News from Germany: Organ Transplantation and “Research Donations” – Round 2?

On July 21, 2012, the Bundespraesident, the German Chancellor Dr. Angela Merkel and the German Health Minister D. Bahr finally signed the “The Act to Amend the German Transplantation Act” (“Transplantationsgesetz”, “TPG”.  It is published in the Federal Law Gazette Number 1, BGBl. I 35/2012, p. 1601 and became effective on August 1, 2012.  The act has been described here at PredictER News, July 20, 2012.

From day one, the act has had its critics, in large part, because of the organ transplantation scandal uncovered at the University of Goettingen (Germany) in June 2012.  An organ transplantation specialist is believed to have manipulated medical records in exchange for money so that several patients were able to receive organs through Eurotransplant earlier than it otherwise would have happened. Eurotransplant is responsible for the allocation of donor organs in Austria, Belgium, Croatia, Germany, Luxembourg, the Netherlands and Slovenia (information from Eurotransplant). Currently, because of the suspicion of homicide in 23 cases, the German Law Enforcement Agency (“Staatsanwaltschaft Goettingen”) is leading investigations. The Staatsanwaltschaft Goettingen is investigating if the manipulation of the medical records caused the death of other patients. The agency is investigating whether or not patients were not able to obtain organs in time, because the donations had been given to other patients for whom the medical records and (with that) the listings in Eurotransplant had been manipulated.

Because of this severe incident, the German Organ Foundation, among others, is already advocating for amendments to the TPG to better ensure the safety and quality of organ donations. A better control system other than as regulated in the Act to Amend the German Transplantation Act should be established.  For now the German Health Minister does not see the necessity for changes; however, he does not exclude changes in the future.

Consequences for Research with Human Cells and Tissue?

The incident might also influence the use of human cells and tissue in research. At the moment, the confidence in the fairness of organ and tissue donations has decreased. It remains to be seen, to what extent the organ transplantation scandal will influence research donations and if the German Organ Transplantation Act will be amended again. In both cases, the trust of the citizenry has to be regained.

-- Bianca Buechner, Ph.D., LL.M. Candidate
Indiana University Robert H. McKinney School of Law

News from Germany: Organ Transplantation and “Research Donations”

On May 25, 2012, the Parliament of the Federal Republic of Germany (“Deutscher Bundestag”) passed “The Act to amend the German Transplantation Act” (“Transplantationsgesetz”, “TPG”, BT-Drs. 17/9773) and “The Law to Regulate the Opt-In Solution for Organ Transplantation” (BT-Drs. 17/9774, BT-Drs. 17/9030). Only a couple of weeks later, on June 15, 2012, the Bundesrat (one of the German constitutional bodies) has acknowledged both acts (Art. 77, 78 of the German Constitution). According to Art. 50 of the German Constitution, the federal states participate in the legislation and administration at a federal level and in matters concerning the EU through the Bundesrat.

Last but not least, the acts have to be signed and certified by the current Federal President Joachim Gauck (“Bundespraesident”) and promulgated in the Federal Law Gazette to become effective (Art. 82 of the German Constitution). On July 12, 2012, the Bundespraesident, the German Chancellor Dr. Angela Merkel and the German Health Minister D. Bahr signed the Law to Regulate the Opt-In Solution for Organ Transplantation. It is published in the Federal Law Gazette Number 1, BGBI. I 33/2012, p 1504 and becomes effective on November 1, 2012. The signature for the Act to amend the German Transplantation Act is still pending, but is expected soon. The goal of both laws is to increase the number of organ donations.

The Act to Amend the German Transplantation Act

The Act to Amend the German Transplantation Act (BR-Drs. 292/12) results from the implementation in national German law of the European Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation. Directive 2010/45/EC only applies to organs used in research where they are intended for transplantation into the human body, Art. 2 Subsec. 2 Directive 2010/45/EU.

The Act to Amend the German Transplantation Act not only amended the TPG, but also the Social Act related to the statutory health insurance (Social Security Code 5), statutory accident insurance (Social Security Code 7) and the Act of Continued Payment in Case of Sickness (“Entgeltfortzahlungsgesetz”, “EFZG”). The new regulations shall ensure the quality and safety of human organs and improve the transplantation processes in hospitals. Each hospital with an intensive care united must appoint a transplantation officer (§§ 9a, 9b TPG as amended).

The rights of living donors are also enhanced. Each living donor is now entitled to claim reimbursement for medical treatment expenses, travel expenses, expenses for rehabilitation and sick payments related to the transplantation from the organ recipient’s statutory or private health insurance (§ 3a of the Act of Continued Payment in Case of Sickness; Paragraphs 27 Subsec. 1a, 44a Social Security Code 5). The private health insurance companies entered into a voluntary agreement on February 9, 2012 to cover the expenses of living organ donors, including medical treatment, travel, lost earnings, and rehabilitation. In addition, organ transplantation is now considered as unemployment through no fault of the donor so that the living donor now can claim continued payment of remuneration for six weeks. Medical treatment of donors will be provided by highly specialized physicians.

The most important change addresses the statutory accident insurance for any health damages caused by the organ donation procedure, which exceed the regular impairment of health (§ 12a Social Security Act 7). In this case, any claim related to the health damage, e.g. kidney failure after kidney donation, will be covered by the accident insurance instead of the health insurance. The Act to Amend the German Transplantation Act also covers cases of health damages occurred since 1997 (§ 213 Subsect. 4 Social Security Act 7). With these new regulations, statutory health insurance does not have to cover the costs and will be financially relieved.

The Law to Regulate the Opt-In Solution for Organ Transplantation 

To increase the willingness to donate organs among the citizens, the Law to Regulate the Opt-In Solution for Organ Transplantation regulates the opt-in solution for living and post mortem donations. The extended approval has been changed to informed consent (opt-in). The new informed consent requirement is regulated in § 1 Subsec. 1 TPG (as amended) as follows:

"(1) Goal of this Act is to support the willingness of organ donation in Germany. Thus, each citizen has to be put in a position to question the own willingness to donate organs on a regular basis and to document the decision. To ensure a voluntary and informed consent a broad general education about the possibilities to donate organs and tissues is included." (my translation)

The new law, while protecting donors, asks each German citizen to make a decision on organ transplantation. Each German citizen older than 16 years will receive a letter from the health insurer informing them about the possibility to donate organs (§ 1 Subsec. 1a TPG as amended). Everyone will be informed and asked on a regular basis. To ensure that a voluntary consent is given, the German Federal Centre for Health Education (“BZgA”) as well as the statutory and private health insurances are responsible to educate the citizens as well.

Consequences for Research with Human Cells and Tissue?

The most recent changes to the TPG do not have direct consequences to biobanks and research with human cells and tissue. However, the TPG justifies the necessity to obtain an informed consent from study subjects before using human cells and tissues in research. Specifically, based on the regulations in the TPG, informed consent is required prior to post mortem donations of cells and tissue for research. The use of human cells and tissue in research is not directly regulated under German laws. Therefore, other laws such as the TPG are applied to the research use. Thus, the same standard that applies to organ donations should also apply to research donations. As such informed consent is now, more than ever, mandatory.

These developments lead to important questions. For example: How, following the organ donation model, can increased education about the use of human tissue in research improve patients willingness to be research donors? Would it be ethical to require people to make a decision to donate their cells and tissue for research? Would such a regulation have an influence on the voluntariness of informed consent?

In addition, the Act to Amend the German Transplantation Act only regulates that donors of organs and tissue will be reimbursed for their expenses (see above). The Act does not state explicitly if this regulation is also applicable for donors of organs and tissues used in research. At the same time, nothing in the act says that the new regulation is not applicable for the research donations. Can the act be used to reimburse “research donors”? Would it be legal and ethical to reimburse research donors in the same way as organ donors? Should a research donation be seen in the same way as the commonly known organ transplantation?

I intend to address these and other questions in a separate publication that I will describe in future posts.

-- Bianca Buechner, Ph.D., LL.M. Candidate
Indiana University Robert H. McKinney School of Law

Community Roundtable, April 9: Biobanking 101: What are they and how can the public participate?

If you're in central Indiana this coming April, you might want to attend a community event on biobanks. PredictER's Eric M. Meslin will be directing a roundtable discussion on biobanks on April 9 from 11:30 a.m. to 1 p.m. at the Indiana Historical Society, 450 W. Ohio St.

This event is sponsored by The Fairbanks Institute for Healthy Communities and the Indiana Clinical and Translational Sciences Institute Community Health Engagement Program.

Eric M. Meslin, PhD, is director of IU Center for Bioethics and associate dean for bioethics at the IU School of Medicine. He also co-directs the IU Center for Law, Ethics and Applied Research in Health Information and directs the Indiana CTSI Bioethics and Subject Advocacy Program.

Parking is free and lunch will be provided. To register, visit redcap.uits.iu.edu/surveys/?s=g6M4FP.

For more information, see the event flier.

Newborn Blood Spot Banking in Canada

A controversy that began in Minnesota and Texas has spread north of the Canadian border to British Columbia. The BC Civil Liberties Association (BCCLA) is opposing the potential research use, without parental consent, of 800,000 newborn blood spots stored in a facility operated by Iron Mountain of Burnaby, B.C. The BCCLA published a press release on May 12 explaining its opposition and its concerns regarding B.C. Legislative Assembly 2010, Bill 11. The BCCLA describes Bill 11 as: "a grab bag of miscellaneous legislative provisions, including sections 165-167 that give the Minister of Health power to collect, gather, use and share personal information without any notice to or consent from affected individuals."

In addition to opposing Bill 11, the BCCLA's David Eby and an unnamed parent are challenging the privacy practices of the B.C. Newborn Screening Program operated by the B.C. Women's Hospital. The hospital's president, Dr. Jan Christilaw, insists (in The Province), “No researcher is actually going to walk out of there with someone else’s blood.” However, at CBC News, the Screening Program's director confirms "some of the samples have ... been used by medical researchers to establish 'normal values and ranges'" to improve testing methods. Nonetheless, privacy advocates are not satisfied. The Globe and Mail (and others) quoted one worried parent, Rhian Walker:

“This was never, ever explained anywhere to me .... I think this would change a lot of parents’ perception of that test. You’re trying to do what’s best for your baby, so I’m a bit taken aback to learn that now that information is being stored and utilized in a way that I haven’t given consent for.”

Although, Eby wants samples stored without consent to be destroyed, Christilaw confirmed in The Vancouver Sun that "staff are finalizing an opt-out part of the program, so parents will be able to decide up front if they wish to participate in the screening."

While BCCLA's advocacy may or may not slow the progress of Bill 11, will it discourage the uptake of a valuable public health service?

Related:

Katherine Drabiak-Syed. Newborn blood spot banking: approaches to consent. PredictER Law and Policy Update. Indiana University Center for Bioethics. March 12, 2010.
Jere Odell. Newborn Blood Spots, Biobanks, and the Law: Research Ethics in the News. Indiana Bioethics. February 2010.
Link: National Newborn Screening and Genetics Resource Center

Other Predictive Health Ethics News

Dan Vorhaus. DNA Spit Kits Off Walgreens’ Shelves? Try Amazon.com. Genomics Law Report. May 13, 2010.
Michael Rugnetta. FDA Intervention Shelves Plan for Drugstore Genome Tests. Science Progress. May 13, 2010.
Andrew Pollack. Walgreens Delays Selling Personal Genetic Test Kit. The New York Times. May 12, 2010.
Courtney Hutchison. Over-the-Counter DNA Testing: Wave of the Future or Waste of Money? ABC News. May 11, 2010.
Philippa Brice. US genetic discrimination complaint. PHG Foundation News. May 7, 2010.
Sound Ethics. The Immortal Life of Henrietta Lacks. Sound Medicine. May 2, 2010.
Bridget M. Kuehn. NIH Launching Genetic Test Registry. JAMA. 2010;303(17):1685.
Keith Doyle. UK Biobank 'close to signing up 500,000 participants'. BBC News. April 24, 2010.
Nuffield Council on Bioethics. Human bodies in medicine and research: consultation. Nuffield Council on Bioethics. April 19, 2010.
Larry Greenemeier. Case Studies Reveal that Patents Can Hinder Genetic Research and Patient Care. Scientific American. April 16, 2010.

- J.O.

Havasupai Tribe and Arizona State University Settlement Agreement: ASU to Return the Blood Samples

On April 21, 2010 the New York Times reported that the Havasupai tribe and Arizona State University (ASU) arrived at a settlement agreement relating to litigation over ASU’s alleged misuse of the Havasupai tribe’s blood samples originally collected for diabetes research. (Visit our forthcoming Human Specimen Collection, Biobanking, and Genetic Research Law and Policy Update for more information on the case.)

After millions of dollars spent on litigation in various suits, the tribe and ASU entered into the settlement agreement in March of this year. The settlement contains several provisions including details for ASU’s performance obligations such as:

(1) ASU will pay the plaintiffs a sum of $700,000;

(2) ASU will return all blood samples in its possession; and

(3) ASU will return documents such as lab books and genealogy materials containing research derived from the blood samples, it will direct IRBs at the universities involved in the suit not to approve ongoing or new research using the samples, and it will provide the tribe a list of entities to which it previously transferred the samples.

The settlement agreement also set forth a creative five year collaborative between ASU and the tribe designed to address the tribe’s needs in the areas of education, health and nutrition, economic development, architecture, engineering, and legal governance. Several of these provisions include pursuing funding opportunities to build a high school near the reservation, partnering ASU nursing students to provide clinical care in Supai village, and working with the tribe to develop business plans related to its tourism programs.

Like many other settlements, this agreement specified a monetary exchange. ASU's transfer of $700,000 (split among the forty-one plaintiffs) seems nominal compared to plaintiffs’ request for $25 million in compensatory damages and $25 million in punitive damages. However, unlike other agreements, the money was arguably not the central concern here and would never alone be sufficient to remedy plaintiffs’ alleged damages without addressing the use and possession of the blood samples.

The return of the samples and research materials highlights several important issues that suggest our current standards and assumptions governing biobanking research are inadequate to address the needs of all research subjects, especially if blood and DNA is particularly significant to a group's cultural values and sense of identity.

First, subjects must be fully informed when they provide consent to use their blood for genetic research and the scope of the research should not exceed the original consent. Second, using the blood for purposes beyond the scope of the original consent may present serious dignitary concerns that researchers may overlook because the substance of these concerns may not even register as a possible harm or risk. Indeed, one of the ASU researchers maintained she was advancing important research and refered to the tribe's claims as "hysterical." Lastly, the importance of how the samples are (mis)used can be so vital to a particular group that return of the samples may be the only mechanism to fully remedy the group’s alleged dignitary harms.

-Katherine Drabiak-Syed

In the Literature: Altruism, the Self and Genetic Research

Ethicists and medical researchers often think about the barriers to participation in research. People want to know exactly what keeps potential participants away from a valuable research project? Likewise, many want to know what could be done to (safely and fairly) lower the barriers to participation in research. The opposite question, however, is equally interesting: Why do people do it? What motivates patients and others to consent to medical research?

Nina Hallowell, et al. examine these questions in the context of cancer research and biobanks in their recent paper “An investigation of patients’ motivations for their participation in genetics-related research” (J Med Ethics. 2010 Jan;36(1):37-45). The authors conducted interviews with 59 patients formerly enrolled in research studies at a regional genetics service (Wessex Clinical Genetics Service, Southampton, UK). After pouring through what must have been a large stack of transcripts, the authors identified three frequently expressed motivations: 1) “Selfish” – subjects expected to benefit from the research by receiving better care or other rewards; 2) Familial altruism – subjects wanted to contribute to efforts that might help future cancer patients (including grandchildren) in their families; and 3) Social altruism – subjects expressed a desire to do something that would benefit society and improve the health of all. After using these categories to evaluate the motivational statements, the authors declined to assert that any single type was a sufficient description of why patients consent to genetic research studies. They write: "these framings were frequently juxtaposed within the interviews, so that, in practice, it was difficult to characterise interviewees’ accounts as either self- or other-oriented". And again: "drawing upon any one motive to account for one’s behaviour in this context is not sufficient, for each motive would appear to impact upon, alter and modify others in a recursive or dynamic fashion".

They also provide a graphic to help us visualize the inter-related motivators in the genetic research participation engine:


My thoughts:

While I do not doubt that motivations are multi-layered and that a single individual may be motivated simultaneously by personal need and social altruism, I think the authors decided to down play the importance of the "personal framing" (or “selfish reasons”) in subjects’ decisions to consent to genetic research. In fact, the paper reports: "The majority of interviewees, like P124, offered personally motivated reasons for their research participation at some point in their interview". The importance of self-centered motivations is also clear in the graphic above. In other words, while it may be difficult to untangle these motivations, the gears might stop turning altogether if one were to remove "personal framing". I do not think the authors would disagree with me (and if they read this post, they are more than welcome to comment); perhaps the authors do not want to lose the point that altruism cannot be a stand-alone motivator. In fact, the discussion ends with a compelling statement:

Such observations suggest that we may need to rethink the concept of altruism … the “moral character of research participation”. Also, as we noted earlier, we need to recognise that when it comes to accounting for research participation we can no longer regard altruism and selfishness as incompatible or oppositional concepts. Indeed, it would appear that research participation is experienced as a more ethically contentious activity than has heretofore been assumed.

Reference:

Hallowell N, Cooke S, Crawford G, Lucassen A, Parker M, Snowdon C. An investigation of patients' motivations for their participation in genetics-related research. J Med Ethics. 2010 Jan;36(1):37-45. PubMed PMID: 20026692.

Related:

Dixon-Woods M, Tarrant C. Why do people cooperate with medical research? Findings from three studies. Soc Sci Med. 2009 Jun;68(12):2215-22. Epub 2009 Apr 24. PubMed PMID: 19394741.

Geller G, Doksum T, Bernhardt BA, Metz SA. Participation in breast cancer susceptibility testing protocols: influence of recruitment source, altruism, and family involvement on women's decisions. Cancer Epidemiol Biomarkers Prev. 1999 Apr;8(4 Pt 2):377-83. PubMed PMID: 10207643.

Treloar SA, Morley KI, Taylor SD, Hall WD. Why do they do it? A pilot study towards understanding participant motivation and experience in a large genetic epidemiological study of endometriosis. Community Genet. 2007;10(2):61-71. PubMed PMID: 17380055.

Other Recent Predictive Health Ethics Articles – PubMed, Nov 2009 -Jan 2010

-- J.O.

Children, Biobanks and Consent

In a recent policy forum published in the Science, ethicists argue in favor of a policy to recontact children once they reach "the age of consent" to seek permission for continued research on their DNA samples and data. The authors would make an exception for children with samples in disease-specific biobanks. As they see it, the therapeutic benefits of participation in the disease-specific biobank outweigh the risks to subject. While the authors acknowledge the difficulty of maintaining an active biobank while tracking samples and relocating subjects for adult consent, they point to the "long-term benefits of maintaining public trust in biomedical research".

In a related news story, Mats Hansson of Uppsala University in Sweden, Karen Maschke, of the Hastings Center, Ronald Green, director of the Ethics Institute at Dartmouth College, and other ethicists comment on the Science policy forum; see: Child DNA donors should have their say.

References

Gurwitz D, Fortier I, Lunshof JE, Knoppers BM. Research ethics. Children and population biobanks. Science. 2009 Aug 14;325(5942):818-9. PMID: 19679798.

Dolgin E. Child DNA donors should have their say. Nature News. August 13, 2009. doi:10.1038/news.2009.819.

Other Predictive Health Ethics News

Ameer B, Krivoy N. Direct-to-Consumer/Patient Advertising of Genetic Testing: A Position Statement of the American College of Clinical Pharmacology. J Clin Pharmacol. 2009 Aug;49(8):886-8. PMID: 19602717.

Boddington P. The ethics and regulation of direct-to-consumer genetic testing. Genome Med. 2009 Jul 20;1(7):71. PMID: 19638186

Bowen DJ, Harris J, Jorgensen CM, Myers MF, Kuniyuki A. Socioeconomic Influences on the Effects of a Genetic Testing Direct-to-Consumer Marketing Campaign. Public Health Genomics. 2009 Jul 28. PMID: 19641293

Darnovsky M, Reynolds J. The battle to patent your genes: the meaning of the Myriad case. The American Interest [Online]. September-October, 2009.

Giordano J. Quo vadis? Philosophy, Ethics, and Humanities in Medicine - preserving the humanistic character of medicine in a biotechnological future. Philos Ethics Humanit Med. 2009 Aug 14;4(1):12. PMID: 19682382

Serrano-Delgado M, Novello-Garza BI, Valdez-Martinez E. Ethical issues relating to the banking of umbilical cord blood in Mexico. BMC Med Ethics. 2009 Aug 14;10(1):12. PMID: 19678958

Wade N. Genes tied to gap in treatment of Hepatitis C. The New York Times. August 16, 2009.

Wade N. Cost of decoding a genome is lowered. The New York Times. August 10, 2009.

Wright C. Understanding DTC gentic risk prediction services. PHG Foundation News. August 14, 2009.

Wright C. Update on genetic non-discrimination legistlation. PHG Foundation News. August 10, 2009.

- J.O.

Consent & Conversation in Population-Based Research

PredictER's Peter H. Schwartz will be presenting the Walter C. Randall Lecture in Biomedical Ethics at the annual Experimental Biology meeting of the American Physiological Society, to be held in New Orleans, April 18-22, 2009. Dr. Schwartz's talk, Consent and Conversation in Population-Based Genetic Research, will take place on Tuesday, April 21st at 2:00 p.m. Additional information is available here.


Abstract: The future of research into the human genome depends on the creation of massive biobanks, databases that combine phenotypic information about individuals (such as their medical history) with genetic information and biologic samples collected from them. Some of the most important biobanks will involve the participation of thousands or millions of people, representing a broad swath of an entire community. But signing up such large numbers raises serious challenges for traditional ideas of consent by research subjects. We need to formulate a new model of ethical research that relies on a conversation with a community rather than just informed consent by individuals.

Amy Lewis Gilbert

Translational Medicine, Cancer and Biobanks: Predictive Health Ethics Events at IU

On December 1-2, 2008 the Indiana Health Industry Forum will present From Basics to Bench to Bedside: Emerging Trends and New Developments in Cancer Discovery, Diagnosis and Treatment. The purpose of this summit, the third in a series, is to examine the state of life sciences research in Indiana with a diverse range of individuals and institutions interested in cancer research, diagnosis and treatment. Of particular interest to those keen on predictive health is a panel discussion on December 2nd at 1:00 PM entitled “Tailored Therapeutics and Implications for Regulatory Endpoints.” Panelists include Jerome Yates, MD, MPH, National Vice President for Research at the American Cancer Society, Eric Meslin, PhD, Director of the Indiana University Center for Bioethics (IUCB), Lawrence Lesko, PhD, FCP, Director of the Office of Clinical Pharmacology at the FDA’s Center for Drug Evaluation and Research, and Silvana Borges, MD, Medical Officer for the Genomics Group of the same.
   
On December 4, 2008 the Indiana Clinical and Translational Sciences Institute and IU Simon Cancer Center are hosting a symposium entitled Biorepositories: Scientific, Technical and Ethical Considerations at the Cancer Research Institute on the Indiana University – Purdue University Indianapolis campus. IUCB Faculty Investigator Jennifer Girod, JD, PhD, RN, will be giving a talk on “Ethical and Legal Considerations in Biobanking.” Other presentations will address issues specific to the storage of biospecimens, the extraction and processing of RNA and DNA, tissue procurement, the impact of storage conditions on DNA, and the benefits of biorepositories to research.

On December 8- 9, 2008 the Indiana University School of Medicine will be holding an event that addresses the FDA in the 21st Century: Issues and Their Impact on Medical Technology. This event, which will focus on the future role of the FDA in a changing market, is part of the medical school’s Medical Technology Leadership Forum [Flyer - PDF]. IUCB Director Eric Meslin, PhD, will be moderating a morning session on December 9th specific to ethics and conflicts of interest with Ora Pescovitz, MD, President and CEO of Riley Hospital for Children and Elazar Edelman, MD, PhD, Director of the Harvard-MIT Biomedical Engineering Center. – Amy Lewis Gilbert

Patient Attitudes Toward Genotyping: Willingness to Donate

The November 2008 issue of Obstetrics & Gynecology included an article addressing an Indiana University study which sought to ascertain the willingness of women to donate DNA specimens. The article, “Patient Attitudes Toward Genotyping in an Urban Women’s Health Clinic” (David M. Haas, Jamie L. Renbarger, Eric M. Meslin, Katherine Drabiak, and David Flockhart), acknowledges the great promise of the emerging fields of genotype association studies and pharmacogenetics, which will theoretically allow for targeted medical interventions, personalized drug therapies and the more efficient allocation of healthcare resources. The study compared women’s willingness to donate DNA specimens via blood and saliva collection, and looked at several other factors to confirm the findings of previous studies regarding which of those factors predicate a willingness to donate. The authors found that more women are willing to donate DNA using saliva than blood, and that higher levels of education (college and beyond) and greater knowledge of genes and DNA increase women’s willingness to donate.

So how do these findings translate into ethical practice? How will they inform the future collection of samples for both medical and research purposes? It seems that researchers and practitioners should bear in mind that less-invasive methods of DNA procurement are preferred, and that education about purpose and use be stressed during the informed consent process. When asked about the translational implications of this study, Dr. Eric Meslin, co-author and Director of the Indiana University Center for Bioethics, said: “the key to success in any biobanking effort lies in the scientific community’s ability to both acquire and maintain the public’s trust. Informed consent may be evidence of the public’s willingness to permit specimens to be used for research, but consent should never be confused with the public’s willingness to trust science to do the right thing.” -Amy Lewis Gilbert

DNA Biobanks: The Five Minutes Between Nashville and Dundee

Here at PredictER we're very interested in the attitudes of healthcare professionals regarding DNA biobanking. In fact, we recently collaborated in a study of attitudes at a local children's hospital. Thus, I was excited to read the results of similar survey research from Vanderbilt University School of Medicine. David A. Leiman, Nancy M. Lorenzi and some other bioinformatics folk in Nashville appear to have been working on this topic for a few years now - beginning with focus groups in 2000 and including a recent international, comparative survey. In "US and Scottish Health Professionals' Attitudes toward DNA Biobanking" [J Am Med Inform Assoc. 2008 May-Jun;15(3):357-62. Epub 2008 Feb 28. | PMID: 18308988], the authors compare the attitudes of healthcare professionals in Nashville with the attitudes of those in Dundee, Scotland. While they expected that the difference between a mostly private (U.S.) and a more socialized (U.K.) healthcare system would impact attitudes, they discovered that the attitudes were not that far apart. Presumably, the authors thought that U.S. health professionals would worry that genetic information might be misused by insurance companies in the private healthcare system and, thus, would be less likely to support biobanking. As it turns out the attitudes of the two survey groups were very similar. Of the fifteen questions in common, significant differences in attitude were found on only three questions. The Dundee professionals were slightly less supportive of creating a DNA biobank and (most importantly) were less comfortable with the idea that they might be asked to consent patients for DNA samples.

In the discussion of the results the authors speculate that time constraints in Scotland might be at the root of this slight difference in professionals' attitudes about "consenting" patients into participating in the biobank:

While many U.S. practices are expected to see patients 12-15 minutes, Scottish doctors are expected to perform the same visit in 7-10 minutes. The additional burden of consenting, or even explaining a biobank project, may be an overwhelming challenge to integrate into the existing workflow.

Those "extra" five minutes of time in which to meet a patient's needs in the U.S., therefore, might account for the greater support ("Strongly Agree" versus "Agree") for DNA biobanking. The authors also mention the difficult nature of obtaining consent for this research – without a complicated: "Traditional consent procedures require researchers to contact participants each time a new investigation is undertaken with the same existing information". Let's hope that the validity of the patient's consent isn't sacrificed to better accommodate the busy schedules of the healthcare professionals. - J.O.

ELSI After Francis Collins: What Now?

In an editorial published today, "This time it's personal" (Nature 453, 697 (2008) | doi:10.1038/453697a ), Nature adds to the many comments on Francis Collins's announcement that he will step down from his 15 year position as head of the US National Human Genome Research Institute (NHGRI). Like most comments on Collins's career at NHGRI, the editorial praises the leader for his ambition, political acumen, and emphasis on the ethical implications of genomic research. In addition to leading the Institute to the successful sequencing of the genome in 2003, Collins helped to initiated the International HapMap Project, ENCODE, and the 1,000 Genomes Project. He also lobbied for the passage of GINA (H.R. 493) and was a constant advocate for the inclusion of public outreach and ethics education in genomic research.

Collins's emphasis on the ethical issues and the NHGRI's ELSI program laid the conceptual groundwork that informs much of the work we do here at PredictER. In fact, thanks to the support of The Richard M. Fairbanks Foundation, Inc, the Indiana University Center for Bioethics has been answering Collins's call to address the ethical implications of genetic and genomic research by focusing on both research ethics and medical ethics as the science is translated into current and future predictive health care.

The editorial also mentions some of the challenges that the next director of NHGRI will face. These challenges include a shrinking budget and waning political support:

Although Collins says he has no concrete plans … the future of NHGRI is more cloudy than his own. The funding situation of the NIH has been gloomy for years, with flat budgets stifling many potentially worthy projects. And with Collins gone, the NHGRI may become more of a target for politicians who feel it has run its course.

Of course, the challenges also include existing and unanticipated ethical and legal issues. As the Nature editorial notes: "Genomics is now at a point where the science and technology are moving much faster than society's ability to assimilate and make sense of the information".

One challenge that this editorial does not mention directly, but seems, nevertheless, to be implied by the shrinking public budget, is the fact that much predictive health research will be (and currently is) receiving commercial support. This should not be a surprise. If we want genomic research to result in better personalized medicine, we should expect that the life science industry will invest in the research. At the same time, however, there's no better moment than now to accelerate the investigation of the specific ethical issues of doing commercially supported genomic and predictive health research. For example, here are a few questions that jump to my mind:

Must a research biobank disclose to donors in the informed consent policy that research results may result in commercial products?

Must or should these biobanks share the income from tissue or data sales with donors?

Should pharmacogenomic companies and other patent holders be expected to share financial rewards with research participants or even with the communities to which these participants belong? - J.O.

Resource Recommendation: NIH Points to Consider - GWAS and IRBs

Genome-Wide Association Studies (GWAS): NIH Points to Consider for IRBs and Institutions in their Review of Data Submission Plans for Institutional Certifications Under NIH's Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) 12 November 2007. Accessed 12 May 2008 from: http://grants.nih.gov/grants/gwas/gwas_ptc.pdf

These guidelines go beyond the regulatory requirements of 45 CFR part 46 as outlined by the OHRP's 2004 policy guidance regarding privacy and biobanks (see NOT-OD-05-020 and http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf). In addition to addressing the NIH's recent emphasis on open-access publication in the context of genomic research, this document provides a de facto outline of the many consent, privacy, and disclosure issues in biobank research. Although it is a must read for anyone conducting or reviewing NIH supported GWAS research, it is also an excellent resource to skim when thinking about the ethical issues and risks of benefit sharing and biobank research.

Biobanks for Breakfast

On April 25, 2008, a collection of community leaders, top medical researchers, and statewide biotech industry leaders met to discuss the bioethical and legal issues surrounding biobanks in Indiana. Biobanks are a growing resource in biotech research. They contain samples of human biological specimens and are often linked in varying degrees to the personal health and demographic information of the donor. Biobanks range from the very small disease specific collections of tissue to the very large national sponsored banks of several million specimens incorporating several different types of biological material from persons both healthy and with known disease. Ownership and commercial involvement are among the most difficult ethical issues in developing successful biobanks. The Bioethics for Breakfast group considered these issues along with Indiana’s role in future biobanking by asking attendees to think about the following questions:

- Are you willing to donate your DNA to a biobank for medical research?
- Are you comfortable allowing Indiana companies to profit by developing commercial products from your samples and donations?

Guest speakers at the event included:

David Flockhart, M.D., Ph.D. , Chief of the Division of Clinical Pharmacology at the Indiana University School of Medicine – Dr. Flockhart outlined the national and international status of biobanks.

Mervin C. Yoder, Jr., M.D., Richard and Pauline Klingler Professor: Department of Pediatrics, Indiana University School of Medicine – Dr. Yoder discussed the therapeutic use of biobank samples.

Andrew R. Klein, J.D., Paul E. Beam Professor of Law, Indiana University School of Law - Indianapolis – Prof. Klein led the group in discussion of the difficult ethical and legal issues.

The Bioethics for Breakfast series is co-sponsored by the Indiana University Center for Bioethics and the law firm of Sommer Barnard. – Patrick Barrett

Purdue Bioethics: Ethical Issues in Constructing and Using Biobanks

PredictER's Eric M. Meslin, PhD, Director, IU Center for Bioethics, will address the Purdue Bioethics lecture series this Wednesday, April 16th, from 6 to 7 pm. Meslin will provide an overview of the ethical issues in developing and using biobanks for genetic research. The Purdue lecture series (now in its second year) intends "to build opportunities for engagement between philosophy, policy, and science at a campus-wide level and to raise awareness of the ethical implications of biotechnological development for our environment both local and global". The current year's series focuses "on two central themes in bioethics: the ethical issues of climate change and those of issues in medical technologies". Read more about Meslin's lecture or to learn more about the series contact Jonathan Beever or Nicolae Morar at Purdue Bioethcs. Also see the international blog, BlogEthics Purdue.

Racing for the Biobank

Here in Indianapolis the city is preparing for one of the biggest annual gathering of runners in the region. On April 19th thousands of runners and walkers will converge on the Indiana University-Purdue University, Indianapolis (IUPUI) campus for the The 2008 Komen Indianapolis Race for the Cure. While there will be plenty of people milling around after the 5k race and walk, many of the participants will also donate DNA and blood to a predictive health research study. The Susan G. Komen for the Cure Tissue Bank at the IU Simon Cancer Center will collect blood samples for the biobank from both women with and without a high risk for breast cancer. In a press release from the Indiana University School of Medicine, Dr. Susan Clare, a co-principal investigator of the tissue bank, notes that:

Collecting blood from women who have not had breast cancer provides an opportunity for these donors to give a unique gift to science …. Even though these donors will not benefit directly from their donation of blood, they are providing an invaluable resource to enable research that will benefit generations to come.

The upbeat tone in this quotation is nurtured by more than a keen eye for good public relations—past tissue bank drives at the race have been a wild success. So, is this a good way to build a predictive health biobank? Would similar outreach methods work for other diseases? How about a 5k race to cure for diabetes or schizophrenia? Would runners turn out in equal numbers? Would participants be as willing to donate after the race? Undoubtedly the organizers of this tissue bank and the Komen Race for the Cure have done an excellent job of advocating for this research, but is there something about breast cancer or about our culture that might (perhaps disproportionately) encourage potential research participants to join the cause?

Biobanks: Consent or Re-Consent?

Participants donating samples to research biobanks are, often, contributing to a research resource that may be used for unanticipated research purposes in the future. For example, a participant may donate to a cardiovascular research biobank, but this donation might also be of value for future diabetes research. If a secondary use for this donation is discovered, should researchers be required to re-contact participants to secure consent for the previously unspecified research? Many researchers consider the labor of re-contact and re-consent to be a burden that will inhibit future research. Acquiring one-time, general consent for research, therefore, would seem to be the best and most efficient way to encourage the pace of medical research.

Many ethicists, and the World Health Organization (WHO), however, argue that one-time consent violates a research participant's autonomy. If a participant does not have the opportunity to evaluate these possible future uses and to decide whether their sample and information can be used for them, is the importance of informed consent being undermined?

Wednesday, at a noon seminar hosted by the IU School of Medicine's Department of Medical and Molecular Genetics, PredictER's Peter Schwartz critically evaluated some of the most prominent ethical arguments against one-time consent and described the complexity of deciding the role of autonomy in this realm. In his presentation, "Changing the Rules? Consent and Re-Consent in Predictive Health Research", Schwartz argued that it is not clear that a carefully constructed policy of one-time consent violates autonomy of subjects. While it would be inappropriate to justify such “one-time consent” simply on the basis of the social value of the research involved, or public support for such a policy, a careful reconsideration of autonomy may allow certain kinds of “blanket consent” policies. In his assessment, the path forward for consent for research involving biobanks is far from clear, but a possibility like one-time consent cannot be dismissed simply by appealing to a simple notion of autonomy. The crafting of responsible policies in this area will require more careful reflection on the relevant ethical notions.

Additional Reading:

45 CFR §46.116 - General requirements for informed consent. Department of Health and Human Services.

Caulfield T, Upshur RE, Daar A. DNA databanks and consent: a suggested policy option involving an authorization model. BMC Med Ethics. 2003 Jan 3;4:E1. PMID: 12513704

Genetic databases. Assessing the benefits and the impact on human and patient rights. World Health Organization, 2003. [PDF]

Predictive Health: Best Ethics Blogs - February 2008

This second, monthly installment (see January's Best Ethics Blogs) includes blogs on the ethical issues of biobanking, the risks of genetic testing and discrimination, responses to a recent New York Times article, and thoughts about Google Health and HIPAA compliance. Entries are listed below by topic and date.

Biobanks

Biobanking, part 3: returning research results to participants. Sue Trinidad, Women's Bioethics Blog. 4 February 2008.

Continuing her excellent series on biobanking, Sue Trinidad, asks readers to consider the following scenario: "Let's say that--20 years after you consented to participate in a breast cancer study--researchers working on a different project discover that you carry a genetic mutation that has been definitively linked to Serious Medical Problem X. ... Do the researchers have a professional and/or moral obligation to share this information with you?"

More on BioBanking. Sue Trinidad, Women's Bioethics Blog. 6 February 2008.

In a fourth post on biobanking, Trinidad responds to a BBC News story ("Change planned on cloning consent", 2 February 2008). The story reports that the UK government may allow the use of tissues donated for research for embryonic cloning without requiring the explicit consent of donors. Sue asks: "[J]ust what should be the scope of allowed activities under a 'blanket' or 'one-time' consent? Also, should the research imperative (and perhaps the common good) outweigh individuals' preferences in such cases?"

[Also see Trinidad's posts on the clinical utility of genetic tests (1 February 2008) and beneficiaries of prenatal genetic diagnosis (22 February 2008).]

Consumer Genetics

While The DNA Network provides a constant stream of quality blogs on the ups and downs, ins and outs of direct-to-consumer, genetic medicine, two caught my attention this month for demonstrating creativity and gumption.

Polls Closed, Myriad Tallies Up and We await Navagenics! Steve Murphy, Gene Sherpas: Personalized Medicine and You. 11 February 2008.

In an informal survey of his readers, Murphy discovers that most think 23andMe is the most likely to be sued first. In assessing the litigious environment, the Sherpa (Murphy's pithy alter-ego) comments: "If I had a law degree … I would bone up on genetics legal precedent, corporate protections and genetic discrimination. If you think a certain ex-candidate for president made a bundle suing OB/Gyns, you haven't seen the beginning of the legal fortune to be made in genomics."

DNA Videos: Genetic Testing on NBC Nightly News. Hsien-Hsien Lei, Eye on DNA. 13 February 2008.

In this post Lei embeds videos from the Robert Bazell NBC Nightly News series "The Truth About DNA". One of these features Stanford's Hank Greely, who expresses his worries about the genetic testing market place. In a follow-up blog post, Bazell laments a "frightening lack of government regulations". After wondering if Greely and Bazell are "easily scared", Lei takes the advice of a genetic counselor (Ellen Matloff) and writes a sample letter for "Johnny" to open a discussion of his genetic test results with his family members. Will his parents be surprised to discover that he blames them for everything? Maybe someone should persuade Johnny's "parents" to write a reply.

Discrimination

Q&A with MDV’s Bill Ericson: On PacBio’s origin, why Gattaca isn’t our future, and throwing out your statins. David P Hamilton, VentureBeat: Life Sciences. 15 February 2008.

In this interview with Bill Ericson of Mohr Davidow Ventures, Hamilton asks: "What about the potential downsides, such as genetic discrimination that could leave many people uninsurable, or even the possibility that society could end up stratified by genetic caste, as in the movie Gattaca?" Ericson responds, in part, "I worried a lot about those negative implications when we started investing, but American society is, I think, mature enough to deal with the information, whether by legislation or via general social norms."

Rewarding Ignorance. Doug Masson, Masson's Blog – A Citizen's Guide to Indiana. 24 February 2008.

Doug Masson was among the many bloggers (including Steve Murphy and Sue Trinidad) responding to Amy Harmon's New York Times article "Insurance Fears Lead Many to Shun DNA Tests" (24 February 2008). After describing how the insurance industry needs a degree of "ignorance" to survive, Masson observes: "as our knowledge of a person’s likely health care profile increases, paying for medical treatment becomes less about managing risk through insurance and more about determining what our obligations might be toward our fellow humans in subsidizing their ability to live and/or remain healthy".

Bipolar Blood Test? Let The Bloodbath Begin. Philip Dawdy, Furious Seasons. 28 February 2008.

Dawdy, a patient, reacts to the latest research news about the search for psychiatric biomarkers. Research at Indiana University School of Medicine has isolated blood markers to identify mood disorders. Lead author, Alexander B. Niculescu III, M.D., Ph.D. (a future guest at our weekly PredictER meeting), hailed the research as "a major step towards bringing psychiatry on par with other medical specialties that have diagnostic tools to measure disease states and the effectiveness of treatments". If, however, a test is developed, Dawdy declares, "I am going nowhere near that test because its results--unless you do the test privately--will follow me the rest of my life and be used to discriminate against me and people like me in insurance (health and life), employment, schools, housing and God knows what all".

Health IT and Medical Records

Of Slelling and Men. Steve Murphy, Gene Sherpas: Personalized Medicine and You. 3 February 2008.

After defining "slelling" and recounting the scandals that have limited the possibility of selling health data without the explicit consent of patients, Murphy cites Emanuel EJ, Wendler D, and Grady C (2000) to summarize how "ethicists feel" about data acquisition in clinical research.

Engineering Grand Challenges – Advancing health informatics. Deepak Singh, bbgm. 19 February 2008.

In reviewing an article published on the National Academy of Engineering website, Deepak Singh notes that the technological challenges of health informatics are inseparable from some common ethical concerns. Singh's notes that "[w]hile the article refers to privacy and security, it does not address the issues of content ownership and data portability". Among the questions the Singh would like to see answered are: "Who owns someones medical data? How does it move from one system to another? What parts can a physician have access to? [And] what are the dangers of a system controlled by the user … [?]"

Google PHR roll-out: how personal will a personal health record be? David Harlow, HealthBlawg. 24 February 2008.

Although any news about Google's developing personal health records platform "Google Health" results in an avalanche of blog posts, David Harlow was among the rare bloggers to recognize and speculate about the medical research potential of these records. In reflecting on the privacy and HIPAA challenges that Google's personal health records may bring, Harlow remarks:

So let's assume the worst: Google will sell ads to the highest bidders for keywords in your PHR (kinda OK so long as there's adequate disclosure up front), will sell aggregated de-identified data for population-based health studies (ditto, but this seems more like a good thing, and is really at the heart of the value of EHRs and PHRs generally -- though the utility depends on how much data really finds its way into the PHR, and how it's organized) and worst of all, will mistakenly convert your PHR into an RSS feed that ends up on every computer in America (eek! . . . but is that worse than dropping a paper record behind a file cabinet and never finding it again?) … Every innovation comes with a set of benefits and burdens.

Politics

One gene, two genes; red genes, blue genes. Jesse Reynolds, Biopolitical Times. 14 February 2008.

Reynolds responds to an article published in New Scientist, "Two tribes: Are your genes left-wing or right-wing?" (2 February 2008). Following a critical assessment of the media coverage and a skeptical review of efforts to study the genetics of political attitudes and behavior, Reynolds identifies a potential "disturbing" social implication for such research: "accepting that genes determine political orientation could cause deepening political apathy … Heck, why bother voting when you could just have your cheek swabbed?"

The Genetics & Public Policy Center - Public Consultation Dates

The Genetics & Public Policy Center at Johns Hopkins University recently released the dates for its upcoming town hall discussions to "gather feedback from the public on their views related to a proposed large cohort study on the role of genes and environment in health". Meetings will be held March 8th (Kansas City, MO), April 5th (Phoenix, AZ), April 19th (Jackson, MS), April 24th (Portland, OR), and May 13th (Philadelphia, PA). These meetings follow similar meetings in the same cities last year. The scheduled "town hall" meetings are a part of the second stage in a two-year, $2 million pilot project funded by the National Human Genome Research Institute, "Making Every Voice Count: Public Consultation on Genetics, Environment, and Health". The results of last year's public consultations regarding the feasibility of a pediatric biobank were recently published in the American Journal of Medical Genetics:

Kaufman D, Geller G, Leroy L, Murphy J, Scott J, Hudson K. Ethical implications of including children in a large biobank for genetic-epidemiologic research: a qualitative study of public opinion. Am J Med Genet C Semin Med Genet. 2008 Feb 15;148(1):31-9. PMID:18189289

Predictive Health: Best Ethics Blogs - January 2008

This is the first in a series of monthly posts in which I share some of my favorite posts on the ethical, legal and social issues of predictive health research and medicine. A public and open discussion of these issues will increase the likelihood that individuals and communities will realize the benefits of advances in genetic and personalized medicine, human genome sequencing, predictive neuroimaging, biobanking, and health IT. PredictER Blog commends the following blogs for doing their part to inform and foster dialogue.

Listed by Topic and Date:

Biobanks

Biobanking and you. Sue Trinidad, Women's Bioethics Blog. 19 January 2008.
In the one of the first of what I hope will be long series, Sue Trinidad asks good questions about informed consent and reminds us that even "anonymized" DNA samples might be identifiers. She writes: "nothing is a more precise identifier of who you are than your so-called genetic fingerprint. Is this worrisome?"

Should genetic researchers be able to share your DNA? Sue Trinidad, Women's Bioethics Blog. 23 January 2008.
In her second post on ethical issues of genetic research and biobanks, Trinidad adds additional compelling questions, including: "If you'd consented to participate in that study at your local research university, how would you feel about your (de-identified) information being used by researchers somewhere else?" and "Say the researchers did [a] breast cancer study, and in the course of that work they noticed that there seemed to be a correlation between certain genetic patterns and alcoholism or schizophrenia. Would it be ok with you for them to pursue this line of inquiry using your genetic information?"

Consumer Genomics

American Society of Human Genetics (ASHG) Statement on Direct-to-Consumer Genetic Testing. Hsien-Hsien Lei, Eye on DNA. 2 January 2008.
Getting the month off to a good start, Hsien-Hsien Lei reviews the ASHG's policy statement [PMID: 18055737 excerpt] on Direct-to-Consumer Genetic Testing. Lei makes the following observation:"With increased competition in the field of direct-to-consumer personal genomics in 2008, I predict that only companies that can fully address the [ASHG] recommendations ... will survive .... Consumers are getting up to speed on what genetic testing can offer them and won’t settle for fuzzy, incomplete information."

Also see Lei's related posts on the subject, including: "The New England Journal of Medicine Gives Direct-to-Consumer Genome Scans Thumbs Down" (Eye on DNA, 10 January 2008).

Do I need a personal trainer or a personal genetic counsellor? Myles Axton, Free Association. 11 January 2008.In the editor's blog of the journal Nature Genetics, Myles Axton reviews the NEJM editorial “Letting the Genome out of the Bottle--will we get our wish?” (Hunter DJ, Khoury MJ, Drazen JM. N Engl J Med 2008; 358 (2):105-7. PMID:18184955 excerpt) Axton appreciates the skepticism and applauds "efforts to build genetics into every stage of medical education", but adds: "The authors have some good points, but largely ignore the unpredictable motivational potential inherent in handing people their genomes and asking them to participate in finding out more about their variation and phenotypes. Sometimes, the best doctor will say “we don’t know yet, let’s find out together”.

Privacy Issues

Your personal health: The internet and privacy. Deepak Singh, businessbytesgenesmolecules (bbgm). 2 January 2008.
Singh compares the success of Web 2.0, which relies, in part on "the forfeiture of privacy" to the rise of consumer genomics. Singh writes: "the moment you leave your footprint online, you are giving away some of your privacy. The moment you sign up for a genomic service, you are giving away some of your privacy. The question we need to answer is a simple one in a way. Is the benefit we get from being online, or getting yourself genotyped, worth the loss of privacy?" Singh has obviously traded some of his privacy for the benefits of Web 2.0; will he do the same for consumer genomics?

Respecting patient privacy preferences. John D. Halamka, Life as a Healthcare CIO. 21 January 2008.
Halamka is Chief Information Officer of CareGroup Health System and Harvard Medical School, a practicing Emergency Physician, a participant in the Personal Genome Project, and (among many more things) a vegan. Halamka writes: "One of the greatest challenges for healthcare information exchanges is to ensure continuity of care for patients while also respecting patient privacy preferences." He envisions a future in which electronic consent wizard will support a truly itemized process for sharing personal medical records and health data. Patients and research participants, might provide very specific consent statements, for example: "If I'm unconscious in an emergency room, share everything including mental health, substance abuse and HIV status data. If I'm visiting a Minuteclinic do not include my mental health and substance abuse history. If I'm sharing my data for a population-based research study, do not include my HIV status."

Whole Genome Sequencing

The ethical challenges of whole-genome sequencing part 1. Daniel MacArthur, Genetic Future. 22 January 2008.
In the first of a two(?) part post reviewing "Research ethics and the challenge of whole-genome sequencing" (McGuire AL, Caulfield T, Cho MK. Nat Rev Genet 2008; 9 (2):152-6. PMID:18087293), MacArthur summarizes advances in whole-genome sequencing technologies and evaluates the authors' comments on: the return of genome data to participants, the provision of clinical follow-up, and the integration of genome data and medical records. If you've read the NRG commentary, you'll be interested in this post; if you don't have a subscription to journal, you'll value MacArthur's outline of the issues. In his forthcoming part 2, MacArthur plans to "discuss the other major ethical challenges discussed in the NRG commentary: obligations to close relatives of study participants, and future uses of samples and data." Stay tuned! -J.O.