Tag Archives: pediatrics

Conference on Infant Mental Health to Focus on Ethics

The Indiana Association for Infant and Toddler Mental Health will hold its 13th Annual Conference on Infant Mental Health on August 12, 2011 at the Riley Outpatient Center at Riley Hospital in Indianapolis. This year’s conference is entitled, “Ethics in Early Childhood Fields: A Moral Psychological Approach.”

The conference features keynote presentations by Darcia Narvaez, PhD and Daniel Lapsley, PhD, both from University of Notre Dame; a presentation discussing ethics in early childhood by Margaret Gaffney, MD, of the IU Center for Bioethics; interactive sessions moderated by IU Conscience Project members; and a panel discussion highlighting practical applications of the information presented throughout the day. Continuing education is available for social workers, psychologist, and physicians (see brochure for details).

Sponsors and partners for this year’s conference include: the Indiana Department of Child Services, Indiana Head Start Collaboration Office, Indiana State Department of Health’s Sunny Start Project, Indiana University School of Medicine, Department of Psychiatry, the Indiana University Conscience Project, the Indiana University Center for Bioethics and the Riley Child Development Center LEND Program.

Please note that you can register by mail/FAX using the form in the brochure OR online through the MHAI website: https://secure.entango.com/donate/MHAIInfTod2011

Autism, MMR, Wakefield and the GMC: Research Ethics in the News

Thursday (January 28, 2010) the General Medical Council (GMC), which registers doctors, promotes standards and provides ethical guidance to protect the public in the U.K., issued a long awaited report of a Fitness to Practise Panel Hearing [PDF – 349 KB]. The Hearing addressed the case of Andrew Jeremy Wakefield, John Angus Walker-Smith, and C. Professor Simon Harry Murch and their (primarily Wakefield’s) pediatric research regarding a purported link between the MMR vaccine, autism and bowel disease. The GMC concluded the doctors are responsible for the unethical conduct of the clinical trial involving 12 pediatric patients. Some of the young children were subjected to unapproved and invasive tests, including spinal taps. In one case, a blood draw was conducted on children attending a birthday party for Wakefield’s son; the party-goers were paid $8 for their trouble. Furthermore, Wakefield et al. published the results of this dubious research in The Lancet without mentioning the £50,000 he was paid to carry out the research on behalf of attorneys representing parents who believed the MMR vaccine harmed their children.

Exaggerating, perhaps, Brian Deer in The Sunday Times declares that The Lancet publication [1998 Feb 28;351(9103):637-41 | PubMed PMID 9500320] and the resulting media coverage triggered “the health scare of our time”. The groundless fear of MMR-induced autism led many parents to refuse vaccinations for their children. According to the U.K.’s Health Protection Agency, cases of measles have sharply increased in recent years.

In April the GMC will reconvene to determine if the doctors have committed serious professional misconduct; one or all of them may lose their right to practice medicine in the U.K. Wakefield, however, continues to have a vocal following of parents (some heckled at the hearing); he currently lives in the States and runs an autism clinic, Thoughtful House, in Austin, Texas.

Related News and Links:

MMR scare doctor ‘acted unethically’, panel finds. Nick Triggle. BBC News. January 28, 2010.

British doctor rebuked over research linking vaccine and autism. Henry Chu. Los Angeles Times. January 29, 2010.

Fall of Andrew Wakefield, ‘dishonest’ doctor who started MMR scare. David Rose. The Times Online. January 29, 2010.

CDC, Vaccine Saftey: Measles, Mumps, and Rubella (MMR) Vaccine

Autism, MedlinePlus

Measles, MedlinePlus

Other Research Ethics News

Scrutiny emerges concerning conflicts of interest in veterinary literature. Jennifer Fiala. VIN News Service. January 26, 2010.

BMJ feature story peers into MIST controversy. Shelley Wood. HeartWire. January 26, 2010.

Corporate Backing for Research? Get Over It. John Tierney. The New York Times. January 25, 2010.

‘Guinea pigs’ also have rights. Kumudini Hettiarachchi. The Sunday Times (Sri Lanka). January 24, 2010.

Amphastar Pharmaceuticals files new appeal in FDA conflict-of-interest case. Andrew Zajac. Los Angeles Times. January 21, 2010.

A dubious practice, any way you slice it. Stuart Laidlaw. The Star (Toronto). January 15, 2010.

Chinese scientists dismissed after 70 suspect papers. Wu Ni. SciDev.Net. January 13, 2010.

Related: Publish or perish in China. Jane Qiu. Nature News (subscription required). January 12, 2010.

Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval; Availability. Food and Drug Administration, HHS. Federal Register: January 13, 2010 (Volume 75, Number 8 ).

– J.O.

Pediatric Biobanks: Research Ethics in the Academic Literature

Have you ever tried to find an old friend from school? Where did they move? Did they change their name? It is not always easy, is it? Well, imagine that you are trying to find a few hundred research subjects to get consent to use their pediatric data or tissue in a research study. Sure, their mom or dad said that it was fine to use this sample or this medical information for research, but that was decades ago when the subject was a child. Now that the child is an adult, perhaps the subject has their own ideas about whether or not researchers should be using these resources for science. Finding them, however, could be a problem. Who are they? Where are they? Do you really have to go through the trouble and expense to find them? What would these “donors” think if you just skipped that step?

To shed some light on some of these questions, the authors of a new article (Goldenberg AJ, Chandros Hull S, Botkin JR, Wilfond BS. Pediatric biobanks: approaching informed consent for continuing research after children grow up. J Pediatr. 2009 Jul 10. PMID: 19595370.) conducted a survey based on a hypothetical scenario:

“When you were an infant, your parents gave their permission for a blood sample of yours to be used in research on children’s health. Your doctor collected samples from hundreds of infants this way. Since then, your blood sample has been stored in a freezer along with a unique identification number and some background medical information about you. Several decades have passed and all of the infants whose blood samples were collected are adults. The researcher now wishes to continue to use your sample for research.”

The survey asks four questions to measure the level of concern about using this data in research. The final question asks: “Suppose that the researcher could not locate you. Would it be acceptable to you for the researcher to use your sample anyway?”

The survey of 1186 patients at 5 academic medical centers found that 54% of the respondents did not think that researchers should have to ask the adult for consent to continue using their pediatric samples. Of the 543 (46%) people responding that researchers should have to ask for consent, 228 found it “acceptable” for a researcher to use the samples if the subject could not be located. While these numbers might be encouraging to researchers using pediatric samples, one must remember that 310 people would NOT find it acceptable for the researchers to use the samples without consent. The survey also gathered valuable information about trust in researchers, attitudes regarding genetic research in general, and privacy about medical information.

In the discussion, the authors observe that contacting every subject “may not be feasible for those studies that lack the funding and administrative support to keep track of children years after the initial participation.” Therefore, the authors recommend increased public engagement. By using focus groups, community meetings, and other engagement methods, the authors suggest that the public might become more comfortable with the concept of ongoing use of pediatric samples without explicit consent from adults. Researchers would also be better equipped to identify communities and studies in which the subjects would absolutely expect to be contacted as adults for explicit consent for ongoing research with their pediatric samples. Further research, the authors suggest, could go beyond hypothetical scenarios and explore what actually patients enrolled in pediatric biobanks think (as children and later as adults) about these issues.

Reference:

Goldenberg AJ, Chandros Hull S, Botkin JR, Wilfond BS. Pediatric biobanks: approaching informed consent for continuing research after children grow up. J Pediatr. 2009 Jul 10. PMID: 19595370.

Related Articles:

Haas DM, Renbarger JL, Meslin EM, Drabiak K, Flockhart D. Patient attitudes toward genotyping in an urban women’s health clinic. Obstet Gynecol. 2008 Nov;112(5):1023-8. PMID: 18978101.

Hull SC, Sharp RR, Botkin JR, Brown M, Hughes M, Sugarman J, Schwinn D, Sankar P, Bolcic-Jankovic D, Clarridge BR, Wilfond BS. Patients’ views on identifiability of samples and informed consent for genetic research. Am J Bioeth. 2008 Oct;8(10):62-70. PMID: 19003716.

Neidich AB, Joseph JW, Ober C, Ross LF. Empirical data about women’s attitudes towards a hypothetical pediatric biobank. Am J Med Genet A. 2008 Feb 1;146(3):297-304. PMID: 18205141.

Tarini BA, Goldenberg A, Singer D, Clark SJ, Butchart A, Davis MM. Not without my permission: parents’ willingness to permit use of newborn screening samples for research. Public Health Genomics. 2009 Jul 11. PMID: 19602864.

Links:

For more on the ethics of pediatric biobanks, read about the Predictive Health Ethics Research (PredictER) program of the Indiana University Center for Bioethics or follow PredictER Blog.

Other Recent Research Ethics Articles (July 2009)

— J.O.