1. Competency of investigators
- Do the investigators have the necessary experience and skills to conduct the study?
2. Importance of the study
- Does this study answer an important question?
- Have similar studies been done before?
3. Appropriateness of the objectives and outcome measures
- Are the objectives and outcomes clear and measurable?
- Do they correspond to the research question?
4. Scientific rigour
- Is the study design appropriate to answer the research question?
5. Protection of vulnerable population
- Does the study involve vulnerable subjects?
- Are steps being taken to ensure they are not being disadvantaged?
- Are any groups of individuals unfairly excluded?
6. Recruitment and consent procedures
- Could circumstances of the recruitment put undue influence or pressure on potential subjects?
- Is the language of the participant information sheet and consent form understandable?
- Does the participant information sheet accurately describe the study?
- Does the consent form state that participation is voluntary?
7. Confidentiality
- Will participants’ information be anonymised?
- Will data be kept, transferred and disposed securely?
8. Risks and benefits to subjects
- Are there potential benefits to the subjects?
- Are there risks to the subjects in terms of potential physical, psychological, social-legal and financial / economic harm, discomforts or burdens?
- Are actions taken to minimise them?
- Are the risks justified by the potential benefits of the study?
9. Compensation to subjects
- Will subjects be compensated for their travel and inconvenience?
- Will subjects be compensated in the event of harm or injury?
Adapted from: UMMC MREC Research ethics application form and UMMC MREC Ethics Review Checklist (2,3) (Click to download)
Minimal risk studies vs. More-than-minimal risk studies →
Medical Research Ethics Committee. Research Ethics Application Form [Internet]. University of Malaya Medical Centre; 24 Aug 16. Available from: https://www.ummc.edu.my/files/ethic/NEW%20STUDY%20APPLICATION%20FORM_24Aug16.docx
Medical Research Ethics Committee. Ethics Review Checklist [Internet]. University of Malaya Medical Centre; Available from: https://www.ummc.edu.my/files/ethic/UMMC-MREC%20Review%20Checklist.docx