Table 2.
The scope and matter of an ethics review in epidemiological studies
| Symbol | Name | Title of guidelines | ||||
|---|---|---|---|---|---|---|
| Ethical Guidelines for Epidemiologists (IEF-EGE) | American College of Epidemiology Ethics Guidelines (ACEEG) | Good Epidemiological Practice. IEA Guidelines for proper conduct in epidemiological research (IEA-GEP) | Guidelines for Good Phamacoepidemiology Practices (GGPP) | International Guidelines for Epidemiological Studies (CIOMS-IEGES) | ||
| A. Information policy | ||||||
| A1 | Scope/content/procedures of obtaining informed consent | X | X | X | ||
| A2 | Scope/content/procedures of obtaining proxy consent | X | ||||
| A3 | Scope/content/procedures of obtaining assent/agreement of incapable subjects | X | ||||
| A4 | Deviation from standard written informed consent form | X | X | X | ||
| A5 | Withholding information, deception of the subject, debriefing | X | X | |||
| A6 | Access to information (including clinical and personal data) collected in the course of study | X | ||||
| A7 | Communication with subjects, who did not give their IC | X | X | |||
| A8 | Communication with community; community consultation and involvement | X | ||||
| A9 | Communication of results to media and general public | X | X | |||
| A10 | Communication of results in scientific journals | X | ||||
| B. Protection of subjects | ||||||
| B1 | Subjects’ rights, well-being, and safety | X | X | X | ||
| B2 | Proper balance between risk and benefits for subjects and the public | X | X | X | ||
| B3 | Report of adverse events (physical and/or psychological) | X | ||||
| B4 | Equitable enrollment of subjects | X | X | |||
| B5 | Use of placebo/no-treatment | X | ||||
| B6 | Exceptional breach of confidentiality | X | ||||
| B7 | Waiver of informed consent (also in research utilizing existing personal information/specimen) | X | X | X | X | |
| B8 | Procedures protecting subjects’ privacy and confidentiality | X | X | X | ||
| B9 | Collecting, use, reuse, sharing exchanging, and final destination of data (personal information and/or biospecimens, genetic information) | X | X | X | ||
| B10 | Anonymization of data/biospecimens | X | ||||
| B11 | Request for removal of data from the study | X | ||||
| B12 | Safeguards protecting vulnerable subjects | X | X | X | ||
| B13 | Payment, reimbursement, medical services in the study, compensation | X | ||||
| B14 | Plans for studies in emergency | X | ||||
| B15 | IRB/REC from sponsoring country reviews research protocol in host country | X | ||||
| B16 | IRB/REC from host country ensures that all ethical provisions are met and study is in accordance with local values | X | ||||
| C. Guards for research integrity | ||||||
| C1 | All ethical aspects of the study | X | X | X | ||
| C2 | Scientific merit of the study | X | X | |||
| C3 | Oversight of the study conduct | X | X | X | ||
| C4 | Significance of observational character of most epidemiological studies | X | X | |||
| C5 | Improving ethical/scientific/operational aspects of studies | X | X | |||
| C6 | Conflict of interests | X | X | |||
| C7 | Ethical approval | X | X | X | ||
| C8 | Reporting unethical behavior and/or misconduct | X | ||||
| D. Formal and operational requirements | ||||||
| D1 | Independence | X | X | |||
| D2 | Rules of proceeding | X | X | X | ||
| D3 | Communication of proceeding rules | X | ||||
| D4 | Obstruction of the study | X | X | |||
| D5 | Disclosure and avoidance of conflict of interest | X | X | |||
| D6 | Adequate composition of membership | X | X | |||
| D7 | Periodical replacement of members | X | ||||
| D8 | Respecting sponsors’ rights | X | X | |||
| D9 | Different levels of functioning (local/national/international) | X | X | |||
| D10 | Appeal procedure | X | ||||
| D11 | Fast-track review | X | X | |||
| D12 | Cooperation between IRBs/RECs | X | X | |||
| E. Types of studies | ||||||
| E1 | Studies involving human beings | X | X | X | X | |
| E2 | Use of identifiable data without informed consent | X | X | |||
| E3 | Use of human specimens without informed consent | X | X | X | ||
| E4 | Studies of unclear nature | X | ||||
| E5 | Sensitive topics studies | X | ||||
| E6 | Studies using clinical data without informed consent | X | X | |||
| E7 | Studies using publicly available data | X | ||||
| E8 | Minimal risk | X | X | |||
| E9 | Studies using anonymized data/specimens | X | X | |||
| E10 | Studies without informed consent regulated by local laws | X | X | |||
| E11 | Public health, routine surveillance | X | X | |||
| E12 | Studies in emergency, acute communicable diseases | X | X | |||
| E13 | Simple aggregation of records | |||||
| Numbers of categories mentioned in the guidelines | 21 | 18 | 13 | 5 | 55 | |
| Symbol | Name | Title of guidelines | |||
|---|---|---|---|---|---|
| Ethical Guidelines for Epidemiological Research (JAPAN-EGES) | Ethical Guidelines for Observational Studies: Observational research, audits, and related activities. Revised edition (NEW-ZEALAND-EGOS) | Ethical Guidelines for Environmental Epidemiologists (EGEE) | Number of guidelines mentioning the category | ||
| A. Information policy | |||||
| A1 | Scope/content/procedures of obtaining informed consent | X | X | X | 6 |
| A2 | Scope/content/procedures of obtaining proxy consent | X | 2 | ||
| A3 | Scope/content/procedures of obtaining assent/agreement of incapable subjects | X | 2 | ||
| A4 | Deviation from standard written informed consent form | X | X | 5 | |
| A5 | Withholding information, deception of the subject, debriefing | 2 | |||
| A6 | Access to information (including clinical and personal data) collected in the course of study | 1 | |||
| A7 | Communication with subjects, who did not give their IC | X | 3 | ||
| A8 | Communication with community; community consultation and involvement | X | X | 3 | |
| A9 | Communication of results to media and general public | X | 3 | ||
| A10 | Communication of results in scientific journals | 1 | |||
| B. Protection of subjects | |||||
| B1 | Subjects’ rights, well-being, and safety | X | X | X | 6 |
| B2 | Proper balance between risk and benefits for subjects and the public | X | X | 5 | |
| B3 | Report of adverse events (physical and/or psychological) | 1 | |||
| B4 | Equitable enrollment of subjects | X | 3 | ||
| B5 | Use of placebo/no-treatment | 1 | |||
| B6 | Exceptional breach of confidentiality | X | 2 | ||
| B7 | Waiver of informed consent (also in research utilizing existing personal information/specimen) | X | X | X | 7 |
| B8 | Procedures protecting subjects’ privacy and confidentiality | X | X | X | 6 |
| B9 | Collecting, use, reuse, sharing exchanging, and final destination of data (personal information and/or biospecimens, genetic information) | X | X | X | 6 |
| B10 | Anonymization of data/biospecimens | 1 | |||
| B11 | Request for removal of data from the study | 1 | |||
| B12 | Safeguards protecting vulnerable subjects | X | X | 5 | |
| B13 | Payment, reimbursement, medical services in the study, compensation | X | 2 | ||
| B14 | Plans for studies in emergency | 1 | |||
| B15 | IRB/REC from sponsoring country reviews research protocol in host country | X | 2 | ||
| B16 | IRB/REC from host country ensures that all ethical provisions are met and study is in accordance with local values | X | 2 | ||
| C. Guards for research integrity | |||||
| C1 | All ethical aspects of the study | X | X | 5 | |
| C2 | Scientific merit of the study | X | X | 4 | |
| C3 | Oversight of the study conduct | X | X | 5 | |
| C4 | Significance of observational character of most epidemiological studies | 2 | |||
| C5 | Improving ethical/scientific/operational aspects of studies | X | 3 | ||
| C6 | Conflict of interests | X | X | X | 5 |
| C7 | Ethical approval | X | X | 5 | |
| C8 | Reporting unethical behavior and/or misconduct | 1 | |||
| D. Formal and operational requirements | |||||
| D1 | Independence | 2 | |||
| D2 | Rules of proceeding | X | X | 5 | |
| D3 | Communication of proceeding rules | X | X | 3 | |
| D4 | Obstruction of the study | X | 3 | ||
| D5 | Disclosure and avoidance of conflict of interest | X | X | 4 | |
| D6 | Adequate composition of membership | X | X | 4 | |
| D7 | Periodical replacement of members | 1 | |||
| D8 | Respecting sponsors’ rights | X | 3 | ||
| D9 | Different levels of functioning (local/national/international) | X | 3 | ||
| D10 | Appeal procedure | 1 | |||
| D11 | Fast-track review | X | X | 4 | |
| D12 | Cooperation between IRBs/RECs | X | X | 4 | |
| E. Types of studies | |||||
| E1 | Studies involving human beings | X | 5 | ||
| E2 | Use of identifiable data without informed consent | X | X | X | 5 |
| E3 | Use of human specimens without informed consent | X | X | X | 6 |
| E4 | Studies of unclear nature | 1 | |||
| E5 | Sensitive topics studies | 1 | |||
| E6 | Studies using clinical data without informed consent | X | 3 | ||
| E7 | Studies using publicly available data | 1 | |||
| E8 | Minimal risk | X | X | 4 | |
| E9 | Studies using anonymized data/specimens | X | 3 | ||
| E10 | Studies without informed consent regulated by local laws | X | X | 4 | |
| E11 | Public health, routine surveillance | X | X | 4 | |
| E12 | Studies in emergency, acute communicable diseases | X | 3 | ||
| E13 | Simple aggregation of records | X | 1 | ||
| Numbers of categories mentioned in the guidelines | 36 | 12 | 28 | ||