Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research Workshop Summary (2010) / Chapter Skim
Currently Skimming:
5 Review and Consent in the Use of Residual Newborn Screening Samples
5 Review and Consent in the Use of Residual Newborn Screening Samples
Pages 31-44
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 31... ...
DISTINGuISHING BETWEEN ANONyMIZED AND DE-IDENTIFIED SAMPLES Alan Fleischman drew a crucial distinction between anonymized and de-identified samples, a distinction that is usually not appreciated by the public (and sometimes not even by researchers)
|
From page 32... ...
Other speakers pointed out that legal provisions can also be used to prohibit the identification of anonymized samples. A SENSE OF STEWARDSHIP Public health programs are the stewards of newborn screening samples, Kelly Edwards said, in the sense that these programs are responsible and accountable for the fair use of samples and for follow-up with the public.
|
From page 33... ...
Furthermore, one-time consents do not allow appropriate responses and modifications that reflect the rapidly changing nature of research and of society. The use of residual newborn screening samples in research raises special considerations.
|
From page 34... ...
A range of consent options needs to be available for use with residual newborn screening samples. Some states and research repositories use a community consent model in which town hall meetings are held to let people know about research using their samples.
|
From page 35... ...
• The Department of Health/Department of Social and Health Ser vices human subjects research review board has reviewed and approved the investigation. Residual newborn screening samples have been used in Washington State to study type 1 diabetes, hearing loss, maternal smoking, H1N1 infection, and lysosomal storage diseases.
|
From page 36... ...
In particular, several speakers and participants raised questions about whether the consent process should differ in form or substance from what is typical today. Ann Waldo pointed to a study by the University of Michigan establishing that roughly three-fourths of people would be willing to have their children's residual newborn screening samples stored and used in research if a consent mechanism existed.
|
From page 37... ...
If parents in large numbers began to refuse screening, an extremely valuable program could be destroyed. For this reason, Alan Fleischman argued that parents should be offered the choice to opt out of long-term storage of samples for research unrelated to the newborn screening program, but only after the blood samples have been obtained and screened.
|
From page 38... ...
"The Washington State newborn screening program directors are taking their job as stewards of this public health program very seriously," Edwards said. They have chosen to maintain high standards to meet public expectations and have insisted on proactive consent if research samples are identifiable.
|
From page 39... ...
The director of one state public health laboratory stated that a law or regulation to track consent or dissent in the use of existing residual dried blood spots would be impossible to adhere to with current budgets. States have enough trouble tracking their citizens for more immediate purposes; tracking them for consent to research would be much harder.
|
From page 40... ...
Partnerships with federal and state agencies, communities, disease advocacy groups, or philanthropies can bring in resources. Given the prospect of future uses, residual newborn screening samples should not be destroyed, Clayton and several other workshop participants urged.
|
From page 41... ...
"We have to make decisions and set priorities about how those resources are going to get used," said Kelly Edwards. TRANSPARENCy IN SCREENING PROGRAMS AND RESEARCH Review boards offer one way to increase transparency in the uses of residual newborn screening samples, but other steps are necessary as well.
|
From page 42... ...
My child died of a rare disease and I wanted that blood made available so that other children wouldn't go through what my child went through." A large amount of valuable epidemiologic research goes on without patient or parental consent, Clayton said, and this is generally appropriate.
|
From page 43... ...
This new information may be passed along in the form of a written consent process or via a public information campaign, but the public needs to be brought along, Edwards said. Relationships are based in part on trust.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.