, antitrust enforcement has limited force against extant monopolies, so rate regulation is the only hospital pricing solution capable of addressing the problem of provider market power. Rate regulation can take many forms, such as Maryland’s all-payer rate setting system, caps on negotiated prices, or a single payer system like Medicare. A predictable criticism is that rate regulation is inefficient and the regulators are subject to political capture. These concerns point to the importance of institutional design to counteract inefficiency and capture, but they do not let us off the hook from considering rate regulation seriously. The current system of unregulated prices is bloated with enormous administrative costs from the fragmented payer landscape, far exceeding other countries’ single or regulated payment systems. Like it or not, rate regulation may be the only option that has any hope of disciplining outrageous hospital prices in concentrated markets.

The bottom line

The story of our unchecked health care spending in the U.S. is a story about high and undisciplined prices. Our health care pricing problem is driven at its core by a growing provider monopoly problem. For the increasing preponderance of noncompetitive health care provider markets, the only policy capable of addressing the market power of providers is direct rate regulation. Antitrust enforcement cannot restore competition to already concentrated markets and no amount of competitive pressure will create choices for consumers where none exist. For the vast majority of jurisdictions with concentrated provider markets, health care rate regulation must be a central part of any policy strategy to control health care spending.

Erin C. Fuse Brown is an assistant professor with Georgia State University College of Law teaching health care law and administrative law.

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Listen to Prof. Fuse Brown’s Podcast on Irrational Hospital Pricing

FuseBrown_headshot-300x300Listen to this podcast on irrational hospital pricing featuring Professor Erin Fuse Brown at “The Week in Health Law.” It is posted here.

Also, read Professor Fuse Brown’s discussion of the potential implications of King v. Burwell for Georgia at


“Nonprofit Hospitals Sue Patients, and New IRS Rules Offer Limited Protection” by Erin Fuse Brown

LFuseBrown_headshot-300x300ast month, NPR and ProPublica reported a story that would be shocking if it weren’t sadly familiar about how nonprofit hospitals like Heartland Regional Medical Center in Missouri are suing their patients and garnishing their wages for unpaid bills.  A few days later, on December 31, 2014, the IRS issued final rules for tax-exempt hospitals that ostensibly will make these practices more difficult, if not illegal.

The IRS rules implement the requirements of Section 501(r) of the Internal Revenue Code added by the Affordable Care Act in 2010. Despite characterizations that these are “sweeping new rules” that protect financially vulnerable patients from excessive charges and aggressive debt collection by nonprofit hospitals, the rules provide fairly thin and spotty levels of protection for patients.

Among the rules’ requirements are provisions that limit the amounts tax-exempt hospitals may charge patients who qualify for financial assistance to the “amounts generally billed” to insured patients and also prevent such hospitals from using “extraordinary collection actions” before the hospital has made a reasonable effort to determine the patient’s eligibility for financial assistance.

These requirements are an incomplete solution to the problems of unfair hospital prices and onerous debt collection practices. There are two big gaps in these rules’ protections: (1) they do not apply to for-profit or government-run hospitals, which make up over 40% of all hospitals in the U.S.; and (2) the rules leave eligibility for financial assistance (which triggers the protections) to the complete discretion of the hospital. A hospital could adopt a stingy financial assistance policy or exclude from the policy patients with insurance who may be paying excessive prices because they are out-of-network or have a high deductible.

With the new 501(r) rules for tax-exempt hospitals, we may be tempted to believe that patients are now protected from excessive and unfair hospital pricing and onerous debt collection activities. This belief may create a complacency or false sense of security among patients and policymakers alike that we have slayed the hospital pricing and collection beast, at least with respect to the most financially vulnerable patients. Instead, we have created an uneven and opaque system where the protections of 501(r) depend on hospital characteristics that are generally beyond discovery or control by the patient. Patients generally do not know whether a hospital is for-profit or nonprofit, and it can be difficult for a patient to find this information especially if the hospital is for-profit. Similarly, patients may be unable to determine whether they will be eligible for financial assistance at a particular hospital before seeking care, especially in an emergency.

We have a better model in the form of various state fair pricing and collection laws. California’s Hospital Fair Pricing Act, for example, applies to all hospitals in California, not just the ones seeking exemption from state or local taxes. It also applies to both insured and uninsured patients who meet defined income or affordability criteria. California’s experience demonstrates that hospitals are able to adjust to fair pricing and collection requirements that are broader than those offered by the IRS rules. Taking these state laws as a model, a better national approach would decouple the fair pricing and collection rules from tax status, and instead make compliance with fair hospital pricing and collection rules a condition of participation in Medicare. Under this proposal, all hospitals that participate in Medicare would have to limit charges and collection activities for self-pay patients who fall within certain income limits or whose medical bills exceed a defined percentage of income. Because fairness is not charity, the 501(r) fair pricing and collection rules ought to be decoupled from tax-exempt status to apply to all hospitals and a broader range of patients.

Erin C. Fuse Brown is an assistant professor with Georgia State University College of Law teaching health care law and administrative law.