Table 1. Nature of requested changes in the informed consent documents of two studies submitted to N = 35 IRBs.
| Study 1 | Study 2 | Both studies | |
|---|---|---|---|
| Item | N (percentage) | N (percentage) | N (percentage) |
| Readability, syntax, usage, grammar | 5 (23%) | 18 (42%) | 23 (35%) |
| Content information | 7 (32%) | 8 (19%) | 15 (23%) |
| Data protection | 4 (18%) | 7 (16%) | 11 (17%) |
| Obtaining consent | 0 (0%) | 6 (14%) | 6 (9%) |
| Sample storage | 5 (23%) | 1 (2%) | 6 (9%) |
| Risk about intervention | 1 (4%) | 1 (2%) | 2 (3%) |
| Format of the document, layout, letter head | 0 (0%) | 2 (5%) | 2 (3%) |
| Total | 22 (100%) | 43 (100%) | 65 (100%) |
The suggested changes to the protocol were either clarifications of wordings or more general scientific discussions that did not lead to a protocol amendment.