Institutional review boards and multisite studies in health services research: is there a better way?
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OBJECTIVE: The following paper examines the issue of whether the current system for ethics review of multisite health services research protocols is adequate, or whether there exist alternative methods that should be considered. PRINCIPAL FINDINGS: (1) Investigators at different sites in a multisite project often have very different experiences with respect to the requirements and requests of the review board. Other problems include the waste of time and resources spent on document preparation for review boards, and delays in the commencement of research activities. (2) There are several possible reasons why there is variability in ethics review. These include the absence of standardized forms, differences in the background and experiences of board members, the influence of institutional or professional culture, and regional thinking. (3) Given the limited benefits derived from the variability in recommendations of multiple boards and the numerous problems encountered in seeking ethics approval from multiple boards suggest that some sort of reform is in order. CONCLUSIONS: The increasing number of multisite, health services research studies calls for a centralized system of ethics review. The local review model is simply not conducive to multisite studies, and jeopardizes the integrity of the research process. Centralized multisite review boards, together with standardized documents and procedure, electronic access to documentation, and training for board members are all possible solutions. Changes to the current system are necessary not only to facilitate the conduct of multisite research, but also to preserve the integrity of the ethics approval process in general. (+info)
Ethics and ethics committees: HIV serosurveillance in Scotland.
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Knowledge of the heterosexual spread of HIV is needed to plan future health-care needs. In December 1989 we gained approval and finance for unlinked anonymous testing of neonatal Guthrie card samples in Scotland. Local ethics committee approval was required before testing could start. Twenty ethics committees were approached in the 15 Scottish health board areas. Nineteen of the committees have agreed, representing 99.6 per cent of births in Scotland. Our method of contacting ethics committees is discussed, as are the points raised. (+info)
Looking into the institutional review board: observations from both sides of the table.
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Institutional review board (IRB) reviews offer the benefit of perspective afforded by the board's distance from the research and the research subjects. At the same time, distance from research subjects that is geographic, socioeconomic, cognitive, linguistic, and cultural can undermine the positive role of perspective. In addition, distance between IRB and investigators, largely a result of attitudes and communication, can prolong the review process and can obscure its message. The tension that often characterizes IRB-investigator relationships is due, in part, to variability in the application of federal regulations by IRBs across institutions and, on the part of investigators, inexperience, communication problems, and difficulties in anticipating the needs of their subjects. Contributing to the variability are the demographics and the culture of the IRB, attitudes that influence IRB-investigator relationships, and the adequacy of support from the institution. The effects of these factors on review decisions and on the performance of the human subjects protection system are largely unstudied. The movement for IRB accreditation is causing institutions to examine their overall research protection system and promises a more collaborative approach, where IRB and investigators accept their common charge to meet the needs of subjects and to improve the quality of research. (+info)
Being uninformed on informed consent: a pilot survey of medical education faculty.
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BACKGROUND: This paper describes a pilot survey of faculty involved in medical education. The questionnaire focuses on their understanding of IRB policies at their institution, specifically in relation to the use of student assessment and curriculum evaluation information for scholarship. METHODS: An anonymous survey was distributed to medical educators in a variety of venues. Two brief scenarios of typical student assessment or curriculum evaluation activities were presented and respondents were asked to indicate their likely course of action related to IRB approval. The questionnaire also asked respondents about their knowledge of institutional policies related to IRB approval. RESULTS: A total of 121 completed surveys were obtained; 59 (50%) respondents identified themselves as from community-based medical schools. For the first scenario, 78 respondents (66%) would have contact with the IRB; this increased to 97 respondents (82%) for the second scenario. For both scenarios, contact with the IRB was less likely among respondents from research-intensive institutions. Sixty respondents (55%) were unsure if their institutions had policies addressing evaluation data used for scholarship. Fifty respondents (41%) indicated no prior discussions at their institutions regarding IRB requirements. CONCLUSION: Many faculty members are unaware of IRB policies at their medical schools related to the use of medical student information. To the extent that policies are in place, they are highly variable across schools suggesting little standardization in faculty understanding and/or institutional implementation. Principles to guide faculty decision-making are provided. (+info)
Methodological quality and reporting of ethical requirements in phase III cancer trials.
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BACKGROUND: The approval of a research ethics committee (REC) and obtaining informed consent from patients (ICP) could be considered the main issues in the ethics of research with human beings. The aim of this study was to assess both methodological quality and ethical quality, and also to assess the relationship between these two qualities in randomised phase III cancer trials. METHOD: Methodological quality (Jadad score) and ethical quality (Berdeu score) were assessed for all randomised controlled trials (RCTs) published in 10 international journals between 1999 and 2001 (n = 231). RESULTS: The mean Jadad score was 9.86 +/- 1.117. The methodological quality was poor in 75 RCTs (Jadad score <9). The mean Berdeu score was 0.42 +/- 0.133. The mean ethical quality score for poor methodological quality RCTs (n = 75) was 0.39 +/- 0.133; it was 0.43 +/- 0.133 for good (n = 156) methodological quality RCTs (p = 0.07). There was improvement in ethical quality according to the year of commencement of the trials (p < 0.001). There was no correlation between methodological quality and the number of participating patients (R2 = 0.003, p = 0.78), between ethical quality and the number of participating patients (R2 = 0.003, p = 0.76 ), or between ethical quality and methodological quality (R2 = 0.012, p = 0.1). ICP and REC approval were not obtained for 21 and 77 trials respectively. CONCLUSION: The association between methodological quality and the reporting of ethical requirements probably reflects the respect shown for patients during the whole research process. These results suggest that closer attention to the conduct of clinical research, as well as the reporting of its ethical aspects, is needed. (+info)
Patient-specific embryonic stem cells derived from human SCNT blastocysts.
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Patient-specific, immune-matched human embryonic stem cells (hESCs) are anticipated to be of great biomedical importance for studies of disease and development and to advance clinical deliberations regarding stem cell transplantation. Eleven hESC lines were established by somatic cell nuclear transfer (SCNT) of skin cells from patients with disease or injury into donated oocytes. These lines, nuclear transfer (NT)-hESCs, grown on human feeders from the same NT donor or from genetically unrelated individuals, were established at high rates, regardless of NT donor sex or age. NT-hESCs were pluripotent, chromosomally normal, and matched the NT patient's DNA. The major histocompatibility complex identity of each NT-hESC when compared to the patient's own showed immunological compatibility, which is important for eventual transplantation. With the generation of these NT-hESCs, evaluations of genetic and epigenetic stability can be made. Additional work remains to be done regarding the development of reliable directed differentiation and the elimination of remaining animal components. 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. (+info)
Multicentre trials review process by research ethics committees in Spain: where do they stand before implementing the new European regulation?
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OBJECTIVES: To review the performance of research ethics committees (RECs) in Spain in assessing multicentre clinical trial (MCT) drug protocols, and to evaluate if they would comply with the requirements of the new EU Directive to be implemented by May 2004. DESIGN AND SETTING: Prospective study of applications of MCT submitted to RECs. MAIN MEASUREMENTS: Protocol related features and evaluation process dynamics. RESULTS: 187 applications (24 protocols, 18 study drugs) to be performed in 114 centres, were reviewed by 62 RECs. RECs had a median number of 14 members, of which three were lay members. All applications were approved except four which were however approved by the other RECs involved. The median times from submission to approval and from submission to reception at the sponsor's offices were 48 and 62 days, respectively. In 55% (101/183) of all applications approved, 41 RECs raised 307 queries, 40% of these were protocol related issues, and 38% related to the patients' information sheets. RECs charging an evaluation fee in advance and applications with no queries raised were statistically significantly associated with shorter evaluation times. However, there is a gap of at least 1.5 weeks between the date of the meeting and the reception of the approval letter in the sponsor's office. CONCLUSIONS: Evaluating MCT protocols by RECs is a time consuming process. Needing 1.5 weeks for communicating the decision taken by RECs to the sponsor suggests serious administrative shortcomings within most RECs. By significantly reducing the time for communication of their decisions, the majority of RECs would comply with the Directive requirement of a maximum 60 day period for the assessment of MCT. (+info)
Human subjects issues and IRB review in practice-based research.
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PURPOSE: 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. METHODS: We used a regulatory and literature review, our previous research involving PBRN researchers, and our experience to identify issues in regulatory compliance and human subjects protections that present challenges to PBRNs and to suggest possible responses. RESULTS: We identified 3 challenges that PBRNs face with respect to regulatory compliance and human subjects protections. First, ensuring compliance with federal regulations governing human subjects research across all participating practices may be difficult. Clinicians may be unfamiliar with the regulatory requirements and may not have access to an IRB that can provide the required protocol review; moreover, different IRBs may impose inconsistent requirements. Second, conducting research in the practice setting presents unique issues regarding identification of human subjects, consent, and confidentiality. Finally, the use of electronic databases across practices for research raises concerns about how to respect the wishes of participants when combining data and how to maintain confidentiality of data. CONCLUSIONS: PBRN research makes unique contributions to the clinical evidence base by collecting data in community settings where most clinical care is provided. Such research, however, also presents unique challenges to human subject protections and regulatory compliance. Addressing these challenges is necessary to maintain public trust in and support for PBRN research. With careful planning, these ethical and regulatory challenges can be overcome. (+info)