Best practice: protecting research subjects, patients and experimental animals
C. A. LEE
Abstract
Open-access reader
C. A. LEE
Abstract
Open-access reader
The following is the best practice guideline from guidelines on publication ethics [1]. Policing the standards of human or animal research is beyond the responsibilities of an editor. Even so, medical journals can encourage authors to follow the highest standards and may consider requiring, for example, statements from authors that trials conformed to Good Clinical Practice, for example, the World Medical Association Declaration of Helsinki [2], US Food and Drug Administration Good Clinical Practice in FDA-regulated Clinical Trials [3] and UK Medicines Research Council Guidelines for Good Clinical Practice in Clinical Trials [4]. Journals should ask authors to state that the study they are submitting was approved by the relevant research ethics committee or institutional review board. If human participants were involved, manuscripts must be accompanied by a statement that the experiments were undertaken with the understanding and appropriate informed consent of each. If experimental animals were used, the Materials and methods (Experimental procedures) section must clearly indicate that appropriate measures were taken to minimize pain or discomfort, and details of animal care should be provided. Blackwell Publishing suggests that all these standards are defined by the lead investigator’s national standards. Editors should reserve the right to reject papers if there is doubt whether appropriate procedures have been followed. If a paper has been submitted from a country where there is no ethics committee, institutional review board or similar review and approval, editors should use their own experience to judge whether the paper should be published. If the decision is made to publish a paper under these circumstances a short statement should be included to explain the situation. In this journal, we publish the paper entitled ‘The impact of joint bleeding and synovitis physical ability and joint function in a murine model of haemophilic synovitis’ [5]. This paper has proved challenging on review. We have therefore invited two commentaries which present opposing views about this study. We invite further correspondence from our readers. The author stated that she has no interests which might be perceived as posing a conflict or bias.
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The following is the best practice guideline from guidelines on publication ethics [1]. Policing the standards of human or animal research is beyond the responsibilities of an editor. Even so, medical journals can encourage authors to follow the highest standards and may consider requiring, for example, statements from authors that trials conformed to Good Clinical Practice, for example, the World Medical Association Declaration of Helsinki [2], US Food and Drug Administration Good Clinical Practice in FDA-regulated Clinical Trials [3] and UK Medicines Research Council Guidelines for Good Clinical Practice in Clinical Trials [4]. Journals should ask authors to state that the study they are submitting was approved by the relevant research ethics committee or institutional review board. If human participants were involved, manuscripts must be accompanied by a statement that the experiments were undertaken with the understanding and appropriate informed consent of each. If experimental animals were used, the Materials and methods (Experimental procedures) section must clearly indicate that appropriate measures were taken to minimize pain or discomfort, and details of animal care should be provided. Blackwell Publishing suggests that all these standards are defined by the lead investigator’s national standards. Editors should reserve the right to reject papers if there is doubt whether appropriate procedures have been followed. If a paper has been submitted from a country where there is no ethics committee, institutional review board or similar review and approval, editors should use their own experience to judge whether the paper should be published. If the decision is made to publish a paper under these circumstances a short statement should be included to explain the situation. In this journal, we publish the paper entitled ‘The impact of joint bleeding and synovitis physical ability and joint function in a murine model of haemophilic synovitis’ [5]. This paper has proved challenging on review. We have therefore invited two commentaries which present opposing views about this study. We invite further correspondence from our readers. The author stated that she has no interests which might be perceived as posing a conflict or bias.
Key concepts: Declaration of Helsinki, Medicine, Publication, Guideline, Clinical trial, Good clinical practice, Helsinki declaration, Institutional review board