Variability among institutional review boards' decisions within the context of a multicenter trial.

PubWeight™: 3.15‹?› | Rank: Top 1%

🔗 View Article (PMID 11246299)

Published in Crit Care Med on February 01, 2001

Authors

H Silverman1, S C Hull, J Sugarman

Author Affiliations

1: Division of Pulmonary and Critical Care, Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA. hsilverm@medicine.umaryland.edu

Associated clinical trials:

Acute Respiratory Distress Syndrome Clinical Network (ARDSNet) | NCT00000579

Health Literacy Intervention for Informed Consent of Cancer Patients Considering Clinical Trial Participation | NCT01964222

Articles citing this

Impact of institutional review board practice variation on observational health services research. Health Serv Res (2006) 2.74

The structure and function of research ethics committees in Africa: a case study. PLoS Med (2007) 2.57

Variations among Institutional Review Board reviews in a multisite health services research study. Health Serv Res (2005) 2.52

A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn. J Empir Res Hum Res Ethics (2011) 2.03

Informed consent in genomics and genetic research. Annu Rev Genomics Hum Genet (2010) 1.98

Institutional review boards and multisite studies in health services research: is there a better way? Health Serv Res (2005) 1.94

Developing a simplified consent form for biobanking. PLoS One (2010) 1.45

Disclosure of incidental findings from next-generation sequencing in pediatric genomic research. Pediatrics (2013) 1.44

Human subjects issues and IRB review in practice-based research. Ann Fam Med (2005) 1.44

Navigating the institutional review board approval process in a multicenter observational critical care study. Crit Care Med (2014) 1.42

How variability in the institutional review board review process affects minimal-risk multisite health services research. Ann Intern Med (2012) 1.37

Practice-based research network studies in the age of HIPAA. Ann Fam Med (2005) 1.36

Variation among institutional review boards in evaluating the design of a multicenter randomized trial. J Perinatol (2009) 1.31

Simplifying informed consent for biorepositories: stakeholder perspectives. Genet Med (2010) 1.29

Is your ethics committee efficient? Using "IRB Metrics" as a self-assessment tool for continuous improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand. PLoS One (2014) 1.16

Research risk for persons with psychiatric disorders: a decisional framework to meet the ethical challenge. Psychiatr Serv (2009) 1.10

Human subjects protection issues in QUERI implementation research: QUERI Series. Implement Sci (2008) 1.08

Use of altered informed consent in pragmatic clinical research. Clin Trials (2015) 1.00

Easy-to-read informed consent forms for hematopoietic cell transplantation clinical trials. Biol Blood Marrow Transplant (2011) 1.00

Participant-Centric Initiatives: Tools to Facilitate Engagement In Research. Appl Transl Genom (2012) 0.99

Industry-sponsored pharmaceutical trials and research ethics boards: are they cloaked in too much secrecy? CMAJ (2002) 0.95

Institutional variability in a minimal risk, population-based study: recognizing policy barriers to health services research. Health Serv Res (2005) 0.95

Applying research ethics guidelines: the view from a sub-saharan research ethics committee. J Empir Res Hum Res Ethics (2007) 0.93

Are central institutional review boards the solution? The National Heart, Lung, and Blood Institute Working Group's report on optimizing the IRB process. Acad Med (2012) 0.93

Institutional review board barriers and solutions encountered in the Collaboration Among Pharmacists and Physicians to Improve Outcomes Now Study: a national multicenter practice-based implementation trial. Pharmacotherapy (2013) 0.92

Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective. BMC Health Serv Res (2010) 0.88

Bench-to-bedside review: human subjects research--are more standards needed? Crit Care (2006) 0.86

Ethical and logistical considerations of multicenter parental bereavement research. J Palliat Med (2008) 0.86

Ethical considerations in the collection of genetic data from critically ill patients: what do published studies reveal about potential directions for empirical ethics research? Pharmacogenomics J (2009) 0.86

Research ethics issues in geriatric psychiatry. Psychiatr Clin North Am (2009) 0.85

How good does the science have to be in proposals submitted to Institutional Review Boards? An interview study of Institutional Review Board personnel. Clin Trials (2013) 0.83

Variability among institutional review boards and the value of local research context. Crit Care Med (2001) 0.83

Emerging issues in paediatric health research consent forms in Canada: working towards best practices. BMC Med Ethics (2013) 0.83

Accelerating regulatory progress in multi-institutional research. EGEMS (Wash DC) (2014) 0.82

A survey of the SWISS researchers on the impact of sibling privacy protections on pedigree recruitment. Neuroepidemiology (2005) 0.81

Protecting vulnerable research subjects in critical care trials: enhancing the informed consent process and recommendations for safeguards. Ann Intensive Care (2011) 0.80

Do research procedures pose relatively greater risk for healthy persons than for persons with schizophrenia? Schizophr Bull (2005) 0.79

Evaluation of clinical innovation: a gray zone in the ethics of modern clinical practice? J Gen Intern Med (2008) 0.78

Perspectives of Decisional Surrogates and Patients Regarding Critical Illness Genetic Research. AJOB Empir Bioeth (2015) 0.75

Surrogate receptivity to participation in critical illness genetic research: aligning research oversight and stakeholder concerns. Chest (2015) 0.75

Those Responsible for Approving Research Studies Have Poor Knowledge of Research Study Design: a Knowledge Assessment of Institutional Review Board Members. Acta Inform Med (2015) 0.75

Ethical considerations of research policy for personal genome analysis: the approach of the Genome Science Project in Japan. Life Sci Soc Policy (2014) 0.75

Research ethics committee decision-making in relation to an efficient neonatal trial. Arch Dis Child Fetal Neonatal Ed (2016) 0.75

Articles cited by this

Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. The Acute Respiratory Distress Syndrome Network. N Engl J Med (2000) 48.03

The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research. J Am Coll Dent (2014) 22.13

Informed consent for clinical trials: a comparative study of standard versus simplified forms. J Natl Cancer Inst (1998) 3.89

The gap between patient reading comprehension and the readability of patient education materials. J Fam Pract (1990) 2.68

Emergency department patient literacy and the readability of patient-directed materials. Ann Emerg Med (1988) 2.68

Updating protections for human subjects involved in research. Project on Informed Consent, Human Research Ethics Group. JAMA (1998) 2.26

Evaluation of Institutional Review Board review and informed consent in publications of human research in critical care medicine. Crit Care Med (1998) 2.14

Patient literacy and the readability of written cancer educational materials. Oncol Nurs Forum (1995) 1.70

A case study in adolescent participation in clinical research: eleven clinical sites, one common protocol, and eleven IRBs. IRB (2000) 1.39

Research involving persons with mental disorders that may affect decisionmaking capacity. J Int Bioethique (2003) 1.36

Ethical aspects of human experimentation in health services research. JAMA (1991) 1.31

Ethical considerations in planning and conducting research on human subjects. Acad Med (1993) 1.00

Articles by these authors

Unintended changes in cognition, mood, and behavior arising from cell-based interventions for neurological conditions: ethical challenges. Am J Bioeth (2009) 6.13

Determining when quality improvement initiatives should be considered research: proposed criteria and potential implications. JAMA (2000) 5.26

Trust, The fragile foundation of contemporary biomedical research. Hastings Cent Rep (1997) 2.93

Teaching professional development in medical schools. Lancet (2001) 2.48

Regulation of retinoid signalling by receptor polarity and allosteric control of ligand binding. Nature (1994) 2.43

A comparison of the national registry of myocardial infarction 2 with the cooperative cardiovascular project. J Am Coll Cardiol (1999) 1.71

Cell-based interventions for neurologic conditions: ethical challenges for early human trials. Neurology (2008) 1.57

Ethical issues in cord blood banking: summary of a workshop. Transfusion (1998) 1.44

Monitoring and ensuring safety during clinical research. JAMA (2001) 1.26

Measuring defensive medicine using clinical scenario surveys. J Health Polit Policy Law (1996) 1.25

How physicians face ethical difficulties: a qualitative analysis. J Med Ethics (2005) 1.19

Lessons from the failure of human papillomavirus vaccine state requirements. Clin Pharmacol Ther (2007) 1.18

Talking about cases in bioethics: the effect of an intensive course on health care professionals. J Med Ethics (2000) 1.14

Moral maladaptation? Reflections on a report of research involving the correction of endemic hypothyroidism in Africa. Nutrition (1999) 1.11

Improving informed consent in clinical trials: a duty to experiment. Control Clin Trials (1999) 1.07

Medicine. Placebo-controls in short-term clinical trials of hypertension. Science (2001) 1.02

Are withholding and withdrawing therapy always morally equivalent? J Med Ethics (1994) 0.99

Regulation of c-fos and c-jun protooncogene expression by the Ca(2+)-ATPase inhibitor thapsigargin. Proc Natl Acad Sci U S A (1991) 0.98

Patient perspectives on group benefits and harms in genetic research. Public Health Genomics (2010) 0.95

Clinical performance measurements proposed to compare diabetes care among health care systems. Am J Med Qual (2000) 0.95

So much for keeping secrets: the importance of considering patients' perspectives on maintaining confidentiality. AIDS Care (2001) 0.92

Toward the ethical evaluation and use of maternal-fetal surgery. Obstet Gynecol (2001) 0.92

Retinoic acid receptor alpha suppresses transformation by v-myb. Mol Cell Biol (1995) 0.91

Brn-5 is a divergent POU domain factor highly expressed in layer IV of the neocortex. J Biol Chem (1993) 0.91

Understanding the patient: medical words the doctor may not know. N C Med J (1985) 0.86

Reading between the lines: direct-to-consumer advertising of genetic testing. Hastings Cent Rep (2001) 0.86

Attitudes of maternal-fetal specialists concerning maternal-fetal surgery. Am J Obstet Gynecol (2001) 0.84

Between the modern and the postmodern. The possibility of self and progressive understanding in psychology. Am Psychol (2000) 0.83

Catalysts for conversations about advance directives: the influence of physician and patient characteristics. J Law Med Ethics (1994) 0.82

You're in for a treat: asparagus. N C Med J (1985) 0.80

Pediatric cervical spine injury sustained in falls from low heights. Ann Emerg Med (1997) 0.78

Medical, ethical and legal issues regarding thrombolytic therapy in the Jehovah's Witness. Am J Cardiol (1991) 0.77

Structural and functional differences between decay-accelerating factor and red cell acetylcholinesterase. Blood (1986) 0.77

Is the emperor really wearing new clothes? Informed consent for acute coronary syndromes. Am Heart J (2000) 0.76

Relevance of the biopsychosocial model. N C Med J (1992) 0.75

Screening for sickle cell trait. J Gen Intern Med (1995) 0.75

Ethical issues on informed consent and recruitment for clinical trials. Anesthesiology (2000) 0.75

Blood money: ethical and legal implications of treating cord blood as property. J Pediatr Hematol Oncol (2001) 0.75

Outcomes research and advance directives. J Clin Ethics (1994) 0.75

Placebo revisited. Acta Psychiatr Scand (2000) 0.75

Epidemiological abuse. J Am Board Fam Pract (1991) 0.75

Noninsulin-dependent diabetes mellitus. Am Fam Physician (1991) 0.75

Severe cutaneous hypersensitivity reactions during treatment of tuberculosis in patients with HIV infection in Tanzania. Trop Geogr Med (1992) 0.75

A community policy on futility? A conversation of the North Carolina community. N C Med J (1995) 0.75

Looking at renal failure upside down. N C Med J (1985) 0.75

Modernity, postmodernity, and psychology. Am Psychol (2001) 0.75

Request from a Middle Eastern Bride. Camb Q Healthc Ethics (1994) 0.75

Informed consent for BRCA1 and BRCA2 testing. Breast Dis (1998) 0.75

Striking memories of medical education: a glimpse of three physician writers. Pharos Alpha Omega Alpha Honor Med Soc (1987) 0.75

Facts and fears regarding blood transfusions in decision making for thrombolytic therapy. Am Heart J (1993) 0.75

Scientific, logistical, and ethical issues related to creation of a stem cell repository for use in experimental trials of gene therapy for AIDS. AIDS Res Hum Retroviruses (1997) 0.75

North Carolina hospitals' policies on medical futility. N C Med J (1995) 0.75

Resonant misconception? AJR Am J Roentgenol (1985) 0.75

More attention to the problem of research misconduct. Nutrition (2001) 0.75

Simultaneous patient-side measurement of hemoglobin, glucose, and cholesterol in finger-stick blood. Clin Chem (1992) 0.75

The "new look" in studies of schizophrenic attention and information processing. Schizophr Bull (1977) 0.75