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Step 3: Application Review Process

After researchers submit an application, administrators and, in later stages of review, full board member(s) and expert consultant(s) read through the research proposal. It is expected that the researchers submit a thorough and internally consistent application with all necessary supplemental documents.

The convened IRB full board is made up of faculty, staff, students, community members, scientists, and non-scientists. Each full board member has a diverse background ranging from diversity in sex, gender identity, race, ability, religion, culture, sexual orientation, age, ethnicity, areas of expertise, and life experiences (among many other things). These diverse perspectives allow for the convened full board to thoroughly review studies engaging most people. If a study requires expertise that is not represented by the convened full board, the IRB will identify someone appropriate to advocate for that participant group throughout the review process. If you are interested in serving NC State University and the community at large by serving as an IRB full board member, please contact for more information.

How the Initial Review Process Works

During the initial review of an application, the IRB office staff reviews the submission and identifies any internal inconsistencies, missing documents, human subjects training certifications, and applicable laws and regulations. This includes an initial risks/benefits assessment to determine the level of review that is required. It’s normal for submissions to be returned to researchers, requesting additional information or reconciliation.

The review of each individual study begins with the reviewer thinking about the participants’ experience, what information participants will need in order to decide to be in the study, and how the risks and benefits of the study design will impact participants through the articulated research plan. Throughout this initial review process, the IRB office staff helps the researcher prepare the application for final review by making sure all materials are included, the application is consistent, and it meets all regulatory requirements.

When the application is complete, the IRB office staff sends the application for final review. The review level for a study is determined by the study design (including participant type, risks to participants, methods used in the study, etc.) and the regulatory requirements for that design. Depending on the level of review required, the study’s final review might be completed by IRB office staff, an individual full board member, or the convened full board.

When the IRB office determines that the study is ready for final review, the IRB staff either make an exemption determination, send the study to a full board reviewer for expedited review, or send the study to the IRB full board membership for review by the convened full board. The expedited reviewer or convened full board may have stipulations for final approval to occur. 

Additional Reviews

In some cases, during the initial review, additional pieces of information are required by a sponsor or an additional law or regulation; needed to assess the risks and benefits; or are needed to provide additional evidence of expertise or training.  

A local or participant context review evaluates the risks to participants in the proposed research. This review is completed by an expert in either the population being studied or the local culture and laws of the population being studied. This type of review is facilitated by the researcher and completed by a subject matter expert who is not an IRB full board member, a member of the research team, or someone with a conflict of interest. The local or context reviewer will provide insight and information about the culture, laws, or participants that the IRB may need to assess risk to participants in your research design.

Local and participant context reviews are conducted during the IRB review process, usually prior to the final review of the protocol. The researcher is expected to facilitate the local and participant context reviews, per the NC State IRB unit standard on local context and participant context reviews. For most expedited and convened full board studies using unique or international populations, an IRB application often cannot be approved without a context review. This type of review will always occur for international research reviewed at the expedited or convened full board level — and, on a case-by-case basis, may be required for studies deemed exempt.

When performing research with human subjects that is funded by the Department of Defense (DoD) and/or uses any DoD resources or people (including those in ROTC), the project is subject to additional regulations. These requirements are detailed in the IRB unit standard for research associated with the DoD. One of the main additional requirements is that a scientific merit review must occur before IRB approval can be granted. 

  • Scientific Merit Reviews: A scientific merit review is an independent review and approval that assesses the scientific merit of a study.
    • The NC State IRB office does not require a scientific merit review unless your study is affiliated with the DoD and reviewed at the expedited or convened full board level.
    • As the researcher, it is your responsibility to facilitate the scientific merit review process and to submit the completed review with your IRB application. The review cannot be done by you or anyone on your research team due to conflicts of interest.
  • HRPO Review: Research subject to the DoD regulations undergoes a second review after IRB approval is granted. This is called HRPO review. This is facilitated between the researcher and the DoD’s HRPO officer. 

Some studies involve the use of medical devices where the researcher studies the safety and efficacy of the device or uses the device “off label” in the research. When either is done in a research study the IRB needs to determine during the review process the risk of the device. The risk determination informs the level of required FDA review as to whether an Investigational Device Exemption (IDE) or an abbreviated IDE is needed and whether the project is considered a clinical trial

The NC State IRB reviews studies considered “exempt from the IDE requirements” and studies that are eligible for an “Abbreviated IDE.” Studies requiring a full IDE with the FDA are reviewed and approved by the WCG private IRB with which NC State has a standing agreement. Few studies completed at NC State require a full IDE. 

Federally funded studies that try to answer a research question about health-related outcomes by prospectively assigning human participants to either a control group or one or more interventions in order to evaluate the effects of the intervention on biomedical or behavioral health-related outcomes are considered  “clinical trials” under federal regulation 45.CFR.46. 102(b). All federally funded studies will be reviewed for intent and procedures that categorize the research as a “clinical trial.” This review occurs during the normal IRB review and approval process and it requires the researchers to take action after IRB approval is granted. 

  • When NC State University is serving as the IRB of record for a cooperative study the NC State researcher and their collaborators must submit the “Research Site Context Worksheet” with their IRB application request. This review is concurrent with the IRB review and approval or amendment process. 
  • When NC State University is serving as the IRB of Record for a cooperative study, the NC State researcher and their collaborators must submit the Conflicts of Interest Attestation or Management Plan with the reliance agreement request. This is only used for cooperative research.  This form allows all COI issues to be addressed within each individual IRB protocol. This review is concurrent with the IRB review and approval or amendment process.