T/CGCPU 013-2020 Ethical considerations for managing pain in clinical trials

Scope

Scope: This standard describes the main sources of pain in clinical trials, proposes general ethical considerations for pain management in clinical trial subjects, and through enumerating the risks and burdens of some invasive trial operations in clinical trials, proposes measures to minimize the burden of pain and other issues when involving invasive trial operations in clinical trials, and provides guidance on considerations during ethical review. This standard applies to ethical considerations for pain management in subjects during ethical review, as well as to researchers' attention to pain management in subjects during the development of clinical trial protocols and trial processes. The pain referred to in this standard broadly includes pain, discomfort, fear, and suffering, and is either caused by participation in clinical trials or exacerbated by factors related to clinical trials. Pain caused by the disease itself or routine clinical treatment activities is not within the scope of this standard. Main technical content: 1. Scope 2. Normative reference documents 3. Terms and definitions, abbreviations 3.1 Terms and definitions 3.1.1 Pain 3.1.2 Clinical trial/Study 3.1.3 Subject/Trial Subject 3.1.4 Vulnerable Subjects 3.1.5 Minimal Risk 3.1.6 Risks 3.1.7 Burden 3.2 Abbreviations 4. Classification of pain and main sources of pain in clinical trials 4.1 Classification of pain 4.2 Main sources of pain in clinical trials 5. General ethical considerations for pain management in subjects during clinical trials 6. Ethical considerations for pain and other burdens in subjects during some invasive trial operations in clinical trials 6.1 Risks and burdens of some invasive trial operations in clinical trials 6.2 Measures to minimize the burden of pain and other issues when involving invasive trial operations in clinical trials 6.3 Considerations during ethical review Appendix A (informative appendix) Examples of risks and burdens of some invasive trial operations Appen

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