IRB application, q. 46-48

Questions 46-48 of the IRB application relate to including minors (under 18 years of age) in a study.  

q. 46 asks if you will have minors in the study, if yes go on to q. 48. If no skip to q. 49 

q. 47 asks you to read the federal regulations (I could not get the link to work in the application; however, there is another link to it on the IRB website).

Here is an explanation of the regulations 

Minimal risk – when "adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians" (section 46.404) 

Greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.

an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, only if the IRB finds that:

(a) The risk is justified by the anticipated benefit to the subjects;

(b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and

(c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians (Section 46.405) 

Greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition

an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject, only if the IRB finds that:

(a) The risk represents a minor increase over minimal risk;

(b) The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;

(c) The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and

(d) Adequate provisions are made for soliciting assent of the children and permission of their parents or guardians (Section 46.406) 

You need to indicate the level of risk in your study.  

q. 48 asks you to explain how your study meets the level of risk that you identified in q. 47. 

Next time we will continue examining the IRB application, with q. 49-50. Do you have an issue or a question that you would like me to discuss in a future post? Would you like to be a guest writer? Send me your ideas! leann.stadtlander@waldenu.edu