National Academies Report Recommends Withdrawing the NPRM and Calls for a New Belmont Report

[Crossposted from Ampersand – The PRIM&R Blog]

By Elisa A. Hurley

On June 29, the National Academies of Science, Medicine, and Engineering released Part 2 of their report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. The report, written by the Committee on Federal Research Regulations and Reporting Requirements in response to a Congressional request, examines the impact of regulations and policies governing federally funded academic research in the United States. Part 1, released in September 2015, concluded that the continued expansion of federal regulations is “diminishing the effectiveness of the U.S. research enterprise, and lowering the return on federal investment in basic and applied research by diverting investigators’ time and institutional resources away from research and toward administrative and compliance matters” (xii). It made specific recommendations to reduce regulatory burden, and also recommended the creation of a “public-private Research Policy Board to streamline research policies.”

Part 2 concludes the analysis of regulations governing federally funded research and includes, in Chapter 9, a critical examination of the ethical, legal, and regulatory framework for human subjects research. The chapter begins by acknowledging that the research landscape has changed dramatically since the publication nearly 40 years ago of the Belmont Report, which established the three basic principles that provide the ethical foundation for the conduct of human subjects research in the United States. Changes in research methodologies and technologies, including comparative effectiveness research, research on de-identified biospecimens, observational studies of large datasets, cluster randomized trials, and research in emergency settings—as well as longstanding questions about the applicability to social and behavioral research of rules written for the biomedical research context—raise challenging questions about how to apply and balance the Belmont principles of respect for persons, beneficence, and justice across much of today’s research enterprise. Continue reading

Trial by Fire: CRISPR takes the next step

CRISPR-Cas9 has drawn applause for being one of the biggest technological advancements in recent history, but it also raises important ethical issues. This technology, an efficient genome editing tool, is now taking its next big step: CRISPR might be going in for human trials for its potential use in fighting cancer (namely, by altering T-cells to treat cancer cells as “foreign bodies”). Trials have been proposed to be conducted at three sites over a period of two years. The Recombinant DNA Advisory Committee (RAC) at the NIH gave its unanimous approval for these trials earlier this week. Now permissions from FDA and Institutional Review Boards remain before this becomes a reality.

Whether or not the studies will get that approval is uncertain. The RAC already expressed concerns about conflict of interest, and the ghosts of the trial involving Jesse Gelsinger 17 years ago at UPenn have resurfaced.  There are also important questions about risks, uncertainty, and informed consent from the research participants.

The scientific community and regulators have been wary of the gravity of the implications of genome editing. When a Chinese study involving gene editing in human embryos was submitted for publication, there was a hue and cry over whether journals should accept it, given ethical concerns. Currently, there is a moratorium on altering DNA that will subsequently pass on to new generations. Even when the CRISPR technology was approved for editing human embryos in the UK, it was mandated that embryos be destroyed within fourteen days.

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Use of Estimated Data Should Require Informed Consent

Guest post by Donna M. Gitter, Zichlin School of Business, Baruch College, based on Professor Gitter’s presentation at the Petrie-Flom Center’s 2016 Annual Conference, “Big Data, Health Law, and Bioethics,” held May 6, 2016, at Harvard Law School.

Cross-posted from the Hastings Center’s Bioethics Forum.

The Icelandic biotech firm deCODE Genetics has pioneered a means of determining an individual’s susceptibility to various medical conditions with 99 percent accuracy by gathering information about that person’s relatives, including their medical and genealogical records. Of course, inferences have long been made about a person’s health by observing and gathering information about her relatives. What is unique about deCODE’s approach in Iceland is that the company uses the detailed genealogical records available in that country in order to estimate genotypes of close relatives of individuals who volunteered to participate in research, and extrapolates this information in order to make inferences about hundreds of thousands of living and deceased Icelanders who have not consented to participate in deCODE’s studies. DeCODE’s technique is particularly effective in Iceland, a small island nation that, due to its largely consanguineous population and detailed genealogical records, lends itself particularly well to genetic research.

While Iceland’s detailed genealogical records enable the widespread use of estimated data in Iceland, a large enough U.S. database could be used to make similar inferences about individuals here. While the U.S. lacks a national database similar to Iceland’s, private companies such as 23andme and Ancestry.com have created rough gene maps of several million people, and the National Institutes of Health plans to spend millions of dollars in the coming years sequencing full genome data on tens of thousands of people. These databases could allow the development of estimated data on countless U.S. citizens.

DeCODE plans to use its estimated data for an even bolder new study in Iceland. Having imputed the genotypes of close relatives of volunteers whose DNA had been fully catalogued, deCODE intends to collaborate with Iceland’s National Hospital to link these relatives, without their informed consent, to some of their hospital records, such a surgery codes and prescriptions. When the Icelandic Data Protection Authority (DPA) nixed deCODE’s initial plan, deCODE agreed that it will generate for only a brief period a genetic imputation for those who have not consented, and then delete that imputation from the database. The only accessible data would be statistical results, which would not be traceable to individuals.

Are the individuals from whom estimated data is gathered entitled to informed consent, given that their data will be used for research, even if the data is putatively unidentifiable? In the U.S., consideration of this question must take into account not only the need for privacy enshrined in the federal law of informed consent, but also the right of autonomy, which empowers individuals to decline to participate in research. Although estimated DNA sequences, unlike directly measured sequences, are not very accurate at the individual level, but rather at the group level, individuals may nevertheless object to research participation for moral, ethical, and other reasons. A competing principle, however, is beneficence, and any impediment to deCODE using its estimated data can represent a lost opportunity for the complex disease genetics community.

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George Annas on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we talked with George J. Annas, Chairman of the Bioethics & Human Rights Department, and William Fairfield Warren Distinguished Professor, at Boston University. George’s work is legendary among health policy experts; a 1998 tribute from Jay Katz gives some sense of its breadth and depth. Having reviewed numerous works, Katz states:”I have barely conveyed the richness of George Annas’ observations on the ambiguities in motivations and actions that persist in current research practices. The many recommendations he makes, should be of valuable assistance to those interested in reforming current rules governing research on humans. Plagued by Dreams…reveal[s] another facet of George Annas’ personality: His commitment to public advocacy. He values scholarship but he also wants it to have an impact on shaping institutions and health care policies…In the many settings in which I have encountered George Annas over the years, I have admired his boldness, intellect, compassion and moral vigor.” Our conversation had the theme  “paternalism & its critics,” based on articles George had recently authored (or co-authored with last week’s guest, Wendy Mariner) on informed consent, genomics, and sugary drinks.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Henrietta Lacks and the Great Healthdata Giveaway

Part Seven of Seven-Part Blog Series by Guest Blogger Patrick Taylor

A suggestion runs through the debate on the NPRM to amend the Common Rule that the proposed changes are a tribute to Henrietta Lacks, a necessity so her story is not repeated.

That story was told in a the national bestseller  The Immortal Life of Henrietta Lacks, a moving biography of the young woman whose  aggressive tumor was the source of the ubiquitous HeLa cells (probably without her consent, certainly without her awareness of what followed); her family;  the  cells’  (and her) dehumanization into a research tool to be exploited unthinkingly; and the poverty, disconnection, racism,  lack of health care and lack of concern for her family. Society and scientists received a bonanza, and did nothing for her family in return.  The book criticizes phony consent, and advocates sharing  cell line proceeds with donors and their families. It rekindled discussion of consent and racist legacies, while urging that injustice required social change.

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NPRM Symposium: Consent, Causality, and Castles in the Air

Part Six of Seven-Part Blog Series by Guest Blogger Patrick Taylor

Reading the NPRM and its government commentary, one is subtly, slowly led to a sense of inevitability.  Arguments from abstract principles emerge, leave a footprint and then, in the wake of another tide of interests and arguments, another principal supplants them.  But we are to believe that each previous  footprint endures intact.  There’s “autonomy,” said to require expanding opportunity to consent to honor individual preferences, overtrodden by scientific convenience, which demands just one-time consent, and suggests that world-changing choices to be privacy-bare may be irrevocable.  There’s privacy demanding that information meet HIPAA deidentification standards at least some of the time; but there is some undisclosed vector requiring that there is no limit on who government may share your medical information with.  Surrender to the illusion that these are not inconsistent,  and the proposal is the best of all possible worlds, in which every inconsistent good is maximized and every tradeoff ignored.  Surrender the illusion itself and one sees a mix of juxtaposed  partial-prints going different directions, each incomplete.

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NPRM Symposium: “I prefer to be asked”

Part Five of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The preamble to the NPRM justifies requiring consent for data and specimen research by contending  that studies indicate that people want to be asked for permission.  However, the literature on this topic is relatively thin.  Available evidence suggests that many people, upon being informed that their heath data and tissues could or would be used in research without their consent (and nothing further is said to prompt the idea that research might delve into controversial matters) are generally fine with such use.  But when also queried whether they would prefer to have been asked, people say they would.  What the literature does not show is that people say: “I object to any use without my consent,” let alone “and I choose that over all the advantages of minimal risk research involving analysis by a computer of digitized files not humanly readable limited to disease-gene associations of thousands of medical records where consent would not be possible but the results will be essential or important to my health, the health of others, and the national health.”  Pluralistic discussion of tradeoffs over time, or an extended, candid national dialogue about the reasons for the present rules, were not in the mix.   Yet still, people said the opposite of “This must not occur without my consent!”

We have already seen one way in which the claim to be respecting the preference to be asked is untrue – it applies to only some research by some organizations.   Now here is another. The commentaries to the NPRM celebrate as fact that a patient need be asked only once, for all time, and then the only acceptable “yes” answer grants permission for any research by anybody.    It seems doubtful that a one-time consent to any future scientific research by any researcher for any purpose, without ever going back to inform or re-query,  without any regulatory provisions ensuring it was revocable, was what  participants meant by  “being asked.” Rationally, that option is far worse than no consent, for reasons we shall come to. Continue reading

NPRM Symposium: Quick Take on New Analysis of the Comments on the NPRM to Amend the Common Rule (and the Challenge for Bioethics and the Public)

The Council on Governmental Relations (COGR), with support from the Association of Public and Land-grant Universities (APLU), undertook “to review and analyze the 2,186 public comments submitted in response to the 2015 Federal Policy for the Protection of Human Subjects” or “Common Rule” Notice of Proposed Rulemaking (NPRM).

I am going to discuss some highlights of their just released report, but this is far from exhaustive and you should read the whole report.

For the non-cognoscenti this is the most important revision to the rules for U.S. human subjects research since their inception. The report is largely unfavorable to several key proposed rule changes on my first read, but you should read it yourself to make up your own mind.

I’ll share some choice passages from the analysis

The results of our review (Table 2) find significant opposition to most major proposals, with mixed support for mandated use of a single IRB and extending the Common Rule and greater support for the concept of standard security safeguards. In addition, a number of responses suggested that the NPRM is overly complex, poorly written, and not supported by data; highlighted areas that could have a substantial impact on a final rule but were not included in the NPRM (e.g., proposed security safeguards, a consent template, a list of minimal risk studies and a decision tool); and suggested that some of the proposals would adversely affect human health with little perceived benefit.

Turning to Biospecimens, where we had a conference last year that will soon generate a book with MIT press:

The majority of responses, approximately 1,520, addressed one or more of the proposed changes detailed above involving non-identified biospecimens. Of these responses, 94 – 100% of patients and members of the research community, including researchers, universities, medical centers and industry, opposed the changes. Those commenting suggested that the proposed changes will significantly reduce the availability of biospecimens for research, will have a significant negative impact on medical advances, and will adversely affect human health. Per one patient, “I am asking for life saving policy not life ending policies.” From a biorepository, “Respecting autonomy at the expense of patient lives is a significant ethical concern.”

More surprising was their finding that “Among members of the general public, 55% opposed and 45% supported one or more of the major proposed changes related to biospecimens.” (They do a better breakdown of the various sub-constituencies in the report).

Turning to “broad consent” for biospecimen use:

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NPRM Symposium: So many left behind…

Part Four of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The development of research benefits depends on research participation.  Research participation, in turn, depends on being asked to participate, and how people evaluate what is being asked of them.  This post focuses on a few, not all, of those disproportionately excluded from research through one mechanism or another.  It illustrates some of what the proposed amendments to the Common Rule governing human subjects research will likely mean in practice absent some special vector that changes the outcome.  We will discuss what such a social vector might look like at the end.

We will start with those people who, understanding the real impact and meaning of providing their “blanket consent” to research, and uncomfortable with the sweeping right to invade and permit others to invade their privacy, refuse to sign it.   Who are they? Continue reading

NRPM Symposium: “We are holding health care for ransom, just get naked already!” or “Consent neutrality is non-neutral in effect”

Part Three of Seven-Part Blog Series by Guest Blogger Patrick Taylor

In the previous post of this series, we took a look at how comprehensively certain proposed revisions to human subject research regulations would apply and whether they would, if effective, really fulfill a broad goal of enabling the consent of everyone to researchers’ use of their clinical data.  The answer is a big “No,” based on their scope.  If public trust in science depends, as the government claims, on individuals’ consent reliably and consistently governing research use of their data, then science is in trouble; all the government has proposed is a restriction on the institutions a supermajority of the people trust already to protect their privacy: healthcare providers, researchers funded by the NIH, and a handful of other federal agencies.   Everyone else, from Google to spymaster, drug company to next-door neighbor, is unaffected except to the extent that those entities, or reviewing IRBs, require contracts that say something more, which in this case is left to chance.

The proposed regulations call for government to draft a general blanket consent to govern tissue banking and banked data.  “Blanket” means that it covers everything, in undifferentiated language, with no opt outs – all or nothing.   Such an approach will eliminate most or any choice about what one is consenting to.  It will require consent to any research by anybody using any technique, with any goal in mind.  The options will be to consent to that or not consent at all. Continue reading

NPRM Symposium: Privacy and Promises, Promises, Promises

Part Two of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The first blog post in this series probably provided a few surprises, but the surprises are just beginning. Can the NPRM to amend the Common Rule keep its promises?

The NPRM promises that patients will be able to consent to use of their clinical data in research, which is actually two promises, not one. The first is that the consent will be given effect. The second is that the refusal will be given effect.  As to refusal, the NPRM absolutely does not keep its promise.

The NPRM is filled with page after page of exceptions where your consent is not required. These include examples like trailing you and spying on you in public, some tests done on how to affect children’s behavior, and more. Continue reading

NPRM Symposium: Your Privacy or Your Life – Human Research Subjects and the Great Healthdata Giveaway

Part One of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The recent Apple-FBI controversy has highlighted the fact that our government, obligated to protect our privacy in some contexts, actively undermines it in others. The same internal conflict of interest is responsible, at least in part, for the U.S. government’s recent proposal to revise longstanding regulations to protect people who participate in research.

The proposals emerged last September, 2015, and were hailed as the first major reworking of the regulations in several decades, four years after an Advance Notice of Proposed Rulemaking buried somewhat different approaches to the same desired adverse privacy effects in a tome of hundreds of pages. It’s a safe bet that few if any members of the public not professionally involved ever read them. The feds gave themselves four years to consider and devise the current proposal, but they gave the public about four months to consider it and with no evident structured interaction with public opinion. Continue reading

NPRM Symposium: Consent and Consistency in the NPRM

By Luke Gelinas, Guest Blogger

  1.  Interpreting the proposed consent requirement

One of the most discussed and controversial aspects of the Department of Health and Human Services’ recent notice of proposed rule-making (NPRM), which stands to change the federal regulations governing research with human beings, is a new consent requirement for secondary research on bio-specimens.  ‘Secondary research’ involves leftover blood or tissue samples that are re-purposed for research after their original use as clinical samples or in prior research studies has been served.  Whereas the current regulations permit re-purposed samples to be used in research without consent so long as the samples are anonymized or de-identified, the new rule would require individuals to be notified that their samples will be used in research, and to give broad permission or consent for such use, before research using them is permitted.

One possible justification for the new consent requirement is what I will call the ‘rights-violation’ interpretation.  The rights-violation approach maintains that consent for research with biospecimens is ethically required to avoid a rights-violation—which is what, the view claims, using someone’s samples without their consent amounts to.

Defenders of this view face the challenge of saying precisely which right is violated by research with re-purposed specimens.  One idea is that the samples still count as part of the individual’s body, even if they are no longer spatially continuous with it, so that using them without consent infringes a bodily right.  A second possibility is that, even if donated specimens are not part of one’s body in the relevant sense, we yet have ownership interests in and claims to our biological materials, so that  something closer to a property right at stake.  A third view focuses on the personal health information that can be garnered from certain sorts of research with bio-specimens (e.g., research involving whole genome sequencing), claiming that privacy rights stand to be infringed when specimens are used without consent.  Each of these views raises complex ethical (and indeed in some cases metaphysical) issues that defenders of the rights-violation interpretation must work out.  Continue reading

Stem cell patenting on the other side of the pond

We are pleased to announce a new publication in the International Review of Intellectual Property and Competition Law (IIC). Our paper analyzes new case law in European stem cell patenting and compares these developments with the US situation and International treaties. Further information and an abstract is available below:

Authors: Ana Nordberg & Timo Minssen, University of Copenhagen, Centre for Information and Innovation Law (CIIR)

Title: A “Ray of Hope” for European Stem Cell Patents or “Out of the Smog into the Fog”? An Analysis of Recent European Case Law and How it Compares to the US
Journal: IIC – International Review of Intellectual Property and Competition Law, 47(2), 138-177
DOI: 10.1007/s40319-016-0449-x

ABSTRACT:  Continue reading

Should healthcare systems implement routine recontacting services in clinical practice? Some legal and logistical considerations

By Daniele Carrieri, Angus Clarke, Anneke Lucassen, Susan Kelly

Advances in genetic and genomic medicine are resulting in better diagnosis and treatment of some health conditions, and the question of whether former patients should be recontacted is therefore timely. Recontacting patients to inform them of new information or new testing, that could be relevant to their health or that of their biological relatives is made more pressing by the increasing use of whole genome approaches in healthcare, where variants previously of unknown significance (VUSs) may now have known disease effects.  However, there is currently no consensus about whether or not healthcare professionals have a duty or responsibility to recontact former patients in light of this new information. There is also very little empirical evidence in this area. In a recent article published in Genetics in Medicine, we present the results of a survey of recontacting practices of clinical genetics services across the United Kingdom (UK). As far as we know, this is the first study that specifically explores current recontacting practices in clinical genetic services.

One of the questions of the survey asked was whether clinical genetics services should implement routine recontacting systems. The majority of genetic services were undecided for several reasons.  The main arguments given in favor of implementing such systems revolved around patient choice and the idea of keeping patients up to date.  The main arguments against pointed to the logistical difficulties of implementing recontacting systems and the possible legal implications of doing so, if that were seen as establishing a new standard of care without the additional resources required for this to be a sustainable activity. Continue reading

Breaking News: NAM Releases Report on Mitochondrial Replacement Therapy (Part I Summary)

By I. Glenn Cohen

As readers know I’ve written on mitochondrial replacement therapy and its attendant ethical and regulatory issues. Today the National Academy of Medicine (formerly known as the IOM) released a terrific report today with its recommendations. I’ll have a second post with my reactions but here is a summary from the report of their recommendations. The big headline is they have recommended FDA largely move towards allowing it to go forward under a regulatory pathway with restrictions, the most important of which is the transfer only of male embryos (to avoid germ-line issues).

In the NAM’s own words:

Recommendation 1: Initial clinical investigations of mitochondrial replacement techniques (MRT) should be considered by the U.S. Food and Drug Administration (FDA) only if and when the following conditions can be met: Continue reading

REGISTER NOW! (3/29) The Future of Health Law and Policy: The Petrie-Flom Center’s 10th Anniversary Conference Celebration

PFC 10th Logo-Horizontal-Otlns-FnlThe Future of Health Law and Policy: The Petrie-Flom Center’s 10th Anniversary Conference Celebration
March 29, 2016 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Petrie-Flom Center is celebrating its first decade and kicking off the next by looking at the future of health law and policy!

Please join us as we bring together Petrie-Flom and other prominent Harvard Law School alumni to discuss major trends, developments, and open questions in the fields of health law policy, biotechnology, and bioethics. We’ll hear about the founder’s vision for the Center and the Dean’s perspective on the Center’s influence within the Harvard Law School community and beyond. Center Leadership will discuss what we have accomplished in the first ten years, and more important, our plans for the future. Alan Weil JD ’89, Editor-in-Chief of Health Affairs, will deliver the keynote address.

Agenda

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TOMORROW, 1/29! Fourth Annual Health Law Year in P/Review Symposium


MORE SEATS AVAILABLE! Fourth Annual Health Law Year in P/Review
January 29, 2016 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein West AB 
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Fourth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2015 and what to watch out for in 2016. The discussion at this day long event will cover hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients.

In addition to presenting at the conference, many of our speakers will write about their topics for a collaborative blog series that will begin in February 2016 on the Health Affairs Blog.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, the New England Journal of MedicineHealth Affairs, the Hastings CenterHarvard Health Publications at Harvard Medical School, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

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The Common Rule NPRM Blog Series: Posting of Consent Forms

By: Academic and Clinical Research Group at Verrill Dana LLP

[Crossposted from the The Common Rule NPRM Blog Series on the Endpoints Blog]

The Notice of Proposed Rulemaking (“NPRM”) issued by the Department of Health and Human Services (“HHS”) and fifteen other federal agencies outlining changes to their existing human subject protection regulations (the “Common Rule”), proposes a new provision that would require a copy of the final version of the consent form (absent any signatures) for each clinical trial conducted or supported by a Common Rule department or agency to be posted (within 60 days after the trial is closed for recruitment) on a publically available federal website that would be established for such purpose.

In Part 3 of our Academic and Clinical Research Group (“ACRG”) blog series on the Common Rule NPRM, we address the rationale behind this proposal and its potential benefits, downsides, and missed opportunities. Continue reading

Some Commentary on How to Think About Secondary Research with Biospecimens

The public comment period on the NPRM to revise the Common Rule has just closed, and now we wait to see what happens (if anything), and when.  One of the most controversial proposals in the NPRM would require at least broad consent for secondary research with biospecimens (i.e., research on specimens originally collected for another purpose, either clinical care or a different study), regardless of whether those specimens retain identifiers.  This is a substantial change from the status quo, which does not require consent for such research with de-identified specimens.  How should we feel about this status quo, and the proposed change?  My own view is that it’s really not so bad: the risks to individual research participants are quite low, and the current approach facilitates critically important scientific advancement.  There is certainly room for improvement, e.g., to impose punishment on those who would act to re-identify de-identified specimens without permission, to inform the public that such research takes place, and to educate them about its value, perhaps allowing those who still feel very strongly that they prefer not to be included an opportunity to opt-out.  But what has been actually proposed has more problems than what it would replace, and in fact, wouldn’t solve some of those it seems to be a response to.

Rebecca Skloot feels otherwise.  She is the author of a book called The Immortal Life of Henrietta Lacks, which chronicles the origin of one particularly important cell line – HeLa  – derived from cells that had been excised from Ms. Lacks in the course of a 1951 surgery to treat her cancer, and later used for research without her knowledge or permission.  Ms. Lacks was poor, uneducated, and black, and her descendants have also faced more than their fair share of adversity.  Ms. Skloot paints a compelling story of exploitation, but in my opinion, it is much more effective as a narrative about the horrible and enduring legacy of racism in this country than as proof that researchers who conduct secondary research with biospecimens without consent (as permitted under the current regulations, remember) or even without profit-sharing have behaved badly. After all, if individual risks are low and social benefits high – both true – then what’s the problem?  And it is far from clear that specimen sources deserve compensation for no other reason than that their discarded material actually proves valuable to scientists.  Nonetheless, the book has been used as a rallying cry by people from all walks of life who believe that they should be allowed to control whether, and potentially how, their specimens are used for research. Indeed, The Immortal Life of Henrietta Lacks is probably the single most important development that pushed the proposed revisions to the Common Rule forward, for the first time since they were released in 1991.

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