Skip to main content

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