187 results match your criteria: "and the University of Minnesota[Affiliation]"
Anergy into T regulatory cells: an integration of metabolic cues and epigenetic changes at the Foxp3 conserved non-coding sequence 2.
F1000Res
March 2019
Division of Rheumatic and Autoimmune Diseases, Center for Immunology, and the University of Minnesota Medical School, Minneapolis, USA.
Peripheral immune self-tolerance relies on protective mechanisms to control autoreactive T cells that escape deletion in the thymus. Suppression of autoreactive lymphocytes is necessary to avoid autoimmunity and immune cell-mediated damage of healthy tissues. An intriguing relationship has emerged between two mechanisms of peripheral tolerance-induction of anergy and Foxp3 regulatory T (Treg) cells-and is not yet well understood.
View Article and Find Full Text PDFCollagen Vascular Diseases: SLE, Dermatomyositis, Scleroderma, and MCTD.
Pediatr Rev
October 2018
Division of Pediatric Rheumatology, Department of Pediatrics, University of Minnesota and the University of Minnesota Masonic Children's Hospital, Minneapolis, MN.
Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly.
N Engl J Med
October 2018
From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).
Background: Aspirin is a well-established therapy for the secondary prevention of cardiovascular events. However, its role in the primary prevention of cardiovascular disease is unclear, especially in older persons, who have an increased risk.
Methods: From 2010 through 2014, we enrolled community-dwelling men and women in Australia and the United States who were 70 years of age or older (or ≥65 years of age among blacks and Hispanics in the United States) and did not have cardiovascular disease, dementia, or disability.
Effect of Aspirin on All-Cause Mortality in the Healthy Elderly.
N Engl J Med
October 2018
From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., M.R.N., R.L.W., J.E.L., R.W., C.M.R., E.S., J.R., A.M.T., S.M.F., S.G.O., R.E.T., C.I.J.), Walter and Eliza Hall Institute of Medical Research (P.G.), and Baker Heart and Diabetes Institute (C.I.J.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, College of Medicine, Biology, and Environment, Australian National University, Canberra, ACT (W.P.A.), and Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute (B.K., R.G., A.M.M.), and the Division of Geriatrics, Department of Medicine (A.M.M.), Hennepin Healthcare, HealthPartners Institute (K.L.M.), and the University of Minnesota (A.M.M.) - all in Minneapolis; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); the Center for Aging and Population Health, Department of Epidemiology, University of Pittsburgh, Pittsburgh (D.G.I., A.B.N.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); and the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.).
Background: In the primary analysis of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, now published in the Journal, we report that the daily use of aspirin did not provide a benefit with regard to the primary end point of disability-free survival among older adults. A numerically higher rate of the secondary end point of death from any cause was observed with aspirin than with placebo.
Methods: From 2010 through 2014, we enrolled community-dwelling persons in Australia and the United States who were 70 years of age or older (or ≥65 years of age among blacks and Hispanics in the United States) and did not have cardiovascular disease, dementia, or disability.
Pragmatic Tools for Sharing Genomic Research Results with the Relatives of Living and Deceased Research Participants.
J Law Med Ethics
March 2018
Susan M. Wolf, J.D., is McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; Professor of Medicine; and Chair of the Consortium on Law and Values in Health, Environment & the Life Sciences, University of Minnesota. She was one of three Principal Investigators on NIH/NCI/NHGRI grant 1R01CA154517 on return of genomic results to family members, including after the death of the proband. Emily Scholtes, J.D., is a graduate of the University of Minnesota Law School, where she served as a Research Assistant on the project on return of genomic results to family members. She then clerked for the U.S. Court of Appeals for the Eighth Circuit before going into private practice. The views expressed in this article are exclusively those of the authors. This article has been prepared for informational purposes only and does not constitute legal advice. Barbara A. Koenig, Ph.D., is Director of Bioethics and Professor of Bioethics and Medical Anthropology based at the Institute for Health & Aging, University of California, San Francisco. She was one of three Principal Investigators on NIH/NCI/NHGRI grant 1R01CA154517 on return of genomic results to family members, including after the death of the proband. Gloria M. Petersen, Ph.D., is Professor of Epidemiology, Department of Health Sciences Research, Mayo Clinic College of Medicine. She is a Founding Fellow of the American College of Medical Genetics and Genomics. She was one of three Principal Investigators on NIH/NCI/NHGRI grant 1R01CA154517 on return of genomic results to family members, including after the death of the proband. Susan A. Berry, M.D., is Professor of Pediatrics & Genetics and Division Director for Genetics and Metabolism in the Department of Pediatrics, University of Minnesota. She is a Fellow of the American Academy of Pediatrics and the American College of Medical Genetics. Laura M. Beskow, M.P.H., Ph.D., is Professor of Health Policy and Director of Research Ethics, Center for Biomedical Ethics & Society, Vanderbilt University. She received her M.P.H. with a concentration in health law from Boston University and her Ph.D. in Health Policy and Administration, with a minor in Epidemiology, at the University of North Carolina at Chapel Hill. Mary B. Daly, M.D., Ph.D., is a medical oncologist and epidemiologist who chairs the Department of Clinical Genetics at Fox Chase Cancer Center. Her research focuses on defining the best methods of communicating hereditary cancer risk information and on providing risk management strategies and coping skills to family members dealing with an increased risk for cancer. Conrad V. Fernandez, B.Sc., M.D., is Professor and Head of the Division of Pediatric Hematology/Oncology in the Department of Pediatrics, IWK Health Centre, Dalhousie University and is cross-appointed in Bioethics, Medicine, and Postgraduate Studies. He obtained his medical degree at McMaster University, specialist certification in Pediatrics as a Fellow of the Royal College of Physicians and Surgeons of Canada at Dalhousie University, and completed specialty training in Pediatric Hematology/Oncology at the University of British Columbia. Robert C. Green, M.D., M.P.H., is a medical geneticist and physician-scientist who directs the G2P Research Program in translational genomics and health outcomes in the Division of Genetics, Brigham and Women's Hospital and Harvard Medical School. He is also Associate Director for Research at Partners Personalized Medicine. Dr. Green leads and co-leads the MedSeq Project and the BabySeq Project respectively, two NIH-funded randomized trials designed to explore the medical, behavioral, and economic implications of integrating genome sequencing into the medical care of adults and newborns. Bonnie S. LeRoy, M.S., C.G.C., is Professor and Director of the Graduate Program in Genetic Counseling, University of Minnesota. Her work focuses on preparing graduate students to enter the profession of genetic counseling. Her research examines the ethical and social challenges associated with the genetic counseling profession. She served as the President of the American Board of Genetic Counseling from 2001-03. Noralane M. Lindor, M.D., is Professor of Medical Genetics in the Department of Health Sciences Research at Mayo Clinic in Scottsdale, Arizona. She received her medical degree from Mayo Medical School, and did her residencies at Bowman Gray School of Medicine in Winston-Salem, North Carolina, and at Mayo Clinic in Rochester. P. Pearl O'Rourke, M.D., is Director of Human Research Affairs at Partners HealthCare in Boston, and Associate Professor of Pediatrics at Harvard Medical School. She completed medical school at Dartmouth Medical School and the University of Minnesota Medical School. Carmen Radecki Breitkopf, Ph.D., is Professor of Health Services Research in the Department of Health Sciences Research at Mayo Clinic College of Medicine and Science in Rochester, Minnesota. She earned her Master's and Doctoral degrees in Psychology from the State University of New York at Albany. Mark A. Rothstein, J.D., is Herbert F. Boehl Chair of Law & Medicine and Director of the Institute for Bioethics, Health Policy & Law at the University of Louisville School of Medicine. He is past-President of the American Society of Law, Medicine & Ethics and serves as Public Health Ethics editor for the American Journal of Public Health. Brian Van Ness, Ph.D., is Professor of Genetics, Cell Biology and Development at the University of Minnesota. He earned his doctorate in Biochemistry from the University of Minnesota, completed a postdoctoral fellowship at Fox Chase Cancer Center, and has served as the Department Head and Director of the Institute of Human Genetics at the University of Minnesota. Benjamin S. Wilfond, M.D., is Director of the Treuman Katz Center for Pediatric Bioethics, Seattle Children's Hospital; Professor and Chief of the Division of Bioethics; Professor, Pulmonary and Sleep Medicine, Department of Pediatrics; and Adjunct Professor, Department of Bioethics and Humanities, University of Washington School of Medicine. He is past-President of the Association of Bioethics Program Directors, Chair for the Clinical Research Ethics Consultation Working Group for the Clinical and Translational Science Awards program, and a member of the Bioethics and Legal Working Group of the Newborn Screening Translational Research Network.
Individual Treatment of Posttraumatic Stress Disorder Using Mantram Repetition: A Randomized Clinical Trial.
Am J Psychiatry
October 2018
From the Center of Excellence for Stress and Mental Health, VA San Diego Healthcare System, San Diego; the University of San Diego Hahn School of Nursing and the Beyster Institute for Nursing Research, San Diego; the California School of Professional Psychology at Alliant International University, San Diego; the Center for Healthcare Organization and Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, Mass., and the Departments of Psychiatry and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester; the Department of Statistics, Harvard University, Cambridge, Mass.; the Center for Chronic Disease Outcomes Research, Minneapolis VA Health Care System, and the University of Minnesota; the PsychArmor Institute and the Department of Psychiatry, University of California San Diego; the Psychology Service, VA San Diego Healthcare System, San Diego; the Department of Psychiatry, Boston University School of Medicine, Boston; and the VA Boston Healthcare System and the Boston University School of Public Health, Boston.
Objective: Previous studies suggest that group "mantram" (sacred word) repetition therapy, a non-trauma-focused complementary therapy for posttraumatic stress disorder (PTSD), may be an effective treatment for veterans. The authors compared individually delivered mantram repetition therapy and another non-trauma-focused treatment for PTSD.
Method: The study was a two-site, open-allocation, blinded-assessment randomized trial involving 173 veterans diagnosed with military-related PTSD from two Veterans Affairs outpatient clinics (January 2012 to March 2014).
Monitoring Neuromuscular Function.
N Engl J Med
January 2018
From the Department of Anesthesiology, Boston Medical Center, and Boston University School of Medicine (R.O., R.D.L.C., C.M.C.), and Boston University (A.G.) - all in Boston; the Mayo Clinic, Jacksonville, FL (S.J.B.); and the University of Minnesota Medical School Twin Cities, Minneapolis (R.P.).
Acute Pyelonephritis in Adults.
N Engl J Med
January 2018
From Minneapolis Veterans Affairs (VA) Health Care System and the University of Minnesota, Minneapolis (J.R.J.); and the University of Buffalo, State University of New York, and VA Western New York Health Care System, Buffalo (T.A.R.).
Sporadic Nocturnal Frontal Lobe Epilepsy--Report on Two Cases and Review of the First Taiwanese Series of 10 Cases.
Acta Neurol Taiwan
June 2017
Minnesota Regional Sleep Disorders Center and Department of Psychiatry, Hennepin County Medical Center and the University of Minnesota Medical School, Minneapolis, MN, USA.
Purpose: To report two additional cases of sporadic (i.e. non-familial) Nocturnal Frontal Lobe Epilepsy (NFLE) and integrate these two cases within the first series of 10 cases of sporadic NFLE reported in Taiwanese patients, and compare the findings with familial NFLE and with findings from Caucasian NFLE patients.
View Article and Find Full Text PDFA Molecular and Cytogenetic Update on Non-Small Cell Lung Carcinoma.
J Assoc Genet Technol
January 2017
The International Circle of Genetic Studies, Los Angeles, CA; Allina Health, Inc., Minneapolis, MN; Hospital Pathology Associates, Minneapolis, MN, and the University of Minnesota School of Medicine, Department of Laboratory Medicine and Pathology. Minneapolis, MN.
Lung cancer is one of the leading causes of cancer-related death worldwide. Among patients with lung cancer, approximately 85% have non-small cell lung carcinoma (NSCLC). The discovery of oncogenic driver mutations in NSCLC opened new personalized treatment options.
View Article and Find Full Text PDFElucidation of Novel Chromosomal Abnormalities in Pancreatic Cancer: Conventional and Molecular Cytogenetic Characterization of 16 Pancreatic Cell Lines.
J Assoc Genet Technol
January 2017
The International Circle of Genetic Studies, Los Angeles, CA and Allina Health, Minneapolis, MN, HPS, Minneapolis, MN, and The University of Minnesota, School of Medicine. Department of Laboratory Medicine and Pathology, Minneapolis, MN.
Pancreatic carcinoma is a major cause of cancer-related death in the United States, with a five-year survival rate of approximately 5%. Cytogenetic analysis has identified clinically significant chromosomal abnormalities in numerous malignancies, but it is not utilized in the clinical management of pancreatic carcinoma. We performed conventional and molecular cytogenetic analysis of 16 pancreatic carcinoma cell lines using Giemsa banding and DNA-based fluorescence in situ hybridization (FISH).
View Article and Find Full Text PDFThe t(12;21)(p13;q22) in Pediatric B-Acute Lymphoblastic Leukemia: An Update.
J Assoc Genet Technol
January 2017
The International Circle of Genetic Studies, Los Angeles, CA and Allina Health, Minneapolis, MN, HPS, Minneapolis, MN, and The University of Minnesota, School of Medicine. Department of Laboratory Medicine and Pathology, Minneapolis, MN.
Pediatric B-cell acute lymphoblastic leukemia (B-ALL) is the most common hematological malignancy in children, and the t(12;21)(p13;q22) occurs in approximately 25% of these cases, making it is the most prevalent chromosomal abnormality. The t(12;21) which disrupts hematopoietic differentiation and proliferation, and can be present as a sole abnormality or within the context of a complex karyotype characterized by three or more chromosomal abnormalities. The prognosis of t(12;21) within a complex karyotype is extensively debated.
View Article and Find Full Text PDFObjective Measurement of Adherence to Out-Patient Airway Clearance Therapy by High-Frequency Chest Wall Compression in Cystic Fibrosis.
Respir Care
July 2017
Pediatric Pulmonology, University of Minnesota Cystic Fibrosis Center and Masonic Children's Hospital, Minneapolis, Minnesota.
Background: Objective measures of adherence to high-frequency chest wall compression (HFCWC), a form of airway clearance therapy for patients with cystic fibrosis, are lacking. We used a novel electronic monitoring device integrated into an HFCWC vest to measure adherence compared with self-reported adherence. We determined factors that influenced adherence and how adherence correlated with baseline pulmonary function and pulmonary exacerbations.
View Article and Find Full Text PDFFit for purpose: perspectives on rapid reviews from end-user interviews.
Syst Rev
February 2017
Center for Evidence-based Practice, University of Pennsylvania, 3535 Market Street, Mezzanine, Suite 50, Philadelphia, PA, 19104, USA.
Background: There is increasing demand for rapid reviews and timely evidence synthesis. The goal of this project was to understand end-user perspectives on the utility and limitations of rapid products including evidence inventories, rapid responses, and rapid reviews.
Methods: Interviews were conducted with key informants representing: guideline developers (n = 3), health care providers/health system organizations (n = 3), research funders (n = 1), and payers/health insurers (n = 1).
Prognostic utility of estimated albumin excretion rate in chronic kidney disease: results from the Study of Heart and Renal Protection.
Nephrol Dial Transplant
February 2018
Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, Oxford, UK.
Background: Estimated albumin excretion rate (eAER) provides a better estimate of 24-h albuminuria than albumin:creatinine ratio (ACR). However, whether eAER is superior to ACR in predicting end-stage renal disease (ESRD), vascular events (VEs) or death is uncertain.
Methods: The prognostic utility of ACR and eAER (estimated from ACR, sex, age and race) to predict mortality, ESRD and VEs was compared using Cox proportional hazards regression among 5552 participants with chronic kidney disease in the Study of Heart and Renal Protection, who were not on dialysis at baseline.
Letter by Asinger et al Regarding Articles, "Should Patients With Atrial Fibrillation and 1 Stroke Risk Factor (CHA2DS2-VASc Score 1 in Men, 2 in Women) Be Anticoagulated? Yes: Even 1 Stroke Risk Factor Confers a Real Risk of Stroke" and "Should Patients With Atrial Fibrillation and 1 Stroke Risk Factor (CHA2DS2-VASc Score 1 in Men, 2 in Women) Be Anticoagulated?: The CHA2DS2-VASc 1 Conundrum: Decision Making at the Lower End of the Risk Spectrum".
Circulation
November 2016
From Division of Cardiology, Department of Medicine, Hennepin County Medical Center and the University of Minnesota, Minneapolis (R.W.A., G.A.S, C.A.H.); and Chronic Disease Research Group, Minneapolis Medical Research Foundation, MN (C.A.H.).
Intractable Insomnia as a Major Comorbidity of Grand Mal on Awakening: Case Report with Diagnostic Polysomnographic Findings and Successful Treatment Outcome.
Acta Neurol Taiwan
September 2015
Minnesota Regional Sleep Disorders Center and Department of Psychiatry, Hennepin County Medical Center and the University of Minnesota Medical School, Minneapolis, MN, USA.
Purpose: We report a novel case of "grand mal on awakening" from sleep presenting with intractable insomnia associated with interictal epileptiform activity (IEA) during sleep.
Case Report: A 36-year-old woman with a seizure history of grand mal on awakening since age 13 years suffered from severe, persistent insomnia despite seizure control with daytime valproic acid therapy. Bedtime hypnotic therapy with zolpidem and clonazepam was ineffective.
A new approach to treatment of acute heart failure.
J Cardiol
May 2016
Hennepin County Medical Center and the University of Minnesota, Minneapolis, MN, USA. Electronic address:
Conventional therapies for acute decongestion have yielded uniformly poor results in patients with acute heart failure (AHF). The failure of current strategies may be due to advanced disease in hospitalized patients, incomplete therapy, inherent limitations to existing therapy, or some combination of all three factors. Loop diuretics are the mainstay of current therapy and are in theory not ideal since while producing immediate intravascular volume reduction and relief of symptoms they activate neurohormonal forces that are deleterious to both the heart and the kidney.
View Article and Find Full Text PDFVarious studies have evaluated the adjunctive use of chemical and antimicrobial treatments to assist in the mechanical removal of oral microbial biofilm from tissue surfaces during scaling and root planning therapy (SRP). The current study demonstrates the elimination of two classes of surrogate molecular markers from periodontal disease sites. This suggests the current agent may be a more effective adjunctive cleansing agent for complete biofilm removal.
View Article and Find Full Text PDFBreast Cancer Screening for Women at Average Risk: 2015 Guideline Update From the American Cancer Society.
JAMA
October 2015
American Cancer Society, Atlanta, Georgia.
Importance: Breast cancer is a leading cause of premature mortality among US women. Early detection has been shown to be associated with reduced breast cancer morbidity and mortality.
Objective: To update the American Cancer Society (ACS) 2003 breast cancer screening guideline for women at average risk for breast cancer.
Sporadic nocturnal frontal lobe epilepsy: A consecutive series of 8 cases.
Sleep Sci
September 2014
Minnesota Regional Sleep Disorders Center and Department of Psychiatry, Hennepin County Medical Center and the University of Minnesota Medical School, Minneapolis, MN, USA.
Objective: To present findings on a series of cases of sporadic nocturnal frontal lobe epilepsy (NFLE), a form of NFLE that is infrequently reported, in contrast to familial (autosomal dominant) NFLE. Both forms of NFLE need to be distinguished from parasomnias, nocturnal temporal lobe epilepsy, and other nocturnal disorders.
Methods: Eight consecutive cases of sporadic NFLE were evaluated at a sleep clinic in Taiwan.
Canadian Research Ethics Board Leadership Attitudes to the Return of Genetic Research Results to Individuals and Their Families.
J Law Med Ethics
January 2017
Associate Professor at the Duke University School of Medicine and Duke Clinical Research Institute, where her work focuses on ethics and policy issues in biomedical research-particularly human subjects issues in large-scale genomic and translational research. She holds a B.S. in nutrition from Iowa State University, an M.P.H. with a concentration in health law from Boston University, and a Ph.D. in health policy and administration from the University of North Carolina at Chapel Hill.
Genomic research may uncover results that have direct actionable benefit to the individual. An emerging debate is the degree to which researchers may have responsibility to offer results to the biological relatives of the research participant. In a companion study to one carried out in the United States, we describe the attitudes of Canadian Research Ethics Board (REB) chairs to this issue and their opinions as to the role of the REB in developing related policy.
View Article and Find Full Text PDFReturn of Genetic Research Results to Participants and Families: IRB Perspectives and Roles.
J Law Med Ethics
January 2017
Director of Human Research Affairs at Partners HealthCare in Boston. She is an Associate Professor of Pediatrics at Harvard Medical School. She received her B.A. from Yale University, and completed medical school at Dartmouth Medical School and the University of Minnesota Medical School.
We surveyed IRB chairs' perspectives on offering individual genetic research results to participants and families, including family members of deceased participants, and the IRB's role in addressing these issues. Given a particular hypothetical scenario, respondents favored offering results to participants but not family members, giving choices at the time of initial consent, and honoring elicited choices. They felt IRBs should have authority regarding the process issues, but a more limited role in medical and scientific issues.
View Article and Find Full Text PDFReturning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations.
J Law Med Ethics
January 2017
Director of the Treuman Katz Center for Pediatric Bioethics, Seattle Children's Hospital; Professor and Chief of the Division of Bioethics; Professor, Pulmonary and Sleep Medicine, Department of Pediatrics; and Adjunct Professor, Department of Bioethics and Humanities, University of Washington School of Medicine. He is President of the Association of Bioethics Program Directors, Chair for the Clinical Research Ethics Consultation Working Group for the Clinical and Translational Science Awards program, and a member of the Bioethics and Legal Working Group of the Newborn Screening Translational Research Network.
Genomic research results and incidental findings with health implications for a research participant are of potential interest not only to the participant, but also to the participant's family. Yet investigators lack guidance on return of results to relatives, including after the participant's death. In this paper, a national working group offers consensus analysis and recommendations, including an ethical framework to guide investigators in managing this challenging issue, before and after the participant's death.
View Article and Find Full Text PDFRandomized Trial of Reduced-Nicotine Standards for Cigarettes.
N Engl J Med
October 2015
From the Departments of Psychology (E.C.D., R.L.D., S.S.D., T.L.) and Medicine (H.T.), University of Pittsburgh, Pittsburgh; the Center for Alcohol and Addiction Studies, Brown University, Providence, RI (J.W.T.); the Division of Biostatistics, School of Public Health (J.S.K., C.T.L.), the Departments of Biochemistry, Molecular Biology, and Biophysics (S.E.M.) and Psychiatry (D.K.H.) and the Masonic Cancer Center (J.S.K., S.G.C., S.S.H., J.J., C.T.L., S.E.M., D.K.H.), University of Minnesota, Minneapolis, and the University of Minnesota Medical School, Duluth (M.A.) - all in Minnesota; the Departments of Medicine and Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco (N.L.B.); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore (R.G.V., M.L.S.), and National Institute on Drug Abuse, Bethesda (I.D.M.) - both in Maryland; the Department of Behavioral Science, University of Texas M.D. Anderson Cancer Center, Houston (P.M.C., J.D.R.); the Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL (D.J.D.); the Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC (F.J.M.); and the Department of Psychiatry, Perelman School of Medicine, and Abramson Cancer Center, University of Pennsylvania, Philadelphia (A.A.S.).
Background: The Food and Drug Administration can set standards that reduce the nicotine content of cigarettes.
Methods: We conducted a double-blind, parallel, randomized clinical trial between June 2013 and July 2014 at 10 sites. Eligibility criteria included an age of 18 years or older, smoking of five or more cigarettes per day, and no current interest in quitting smoking.