Table 1

Essential Elements and survey results (sample size=100 protocols)

Essential ElementPercent of protocols covering element (%)
1. Addressing relevant question96
2. Choice of control and standard of care59
3. Choice of study design44
4. Choice of subject population39
5. Potential benefits and harms76
6. Informed consent56
7. Community engagement9
8. Return of research results and incidental findings49
9. Post-trial access22
10. Payment for participation40
11. Study related injury43