Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Scholar calls for a new legal, ethical framework for research with human tissue specimens

22.06.2010
A lawyer and researcher at the Johns Hopkins Berman Institute of Bioethics says a new legal and ethical framework needs to be placed around the donation and banking of human biological material, one that would more clearly define the terms of the material's use — and address donor expectations before research begins.

In a new law review article, "Why Not Take All of Me? Reflections on The Immortal Life of Henrietta Lacks and the Status of Participants in Research Using Human Specimens," Gail Javitt, J.D., M.P.H., uses the story of a woman whose cancerous cells revolutionized medical research as the launching point for an exploration of the flaws in the current legal approach to the use of human specimens in research.

The Immortal Life of Henrietta Lacks, by science journalist Rebecca Skloot, has stoked public interest in the ethical obligations owed to tissue contributors. Javitt says the "story is a powerful reminder that, behind every tissue sample in a laboratory, is the person it came from."

Recently, Skloot announced that her book will be adapted and turned into a cable-television movie. Javitt applauds moving the discussion of these issues into the public forum. As she writes, "by telling the Lacks family's story in such an engaging, accessible way, Skloot has moved the discussion beyond the narrow confines of courtrooms and academia and into the public domain, where all those with a stake in the answers can participate."

Published in the Minnesota Journal of Law, Science and Technology, Javitt's article reports that human tissue and DNA are increasingly being collected and used in research. Yet they are obtained and stored under a patchwork of policies — some broad, some specific — that dictate how they may or may not be used in the future.

Many in the legal and scientific arenas say this is because federal and case law have fallen behind modern research demands and techniques.

The federal human subject protection law known as the "Common Rule" requires informed consent be obtained from participants in all federally funded research, and that includes tissue research. However, if identifying information has been removed, the law doesn't apply.

Even where informed consent is required, Javitt says, the human subject paradigm is not an adequate one for this type of research. She points out that informed consent is a mechanism aimed at protecting subjects from the type of harm and abuse that unwitting participants experienced in past research — such as the Tuskegee studies — and was never meant to be the process by which researchers negotiate to engage in a legal transaction.

"Informed consent was not conceptualized as a contract between two individuals with equal bargaining power," says Javitt, who has closely examined some of the best-known court cases involving the rights and expectations of human tissue contributors. "Rather, informed consent is an ethical duty that the researcher owes the human subject under conditions that historically have involved unequal power."

In contrast, the concept of donation "presumes an individual who understands that he is giving away something of value and the consequences of making that choice."

Javitt's article cites legal cases that she says show the courts' failure to appreciate that those who contribute tissue for research are owed duties as research subjects to be informed that their tissue will be used for research. For instance, in Moore v. Regents of the University of California, the court ruled that a physician violated informed consent obligations to his patient (Moore) by performing surgery and ordering follow-up blood draws without disclosing that he was also developing a potentially lucrative cell line from the patient's specimens.

"The court's reasoning with respect to informed consent is flawed," Javitt says, because "the court failed to distinguish between Moore as patient and Moore as research subject."

The cases also show a failure to appreciate the dual role of the tissue contributor as both research subject and participant in the legal transaction of donation, according to Javitt. So, she argues for a bifurcation of the process: As research subjects, participants must be informed of the risks and benefits of the research, and consent to participation. As donors of tissue, participants also must be informed that they are entering into a legal transaction — donation — and made aware of the terms of that transaction.

"Although requiring separation ... may seem like a proposal for adding yet another piece of paper to an arguably already cumbersome process, the small piece of paper is performing a huge ethical and legal task," Javitt writes in her article.

Javitt also says she was troubled by what she sees as the courts' consistent preference for the needs of the research enterprise over the claims of the tissue contributors. Although the public generally is supportive of research, Javitt says, this may change if prospective contributors of tissue samples feel deceived.

For example, in February, angry parents in Texas sued over the state's use of their babies' blood samples for research. Just two months later, the Havasupai tribe in Arizona succeeded in reclaiming their DNA samples from researchers at the state university system. Meanwhile, the book about Henrietta Lacks has amplified the frustration of her descendants in Baltimore over the use of her cells without their knowledge.

Across the board, mistrust was fueled by a lack of transparency and the discovery of details only after samples were used.

"How fitting it would be," Javitt's article concludes, "if the development of a new, transparency-based framework for tissue donation, one that is premised on the simple notion that tissue contributors should be asked—within a context that allows a meaningful answer—was Henrietta Lacks's true legacy."

Gail Javitt, J.D., M.P.H.
http://www.bioethicsinstitute.org/mshome/?id=92

Michael Pena | EurekAlert!
Further information:
http://www.jhsph.edu

More articles from Life Sciences:

nachricht Bare bones: Making bones transparent
27.04.2017 | California Institute of Technology

nachricht Link Discovered between Immune System, Brain Structure and Memory
26.04.2017 | Universität Basel

All articles from Life Sciences >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Making lightweight construction suitable for series production

More and more automobile companies are focusing on body parts made of carbon fiber reinforced plastics (CFRP). However, manufacturing and repair costs must be further reduced in order to make CFRP more economical in use. Together with the Volkswagen AG and five other partners in the project HolQueSt 3D, the Laser Zentrum Hannover e.V. (LZH) has developed laser processes for the automatic trimming, drilling and repair of three-dimensional components.

Automated manufacturing processes are the basis for ultimately establishing the series production of CFRP components. In the project HolQueSt 3D, the LZH has...

Im Focus: Wonder material? Novel nanotube structure strengthens thin films for flexible electronics

Reflecting the structure of composites found in nature and the ancient world, researchers at the University of Illinois at Urbana-Champaign have synthesized thin carbon nanotube (CNT) textiles that exhibit both high electrical conductivity and a level of toughness that is about fifty times higher than copper films, currently used in electronics.

"The structural robustness of thin metal films has significant importance for the reliable operation of smart skin and flexible electronics including...

Im Focus: Deep inside Galaxy M87

The nearby, giant radio galaxy M87 hosts a supermassive black hole (BH) and is well-known for its bright jet dominating the spectrum over ten orders of magnitude in frequency. Due to its proximity, jet prominence, and the large black hole mass, M87 is the best laboratory for investigating the formation, acceleration, and collimation of relativistic jets. A research team led by Silke Britzen from the Max Planck Institute for Radio Astronomy in Bonn, Germany, has found strong indication for turbulent processes connecting the accretion disk and the jet of that galaxy providing insights into the longstanding problem of the origin of astrophysical jets.

Supermassive black holes form some of the most enigmatic phenomena in astrophysics. Their enormous energy output is supposed to be generated by the...

Im Focus: A Quantum Low Pass for Photons

Physicists in Garching observe novel quantum effect that limits the number of emitted photons.

The probability to find a certain number of photons inside a laser pulse usually corresponds to a classical distribution of independent events, the so-called...

Im Focus: Microprocessors based on a layer of just three atoms

Microprocessors based on atomically thin materials hold the promise of the evolution of traditional processors as well as new applications in the field of flexible electronics. Now, a TU Wien research team led by Thomas Müller has made a breakthrough in this field as part of an ongoing research project.

Two-dimensional materials, or 2D materials for short, are extremely versatile, although – or often more precisely because – they are made up of just one or a...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Expert meeting “Health Business Connect” will connect international medical technology companies

20.04.2017 | Event News

Wenn der Computer das Gehirn austrickst

18.04.2017 | Event News

7th International Conference on Crystalline Silicon Photovoltaics in Freiburg on April 3-5, 2017

03.04.2017 | Event News

 
Latest News

Bare bones: Making bones transparent

27.04.2017 | Life Sciences

Study offers new theoretical approach to describing non-equilibrium phase transitions

27.04.2017 | Physics and Astronomy

From volcano's slope, NASA instrument looks sky high and to the future

27.04.2017 | Earth Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>