Appendix.
Complete Knowledge Questionnaire
| Question | Response Options |
Number (%) Selecting Answer |
|
|---|---|---|---|
| Which statement regarding parental permission for a child’s involvement in IRB-approved research is correct? | Best | Permission of both parents, if they are reasonably available, is required for research that lacks the prospect for direct benefit and involves a minor increment over minimal risk. | 3 (8%) |
| Parental permission is always required before a child can participate in clinical research. | 28 (74%) | ||
| Alternatives | Parental permission may be waived whenever the research poses no greater than minimal risk to the child. | 0 (0%) | |
| Permission of both parents, if they are reasonably available, is required for research that offers the prospect of direct benefit to the child but carries substantial risks. | 6 (16%) | ||
| Not sure | 1 (2%) | ||
| According to the regulations, children are considered capable of assent when: | Best | The IRB determines that they are capable of assent on the basis of age, maturity and psychological state. | 11 (27%) |
| They are at least seven years of age and of normal cognitive ability. | 9 (22%) | ||
| Alternatives | They are at least twelve years of age and of normal cognitive ability. | 10 (24%) | |
| Their parents determine that they are capable of assent on the basis of age, maturity and psychological state. | 6 (15%) | ||
| Not sure | 5 (12%) | ||
| Federal regulations define the concept of “minimal risk” as situations where: | Best | The anticipated risks of participating in the research are not greater than those ordinarily encountered in daily life. | 16 (40%) |
| The anticipated risks of participating in the research are not greater than those ordinarily encountered during the course of the subjects’ medical care. | 9 (22%) | ||
| Alternatives | The anticipated risks of participating in the research are only slightly greater than those ordinarily encountered in daily life. | 4 (10%) | |
| The anticipated risks of participating in the research are only slightly greater than those ordinarily encountered during the course of the subjects’ medical care. | 11 (28%) | ||
| Not sure | 0 (0%) | ||
| Which statement about child assent is correct? | Best | An IRB may waive the requirement for assent if the research offers benefits to the child that are unavailable outside the research. | 11 (28%) |
| An investigator can assume that a child has assented to research participation as long as the child does not voice an objection. | 1 (2%) | ||
| Alternatives | An investigator can assume that a child has assented to research participation as long as the child does not voice an objection, provided that the parent agrees with this assessment. | 8 (20%) | |
| Assent can be waived if the parent thinks that the purpose of the research is sufficiently important. | 6 (15%) | ||
| Not sure | 14 (35%) | ||
| Which statement regarding the ability of an IRB to approve pediatric research is correct? | Best | An IRB can approve a protocol that presents a minor increase over minimal risk if it determines that the research is likely to yield generalizable information about the subject’s disorder or condition. | 12 (30%) |
| To approve a protocol that presents greater than minimal risk, the IRB must determine that the research offers the prospect of direct benefit to the child. | 13 (33%) | ||
| Alternatives | An IRB must refer all protocols enrolling children that present greater than minimal risk and no prospect of direct benefit to the child to the Department of Health and Human Services. | 2 (5%) | |
| An IRB can approve a protocol that presents a minor increase over minimal risk only if it also offers the prospect of direct benefit to the child. | 8 (20%) | ||
| Not sure | 5 (12%) |