Table 3.
Ethical Classification | EthicsCommittee Concern | Total | |||
---|---|---|---|---|---|
|
|
||||
Consent | Protocol | Forms | Frequency | Percentage | |
Justice | 3 | 12 | 2 | 14 | 19% |
Requires attention to participant recruitment | 2 | 10 | 0 | 11 | 15% |
Inclusion and exclusion criteria for selecting participants | 1 | 2 | 2 | 3 | 4% |
Beneficence | 2 | 18 | 10 | 30 | 42% |
Requires an examination of the experimental design | 0 | 6 | 5 | 11 | 15% |
Minimization of the risks of research participation | 2 | 10 | 3 | 15 | 21% |
Qualifications of the principal investigator to conduct the study | 0 | 2 | 2 | 4 | 6% |
Respect for Persons | 24 | 15 | 5 | 41 | 57% |
Requires attention to informed consent information, comprehension, and voluntariness | 18 | 4 | 0 | 22 | 31% |
Surrogate permission | 1 | 1 | 0 | 1 | 1% |
Maximization of choice | 2 | 1 | 1 | 3 | 4% |
Protection of privacy and confidentiality | 0 | 5 | 4 | 8 | 11% |
Protection of vulnerable population | 3 | 4 | 0 | 7 | 10% |
Untoward Effects | 0 | 4 | 0 | 4 | 6% |
Study staff safety | 0 | 4 | 0 | 4 | 6% |
Note: A single ethics committee concern may have multiple ethical labels, resulting in table totals in excess of the seventy-two substantive ethics committee concerns. In addition, one ethics committee concern could affect more than one content type resulting in a total greater than the overall frequency.