Quantitative | ||||||
Qualitative | ||||||
Mixed methods | ||||||
Population Topic | Lay(a) | Professional(b) | Mixed(a and b) | Total | ||
A. Primary research: Knowledge (or awareness/comprehension), attitudes (or perceptions), practice (or behaviour)* | ||||||
Comprehension of the informed consent form and/or verbal information provision in: | ||||||
Real | Randomised Controlled Trial | 265 116† | 2 | |||
Clinical Trial | 362 78 82 | 3 | ||||
Cohort Study | 287 117 | 1104 | 3 | |||
Hypothetical | Randomised Controlled Trial | 180 | 1 | |||
Clinical Trial | 191 | 1 | ||||
Knowledge, Attitudes, Practices in relation to: | ||||||
Broad topics: | Clinical Trials | 2122 134 | 375 100 129 | 7 | ||
188 | 1112 | |||||
Clinical Research | 269 113 | 1131 | 3 | |||
Clinical Research Ethics and/or Ethics Committees | 577 81 98 135 137 | 5 | ||||
Specific topics within: | Clinical Trials | Compensation for clinical trial related injury | 1125‡ | 1 | ||
Clinical Research Ethics | Ethical guidelines | 1101 | 1 | |||
Informed consent | 1138 | 2 | ||||
1114 | ||||||
Ethics committees’ composition and/or functioning (incl. ethical review) | 397 102 130§ | 3 | ||||
Subtotal | 13 | 18 | 1 | 32 | ||
A. Primary research: Perceptions, experiences, practices/processes¶ in relation to: | ||||||
Real | Randomised Controlled Trial | Feasibility of informed consent procedure | 170 | 1 | ||
Patient participation in / content of informed consent discussion (examined through audio-visual recordings) | 183 | 1 | ||||
Cohort study | Patient participation in informed consent discussion | 1111 | 1 | |||
Clinical Trial | Audio-visual recording of informed consent process (description and views) | 179 | 1 | |||
Clinical Research | Recruitment experience/process and informed consent in bioavailability/bioequivalence studies | 1140 | 1 | |||
Hypothetical | Clinical Trial | Audio-visual recording of informed consent process (acceptability) | 172 | 1 | ||
Clinical Trial and Biobanking Research (meaning of consent, benefit sharing, incentives) | 1127 | 1 | ||||
Biobanking Research (results sharing, benefits sharing, data ownership) | 1128 | 1 | ||||
Real and hypothetical | Clinical Research | Coercion in research participation | 1126 | 1 | ||
Broad topics: | Clinical Research Ethics and/or Ethics Committees | 367 133 136 | 1103 | 4 | ||
Specific topics within: | Clinical Research Ethics | Ethics Committees (composition, functioning, ethical review process) | 268 108 | 5 | ||
292 121 | ||||||
173 | ||||||
Data sharing | 184 | 1 | ||||
Outsourcing, Clinical Research Organisations and Civil Society Organisations | 390 114 115 | 3 | ||||
Community stakeholder engagement | 1105 | 1 | ||||
Informed consent documents and processes | 1109 | 1 | ||||
Impact of regulatory changesf** | 276 89 | 2 | ||||
Subtotal | 4 | 16 | 6 | 26 | ||
Primary Research Total | 17 | 34 | 7 | 58 |
B. Secondary Research | ||||||||
Population Reviews of: | EC documents | Informed consent documents | Study data / documents | Websites | Journal articles | Total | ||
Application forms | Governance†† | |||||||
Completeness, errors, quality | 385 118 120 | 1110 | 4 | |||||
Payment / compensation for: | Participation | 199 | 2 | |||||
Injury | 164 | |||||||
Compliance / adherence with: | Regulations | 195 | 4 | |||||
Guidelines | 1123 | 1107 | ||||||
Protocol | 1119 | |||||||
Readability | 186‡‡ | 1 | ||||||
Ethics committee: | Registration / accreditation | 1106 | 2 | |||||
Changes in composition/structure after regulatory changes | 166 | |||||||
Reasons for uninitiated studies | 196 | 1 | ||||||
Registered clinical trials and disease burden | 2139 141 | 2 | ||||||
Reporting practices on: | Ethical clearance and/or obtaining informed consent/assent | 463 71 74 94 | 6 | |||||
Funding sources and conflicts of interest | 193 | |||||||
Ethical issues/methods of RCTs; journal editorial policies | 1§§124 | |||||||
Secondary Research Total | 22 |
Some studies were with parents of children.83 111 116 117
Studies where India is one of the countries among others, but where some findings specific to India were reported have been included.74 93 94 121
*Studies that explored knowledge/comprehension were included here, even when Attitude and Practice components were not studied; some studies not included here that minimally explored or mentioned knowledge/awareness have been included elsewhere.68 103 127
†There is only one RCT116 in the dataset.
‡This study comprised no lay people, but was categorised as ‘Mixed’ because the population comprised Professionals and Documents.
§Pharmacovigilance studies were excluded in general; this study was included as it was in relation to clinical trials in particular and included views on EC functioning.
¶Studies that explored perceptions (or attitudes) or experiences or practices, or a combination of these, were included here.
**Five other studies also address the impact of regulatory changes.66 72 78 79 106
††Governance related documents included meeting minutes, project registers/files, standard operating procedures, site visit monitoring reports,study approval letters.
‡‡One other study62 also included readability of informed consent form.
§§Study data included journal articles and website (Clinical Trials Registry-India); could also be categorised within compliance/adherence with guidelines (includes journal editorial policy compliance with international guidelines).
EC, ethics committee; RCT, randomised conrolled trial.