Human Services Administration Research Articles

Design, Development, Validation, and Use of Synthetic Nucleic Acid Controls for Diagnostic Purposes and Application to Cystic Fibrosis Testing

We have designed, tested, and validated synthetic DNA molecules that may be used as reference standard controls in the simultaneous detection of mutations in one or more genes. These controls consist of a mixture of oligonucleotides (100 to 120 bases long) each designed for the detection of one or more disease-causing mutation(s), depending on the proximity of the mutations to one another. Each control molecule is identical to 80 to 100 bases that span the targeted mutations. In addition, each oligonucleotide is tagged at the 5' and 3' ends with distinct nucleic acid sequences that allow for the design of complementary primers for polymerase chain reaction amplification. We designed the tags to amplify control molecules comprising 32 CFTR mutations, including the American College of Medical Genetics minimum carrier screening panel of 23, with one pair of primers in a single tube. We tested the performance of these controls on many platforms including the Applied Biosystems/Celera oligonucleotide ligation assay and the Tm Bioscience Tag-It platforms. All 32 mutations were detected consistently. This simple methodology allows for maximum flexibility and rapid implementation. It has not escaped our notice that the design of these molecules makes possible the production of similar controls for virtually any mutation or sequence of interest.

HIV/AIDS in Bangladesh: The Role of Government in Health and Human Services Administration

Explore the susceptibility of the People of Bangladesh to HIV/AIDS. The prevalence of HIV/AIDS in the neighboring countries may have reasonable proportions of impact in our country. According to the data provided by a Bangladesh University, the number of detected People living with HIV/AIDS reached 567 as of Dec 2005. Importance of appropriate education on safe sex, violence, HIV/AIDS at all levels of our society, including counseling and advocacy, is emphasized and recommends governmental policy and research for prevention of HIV/AIDS.

Impact of Intimate Partner Violence on Unmet Need for Mental Health Care: Results From the NSDUH

Impact of Intimate Partner Violence on Unmet Need for Mental Health Care: Results From the NSDUH

Don't Ask, Don't Tell: Substance Use by Resident Physicians

Academic Emergency MedicineVolume 13, Issue 8 p. 893-895 Free Access Don't Ask, Don't Tell: Substance Use by Resident Physicians Brian D. McBeth MD, Brian D. McBeth MD (brian.d.mcbeth@healthpartners.com)Search for more papers by this authorFelix K. Ankel MD, Felix K. Ankel MD Department of Emergency Medicine, Regions Hospital, St. Paul, MNSearch for more papers by this author Brian D. McBeth MD, Brian D. McBeth MD (brian.d.mcbeth@healthpartners.com)Search for more papers by this authorFelix K. Ankel MD, Felix K. Ankel MD Department of Emergency Medicine, Regions Hospital, St. Paul, MNSearch for more papers by this author First published: 28 June 2008 https://doi.org/10.1197/j.aem.2006.03.564Citations: 5AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat References Trunkey DD, Botney R. Assessing competency: A tale of two professions. J Am Col Surg. 2001; 192: 385– 95. Reuben DB, Noble S. House officer responses to impaired physicians. JAMA. 1990; 263: 958– 60. McNamara RM, Margulies JL. Chemical dependency in emergency medicine residency programs: perspective of the program directors. Ann Emerg Med. 1994; 23: 1072– 6. McNamara RM, Sanders AB, Ling L, Witzke DB, Bangs KA. Substance use and alcohol abuse in emergency medicine training programs, by resident report. Acad Emerg Med. 1994; 1: 47– 53. Hughes PH, Conard SE, Baldwin DC, Storr CL, Sheehan DV. Resident physician substance use in the United States. JAMA. 1991; 265: 2069– 73. Hughes PH, Baldwin DC, Sheehan DV, Conard S, Storr CL. Resident physician substance use, by specialty. Am J Psych. 1992; 149: 1348– 54. Gill M, Haerich P, Westcott K, Godenick KL, Tucker JA. Cognitive performance following modafinil versus placebo in sleep-deprived emergency physicians: a double-blind randomized crossover study. Acad Emerg Med. 2006; 13: 158– 65. Johnston LD, O'Malley PM, Bachman JG, Schulenberg JE. Monitoring the Future: National Results on Adolescent Drug Use. Institute for Social Research, University of Michigan, 2004. Available at:http:www.monitoringthefuture.org. Accessed Apr 7, 2006. U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Office of Applied Studies. 2004 National Survey on Drug Use and Health: National Findings. Available at: http:www.oas.samhsa.gov. Accessed May 9, 2006. Gopal R, Glasheen JJ, Miyoshi TJ, Prochazka AV. Burnout and internal medicine resident work-hour restrictions. Arch Int Med. 2005; 165: 2595– 600. Domino KB, Hornbein TF Polissar NL, et al. Risk factors for relapse in health care professionals with substance use disorders. JAMA. 2005; 293: 1453– 60. Citing Literature Volume13, Issue8August 2006Pages 893-895 ReferencesRelatedInformation

The Multicultural Research Process

Qualitative research allows students to explore the complex experiences of health and illness and examine assumptions related to class, race, gender, and ethnicity. Faculty who teach qualitative research can promote culturally congruent nursing practice, and students can learn how such practice is grounded in research. The experiential approach taken in this class acquainted students with basic principles of qualitative research, used such principles to foster recognition of assumptions and increase cultural awareness, and encouraged a new way of knowing and being in nursing. The learning goals were to experience the "flavor" of qualitative data analysis using a filmed interview of an American Indian nurse and written interviews of a Hispanic/Latina nurse and nursing student, speaking about their educational experiences in nursing. In this process, the nurse educator exemplified principles of multicultural education for these budding teachers, such as weaving cultural content across the curriculum and role modeling concern for cultural issues in teaching, research, and service.

Calcium supplementation during pregnancy and lactation: Effects on the mother and the fetus

Calcium consumption is essential for bone development and maintenance throughout life, yet more than one half of the female population in the United States does not consume the recommended amount of calcium. Calcium intake is especially crucial during pregnancy and lactation because of the potential adverse effect on maternal bone health if maternal calcium stores are depleted. There is often a transient lowered bone mineral density and increased rate of bone resorption, with the greatest consequence during the third trimester and throughout lactation. Studies indicate that calcium consumption should be encouraged, especially during pregnancy and lactation, to replace maternal skeletal calcium stores that are depleted during these periods. Because the fetus in utero and the neonate through breast-feeding are dependent on maternal sources for the total calcium load, adequate maternal calcium intake also can affect fetal bone health positively. Proper calcium consumption can be attained through the diet by the consumption of dairy products or leafy greens (such as kale), the consumption of fortified foods, or by supplementation with widely available calcium-containing supplement products. Because many women experience heartburn during pregnancy, calcium-based antacids are ideal for providing heartburn relief, and they offer a calcium supplement to ensure maternal and fetal bone health, without the danger of adverse effects on the neonate.

Pharmacogenetics: Development Issues and Solutions for Safe and Effective Medicines

PharmacogenomicsVol. 7, No. 2 Conference ScenePharmacogenetics: Development Issues and Solutions for Safe and Effective MedicinesHans Peter Arnold & Duncan McHaleHans Peter Arnold† Author for correspondenceSearch for more papers by this author & Duncan McHaleSearch for more papers by this authorPublished Online:3 Mar 2006https://doi.org/10.2217/14622416.7.2.149AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articleBibliography1 Gilbert J, Henske P, Singh A: Rebuilding Big Pharma’s Business Model. In: In vivo, the Business & Medicine Report. Windhover Information, Inc., CT, USA, Vol. 21, No. 10 (2003).Google Scholar2 Arnold HP, Hall S: Pharmacogenomics and Clinical R&D. Pharmacogenomics6(8), 801–806 (2005).Link, Google Scholar101 Position Paper on terminology in Pharmacogenetics. The European Agency for the Evaluation of Medicinal Products (EMEA), Committee for Medicinal Products for Human Use (CHMP), November 21, 2002, EMEA/CHMP/3070/01. www.emea.eu.int/pdfs/human/press/pp/307001en.pdfGoogle Scholar102 Innovation or Stagnation? Challenge and Opportunity on the Critical Path to New Medicinal Products. Department of Health and Human Services. Food and Drug Administration (FDA), March 2004. www.fda.gov/oc/initiatives/criticalpath/ whitepaper.pdf.Google Scholar103 DIA/EMEA/CIOMS/EFPIA Joint Workshop Pharmacogenetics: Development Issues and Solutions for Safe and Effective Medicines brochure. www.diahome.org/Content/Events/05116.pdfGoogle Scholar104 Italian Proposed Guidelines for the Evaluation of Pharmacogenetic Research. English translation. http://sigu.univr.it/sigu/html/documenti/LGFG_eng.pdfGoogle Scholar105 Pharmacogenetics: Ethical Issues. Nuffield Council on Bioethics, September 2003. www.nuffieldbioethics.org/fileLibrary/pdf/pharmacogenetics_report.pdf.Google Scholar106 Pharmacogenetics. Towards improving treatment with medicines. ISBN 92 9036 078 X. www.cioms.ch/frame_pharmacogenetics_febr_2005.htm.Google Scholar107 Guidance for Industry: Pharmacogenomic Data Submissions. US Department of Health and Human Services, Food and Drug Administration, March 2005. www.fda.gov/cder/guidance/6400fnl.pdfGoogle Scholar108 Guideline on Pharmacogenetics Briefing Meetings. The European Agency for the Evaluation of Medicinal Products (EMEA), Committee for Medicinal Products for Human Use (CHMP), March 17, 2005. EMEA/CHMP/20227/2004. www.emea.eu.int/pdfs/human/pharmacogenetics/2022704en.pdfGoogle Scholar109 Concept Paper on the Development of a Guideline on Biobanks Issues Relevant to Pharmacogenetics. The European Agency for the Evaluation of Medicinal Products (EMEA), Committee for Medicinal Products for Human Use (CHMP), March 17, 2005, EMEA/CHMP/6806/2005. www.emea.eu.int/pdfs/human/pharmacogenetics/680605en.pdfGoogle Scholar110 Application and validation of genomic biomarkers for use in drug development and regulatory submissions workshop brochure. www.diahome.org/Content/Events/ 05020.pdfGoogle Scholar111 Drug–Diagnostic Co-Development Concept Paper (Draft). Department of Health and Human Services (HHS), Food and Drug Administration (FDA) April 2005. www.fda.gov/cder/genomics/pharmacoconceptfn.pdf.Google Scholar112 Perlegen Sciences Genotype Browser. http://genome.perlegen.comGoogle Scholar113 Mandate, Objectives and Rules of Procedure for the CHMP Pharmacogenetics Working Party. The European Agency for the Evaluation of Medicinal Products (EMEA), Committee for Medicinal Products for Human Use (CHMP), February 17, 2002. EMEA/CHMP/101592/2004. www.emea.eu.int/pdfs/human/pharmacogenetics/10159204en.pdfGoogle ScholarFiguresReferencesRelatedDetailsCited ByThe Promise of Individualized Therapy15 March 2010EU policies in personalized medicine-related technologiesSibylle Gaisser, Etienne Vignola-Gagné, Bärbel Hüsing, Christien Enzing, Tessa van der Valk23 December 2008 | Personalized Medicine, Vol. 6, No. 1Perspectives on the Current State of Pharmacogenomics in Drug DevelopmentYAKUGAKU ZASSHI, Vol. 129, No. 1Evaluación económica en la era de la farmacogenética y farmacogenómica: ¿un rayo de luz en la oscuridad?Medicina Clínica, Vol. 127, No. 17 Vol. 7, No. 2 Follow us on social media for the latest updates Metrics Downloaded 473 times History Published online 3 March 2006 Published in print March 2006 Information© Future Medicine LtdNoteAlthough there are explicit definitions available [101], ‘pharmacogenetics’ is often used interchangeably with the term ‘pharmacogenomics', and since many of the speakers did not differentiate between these two terms in their presentations, these terms are used interchangeably also in this article. DisclosureBoth authors are members of the ad hoc pharmacogenetic working group of the European Federation of Pharmaceutical Industries and Associations (EFPIA).PDF download

Innovative Approaches to Improving Organ Availability for Small Bowel Transplant Candidates

Small bowel transplant candidates have unique features that create special challenges for providing them with organs in a timely manner. More than half of intestinal transplant candidates also need livers. Because there is a greater overall demand for livers than for small bowels, organ allocation in this candidate subset is dictated by the liver allocation policies. However, the extremely high mortality rate associated with patients on the waiting list for combined liver-intestinal transplantation (LIT) attests to the inadequacies of the liver allocation system in recognizing the unique risk factors in patients with intestinal failure who develop end-stage liver disease (ESLD). This report addresses some of the organ allocation issues underlying the discrepancies in waiting list outcomes seen in LIT candidates and discusses possible contributory factors and potential solutions to this problem. The use of living donor and segmental grafts from deceased donors are discussed specifically as potential surgical solutions to the problem, and the potential utility, limitations, and ethical concerns associated with these innovative strategies are discussed.

Creating and enforcing patent rights in the fast moving field of personalized medicine.

Personalized MedicineVol. 3, No. 1 Special ReportCreating and enforcing patent rights in the fast moving field of personalized medicineDavid S Resnick, Ronald I Eisenstein, J Amelia Feulner & Leena H KarttunenDavid S Resnick† Author for correspondenceSearch for more papers by this author, Ronald I EisensteinSearch for more papers by this author, J Amelia FeulnerSearch for more papers by this author & Leena H KarttunenSearch for more papers by this authorPublished Online:23 Jan 2006https://doi.org/10.2217/17410541.3.1.89AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail View articleKeywords: diagnostic methodearly publicationenforcementinterferenceNixon Peabody LLPoppositionpatentpatenting strategiespetition to make specialBibliography1 Lynch TJ, Bell DW, Sordella R et al.: Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small cell lung cancer to gefitinib. N. Engl. J. Med.350(21), 2129–2139 (2004).Google Scholar2 Paez JG, Janne PA, Lee JC et al.: EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science304(5676), 1497–1500 (2004).Google Scholar3 35 U.S.C. 271(a): Infringement of Patent – Patent Laws.Google Scholar4 Bayer AG v. Housey Pharma., Inc., 128 Fed. Appx. 767 (Fed. Cir. 2005).Google Scholar5 State St. Bank & Trust Co. v. Signature Fin. Group, 149 F.3d 1368 (Fed. Cir. 1998).Google Scholar6 Informatics Act of 2005. H.R. 4208. IH.Google Scholar7 Taylor AL, Ziesche S, Yancy C et al.: Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N. Engl. J. Med.351(20), 2049–2057 (2004).Google Scholar8 Karttunen LH, Feulner JA, Resnick DS: Patenting Personalized Medicine. J. Biolaw & Bus.9(1) (2006).Google Scholar9 35 U.S.C. §154(d): “The applicants must also give actual notice of the published application to the accused infringer and explain, what acts are regarded as giving rice of provisional right.” Legislative History, Congr. Rec. S14719 (November 17, 1999).Google Scholar10 37 Code of Federal Regulations (CFR) 1.219: Early Publication. Patent Rules, Chapter I. United States Patent and Trademark Office, Department of Commerce, Part 1 – Rules of Practice in Patent Cases.Google Scholar11 37 CFR 1.18(d): Patent Post Allowance (including issue fees), (d) Publication Fee. Fees are according to schedule effective from January 1, 2006.Google Scholar12 MPEP § 1120: Section 1120 of Manual of Patent Examining Procedure (MPEP), 8th edition. US Patent and Trademark Office, Department of Commerce. (August 2001, last revision October 2005).Google Scholar13 37 CFR 1.17(h): Patent Application and Reexamination and Processing fees. Fees are according to schedule effective from January 1, 2006.Google Scholar14 37 CFR 1.102: Advancement of Examination and MPEP 708.02, VIII. Special Examination Procedure for Certain New Applications.Google Scholar101 Genzyme's EGFR Mutation Assay. Genzyme press release September 29, 2005. www.genzymegenetics.com/about/news/GENZ%20PR-092705.aspGoogle Scholar102 Guidance for Industry: Pharmacogenomic Data Submissions. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). March 2005 www.fda.gov/cder/guidance/index.htmGoogle Scholar103 United States Patent and Trademark Office http://portal.uspto.gov/external/portal/pairGoogle Scholar104 European Patent Office website. Go to “Public File Inspection”. http://my.epoline.org/portal/publicGoogle ScholarFiguresReferencesRelatedDetailsCited ByPharmacogenomics: A New Frontier for the Evergreening of Pharmaceutical DrugsSSRN Electronic Journal Vol. 3, No. 1 Follow us on social media for the latest updates Metrics Downloaded 142 times History Published online 23 January 2006 Published in print February 2006 Information© Future Medicine LtdKeywordsdiagnostic methodearly publicationenforcementinterferenceNixon Peabody LLPoppositionpatentpatenting strategiespetition to make specialDisclaimerThe views in the article represent the current views of the authors only, not Nixon Peabody LLP. The views of the authors are subject to change due to changes in the constantly evolving field of patent law.PDF download

Considerations in Retransplantation of the Failed Renal Allograft Recipient

Routine success in kidney transplantation has significantly improved the quality and length of life for the majority of recipients and made this option the treatment of choice for suitable candidates. Improved patient survival combined with a relative static improvement in long-term graft outcomes has led to an increasing number of transplant recipients with failed allografts who face the eventual option of either returning to dialysis or seeking retransplantation. Although retransplantation is presumed to be a favorable option for many, data to support this belief is limited. Given the wide variance in predicted outcomes for retransplantation, on the basis of the underlying kidney disease and other individual patient comorbidities as well as the expected wait time for a second transplant, each case should be evaluated independently. This review discusses available data and individual considerations that should be taken into account when retransplantation is proposed after failure of a primary allograft.

Collection and Use of Exposure Data from Human Milk Biomonitoring in the United States

Human milk is a unique biological matrix that can be used to estimate exposures in both the mother and the breastfed infant. In addition, the presence of environmental chemicals in human milk may act as a sentinel for exposures to a broader population. Several factors play a role in determining the quantity of chemicals transferred to milk and, subsequently, to the breastfeeding infant, including maternal, infant, and chemical characteristics. Exposure to certain environmental chemicals during critical periods can disrupt normal infant development, yet few data exist to quantify the hazards posed by environmental chemicals in human milk. Chemicals measured in human milk may also provide insights to agents suspect in altering breast development and breast-related disease risk. Carefully designed exposure assessment and toxicokinetic studies are needed to elucidate mechanisms and establish relationships between human milk and other biologic matrices. Data from human milk biomonitoring studies can be used to inform and validate models that integrate information about chemical properties, human metabolism, and biomarker concentrations. Additional research is needed to determine the degree to which environmental chemicals enter, are present in, and are excreted from human milk, their impact on the host (mother), and the extent of their bioavailability to breastfeeding infants. This article describes how the collection and use of exposure data from human milk biomonitoring in the United States can be designed to inform future research and policy. We thank the following organizations for generously providing support for the Workshop: the American Chemistry Council; the Centers for Disease Control and Prevention (C13/CCU323635-01); the Department of Health and Human Services, Health Resources and Services Administration (HHSH240200415021P); Health Canada (H405-03-ExSD079/4500078209); 3M; Pennsylvania State University College of Medicine; the Research Foundation for Health and Environmental Effects; and the U.S. Environmental Protection Agency, Office of Children’s Health (CH-83213101-0). The views expressed in this report are those of the authors and do not necessarily reflect the opinions and/or policies of the U.S. Environmental Protection Agency.

Methodologic Considerations for Improving and Facilitating Human Milk Research

Over the past several decades, interest in using human milk as a biomonitoring matrix has increased. However, it is not always an easy matter for a new mother to provide a milk sample. In this article, guidance on facilitating collection of human milk is provided. This includes addressing the mother’s ease in expressing a milk sample, and engaging with many audiences to reduce the likelihood of negatively impacting the already low breastfeeding rates in the United States. In addition, this article covers concepts regarding long-term storage and integrity of human milk samples to maximize the utility of those samples, and proposed methods for improving public access to the full spectrum of human milk biomonitoring data, with context to understand the information presented. The environmental chemicals and chemical classes for which robust analytical methods exist are enumerated, and a process for prioritizing the development of analytical methods for additional environmental chemicals is described. We thank the following organizations for generously providing support for the Workshop: the American Chemistry Council; the Centers for Disease Control and Prevention (C13/CCU323635-01); the Department of Health and Human Services, Health Resources and Services Administration (HHSH240200415021P); Health Canada (H405-03-ExSD079/4500078209); 3M; Pennsylvania State University College of Medicine; the Research Foundation for Health and Environmental Effects; and the U.S. Environmental Protection Agency, Office of Children’s Health (CH-83213101-0). The opinions expressed in this article are those of the authors and do not necessarily reflect the views and/or policies of their affiliations.

Human Milk Biomonitoring Data: Interpretation and Risk Assessment Issues

Biomonitoring data can, under certain conditions, be used to describe potential risks to human health (for example, blood lead levels used to determine children’s neurodevelopmental risk). At present, there are very few chemical exposures at low levels for which sufficient data exist to state with confidence the link between levels of environmental chemicals in a person’s body and his or her risk of adverse health effects. Human milk biomonitoring presents additional complications. Human milk can be used to obtain information on both the levels of environmental chemicals in the mother and her infant’s exposure to an environmental chemical. However, in terms of the health of the mother, there are little to no extant data that can be used to link levels of most environmental chemicals in human milk to a particular health outcome in the mother. This is because, traditionally, risks are estimated based on dose, rather than on levels of environmental chemicals in the body, and the relationship between dose and human tissue levels is complex. On the other hand, for the infant, some information on dose is available because the infant is exposed to environmental chemicals in milk as a “dose” from which risk estimates can be derived. However, the traditional risk assessment approach is not designed to consider the benefits to the infant associated with breastfeeding and is complicated by the relatively short-term exposures to the infant from breastfeeding. A further complexity derives from the addition of in utero exposures, which complicates interpretation of epidemiological research on health outcomes of breastfeeding infants. Thus, the concept of “risk assessment” as it applies to human milk biomonitoring is not straightforward, and methodologies for undertaking this type of assessment have not yet been fully developed. This article describes the deliberations of the panel convened for the Technical Workshop on Human Milk Surveillance and Biomonitoring for Environmental Chemicals in the United States, held at the Hershey Medical Center, Pennsylvania State College of Medicine, on several issues related to risk assessment and human milk biomonitoring. Discussion of these topics and the thoughts and conclusions of the panel are described in this article. We thank the following organizations for generously providing support for the Workshop: the American Chemistry Council; the Centers for Disease Control and Prevention (C13/CCU323635-01); the Department of Health and Human Services, Health Resources and Services Administration (HHSH240200415021P); Health Canada (H405-03-ExSD079/4500078209); 3M; Pennsylvania State University College of Medicine; the Research Foundation for Health and Environmental Effects; and the U.S. Environmental Protection Agency, Office of Children’s Health (CH-83213101-0). The opinions expressed in this article are those of the authors and do not necessarily reflect the views and/or policies of their affiliations.

Human Milk Research for Answering Questions about Human Health

Concerns regarding human milk in our society are diverse, ranging from the presence of environmental chemicals to the health of breastfed infants and the economic value of breastfeeding to society. The panel convened for the Technical Workshop on Human Milk Surveillance and Biomonitoring for Environmental Chemicals in the United States, held at the Hershey Medical Center, Pennsylvania State College of Medicine, on 24–26 September 2004, considered how human milk research may contribute to environmental health initiatives to benefit society. The panel concluded that infant, maternal, and community health can benefit from studies using human milk biomonitoring. Unlike other biological specimens, human milk provides information regarding exposure of the mother and breastfed infant to environmental chemicals. Some of the health topics relevant to this field of research include disorders of growth and development in infants, cancer origins in women, and characterization of the trend of exposure to environmental chemicals in the community. The research focus will determine the design of the study and the need for the collection of alternative biological specimens and the long-term storage of these specimens. In order to strengthen the ability to interpret study results, it is important to identify reference ranges for the chemicals measured and to control for populations with high environmental chemical exposure, because the amount of data on environmental chemical levels in human milk that is available for comparison is extremely limited. In addition, it will be necessary to validate models used to assess infant exposure from breastfeeding because of the variable nature of current models. Information on differences between individual and population risk estimates for toxicity needs to be effectively communicated to the participant. Human milk research designed to answer questions regarding health will require additional resources to meet these objectives. We thank the following organizations for generously providing support for the workshop: the American Chemistry Council; the Centers for Disease Control and Prevention (C13/CCU323635-01); the Department of Health and Human Services, Health Resources and Services Administration (HHSH240200415021P); Health Canada (H405-03-ExSD079/4500078209); 3M; Pennsylvania State University College of Medicine; the Research Foundation for Health and Environmental Effects; and the U.S. Environmental Protection Agency, Office of Children’s Health (CH-83213101-0). The opinions expressed in this article are those of the authors and do not necessarily reflect the views and/or policies of their affiliations.

Conclusions and Recommendations of the Expert Panel: Technical Workshop on Human Milk Surveillance and Biomonitoring for Environmental Chemicals in the United States

We thank the following organizations for generously providing support for the workshop: the AmericanChemistry Council; the Centers for Disease Control and Prevention (C13/CCU323635-01); the Departmentof Health and Human Services, Health Resources and Services Administration (HHSH240200415021P);Health Canada (H405-03-ExSD079/4500078209); 3M; Pennsylvania State University College of Medicine;the Research Foundation for Health and Environmental Effects; and the U.S. Environmental ProtectionAgency, Office of Children’s Health (CH-83213101-0).The opinions expressed in this article are those of the authors and do not necessarily reflect the viewsand/or policies of their affiliations.Address correspondence to Cheston M. Berlin, Jr., MD, Department of Pediatrics Children’s Hospital,Milton S. Hershey Medical Center, Pennsylvania State University College of Medi cine, M.C. HO85, PO Box850, Hershey, PA 17033, USA. E-mail: cmb6@psu.edu

The Growing, Ethnically Diverse Aging Population: Is Our Field Advancing With It?

The elderly population is growing, not only in population size, but also in racial and ethnic diversity on several fronts—in the United States as well as original places of origin. The United States' aging population is more diverse than ever before, and population projections suggest that diversity trends will continue. 1 U.S. Dept. of Health and Human Services Mental Health: Culture, Race, and Ethnicity—A Supplement to Mental Health: A Report of the Surgeon General. U.S. Dept. of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Mental Health Services, Rockville, MD2001 Google Scholar

Responsible Conduct of Radiology Research

The purpose of the articles in this series is to explain the ethical and legal basis for responsible conduct of radiology research. In the current article, the regulatory framework of human research is explained. There is no overall regulatory process for protecting the rights and welfare of humans participating in research. Instead, legal protections in the United States are an amalgam of regulations from multiple federal and state agencies. The key regulations are from the Department of Health and Human Services, the Food and Drug Administration, and the Federal Privacy Rule of the Health Insurance Portability and Accountability Act. Which of these apply in any situation depends on many factors, including the funding source of the research, the site of the research, and the items being tested. Radiologists conducting human research need to know which regulations apply and how to comply with them. The regulations represent a set of rules based on the ethical principles of respect for persons, beneficence, and justice. Radiologists should understand these ethical principles for situations when the regulations are silent, ambiguous, or incomplete. (c) RSNA, 2005.

Advanced Nursing Training in Health Policy: Designing and Implementing a New Program

Although the nursing profession has a growing role in the health policy arena, the rapidly changing health care environment means that clinicians need a sophisticated understanding of health policy. Nurses are assuming leadership roles in advocacy, research, analysis, and policy development, implementation, and evaluation, contributing to a growing need to educate nurses to specialize in health policy research and analysis. This article provides an overview of a new master's and doctoral educational program specializing in health policy for advanced practice nurses who are culturally diverse and sensitive to issues of diversity. The program, currently in its third year of operation at the University of California San Francisco, School of Nursing, is addressing the gap in nursing education and practice expertise in health policy. The program is supported through funding by the Department of Health and Human Services Health Resources and Services Administration, Advanced Nurse Training program.

Using Scientific Knowledge to Inform Preschool Assessment: Making the Case for “Empirical Validity”

The No Child Left Behind Act of 2001 crystallized the concern for accountability in education. National testing was mandated as a way to improve the “broken” educational system. Publicly funded early education programs were not spared from such testing. While the positive effects of high-quality early education on children’s later school achievement is well demonstrated, too many early care and educational settings in the United States are of minimal or poor quality. Accountability is clearly important for increasing the quality of our early childhood programs, however, it is not yet evident how best to formulate a standard of accountability that reflects the body of knowledge we have gained concerning how young children learn. In this report, we propose two major thrusts designed to bring about a more scientifically informed accountability system: reconceptualizing the ways in which we think about the validity of our test instruments, and reconceptualizing markers of development from products of learning (performance standards) to processes of learning. We introduce the term “empirical validity” to draw attention to the fact that assessments should be built on current empirical work in the various developmental domains. This report focuses on the domains of language and literacy, two areas of major concern for the Federal Head Start program and for which there is an abundance of current research. This body of knowledge provides many examples illustrating how an emphasis on process rather than product can be vital for improving the quality of education. For example, although vocabulary is centrally important and psychometrically adequate tests of early vocabulary exist, these tests do not measure essential aspects of word learning that have been identified as predictive of later language and reading success in early language learning literature. Our case study of language and literacy illustrates how today’s developmental science offers a new knowledge that can be strategically incorporated in assessments for empirically valid testing of children’s competencies. The same argument for “empirically valid” and evidence-based assessments applies to other domains of cognitive growth and to socio-emotional development. The future of preschool assessment would be well served by attention to primary research that focuses on the processes of learning. In this report, we also suggest that one possible avenue for progress in assessment would center on integrative and dynamic assessment techniques that would comprehensively capture the nature of children’s learning, minimize validity concerns related to context and culture, and evaluate how competencies in different developmental domains interact for optimal learning. To bridge the gap between science and policy, developmental scientists and test developers are urged to work together to create innovative ways to chart the developmental processes that support learning and progress toward social maturity in ways designed to ensure that research findings are continuously reflected in current assessments.

Resdiscovering the Administrative State: A New Appreciation Tor the Role of Government in Health and Human Services Administration

Resdiscovering the Administrative State: A New Appreciation Tor the Role of Government in Health and Human Services Administration