Introducing NPRM Symposium Blogger Govind Persad

GPersad 8-23-12Govind Persad will contribute to Bill of Health’s symposium on the 2015 notice of proposed rulemaking (NPRM) on human subjects regulations.

Govind is a postdoctoral fellow at Georgetown University and will be an Assistant Professor (beginning 2016) in the Department of Health Policy and Management and Berman Center for Bioethics at Johns Hopkins University. His research is at the intersection of political philosophy, applied ethics, and health law.

Govind has been a visiting scholar at the Department of Medical Ethics and Health Policy at the University of Pennsylvania. He holds a JD/PhD from Stanford, where he was a student fellow at Stanford’s Center on Law and Biosciences; he was a pre-doctoral fellow at the Department of Bioethics, National Institutes of Health.

Representative publications:

Should a patient have a right not to know genetic information about him or herself?

By Benjamin E. Berkman, JD, MPH

While promising to eventually revolutionize medicine, the capacity to cheaply and quickly generate an individual’s entire genome has not been without controversy.  Producing information on this scale seems to violate some of the accepted norms governing how to practice medicine, norms that evolved during the early years of genetic testing when a targeted paradigm dominated.  One of these widely accepted norms was that an individual had a right not to know (“RNTK”) genetic information about him or herself.  Prompted by evolving professional practice guidelines, the RNTK has become a highly controversial topic.  The medical community and bioethicists are actively engaged in a contentious debate about the extent to which individual choice should play a role (if at all) in determining which clinically significant findings are returned.

In a recent paper published in Genetics in Medicine, my coauthors and I provide some data that illuminates this and other issues. Our survey of 800 IRB members and staff about their views on incidental findings demonstrates how malleable views on the RNTK can be.  Respondents were first asked about the RNTK in the abstract: “Do research participants have a right not to know their own genetic information?  In other words, would it be acceptable for them to choose not to receive any GIFs?”  An overwhelming majority (96%) endorsed the right not-to-know.  But when asked about a case where a specific patient has chosen not to receive clinically beneficial incidental findings, only 35% indicated that the individual’s RNTK should definitely be respected, and 28% said that they would probably honor the request not to know.  Interestingly, the percentage of respondents who indicated that they do not support the RNTK increased from 2% at baseline to 26% when presented with the specific case.  The percentage of people who are unsure similarly jumps, from 1% to 11%.

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How broad can consent be?

By Nanibaa’ A. Garrison, Ellen Wright Clayton and Ingrid A. Holm

Based on today’s publication of the paper A systematic literature review of individuals’ perspectives on broad consent and data sharing in the United States in Genetics in Medicine. 

The recent Notice of Proposed Rule Making (NPRM) issued by the Office of Human Research Protections proposes to require researchers to obtain informed consent from virtually every patient and research participant for use of biospecimens for research. The proposed regulations also permit obtaining broad consent for future uses, without any IRB oversight unless individual results are going to be returned so long as an elaborate consent form is signed. The NIH Genomic Data Sharing Policy, which went into effect earlier this year, requires almost all investigators who receive NIH funding to seek broad consent from participants to allow their data to be shared with other investigators. Thus, in a short period of time, two major policies promoted broad consent for biobank research, changes in the practice of recruiting participants for research that make us take notice. They also raise new questions, including: What do research participants think about having their biospecimens and data shared, and about giving broad consent to do so?

Who is comfortable with Broad Consent?
The Electronic Medical Records and Genomics (eMERGE) Network’s Consent, Education, Regulation, and Consultation (CERC) working group set out to find some answers. As a part of this effort, we conducted a systematic review, which revealed that males, whites, older individuals, and more affluent individuals are generally pretty comfortable with broad consent that can be found here. By contrast, Asian and African American individuals are less comfortable with broad consent. Will these different levels of concern create a divide between those who will and will not participate? The consequences of lack of participation are clear – we will know less about how genetic variation in groups that do not take part affects health and less about how to provide optimal care. Read More

Fixing the Broken Law of Military Medical Malpractice for Birth-Related Injuries

By Alex Stein and Dov Fox

Bill of Health bloggers Alex Stein and Dov Fox have just filed an amicus brief urging the Supreme Court to hear the case of U.S. Air Force Major Heather Ortiz and her baby, who were denied legal remedies for obstetric malpractice by military doctors that left the baby with severe brain damage. The case is No. 15-488 Ortiz v. U.S. ex rel. Evans Army Community Hospital. Professors Fox and Stein urge the Court to overturn the Tenth Circuit’s holding that the federal government’s immunity against liability for intramilitary torts extends to wrongful injuries like those sustained by Major Ortiz’s baby. They argue that this holding misinterprets the immunity, misapplies the Federal Tort Claims Act (FTCA), and constitutes no less than unconstitutional sex discrimination. Fox and Stein explain:

When a civilian spouse of a serviceman receives negligent prenatal care from military doctors and delivers an injured baby as a result of that malpractice, there is no question that Feres immunity does not apply and that the baby can sue the United States under the FTCA. When military medical malpractice injures the baby of a servicewoman, this baby should be equally able to obtain redress under the FTCA.  A system that would single out the civilian children of servicewomen for adverse treatment discriminates against women who serve in the armed forces. . . To interpret the FTCA as the Tenth Circuit did permits discrimination between these two classes of similarly situated victims of military malpractice and violates fundamental principles of equal protection.

To download this brief, click here.

Texas, Self-Induced Abortion, and an Ode to Justice Powell

Flickr/Creative Commons—Edson Chilundo
Flickr/Creative Commons—Edson Chilundo

By Gregory M. Lipper

With the Supreme Court ready to review the constitutionality of restrictions on abortion providers in Texas, new research from the Texas Policy Evaluation Project suggests that between 100,000–240,000 Texas women ages 18 to 49 have attempted to terminate a pregnancy on their own (that is, without help from a licensed medical professional). According to the authors, “the populations we found to be most familiar with abortion self-induction are among those that have been most directly affected by the closure of abortion clinics in the state.” As a result, the study predicts, “abortion self-induction will increase as clinic-based care becomes more difficult to access.”

This data reinforces that efforts to ban, restrict, or otherwise interfere with efforts to obtain legal abortion don’t stop abortion—they often push women to obtain abortion by other means that are far more dangerous.

Those consequences, as it turns out, are what led one conservative Supreme Court Justice, Lewis Powell, to support abortion rights. Justice Powell was no right-to-privacy diehard; he infamously cast the deciding vote upholding the Georgia sodomy ban in Bowers v. Hardwick. But when it came to reproductive freedom, Justice Powell joined the majority opinion in Roe v. Wade and continued to support abortion rights while sitting on the Court.

According to Justice Powell’s biographer, an incident from earlier in his career reinforced that if women lacked access to legal abortion, the result would be unsafe, off-the-books procedures:

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Abortion Derangement Syndrome, Missouri Edition

Flickr/Creative Commons—Nicola
Flickr/Creative Commons—Nicola

By Gregory M. Lipper

Although the biggest abortion-related news last week came from the U.S. Supreme Court, a Missouri state senator (turned Attorney General candidate) took the prize for most bizarre.

Senator Kurt Schaefer—chairman of the Missouri Senate’s interim “Committee on the Sanctity of Life”—wrote a stern letter to the University of Missouri; he suggested that state law prohibited a Ph.D student from researching the effects of Missouri’s mandatory 72-hour waiting period for women who want to have an abortion. The law he cited provides, “It shall be unlawful for any public funds to be expended for the purpose of performing or assisting an abortion, not necessary to save the life of the mother, or for the purpose of encouraging or counseling a woman to have an abortion not necessary to save her life.”

This farfetched attempt to censor academic research on the effects of government policy raises a pair of legal issues (and one psychological observation…).

First, Senator Schaefer’s interpretation of the statute is, to put it mildly, a stretch. The student isn’t going to be “performing or assisting an abortion”; she’s going to be studying abortion—more precisely, the 72 hours between when a woman seeks an abortion and is allowed to have an abortion.

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‘The Week in Health Law’ Podcast

By Nicolas Terry

twihl 14x14

This week we welcomed back Brietta R. Clark, Associate Dean for Faculty and Professor of Law at Loyola Law School in Los Angeles. Brie is an expert on health care law and inequality.  Her research focuses on the structural defects and biases that create inequity in our health care delivery and financing systems, and the role that law and government regulators play in ensuring equitable access to health care resources.

We began the show with our “lightning round” by discussing a Kentucky Supreme Court case limiting nursing home arbitration agreements in some scenarios. (Interested readers should check out Nic’s prophetic article on malpractice arbitration, and later work citing it.) We briefly mentioned the contraceptive cases granted cert this term, and hope to return to them in a later episode. Read More

Identified versus Statistical Lives at the Movies

Imagine you had 10 million dollars to spend to save the life of one person whose name you knew or 10,000 whose name you didn’t? How would you spend it? What would you think of a government policy that chose to save the 1 person rather than the 10,000? I would think pretty badly of such a government, but that’s exactly what happens in some popular new movies. And the expectation of the filmmakers (and my own take on audience reaction) is that the audience cheers.

sq_martianFirst, The Martian (spoiler alert) where America spends tens of millions and diverts the entirety of the space program to bring back one man left behind on Mars. Second, the new movie 33, which I have not seen yet but is based on a true story involving the successful attempt to save 33 Chilean miners trapped in a mine collapse at a huge financial cost. Read More

Monday, 11/16, HLS Health Law Workshop with Seema Shah

HLS Health Law Workshop: Seema Shah

November 16, 2015, 5:00 PM
Lewis International Law Center, Room 214A
1557 Massachusetts Ave, Cambridge MA 02138

Download the paper: “Uncertainty and the Eighth Amendment”

Seema Shah is a faculty member in the National Institutes of Health Clinical Center Department of Bioethics and has a joint appointment at the Division of AIDS. Her research focuses on the ethics of international research, the ethics of research with children, and the intersection of law and bioethics. She currently serves as a consultant for the Division of AIDS on its clinical sciences review committee and as an ethics consultant for the Clinical Center.

She earned her bachelor’s and juris doctor degrees from Stanford University. She previously served as a federal law clerk in the Eastern District of California and a predoctoral fellow in the NIH Department of Bioethics.

She has lectured on the ethics of clinical research at conferences run by PRIM&R, ASBH, IAB, ASTMH, and internationally in such locations as Botswana, South Africa, Vietnam, Japan, Indonesia, and Mali.

The ACA’s Nondiscrimination Rule: A Right In Search of a Remedy

By Elizabeth Sepper

Every law student learns the ancient adage that there is no right without a remedy. Section 1557 makes clear that individuals have rights against discrimination in healthcare and a private right of action to enforce them. But it’s less clear as to when and how they have remedies.

Section 1557 provides individuals protection against discrimination on “the ground prohibited under” four preexisting civil rights statutes–Title VI of the Civil Rights Act, Title IX of the Education Amendments, the Age Discrimination Act, and Section 504 of the Rehabilitation Act. The statute also makes available “the enforcement mechanisms provided for and available under” these four civil rights statutes. This language makes two things clear. First, Section 1557 prohibits discrimination on grounds of race, color, or national origin (Title VI); sex (Title IX); age (Age Discrimination Act); and disability (Rehab Act). Second, as district courts have agreed, the statute authorizes both private rights of action and agency enforcement as “enforcement mechanisms.”

So far, so good. But each statute has its own specific legal standards, and remedies. For example, a plaintiff alleging age discrimination under the Age Discrimination Act must first exhaust administrative remedies. By contrast, a plaintiff can file a private suit directly when suing under Title IX. And private parties can’t bring lawsuits targeting policies with disparate impacts on racial minorities under Title VI. But people with disabilities can allege disparate impact pursuant to Section 504.

The text of Section 1557 is ambiguous: either (1) claims that Section 1557 has been violated are treated uniformly across prohibited grounds or (2) plaintiffs have different rights and remedies depending upon whether they allege race, sex, disability, or age discrimination. Courts have already divided on this question.

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