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At least 19 recordsLinked to original sources
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↗
PubMed1992

Do Australian researchers accept committee review and conduct ethical research?

We sought researchers' views on the ethics of research practice and the Australian system of review of research proposals by research ethics committees (RECs). Researchers were found to be supportive of review of research proposals, even though they thought that the process of review was time consuming and demanding. However, our findings suggest that not all researchers present their research proposals for review by committees, and that some researchers deviate from their approved proposals without seeking approval for those deviations from an REC. Researchers supported monitoring of research by RECs.

Advisory Committees↗
PubMed1992

Local research ethics committees. Report of the 2nd National Conference.

The major theme of this conference was the present variable performance of local research ethics committees (LRECs). Opening the meeting, Dame Margaret Turner-Warwick pointed to the tremendous advances that were taking place in medical practice and science and that this was therefore an opportune moment to 'see where we are, and share solutions as well as problems in the discussion and debate of this meeting'.

Epidemiology↗
PubMed1992

Fate of research studies.

A retrospective survey was conducted of 720 research protocols, approved by the Central Oxford Research Ethics Committee between 1984 and 1987, to determine the fate of research studies from inception. Forty-five per cent were clinical trials, 23% were observational studies and 32% were laboratory-based experimental studies. Further information was obtained on 487 studies, of which 287 (59%) had been completed, 100 (21%) had never started, 58 (12%) had been abandoned or were in abeyance and 42 (9%) were still ongoing, as of May 1990. Forty-three per cent of the original 487 studies were subsequently published or presented. The most frequent reason for not starting a study was failure to obtain funding (40%). The main reason for abandoning a study was difficulty in recruiting study participants (28%). Departure of one of the investigators from the institution and a variety of logistical problems were also common reasons for either not starting or abandoning a study. A thorough review of the pragmatic as well as the scientific aspects of a planned research project is important to minimize the initiation of studies that are unlikely to succeed.

Biomedical Research↗
PubMed1992

Compensation for harm: the implications for medical research.

The rising incidence of medical litigation in the 1980's led to a relatively minor modification in January 1990 of the United Kingdom's negligence-based system of medical compensation, as a result of which employing Health Authorities now accept full vicarious liability for the negligent (but not other) actions of employed clinicians (Crown indemnity). During the same period, by contrast, bodies such as the Royal College of Physicians have strongly influenced locally established Research Ethics Committees towards favouring no-fault compensation for harm resulting from medical research. The discordance between these two approaches to compensation has caused anxiety during the last year. There has been particular concern about the possible discouragement of non-commercially sponsored research. Hitherto however, no data has been available to inform this discussion. This paper reports the findings of a questionnaire survey of all research ethics committees in the United Kingdom (64% response rate), which indicates that 61% of committees require no-fault compensation for at least some projects and that 33% of these committees have rejected projects solely or mainly due to the lack of such provision. Rejection is significantly more common in Health Districts which contain teaching hospitals. Our critical analysis of the arguments advanced in favour of no-fault provision for research subjects suggests that they do not place adequate emphasis upon respect for the autonomy of individuals. We consider that it is in general more consistent with such respect fully to inform research subjects of the available compensation arrangements, rather than for ethics committees to make no-fault compensation a general requirement before ethical approval is given.

Compensation and Redress↗
PubMed1992

Perspectives of research participants, psychologist investigators, and institutional review boards.

This study investigated the views of 100 student research participants, 107 psychologist investigators, and 45 members of Institutional Review Boards (Human Subject Committees). Participants in these three groups responded to questions regarding the ethical parameters of a fictitious psychological research protocol. Psychologist investigators' endorsements are similar to those of Institutional Review Board members when the debriefing procedure of the protocol and its potential benefits to others are questioned. The views of psychologist investigators are similar to those of students when the topic of risks to participant is at issue. Implications of these findings for review of research proposals in psychology by Institutional Review Boards are discussed.

Adult↗