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Results for “Ethics Committees”

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PubMed1997

Local Research Ethics Committees can audit ethical standards in research.

OBJECTIVES: To show that a Local Research Ethics Committee (LREC) can carry out an audit of ethical standards in research. To find out if a researcher met certain ethical standards in recruiting subjects for clinical trials and in obtaining their consent. DESIGN: Postal questionnaire. SETTING: Clinical research by one doctor during one year. SUBJECTS: Eleven patients entered in clinical trials. MAIN OUTCOME MEASURES: Success in ethics committee obtaining data. Achievement of ethical standards in recruitment of subjects and in obtaining consent. RESULTS: The audit was successfully carried out and standards were partly met. CONCLUSIONS: Local Research Ethics Committees can carry out audits of the conduct of research projects which they have approved. Provision for possible audits can be made at the time of application to the committee. Our committee thought the ethical standards in the research which we audited were acceptable.

Comprehension↗
PubMed1999

Role of the research ethics committee.

Research ethics committees have an important role to play in ensuring the ethical standards and scientific merit of research involving human subjects. There are three important obligations placed on the ethics committee. Firstly, and most importantly, the ethics committee must ensure that the rights of research participants are protected. This is achieved by ensuring that individuals receive sufficient information, which can be easily understood, and ensuring that appropriate strategies are in place to protect participants from potential adverse consequences of the research. Secondly, the research ethics committee has an obligation to society which provides the resources for research and will ultimately be affected by the results. Thirdly, the research ethics committee has an obligation to the researcher. The research proposal should be treated with respect and consideration. The research ethics committee should strive to meet each of these obligations. All researchers should welcome the contribution made by research ethics committees to the research process because they help to ensure that research meets the high ethical and scientific standards expected by society.

Ethics Committees↗
PubMed2002

Hospital ethics committees in Israel: structure, function and heterogeneity in the setting of statutory ethics committees.

OBJECTIVES: Hospital ethics committees increasingly affect medical care worldwide, yet there has been little evaluation of these bodies. Israel has the distinction of having ethics committees legally required by a Patients' Rights Act. We studied the development of ethics committees in this legal environment. DESIGN: Cross-sectional national survey of general hospitals to identify all ethics committees and interview of ethics committee chairpersons. SETTING: Israel five years after the passage of the Patients' Rights Act. MAIN MEASUREMENTS: Patients' rights and informal ethics committee structure and function. RESULTS: One-third of general hospitals have an ethics committee, with committees concentrated in larger facilities. Hospitals without committees tended to lack any structure to handle ethics issues. Committees tend to be interdisciplinary and gender-mixed but ethnic mix was poor. Confidentiality is the rule, however, legal liability is a concern. One-third of patients' rights ethics committees never convened and most committees had considered fewer than ten consults. Access to the consultation process and the consultation process itself varied substantially across committees. Some patients' rights ethics committees attempted to solve cases, others only rendered decisions. Informal committees often refused to consider cases within Patients' Rights Act jurisdiction. CONCLUSIONS: Despite statutory requirement, many Israeli patients and clinicians do not have access to ethics committees. The scant volume of cases shows serious discrepancies between practice and Patients' Rights Act regulations, suggesting the need for education or revision of the law. Heterogeneity in committee function demonstrates need for substantial improvement.

Confidentiality↗
PubMed2006

[Standard operating procedures in ethic committees].

Polish ethic committees should have to work together in order to maintain and develop high quality standards in the protection of human subjects. Exchanging knowledge, know-how and information polish ethic committees should have to implement standard operating procedures. Procedures should improve quality and proficiency of all types of ethic committee's activities. Standard operating procedures should cover as important problems as conflict of interest, trial's insurance or elections of ethic committees. The opinions of experts who have been reviewing medical research projects for several years may prove to be especially valuable in this setting. Governmental initiatives and creation of forum for polish ethic committees are essential in the effective standardisation, coordination and implementation of procedures in regional ethic committees. These projects need support via public funding from our authorities.

Conflict of Interest↗
PubMed2001

From a culture of blame to a culture of safety--the role of institutional ethics committees.

Institutional ethics committees are largely absent from the literature on patient safety, but if health service organizations are adequately to address medical error and patient safety, they must change internally from a "culture of blame" to a "culture of safety." This paper (1) looks at the concept of organizational culture as it currently exists and its components (jobs, people, and situations); (2) describes the safety culture in other high risk industries and (3) makes concrete suggestions to the health services industry. In particular, the author suggests that the functions and roles of ethics committees (ethics education, policy review and development, and case consultation) lend themselves perfectly to the development of those organizational characteristics that would support the creation and maintenance of patient safety culture in the healthcare industry.

Ethics Committees, Clinical↗
PubMed1992

Auditing a research ethics committee.

Research ethics committees approve research on human subjects performed locally. They have been criticised for failing to perform this function adequately. I have, therefore, examined the structure and process of the committee for Leicestershire and compared it with the guidelines for these committees produced by the Royal College of Physicians and the Department of Health. The structure and function of the committee are described and conform well with the recommendations of the Royal College of Physicians and the Department of Health. An annual report to the health authority has not previously been produced but the need for this is now accepted. The suggestion for a lay chairman or vice-chairman has, however, been rejected. The workload has steadily increased over the past 10 years, from 66 protocols a year to 302. During a recent 12-month period, 277 research submissions were received; 143 of them were agreed without amendment, 93 with minor amendments, and 41 were rejected or required further information before they could be reconsidered. Assessment of outcome is more difficult. In future, the committee may ask for annual reports from investigators on their research and on any ethical problems encountered. Ethics committees need to foster good ethical research and inform researchers of ethical issues. Most of the latter are highlighted on the Leicestershire application form but are supplemented by short guidelines on particular topics. The committee consumes time and money; it is not clear if it will be adequately funded under the new NHS structure.

England↗