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Research Ethics Committees (research + ethics_committee)
Selected AbstractsCHALLENGES FACED BY RESEARCH ETHICS COMMITTEES IN EL SALVADOR: RESULTS FROM A FOCUS GROUP STUDYDEVELOPING WORLD BIOETHICS, Issue 1 2009JONATHAN W. CAMP ABSTRACT Objective:, To identify perceived barriers to capacity building for local research ethics oversight in El Salvador, and to set an agenda for international collaborative capacity building. Methods:, Focus groups were formed in El Salvador which included 17 local clinical investigators and members of newly formed research ethics committees. Information about the proposed research was presented to participants during an international bioethics colloquium sponsored and organized by the St. Jude Children's Research Hospital in collaboration with the National Ethics Committee of El Salvador and the University of El Salvador. Interviews with the focus group participants were qualitatively analyzed. Results:, Participants expressed the need to tailor the informed consent process and documentation to the local culture; for example, allowing family members to participate in decision-making, and employing shorter consent forms. Participants indicated that economic barriers often impede efforts in local capacity building. Participants valued international collaboration for mutual capacity building in research ethics oversight. Conclusions:, Research ethics committees in El Salvador possess a basic knowledge of locally relevant ethical principles, though they need more training to optimize the application of bioethical principles and models to their particular contexts. Challenges increase the value of collaborative exchanges with ethics committee members in the United States. Further research on facilitating communication between host country and sponsor country ethics committees can maximize local research ethics expertise, and thus raise the standard of protecting human participants involved in international research. [source] Lower urinary tract symptoms: a hermeneutic phenomenological study into men's lived experienceJOURNAL OF CLINICAL NURSING, Issue 2 2005BSc (Hons), Mark Wareing MSc Aim., This was an investigation to discover the lived experience of men with lower urinary tract symptoms arising from benign prostatic hyperplasic. Design., A hermeneutic phenomenological study. Methods., Approval was granted by the local Applied and Qualitative Research Ethics Committee (AQREC) prior to the commencement of the study. Data were gathered via semi-structured interviews that were audio taped, and subsequently transcribed. Each transcripted interview was analysed by the investigator and a team of ,expert readers'. The team agreed on a total of 57 sub-themes divided into seven categories with unanimity, therefore obviating the need for participant validation. Findings., The major findings of the study suggest that men experience a broad and dramatic spectrum of phenomena while living with a benign prostate condition. This includes profound embarrassment, fear, revulsion as well as humour that require a range of methods and life adjustments to manage and contain their symptoms. Conclusions., The participant's narratives provide a thick, rich and meaningful insight into how men understand their bodies, and make sense of prostate disease; a significant men's health issue. Relevance to clinical practice., Several studies have already been published describing men's lived experience of prostate surgery for benign prostatic hyperplasia. This research has captured men's lived experience of lower urinary tract symptoms ahead of surgical intervention. Men experience a broad scope of phenomena resulting from life with a benign prostate condition that encompasses fear and embarrassment and the development of coping mechanisms and changes in life style. Recent media awareness campaigns to raise public awareness of prostate disease as a men's health issue appear to be changing how men perceive their bodies, how they converse with one another, and their help seeking behaviour. [source] Genetic polymorphism of CYP2C8 in three Malaysian ethnics: CYP2C8*2 and CYP2C8*3 are found in Malaysian IndiansJOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 5 2005Y. D. Muthiah PhD candidate Summary Background:,CYP2C8 is genetically polymorphic. Four variants, CYP2C8*2, CYP2C8*3, CYP2C8*4 and CYP2C8*5, which contain mutations in the coding regions have been reported to exhibit different enzyme activity as compared with CYP2C8*1. Objective:, To determine the allele frequency of three codon-changing variants (CYP2C8*2, CYP2C8*3 and CYP2C8*4) in the Malaysian population. Method:, Healthy unrelated volunteers from three major races in Malaysia were recruited. The study was approved by the local Research Ethics Committee. DNA was extracted using a standard protocol. A two-step multiplex PCR method was developed to detect three alleles of CYP2C8. PCR results were confirmed by subsequent direct DNA sequencing. Result:, Only the Indians showed CYP2C8 polymorphism with allele frequency of 98% for CYP2C8*1, 0·8% for CYP2C8*2 and 1·2% for CYP2C8*3. CYP2C8*4 was not detected in any of the ethnic groups. Conclusion:, To the best of our knowledge, the current study described, for the first time polymorphisms of CYP2C8 in Malaysian Indians. [source] Gaining ethical approval for research into sensitive topics: ,two strikes and you're out?',BRITISH JOURNAL OF LEARNING DISABILITIES, Issue 4 2003Sarah-Jane Hays Summary Researching sensitive topics, such as the treatment of men with intellectual disabilities and sexually abusive behaviour, present a number of ethical issues for researchers. This paper describes our experiences in working with Multi-Centre Research Ethics Committees on a research proposal designed to assess the efficacy of cognitive behaviour therapy for men with intellectual disabilities who are at risk of sexual offending. After submitting to three Multi-Centre Research Ethics Committees and spending a year trying to get ethical approval, we questioned whether: , , the issue of study design should be part of the Multi-Centre Research Ethics Committees remit; , , Multi-Centre Research Ethics Committees were sufficiently responsive to concerns raised by researchers; , , Multi-Centre Research Ethics Committees always understood the research; and , , the Central Office for Research Ethics Committees should disallow re-submission after rejection by two Multi-Centre Research Ethics Committees (,two strikes and you're out'). [source] CHALLENGES FACED BY RESEARCH ETHICS COMMITTEES IN EL SALVADOR: RESULTS FROM A FOCUS GROUP STUDYDEVELOPING WORLD BIOETHICS, Issue 1 2009JONATHAN W. CAMP ABSTRACT Objective:, To identify perceived barriers to capacity building for local research ethics oversight in El Salvador, and to set an agenda for international collaborative capacity building. Methods:, Focus groups were formed in El Salvador which included 17 local clinical investigators and members of newly formed research ethics committees. Information about the proposed research was presented to participants during an international bioethics colloquium sponsored and organized by the St. Jude Children's Research Hospital in collaboration with the National Ethics Committee of El Salvador and the University of El Salvador. Interviews with the focus group participants were qualitatively analyzed. Results:, Participants expressed the need to tailor the informed consent process and documentation to the local culture; for example, allowing family members to participate in decision-making, and employing shorter consent forms. Participants indicated that economic barriers often impede efforts in local capacity building. Participants valued international collaboration for mutual capacity building in research ethics oversight. Conclusions:, Research ethics committees in El Salvador possess a basic knowledge of locally relevant ethical principles, though they need more training to optimize the application of bioethical principles and models to their particular contexts. Challenges increase the value of collaborative exchanges with ethics committee members in the United States. Further research on facilitating communication between host country and sponsor country ethics committees can maximize local research ethics expertise, and thus raise the standard of protecting human participants involved in international research. [source] Research ethics committees , the weakest link?FOCUS ON ALTERNATIVE AND COMPLEMENTARY THERAPIES AN EVIDENCE-BASED APPROACH, Issue 4 2002Julie Stone MA [source] Do Committees Ru(i)n the Bio-Political Culture?BIOETHICS, Issue 4 2003On the Democratic Legitimacy of Bioethics Committees Bioethical and bio-political questions are increasingly tackled by committees, councils, and other advisory boards that work on different and often interrelated levels. Research ethics committees work on an institutional or clinical level; local advisory boards deal with biomedical topics on the level of particular political regions; national and international political advisory boards try to answer questions about morally problematic political decisions in medical research and practice. In accordance with the increasing number and importance of committees, the quality of their work and their functional status are being subjected to more and more scrutiny. Besides overall criticism regarding the quality of their work, particular committees giving political advice are often suspected of being incompatible with democratic values, such as respect for affected parties, representation of diverse values and transparency in the decision-making processes. Based on the example of the German National Ethics Council, whose inauguration caused a still ongoing debate on the aims and scopes of committees in general, this paper discusses: (1) the requirements of modern democratic societies in dealing with complex scientific-technical problems; (2) the composition and organisation of committees working as political advisory boards; and (3) the appointment procedures and roles of laymen and experts, and here in particular of ethicists, who may legitimately be taken on by a committee. I will argue that bioethics committees do not necessarily endanger democratic values, but can considerably improve their realisation in democratic decision-making procedures , if, and only if, they do not act as substitutes for parliamentarian processes, but help prepare parliamentarian processes to be organised as rationally as possible. [source] 2352: The influence of central corneal thickness and corneal biomechanics in glaucomaACTA OPHTHALMOLOGICA, Issue 2010FC LAM Purpose To look at the impact that central corneal thickness and corneal biomechanics can have on intraocular pressure (IOP) measurements and their effect on visual fields. Methods Written and informed consent from patients and guidance from the local research ethics committee was obtained. Ocular diagnoses and ocular medications were recorded. IOPs were recorded using Goldmann applanation tonometry (GAT)followed by dynamic contour tonometry with the Pascal tonometer. Central corneal thickness(CCT) was measured using ultrasound. Visual fields were recorded using Humphries perimetry. Bland-Altman plots were used to compare the 2 methods. Results 92 eyes of 46 patients were included. Median CCT 556µm(range:427µm-634µm). Despite a good correlation of the IOP measurements usin the two different techniques(r=0.7; p< 0.01), there was a significant difference in limits of agreement(LOA) of DCT to GAT on the Bland-Altman analysis. The LOA was 8.6mmHg to -4.8mmHg with a mean bias of 1.9mmHg. This persisted even after correction for CCT. Ocular hypertensives had a wider LOA than glaucoma patients. Conclusion DCT IOP measurements can be significantly different from GAT IOPs even after taking into account central corneal thickness. Compared to CCT, corneal hysteresis appears to have a greater impact on IOP measurements. This could have important prognostic implications. [source] CURRICULUM GUIDE FOR RESEARCH ETHICS WORKSHOPS FOR COUNTRIES IN THE MIDDLE EASTDEVELOPING WORLD BIOETHICS, Issue 2 2010HENRY SILVERMAN ABSTRACT To help ensure the ethical conduct of research, many have recommended educational efforts in research ethics to investigators and members of research ethics committees (RECs). One type of education activity involves multi-day workshops in research ethics. To be effective, such workshops should contain the appropriate content and teaching techniques geared towards the learning styles of the targeted audiences. To ensure consistency in content and quality, we describe the development of a curriculum guide, core competencies and associated learning objectives and activities to help educators organize research ethics workshops in their respective institutions. The curriculum guide is divided into modular units to enable planners to develop workshops of different lengths and choose content materials that match the needs, abilities, and prior experiences of the target audiences. The content material in the curriculum guide is relevant for audiences in the Middle East, because individuals from the Middle East who participated in a Certificate Program in research ethics selected and developed the training materials (e.g., articles, powerpoint slides, case studies, protocols). Also, many of the activities incorporate active-learning methods, consisting of group work activities analyzing case studies and reviewing protocols. The development of such a workshop training curriculum guide represents a sustainable educational resource to enhance research ethics capacity in the Middle East. [source] CHALLENGES FACED BY RESEARCH ETHICS COMMITTEES IN EL SALVADOR: RESULTS FROM A FOCUS GROUP STUDYDEVELOPING WORLD BIOETHICS, Issue 1 2009JONATHAN W. CAMP ABSTRACT Objective:, To identify perceived barriers to capacity building for local research ethics oversight in El Salvador, and to set an agenda for international collaborative capacity building. Methods:, Focus groups were formed in El Salvador which included 17 local clinical investigators and members of newly formed research ethics committees. Information about the proposed research was presented to participants during an international bioethics colloquium sponsored and organized by the St. Jude Children's Research Hospital in collaboration with the National Ethics Committee of El Salvador and the University of El Salvador. Interviews with the focus group participants were qualitatively analyzed. Results:, Participants expressed the need to tailor the informed consent process and documentation to the local culture; for example, allowing family members to participate in decision-making, and employing shorter consent forms. Participants indicated that economic barriers often impede efforts in local capacity building. Participants valued international collaboration for mutual capacity building in research ethics oversight. Conclusions:, Research ethics committees in El Salvador possess a basic knowledge of locally relevant ethical principles, though they need more training to optimize the application of bioethical principles and models to their particular contexts. Challenges increase the value of collaborative exchanges with ethics committee members in the United States. Further research on facilitating communication between host country and sponsor country ethics committees can maximize local research ethics expertise, and thus raise the standard of protecting human participants involved in international research. [source] Ethical suicide research: A survey of researchersINTERNATIONAL JOURNAL OF MENTAL HEALTH NURSING, Issue 1 2009Richard Lakeman ABSTRACT Research is needed to better understand and respond effectively to people who are suicidal. Involving people who are suicidal in research poses some ethical and pragmatic problems. The ethical problems and difficulties in obtaining approval to involve people who are suicidal in research has contributed to the current paucity of research that explores the suicidal experience. To explore some of these problems, a web-based survey of suicide researchers was undertaken. Researchers identified from published reports were contacted by email and invited to participate in a web-based survey. Researchers were asked to describe any problems they encountered, how ethical problems were negotiated or resolved, and any advice received from human research ethics committees. The main problems identified were accessing the population, maintaining confidentiality, the extent of care owed by the researcher to participants, and the facilitation of support to participants. As with clinical practice, ethical research involving people who are suicidal involves a process of sensitive engagement, and careful consideration and remediation of risk. [source] The validation of a rating scale to assess dietitians' use of behaviour change skillsJOURNAL OF HUMAN NUTRITION & DIETETICS, Issue 4 2008G. Bonner Background:, Evidence suggests that education alone is unlikely to elicit dietary-behavioural change (Contento, 1995). Consequently, many dietitians are moving from a traditional advice-giving role to one which utilises ,behaviour change skills' (BCS) in dietary counselling. BCS is an umbrella term used to cover a wide range of skills and techniques drawn from the fields of counselling, motivational interviewing (MI) and cognitive behavioural therapy (CBT). In order to assess the efficacy of this approach, a means of quantifying BCS-use is required. This two-stage study aimed to validate a newly-devised scale to assess dietitians' BCS-use in one-to-one dietary counselling. Methods:, Items for the scale were generated by drawing on the literature, syllabi for training in BCS and its parent disciplines (counselling, MI and CBT), and specialist dietitians. The resulting scale and manual were revised following assessment of content validity by expert panel and piloting. In stage one, 21 dietetic consultations were audiotaped and rated for BCS-use by three BCS-trained dietitians. Inter-rater agreement was calculated using the kappa statistic and intra-class correlation (ICC), to give a ,chance corrected' measure of agreement. Validity was tested using a psychologist's subjective assessment of BCS-use as a proxy ,gold-standard' compared with the dietitians' ratings, again using kappa and ICC. In stage two the scale was further revised before an additional 20 audiotaped consultations were analysed using the same procedure. Ethical approval for the study was given by the appropriate NHS and university research ethics committees. Results:, At stage one, although kappas were fairly poor for agreement on individual criteria, the ICC for overall scores indicated a ,fair' level of agreement, according to Shrout's (1998) classifications: ICC = 0.584 (CI 0.339,0.784). Results for validity were poor with the psychologist frequently rating higher than the dietitians. At stage two, following scale revision, results for inter-rater agreement improved with more criteria showing ,moderate' or ,substantial' agreement. Ten out of the 21 criteria achieved levels of agreement classified as ,fair' or higher for all three rater pairs. The ICC for overall scores improved to indicate ,moderate' agreement: ICC = 0.640 (CI 0.404,0.821). Validity results remained poor. Discussion:, The moderate level of overall inter-rater agreement observed in the revised scale is considered acceptable (Jones, 2006) and indicates this tool is useful. This measure is more relevant to the purpose of the tool than agreement on individual criteria given it is intended to classify consultations overall as low/medium/high use of BCS rather than to examine individual skills. However, in terms of validity, the discrepancy between dietitian and psychologist ratings requires further investigation. It is hypothesized that the dietitians had higher expectations of what a dietitian could achieve in terms of proficiency in BCS and, as such, rated more stringently than the psychologist. Achieving a clear picture of validity usually necessitates a series of assessments (Murphy & Davidshofer, 2005); the BCS rating scale is no exception with further testing required. Conclusions:, The revised scale shows acceptable inter-rater reliability and robust content validity in our study sample. However, quantitative examination of validity gave poor results and further assessment is required to provide a tool with which we can confidently assess dietitians' use of BCS. References, Contento, I., Balch, G.I., Bronner, Y.L. et al. (1995) The effectiveness of nutrition education and implications for nutrition education policy, programs, and research: a review of the research. J. Nutr. Educ.27, 355,364. Jones, J.M. (2006) Nutritional Screening and Assessment Tools. New York: Nova Science Publishers. Murphy, K.R. & Davidshofer, C.O. (2005) Psychological Testing , Principles and Applications, 6th edn. New Jersey: Pearson Education Inc. Shrout, P. (1998) Measurement reliability and agreement in psychiatry. Stat. Methods Med. Res. 7, 301,317. [source] Statistical review by research ethics committeesJOURNAL OF THE ROYAL STATISTICAL SOCIETY: SERIES A (STATISTICS IN SOCIETY), Issue 1 2000P. Williamson This paper discusses some of the issues surrounding statistical review by research ethics committees (RECs). A survey of local RECs in 1997 revealed that only 27/184 (15%) included a statistician member at that time, although 70/175 (40%) recognized the need for such. The role of the statistician member is considered and the paper includes a summary of a meeting of the Royal Statistical Society to discuss statistical issues that frequently arise in the review of REC applications. A list of minimum qualifications which RECs should expect from anyone claiming to be a statistician would be useful, together with a list of statisticians who are well qualified and willing to serve on RECs, and a list of training courses for REC members covering the appropriate statistical issues. [source] | |||||||||||||