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.

Biomedical Research Ethics 2.0: MySpace and Pediatrics

Much of the excitement about the future of personalized medicine revolves around the creation of consumer managed, personal health records. To acquire a measure of the anticipation, revisit the blogging blitz inspired the by implicit competition between Microsoft's HealthVault and Google Health (see, for example, David Hamilton's reviews of HealthVault at Venture Beat and Bertalan Meskó's coverage of Google Health at ScienceRoll). Although most are interested in the potential these Web 2.0 developments hold for enhanced, individualized health care, others have speculated that personal health information may become a more common feature of social-networking sites. The big names in social-networking (MySpace and Facebook) already host user-generated groups for individuals with shared health conditions; others, such as iMedix and MyOpenCare (for more examples visit Medicine 2.0) have entered the market with an obvious interest in health 2.0 and shared, personal medical records.

Although many worry about how advertisers might data mine personal information to target potential customers, these networks also offer a new source of information for medical research data and research recruitment. With this in mind, "Research Ethics in the MySpace Era" (Moreno MA, Fost NC, Christakis DA. Pediatrics 2008;121;157-161. PMID:18166570) is a very timely publication. The authors explore the ethical implications of using MySpace profiles as: a source for observational research (potentially exempt from IRB oversight); a tool for research recruitment; and a platform for health intervention studies. Although the authors are particularly interested in the risks and benefits of social-networking sites for pediatric research, the investigation could easily be generalized for research with adult users. The authors, however, do not address the ethical implications of using shared, genetic information. Imagine a day in which users update their profiles and replace zodiac signs with significant genetic biomarkers. How would this "shared" information challenge the ethical framework proposed by Moreno, Fost and Christakis? - J.O.

Predictive Health Legislative Update: GINA, HIPSA and more ...

If you are interested in U.S. legislative developments that may impact the progress of predictive health and genetic research, you've probably heard of The Genetic Information Nondiscrimination Act (GINA). If enacted, GINA (S.358) would "prohibit discrimination on the basis of genetic information with respect to health insurance and employment". Although widely supported, GINA's progress has been stalled by the opposition of one legislator, Sen. Coburn [OK]. Coburn has placed a block on the bill and offers an evolving account for his opposition. As reported in Wired, November 17, 2007, Coburn objects to "the possibility that an employer who provides health insurance for its workers could be sued both as an insurer and as an employer". The bill's sponsor, Rep. Slaughter (NY), dismissed the latest justification for Coburn's hold as "creative".

Although GINA has received the most attention from the press and legislators (and rightly so, as it is only one roadblock away from a vote) other bills relevant to predictive health research have also been introduced. Like GINA, two of these were written with the intent to enhance the privacy of medical records. Both of these are currently waiting for review in the Senate's Committee on Health, Education, Labor, and Pensions:

S.1455 National Health Information Technology and Privacy Advancement Act of 2007
Introduced May 23, 2007, this bill aims "to provide for the establishment of a health information technology and privacy system". The bill's sponsor, Sen. Sheldon Whitehouse [RI], and four cosponsors ask for creation of the "Office of the National Coordinator for Health Information Technology". Among other things, this new "nonprofit national health information technology and privacy corporation" would identify rules for the research use of non-identifiable health care data.

S.1814 Health Information Privacy and Security Act (HIPSA)
HIPSA, reviewed here at PredictER Blog, was introduced by Sen. Leahy [VT] on July 18, 2007. While intending, in part, to "promote the use of non-identifiable information for health research", the bill strengthens personal privacy protections. If passed, individuals would be permitted to inspect a copy of this information and would be notified of security breaches. HIPSA also requires the Health and Human Services Secretary to provide "model written authorization for the disclosure" of health information and establishes criminal and civil penalties for intentional violations.

Readers interested in the development of biobanks and genetic databases for pediatric research, will want to follow the progress of a third bill: S.911 Conquer Childhood Cancer Act of 2007. This bill amends the Public Health Service Act to establish a grant mechanism to sponsor the creation of a national, population-based database for pediatric cancer research—the Childhood Cancer Research Network. The Act, introduced by Sen. Reed [RI], would also provide grants for Research Fellowships and for the public awareness and communication efforts of relevant advocacy organizations. This bill was recently reviewed by the Senate's Committee on Health, Education, Labor, and Pensions and placed on the Senate Legislative Calendar (see General Orders, No. 535). A version of the bill is also making its way through the House of Representatives; H.R.1553 is sponsored by Rep. Deborah Pryce of Ohio and was referred to the House Subcommittee on Health on March 16, 2007. - J.O.

Subscribe to PredictER Blog for updates on these and other legislative developments.

Prediction and Addiction

Pediatrics and Nicotine -

A recent publication on pediatric genetic testing for nicotine addiction reported the results of an attitudes survey of 232 health providers attending a conference on adolescent health. In "Interest in Genetic Counseling and Testing for Adolescent Nicotine Addiction Susceptibility ... ", the authors from the Lombardi Comprehensive Cancer Center at Georgetown University (Kenneth Tercyak, Beth Peshkin, Anisha Abraham and Leslie Walker) examined correlates in providers' interests:

Providers who engaged in more regular tobacco screening behaviors with their adolescent patients ... and those who were more optimistic that biobehavioral research would lead to significant improvements in adolescent smoking prevention and treatment ... , were more interested in counseling and testing.

Although the genetic test is not yet clinically available, the authors conclude that "future, adolescent wellness visits may present an opportunity to offer genetic counseling and testing for nicotine addiction susceptibility.
See:

Tercyak KP, Peshkin BN, Abraham A, Wine L, Walker LR. Interest in genetic counseling and testing for adolescent nicotine addiction susceptibility among a sample of adolescent medicine providers attending a scientific conference on adolescent health. J Adolesc Health. 2007 Jul;41(1):42-50. [Abstract at PredictER Connotea.]

Criminal Justice and Addiction Risks -

Genetic testing for addiction could have far reaching implications in the criminal justice system. A press release from The University of Texas Health Center at Tyler ("Four researchers at UT Health Center receive grants ... ".News & Information. Thursday, July 19, 2007) announced a four year of $1.76 million from the NIH to study the ethical, legal, and social implications of the non-health use of personal genetic data. Genetic tests could be used, for example, in determining the length of sentences for offenders with genetic risks for addiction. The project will:

· Create an open-access online database of the current criminal and sentencing laws employing drug addiction information;

· Survey the attitudes and information needs of drug-court judges, corrections officers, and drug treatment professionals regarding genetic research and the science of addiction;

· Engage these stakeholders in public discussions of the issues;

· Develop an open access, online resource for training, education, and reference materials on the subject.

In describing the need for the program, the director, T. Howard Stone, Associate Professor of Bioethics, remarked:

We hope that our findings have some influence on the development of state laws and policies for the use of this genetic data in these settings. Right now there’s no uniformity. Jurisdictions may treat this information very differently.

Other institutions involved in this study include the Mayo Clinic Foundation, Stanford University, University of Louisville, St. Louis University (MO), The Hastings Center, and the Pacific Institute for Research and Evaluation (Louisville, KY).

Parents support genetic testing, DNA biobanks - even without available treatments.

From Child Health and Evaluation Research (CHEAR) Unit: U-M C.S. Mott Children's Hospital

UMHS Press Release:
Parents support genetic testing, DNA biobanks - even without available treatments.
C.S. Mott Children’s Hospital National Poll on Children’s Health finds 54% of parents endorse genetic testing even for diseases with no available treatments.

Website:
CHEAR - National Poll on Children's Health
C.S. Mott Children's Hospital National Poll on Children’s Health, Vol. 1, Issue 4; June 20, 2007
A publication from the University of Michigan Department of Pediatrics and Communicable Diseases and the University of Michigan Child Health Evaluation and Research (CHEAR) Unit.

DNA Biobanks and Genetic Testing - For Whom, and When?
Report Highlights
* 54% of adults endorsed genetic testing even if no effective treatment is available.
* 38% of parents were willing to have their children’s DNA stored in a government biobank.
* Adults were more likely to store DNA in a government biobank if they support genetic testing for diseases despite the lack of available effective treatment.
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Data Source
This report presents findings from a nationally representative household survey conducted exclusively by Knowledge Networks, Inc, for C.S. Mott Children’s Hospital. The survey was administered from March 14-26, 2007, to a randomly selected, stratified group of adults aged 18 and older (n=2,076) with and without children from the Knowledge Networks standing panel that closely resembles the U.S. population.

PredictER Note: SEE ALSO "Storing and Testing Children's DNA". Eye on DNA, June 20, 2007.