Louisa A. Stark

Public Attitudes Regarding the Use of Residual Newborn Screening Specimens for Research

BACKGROUND AND OBJECTIVES: Many state newborn screening (NBS) programs retain residual NBS bloodspots after the completion of screening. Potential uses for residual specimens include laboratory quality assurance, biomedical research, and, rarely, forensic applications. Our objective was to evaluate public opinion about the policies and practices relevant to the retention and use of residual bloodspots for biomedical research. METHODS: A total of 3855 respondents were recruited using 3 methods: focus groups (n = 157), paper or telephone surveys (n = 1418), and a Knowledge Networks panel (n = 2280). Some participants (n = 1769) viewed a 22-minute movie about the retention and use of residual specimens while other participants were provided only written information about this practice. All participants were surveyed using a 38-item questionnaire. RESULTS: A diverse set of participants was recruited. Respondents were very supportive of NBS in general and accepting of the use of residual bloodspots for important research activities. Respondents were evenly divided on the acceptability of NBS without parental permission, but the majority of respondents supported the use of an “opt-in” process for parental permission for residual bloodspot retention and use. Viewing the educational movie was associated with greater support for bloodspot retention and use. CONCLUSIONS: Our results show that the general public surveyed here was supportive of NBS and residual sample retention and research use. However, there was a clear preference for an informed permission process for parents regarding these activities. Education about NBS was associated with a higher level of support and may be important to maintain public trust in these important programs.

Assessing public attitudes on the retention and use of residual newborn screening blood samples: a focus group study.

This paper discusses attitudes and opinions of a diverse group of participants toward the retention and use of residual newborn blood samples for research. Data were drawn from focus groups based in six states in the USA, and results provide support for the retention and use of residual newborn blood samples for research when parental permission is asked beforehand. However, there were a number of concerns that also warrant attention for the development of policy and maintaining trust with the public, such as timing of permission, use of samples already stored, level of personal control of sample use and education. The results demonstrate the complexity of the topic and the ethical ambiguities associated with the retention and use of residual newborn blood samples.

Concerns of Newborn Blood Screening Advisory Committee Members Regarding Storage and Use of Residual Newborn Screening Blood Spots

OBJECTIVES We assessed attitudes and opinions of members of newborn blood screening (NBS) advisory committees regarding the storage and secondary research use of residual specimens from NBS. METHODS We conducted focus groups in 2008 and 2009 with NBS advisory committees (4 focus groups; n = 39 participants) in the Mountain States region (i.e., AZ, CO, MT, NM, NV, TX, UT, and WY). RESULTS Participants identified several challenges to implementing policies for storage of and research on residual newborn blood specimens. Themes that emerged from the data were public health relevancy; improvement of parental knowledge; impact of enhanced parental involvement; concerns over ownership, privacy, and confidentiality; identification of secondary research uses; and role of advisory committees. CONCLUSIONS Participants indicated that secondary uses of residual specimens entailed opportunities for improvements in NBS programs but also carried significant risks for their programs. Addressing concerns from stakeholders will be necessary for state-level adoption of national recommendations.

A randomized controlled trial of an electronic informed consent process.

A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study.

What parents want to know about the storage and use of residual newborn bloodspots

Many state newborn screening programs retain residual newborn screening bloodspots for a variety of purposes including quality assurance, biomedical research, and forensic applications. This project was designed to determine the information that prospective parents want to know about this practice. Eleven focus groups were conducted in four states. Pregnant women and their partners and parents of young children (N = 128) were recruited from the general public. Focus group participants viewed two educational movies on newborn screening and DBS retention and use. Transcripts were analyzed with qualitative methods and the results were synthesized to identify key information items. We identified 14 categories of information from the focus groups that were synthesized into seven items prospective parents want to know about residual DBS. The items included details about storage, potential uses, risks and burdens, safeguards, anonymity, return of results, and parental choice. For those state programs that retain residual dried bloodspots, inclusion of the seven things parents want to know about residual dried bloodspots in educational materials may improve parental understanding, trust, and acceptance of the retention and use of stored bloodspots.

Making Genetics Easy to Understand

An integrated pair of Web sites for students and teachers supports genetics and genomics education worldwide. The Human Genome Project and the subsequent explosion of genomic information are transforming our knowledge of how organisms function and how genes and the environment interact. These insights have led to advances in personalized medicine, stem cell treatments, and genetic testing. Students, teachers, and the public must be prepared to make informed decisions about participation in genomics research, genome-related health care, use of genetically modified agricultural products, and public funding for stem cell research. Education has been identified as a crosscutting element that is critical to achieving the potential of genomics research (1).

Using Small-Scale Randomized Controlled Trials to Evaluate the Efficacy of New Curricular Materials

The authors provide a description of their experience conducting a randomized controlled trial in high school classrooms to test the efficacy of epigenetics curricular materials. This is a case study for science faculty members who wish to employ scientifically rigorous evaluations of educational interventions while limiting their scope and budget.

A gender-based approach to developing a healthy lifestyle and healthy weight intervention for diverse Utah women

Utah women from some cultural minority groups have higher overweight/obesity rates than the overall population. We utilized a gender-based mixed methods approach to learn about the underlying social, cultural and gender issues that contribute to the increased obesity risk among these women and to inform intervention development. A literature review and analysis of Utahs Behavioral Risk Factor Surveillance System data informed the development of a focus group guide. Focus groups were conducted with five groups of women: African immigrants from Burundi and Rwanda, African Americans, American Indians/Alaskan Natives, Hispanics/Latinas, and Pacific Islanders. Six common themes emerged: (1) health is multidimensional and interventions must address health in this manner; (2) limited resources and time influence health behaviors; (3) norms about healthy weight vary, with certain communities showing more preference to heavier women; (4) women and men have important but different influences on healthy lifestyle practices within households; (5) women have an influential role on the health of families; and (6) opportunities exist within each group to improve health. Seeking insights from these five groups of women helped to identify common and distinct cultural and gender themes related to obesity, which can be used to help elucidate core obesity determinants.

Online Resources for Understanding Outbreaks and Infectious Diseases

Disease outbreaks can be a powerful topic for teaching about science and health. This Feature reviews resources for bringing up up-to to-date information on this hot topic into the classroom.

Engaging with Molecular Form to Understand Function

Understanding the relationship between form and function is critical for appreciating biology at the molecular level. This feature explores online materials that connect molecular structures with their functional relevance.