IRB Approval Letter

Dear Chaunetta Jones,
Your recent IRB registration 16-054CTP has been Approved and can be found under your
myResearch tab.

If you have any additional questions, please contact RIHSC at RIHSC@fda.hhs.gov.
Comments: 8-29-16
Your research study, RIHSC# 16-054CTP, 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). In the future if you propose changes that might alter the exemption status of this study, you
must file an amendment. At that time, please also include a narrative describing any changes made since
the original 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/OC/OfficeofScientificMedicalPrograms/OfficeofScientificIntegrity/ucm336966
.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.

Best Regards,
RIHSC SIPS Support

Email Reference: [7ca7b58da93af30391919b9ccc92166d]
Time Sent: [8/29/2016 5:13 PM]