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Table 1 Classification checklist for REC review of protocols of drug trials

From: Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review

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
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