Sponsors of clinical trials must allow all study investigators and manuscript authors access to the full study data set and the right to use all study data for publication. Every research study involving human subjects must be registered in a publicly accessible database (e.g., ANZCTR, , CTRI ) and the results made publicly available. There are also general principles regarding risk assessment, scientific requirements, research protocols and registration, function of ethics committees, use of placebo, post-trial provisions and research publication.Īgreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.Īuthors and researchers have an ethical obligation to ensure the accuracy, publication and dissemination of the result of research, as well as disclosing to publishers relevant corrections, retractions and errata, to protect scientific integrity of published evidence. The potential subjects must be informed of the right to refuse to participate or withdraw consent to participate at any time without reprisal and without affecting the patient–physician relationship. Informed consent is documented by means of written, signed and dated informed consent form. This information should be delivered in the language and method that individual potential subjects can understand, commonly in the form of a printed Participant Information Sheet. The essential components of informed consent are listed in Table 1. However, due to the research-centred, rather than patient-centred primary purpose, additional relevant information must be provided in clinical trials or research studies in informed consent form. As for a standard (therapeutic) intervention that carries certain risks, informed consent – that is voluntary, given freely and adequately informed – must be sought from participants. Some of the core principles of GCP in research include defining responsibilities of sponsors, investigators, consent process monitoring and auditing procedures and protection of human subjects.īased on ICH definition, ‘informed consent is a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate’. In this article, we will briefly review the legal and ethical issues pertaining to recruitment of human subjects, basic principles of informed consent and precautions to be taken during data and clinical research publications. Therefore, it is important to be familiar with Good Clinical Practice (GCP), an international quality standard that is provided by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), or the local version, GCP of the Central Drugs Standard Control Organization (India's equivalent of US Food and Drug Administration) and local regulatory policy to ensure that the research is conducted both ethically and legally. The purpose of a clinical research is to systematically collect and analyse data from which conclusions are drawn, that may be generalisable, so as to improve the clinical practice and benefit patients in future. The Declaration of Helsinki established ethical principles applied to clinical research involving human participants. The ethical and legal issues relating to the conduct of clinical research involving human participants had raised the concerns of policy makers, lawyers, scientists and clinicians for many years. Hence, specific ethical advice should be sought at local Ethics Review Committees. Researchers should note the major international guidelines and regional differences in legislation. Relevant original publications (The Declaration of Helsinki, Belmont Report, Council for International Organisations of Medical Sciences/World Health Organisation International Guidelines for Biomedical Research Involving Human Subjects, World Association of Medical Editors Recommendations on Publication Ethics Policies, International Committee of Medical Journal Editors, CoSE White Paper, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Legal and ethical issues form an important component of modern research, related to the subject and researcher.
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