Category: Human Tissue

Some Commentary on How to Think About Secondary Research with Biospecimens

Holly Fernandez Lynch Leave a comment

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.

Read More

NPRM Symposium: How Should We Think About Whether To Donate Our Leftover, Non-Identified Tissue to Research?

mmeyer Leave a comment

By Michelle Meyer

Proposed changes to the federal Common Rule would ask patients for the first time to decide whether to allow their non-identified, leftover tissue to be used for research or thrown away. For that choice to be meaningful, the public needs to be aware of the nature, risks, and benefits of biospecimens research, and of what the proposed changes will—and will not—do. In my latest Forbes essay, “No, Donating Your Leftover Tissue To Research Is Not Like Letting Someone Rifle Through Your Phone,” I consider the power of analogies and other reflections on Rebecca Skloot’s recent New York Times op-ed on the NPRM.

Blog Series on NPRM at PRIM&R’s “Ampersand”

The Petrie-Flom Center Staff Leave a comment

Our colleagues at PRIM&R are hosting a series on “Unpacking the NPRM.” Check it out at their blog Ampersand, or by clicking on the links below!

Monday, 9/21, HLS Health Law Workshop with Jessica Roberts

Jennifer Minnich Leave a comment

HLS Health Law Workshop: Jessica Roberts

September 21, 2015 5:00 PM
Hauser Hall, Room 102
Harvard Law School, 1575 Massachusetts Ave, Cambridge MA

Download the paper: “Theories of Genetic Ownership”

Jessica L. Roberts is the Director of the Health Law and Policy Institute and an Associate Professor of Law at the University of Houston Law Center. She specializes in health law, disability law, and genetics and the law. Prior to UH, Professor Roberts was an Associate-in-Law at Columbia Law School and an Adjunct Professor of Disability Studies at the City University of New York. Immediately after law school, she clerked for the Honorable Dale Wainwright of the Texas Supreme Court and the Honorable Roger L. Gregory of the Fourth Circuit Court of Appeals.

Professor Roberts’ research operates at the intersection of health law and antidiscrimination law. Her scholarship has appeared, or is forthcoming, in the Indiana Law Journal, the William and Mary Law Review, the Iowa Law Review, the Minnesota Law Review, the University of Illinois Law Review, the Notre Dame Law Review, the Vanderbilt Law Review, the University of Colorado Law Review, the American Journal of Law and Medicine and the Journal of Law and the Biosciences, among others. Professor Roberts teaches, or has taught, Contracts, Disabilities and the Law, Genetics and the Law, and Health Law Survey. In 2015, she received the university-wide Teaching Excellence Award and the Provost’s Certificate of Excellence. Professor Roberts was named a 2018 Greenwall Faculty Scholar in Bioethics.

NPRM Summary from HHS

I. Glenn Cohen Leave a comment

As Michelle noted, the Notice of Proposed Rule Making (NPRM) on human subjects research is out after a long delay. For my (and many Bill of Health bloggers’) view about its predecessor ANPRM, you can check out our 2014 book, Human Subjects Research Regulation: Perspectives on the Future.

Here is HHS’s own summary of what has changed and what it thinks is most important:

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991.  A Notice of Proposed Rulemaking (NPRM) was put on public display on September 2, 2015 by the Office of the Federal Register.  The NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. It is expected that the NPRM will be published in the Federal Register on September 8, 2015.  There are plans to release several webinars that will explain the changes proposed in the NPRM, and a town hall meeting is planned to be held in Washington, D.C. in October. Read More

FDA’s Non-Response Response to My New York Times Op-Ed on Gay Blood Ban

I. Glenn Cohen Leave a comment

On May 21, along with my frequent co-author Eli Adashi, I published an op-ed in the New York Times raising some questions about FDA’s proposed guidance recommending a ban on taking the blood on any man who has had sex with another man in the past year, or in other words imposing a one year celibacy requirement on gay men if they want to donate blood. This built on our critique last July in JAMA, wherein we argued that FDA’s then-lifetime ban on gay men and MSM donating blood was out of step with science and the practice of our peer countries, as well as potentially unconstitutional.

Thanks to our work, and a concerted effort by public health, medical, and gay rights groups, FDA has finally moved off of that prior policy and recognized that it was unjustified, and discriminatory.

Just to put this in context It took more than 30 years to convince FDA that it was problematic to ban blood donation for a lifetime any man who ever had sex with another man, even if both have repeatedly tested negative for HIV, while it imposed only a one year ban on people who had sex with individuals known to be HIV positive or a sex worker. FDA is appropriately a conservative agency, but on this issue of the lifetime ban its willingness to listen and reconsider has gone beyond conservatism to the point of lunacy. [By the way to be clear, I *love* FDA. I represented them while at the DOJ and have a new book coming out about FDA in the fall. You can think highly of an agency but think they have a bad track record on an issue. This is critique not hater-aide].

Well with that background, one should be not so quick to assume that a move to a one year ban — a de facto lifetime ban for any gay man who is sexually active, even one who is monogamously married with children — is the best policy. To put it bluntly, refusing to change a lifetime ban for such a long period makes me skeptical we should accept a “just trust us” line on their new restrictive policy.

The question we raised in our op-ed was whether FDA had adequately justified retaining a one year ban in light of the evidence from places like South Africa (with a much shorter time period ban), Italy (which does individualized risk assessment instead of stigmatizing all gay men as high risk for disease), etc.

Well FDA responded…sort of … through a NY TImes Letter To the Editor.

Here is what FDA said with my analysis in bold:

Read More

Fundraising and the Delayed Kidney Transplantation: A Loophole in the Ban against Commercialization?

Cansu Canca Leave a comment

By Cansu Canca

In April, a kidney donation from an unrelated living donor was put on hold in South Portland, Maine. The reason was unusual: the generosity of the community.  In response to an online fundraising for the donor, 768 people contributed over $49,000—well beyond what can reasonably be called “compensation.” The hospital thus had to ask the question: Is the donation procedure in conflict with the law now that the donor stands to profit from it? After initial media coverage, there was no further news about this case. On Monday, however, it was announced on the fundraising page that the transplant is back on track and due to happen in two weeks. Does that mean that we now have a loophole in the ban against commercialization of organs?

The case is unprecedented. There are and have been other online fundraisers to compensate donors. But this is the first time that the unpredictable powers of the internet kicked in (remember the guy who raised $55,000 to make a potato salad?). The law prohibits any monetary payments to organ donors. The situation poses two questions: What should be done in this particular case, and how should fundraising for organ donors be regulated going forward?

It appears that the first question was somehow resolved even though we don’t know how: Did the hospital decide it was not a problem after all, or did the donor agree with the hospital’s reported initial suggestion of donating the “excess” money to some other organization? In either case, what follows remains problematic.

Read More

China stops using executed prisoners as a source of organs for transplants

lferreira Leave a comment

By Lydia Stewart Ferreira

According to the Lancet, China will stop using executed prisoners as a source of organs for transplants as of January 1, 2015. After January 1, 2015, “only voluntary donated organs from civilians can be used in transplants.” This decision was officially announced December 3, 2014 by Jiefu Huang, the former vice-Minister of Health at a seminar of China’s Organ Procurement Organization. While China needs to be commended for this government initiative, I find the fact that this initiative takes effect in 2015 quite shocking.

China has one of the largest organ transplant systems in the world, yet it has one of the lowest levels of organ donation – with a rate of 0.6 per 1 million people. In a 2011 Lancet article, Huang and colleagues reported that 65% of transplants in China used organs from deceased donors, more than 90% of whom were executed prisoners. The Lancet also reports that since 1984, it has been legal in China to harvest the organs of executed prisoners with the consent of the prisoner or their family. It was not until 2007 that China implemented its first legal regulatory framework for the oversight of their organ transplant system. In 2013, China went on to establish a national electronic organ allocation system.

Clearly, China has had a government endorsed organ procurement system. However, this procurement system has been internationally condemned by medical, scientific and human rights organizations. There were concerns about coercion, exploitation, undue inducement, non-existent consent, unjustified paternalism and the corruption of organ allocation. This organ procurement system used by China was legal under Chinese law. It is not clear to what extent illegal organ procurement – through transplant tourism and the black market sale of organs – was and is also taking place in China.

Read More

Two forthcoming publications on (1) European Stem Cell Patenting, and (2) IP issues in Biobanking

Timo Minssen Leave a comment

By Timo Minssen

I am happy to announce the following publications:

1) Minssen, Timo and Nordberg, A., The Evolution of the CJEU’s Case Law on Stem Cell Patents: Context, Outcome and Implications of Case C‑364/13 International Stem Cell Corporation (March 11, 2015). Available at SSRN: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2576807  (under review for journal publication)

Abstract:  

On 18th December 2014, the CJEU rendered its’ much-anticipated decision in C‑364/13 International Stem Cell Corporation v Comptroller General of Patents (ISCC). Qualifying its’ earlier ruling in Brüstle v. Greenpeace (Brüstle) with regard to non-fertilised human ova stimulated by parthenogenesis, the Court held that in order to constitute a ‘human embryo’ – and thus to be unpatentable under the EU Biotechnology Directive – the stimulated ovum must have the “inherent capacity to develop into a human being”. This would allow patents on innovative parthenotes which had not been genetically modified to achieve totipotent capabilities. Hence the judgment establishes a crucial limitation of the broad interpretation of “human embryos” in Brüstle, where the CJEU held that parthenotes are covered by the term “human embryo” since they are “capable of commencing the process of development of a human being”. The ISCC decision is to be welcomed since it provides an ethically justifiable leeway for patenting and offers reasonable support to the commercial viability of European cell therapy research. Yet, ISCC’s impact still depends on national implementations and only applies to certain hESC cells. Thus, further clarifications would be helpful concerning other non-totipotent hESCs.

Read More