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IRB Approval (irb + approval)

Distribution by Scientific Domains
Medical Sciences100%

Selected Abstracts

Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Clinical Trial

ACADEMIC EMERGENCY MEDICINE, Issue 6 2001
Thomas O. Stair MD
Abstract. Multicenter clinical trials require approval by multiple local institutional review boards (IRBs). The Multicenter Airway Research Collaboration mailed a clinical trial protocol to its U.S. investigators and 44 IRBs ultimately reviewed it. Objective: To describe IRB responses to one standard protocol and thereby gain insight into the advantages and disadvantages of local IRB review. Methods: Two surveys were mailed to participants, with telephone follow-up of nonrespondents. Survey 1 was mailed to 82 investigators across North America. Survey 2 was mailed to investigators from 44 medical centers in 17 U.S. states. Survey 1 asked about each investigator's local IRB (e.g., frequency of meetings, membership), whereas survey 2 asked about IRB queries and concerns related to the submitted clinical trial. Results: Both surveys had 100% response rate. Investigators submitted applications a median of 58 days (interquartile range [IQR], 40-83) after receipt of the protocol, and IRB approval took an additional 38 days (IQR, 26-62). Although eight applications were approved with little or no changes, IRBs requested an average of 3.5 changes per site. Changes involved study logistics and supervision for 45%, the research process for 43%, and the consent form for 91%. Despite these numerous requests, all eventually approved the basic protocol, including inclusion criteria, intervention, and data collection. Conclusions: The IRBs showed extreme variability in their initial responses to a standard protocol, but ultimately all gave approval. Almost all IRBs changed the consent form. A national, multicenter IRB process might streamline ethical review and warrants further consideration. [source]

IRB approval: Consideration of power is essential for ethical approval

NEUROUROLOGY AND URODYNAMICS, Issue 4 2005
Peter Herbison
[source]

(216) Pain and Addiction: Screening Patients at Risk

PAIN MEDICINE, Issue 3 2001
Victor Li
Introduction: Addictive disease is a common co-morbidity in chronic pain patients [1]. 26% of patients on methadone treatment believed that prescribed opioids led to their addiction [2]. We report initial validation of a Screening Tool for Addiction Risk (STAR). Methods: Questions based on prior studies of pain and addiction, addiction-screening tools [3,4], discussions with clinicians experienced in pain medicine and addiction, and our clinical experience were used to develop the STAR. After obtaining IRB approval, chronic pain patients completed the 14-item STAR questionnaire. 14 patients with chronic pain and history of drug addiction (DSM-IV Criteria) and 34 additional chronic pain patients completed the survey as part of their initial clinical evaluation. Patient responses were compared to determine which were questions accounted for statistically significant differences. Results: Questions related to respondent classification of addict based on chi-square analysis and Fisher's exact test were: prior treatment in a drug rehabilitation facility (p < 0.00001), nicotine use (p < 0.0032), feeling of excessive nicotine use (p < 0.0007), and treatment in another pain clinic (p < 0.018). A factor analysis linked addiction to first three questions mentioned above. Question: "Have you ever been treated in a drug or alcohol rehabilitation facility?" had a positive predictive value of 93% for addiction. Responses to recreational substance use, alcohol abuse, recent anxiety or depression, unemployment, emergency room visits, family history of drug or alcohol abuse, multiple physicians prescribing pain medication, or a prior history of physical or emotional abuse were not different between either patient group. Discussion: Screening for addiction is an important part of management of chronic pain patients. A history of treatment in drug or alcohol rehabilitation facility and questions related to cigarette smoking may be useful to screen for potential risk of addiction. Further investigations needed to validate results of this study. [source]

Are We Training Future Pain Specialists?

PAIN PRACTICE, Issue 4 2003
Janice M. Livengood PhD
,,Abstract: The purpose of this study was to determine whether pain practices in Tennessee are training future pain specialists. Following IRB approval, a questionnaire designed for the study was administered to members of the TN Pain Society. Results indicate that none of the subjects are training residents at their pain practice and the majority are not training pain fellows. Few attendings reported having trained in a pain fellowship themselves and the majority are reportedly not engaged in continuing pain management education through national or international organizations, such as the American Pain Society (APS) or the International Association for the Study of Pain (IASP). Of concern is whether or not this sample reflects the nature of pain practices throughout the country. If so, will there be a shortage of pain residents and fellows in the near future? Will pain practices be opened and operated by those who are not trained to treat chronic pain?,, [source]

Variation in Institutional Review Board Responses to a Standard, Observational, Pediatric Research Protocol

ACADEMIC EMERGENCY MEDICINE, Issue 4 2007
Jonathan Mansbach MD
Abstract Background: Multicenter studies are becoming more common, and variability in local institutional review board (IRB) assessments can be problematic. Objective: To investigate the variability of IRB responses to a multicenter observational study of children presenting to emergency departments. Methods: The authors collected the original IRB applications, subsequent correspondence, and a survey assessing submission timing and response and the nature of IRB queries. The study was conducted as part of the Emergency Medicine Network http://www.emnet-usa.org Results: Of 37 sites initiating the IRB process, 34 (92%) participated in this IRB-approved study. Institutional review boards returned initial applications in a median of 19 days (IQR, 11,34 d), and 91% considered the protocol to be minimal risk. Of 34 submissions, 13 required no changes, 18 received conditional approvals, and 3 were deferred. The median time from initial submission to final approval was 42 days (IQR, 27,61 d). Seven sites did not participate in patient recruitment: two had institutional issues, one obtained IRB approval too late for participation, and four sites (12%) reported that IRB hurdles contributed to their lack of participation. Nonetheless, 68% of sites that recruited patients reported that the overall experience made them more likely to participate in future multicenter research. Conclusions: There was substantial variation in IRB assessment of a standard protocol in this study. The burden of the application process contributed to some investigators not participating, but the majority of investigators remain enthusiastic about multicenter research. A national IRB may streamline the review process and facilitate multicenter clinical research. [source]