Genomes and Genes
research ethics committees
Summary: Hospital or other institutional committees established to protect the welfare of research subjects. Federal regulations (the "Common Rule" (45 CFR 46)) mandate the use of these committees to monitor federally-funded biomedical and behavioral research involving human subjects.
Publications231 found, 100 shown here
- Ethical oversight of research in developing countriesNancy Kass
Johns Hopkins Bioethics Institute, Bloomberg School of Public Health, Baltimore, Maryland, USA
IRB 25:1-10. 2003
- Beyond informed consentZulfiqar A Bhutta
Aga Khan University, Karachi 74800, Pakistan
Bull World Health Organ 82:771-7. 2004..Further research is needed to examine the validity and user friendliness of innovations in information sharing procedures for obtaining consent in different cultural settings...
- Views of the process and content of ethical reviews of HIV vaccine trials among members of US institutional review boards and South African research ethics committeesRobert Klitzman
Columbia University College of Physicians and Surgeons, New York, NY 10032USA
Dev World Bioeth 8:207-18. 2008..an exploratory study how members of institutional review boards (IRBs) in the United States (US) and research ethics committees (RECs) in South Africa (SA) view issues concerning the process and content of reviews of these studies...
- Do research ethics committees identify process errors in applications for ethical approval?E Angell
Department of Health Sciences, University of Leicester, Leicester, UK
J Med Ethics 35:130-2. 2009..Important questions arise about why the level of error identified by RECs is so high, and about how errors of different types should be handled...
- Online survey tools: ethical and methodological concerns of human research ethics committeesElizabeth A Buchanan
Center for Information Policy Research, University of Wisconsin Milwaukee, WI 53202, USA
J Empir Res Hum Res Ethics 4:37-48. 2009..The paper concludes with considerations and suggestions towards consistent protocol review of online surveys to ensure appropriate human subjects protections in the face of emergent electronic tools and methodologies...
- Reuse of samples: ethical issues encountered by two institutional ethics review committees in KenyaSimon K Langat
P O Box 30568, 00100 Nairobi, Kenya
Bioethics 19:537-49. 2005..It is proposed that these issues should be addressed through policy interventions at both the national and global levels...
- Oversight of human participants research: identifying problems to evaluate reform proposalsEzekiel J Emanuel
Department of Clinical Bioethics, Warren G Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland 20892 1156, USA
Ann Intern Med 141:282-91. 2004....
- Research ethics committees: differences and moral judgementSarah J L Edwards
Centre for Ethics in Medicine, 73 St Michael s Hill, University of Bristol, BS2 8BH, United Kingdom
Bioethics 18:408-27. 2004Many people argue that disagreements and inconsistencies between Research Ethics Committees are morally problematic and there has been much effort to 'harmonise' their judgements...
- What do research ethics committees say about applications to do cancer trials?Mary Dixon-Woods
Social Science Research Group, Department of Health Sciences, University of Leicester, Leicester, UK
Lancet Oncol 9:700-1. 2008
- Native Hawaiian preferences for informed consent and disclosure of results from research using stored biological specimensMegan Fong
Imi Hale Native Hawaiian Cancer Awareness, Research and Training Network, Papa Ola Lokahi, Honolulu, HI 96813, USA
Pac Health Dialog 11:154-9. 2004..These findings call into question the "Common Rule" and the guidelines of the American Society of Human Genetics, which do not require researchers to obtain informed consent for research use of anonymized specimens...
- Assessment of medical school institutional review board policies regarding compensation of subjects for research-related injuryMichael K Paasche-Orlow
Department of Medicine, Boston University School of Medicine, Boston, Massachusetts 02118, USA
Am J Med 118:175-80. 2005..We hypothesized that informed consent language at U.S. medical schools would be particularly complex and fall short of IOM goals, especially for projects without industry sponsorship...
- Research ethics committees and paternalismS J L Edwards
Centre for Ethics in Medicine, University of Bristol, Bristol, UK
J Med Ethics 30:88-91. 2004In this paper the authors argue that research ethics committees (RECs) should not be paternalistic by rejecting research that poses risk to people competent to decide for themselves...
- Health Research Ethics Committees in South Africa 12 years into democracyKeymanthri Moodley
Associate Professor, Bioethics Unit Tygerberg Division, Centre for Applied Ethics and Faculty of Health Sciences, University of Stellenbosch, South Africa
BMC Med Ethics 8:1. 2007Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting...
- What do research ethics committees say about applications to conduct research involving children?E Angell
Social Sciences Research Group, Department of Health Sciences, University of Leicester, Leicester, UK
Arch Dis Child 95:915-7. 2010To identify issues raised by research ethics committees (RECs) in letters about applications to conduct research involving children.
- A relational ethical dialogue with research ethics committeesPhilip J Larkin
School of Nursing and Midwifery, National University of Ireland, Galway, Republic of Ireland
Nurs Ethics 15:234-42. 2008..of this article is to take relational ethics concepts and apply them to the context of application to research ethics committees for approval to carry out research...
- Factors influencing the effectiveness of research ethics committeesC A Schuppli
Animal Welfare Program, University of British Columbia, 2357 Main Hall, Vancouver, British Columbia, V6T 1Z4, Canada
J Med Ethics 33:294-301. 2007b>Research ethics committees - animal ethics committees (AECs) for animal-based research and institutional research boards (IRBs) for human subjects - have a key role in research governance, but there has been little study of the factors ..
- Research ethics committees in the UK--the pressure is now on research and development departmentsRustam Al-Shahi
Division of Clinical Neurosciences, Centre for Clinical Brain Sciences, School of Molecular and Clinical Medicine, College of Medicine and Veterinary Medicine, University of Edinburgh, Western General Hospital, Edinburgh EH4 2XU, Scotland, UK
J R Soc Med 98:444-7. 2005
- Breaking the camel's back: multicenter clinical trials and local institutional review boardsW J Burman
Denver Public Health, 605 Bannock Street, Denver, CO 80204, USA
Ann Intern Med 134:152-7. 2001..Instead of rigid enforcement of outmoded regulations that do not contribute to patient safety, the responsibilities of the local IRB in the oversight of multicenter clinical trials must be systematically evaluated...
- Current status of the institutional review boards in Korea: constitution, operation, and policy for protection of human research participantsOck Joo Kim
The Korean Association of Institutional Review Boards KAIRB, Seoul, Korea
J Korean Med Sci 18:3-10. 2003..This survey reveals many shortcomings and points for improvement by the institutional support bodies, including the need to establish regular education programs for IRB members and investigators...
- Moving beyond compliance: measuring ethical quality to enhance the oversight of human subjects researchHolly A Taylor
Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA
IRB 29:9-14. 2007
- Consistency in decision making by research ethics committees: a controlled comparisonE Angell
Department of Health Sciences, University of Leicester, Leicester, UK
J Med Ethics 32:662-4. 2006There has been longstanding interest in the consistency of decisions made by research ethics committees (RECs) in the UK, but most of the evidence has come from single studies submitted to multiple committees...
- Informed consent for pediatric research: is it really possible?Eric Kodish
J Pediatr 142:89-90. 2003
- The reform of UK research ethics committees: throwing the baby out with the bath water?S Kerrison
School of Public Policy, University College London Hospitals NHS Trust, London, UK
J Med Ethics 31:487-9. 2005On 1 May 2004 research ethics committees became legally accountable to a new government body, the United Kingdom Ethics Committee Authority. This marks the end of the self regulation of research ethics...
- The activity of French research ethics committees and characteristics of biomedical research protocols involving humans: a retrospective cohort studyEvelyne Decullier
French National Conference of Research Ethics Committees, Lyon, France
BMC Med Ethics 6:E9. 2005Clinical trials throughout the world must be evaluated by research ethics committees. No one has yet attempted to clearly quantify at the national level the activity of ethics committees and describe the characteristics of the protocols ..
- When is informed consent appropriate in educational research?: regulatory and ethical issuesJames M DuBois
Saint Louis University, USA
IRB 24:1-8. 2002
- Research ethics committees and public dissemination of clinical trial resultsHoward Mann
University Hospital, 50 North Medical Drive, Salt Lake City, UT 84132, USA
Lancet 360:406-8. 2002..subject to codes of ethical conduct that mandate review, approval, and monitoring of clinical trials by research ethics committees (RECs)...
- Patient-specific embryonic stem cells derived from human SCNT blastocystsWoo Suk Hwang
College of Veterinary Medicine, Seoul National University, Seoul 151 742, Korea
Science 308:1777-83. 2005..Before clinical use of these cells can occur, preclinical evidence is required to prove that transplantation of differentiated NT-hESCs can be safe, effective, and tolerated...
- Human research ethics committees: issues in palliative care researchSusan Lee
School of Nursing, Monash University, Melbourne, Australia
Int J Palliat Nurs 9:13-8. 2003..However, researchers may be powerless to overcome the discomfort of members of human research ethics committees (HRECs) who disallow access to palliative care patients and families...
- Polish Research Ethics Committees in the European Union system of assessing medical experimentsMarek Czarkowski
Department of Endocrinology and Internal Medicine, Medical University of Warsaw, ul Banacha 1a, 02 097 Warszawa, Poland
Sci Eng Ethics 15:201-12. 2009The Polish equivalents of Research Ethics Committees are Bioethics Committees (BCs). A questionnaire study has been undertaken to determine their situation. The BC is usually comprised of 13 members...
- Research involving adults who lack capacity: how have research ethics committees interpreted the requirements?M Dixon-Woods
Mary Dixon Woods, Social Science Research Group, Department of Health Sciences, 2nd Floor Adrian Building, University of Leicester, Leicester LE1 7RH, UK
J Med Ethics 35:377-81. 2009..A service evaluation was conducted to investigate how research ethics committees (RECs) are interpreting the requirements...
- New governance arrangements for research ethics committees: is facilitating research achieved at the cost of participants' interestE Cave
Department of Law, University of Leeds, Leeds, UK
J Med Ethics 28:318-21. 2002..of Health, Central Office for Research Ethics Committee guidance, Governance Arrangements for NHS Research Ethics Committees. The revisions have been long awaited by researchers and research ethics committee members alike...
- Two deaths and two lessons: is it time to review the structure and function of research ethics committees?J Savulescu
J Med Ethics 28:1-2. 2002
- Role of a research ethics committee in follow-up and publication of resultsJudit Pich
Clinical Pharmacology Unit, Hospital Clinic, Barcelona, Institut d Investigacions Biomediques August Pi i Sunyer, Barcelona, Spain
Lancet 361:1015-6. 2003Follow-up of clinical trials is a commitment rarely fulfilled by research ethics committees (RECs)...
- Identifying structures, processes, resources and needs of research ethics committees in EgyptHany Sleem
National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt
BMC Med Ethics 11:12. 2010..Limited data are available regarding the structural and functional status of Research Ethics Committees (RECs) in the Middle East...
- Ethics review for sale? Conflict of interest and commercial research review boardsT Lemmens
Faculty of Law, University of Toronto, 78 Queen s Park, Toronto, Ontario, Canada M5S 2C5
Milbank Q 78:547-84, iii-iv. 2000..The structure of private review tends to breach a core principle of administrative law and procedural justice. Reform of the research review system will reinforce public trust in the process...
- The effect of the new federal medical-privacy rule on researchJennifer Kulynych
Association of American Medical Colleges, Washington, DC 20037, USA
N Engl J Med 346:201-4. 2002
- Variation in Institutional Review processes for a multisite observational studyCatherine C Vick
Deep South Center on Effectiveness, Birmingham Veterans Administration Medical Center, Birmingham, AL, USA
Am J Surg 190:805-9. 2005..This study examines the burden of multisite IRB approval on a Health Services Research and Development (HSRD) ventral hernia outcomes observational study...
- Ethics review roulette: what can we learn?Paul Glasziou
BMJ 328:121-2. 2004
- Attitudes of research ethics board chairs towards disclosure of research results to participants: results of a national surveyS Danielle MacNeil
Department of Surgery, Division of Otolaryngology, University of British Columbia, Vancouver, British Columbia, Canada
J Med Ethics 33:549-53. 2007..The attitudes of research ethics board (REB) chairs towards this practice, although integral to policy development, are unknown...
- Study of the involvement of research ethics committees in the constitution and use of biobanks in FranceGregoire Moutel
Laboratoire d éthique médicale, de droit de la santé et de santé publique et Institut International de Recherche en Ethique Biomédicale IIREB, Faculté de Médecine Paris Necker, Universite Paris, 5 René Descartes, Paris, France
Pharmacogenetics 14:195-8. 2004..We used several items of a questionnaire sent to 48 French research ethics committees (RECs) to investigate the means by which they evaluate the constitution and use of biobanks, and the ..
- Canadian governance of health research involving human subjects: is anybody minding the store?M McDonald
Centre for Applied Ethics, University of British Columbia
Health Law J 9:1-21. 2001..I will close with some more general reflections on ethics, law, and governance...
- Offering to return results to research participants: attitudes and needs of principal investigators in the Children's Oncology GroupConrad V Fernandez
Department of Pediatrics, IWK Health Centre, Dalhousie University, Halifax, Nova Scotia, Canada
J Pediatr Hematol Oncol 25:704-8. 2003..The authors determined current practice and attitudes and needs of researchers in establishing programs to return results to research participants...
- Research ethics committees in Africa: building capacitySolomon Benatar
PLoS Med 4:e135; author reply e136. 2007
- Research ethics committees in Europe: implementing the directive, respecting diversityA Hedgecoe
Department of Sociology, School of Social Sciences, University of Sussex, Falmer, Brighton BN1 9QN, UK
J Med Ethics 32:483-6. 2006With the recent Clinical Trials Directive, a degree of harmonisation into research ethics committees (RECs) across Europe, including the time taken to assess a trial proposal and the kinds of issues a committee should take into account, ..
- How can research ethics committees protect patients better?Silvio Garattini
Mario Negri Institute, Via Eritrea 62, 20157 Milan, Italy
BMJ 326:1199-201. 2003
- Research ethics committees: what is their contribution?Bebe Loff
Department of Epidemiology and Preventive Medicine, Monash University, Prahran, VIC 3181, Australia
Med J Aust 181:440-1. 2004
- A central institutional review board for multi-institutional trialsMichaele C Christian
National Cancer Institute, Bethesda, MD 20892, USA
N Engl J Med 346:1405-8. 2002
- Access to medical records for research purposes: varying perceptions across research ethics boardsD J Willison
Centre for Evaluation of Medicines, St Joseph s Healthcare, McMaster University, 105 Main Street East, P1, Hamilton, ON L8N 1G8, Canada
J Med Ethics 34:308-14. 2008..Variation across research ethics boards (REBs) in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy...
- The practice of obtaining approval from medical research ethics committees: a comparison within 12 European countries for a descriptive study on acetylcholinesterase inhibitors in Alzheimer's dementiaM G M Olde Rikkert
University Medical Centre Nijmegen UMCN, Alzheimer Centre Nijmegen, The Netherlands
Eur J Neurol 12:212-7. 2005..Procedures for the assessment of informed consent in dementia research should be harmonized by central national or European bodies...
- Ethics of innovative surgery: US surgeons' definitions, knowledge, and attitudesAngelique M Reitsma
Center for Biomedical Ethics, University of Virginia, PO Box 800758, Charlottesville, VA 22908 0758, USA
J Am Coll Surg 200:103-10. 2005..Surgeons were also invited to self-report knowledge about current federal regulations guiding human subject research and rules for informed consent for and IRB review of clinical research...
- To IRB or not to IRB?John M Tomkowiak
Florida State University College of Medicine, Tallahassee, Florida 32306 4300, USA
Acad Med 79:628-32. 2004....
- The role of institutional review boards in protecting human subjects: are we really ready to fix a broken system?Hazel Glenn Beh
William S Richardson School of Law, University of Hawaii, USA
Law Psychol Rev 26:1-47. 2002
- Resource and needs of research ethics committees in Africa: preparations for HIV vaccine trialsCecilia Milford
HIV AIDS Vaccines Ethics Group HAVEG, School of Psychology, University of KwaZulu Natal, Scottsville, South Africa
IRB 28:1-9. 2006
- An analysis of decision letters by research ethics committees: the ethics/scientific quality boundary examinedE L Angell
Social Science Research Group, Department of Health Sciences, 2nd Floor, Adrian Building, University of Leicester, Leicester LE1 7RH, UK
Qual Saf Health Care 17:131-6. 2008The performance of NHS research ethics committees (RECs) is of growing interest. It has been proposed that they confine themselves to "ethical" issues only and not concern themselves with the quality of the science...
- Rationalising public participation in the health service: the case of research ethics committeesSarah Dyer
Geography Department, King s College London, The Strand, London WC2R 2LS, UK
Health Place 10:339-48. 2004..It examines the case study of lay participation on Local Research Ethics Committees (LRECs')...
- The new system of review by multicentre research ethics committees: prospective studyJ Tully
Department of Epidemiology, Institute of Child Health, London WC1N 1EH
BMJ 320:1179-82. 2000To assess the function of the new system of review by multicentre research ethics committees and to highlight areas where improvement is still needed.
- The current situation of health research and ethics in SudanDya Eldin M Elsayed
al Nil Street, Council of Public Health, Federal Ministry of Health, Khartoum, Republic of Sudan
Dev World Bioeth 4:154-9. 2004..Unfortunately, the committee devoted all the jobs in reviewing only externally-sponsored health research and research carried out by expatriate researchers or international organisations...
- Informing research participants of research results: analysis of Canadian university based research ethics board policiesS D MacNeil
IWK Health Centre, PO Box 9700, 5850 5980 University Avenue, Halifax, Nova Scotia, B3K 6R8 Canada
J Med Ethics 32:49-54. 2006..The policies of Canadian research ethics boards (REBs) are unknown...
- Standards for research ethics committees: purpose, problems and the possibilities of other approachesH Davies
H Davies, National Research Ethics Service, 4 8 Maple Street, London W1T 5HD, UK
J Med Ethics 35:382-3. 2009Criticism of ethical review of research continues and research ethics committees (RECs) need to demonstrate that they are "fit for purpose" by meeting acknowledged standards of process, debate and outcome...
- Reforming research ethics committeesRichard E Ashcroft
BMJ 331:587-8. 2005
- Access to death certificates: what should research ethics committees require for approval?Tore Nilstun
Lund University, Department of Medical Ethics, Sweden
Ann Epidemiol 16:281-4. 2006To present and discuss the reactions of research ethics committees (RECs) in a number of countries when asked for approval of a study requiring access to death certificates to identify the physicians signing the certificates and to send ..
- Human subjects issues and IRB review in practice-based researchLeslie E Wolf
University of California, San Francisco, San Francisco, California 94143 0903, USA
Ann Fam Med 3:S30-7. 2005..This article explores the challenges that practice-based research networks (PBRNs) face with respect to the regulatory requirements for institutional review board (IRB) review and the protection of human subjects in research...
- Ethical approval for health research in central and eastern Europe: an international surveyR Coker
European Centre on Health of Societies in Transition, London School of Hygiene and Medicine
Clin Med 1:197-9. 2001b>Research ethics committees in central and eastern Europe are increasing in importance as institutions in this region host a growing and more diverse range and volume of health-related research, with funding from an increasingly wide ..
- Ethics. Issues in oocyte donation for stem cell researchDavid Magnus
Stanford Center for Biomedical Ethics and Department of Pediatrics, Stanford University, Palo Alto, CA 94304, USA
Science 308:1747-8. 2005
- Impact of institutional review board practice variation on observational health services researchLee A Green
Department of Family Medicine, University of Michigan, Ann Arbor, MI 48109, USA
Health Serv Res 41:214-30. 2006..DATA SOURCE AND SETTING: Primary data collection during 2002, 2003, and 2004 at 43 United States Department of Veterans Affairs (VA) primary care clinics...
- The cost of institutional review boards in academic medical centersJeremy Sugarman
N Engl J Med 352:1825-7. 2005
- Ethics and research governance in a multicentre study: add 150 days to your study protocolGlyn Elwyn
BMJ 330:847. 2005
- Reflections and recommendations on research ethics in developing countriesS R Benatar
Faculty of Health Sciences, Groote Schuur Hospital, University of Cape Town, Western Cape, South Africa
Soc Sci Med 54:1131-41. 2002..A wider role is proposed for research ethics committees, one that includes an educational component and some responsibility for audit...
- Looking into the institutional review board: observations from both sides of the tableGeorgine S Burke
Department of Research, Connecticut Children s Medical Center, University of Connecticut, Hartford, CT 06106, USA
J Nutr 135:921-4. 2005....
- Developing capacity to protect human research subjects in a post-conflict, resource-constrained setting: procedures and prospectsS B Kennedy
Pacific Institute for Research and Evaluation PIRE, Louisville Center, 1300 S Fourth Street, Suite 300, Louisville, KY 40208, USA
J Med Ethics 32:592-5. 2006....
- Supplementing the traditional institutional review board with an environmental health and community review boardSteven G Gilbert
Institute of Neurotoxicology and Neurological Disorders, Seattle, Washington 98115, USA
Environ Health Perspect 114:1626-9. 2006..For projects involving community members, IRBs should be more sensitive to issues related to the broader community concerns...
- Ethics committees. Research ethics: beyond the guidelinesC C Macpherson
St George s University School of Medicine, PO Box 7, St George s, Grenada, West Indies
Dev World Bioeth 1:57-68. 2001There is international recognition of the need for sustainable research ethics committees to provide ethical review of human subjects research in developing countries, but many developing countries do not have such committees (often ..
- The structure and function of research ethics committees in Africa: a case studyNancy E Kass
Phoebe R Berman Professor of Bioethics and Public Health, Berman Institute of Bioethics, Johns Hopkins School of Public Health, Baltimore, Maryland, United States of America
PLoS Med 4:e3. 2007
- Improving disclosure and consent: "is it safe?": new ethics for reporting personal exposures to environmental chemicalsJulia Green Brody
Silent Spring Institute, Newton, MA 0245, USA
Am J Public Health 97:1547-54. 2007..Our discussion is informed by our experience with 120 women in a study of 89 pollutants in homes and by interviews with other researchers and institutional review board staff...
- How do institutional review boards apply the federal risk and benefit standards for pediatric research?Seema Shah
Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD 20892, USA
JAMA 291:476-82. 2004..Despite this reliance on IRBs, no data exist on how IRBs apply the risk and benefit categories for pediatric research...
- The dysregulation of human subjects researchNorman Fost
JAMA 298:2196-8. 2007
- What do IRBs look like? What kind of support do they receive?Raymond G De Vries
Center for Bioethics, University of Minnesota, N504 Boynton, 410 Church St SE, Minneapolis, MN 55455 0346, USA
Account Res 9:199-216. 2002
- How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics reviewCarl H Coleman
Seton Hall Law School, Newark, New Jersey, USA
BMC Med Ethics 9:6. 2008Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of ..
- Down's syndrome screening is unethical: views of today's research ethics committeesT M Reynolds
Clinical Chemistry Department, Queen s Hospital, Burton on Trent, Staffordshire, UK
J Clin Pathol 56:268-70. 2003..Ethical considerations relating to genetic screening form a major part of the workload of research ethics committees. This study investigated the attitudes of research ethics committee members to several conditions ..
- Ethics in studies on children and environmental healthD F Merlo
Epidemiology and Biostatistics, Istituto Nazionale per la Ricerca sul Cancro, Largo Rosanna Benzi 10, 16132 Genova, Italy
J Med Ethics 33:408-13. 2007..For evaluation of the studies including children, a paediatrician should always be involved in the research ethics committee...
- Problematic variation in local institutional review of a multicenter genetic epidemiology studyRita McWilliams
Bloomberg School of Public Health, Johns Hopkins Medical Institutions, Baltimore, MD, USA
JAMA 290:360-6. 2003..Sequencing of the human genome provides an immense resource for studies correlating DNA variation and epidemiology. However, appropriately powered genetic epidemiology studies often require recruitment from multiple sites...
- Ethical review of health research: a perspective from developing country researchersA A Hyder
Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA
J Med Ethics 30:68-72. 2004....
- Non-therapeutic research with minors: how do chairpersons of German research ethics committees decide?C Lenk
Department for Medical Ethics and History of Medicine, University of Goettingen, Germany
J Med Ethics 30:85-7. 2004Clinical trials in humans in Germany-as in many other countries-must be approved by local research ethics committees (RECs)...
- Ethics committees in western and central Africa: concrete foundationsPierre Effa
Dev World Bioeth 7:136-42. 2007..As a result of the commitment of mandated delegates, a further prominent outcome followed these workshops: the creation of national structures, where none existed before, dedicated to the ethical review of clinical trials...
- The roles and experiences of nonaffiliated and non-scientist members of institutional review boardsSohini Sengupta
Department of Social Medicine, University of North Carolina at Chapel Hill, NC 27599 7164, USA
Acad Med 78:212-8. 2003..This study investigated the experiences of IRB lay members from leading academic medical institutions in the United States and presents their recommendations for future education and training...
- Comparison of requirements of research ethics committees in 11 European countries for a non-invasive interventional studyHilary Hearnshaw
Centre for Primary Health Care Studies, Warwick Medical School, University of Warwick, Coventry CV4 7AL
BMJ 328:140-1. 2004
- Health research ethics review and needs of institutional ethics committees in TanzaniaJ K B Ikingura
National Institute for Medical Research, P O Box 9653, Dar es Salaam, Tanzania
Tanzan Health Res Bull 9:154-8. 2007..85) These findings indicate the need for capacity strengthening (through training and resource support), inclusion of more female representation and other mandatory professions to the research ethics committees.
- Writing an application for a human subjects institutional review boardHenri G Colt
Department of Pulmonary and Critical Care Medicine, University of California Irvine, Orange, CA 92868, USA
Chest 130:1605-7. 2006....
- Financial relationships between institutional review board members and industryEric G Campbell
Institute for Health Policy, Massachusetts General Hospital, Boston, USA
N Engl J Med 355:2321-9. 2006..Little is known about the nature, extent, and consequences of financial relationships between industry and institutional review board (IRB) members in academic institutions. We surveyed IRB members about such relationships...
- Rationalizing risk assessment in human subject researchCarl H Coleman
Health Law and Policy Program, Seton Hall Law School, USA
Ariz Law Rev 46:1-51. 2004
- Putting the "ethics" into "research ethics"Jeffrey Spike
Florida State University, USA
Am J Bioeth 5:51-3; author reply W15-8. 2005
- The current situation regarding the establishment of national ethical guidelines for biomedical research in Thailand and its neighboring countriesSomei Kojima
Asian Center of International Parasite Control, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
Southeast Asian J Trop Med Public Health 36:728-32. 2005..This indicates that further efforts should be made to establish research guidelines and/or principles dealing with the human genome...
- Undue inducement: nonsense on stilts?Ezekiel J Emanuel
National Institutes of Health, USA
Am J Bioeth 5:9-13; discussion W8-11, W17. 2005
- Human research protections: time for regulatory reform?Karen J Maschke
Hastings Cent Rep 38:19-22. 2008
- The limitations of "vulnerability" as a protection for human research participantsCarol Levine
United Hospital Fund
Am J Bioeth 4:44-9. 2004..Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges...
- Undue inducement: the only objection to payment?Ari VanderWalde
Am J Bioeth 5:25-7. 2005
- Ethical considerations in phenomenological researchWendy Walker
School of Health Sciences, University of Birmingham, UK
Nurse Res 14:36-45. 2007..Wendy Walker examines some important ethical issues that researchers need to consider before and during phenomenological research. She argues that failure to address such issues means putting at risk the rights of research participants...
- The ethics of using QI methods to improve health care quality and safetyMary Ann Baily
The Hastings Center, Garrison, NY 10524, USA
Hastings Cent Rep 36:S1-40. 2006
- Informed consent: an international researchers' perspectiveRoberto Rivera
Office of International Research Ethics, Family Health International, Research Triangle Park, NC 27713, USA
Am J Public Health 97:25-30. 2007....
- Disclosing conflicts of interest in clinical research: views of institutional review boards, conflict of interest committees, and investigatorsKevin P Weinfurt
Duke University School of Medicine, USA
J Law Med Ethics 34:581-91, 481. 2006....
- Conducting ethical research in pediatrics: a brief historical overview and review of pediatric regulationsDouglas S Diekema
University of Washington, Treuman Katz Center for Pediatric Bioethics, Children s Hospital and Regional Medical Center, Seattle, Washington 98101, USA
J Pediatr 149:S3-11. 2006..Good research is ethical research, and that requires investigators who take seriously the importance of participant welfare, meaningful informed consent, and respect for research participants...
- High Throughput Genotyping and DNA Sequencing for Studying the Genetic ContributiSonia Dua; Fiscal Year: 2013..The contractor is responsible for providing staff with the credentials required by CLIA. ..
- Sutureless Laparoscopic Partial Nephrectomy Using Laser Tissue Welding: PreclinicYasmin Wadia; Fiscal Year: 2013..Fibro-optic capable: Minimally invasive laparoscopic &robotic applications. ..
- Recombinant Attenuated Salmonella Vaccines for HumansRoy Curtiss; Fiscal Year: 2012..We will also develop a RASV using S. Typhi as vector to prevent transmission and infection by Mycobacterium tuberculosis. ..
- Salmonella Vaccines Against Bacterial EnteropathogensRoy Curtiss; Fiscal Year: 2013..If successful, this vaccine(s) should have a societal public health benefit of a magnitude similar to the impact of the smallpox vaccine. ..
- Non-invasive zoonotic pathogen exposure and outcome biomarkers with follow-up inChristopher D Heaney; Fiscal Year: 2013....
- A multicenter clinical trial of allopurinol to prevent GFR loss in T1DS MICHAEL MAUER; Fiscal Year: 2012..The reduction in morbidity and mortality resulting from this would have a major impact on the lives of T1D patients as well as on society at large, significantly reducing the human and financial costs associated with this condition. ..
- Comparative Effectiveness Research in Pediatric Rheumatic Diseases: Leveraging CACAROL A contact WALLACE; Fiscal Year: 2010..With 95% of members working at academic centers, knowledge gained from research investigations will be rapidly disseminated and translated into practice. ..
- Anti- IL5 therapy for Churg-Strauss Syndrome: a double blind randomized, placebo-Michael E Wechsler; Fiscal Year: 2010....
- Design of a Multicenter Clinical Trial of Allopurinol to Prevent GFR Loss in T1DS MICHAEL MAUER; Fiscal Year: 2011..The reduction in morbidity and mortality resulting from this would have a major impact on the lives of T1D patients as well as on society at large, significantly reducing the human and financial costs associated with this condition. ..
- Biologic Activities of IL-36 Cytokines in PsoriasisAndrew Johnston; Fiscal Year: 2013....
- Vitamin D and Arterial Function in Patients with Chronic Kidney DiseaseJessica B Kendrick; Fiscal Year: 2013..Furthermore, clinical and in vitro methods will be used to identify the mechanisms by which vitamin D affects vascular endothelial function, which will enhance our understanding of the non-calcemic effects of vitamin D. ..
- Core Center for BioBehavioral Sciences of Communication DisordersMabel L Rice; Fiscal Year: 2013..PARC works collaboratively with the DEEC and ATT cores in developing the data management systems for integrative science. ..
- Inhibiting EGFR and ER pathways in NSCLCEdward B Garon; Fiscal Year: 2013..At the conclusion of this research training, I will be well positioned to function as an independent physician scientist in patient-oriented lung cancer research, and I anticipate competing for independent research funding. ..
- Nanodiagnostics and Nanotherapeutics: Building Research Ethics and OversightSusan M Wolf; Fiscal Year: 2010..abstract_text> ..
- Ethical and Legal Challenges in Communicating Individual Biomonitoring and PersonRachel Morello-Frosch; Fiscal Year: 2013....
- Effect of Metformin on Vascular and Mitochondrial Function in Type 1 DiabetesIrene E Schauer; Fiscal Year: 2013..The results of this study may validate a novel approach to T1D treatment that could significantly improve current management of cardiovascular disease risk in this high risk population. ..
- VCU Building Interdisciplinary Research Careers in Women's HealthJerome F Strauss; Fiscal Year: 2011....
- Planning a clinical trial of Flash-heated breast milk to decrease morbidity, imprCaroline J Chantry; Fiscal Year: 2010....
- Treating cutaneous leishmaniasis by radio-frequency induced heat (RFH) therapyAbhay R Satoskar; Fiscal Year: 2012....
- E-Education in Research Ethics: Central and Eastern EuropeMARTIN STROSBERG; Fiscal Year: 2013..of note include: the establishment of a national bioethics center in Poland;the creation of new research ethics committees at several institutions, including the first such committee in Moldova;numerous peer-reviewed ..
- Randomized trial of active vitamin D, cholecalciferol and placebo for CKD-MBDSharon M Moe; Fiscal Year: 2011..The trial will compare vitamin D with active vitamin D or placebo in a multi center two year study to determine the differences in the effect on bone health, muscle strength, and kidney disease. ..
- Scripps Translational Science Institute (TL1)ERIC JEFFREY TOPOL; Fiscal Year: 2013..abstract_text> ..
- Fluorescein for Sentinel Lymph Node DetectionJames M McGreevy; Fiscal Year: 2012..Vestan has developed this technology to be inexpensive, high-impact, easy to manufacture, and commercially available within a very short time after completion of clinical trials. ..
- Comparative effectiveness of Brain Imaging and Blood Biomarkers in Alzheimer??s dOrly Lazarov; Fiscal Year: 2010....
- GENE EXPRESSION EXON ARRAY BIOMARKERS TO DIAGNOSE SCHIZOPHRENIATerry W Osborn; Fiscal Year: 2010..If successful, this transforming development will establish a revolutionary platform to address the myriad of other mental disorders affecting 57 million Americans for which no 'objective'clinical test yet exists. ..
- Assessment of lung function in neonates and infantsIULIAN CONSTANTIN RUSET; Fiscal Year: 2013..One subject will be a neonate born prematurely who has early BPD. The second subject will be a neonate under care due to an hypoxic ischemic event. This subject's lungs should be structurally normal. ..
- ESTABLISHMENT OF RESEARCH RESOURCEFOR THE IDENTIFICATION OF GENETIC AND ENVIRONMVAINORIOUS E; Fiscal Year: 2009....
- Preventive Approach to Congenital Heart Block with Hydroxychloroquine (PATCH)JILL PAMELA BUYON; Fiscal Year: 2013..A positive result will likely change the management of all anti-Ro positive women who have had a previous child with CHB. Furthermore, potential prevention would justify screening of all pregnant women for anti-Ro antibodies. ..
- Prevention of ischemia reperfusion injury associated with acute myocardial infarcCraig Sherman; Fiscal Year: 2010....
- Establichment of CHLA's ChilDREN Clinical CenterKASPER SAONUN WANG; Fiscal Year: 2013..ChiLDREN will facilitate the accrual of larger cohorts of patients with these rare diseases to advance knowledge and treatment of these devastating diseases. ..
- Ameliorating Sickle Nephropathy and Pulmonary HypertensionPunam Malik; Fiscal Year: 2013....
- Neurologic manifestations of cerebrovascular disease in Da Nang, Viet NamAnnette L Fitzpatrick; Fiscal Year: 2010....
- Impact of Vaccination against GM2, GD2 and GD3 on Disease Free Survival in ResectWolfgang W Scholz; Fiscal Year: 2012..The primary endpoint for this pivotal multicenter randomized trial is improvement in progression-free survival at one year. ..
- NEWBORN SCREENING TRANSLATIONAL RESEARCH NETWORK (NBSTRN)Michael Watson; Fiscal Year: 2013..abstract_text> ..
- Maryland Pregnancy Risk Assessment Monitoring System: population-based surveillanDiana Cheng; Fiscal Year: 2013..Two publications have been accepted for 2011 - a book chapter and journal research article on alcohol use during pregnancy. ..
- DRUG DEPENDENCE CLINICAL RESEARCH PROGRAMReese T Jones; Fiscal Year: 2013..abstract_text> ..
- Disposable Valved Intraurethral Catheter FeasibilityHarvey D Homan; Fiscal Year: 2010..Neither urologists nor patients consider currently available devices to be satisfactory to the patients'comfort, cost of care, or medical performance. ..
- Fc receptor targeted therapy for immune hemolytic anemiaPeriasamy Selvaraj; Fiscal Year: 2009..Project Description Page 6 ..
- Best Practices in Mental Health Research Ethics Conference SeriesJames M DuBois; Fiscal Year: 2010..The proposed conference series will review empirical studies that address the ethical aspects of mental health research to identify best practices and areas requiring further investigation. ..
- Beta Camera and Laparoscopic Probe for Surgical Cancer Removal.FARHAD DAGHIGHIAN; Fiscal Year: 2010..The ROC analysis of the beta camera with visual detection of the surgeons will show if beta cameras added can help increase the rate of margin detection. ..
- A National Consortium to Explore the Genotypic Basis for ESRD in LupusRobert P Kimberly; Fiscal Year: 2010....
- Medication Intervention in Transitional Care to Optimize CKD Outcomes &CostsKatherine R Tuttle; Fiscal Year: 2012..The proposed research is innovative because it integrates established clinical strategies with systems approaches to improve patient care, thereby testing a fundamentally new approach to advance CKD management. ..
- Anti IL5 and Churg Strauss Syndrome: a double blind, placebo controlled trialMichael E Wechsler; Fiscal Year: 2013....
- Human Functional Brain AnatomyAllen W Song; Fiscal Year: 2010....
- Development of the Cellular Biomarker for Diabetic Foot UlcersMARJANA contact TOMIC CANIC; Fiscal Year: 2010....
- City of Hope Clinical Oncology Career Research Development ProgramJoanne E Mortimer; Fiscal Year: 2013..abstract_text> ..
- Exploring Sarcoma Metastatic PotentialKURT RICHARD WEISS; Fiscal Year: 2013..As part of his career development, Dr. Weiss will continue to cultivate relationships and collaborations within these institutions in order to build a vigorous and productive sarcoma translational research program. ..
- An Evaluation of Treatment with Omalizumab to Improve the Asthmatic Response to aThomas A Platts-Mills; Fiscal Year: 2013..Taken together, these studies are designed to understand the importance of IgE antibodies and to better define the correct targets for the treatment of asthma that is designed to prevent exacerbations. ..
- Analysis of autophagy and mitochondrial homeostasis in a human iPS model of NCLJOHN FRANCOIS STAROPOLI; Fiscal Year: 2013....
- Restoration of Fecal Continence in Aging IASKhalil N Bitar; Fiscal Year: 2012..Project Description Page 6 ..
- More and Better Lungs: Ex-Vivo Perfusion of Lungs from Non-Heart-Beating DonorsThomas M Egan; Fiscal Year: 2013..Successful study completion will revolutionize lung transplant and the care of patients with end-stage lung disease. ..
- Modulated Imaging: A Wide-field Optical Imaging Platform for Clinical ResearchAnthony J Durkin; Fiscal Year: 2010..Economically, the Modulated Imaging device will reduce hospital costs by eliminating unnecessary additional hospital days for these patients. ..
- Transcriptional Regulation of Retinal DevelopmentMengqing Xiang; Fiscal Year: 2012..The proposed studies together are expected to provide important insights into the genetic regulatory networks involved in retinal cell diversification and differentiation. Project Description Page 6 ..
- Global Network for Women's and Children's HealthEdward A Liechty; Fiscal Year: 2012..5.) All cause mortality in >6 month old infants will be decreased in experimental groups. If efficacy is shown, these are highly sustainable interventions that will improve the health and well being of vulnerable infants. ..
- Human Breast Cancer Stem Cell SurrogatesWendy A Woodward; Fiscal Year: 2012..This approach could be used to select patients for individualized therapy using targeted sensitizing agents based on the proposed preclinical studies. ..
- A multicenter outpatient trial of a bihormonal bionic pancreasSteven J Russell; Fiscal Year: 2013....
- NT-3 gene therapy to improve peripheral nerve function induced by genetic defectZarife Sahenk; Fiscal Year: 2012..NT-3) to a phase 1 gene therapy clinical trial for CMT1A. This initial step is obtaining an IND and this proposal describes the studies necessary to make this possible. ..
- Feasibility of the Von Willebrand Disease Minimize TrialMARGARET VICTORIA RAGNI; Fiscal Year: 2013..End of Abstract) ..
- MSC Therapy & Immune Response in Children with Osteogenesis ImperfectaEdwin M Horwitz; Fiscal Year: 2010..Thus, the outcome of this translational research will substantially impact the direction of the next generation of MSC clinical trials. ..
- Pre-clinical Models of Odontic Analogs by Endogenous Stem CellsJeremy J Mao; Fiscal Year: 2013....
- CLINICAL THERAPEUTICSMark J Ratain; Fiscal Year: 2013....
- Anesthesiology &Perioperative Medicine Research TrainingTonya M Palermo; Fiscal Year: 2013..With the aging population, developing physician scientists capable of tackling scientific questions in this important arena of medicine should make care of surgery, trauma, and intensive care patients safer...
- ETHICS COURSE SCIENTIST-PARTICIPANT PARTNERSHIPSCelia Fisher; Fiscal Year: 2000....
- Building a Joint International IRB for Moi University and Indiana UniversityERIC MARK MESLIN; Fiscal Year: 2010....
- Remediation of Word Processing and Short-Term Memory Deficits in AphasiaNadine Martin; Fiscal Year: 2009..The efficacy of the treatment will be examined with probes of acquisition and maintenance in a multiple baseline across multiple stimuli design, and with comparisons of pre- and post-test ..
- Creating Collaborative Research Ethics Education with Costa RicaElizabeth Heitman; Fiscal Year: 2010..A few national hospitals and academic medical centers have established research ethics committees, but only a small number of professionals have the knowledge of national and international standards ..
- Creating Internet-based Research Review, Approval, and Monitoring for Global HealPeter Max Siba; Fiscal Year: 2010..An important outcome of this project will be programs and monitoring tools that can be adapted by US based IRBs working in partnership with collaborators at other international research sites. ..
- Buildiing Research Ethics Capacity in Peru and the USJesus Gonzalez; Fiscal Year: 2004..propose to train the individuals who will become the administrators and members of these local research ethics committees. A second objective is to share the knowledge gained in this effort with other investigators conducting ..
- Botswana Research Ethics Network: A Cross-National Approach to Ethics ReviewJon F Merz; Fiscal Year: 2010..This effort will improve the capacity and quality of local review and increase the cultural and socioeconomic competencies of IRB staff and members in the U.S., resulting in higher quality ethical review of research. ..
- DISTANCE-LEARNING FOR IRBS ON ETHICAL ISSUES IN GENETICSDorothy Wertz; Fiscal Year: 1999....
- SHORT COURSE AND CERTIFICATE PROGRAM IN RESEARCH ETHICSAlbert Jonsen; Fiscal Year: 2000..We will place this document on the Department of Medical History and Ethics web site. ..