{"id":519,"date":"2023-04-25T11:18:05","date_gmt":"2023-04-25T15:18:05","guid":{"rendered":"https:\/\/research.ncsu.edu\/administration\/?page_id=519"},"modified":"2025-12-01T10:07:48","modified_gmt":"2025-12-01T15:07:48","slug":"responsibilities-after-initial-approval","status":"publish","type":"page","link":"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/responsibilities-after-initial-approval\/","title":{"rendered":"Step 4: Responsibilities After Approval"},"content":{"rendered":"\n\n\n\n\n

Reviews After IRB Approval<\/strong><\/h2>\n\n\n\n

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. <\/p>\n\n\n

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Amendments to an Approved IRB Protocol<\/h2>\n <\/summary>\n

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Once a study has been approved by the IRB \u2014 no matter the approval level<\/a> \u2014 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. <\/p>\n\n\n\n

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<\/a> for more details. Amendments are submitted to the IRB via the electronic system. <\/p>\n\n\n <\/p>\n <\/details>\n\n\n

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Annual Approval Renewal<\/h2>\n <\/summary>\n

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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<\/a> for more details.<\/p>\n\n\n\n

All studies funded by the NIH on or after January 25th, 2023 will undergo annual approval renewal (regardless of level of review) due to the NIH\u2019s Data Sharing and Management Plan (DSMP) requirements. To apply for annual renewal for NIH-funded studies, please provide the IRB with a completed “Renewal Request Supplement<\/a>\u201d when you submit your annual approval request in the IRB system.<\/p>\n\n\n <\/p>\n <\/details>\n\n\n

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Post-Approval Monitoring Activities<\/h2>\n <\/summary>\n

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The NC State University IRB will select approved protocols \u201cfor-cause\u201d or at random to be audited as part of our post-approval audit process<\/a>. 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 \u201cwalkthrough\u201d 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\u2019s review and approval of the study. For further details on post-approval monitoring activities, please review the routine audit overview<\/a> and the NC State University IRB unit standard on post-approval monitoring<\/a>.<\/p>\n\n\n <\/p>\n <\/details>\n\n\n

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Registering a Clinical Trial Online<\/h2>\n <\/summary>\n

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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. <\/p>\n\n\n\n

If the IRB approves a study that has been determined a clinical trial, it must be registered with clinicaltrials.gov<\/a> if the study is funded or if otherwise required by a sponsor. <\/p>\n\n\n <\/p>\n <\/details>\n\n\n <\/div>\n <\/div>\n\n\n\n

Additional Requirements for Clinical Trials<\/h2>\n\n\n\n

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:<\/p>\n\n\n\n