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At least 19 recordsLinked to original sources
PubMed1977

Ethical review in the pharmaceutical industry.

1. There seems no reason why clinical pharmacology studies conducted within the pharmaceutical industry should be exempt from the requirement of ethical review, and independent review in this situation reduces the vulnerability of the company and its employees, in addition to serving its primary function of protecting the volunteer subjects. 2. Experience within one company has shown that independent ethical review need not seriously influence the pace of research. 3. It is important that such committees should be seen to be independent and competent.

Drug Evaluation↗
PubMed1989

Evaluating the work of ethical review committees: an observation and a suggestion.

Eight research protocols which had previously been approved by Ethical Research Committees (ERCs) were reviewed in simulated review committees set up during a symposium on medical ethics. Only three protocols were considered to provide fully adequate information to allow ethical review and only one protocol was thought to provide sufficient guarantees on the ethical issues raised by the proposed research. For five other protocols additional safeguards were considered necessary, in particular covering the problem of informed consent. Two protocols were considered to raise unresolvable ethical issues. This artificial exercise does not establish that review by ERCs is ineffective. It does highlight the lack of objective criteria in ethical review. Peer review by exchange of protocols between ERCs could assist in increasing the consistency in the application of ethical standards.

Ethical Review↗
PubMed1988

Monitoring methods, considerations, and statement of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS) Ethical Review Committee.

The Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS) was terminated prematurely when an independent Ethical Review Committee concluded, on the basis of interim analyses, that continuation would not be advisable on either ethical or scientific grounds. Among 124 patients treated with enalapril and 120 randomized to placebo, 6-month mortality rates were 27 and 48%, respectively. The 2 groups were found to be well balanced with regard to baseline clinical characteristics, and a consistent treatment effect was evident among subgroups. Furthermore, the difference favoring enalapril was found to have been present since the beginning of the study and was consistent over time. Based on these findings, the study was halted on December 14, 1986.

Chronic Disease↗
PubMed1988

Prior ethical review of animal versus human subjects research.

During the last decade the animal rights movement has garnered widespread support that now threatens the existence of animal research. Current public sentiment demands researcher accountability and documentation of the potential value of animal research that was largely assumed in the past. One way this can be accomplished is through prior review and approval of animal research protocols by the federally mandated institutional animal care and use committee (IACUC). IACUCs, however, face more difficulty in arriving at consistent and ethically correct decisions than human subject review committees or institutional review boards (IRBs). This article explains why and draws a comparison between animal and human subjects review.

Animal Care Committees↗
PubMed1991

Balancing the scales of public interest: medical research and privacy.

Guidelines for the protection of privacy in the conduct of medical research have been issued by the National Health and Medical Research Council, approved by the Commonwealth Privacy Commissioner, and gazetted on 1 July 1991 (Commonwealth of Australia Gazette No. P19) to remain in force until 30 June 1994. This paper examines the guidelines and seeks to inform researchers, institutional ethics committees and the institutions those committees represent of their content. Responsibilities are placed upon those engaged in the conduct of research and those involved in undertaking ethical review who now have to decide that the public interest in conducting the research substantially outweighs the public interest in privacy. There is also an emphasis on the requirement for surveillance of research projects by institutional ethics committees which has not previously been apparent. Questions are posed to assist in deciding whether a particular research protocol is subject to the guidelines.

Australia↗
PubMed1975

Safeguards for healthy volunteers in drug studies.

Safeguards for healthy volunteers in drug studies have not been as strict as those involving patients. The shortcomings include the lack of surveillance over the scientific validity of the protocol and its ethical review, and over the financial inducements to volunteers. Recruitment is open to abuse because the volunteers may have some allegiance to the investigators. There is an urgent need to institute checks on these aspects. Most important, however, is the lack of legal safeguards for volunteers taking part in research done outside the pharmaceutical industry. The suggested procedure for obtaining consent, for health checks, and for providing compensation can be equitable to all concerned, and yet not restrict initiative, nor curtail research aims.

Biomedical Research↗