Ethical guidelines reviewers

In addition to the Nuremberg Code and Declaration of Helsinki, The International Ethical Guidelines for Biomedical Research Involving Human Subjects was issued in 1982 and revised in 1993 by the Council for the International Organization of Medical Sciences (CIOMS). Those guidelines define national policies for biomedical research, apply ethical standards to the circumstances often present in research in economically developing nations, and define mechanisms for ethical review of human subjects research. 

The principles that govern the ethics of scientific publication are no different than for any other endeavor complete and accurate reporting and appropriate attribution to the contributions of others. However, as always, the devil is in the details. The ethical responsibilities of authors and reviewers are sufficiently important and complex that the editors of the American Chemical Society journals have developed a detailed document outlining these responsibilities. (This document, Ethical Guidelines to Publication of Chemical Research is presented in Appendix 1-1.) The purpose of this chapter is not to duplicate this document, but rather to discuss some of the important underlying principles and situations that often arise. 

With these thoughts in mind, the editors of journals published by the American Chemical Society now present a set of ethical guidelines for persons engaged in the publication of chemical research, specifically, for editors, authors, and manuscript reviewers. These guidelines are offered not in the sense that there is any immediate crisis in ethical behavior, but rather from a conviction that the observance of high ethical standards is so vital to the whole scientific enterprise that a definition of those standards should be brought to the attention of all concerned. 

Reminder Frequently consult the "Ethical Guidelines to Publication of Chemical Research" (Appendix 1-1 in this book, or on the Web at https // paragon.acs.org).The guidelines are reviewed regularly to ensure their clarity. 

Chemical Abstracts Service, 410—414 editorial procedures, 393-396 ethical guidelines, 417-423 home page and Web sites, 365 journals and magazines, 398—409 special projects, 409—410 See also Copyright, Peer review ACS secretariats, 416 ACS Symposium Series description, 396... 

Bv asking many scientists and presenting a broad range of opinions, we hope that this chapter, along with Appendix III, Ethical Guidelines to Publication of Chemical Research , will provide guidance for new and experienced peer reviewers alike. We believe, though, that what you will find here is not only how to review a scientific paper, but also how to write papers that will meet reviewers expectations and thus get published. 

Papers submitted to ACS books and journals are considered for publication with the understanding that they have not been published or accepted for publication elsewhere and are not currently under consideration elsewhere. Appendix III, Ethical Guidelines to Publication of Chemical Research, presents ACS s guidelines for editors, authors, and reviewers. 

From this and other guidelines have developed current principles of good clinical practice ( GCP ) centred on ethical review by committee, with a favourable opinion being at least a moral precondition of the commencement of any human research project. In 1989, the CPMP (the Committee for Proprietary Medicinal Products) adopted GCP guidelines (based on a previous 1987 version) for the European Union. Although they were not in themselves legally enforceable, the pharmaceutical industry saw compliance with the guidelines... 

The AHEC has advised HRECs to continue to regard the national statement as the definitive guideline for the review and conduct of research in Australia. In October 2001 the WMA issued a note of clarification on the interpretation of its guideline on the ethical use of... 

Bankowski, Z. editor. International guidelines for ethical review of epidemiological studies. Geneva Counsil for International Organizations of Medical Sciences 1991. 

Operational Guidelines for Ethics Committees that Review Biomedical Research, World Health Organization, 2000. http //satum.who.ch/ uhtbin/cgisirsi/... 

Operational guidelines for ethics committees that review biomedical research. Geneva, World Health Organization, 2000 (TDR/PRD/ETHICS/2000.1). 

Since many trials are being conducted around the world and submitted to a US IND application, the FDA is working on a separate type of 1572 form to be used for these sites. The reason for this is that an ethical committee (EC), (the international version of our IRB), reviewing the research protocols and informed consents, is composed slightly differently from IRBs in the US. Independent ethical committees (IECs) follow ICH GCP guidelines, which differ slightly from CFR regulations. 

Good Clinical Practice (GCP) regulations in the United States and the ICH guidelines, which meet safety, ethical and efficacy requirements, are comprehensively covered in the clinical research development chapters. Investigator, sponsor, and monitor obligations are detailed and applied practically. Institutional Review Boards (IRBs), Independent Ethics Committees (IECs), and Informed Consent (IC) will be discussed fully along with the... 

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