Bioethics News and Events

Will Stronger Privacy Protections Result in Better Health Data? The Health Privacy Project Recommendations

Wed, 01 Jul 2009 09:28 GMT

The Health Privacy Project of the Center for Democracy & Technology (CDT) recently released a paper arguing for changes in how the HIPAA Privacy Rule protects "de-identified" health information. The recommendations grow from a one-day, CDT workshop held in September 2008. The Health Privacy Project makes the following eight recommendations:

1. Re-examine the Privacy Rule de-identification provisions (in particular, the safe harbor method for de-identification);
2. Strengthen accountability by requiring data use agreements;
3. Expand data anonymization options under the Privacy Rule;
4. Provide incentives to use less than fully identifiable data for certain purposes;
5. Provide support through “Centers of Excellence” in de-identification;
6. Require or encourage the use of limited access datasets and other technical solutions;
7. Require education and training of staff de-identifying data; and
8. Consider increasing public transparency regarding uses of de-identified data.

The Project argues that the HHS needs to re-examine the Privacy Rule "to ensure that the de-identification standard remains robust as re-identification becomes easier."

For readers struggling with the "Babel" of data privacy vocabulary (for example, what's the difference between "anonymous" and "anonymized"?), these recommendations may open the door to additional confusion, especially if #3 (above) means that additional categories of protected data are created. The Privacy Rule currently offers two categories data which are exempt from regulation: "de-identified" (presumed to be beyond the risk of re-identification and therefore not regulated) and not fully identifiable, "limited data sets" (incomplete data which includes some identifiers, for example: birth dates). While the Rule's current categories may seem simple, The Health Privacy Project notes that a "one-size-fits-all de-identification approach" does not, one the one hand, meet the diverse data needs of researchers and health providers, nor does it, on the other hand, provide sufficient protections in era of evolving data technologies.

Reference:

The Health Privacy Project, Center for Democracy & Technology. Encouraging the use of, and rethinking protections for de-identified (and “anonymized”) health data. Center for Democracy & Technology, June 2009. http://www.cdt.org/healthprivacy/20090625_deidentify.pdf

Related:

Knoppers BM, Saginur M. The Babel of genetic data terminology. Nat Biotechnol. 2005 Aug;23(8):925-7. PubMed PMID: 16082354.

Sharyl J. Nass, Laura A. Levit, and Lawrence O. Gostin, Editors; Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule; Institute of Medicine. Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. Washington, D.C.: Institute of Medicine, The National Academies Press, 2009. http://www.nap.edu/catalog.php?record_id=12458

Other Stories in the News

Your Genes Aren’t Covered for That: One Year Later, Gaps in Genetic Discrimination Legislation Reveal the Challenges Ahead. Susannah Baruch, Science Progress. June 29, 2009.

FDA’s Current Ability to Regulate Genetic Testing Is Problematic, FDLI-AAAS Colloquium Attendees Say. Food and Drug Law Institute (FDLI) and the American Association for the Advancement of Science (AAAS) [Press Release]. June 22, 2009. http://www.fdli.org/press/pressrelease/062209.pdf

New Comparative Effectiveness Bill Enhances Dx, Genomics Focus. Matt Jones, GenomeWeb. June 18, 2009.

The GINA Law: Consumer Protection in a New Era of Genetic Testing Research Report. N. Lee Rucker, M.S.P.H., AARP Public Policy Institute, May 2009. http://www.aarp.org/research/health/prevention/fs156_gina.html

-- J.O.

Obama stops The President's Council on Bioethics: Research Ethics in the News

Wed, 24 Jun 2009 10:12 GMT

Last week, Nicholas Wade reported in The New York Times that the President had pulled the plug on the most-recent version of the President's Council on Bioethics. According to White House press officer, Reid Cherlin, President Obama disbanded the Council because it was “a philosophically leaning advisory group.” Wade also reports that Obama plans to create a new, more practical, bioethics commission in the future–Cherlin did not offer a timeframe.

James W. Fossett and Michelle N. Meyer respond in today's Bioethics Forum with a (tongue-in-cheek) “who cares”–a comment in support of a federal commission focused on empirical research on bioethical issues. Similarly, Michael Cook, yesterday at BioEdge, speculated (but less happily) that this direction would mean “no more seminars; lots more Facebook.” Other reactions to this news include “Less Philosophy, More Policy” from Andrew Plemmons Pratt at Science Progress and a good-bye letter from Peter Augustine Lawler in the conservative publication The Weekly Standard.

Related:

President's bioethics council disbanded. Alex Witze, The Great Beyond. June 19, 2009.

Gilbert Meilaender, Paul McHugh, Benjamin Carson, Nicholas Eberstadt, Jean Bethke Elshtain, Alfonso Gómez-Lobo, William Hurlbut, Donald Landry, Peter Lawler, and Diana Schaub. Federal Funding of Embryonic Stem Cell Research Science and Society. Bioethics Forum, March 25, 2009.

Other Research Ethics News:

EU legislation increases clinical-trial workloads. Nature News. June 24, 2009.

Drug ‘reports' found to be faked. Stuart Laidlaw, Toronto Star. June 22, 2009.

Commentary: A Costly and Wasteful FDA. Henry I. Miller, Forbes. June 20, 2009.

NY to pay for eggs for research. Elie Dolgin, The Scientist. June 17, 2009.

Clinical Trials in India: Research Ethics in the News

Thu, 18 Jun 2009 05:33 GMT

The Times of India reports that the Drugs Controller of India has stipulated that all clinical trials (new and ongoing) in India must be registered with The Clinical Trials Registry- India (CTRI). The Indian Council of Medical Research (ICMR) expects that this will increase transparency and assist in the ethical conduct of research while adding to public trust. Read the full story:

Now, all human clinical trials to be registered. The Times of India. June 15, 2009.

Related Links:

Bio-Medical Ethics | ICMR
ICMR. Ethical guidelines for biomedical research on human participants. New Delhi, 2006. [PDF - 3.14 MB]

Other Research Ethics News:

Vaccine Plan Aims to Spur Drug Development for Poor Nations. Michael M. Phillips, The Wall Street Journal. June 12, 2009.

Comment: Human subjects have human rights. Daniel Everett, New Scientist. June 9, 2009.
Biologist Jared Diamond is being sued by people he studied.

Benefits of the stem cell ban. John D. Loike and Ruth L. Fischbach, The Scientist. June 8, 2009.
Federal aversion to embryonic stem cell research had a silver lining: it galvanized the development of new biotechnologies in stem cell science, two bioethicists argue.

Human Subjects Research: Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation: Testimony Before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives. GAO-09-448T. United States Government Accountability Office, March 26, 2009.

In the Literature: Predictive Health 2.0

Wed, 17 Jun 2009 09:50 GMT

The recent double issue of The American Journal of Bioethics (Vol 9 6&7) includes two target articles (followed by open peer commentaries) on the ethical issues of direct-to-consumer (DTC) genomics and social networking.

The issue opens with an editorial by 23&Me's Andro R. Hsu, Joanna L. Mountain, Anne Wojcicki, and Linda Avey: "A pragmatic consideration of ethical issues relating to personal genomics." The editorial offers five points of discussion that the authors find relevant to the discussion of the ethical issues. Facebook users might be surprised to discover that the service is offered as an example of innovative data sharing policies; see point five: "A single data sharing policy cannot fit the needs of all".

The first "target article" reports the result of an attitudes survey about DTC; see: McGuire AL, Diaz CM, Wang T, Hilsenbeck SG. Social networkers' attitudes toward direct-to-consumer personal genome testing. Although the title suggests that "social networkers" are a focus of the article, in reality they are a convenient (or experimental?) survey population--the authors used Zoomerang and Facebook to reach the 1,080 respondents. Of the respondents, 47% reported a pre-existing knowledge of DTC genomics companies like 23&Me, Navigencs, and deCODEme; 6% reported having used one of these services and 64% reported a willingness to use one of the services in the future.

The second "target article" focuses on where all this might be leading; see: Lee SS, Crawley L. Research 2.0: social networking and direct-to-consumer (DTC) genomics. In addition to proposing that social network analysis could be used to explore the impact of these DTC genomics ventures on research, data sharing, and subject recruitment, the authors also ask: "What are the ethical and social implications of new social formations created through the sharing of personal genomic information?" In other words, how will the convergence of Web 2.0 and personal genomic information (PGI) change our social structures?

Commentaries on these articles include a few authored by friends of the PredictER program; see, for example:

Esposito K, Goodman K. Genethics 2.0: phenotypes, genotypes, and the challenge of databases generated by personal genome testing. pp. 19-21.

Caulfield T. Direct-to-consumer genetics and health policy: a worst-case scenario? pp. 48-50.

Other articles and publications of interest:

Genetic privacy and piracy. Nat Cell Biol. 2009 May;11(5):509. PubMed PMID:19404329.
Avard D, Silverstein T, Sillon G, Joly Y. Researchers' perceptions of the ethical implications of pharmacogenomics research with children. Public Health Genomics. 2009;12(3):191-201. PMID: 19204423.

Bombard Y, Veenstra G, Friedman JM, Creighton S, Currie L, Paulsen JS, Bottorff JL, Hayden MR; Canadian Respond-HD Collaborative Research Group. Perceptions of genetic discrimination among people at risk for Huntington's disease: a cross sectional survey. BMJ. 2009 Jun 9;338:b2175. PMID: 19509425.

Borry P, Howard HC, Sénécal K, Avard D. Health-related direct-to-consumer genetic testing: a review of companies' policies with regard to genetic testing in minors. Fam Cancer. 2009 Jun 2. PMID: 19488835.

Dokholyan RS, Muhlbaier LH, Falletta JM, Jacobs JP, Shahian D, Haan CK, Peterson ED. Regulatory and ethical considerations for linking clinical and administrative databases. Am Heart J. 2009 Jun;157(6):971-82. PMID: 19464406.

Forsberg JS, Hansson MG, Eriksson S. Changing perspectives in biobank research: from individual rights to concerns about public health regarding the return of results. Eur J Hum Genet. 2009 May 27. PMID: 19471310.

Goddard KA, Duquette D, Zlot A, Johnson J, Annis-Emeott A, Lee PW, Bland MP, Edwards KL, Oehlke K, Giles RT, Rafferty A, Cook ML, Khoury MJ. Public awareness and use of direct-to-consumer genetic tests: results from 3 state population-based surveys, 2006. Am J Public Health. 2009 Mar;99(3):442-5. PMID: 19106425.

Henrikson NB, Bowen D, Burke W. Does genomic risk information motivate people to change their behavior? Genome Med. 2009 Apr 2;1(4):37. PMID: 19341508.

Maliapen M. Clinical genomics data use: protecting patients privacy rights. Studies in Ethics, Law, and Technology. 2009;3(1):Article 1. Available at: http://www.bepress.com/selt/vol3/iss1/art1

Manion FJ, Robbins RJ, Weems WA, Crowley RS. Security and privacy requirements for a multi-institutional cancer research data grid: an interview-based study. BMC Med Inform Decis Mak. 2009 Jun 15;9(1):31. PMID: 19527521.

Mascalzoni D, Hicks A, Pramstaller PP. Consenting in population genomics as an open communication process. Studies in Ethics, Law, and Technology. 2009;3(1):Article 2. Available at: http://www.bepress.com/selt/vol3/iss1/art2

Rogowski WH, Grosse SD, Khoury MJ. Challenges of translating genetic tests into clinical and public health practice. Nat Rev Genet. 2009 Jun 9. PMID: 19506575.

Wilkinson RH. The single equality bill: a missed opportunity to legislate on genetic discrimination? Studies in Ethics, Law, and Technology. 2009;3(1):Article 3. Available at: http://www.bepress.com/selt/vol3/iss1/art3

Ether and the Moral History of Pain: Research Ethics in the News

Fri, 12 Jun 2009 08:04 GMT

What can the history of medicine teach us about the barriers to translation? What are some of the obstacles between the bench and the bedside?

In a recent edition of The Boston Globe (7 June 2009), Mike Jay recounts an

Source: http://en.wikipedia.org/wiki/Anesthesia

interesting moment in the history of medicine and medical research, one in which “culture had finally caught up with chemistry”. As Jay observes, ether has a long history in science (with its effects on chickens recorded as early as 1525 by Paracelsus), but medicine waited for roughly 300 years to see this knowledge translated into improved medical care. What was in the way? Prior to October 16, 1846 (the date of the first operations conducted under anesthesia) our view of the person seemed inseparable from the concept of pain: “the vast majority of religious and medical opinion held that pain was inseparable from sensation in general, and thus from life itself”. Thus, while the technology was available, the doctors and the patients were not ready for medicine: less painful medical care “required not simply new science, but a radical change in how we saw ourselves”.

Read the full story:
Mike Jay. The day pain died: what really happened during the most famous moment in Boston medicine. The Boston Globe, June 7, 2009.

Other research ethics stories in the news:

Gene Patents on the Radio. PredictER Blog, 10 June 2009.
Rebecca Roberts discusses Patenting Genes with Joshua D. Sarnoff, Hans Sauer, and Shobita Parthasarathy on The Kojo Nnamdi Show.

Conflicts of interest bedevil psychiatric drug research. Marilyn Elias, USA Today. 2 June 2009.
Does it matter if most of the experts who are creating definitions of mental disorders, and standards for the best way to treat them, receive money from pharmaceutical companies?

Stem-cell clarity. [Editorial]. Nature. 2009 Jun 4;459(7247):615-6.
The draft NIH guidelines on stem-cell research are a good first step, but some revision is needed.

Related: Stem Cell Research: Hope or Hype. FasterCures Blog, 5 May 2009.

Ethical and Policy Issues in International Research, Fall 2009

Thu, 11 Jun 2009 13:54 GMT

Please see the attached detailed summary for PHL 555 “Ethical and Policy Issues in International Research,” which will be taught this fall by Dr. Eric Meslin, Director of the Indiana University Center for Bioethics. The class will be held once a week in the IU Center for Bioethics conference room, 3rd floor of the HITS building, Friday mornings from 9am-11:40am. Class begins August 28th and is limited to 15 students.

In addition to counting as a specialized elective for the MA or Graduate Certificate in Bioethics, PHL 555 serves as one of the foundational courses for the MA program's new concentration in International Research Ethics that will be launched this fall. This new concentration has been developed in cooperation with Moi University in Eldoret, Kenya and is supported by a grant from the Fogarty International Center at the National Institutes of Health. Further details will be forthcoming later in the summer.

Jason T. Eberl, Ph.D
http://liberalarts.iupui.edu/directory/bio/jeberl

Gene Patents on the Radio

Wed, 10 Jun 2009 08:59 GMT

Do you own your genes? Should you have a stake in the profits from gene-related products based on "your" genes? What about the "tens of thousands of patents" issues by the U.S. Patent and Trade Office for gene-related products? If you're interested, Rebecca Roberts discusses Patenting Genes with Joshua D. Sarnoff, Hans Sauer, and Shobita Parthasarathy on The Kojo Nnamdi Show (WAMU 88.5 FM, June 4, 2009.)

Listen to the full show online or read a summary Donald Zuhn's summary, "Gene Patenting Debate Continues" (Patent Docs, June 9, 2009).

Industry; Transgenic Monkeys; Offshore Trials: Research Ethics in the News

Mon, 08 Jun 2009 03:11 GMT

Industry

Industry Funding of Research: Assessing the Harms. Susan Gilbert, Bioethics Forum. 29 May 2009.
No one argues about the importance of industry funding to medical research. Most clinical trials could not take place without it. The questions are about the effects of this relationship–does it bias researchers and degrade scientific integrity and, if so, in what ways? … A new study goes deeper than previous studies in answering these questions.

Transgenic Monkeys

Monkeying Around With Genetic ‘Enhancement'. Henry I. Miller, Forbes. 29 May 2009.
New experiments reignite old ethics controversies. Scientists have created a line of monkeys carrying a gene that encodes a green fluorescent protein integrated into their DNA and passed on to their offspring. The research, published this week by a group of Japanese and American scientists in the British journal Nature, marks the first such accomplishment in primates and could lead to new models of human diseases. … But this technology could, at least in theory, also be used not to prevent or treat disease but for “enhancement”. If society is to realize the full spectrum of benefits from human gene therapy, it cannot be considered in a philosophical vacuum. It must be judged in the broader context of what people want and what society permits.

Related:

GM monkeys with glowing feet could help research into Parkinson’s. Mark Henderson, The Times. May 28, 2009

Sasaki E, Suemizu H, Shimada A, et al. Generation of transgenic non-human primates with germline transmission. Nature. 2009 May 28;459(7246):523-7. PMID: 19478777.

Offshore Trials

Reliability of offshore clinical-trial results in doubt. Tom Blackwell, National Post. 2 June 2009.
[S]tatistics show increasing numbers of trials are being outsourced to emerging economies like India, China and Eastern Europe to limit expense and avoid what some researchers call stifling red tape in Canada and other jurisdictions with highly sophisticated medical systems. The trend is sparking debate about the quality and applicability of some of the research, and the treatment of vulnerable subjects in poor nations. … Health Canada said recently it had unearthed problems in a number of developing-world trials submitted by companies trying to get drugs approved here. Key information on side effects and other potential shortcomings had been left out, either deliberately or because of misunderstanding.

Related:

Outsourcing clinical trials: further thoughts. Nancy Walton, The Research Ethics Blog. 5 June 2009.

Monkeying Around With Genetic ‘Enhancement'. Henry I. Miller, Forbes. 29 May 2009.

New experiments reignite old ethics controversies. Scientists have created a line of monkeys carrying a gene that encodes a green fluorescent protein integrated into their DNA and passed on to their offspring. The research, published this week by a group of Japanese and American scientists in the British journal Nature, marks the first such accomplishment in primates and could lead to new models of human diseases. … But this technology could, at least in theory, also be used not to prevent or treat disease but for “enhancement”. If society is to realize the full spectrum of benefits from human gene therapy, it cannot be considered in a philosophical vacuum. It must be judged in the broader context of what people want and what society permits.

GM monkeys with glowing feet could help research into Parkinson’s. Mark Henderson, The Times. May 28, 2009

http://www.timesonline.co.uk/tol/news/uk/science/article6375145.ece

Sasaki E, Suemizu H, Shimada A, et al. Generation of transgenic non-human primates with germline transmission. Nature. 2009 May 28;459(7246):523-7. PMID: 19478777.

http://pubmed.gov/19478777

http://www.forbes.com/2009/05/28/monkeys-genetic-enhancement-opinions-contributors-ethics.html

Reliability of offshore clinical-trial results in doubt. Tom Blackwell, National Post. 2 June 2009.

[S]tatistics show increasing numbers of trials are being outsourced to emerging economies like India, China and Eastern Europe to limit expense and avoid what some researchers call stifling red tape in Canada and other jurisdictions with highly sophisticated medical systems. The trend is sparking debate about the quality and applicability of some of the research, and the treatment of vulnerable subjects in poor nations. … Health Canada said recently it had unearthed problems in a number of developing-world trials submitted by companies trying to get drugs approved here. Key information on side effects and other potential shortcomings had been left out, either deliberately or because of misunderstanding.

REBs and Inclusion: Research Ethics in the Academic Literature (REAL)

Fri, 05 Jun 2009 04:26 GMT

In a recent paper, Holly A. Taylor reports the results of a study on the role of the NIH inclusion guidelines and the attitudes of IRB administrators. Administrators of Research Ethics Boards (REBs) agree that the topic of including women, minorities, and children in research is “often discussed by their Boards”. While most REB administrators believe the NIH inclusion guidelines were “in part responsible” for IRB attention to inclusion/exclusion issues for special populations (nearly 60%), these administrators do not think that the guidelines are responsible for an increase in the number of women, children, and minorities in research. So, are the guidelines doing their job? Maybe. Graduates of ethics courses are more likely to think the NIH guidelines are adequate, but (more importantly, perhaps) administrators who had NOT taken an ethics course, were more likely to attribute attention to issues of inclusion to the guidelines. Given the somewhat mixed review, Taylor observes that small increases on the local level may not seem adequate to administrators, but these could contribute to improvements at the national level.

Reference:

Taylor HA. Inclusion of Women, Minorities, and Children in Clinical Trials: Opinions of Research Ethics Board Administrators. J Empir Res Hum Res Ethics. 2009 Jun;4(2):65-73. PMID: 19480593.

Related:

National Institutes of Health. (1998). NIH policy and guidelines on the inclusion of children as participants in research involving human subjects. http://grants.nih.gov/grants/guide/notice-files/not98-024.html

National Institutes of Health. (2001). Amendment: NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html

National Institutes of Health. (2003). Outreach Notebook for the Inclusion, Recruitment and Retention of Women and Minority Subjects in Clinical Research. NIH Publication NO. 03-7036. http://orwh.od.nih.gov/inclusion/outreach.pdf

Ethics Exchange: Western Australia

Thu, 04 Jun 2009 07:04 GMT

Indiana University Center for Bioethics director Eric Meslin recently

Those pictured from left are Dr. Eric Meslin, Dr. Fiona Stanley, U.S. Consul General Dr. Ken Chern, and Dr. Lyn Beazley. Source: Reception in Honor of Dr. Eric Meslin, Perth — 12 May 2009. 2009 Public Affairs Programs, Consulate General of the United States - Perth, Australia.

returned from his trip to Australia. While adding to our growing collaborations with researchers and ethicists in Australia, Eric served as Visiting Professor-at-Large at the University of Western Australia. Recently, the IU Center for Bioethics, the Indiana CTSI, and the Indiana University School of Medicine, were pleased to welcome Lynette Fernandes from the UWA School of Medicine and Pharmacology, Pharmacology and Anaesthesiology Unit. During her visit, Dr. Fernandes exchanged ideas and compared notes on our institutions' responsible conduct of research training programs.

Related:

Beating swine flu. Karen Dearne, Australian IT. May 26, 2009
e-Health ‘could take fight to swine flu'. Sky News, May 31, 2009.
Visiting professor brings bioethical discussion to Perth. Laura Glitsos, ScienceNetwork Western Australia. 2 June 2009.