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 IRB policy related to amendments and Renewals. Additionally, please refer to the NC State 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 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 about the progress of the research study. Please refer to the IRB policy related to amendments and Renewals.
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” requirements. To apply for annual renewal for NIH funded studies, please provide the IRB with this “IRB Request – NIH Annual Approval Renewal Request” when you submit your annual approval request in the IRB system. The Annual Approval Renewal Request form will be available in November of 2023.
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 Policy and SOP for 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 IRB guidance for research associated with the DoD.
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 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 us.
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 harms’ 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 — unless it is in-person research during COVID-19.
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 your 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 risk to particiants, without IRB approval, is very serious and must be dealt with immediately. Please see our guiding information regarding noncompliance.