• Professor Valerie Gutmann Koch

    Valerie Gutmann Koch

    Visiting Assistant Professor of Law

    – Go to her faculty biography

    – Go to her publications:

    SSRN: http://papers.ssrn.com
    Bepress: http://works.bepress.com/valeriegutmann_koch/

    Professor Koch on Updates to the Common Rule

    by  • January 6, 2016 • Scholarship • 0 Comments

    By Valerie Gutmann Koch


    On January 5, I submitted, along with Jessica Roberts, Associate Professor of Law and Director, Health Law & Policy Institute at the University of Houston Law Center, comments on the Notice of Proposed Rule Making (NPRM) for revisions to the Common Rule (45 CFR 46), the regulations that govern the majority of human subjects research in the United States. These revisions will be the first since the Common Rule was promulgated in 1991. Our letter to Jerry Menikoff, the Director of the Office for Human Research Protections (OHRP), focused on three primary deficiencies in the proposed revisions. We therefore encouraged the Department of Health and Human Services (HHS) to: (1) encourage Congress to provide a statutory private right of action for the Common Rule; (2) clarify whether research subjects have a potential commercial interest in the research done on their biospecimens; and (3) eliminate the distinction between biospecimens and personal information and data. The letter is available here.

    Our letter was also featured on the blog for the Yale Journal of Law and Technology (YJOLT).

    Ventilator Allocation in a Pandemic

    by  • August 20, 2014 • Faculty Commentary • 0 Comments

    Professor Valerie Gutmann Koch will be a guest contributor at the HealthLawProf Blog for the month of August. Check back here for more of her guest posts.

    Koch_Valerie thumbnail By Valerie Gutmann Koch [reposted from HealthLawProf Blog]


    In 2014, the New York State Task Force on Life and the Law, the state’s bioethics commission, will release its updated Allocation of Ventilators in an Influenza Pandemic, which enunciate a comprehensive clinical and ethical framework to guide distribution of ventilators in the event of a severe public health emergency using objective medical criteria, with the ultimate goal of saving the most lives. These guidelines are the product of seven years of hard work by the Task Force and its staff and were developed by incorporating comments, critiques, feedback, and values from numerous stakeholders. They draw upon the expertise of multiple workgroups and committees with special knowledge in scarce resource allocation, pediatric and neonatal medicine, ethics, law, and policy. The 2014 version of these guidelines will not only include an updated clinical protocol for allocation of ventilators to adults; they will also include first of their kind protocols for allocation of ventilators to two important and previously unaddressed segments of the population: pediatric patients and neonates.

    I have had the great fortune to continue serving the Task Force in finalizing these Guidelines. In particular, the brief summary on legal issues from the 2007 draft guidelines has been replaced with a more substantial exploration of the various legal issues that may arise when implementing the clinical protocols for ventilator allocation.

    Of primary concern to the Task Force in its deliberations was the effective implementation of the clinical allocation protocols, which could be stymied by health care workers’ reluctance to follow the guidelines due to concerns about liability. The financial, time, and reputational costs of defending a criminal prosecution, civil lawsuit, or professional disciplinary proceeding, as well as conflicting laws and regulations, all may make abiding by the clinical protocols particularly challenging.

    Click here to read the rest of this post at HealthLawProf Blog→

    How an Obligation to Return Research Results Is (and Should be) Changing the Investigator-Participant Relationship

    by  • August 20, 2014 • Faculty Commentary • 0 Comments

    Professor Valerie Gutmann Koch will be a guest contributor at the HealthLawProf Blog for the month of August. Check back here for more of her guest posts.

    Koch_Valerie thumbnail By Valerie Gutmann Koch [reposted from HealthLawProf Blog]


    Technological advances, such as whole genome or exome sequencing, are changing the nature of research protocols. With these advances, the discovery of incidental or secondary findings (“research findings”)—or other information that could affect the research participant’s health or decision-making—will become more likely and frequent. Whether there is an ethical duty to disclose the results of research to individual participants—regardless of whether the results are directly related to the central research inquiry—has consequently become a central question in human subjects research.

    Over the last decade and a half, scholars and research participants have increasingly called for disclosure of research findings. This is particularly true in genetics research. For example, a 2009 survey found that 90% of 343 genetic researchers agreed that they had a duty to offer subjects aggregate research results, and a 2013 study concluded that a majority of researchers believe that research participants should have the option to receive at least some incidental genetic research results. The transformation in attitudes regarding the duty to disclose incidental or secondary findings is further manifested in the evolution of national bioethics advisory body recommendations on the subject. As recently as 1999, the National Bioethics Advisory Commission (NBAC) appointed by President Clinton stated that disclosure of individual research participants’ results “represents an exceptional circumstance” and recommended return of research findings only under specific conditions. As evidence of changing perspectives, in December 2013, the Presidential Commission for the Study of Bioethical Issues enunciated a series of recommendations for the management of incidental and secondary findings in both treatment and research and acknowledged the fact that, in certain circumstances, researchers may have an ethical duty to disclose and manage incidental and secondary findings. As participants, too, increasingly express a desire to receive research findings, the ethical—and perhaps, even legal—expectation that research findings should be disclosed may be further intensified.

    Click here to read the rest of this post at HealthLawProf Blog→

    FDA Announces Plans to Regulate LDTs (but Not DTC Genetic Tests)

    by  • August 6, 2014 • Faculty Commentary • 0 Comments

    Professor Valerie Gutmann Koch will be a guest contributor at the HealthLawProf Blog for the month of August. Check back here for more of her guest posts.

    Koch_Valerie thumbnail By Valerie Gutmann Koch [reposted from HealthLawProf Blog]


    Oversight of direct-to-consumer (DTC) genetic tests and laboratory developed tests (LDTs) in general has garnered increasing attention in the media. Most recently, on July 31, pursuant to the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), the FDA notified Congress that it intends to issue draft guidance for the oversight of LDTs – diagnostic tests (including genetic tests and tests for rare conditions) developed and performed by a single laboratory.  The FDASIA requires the FDA to provide at least 60 days’ notice before publishing any draft guidance on the regulation of LDTs.

    FDA’s decision to exercise its jurisdiction over LDTs as medical devices has been discussed and even expected for almost a decade. In June 2013 FDA Commissioner Margaret Hamburg called for more active FDA regulation of LDTs, stating that the Agency’s risk-based framework for regulating such tests was under development. Hamburg noted that the FDA has discretion in overseeing certain LDTs as devices. Although historically “they were relatively simple, low-risk tests performed on a few patients being evaluated by physicians at the same facility as the lab,” she explained that they now warrant oversight because they have become “more sophisticated and complex.”

    Speculation about the possibly imminent release of a risk-based oversight framework for LDTs increased after the agency’s November 2013 Warning Letter to the personal genomic testing service 23andMe. The letter demanded an immediate halt to testing “until such time as [23andMe] receives FDA marketing authorization for the device.” The agency claimed that 23andMe hadn’t proven that its tests are clinically valid, thereby leading to possible harm due to the “potential health consequences that could result from false positive or false negative assessments for high-risk indications.” Based on 23andMe’s advertising campaign and its focus on health rather than simply information, the FDA’s letter stated that it considered the personal genome service a Class III device (the agency’s highest-risk classification) under the Medical Device Amendments, requiring the most stringent level of regulation. The letter led to a number of generally thoughtful responses and questions (some of which have been posted here) regarding whether DTC genetic tests are devices subject to FDA oversight (much less Class III devices) and the effects such regulation might have on patient access, innovation, and research.

    In the July 31st press release issued concurrently with the letter to Congress, the FDA expresses concerns about the use of high-risk LDTs similar to those enunciated in the November 2013 Warning Letter to 23andMe. In particular, it focuses on the concern that “[i]naccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether.”

    Click here to read the rest of this post at HealthLawProf Blog→