NIH Certificate of Confidentiality Information
(Please complete only if NIH is the Sponsor or Prime Sponsor)
1)
Is the activity biomedical, behavorial, clinical, or other research?
Yes (Please proceed to question 2)
No (No further action is needed)
2) a. Does the research involve human subjects as defined by 45 CFR Part 46?
Yes**
No
b. Are you collecting or using human biospecimens?
c. Does the research involve the generation of individual level, human genomic data?
Yes**
No
d. Does the research involve de-identified or partially de-identified data?
Yes**
No
**If the answer to 2a, 2b, or 2c is "yes," the NIH
Certificate of Confidentiality (COC) Policy Applies, and
a COC is automatically issued as a term of the award.
The relevant NIH COC language must appear in the
informed consent document.
Continue to page 3
Yes**
No