common records schedule

Minimal Risk Research Involving Human Subjects - Case Files

Consists of records relating to the review by the appropriate committee of research investigations that involve human participants. Minimal risk research means potential subjects can be reasonably expected to regard the probability and magnitude of possible harms implied by participation in the research to be no greater than those encountered by the subject in those aspects of his or her everyday life that relate to the research. Case files may include protocols, assent forms, certificates of approval from other institutions, approval or non-approval decision letters and correspondence.