Table 3 Comparisons of ethical considerations by type of specimen/data use
Ethical issues | New specimen | Archived (linked) | Archive (unlinked) | Medical records/CRF | p value | ||||
|---|---|---|---|---|---|---|---|---|---|
n = 58 | n = 11 | n = 20 | n = 25 | ||||||
n | % | n | % | n | % | n | % | ||
Rationale | |||||||||
 Research question | 9 | 15.5 | 1 | 9.1 | 3 | 15.0 | 1 | 4.0 | 0.49 |
 Objectives | 14 | 24.1 | 1 | 9.1 | 1 | 5.0 | 4 | 16.0 | 0.21 |
Study design | |||||||||
 Study schedule and activities | 27 | 46.6 | 0 | 0.0 | 3 | 15.0 | 4 | 16.0 | <0.01 |
 Risk–benefit balance | 37 | 63.8 | 0 | 0.0 | 2 | 10.0 | 3 | 12.0 | <0.01 |
Study participants | |||||||||
 Inclusion/exclusion criteria | 41 | 70.7 | 3 | 27.3 | 4 | 20.0 | 11 | 44.0 | <0.01 |
 Sample size | 22 | 37.9 | 3 | 27.3 | 3 | 15.0 | 2 | 8.0 | 0.02 |
 Recruitment | 25 | 43.1 | 2 | 18.2 | 0 | 0.0 | 4 | 16.0 | <0.01 |
 Compensation | 23 | 39.7 | 0 | 0.0 | 1 | 5.0 | 2 | 8.0 | <0.01 |
Informed consent process | |||||||||
 Participation information sheet | 51 | 87.9 | 2 | 18.2 | 1 | 5.0 | 10 | 40.0 | <0.01 |
 Informed consent form | 46 | 79.3 | 2 | 18.2 | 1 | 5.0 | 8 | 32.0 | <0.01 |
 Privacy and confidentiality | 10 | 17.2 | 3 | 27.3 | 7 | 35.0 | 7 | 28.0 | 0.38 |
Data collection and analysis | |||||||||
 Specimen/data collection | 45 | 77.6 | 6 | 54.6 | 7 | 35.0 | 11 | 44.0 | <0.01 |
 Case record form | 9 | 15.5 | 0 | 0.0 | 1 | 5.0 | 9 | 36.0 | 0.01 |
 Data analysis | 9 | 15.5 | 2 | 18.2 | 0 | 0.0 | 4 | 16.0 | 0.29 |
Facility and support | |||||||||
 Study site/location | 4 | 6.9 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0.26 |
 Budgeting | 2 | 3.5 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0.58 |
 Other supporting documents | 12 | 20.7 | 1 | 9.1 | 0 | 0.0 | 4 | 16.0 | 0.15 |