Welcome to E&I, how may we assist you?
E&I's staff is available by phone or email anytime.
Please feel free to reach out if you have
research design, challenges in your study, or how to submit a study.
You are our first priority.
JUNE 19, 2018 FEDERAL REGISTER RELEASE:
Federal Policy for the Protection of Human Subjects: Six Month Delay of the General Compliance Date of Revisions While Allowing the Use of Three Burden-Reducing Provisions During the Delay Priod
Changes in the policy on Certificates of Confidentiality went into affect on
October 1st, 2017
This Policy applies to all biomedical, behavioral, clinical, or other research funded wholly or in part by the NIH, whether supported through grants, cooperative agreements, contracts, other transaction awards, or conducted by the NIH Intramural Research Program, that collects or uses identifiable, sensitive information.
Is your NIH funded study a 'clinical trial' that needs to be reported on ClinicalTrials.gov?
Make sure you are using the right definition.
This is not a new policy, but if not correctly understood, may create current problems for your research.
Resources on this policy:
Final Rule Information
NIH Policy on Dissemination of NIH Funded Clinical Trial Info
Comparison of NIH to HHS
Notice of Revised Rule
Or contact the E&I Administration