A Modification is a revision to an approved non-exempt research project. IRB review and approval are required before researchers implement a change to a research protocol, except when necessary to eliminate immediate hazards to the subjects, which rarely applies to social and behavioral research.

• Any proposed change to a previously approved project must be submitted to the IRB as a Modification via the ESTR system.
• The ESTR Study Submission Guide will walk you through the submission process for this follow-on submission.
• For Exempt projects, a Modification is required ONLY if the study is revised in such a way that the Exemption criteria may no longer apply. If uncertain if a Modification should be submitted, contact your IRB Administrator.

The IRB conducts continuing review of research studies that involve more than minimal risk, and in some study-specific special circumstances. An approval period generally last 12 months; however, the IRB may wish to review some studies with greater regularity depending on risk.

The Continuing Review application should be submitted at least 4-6 weeks before the end of the approval period. Researchers will receive ESTR reminders prior to the expiration of the study approval if they are required to submit a Continuing Review.

• The ESTR Study Submission Guide will walk you through the submission process for this follow-on submission.
• IRB approval must be active if you are analyzing the data collected as part of your project, unless the data set has been completely de‐identified (including destruction of the key to coded identifiers).
   

NOTE! If the approval period for an active study has expired (or lapsed), all research‐related procedures must stop, except where doing so would jeopardize the welfare of the human subjects. This means that no subjects may be enrolled in the research, no data may be collected, and data analysis must stop.

Adverse events are events that involve physical, social, economic, or psychological harm to subjects or others. Such adverse events may also indicate risks of harm to other subjects or to others. Such events are one kind of Reportable New Information (RNI).

RNIs are unplanned or unexpected occurrences associated with the research, a significant subject complaint, a deviation from the approved research protocol, or a data security breach such as the theft of a laptop. An RNI is reported to the IRB via the RNI report in the ESTR system.

• The ESTR Study Submission Guide will walk you through the submission.
• Please contact the IRB for guidance if one of these events occurs during your research.

ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.  ClinicalTrials.gov also provides transparency to the public about research outcomes. 

See Requirements for ALL NIH-Funded Human Subjects Research page for detailed information. Check the tab "Expanded Registration and Results Reporting in clinicaltrials.gov."