informed consent

Summary

Summary: Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment.

Top Publications

  1. ncbi Interventions to improve research participants' understanding in informed consent for research: a systematic review
    James Flory
    Department of Clinical Bioethics, Warren G Magnuson Clinical Center, National Institutes of Health, Bethesda, MD 20892, USA
    JAMA 292:1593-601. 2004
  2. pmc Quality improvement report: Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be difficult
    Jenny Donovan
    Department of Social Medicine, University of Bristol, Bristol BS8 2PR, UK
    BMJ 325:766-70. 2002
  3. ncbi Development of a complex intervention improved randomization and informed consent in a randomized controlled trial
    Jenny L Donovan
    Department of Social Medicine, University of Bristol, Bristol BS8 2PR, UK
    J Clin Epidemiol 62:29-36. 2009
  4. ncbi The quality of informed consent: mapping the landscape. A review of empirical data from developing and developed countries
    Amulya Mandava
    Department of Bioethics, National Institutes of Health, Bethesda, MD 20892, USA
    J Med Ethics 38:356-65. 2012
  5. ncbi Genomics really gets personal: how exome and whole genome sequencing challenge the ethical framework of human genetics research
    Holly K Tabor
    Department of Pediatrics, University of Washington, Seattle, Washington, USA
    Am J Med Genet A 155:2916-24. 2011
  6. pmc Informed consent for whole genome sequencing: a qualitative analysis of participant expectations and perceptions of risks, benefits, and harms
    Holly K Tabor
    Department of Pediatrics, University of Washington, Seattle, Washington, USA
    Am J Med Genet A 158:1310-9. 2012
  7. pmc Taking social relationships seriously: lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast
    Caroline Gikonyo
    KEMRI Wellcome Trust Research Programme, P O Box 230, Kilifi, Kenya
    Soc Sci Med 67:708-20. 2008
  8. pmc Experiences with community engagement and informed consent in a genetic cohort study of severe childhood diseases in Kenya
    Vicki M Marsh
    Kenya Medical Research Institute KEMRI Wellcome Trust Research Programme, Kilifi, Kenya
    BMC Med Ethics 11:13. 2010
  9. pmc Patients' perception and actual practice of informed consent, privacy and confidentiality in general medical outpatient departments of two tertiary care hospitals of Lahore
    Ayesha Humayun
    Department of Community Health Sciences, FMH College of Medicine and Dentistry, Lahore, Pakistan
    BMC Med Ethics 9:14. 2008
  10. ncbi Awareness, knowledge and attitude toward informed consent among doctors in two different cultures in Asia: a cross-sectional comparative study in Malaysia and Kashmir, India
    R M Yousuf
    Department of Internal Medicine, Faculty of Medicine, International Islamic University Malaysia, Kuantan, Malaysia
    Singapore Med J 48:559-65. 2007

Detail Information

Publications312 found, 100 shown here

  1. ncbi Interventions to improve research participants' understanding in informed consent for research: a systematic review
    James Flory
    Department of Clinical Bioethics, Warren G Magnuson Clinical Center, National Institutes of Health, Bethesda, MD 20892, USA
    JAMA 292:1593-601. 2004
    Available data suggest that prospective research participants may frequently not understand information disclosed to them in the informed consent process. Little is known about how understanding can be improved.
  2. pmc Quality improvement report: Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be difficult
    Jenny Donovan
    Department of Social Medicine, University of Bristol, Bristol BS8 2PR, UK
    BMJ 325:766-70. 2002
    ..Recruitment to randomised trials is often difficult, and many important trials are not mounted because recruitment is thought to be "impossible."..
  3. ncbi Development of a complex intervention improved randomization and informed consent in a randomized controlled trial
    Jenny L Donovan
    Department of Social Medicine, University of Bristol, Bristol BS8 2PR, UK
    J Clin Epidemiol 62:29-36. 2009
    ..Systematic reviews failed to identify robust strategies to improve recruitment. We developed and evaluated a complex intervention to increase levels of randomization and informed consent.
  4. ncbi The quality of informed consent: mapping the landscape. A review of empirical data from developing and developed countries
    Amulya Mandava
    Department of Bioethics, National Institutes of Health, Bethesda, MD 20892, USA
    J Med Ethics 38:356-65. 2012
    Some researchers claim that the quality of informed consent of clinical research participants in developing countries is worse than in developed countries...
  5. ncbi Genomics really gets personal: how exome and whole genome sequencing challenge the ethical framework of human genetics research
    Holly K Tabor
    Department of Pediatrics, University of Washington, Seattle, Washington, USA
    Am J Med Genet A 155:2916-24. 2011
    ..We explain how use of ES/WGS challenges: (i) models under which informed consent is typically obtained; (ii) how harms associated with data sharing are considered; and (iii) the nature of ..
  6. pmc Informed consent for whole genome sequencing: a qualitative analysis of participant expectations and perceptions of risks, benefits, and harms
    Holly K Tabor
    Department of Pediatrics, University of Washington, Seattle, Washington, USA
    Am J Med Genet A 158:1310-9. 2012
    ..privacy, confidentiality, and return of results for whole genome sequencing (WGS) are effectively conveyed by informed consent (IC) is lacking...
  7. pmc Taking social relationships seriously: lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast
    Caroline Gikonyo
    KEMRI Wellcome Trust Research Programme, P O Box 230, Kilifi, Kenya
    Soc Sci Med 67:708-20. 2008
    Individual informed consent is a key ethical obligation for clinical studies, but empirical studies show that key requirements are often not met...
  8. pmc Experiences with community engagement and informed consent in a genetic cohort study of severe childhood diseases in Kenya
    Vicki M Marsh
    Kenya Medical Research Institute KEMRI Wellcome Trust Research Programme, Kilifi, Kenya
    BMC Med Ethics 11:13. 2010
    ..This paper draws on experiences around community engagement and informed consent during a genetic cohort study in Kenya to contribute to understanding the strengths and challenges of ..
  9. pmc Patients' perception and actual practice of informed consent, privacy and confidentiality in general medical outpatient departments of two tertiary care hospitals of Lahore
    Ayesha Humayun
    Department of Community Health Sciences, FMH College of Medicine and Dentistry, Lahore, Pakistan
    BMC Med Ethics 9:14. 2008
    The principles of informed consent, confidentiality and privacy are often neglected during patient care in developing countries. We assessed the degree to which doctors in Lahore adhere to these principles during outpatient consultations.
  10. ncbi Awareness, knowledge and attitude toward informed consent among doctors in two different cultures in Asia: a cross-sectional comparative study in Malaysia and Kashmir, India
    R M Yousuf
    Department of Internal Medicine, Faculty of Medicine, International Islamic University Malaysia, Kuantan, Malaysia
    Singapore Med J 48:559-65. 2007
    b>Informed consent is now accepted as the cornerstone of medical practice, with reasonable patient standards typically considered to be appropriate in the developed countries; however it is still challenged in many developing countries...
  11. pmc Informed consent in genomics and genetic research
    Amy L McGuire
    Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX 77030, USA
    Annu Rev Genomics Hum Genet 11:361-81. 2010
    There are several features of genetic and genomic research that challenge established norms of informed consent. In this paper, we discuss these challenges, explore specific elements of informed consent for genetic and genomic research ..
  12. ncbi Changing the paradigm for HIV testing--the end of exceptionalism
    Ronald Bayer
    Center for the History and Ethics of Public Health, Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, USA
    N Engl J Med 355:647-9. 2006
  13. pmc When is informed consent required in cluster randomized trials in health research?
    Andrew D McRae
    Department of Epidemiology and Biostatistics, University of Western Ontario, London, ON N6A5C1, Canada
    Trials 12:202. 2011
    ..This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers ..
  14. pmc Ethical issues posed by cluster randomized trials in health research
    Charles Weijer
    Rotman Institute of Philosophy, Department of Philosophy, University of Western Ontario, London, ON, N6A 5B8, Canada
    Trials 12:100. 2011
    ..Who is a research subject? 2. From whom, how, and when must informed consent be obtained? 3. Does clinical equipoise apply to CRTs? 4...
  15. ncbi Misunderstanding in clinical research: distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism
    Sam Horng
    Harvard Medical School, USA
    IRB 25:11-6. 2003
  16. pmc Pitfalls of and controversies in cluster randomization trials
    Allan Donner
    Department of Epidemiology and Biostatistics, University of Western Ontario, London, Canada
    Am J Public Health 94:416-22. 2004
    ..We discuss several topics related to these issues, with emphasis on the choices that must be made in the planning stages of a trial and on some potential pitfalls to be avoided...
  17. pmc Impact of social stigma on the process of obtaining informed consent for genetic research on podoconiosis: a qualitative study
    Fasil Tekola
    School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia
    BMC Med Ethics 10:13. 2009
    ..The aim of this study was to explore the impact of social stigma on the process of obtaining consent for a study on the genetics of podoconiosis in Southern Ethiopia...
  18. ncbi Informed decision making in outpatient practice: time to get back to basics
    C H Braddock
    Department of Medicine, VA Puget Sound Health Care System, Seattle 98108, USA
    JAMA 282:2313-20. 1999
    ..However, little is known about the extent to which physicians foster patient involvement in decision making, particularly in routine office practice...
  19. ncbi Patterns of consent in epidemiologic research: evidence from over 25,000 responders
    Kate M Dunn
    Primary Care Sciences Research Centre, Keele University, Keele, Staffordshire, United Kingdom
    Am J Epidemiol 159:1087-94. 2004
    ..Although consent is high among responders, the additive effect of nonresponse and nonconsent can substantially reduce sample size and should be taken into account in epidemiologic study planning...
  20. ncbi What do our patients understand about their trial participation? Assessing patients' understanding of their informed consent consultation about randomised clinical trials
    C Behrendt
    Department of Psychosomatic Medicine and Psychotherapy, University Hospital Freiburg, Freiburg, Germany
    J Med Ethics 37:74-80. 2011
    Ethically, informed consent regarding randomised controlled trials (RCTs) should be understandable to patients. The patients can then give free consent or decline to participate in a RCT...
  21. pmc Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials
    Adam Nishimura
    University of Washington, Seattle, WA, USA
    BMC Med Ethics 14:28. 2013
    Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified.
  22. ncbi Are women getting relevant information about mammography screening for an informed consent: a critical appraisal of information brochures used for screening invitation in Germany, Italy, Spain and France
    Elisabeth Gummersbach
    Department of General Practice, Universitatsklinikum, Heinrich Heine University, Dusseldorf, Germany
    Eur J Public Health 20:409-14. 2010
    ..brochures on mammography screening in Germany, Italy, Spain and France contain more information to facilitate informed consent than in similar studies carried out over the last few years in Sweden, Canada, USA and the UK, countries with ..
  23. ncbi Collection, storage and use of blood samples for future research: views of Egyptian patients expressed in a cross-sectional survey
    Alaa Abou-Zeid
    Faculty of Medicine, CairoUniversity, Cairo, Egypt
    J Med Ethics 36:539-47. 2010
    ..To determine the attitudes of Egyptian patients regarding their participation in research and with the collection, storage and future use of blood samples for research purposes...
  24. pmc Mental capacity to make decisions on treatment in people admitted to psychiatric hospitals: cross sectional study
    Gareth S Owen
    Department of Psychological Medicine and Psychiatry, Institute of Psychiatry, King s College London, London SE5 8AF
    BMJ 337:a448. 2008
    ..To estimate the prevalence of mental capacity to make decisions on treatment in people from different diagnostic and legal groups admitted to psychiatric hospital...
  25. ncbi Community engagement and informed consent in the International HapMap project
    Charles Rotimi
    National Human Genome Center, Howard University, Washington, DC, USA
    Community Genet 10:186-98. 2007
    ..Processes of community/public consultation and individual informed consent were implemented in each locality where samples were collected to understand and attempt to address both ..
  26. pmc Active choice but not too active: public perspectives on biobank consent models
    Christian M Simon
    Program in Bioethics and Humanities, Carver College of Medicine, Iowa City, Iowa 52242 1190, USA
    Genet Med 13:821-31. 2011
    ..The purpose of this study was to explore public perspectives toward a range of consent models currently being used or considered for use among comprehensive US biobanks...
  27. ncbi No consent should be needed for using leftover body material for scientific purposes. For
    Paul J van Diest
    Department of Pathology, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, Netherlands
    BMJ 325:648-51. 2002
  28. ncbi Quality of informed consent: a new measure of understanding among research subjects
    S Joffe
    Department of Pediatrics, Dana-Farber Cancer Institute, and Division of Hematology/Oncology, Children's Hospital, Boston, USA
    J Natl Cancer Inst 93:139-47. 2001
    BACKGROUND: The informed consent of participants is ethically and legally required for most research involving human subjects. However, standardized methods for assessing the adequacy of informed consent to research are lacking...
  29. ncbi It's not just what you say, it's also how you say it: opening the 'black box' of informed consent appointments in randomised controlled trials
    Julia Wade
    Department of Social Medicine, University of Bristol, 39 Whatley Road, Clifton, Bristol BS8 2PS, United Kingdom
    Soc Sci Med 68:2018-28. 2009
    ..This study investigated what occurs during informed consent appointments in an ongoing multi-centre RCT in the UK...
  30. pmc Risk communication and informed consent in the medical tourism industry: a thematic content analysis of Canadian broker websites
    Kali Penney
    Faculty of Medicine, University of Calgary, 2500 University Drive, NW, Calgary, Alberta, Canada
    BMC Med Ethics 12:17. 2011
    ..This raises important ethical concerns regarding processes such as informed consent and the liability of brokers in the event that complications arise from procedures...
  31. ncbi Ethical and practical challenges in implementing informed consent in HIV/AIDS clinical trials in developing or resource-limited countries
    Kyriaki Mystakidou
    Department of Radiology, Areteion Hospital, University of Athens
    SAHARA J 6:46-57. 2009
    ..research in the developing world remain under continuous evaluation; a critical area of concern includes informed consent. This paper reviews several of the most important ethical and practical aspects of informed consent in HIV ..
  32. ncbi Clinical trials in children
    Patrina H Y Caldwell
    Centre for Kidney Research, The Children s Hospital at Westmead, New South Wales, Australia
    Lancet 364:803-11. 2004
    ..In this review, we explore issues relating to trial participation for children and suggest some strategies for improving the conduct of clinical trials involving children...
  33. pmc Written informed consent and selection bias in observational studies using medical records: systematic review
    Michelle E Kho
    Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main Street West, Hamilton, ON, Canada L8S 4L8
    BMJ 338:b866. 2009
    To determine whether informed consent introduces selection bias in prospective observational studies using data from medical records, and consent rates for such studies.
  34. ncbi Are distinctive ethical principles required for cluster randomized controlled trials?
    J L Hutton
    Department of Statistics, The University of Newcastle, Newcastle upon Tyne, NE1 7RU, UK J L
    Stat Med 20:473-88. 2001
    ..I conclude that cluster randomized controlled trials raise new issues on the nature and practice of informed consent, because of the levels at which consent can be sought, and for which it can be sought...
  35. ncbi Informed patient consent to participation in cluster randomized trials: an empirical exploration of trials in primary care
    Sandra M Eldridge
    Centre for General Practice and Primary Care, Institute of Community Health Sciences, Queen Mary, University of London, UK
    Clin Trials 2:91-8. 2005
    ..A more public debate may clarify the general acceptability of not obtaining consent in certain situations...
  36. pmc Ethical aspects of human biobanks: a systematic review
    Danijela Budimir
    University of Split School of Medicine, Split, Croatia
    Croat Med J 52:262-79. 2011
    ..To systematically assess the existing literature on ethical aspects of human biobanks...
  37. ncbi A typology of shared decision making, informed consent, and simple consent
    Simon N Whitney
    Department of Family and Community Medicine, Baylor College of Medicine, Houston 77098, USA
    Ann Intern Med 140:54-9. 2004
    Enhancing patient choice is a central theme of medical ethics and law. Informed consent is the legal process used to promote patient autonomy; shared decision making is a widely promoted ethical approach...
  38. pmc Informed consent document improvement does not increase patients' comprehension in biomedical research
    Adeline Paris
    INSERM, CHU Grenoble, France
    Br J Clin Pharmacol 69:231-7. 2010
    International guidelines on ethics in biomedical research require that the informed consent of all enrolled participants is obtained...
  39. ncbi HIV vaccine trials: critical issues in informed consent
    G Lindegger
    School of Psychology, University of Natal, Private Bag X01, Scottsville, Pietermaritzburg, 3209 South Africa
    S Afr J Sci 96:313-7. 2000
    b>Informed consent (IC), a fundamental principle of ethics in medical research, is recognized as a vital component of HIV vaccine trials. There are different notions of IC, some legally based and others based on ethics...
  40. pmc The decision making control instrument to assess voluntary consent
    Victoria A Miller
    Department of Anesthesiology and Critical Care Medicine, Children s Hospital of Philadelphia and University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA
    Med Decis Making 31:730-41. 2011
    ..The decision to participate in a research intervention or to undergo medical treatment should be both informed and voluntary...
  41. pmc Tailoring information provision and consent processes to research contexts: the value of rapid assessments
    Susan Bull
    The Ethox Centre, Division of Public Health, University of Oxford, Old Road Campus, Headington, Oxford, United Kingdom
    J Empir Res Hum Res Ethics 7:37-52. 2012
    ....
  42. ncbi Informed consent: how much and what do patients understand?
    Matthew E Falagas
    Alfa Institute of Biomedical Sciences AIBS, Athens, Greece
    Am J Surg 198:420-35. 2009
    We sought to evaluate the degree of patients' understanding of several aspects of the informed consent process for surgery and clinical research.
  43. ncbi Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review
    Yael Schenker
    Department of Medicine, University of California, San Francisco, CA 94143, USA
    Med Decis Making 31:151-73. 2011
    Patient understanding in clinical informed consent is often poor...
  44. pmc Voluntary participation and informed consent to international genetic research
    Patricia A Marshall
    Department of Bioethics, Case Western Reserve University School of Medicine, Cleveland, Ohio 44106 4976, USA
    Am J Public Health 96:1989-95. 2006
    We compared voluntary participation and comprehension of informed consent among individuals of African ancestry enrolled in similarly designed genetic studies of hypertension in the United States and Nigeria.
  45. pmc Repeated assessments of informed consent comprehension among HIV-infected participants of a three-year clinical trial in Botswana
    Lelia H Chaisson
    Berman Institute of Bioethics, Johns Hopkins University, Baltimore, Maryland, United States of America
    PLoS ONE 6:e22696. 2011
    b>Informed consent (IC) has been an international standard for decades for the ethical conduct of clinical trials...
  46. ncbi Towards a framework for community engagement in global health research
    James V Lavery
    Centre for Research on Inner City Health and Centre for Global Health Research, Keenan Research Centre, Li Ka Shing Knowledge Institute of St Michael s Hospital, Toronto, Ontario, Canada
    Trends Parasitol 26:279-83. 2010
    ..We describe here a framework that provides a starting point for broader discussions of community engagement in global health research, particularly as it relates to the development, evaluation and application of new technologies...
  47. pmc Tailoring consent to context: designing an appropriate consent process for a biomedical study in a low income setting
    Fasil Tekola
    School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia
    PLoS Negl Trop Dis 3:e482. 2009
    ..We explored factors relating to information and communication during the process of informed consent, and the approach that should be followed for gaining consent...
  48. ncbi Predictors of comprehension during surgical informed consent
    Aaron S Fink
    Atlanta Veterans Affairs Medical Center, 1670 Clairmont Road, Decatur, GA 30033, USA
    J Am Coll Surg 210:919-26. 2010
    Patient comprehension during surgical informed consent remains problematic...
  49. ncbi Quality of informed consent in cancer clinical trials: a cross-sectional survey
    S Joffe
    Department of Paediatric Oncology, Dana-Farber Cancer Institute, Boston, MA 02115, USA
    Lancet 358:1772-7. 2001
    BACKGROUND: Investigators have to obtain informed consent before enrolling participants in clinical trials...
  50. ncbi Emergency research in children: options for ethical recruitment
    Joe Brierley
    Paediatric and Neonatal Intensive Care Unit, Great Ormond Street Hospital for Children NHS Trust, Great Ormond St, London, UK
    J Med Ethics 37:429-32. 2011
    ..The fundamental protection for research subjects, namely their full informed consent before any recruitment, is not tenable in true emergency situations and so other approaches are warranted if ..
  51. ncbi A brief measure of perceived understanding of informed consent in a clinical trial was validated
    Peter Guarino
    Department of Veterans Affairs, Cooperative Studies Program Coordinating Center, 950 Campbell Avenue, West Haven, CT 06516, USA
    J Clin Epidemiol 59:608-14. 2006
    To develop and evaluate an Informed Consent Questionnaire (ICQ) for measuring self-reported perceived understanding of informed consent in a randomized clinical trial.
  52. ncbi Opt-out plus, the patients' choice: preferences of cancer patients concerning information and consent regimen for future research with biological samples archived in the context of treatment
    E Vermeulen
    Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands
    J Clin Pathol 62:275-8. 2009
    ....
  53. ncbi Informed consent in biobank research: a deliberative approach to the debate
    David M Secko
    Department of Journalism, Concordia University, 7141 Sherbrooke St West, Montreal, QC, Canada
    Soc Sci Med 68:781-9. 2009
    ..In this paper, we report results related to debate over the place of informed consent in biobank research...
  54. ncbi Solidarity and justice as guiding principles in genomic research
    Rogeer Hoedemaekers
    Dept of Ethics, Philosophy and History of Medicine, Radboud University Nijmegen Medical Centre, P O Box 9101, 6500 HB, Nijmegen, Netherlands
    Bioethics 21:342-50. 2007
    ..We conclude with the formulation of a number of conditions that have to be met before autonomy sacrifices can be reasonably demanded in genomic research...
  55. ncbi Is informed consent broken?
    Gail E Henderson
    Department of Social Medicine, School of Medicine, University of North Carolina at Chapel Hill, 333 South Columbia Street, Rm 347 MacNider, Chapel Hill, NC 2799 7240, USA
    Am J Med Sci 342:267-72. 2011
    For as long as the federal regulations governing human subjects research have existed, the practice of informed consent has been attacked as culturally biased, legalistic, ritualistic and unevenly enforced...
  56. pmc The culture of faith and hope: patients' justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials
    Daniel P Sulmasy
    Department of Medicine, MacLean Center for Clinical Medical Ethics, Divinity School, University of Chicago, Chicago, Illinois 60637, USA
    Cancer 116:3702-11. 2010
    Patients' estimates of their chances of therapeutic benefit from participation in early phase trials greatly exceed historical data. Ethicists worry that this therapeutic misestimation undermines the validity of informed consent.
  57. pmc Patients' perception of quality of pre-operative informed consent in athens, Greece: a pilot study
    Matthew E Falagas
    Alfa Institute of Biomedical Sciences, Athens, Greece
    PLoS ONE 4:e8073. 2009
    We sought to perform a study to record and evaluate patients' views of the way surgeons communicate informed consent (IC) in Greece.
  58. ncbi Quality of informed consent for invasive procedures
    Mayer Brezis
    Center for Clinical Quality and Safety, Hadassah Hebrew University Medical Center, 91120 Jerusalem, Israel
    Int J Qual Health Care 20:352-7. 2008
    To assess quality of informed consent among patients undergoing procedures and patient's preferences about decision-making.
  59. ncbi Attitudes towards biomedical use of tissue sample collections, consent, and biobanks among Finns
    Aaro Tupasela
    Department of Sociology, University of Helsinki, Helsinki, Finland
    Scand J Public Health 38:46-52. 2010
    To ascertain the attitudes towards the use of existing diagnostic and research samples, the setting up of a national biobank, and different types of informed consent among Finns.
  60. ncbi Informed consent for thrombolytic therapy for patients with acute ischemic stroke treated in routine clinical practice
    Julie R Rosenbaum
    Department of Internal Medicine, Yale University School of Medicine, West Haven, Conn, USA
    Stroke 35:e353-5. 2004
    Little is known about informed consent for tissue plasminogen activator (tPA)...
  61. ncbi Public attitudes to the use in research of personal health information from general practitioners' records: a survey of the Irish general public
    Brian S Buckley
    Department of General Practice, Clinical Sciences Institute, National University of Ireland, Galway, Ireland
    J Med Ethics 37:50-5. 2011
    ..However, few large studies have been conducted about public attitudes to research access to personal health information...
  62. ncbi Informing the debate: rates of kidney transplantation in nations with presumed consent
    Lucy D Horvat
    University of Western Ontario, London University of Waterloo, Waterloo and University of Toronto, Toronto, Ontario, Canada
    Ann Intern Med 153:641-9. 2010
    ..The organ shortage has caused policymakers in many nations to debate the merits of adopting presumed consent legislation as a way to increase donor organ donation from deceased donors...
  63. pmc Community members as recruiters of human subjects: ethical considerations
    Christian Simon
    School of Medicine, University of Iowa, IA, USA
    Am J Bioeth 10:3-11. 2010
    ..The paper will have relevance to bioethicists, health researchers, and research regulators concerned about the appropriate use of peer-driven recruitment strategies in health research...
  64. ncbi Biobanking residual tissues
    Peter H J Riegman
    Erasmus Medical Center, Department of Pathology, Be 235b, Josephine Nefkens Institute, Dr Molewaterplein 40, PO Box 2040, 3000 CA Rotterdam, The Netherlands
    Hum Genet 130:357-68. 2011
    ..consequences of using residual human material from different sources in distinct situations and why signed informed consent is not always the preferred choice of individual countries regarding the use of residual material...
  65. ncbi The adequacy of informed consent forms in genetic research in Oman: a pilot study
    Asya Al-Riyami
    Ministry of Health, Oman and Research and Ethics Committee, Sultanate of Oman
    Dev World Bioeth 11:57-62. 2011
    Genetic research presents ethical challenges to the achievement of valid informed consent, especially in developing countries with areas of low literacy...
  66. pmc Use of deferred consent for severely ill children in a multi-centre phase III trial
    Kathryn Maitland
    Kemri Wellcome Centre for Geographic medicine, Coast, Kenya
    Trials 12:90. 2011
    ..a subject in research respects a subject's rights, strengthens its ethical conduct, and is formalized by the informed consent process...
  67. pmc The revision of the Declaration of Helsinki: past, present and future
    Robert V Carlson
    Clinical Pharmacology Unit, University of Edinburgh, Western General Hospital, UK
    Br J Clin Pharmacol 57:695-713. 2004
    ....
  68. ncbi Beyond the checklist: assessing understanding for HIV vaccine trial participation in South Africa
    Graham Lindegger
    HIV AIDS Vaccines Ethics Group, School of Psychology, University of KwaZulu Natal, Pietermaritzburg, Private Bag X01, Scottsville 3209, South Africa
    J Acquir Immune Defic Syndr 43:560-6. 2006
    b>Informed consent and understanding are essential ethical requirements for clinical trial participation. Traditional binary measures of understanding may be limited and not be the best measures of level of understanding...
  69. pmc Ethical issues in human genomics research in developing countries
    Jantina de Vries
    The Ethox Centre, Department of Public Health and Primary Care, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK
    BMC Med Ethics 12:5. 2011
    ..In this paper, we draw upon the experiences of the MalariaGEN Consortium to identify specific ethical issues raised by such research in Africa, Asia and Oceania...
  70. ncbi Informed consent and collaborative research: perspectives from the developing world
    Adnan A Hyder
    Dev World Bioeth 6:33-40. 2006
    b>Informed consent has been recognized as an important component of research protocols and procedures of disclosure and consent in collaborative research have been criticized, as they may not be in keeping with cultural norms of developing ..
  71. pmc Principles of human subjects protections applied in an opt-out, de-identified biobank
    Jill Pulley
    Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, Tennessee, USA
    Clin Transl Sci 3:42-8. 2010
    ..Considerations of core principles and protections in the practical implementation of BioVU is the focus of this paper...
  72. ncbi Undue inducement in clinical research in developing countries: is it a worry?
    Ezekiel J Emanuel
    Department of Clinical Bioethics, Warren G Magnuson Clinical Center, National Institutes of Health, Building 10 Room 1C118, Bethesda, MD 20892 1156, USA
    Lancet 366:336-40. 2005
  73. ncbi Who can best recruit to randomized trials? Randomized trial comparing surgeons and nurses recruiting patients to a trial of treatments for localized prostate cancer (the ProtecT study)
    Jenny L Donovan
    Department of Social Medicine, University of Bristol, Canynge Hall, Whiteladies Road, Bristol BS8 2PR, UK
    J Clin Epidemiol 56:605-9. 2003
    ..In a randomized trial nested within a trial of treatments for localized prostate cancer, we investigated the comparative effectiveness and cost-effectiveness of nurses and surgeons in recruiting patients...
  74. pmc Public opinion about the importance of privacy in biobank research
    David J Kaufman
    Genetics and Public Policy Center, Johns Hopkins University, Washington, DC 20036, USA
    Am J Hum Genet 85:643-54. 2009
    ..participants in a proposed biobank were asked about their willingness to participate, their privacy concerns, informed consent, and data sharing. A representative survey of 4659 U.S. adults was conducted...
  75. ncbi Legal and ethical implications of opt-out HIV testing
    Catherine Hanssens
    Center for HIV Law and Policy, New York, New York 10006, USA
    Clin Infect Dis 45:S232-9. 2007
    ..Patient testing protocols should satisfy the legal definition of informed consent, to reduce risk of liability for providers (i.e., health care professionals and facilities)...
  76. pmc Costs and consequences of the US Centers for Disease Control and Prevention's recommendations for opt-out HIV testing
    David R Holtgrave
    Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America
    PLoS Med 4:e194. 2007
    ..In this paper, I estimate the costs and public health impact of opt-out HIV testing relative to testing accompanied by client-centered counseling, and relative to a more targeted counseling and testing strategy...
  77. ncbi What constitutes evidence-based patient information? Overview of discussed criteria
    Martina Bunge
    University of Hamburg, Unit of Health Sciences and Education, 20146 Hamburg, Germany
    Patient Educ Couns 78:316-28. 2010
    ..To survey quality criteria for evidence-based patient information (EBPI) and to compile the evidence for the identified criteria...
  78. ncbi Informed consent in Ghana: what do participants really understand?
    Z Hill
    Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK
    J Med Ethics 34:48-53. 2008
    ....
  79. ncbi Trends in ethical and legal frameworks for the use of human biobanks
    A Cambon-Thomsen
    INSERM, U 558, Dept of Epidemiology, Health Economics and Public Health, Faculty of Medicine, University Paul Sabatier, 37 Allees Jules Guesde, 31073 Toulouse, Cedex, France
    Eur Respir J 30:373-82. 2007
    ..affect the clinician's attitudes and relationship with the patients? The main ethical issues encountered are: informed consent; confidentiality; secondary use of samples and data over time; return of results; and data sharing...
  80. ncbi Consent and assent to participate in research from people with dementia
    Susan Slaughter
    University of Calgary, Primary Care Research and Development Group, Department of Family Medicine, 1635, 1632 14 Ave, NW, Calgary, AB, T2N 1M7, Canada
    Nurs Ethics 14:27-40. 2007
    ..Although it is generally understood that informed consent is a necessary prerequisite to research participation, it is less clear how to proceed when potential ..
  81. doi The organs crisis and the Spanish model: theoretical versus pragmatic considerations
    Muireann Quigley
    J Med Ethics 34:223-4. 2008
  82. ncbi Bad news about bad news: the disclosure of risks to insurability in research consent processes
    Victoria Smith Apold
    Faculties of Law and Medicine, Dalhousie University, Halifax, Nova Scotia, Canada
    Account Res 18:31-44. 2011
    ..In this article, we seek to explain the insurability risks associated with incidental findings and to make recommendations for how researchers and research ethics committees should address the issue of disclosure of these risks...
  83. ncbi Patients' experiences on donation of their residual biological samples and the impact of these experiences on the type of consent given for the future research use of the tissue: a systematic review
    Tuck Wai Chan
    Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore
    Int J Evid Based Healthc 10:9-26. 2012
    ....
  84. ncbi Informed consent in clinical medicine
    Peter B Terry
    Division of Pulmonary and Critical Care Medicine, Department of Medicine, The Johns Hopkins Hospital, Blalock 910 Pulmonary C600 North Wolfe St, Baltimore, MD 21287, USA
    Chest 131:563-8. 2007
    ..It is important to realize that signing a consent form does not constitute informed consent. True informed consent is a process, and, as such, it requires that the health-care provider enter into a ..
  85. ncbi Informed consent in elective surgical procedures: "what do the patients think"?
    Mohammed Amir
    Department of Surgery, Shifa College of Medicine, Shifa International Hospital, Islamabad
    J Pak Med Assoc 59:679-82. 2009
    To analyze the patients' perspective of the process of informed consent in a tertiary care hospital setting.
  86. pmc Inadequate reporting of research ethics review and informed consent in cluster randomised trials: review of random sample of published trials
    Monica Taljaard
    Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa Hospital, Civic Campus, 1053 Carling Avenue, Ottawa, ON, Canada K1Y 4E9
    BMJ 342:d2496. 2011
    ..Journal Editors' uniform requirements for manuscripts (namely, reporting of research ethics review and informed consent), to determine whether the adequacy of reporting has improved over time, and to identify characteristics of ..
  87. ncbi From consent to institutions: designing adaptive governance for genomic biobanks
    Kieran C O'Doherty
    University of Guelph, Psychology, MacKinnon Ext Bldg 154, 87 Trent Lane, Guelph, Ontario, Canada
    Soc Sci Med 73:367-74. 2011
    ..One of the proposed solutions to these challenges involves trading off a reduction in the specificity of informed consent protocols with an increased emphasis on governance...
  88. ncbi Why healthy subjects volunteer for phase I studies and how they perceive their participation?
    Luis Almeida
    Department of Research and Development, BIAL, A Av da Siderurgia Nacional, 4745 457, S Mamede do Coronado, Portugal
    Eur J Clin Pharmacol 63:1085-94. 2007
    To characterize the motivations and attitudes of healthy subjects who volunteer for phase I studies as well as their perception of the informed consent procedure and participation in the study.
  89. ncbi Impact of a clinical trials information handbook on patient knowledge, perceptions, and likelihood of participation
    Heather M Campbell
    Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, University of New Mexico College of Pharmacy, Albuquerque, NM, USA
    IRB 30:6-14. 2008
  90. ncbi Information and informed consent for neonatal screening: opinions and preferences of parents
    Symone Detmar
    TNO Quality of Life Prevention and Healthcare, Leiden, The Netherlands
    Birth 34:238-44. 2007
    ..This study investigated the preferences and views of parents and future parents with respect to information about, and consent to, neonatal screening and the possible expansion of the program...
  91. pmc Length and complexity of US and international HIV consent forms from federal HIV network trials
    Nancy E Kass
    Johns Hopkins Berman Institute of Bioethics, Baltimore, MD 21205, USA
    J Gen Intern Med 26:1324-8. 2011
    b>Informed consent is required in most clinical research with humans. While federal regulations state consent information should be understandable to participants, concerns have been raised that consent forms are overly long and complex.
  92. ncbi Quality assurance questionnaire for professionals fails to improve the quality of informed consent
    Philip W Lavori
    Department of Veterans Affairs Cooperative Studies Program Palo Alto Coordinating Center and Department of Health Research and Policy, Stanford University, School of Medicine, Stanford, CA, USA
    Clin Trials 4:638-49. 2007
    The informed consent process for research warrants improvement but approaches designed to enhance informed consent need testing in the context of actual clinical research.
  93. pmc Extracting information from hospital records: what patients think about consent
    Bruce Campbell
    Royal Devon and Exeter Hospital Wonford, Exeter EX2 5DW, England
    Qual Saf Health Care 16:404-8. 2007
    ....
  94. ncbi Quality in health care and globalization of health services: accreditation and regulatory oversight of medical tourism companies
    Leigh G Turner
    Center for Bioethics and School of Public Health, University of Minnesota, Minneapolis, MN 55455, USA
    Int J Qual Health Care 23:1-7. 2011
    ..Establishing high standards for the operation of medical tourism companies should reduce risks facing patients when they travel abroad for health care...
  95. pmc Ethics and biobanks
    M G Hansson
    1Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics, Uppsala University, Uppsala Science Park, Uppsala SE 751 85, Sweden
    Br J Cancer 100:8-12. 2009
    ..The difficult question regarding the return of information to research subjects is the focus of the current research, but a helpful analysis of some of the issues at stake and concrete recommendations have recently been suggested...
  96. ncbi Turning residual human biological materials into research collections: playing with consent
    Eugenijus Gefenas
    Department of Medical History and Ethics, Vilnius University, M K Ciurlionio St 21 27, Vilnius LT 03101, Lithuania
    J Med Ethics 38:351-5. 2012
    ..However, such precautionary consent should not be construed as blanket, unrestricted consent for any future use...
  97. pmc Monetary incentives improve recall of research consent information: it pays to remember
    David S Festinger
    Treatment Research Institute, University of Pennsylvania, Philadelphia, PA 19106, USA
    Exp Clin Psychopharmacol 17:99-104. 2009
    Research participants often fail to recall substantial amounts of informed consent information after delays of only a few days...
  98. ncbi [Informed consent as viewed by patients participating in cardiology drug trial]
    Silmara Meneguin
    Instituto do Coracao, Hospital das Clinicas, Faculdade de Medicina, USP, Sao Paulo, SP, Brasil
    Arq Bras Cardiol 94:4-9. 2010
    In clinical tests, the Informed Consent is critical to preserve the ethics, but due to its high complexity level, it cannot be fully understood. This study assesses the Informed Consent as viewed by patients.
  99. pmc A trial of consent procedures for future research with clinically derived biological samples
    E Vermeulen
    The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam 1066 CX, The Netherlands
    Br J Cancer 101:1505-12. 2009
    ..The aims of this study were to determine which consent procedure patients prefer for use of stored tissue for research purposes and what the effects of consent procedures on actual consenting behaviour are...
  100. ncbi Informed consent and subject motivation to participate in a large, population-based genomics study: the Marshfield Clinic Personalized Medicine Research Project
    Catherine A McCarty
    Marshfield Clinic Research Foundation, Marshfield, WI 54449, USA
    Community Genet 10:2-9. 2007
    ..The objective of this study was to measure subject perspective and reaction to participation in the Personalized Medicine Research Project (PMRP) and to identify factors predicting understanding of the study elements...
  101. pmc Inability to obtain deferred consent due to early death in emergency research: effect on validity of clinical trial results
    Tim C Jansen
    Department of Intensive Care, Erasmus MC University Medical Center, CA, Rotterdam, The Netherlands
    Intensive Care Med 36:1962-5. 2010
    ..To illustrate the impact on the validity of trial results due to excluding patients from a randomized controlled trial for whom no deferred consent could be obtained after randomization because study procedures had already been finished...

Research Grants85

  1. Transforming PCI Informed Consent into an Evidence-based Decision-making Tool
    John A Spertus; Fiscal Year: 2010
    ..patient-centered healthcare system, this study proposes to test the impact of a new mechanism for eliciting informed consent from patients undergoing percutaneous coronary intervention (PCI) on patients'comprehension of ..
  2. Infant Screening and Diagnosis of Duchenne Muscular Dys*
    Paul Fernhoff; Fiscal Year: 2007
    ..around Duchenne Muscular Dystrophy (DMD) testing, nor does it provide the best opportunity for obtaining informed consent. The applicant argues that presenting the screening at the first visit, but collecting the specimen at the ..
  3. THE ETHICS OF POST-CONFLICT AND POST-DISASTER DNA IDENTIFICATION
    Sarah Wagner; Fiscal Year: 2013
    ..rights organizations that contract their services;and issues of privacy, anonymity, trust, data ownership, informed consent, and illicit use associated with the creation of large genetic databases in countries emerging from conflict ..
  4. Effects of Standardized Aerobic Exercise-Training on Neurocognitive and Neurodege
    Thomas O Obisesan; Fiscal Year: 2010
    ..After obtaining informed consent, participants will undergo initial exercise screening to determine their ability to exercise safely...
  5. Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Joint Pain
    Karen H Costenbader; Fiscal Year: 2013
    ..The mailing will contain a letter describing the trial, an informed consent form, and a questionnaire about past medical history, including autoimmune diseases and a screening ..
  6. Comparative Effectiveness Research in Pediatric Rheumatic Diseases: Leveraging CA
    CAROL A contact WALLACE; Fiscal Year: 2010
    ..Each protocol will have associated IRB and informed consent documents, case report forms and other regulatory documents for immediate implementation and data collection ..
  7. Anti- IL5 therapy for Churg-Strauss Syndrome: a double blind randomized, placebo-
    Michael E Wechsler; Fiscal Year: 2010
    ..systems 3) Prepare U01 CSS Anti-IL5 safety &data monitoring plan and oversight systems 4) Prepare U01 IRB informed consent forms 5) Develop recruitment strategies 6) Work with FDA &pharmaceutical sponsor to obtain IND and ..
  8. Nanodiagnostics and Nanotherapeutics: Building Research Ethics and Oversight
    Susan M Wolf; Fiscal Year: 2010
    ..about both participant and third-party safety both short-term and long-term, and challenges obtaining informed consent. The project group will use normative, empirical, and policy analysis to evaluate current approaches to ..
  9. Ethical and Legal Challenges in Communicating Individual Biomonitoring and Person
    Rachel Morello-Frosch; Fiscal Year: 2013
    ..individual results for chemicals for which health effects are uncertain, and for each study to (a) analyze informed consent and report-back methods and (b) conduct in-depth interviews with study participants, researchers, and IRB ..
  10. Evaluating Economic Subsidies To Improve Dietary Intake Among Low Income Families
    Marian L Fitzgibbon; Fiscal Year: 2010
    ..social contextual variables, and child weight gain trajectory over the first 18 months of the policy (with informed consent)...
  11. Treating cutaneous leishmaniasis by radio-frequency induced heat (RFH) therapy
    Abhay R Satoskar; Fiscal Year: 2012
    ..trial protocol including a statistical analysis plan, data management and safety monitoring plans, and informed consent process and documents (Aim 2)...
  12. Resuscitation Outcomes Consortium (ROC) Regional Clinical Center-Pittsburgh
    Clifton W Callaway; Fiscal Year: 2013
    ..Having established unprecedented infrastructure to successfully accomplish this goal (using exception from informed consent under emergency circumstances) in 245 EMS agencies and nearly 35,000 EMS providers covering a population of ..
  13. Resuscitation Outcomes Consortium (ROC) Regional Clinical Center-Seattle-King
    PETER JAMES KUDENCHUK; Fiscal Year: 2013
    ..Having established unprecedented infrastructure to successfully accomplish this goal (using exception from informed consent under emergency circumstances) in 245 EMS agencies and nearly 35,000 EMS providers covering a population of ..
  14. Resuscitation Outcomes Consortium (ROC) Regional Clinical Centers-Milwaukee
    TOM PAUL AUFDERHEIDE; Fiscal Year: 2013
    ..Having established unprecedented infrastructure to successfully accomplish this goal (using exception from informed consent under emergency circumstances) in 245 EMS agencies and nearly 35,000 EMS providers covering a population of ..
  15. Mapping Etiological Pathways to SV Perpetration from Childhood to Young Adulthood
    Michele Ybarra; Fiscal Year: 2011
    ..least 50% of the time;c) Equally familiar / most familiar with child's daily activities;and d) provided informed consent to participate in the survey, Youth were required to have accessed the Internet at least once in the past 6 ..
  16. Translational refinement of adaptive communication system for locked-in patients
    Melanie Fried-Oken; Fiscal Year: 2013
    ..These individuals with limited to no movement could potentially contribute to their medical decision making, informed consent, and daily care giving if they had faster, more reliable means to interface with communication systems...
  17. Coagulation and Fibrinolysis in Pediatric Insulin Titration Trial
    Anil Sapru; Fiscal Year: 2013
    ..blood glucose, we will approach parents or surrogates of children enrolled in the HALF PINT trial and obtain informed consent for participation in this ancillary study...
  18. Kidney Donor Outcomes Cohort (KDOC) Study
    James R Rodrigue; Fiscal Year: 2013
    ..these outcomes and their predictors are known, we can further develop and refine educational strategies and informed consent processes for both living donors and their intended recipients, as well as provide systematic data to inform ..
  19. ESTABLISHMENT OF RESEARCH RESOURCEFOR THE IDENTIFICATION OF GENETIC AND ENVIRONM
    VAINORIOUS E; Fiscal Year: 2009
    ..1% of the patients from the FPC and ACC, respectively, agreed to participate as evidenced by signing an informed consent form. Only two patients from the FPC withdrew from the study at a later date...
  20. Implementation of phosphoprotein preservation technology for cancer biospecimens
    LANCE ALLEN LIOTTA; Fiscal Year: 2013
    ..We will collect fresh surgical tissue, under informed consent, covering a broad variety of organs and cancer histology to develop an archive of 150 cases of matched ..
  21. Telehealth Tinnitus Intervention for Patients with TBI
    JAMES A contact HENRY; Fiscal Year: 2011
    ..Callers who pass screening are sent a package containing the informed consent form (ICF) and baseline questionnaires...
  22. ETHICAL & SOCIAL IMPLICATIONS OF GENETIC TESTING IN THE CASE OF UNEXPECTED DEATHS
    Siobhan M Dolan; Fiscal Year: 2010
    ..members b) communication to families by forensics professionals versus clinicians c) considerations for informed consent for research versus clinical care 3) To develop recommendations, guidelines and tools specifically for use by ..
  23. Disposable Valved Intraurethral Catheter Feasibility
    Harvey D Homan; Fiscal Year: 2010
    ..5) Finalize Case Report Forms and Informed Consent;obtain approval from FDA for an Investigational Device Exemption and Institutional Review Board approval to ..
  24. Impact of Family History of Colon Cancer on Adenomas in 40-49 Year Olds
    Philip S Schoenfeld; Fiscal Year: 2012
    ..After obtaining informed consent from study patients, we will gather data on the size, morphology, and location of polyps from colonoscopy ..
  25. CNV Atlas of Human Development
    Ronald Wapner; Fiscal Year: 2010
    ..Using a novel "opt-out" consent mechanism in addition to a traditional full informed consent model, we will develop methods for a large consortium of clinical sites and clinical genetics testing ..
  26. MOUNT SINAI EMERGENCY MEDICINE RESEARCH CAREER DEVELOPMENT PROGRAM
    Lynne D Richardson; Fiscal Year: 2013
    ..The PI/PD has extensive research expertise in the exception from informed consent regulations that allow clinical investigations of resuscitation and other life-threatening conditions and ..
  27. Variation in the Safety of Back Pain-Related Surgery
    Sohail K Mirza; Fiscal Year: 2010
    ..making ("Informed Choice"), wherein their values and preferences were recorded, a much higher standard of informed consent than is traditionally practiced...
  28. Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) Trial
    Kurt Kroenke; Fiscal Year: 2013
    ..A total of 300 eligible patients who provide informed consent will be randomized to one of two treatment arms...
  29. Best Practices in Mental Health Research Ethics Conference Series
    James M DuBois; Fiscal Year: 2010
    ..Louis, MO, on the campus of St. Louis University. Conference topics include: "Informed Consent: Assessing Decision-Making Capacity and Enhancing Understanding" (year 1);"Engaging the Stakeholders in ..
  30. Treatment Study Using Depot Naltrexone(1/6)Philadelphia Coord/Data Mgmt Site
    CHARLES P O'BRIEN; Fiscal Year: 2013
    ..most effective treatment approaches is very difficult to obtain for patients under legal restraint because informed consent is problematic...
  31. Medication Intervention in Transitional Care to Optimize CKD Outcomes &Costs
    Katherine R Tuttle; Fiscal Year: 2012
    ..After obtaining IRB-approved written informed consent, patients will be randomized by computer algorithm for group assignment, stratifying according to diabetes ..
  32. VITamin D and omegA-3 triaL (VITAL)
    JOANN ELISABETH MANSON; Fiscal Year: 2013
    ..The mailing will contain a letter describing the trial, an informed consent form, and a questionnaire soliciting information on past medical history, cancer and vascular risk factors, ..
  33. The Use of Whole-Exome Sequencing to Guide the Care of Cancer Patients
    Pasi A Janne; Fiscal Year: 2013
    ..surveys and qualitative interviews of patients and their oncologists at various points surrounding the informed consent, data delivery and decision-making processes (Project 3)...
  34. Treatment Study Using Depot Naltrexone(2/6)Rhode Island Protocol Treatment Site
    Peter D Friedmann; Fiscal Year: 2012
    ..most effective treatment approaches is very difficult to obtain for patients under legal restraint because informed consent is problematic...
  35. Treatment Study Using Depot Naltrexone(3/6)NY/Bellevue Protocol Treatment Site
    JOSHUA D LEE; Fiscal Year: 2013
    ..most effective treatment approaches is very difficult to obtain for patients under legal restraint because informed consent is problematic...
  36. Disclosing Genomic Incidental Findings in a Cancer Biobank: An ELSI Experiment
    Susan M Wolf; Fiscal Year: 2013
    ..biologically at-risk family members are informed? Since relatives were not involved in the original biobank informed consent process, how should re-contact be managed? What disclosure proce- dures best meet family members'..
  37. Treatment Studies Using Depot Naltrexone (4/6) Columbia Protocol Treatment Site
    Edward V Nunes; Fiscal Year: 2012
    ..most effective treatment approaches is very difficult to obtain for patients under legal restraint because informed consent is problematic...
  38. Scleroderma Twin Study
    Carol A Feghali-Bostwick; Fiscal Year: 2013
    ..SSc in patients and the absence of disease in healthy twins, the evaluation of Raynaud phenomenon, obtaining informed consent, administration of questionnaire to patients and controls, use of clinical samples, the examination of DNA ..
  39. Nitric Oxide and Malaria
    JOE BRICE WEINBERG; Fiscal Year: 2012
    ..c) the clinical protocol;(d) the data analysis and (e) statistical management &analysis plans;(f) the informed consent forms;(g) the investigator's brochure;(h) a manual of operations; (i) a data sharing plan;(j) milestones;..
  40. Alcohol treatment & health disparity in American Indians
    R Walker; Fiscal Year: 2009
    ..After informed consent is obtained, subjects will be interviewed using instruments such as the Addiction Severity Index and the ..
  41. A Randomized Trial of the Copper IUD versus DMPA for HIV Prevention in Women
    Helen Rees; Fiscal Year: 2012
    ..recruit, enroll, and follow-up sufficient numbers of eligible participants, and conduct appropriate informed consent, clinical and data collection procedures, c) develop necessary study documents including the study protocol, ..
  42. Oklahoma Pregnancy Risk Assessment Monitoring System (PRAMS): Category B[Existing
    JOYCE Y MARSHALL; Fiscal Year: 2013
    ..Mail packets consist of the PRAMS questionnaire and return envelope, an informed consent sheet, a resource directory, an incentive (Mail 1 only), and a reward sheet (listing several items mothers ..
  43. Preparing for New Antivirals: Preferences for Treatment of Hepatitis C
    Liana Fraenkel; Fiscal Year: 2013
    ..These goals adhere to the VA principles of promoting patient centered care, informed consent and patient autonomy, and meet guidelines calling for individualized decision making for patients with mild ..
  44. Treatment Study Using Depot Naltrexone(5/6)Baltimore Protocol Treatment Site
    Timothy W Kinlock; Fiscal Year: 2013
    ..most effective treatment approaches is very difficult to obtain for patients under legal restraint because informed consent is problematic...
  45. Phase I clinical trial of an immunoadhesin antitoxin for anthrax
    KEITH WYCOFF; Fiscal Year: 2013
    ..the study design;2) to complete all essential study documents, including an Investigator's Brochure, Informed Consent forms, Case Report forms, Study Manual of Operations, Essential Study Document collection (per ICH-E6 and FDA ..
  46. Mind-Body E-Portal: A Practice-to-Research Platform for Consumer-Driven Wellness
    Joel B Bennett; Fiscal Year: 2010
    ..Second, the program will function as a research tool, collecting user information (following informed consent) about health and Qigong practices and monitor the impact of practice...
  47. Intervention for Disabling Anxiety in Older Adults Injured By Falls
    Nimali Jayasinghe; Fiscal Year: 2013
    ..Eligible participants who provide informed consent (N = 32) will receive the ET and be re-assessed upon completion of treatment and at three month follow-up...
  48. Minority-Based CCOP at UMDNJ-NJ Medical School/University Hospital Cancer Center
    Robert Wieder; Fiscal Year: 2013
    ..community to develop trust, we will use a novel IRB-approved 'Consent Aide'process for obtaining informed consent from non-English speaking patients and we will incorporate the experience of an outreach specialist to ..
  49. Low Dose Tamoxifen in Hodgkin Lymphoma Survivors for Breast Cancer Risk Reduction
    Melanie R Palomares; Fiscal Year: 2013
    ..Eligible subjects who provide informed consent will be randomized to 5 mg per day of tamoxifen versus placebo for two years...
  50. Quality of Informed Consent for Adult-to-Adult Living Donor Liver Transplantation
    Elisa J Gordon; Fiscal Year: 2012
    ..Ethical questions remain about whether the current informed consent process adequately informs LDs about ALDLT, maintains their autonomy, and assures their voluntary consent...
  51. Core_plus Option_B_C_Influenza Vaccine Effectiveness in a Wisconsin Population
    Edward Belongia; Fiscal Year: 2013
    ..After obtaining informed consent, nose and throat swabs will be tested for influenza A and B using a nucleic acid amplification test (RT-PCR)...
  52. Informed Consent in Pediatric Phase I Cancer Trials
    Eric D Kodish; Fiscal Year: 2011
    ..The methods employed will include direct observation, digital recording, and coding of informed consent conferences to provide valuable data on what actually transpires during the discussions, as well as parent ..
  53. SURFACTANT PATHWAY GENE VARIANTS AMONG INFANTS WITH RESPIRATORY DISTRESS SYNDROME
    JENNIFER WAMBACH; Fiscal Year: 2013
    ..overrepresented among infants with RDS compared to infants without RDS in already available DNA samples with informed consent (N=940 infants of African and European descent)...
  54. Enabling Medical Research Growth in Emergency Medicine
    BRIAN LESLIE STROM; Fiscal Year: 2013
    ..methodology, clinical decision making, biostatistics, health services research, emergency exception from informed consent, regulatory requirements under exception from informed consent, and emergency medical ethics...
  55. Managing Incidental Findings in the Genomic Era
    JANET K contact WILLIAMS; Fiscal Year: 2010
    ..project are to: 1) examine how the prospect of genomic IFs is currently articulated in patient education and informed consent materials in research and related clinical application;2) determine how the issues surrounding genomic IFs ..
  56. Mesenchymal stromal cells and bronchopulmonary dysplasia
    ANTONIA PETROVA POPOVA; Fiscal Year: 2013
    ..Training Objective: Develop experience and understanding in experimental design, informed consent, and management of a research team. 2...
  57. Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation
    Herbert H Severson; Fiscal Year: 2013
    ..Individuals who complete a mailed enrollment packet (informed consent and baseline assessment) will be randomized to one of the three conditions and receive a combination of ..
  58. ETHICS COURSE SCIENTIST-PARTICIPANT PARTNERSHIPS
    Celia Fisher; Fiscal Year: 2000
    ..on RCTs, the concept of clinical equipoise, and challenge and medication discontinuation designs; (4) informed consent procedures, including special issues associated with child and adolescent participants, adults with impaired ..
  59. SURGICAL TREATMENTS OUTCOMES PROJECT FOR DUB (STOP-DUB)
    Kay Dickersin; Fiscal Year: 2000
    ..Patients presenting with DUB will be asked for informed consent to undergo a baseline examination and screening for the protocol...
  60. Maternal and Infant Health and HAART Outcomes in the Mashi PMTCT Study, Botswana
    Shahin Lockman; Fiscal Year: 2010
    ..We collected (with informed consent and IRB approvals) supplementary data in this valuable cohort of mothers and infants in order to address ..
  61. Achieving Consensus on High Risk Donor to Improve Access to Organ Transplants
    Michael G Ison; Fiscal Year: 2011
    ..classification of living and deceased donors at increased risk of disease transmission in addition to optimal informed consent and post-transplant evaluation of recipients of organs from such donors with the goal of improving the ..
  62. INFORMED CONSENT FOR STUDIES INVOLVING SURGICAL PATIENTS
    ALAN TAIT; Fiscal Year: 2002
    Central to the tenet of biomedical ethics is the issue of informed consent, which affords a research subject the ability to exercise their rights to beneficence and autonomy...
  63. Effect of Informed Consent on Compliance: Statin Therapy
    MICHAEL CROUCH; Fiscal Year: 2005
    ..be competitive for R01 funding, and (2) to develop a program of clinical research examining the effects of informed consent on compliance with chronic preventive medical therapy in different populations...
  64. Shared Decision-making in Surgery to Improve Patient Safety and Reduce Liability
    KAREN BARBARA DOMINO; Fiscal Year: 2010
    ..The intent of this process is to produce an improved informed consent process that is both standardized by procedure and more informative for patients...
  65. A Video DVD Program to Assist with Informed Consent
    Neil Love; Fiscal Year: 2004
    ..of reasons why patients are not enrolled in clinical trials, however the complexity and time demands of the informed consent process make it one of the major obstacles in increasing trial accrual...
  66. A PRACTICUM IN CLINICAL RESEARCH ETHICS
    David Strauss; Fiscal Year: 2000
    Background: The Ideal of Informed Consent in Practice An emerging empirical literature on research participation has provoked a constructive re-evaluation of the standard of informed consent and an awareness of its practical limitations...
  67. A PRACTICUM IN CLINICAL RESEARCH ETHICS
    David Strauss; Fiscal Year: 2001
    Background: The Ideal of Informed Consent in Practice An emerging empirical literature on research participation has provoked a constructive re-evaluation of the standard of informed consent and an awareness of its practical limitations...
  68. Rethinking Informed Consent for Pragmatic Comparative Effectiveness Trials
    Danielle Whicher; Fiscal Year: 2011
    ..medical records for research purposes, including how to manage privacy and confidentiality and whether informed consent is required from patients...
  69. Compensating for Uncertainty Biases in Health Risk Judgments
    SCOTT D FERSON; Fiscal Year: 2010
    ..Without such information, patients are frustrated, and the spirit of informed consent is thwarted. Even when relevant data are available, they may not be correctly communicated...
  70. Ethics of Control and Consent in Brain Stimulation for Parkinson Disease
    CYNTHIA M S KUBU; Fiscal Year: 2010
    ..Personal control is highly individualized and value laden which makes it ethically interesting and central to informed consent. Improvements in symptom control or stimulator control may not match improvements in personal control...
  71. INTERNATIONAL RESEARCH ETHICS: SHORT COURSE
    Nancy Kass; Fiscal Year: 2000
    ..The five topics covered in the five days were: 1. Introduction to principles and regulations; 2. Informed Consent; 3. HIV vaccines; 4. Justice and what is owed to research participants; 5...
  72. INTRACTABLE EPILEPSY--PRESURGICAL STRATEGY AND OUTCOME
    Frank Gilliam; Fiscal Year: 1999
    ..EEG) prior to surgery and will provide critical information for a more complete and appropriate presurgical informed consent process...
  73. Ethics in Behavioral Health Services Research
    Paul Stiles; Fiscal Year: 2005
    ..Issues addressed include historical foundations; informed consent; decisional capacity and competency; confidentiality and privacy; coercion, both direct and indirect; special ..
  74. Informed Consent in Illiterate Subjects
    Donald Krogstad; Fiscal Year: 2009
    DESCRIPTION (provided by applicant): In developed countries, the informed consent process depends primarily on documents approved by local Institutional Review Boards (IRBs) and on the participants'signatures, to indicate they have ..
  75. ENHANCING INFORMED CONSENT IN LATE-LIFE PSYCHOSIS
    Laura Dunn; Fiscal Year: 2006
    ..researcher, with a focus on psychiatric research ethics, specifically the empirical study of improving informed consent for research in older persons with schizophrenia or related disorders...
  76. Research Ethics in Emergency Medical Services: Working conference for development
    Lynn White; Fiscal Year: 2006
    ..to conducting resuscitation research is that victims of sudden cardiac arrest or major injury cannot give informed consent for research...
  77. Informed Consent in People with Multiple Sclerosis
    Michael Basso; Fiscal Year: 2007
    DESCRIPTION (provided by applicant): Ethical standards for obtaining competent informed consent require that a potential participant is able to express a choice concerning research participation...
  78. Simulation Studies of Parental Permission and Childrens Assent for Research
    Holly Antal; Fiscal Year: 2009
    ..and children's assent for research participation is commonly seen as a practical ethical equivalent of informed consent in adults...
  79. Human Subjects Protections:A Public-Private Model
    PATRICK BOGAN; Fiscal Year: 2003
    ..g. classes, seminars and online training; and (5) the production of a video on informed consent that wilt help prospective research participants understand the basis of, and need for, truly informed ..
  80. INFORMED CONSENT FOR PROSTATE SPECIFIC ANTIGEN SCREENING
    EVELYN CHAN; Fiscal Year: 2000
    ..of Health. Research: This K08 proposal builds upon the candidate's fellowship work about informed consent for prostate cancer screening with the prostate specific antigen (PSA) test and is a collaborative project ..