Step 4: Responsibilities After Approval
Reviews After IRB Approval
Once a study protocol has been approved by the IRB, there may be additional reviews required. These include reviews related to making changes to an approved study (regardless of review level), required annual renewal of approval, or secondary reviews based on study design, laws, regulations, or sponsors.
Amendments to an Approved IRB Protocol
Once a study has been approved by the IRB — no matter the approval level (link to where we define levels of approval) — if the researcher wants to change something about the study, they must submit those proposed changes to the IRB for review and approval before the changes can be implemented. Amendments may require a different level of review due to new or different risks/benefits to participants or laws that may apply as a result of the changes.
At NC State, due to our university human subject regulation, all changes must be submitted to the IRB for review. Please refer to the NC State University IRB unit standard on renewals, amendments, closures, and transfers for more details. Additionally, please refer to the IRB guidance for amendments and exempt studies. Amendments are submitted to the IRB via the electronic system.
Annual Approval Renewal
Annual approval renewal, also called continuing review, is required for all convened full board studies and may be required for expedited or exempt studies as determined by the IRB. This review is annual but may occur at a quicker rate as needed. This process provides the IRB with an update on the progress of the research study. Please refer to the NC State University IRB unit standard on renewals, amendments, closures, and transfers for more details.
All studies funded by the NIH will undergo annual approval renewal (regardless of level of review) due to the NIH’s Data Sharing and Management Plan (DSMP) requirements. To apply for annual renewal for NIH-funded studies, please provide the IRB with a completed “IRB Request – NIH Annual Approval Renewal Request” when you submit your annual approval request in the IRB system.
Post-Approval Monitoring Activities
The NC State University IRB will select approved protocols “for-cause” or at random to be audited as part of our post-approval audit process. Audits allow for the intentional continued protection of human subjects and an opportunity to assess compliance within the research community and regulatory compliance. Audits may entail a live “walkthrough” of the procedures; a review of implemented study measures, stimuli, or devices; observation of participant interactions and study procedures; discussions regarding experiences with participants, participant compensation, study documentation, research records/data storage, and study progress. Audits will also include an assessment of the IRB’s review and approval of the study. For more details, please refer to the routine audit overview and the audit process flowchart. For further details on post-approval monitoring activities, please review the NC State University IRB unit standard on post-approval monitoring.
Registering a Clinical Trial Online
Clinical trials try to answer a research question about health-related outcomes by prospectively assigning human participants to an intervention in order to evaluate the effects of the intervention on biomedical or behavioral health-related outcomes.
If the IRB approves a study that has been determined a clinical trial, it must be registered with clinicaltrials.gov if the study is funded or if otherwise required by a sponsor.
Additional Requirements for Clinical Trials
Clinical trials try to answer a research question about health-related outcomes. Clinical trials have a number of specific additional requirements in order to protect human subjects:
- NC State University IRB Unit Standard on Clinical Trials
- PRS Login for ClinicalTrials.gov
- FDA Clinical Trials Information
- FDA Clinical Trials Forms
Secondary Review for DoD Research Activities
When performing research with human subjects that is funded by the Department of Defense (DoD) and/or uses any DoD resources or people (including ROTC), the project is subject to additional regulations. These requirements are detailed in the NC State University IRB unit standard on research with the Department of Defense.
There are two additional reviews related to DoD research and the IRB. The first is a scientific merit review which occurs as part of the initial IRB review and approval process. The second is an additional requirement called “HRPO Review” — which occurs after IRB approval is granted. This type of review is carried out by the Human Research Protection Office (HRPO) and is specifically affiliated with the DoD. This type of review is required for all research subject to the DoD regulations. This review is not carried out by the NC State IRB office, though you will need to submit your NC State IRB-approved materials to HRPO after NC State IRB approves the study.
Report an Unanticipated Problem or Adverse Event
In the course of the research, it is statistically likely that, at some point, there will be an unanticipated problem or adverse event with human subjects. It’s important to first immediately assess and triage the situation so that the participant(s) are not directly in harm’s way. As soon as that is taken care of, please fill out the confidential form below. You have up to five days to file a report.
Not reporting at all — or reporting in an untimely manner — results in non-compliance and could impact your ability to conduct research or use the research data collected. You can also email (firstname.lastname@example.org) or call (919.515.8754) the IRB office if you need immediate help. If you call and leave a message, follow that message up with an email.
Your IRB materials, once approved by the IRB, are the blueprint of your study. You are expected to follow the IRB-approved research protocol and use only IRB-approved materials when conducting your research. Additionally, it is expected that you cultivate a climate of voluntariness and transparency (as appropriate) with your participants. Any unapproved departure from your approved IRB protocol, a departure from ethical practices, or implementation of research with human subjects without appropriate IRB approval is considered noncompliance.
Noncompliance has many different consequences — but can result in you being prevented from using data that were collected outside of IRB approval or require reporting to the federal government. Most importantly, any departure from your approved IRB protocol that increases the risk to participants, without IRB approval, is very serious and must be dealt with immediately. Please see our guiding information regarding noncompliance.