Exempt Approval Notice

Dear Mario Navarro,
Your protocol 18-058CTP has been reviewed with a determination made. The protocol can be found
under your My Research tab. Please see the comments below or in the comments tab for additional
information regarding your application.
Please log into the SIPS system at https://sips.fda.gov and proceed to PI-Dashboard to review this
submission.
If you have any additional questions, please contact RIHSC at RIHSC@fda.hhs.gov.
Comments: 11-2-18 IRB Admin:
Your research study, RIHSC# 18-058CTP, does not require Research Involving Human Subjects
Committee (RIHSC) review and approval because it is exempt from the requirements of 45 CFR
§46.101b(2). Below, RIHSC has provided one recommendation which we think may improve your
study documents. There is no need to submit an amendment for your responses to these
recommendations at this time. In the future if you propose changes that you think have the potential to
alter the exemption status of this study, discuss the changes with your liaison and decide together if you
need to file an amendment. When you file an amendment, please include a narrative describing any
changes made since the last submission.
Although this research activity is exempt from RIHSC oversight, the Sponsor and the Principal
Investigator (PI) are not relieved of the responsibility to ensure that the research activity involving human
subjects is conducted in an ethical manner. It is the Sponsor and PI’s responsibility to safeguard the
rights and welfare of each human subject participating in the research activity. You are reminded of your
obligations under applicable federal, international, state, local laws regulations, and policies that provide
additional protection for human subjects participating research.
Additional relevant documents and information, such as the Belmont Report and links to the Code of
Federal Regulations citations and OHRP’s policy and guidance, as well as a copy of the RIHSC Standard
Operating Policies and Procedures, may be found on the RIHSC webpage
at http://inside.fda.gov:9003/ProgramsInitiatives/CommitteesWorkgroups/ResearchInvolvingHumanSubje
ctsCommitteeRIHSC/default.htm
For your reference, the regulation containing the Department of Health and Human Services general
requirements for informed consent (45 CFR 46.116) can be found at http://www.hhs.gov/ohrp/regulationsand-policy/regulations/45-cfr-46.
Comment: Consider in the informed consent adding a contact for questions about rights as a research
participant in addition to questions about the study. As it stands, those questions would probably go to the
PI, but consider if the PI is the best person for those questions; if not, you might add another contact.
Best Regards,
RIHSC SIPS Support

Email Reference: [7ca7b58da93af30391919b9ccc92166d]
Time Sent: [11/2/2018 11:25 AM]