Review criteria | Definition |
---|---|
1. Proportionality | Risks and burdens to subjects are reasonable in relation to anticipated benefits |
Trial leads to important medical knowledge and/or considerable health benefits | |
Participation does not involve unacceptable/disproportionate risks or burdens to subjects, use of placebo in trial is ethically justified | |
2. Minimisation of risks & burdens | Risks and burdens to subjects are minimized |
Research question cannot be answered without inclusion of human subjects | |
Research question cannot be answered by more simple or less riskful/burdensome research | |
3. Privacy & confidentiality | Adequate provisions are made to protect privacy of subjects and maintain confidentiality of data and body tissues |
Trial data and body tissues are adequately coded, stored and protected, with restricted access for third parties | |
4. Patient safety | Adequate provisions are made to ensure safety of subjects during the trial |
Collected data are adequately monitored and (if necessary) a Data and Safety Monitoring Board (DSMB) is installed | |
Individual and group level stopping criteria are adequate | |
5. Recruitment process | Recruitment methods and payments to subjects are acceptable |
Investigator has access to population that allows recruitment of required number of subjects | |
Subjects are given adequate opportunity and time to ask questions and decide about participation | |
6. Information sheet & consent form | Subject information sheet & consent form contain all required elements |
The length, structure and language use of the information sheet & consent form will allow subjects to understand them correctly | |
7. Subject selection | Subject selection is appropriate to answer the research question |
Inclusion and exclusion criteria are adequate and complete, equity in subject selection | |
8. Protection vulnerable subjects | When vulnerable subjects are included, there are additional safeguards to protect their rights and well-being |
No vulnerable subjects are included, unless they may benefit themselves from participation or trial cannot be conducted without them | |
9. Methodology & statistical analysis | Trial design/methodology is appropriate and properly motivated in protocol |
Selected primary & secondary endpoints and dosage regimen are appropriate | |
Sample size calculations and planned statistical analyses are adequate | |
10. Product information | Product information on the medicinal product(s) used in the study is adequate |
Investigator’s Brochure (IB) and Investigational Medicinal Product Dossier (IMPD)/ Summary of Product Characteristics (SPC) are acceptable | |
11. Supporting documentation | Other documents submitted as part of the research proposal are acceptable |
Data in ABR form are complete and correct and the Clinical Trial Agreement is in accord with Dutch regulations | |
Required insurances for medical research with human subjects are arranged | |
12. Facilities & research staff | Research staff members are experienced and qualified to conduct trial procedures |
Investigator has adequate facilities to conduct the trial | |
13. Financial aspects | All costs incurring during the trial are adequately covered |
Compensation fees paid to investigators or institutions are proportional to the size, nature, and purpose of the trial | |
Conditions (e.g. financial interests) leading to conflicts of interest are prevented |