Element | Abbreviation | n | Extent of information | ||||
---|---|---|---|---|---|---|---|
Mean | SE | SD | Median | IQR | |||
1. General items | |||||||
 1.1 Title of research | Title | (n = 2100) | 4.33 | 0.021 | 0.941 | 5 | (4–5) |
 1.2 Name of researchers | Name | (n = 2091) | 4.08 | 0.024 | 1.088 | 4 | (4–5) |
 1.3 Affiliation or organization of researchers | Affil | (n = 2083) | 4.10 | 0.023 | 1.035 | 4 | (4–5) |
 1.4 Recognition that this is research | Resea | (n = 2095) | 4.29 | 0.021 | 0.963 | 5 | (4–5) |
 1.5 Contact information regarding the research study | cInfo | (n = 2040) | 4.29 | 0.020 | 0.899 | 5 | (4–5) |
 1.6 Contact information about the participant’s right | cInfoR | (n = 2035) | 4.26 | 0.021 | 0.932 | 5 | (4–5) |
 1.7 Source of funds and sponsors | Spons | (n = 2082) | 3.75 | 0.027 | 1.233 | 4 | (3–5) |
 1.8 Conflict of interest | Coi | (n = 2020) | 3.79 | 0.027 | 1.228 | 4 | (3–5) |
2. Study-specific items | |||||||
 2.1 Background and rationale of research | Backg | (n = 2084) | 4.16 | 0.021 | 0.966 | 4 | (4–5) |
 2.2 Purpose of research | Purp | (n = 2093) | 4.35 | 0.019 | 0.868 | 5 | (4–5) |
 2.3 Eligibility of the participant | Eligib | (n = 2104) | 4.28 | 0.020 | 0.915 | 5 | (4–5) |
 2.4 Study design of research | Desig | (n = 2078) | 3.96 | 0.023 | 1.071 | 4 | (3–5) |
 2.5 Interventions under investigation | Interv | (n = 2080) | 4.37 | 0.020 | 0.895 | 5 | (4–5) |
 2.6 Common adverse effects of the intervention | coAE | (n = 2082) | 4.45 | 0.019 | 0.857 | 5 | (4–5) |
 2.7 All possible adverse effects of the intervention | allAE | (n = 2086) | 4.36 | 0.020 | 0.933 | 5 | (4–5) |
 2.8 Other options or alternative treatments | Altern | (n = 2088) | 4.02 | 0.024 | 1.093 | 4 | (3–5) |
 2.9 Duration of the participant’s participation | Durat | (n = 2069) | 4.17 | 0.021 | 0.971 | 4 | (4–5) |
 2.10 Schedule and procedure | Proc | (n = 2089) | 4.29 | 0.020 | 0.894 | 5 | (4–5) |
 2.11 Identification of any experimental procedures | eProc | (n = 2075) | 4.11 | 0.022 | 1.013 | 4 | (4–5) |
 2.12 Number of participants involved | Numb | (n = 2092) | 3.58 | 0.027 | 1.218 | 4 | (3–5) |
 2.13 Criteria for termination | Term | (n = 2045) | 4.23 | 0.022 | 0.975 | 4 | (4–5) |
3. Items related to the subject’s right | |||||||
 3.1 Voluntary participation | Volun | (n = 2093) | 4.19 | 0.022 | 1.014 | 4 | (4–5) |
 3.2 Consequence of withdrawal | cWith | (n = 2039) | 4.04 | 0.024 | 1.097 | 4 | (4–5) |
 3.3 Right to receive new information | nInfo | (n = 2048) | 4.25 | 0.020 | 0.927 | 4 | (4–5) |
4. Items related to risk-benefit | |||||||
 4.1 Major foreseeable risk | mjRis | (n = 2077) | 4.47 | 0.020 | 0.902 | 5 | (4–5) |
 4.2 Minor foreseeable risk | miRis | (n = 2077) | 4.25 | 0.021 | 0.968 | 5 | (4–5) |
 4.3 Possibly unforeseeable risk | ufRis | (n = 2043) | 4.27 | 0.024 | 1.064 | 5 | (4–5) |
 4.4 Direct health benefit | dBene | (n = 2088) | 4.47 | 0.017 | 0.793 | 5 | (4–5) |
 4.5 Indirect benefit | iBene | (n = 2096) | 4.31 | 0.019 | 0.865 | 5 | (4–5) |
 4.6 Societal benefit | sBene | (n = 2049) | 4.30 | 0.020 | 0.901 | 5 | (4–5) |
 4.7 Post-trial benefit or provision | pBene | (n = 2048) | 4.23 | 0.021 | 0.950 | 4 | (4–5) |
5. Items related to data and sample storage | |||||||
 5.1 Confidentiality and the limit of confidentiality | Confi | (n = 2048) | 4.29 | 0.022 | 0.984 | 5 | (4–5) |
 5.2 Storage of human material | Stora | (n = 2041) | 3.97 | 0.025 | 1.148 | 4 | (3–5) |
 5.3 Reuse of human material | Reuse | (n = 2043) | 4.04 | 0.025 | 1.113 | 4 | (4–5) |
6. Items related to monetary issues | |||||||
 6.1 Payment and/or remuneration | Paym | (n = 2040) | 3.85 | 0.026 | 1.156 | 4 | (3–5) |
 6.2 Anticipated expense | Expen | (n = 2025) | 4.00 | 0.024 | 1.099 | 4 | (4–5) |
 6.3 Compensation for injury | Compe | (n = 2038) | 4.32 | 0.020 | 0.912 | 5 | (4–5) |