{"id":13925,"date":"2024-07-15T10:14:01","date_gmt":"2024-07-15T14:14:01","guid":{"rendered":"https:\/\/research.ncsu.edu\/administration\/?page_id=13925"},"modified":"2025-12-02T19:56:36","modified_gmt":"2025-12-03T00:56:36","slug":"administrators-supporting-research","status":"publish","type":"page","link":"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/administrators-supporting-research\/","title":{"rendered":"Administrators Supporting Research"},"content":{"rendered":"\n\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Scope of Roles as Related to the Research with Human Subjects and the IRB<\/strong><\/h2>\n\n\n\n<p>To assist NC State researchers in understanding their responsibilities when completing research with human subjects, the NC State IRB office has detailed <a href=\"https:\/\/docs.google.com\/document\/d\/1h1Xk8Quuy0p3ItTfkyoeqJdS3Eo12Wjb4oABppXdA5E\/edit#heading=h.vhmc8yp5hh9p\">Expectations for those listed as Faculty Points of Contact in the eIRB system<\/a> and created a <a href=\"https:\/\/docs.google.com\/document\/d\/19WFYciiJKBeElvuFdJ1ziPQkmF1nAwqe\/edit\">unit standard for all Faculty Points of Contact<\/a>. In the current eIRB system, the person listed as the \u201cFaculty Point of Contact\u201d is either the lead PI or a student PI\u2019s faculty advisor. To assist research administrators and others supporting researchers at NC State University, the IRB office has provided details about scope of role and responsibilities (noted above in the links) and in summary below.&nbsp;<\/p>\n\n\n<div class=\"is-text wp-block-ncst-accordion\" >\n    <div class=\"accordion isLinked\" id=\"ncst-accordion-4v7twf\">\n          \n<details class=\"wp-block-ncst-accordion-item\" name=\"4v7twf\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\"><strong>Lead PI<\/strong><\/h2>\n      <\/summary>\n      <p>\n        \n\n<p>The lead Principal Investigator (PI) has ultimate responsibility for the research design and implementation for all aspects of the research project. This includes:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Initial study design, IRB application completion;&nbsp;<\/li>\n\n\n\n<li>Recruitment and consent of participants;&nbsp;<\/li>\n\n\n\n<li>Implementation of intervention or interaction;&nbsp;<\/li>\n\n\n\n<li>Determining data access needs; and&nbsp;<\/li>\n\n\n\n<li>Study closure.&nbsp;<\/li>\n\n\n\n<li>Ensuring all research team members are trained on the research protocol itself and have completed relevant ancillary training requirements such as human subjects research training, data management training, blood borne pathogens, HIPAA, etc.&nbsp;<\/li>\n\n\n\n<li>Ensuring consistent and clear communication among the research team regarding the IRB study protocol and participant needs.<\/li>\n\n\n\n<li>Providing necessary information to research administrators assisting the Lead PI with agreements such as a Data Use Agreement (DUA), Memorandum of Understanding (MOU), or Subaward where IRB related information may need to be provided. Subsequently providing the IRB office with relevant terms that need to be addressed in the IRB application.&nbsp;<\/li>\n\n\n\n<li>Ensuring that all research team members are in compliance with <a href=\"https:\/\/policies.ncsu.edu\/regulation\/reg-01-25-01\/\">REG 01.25.01 \u2013 Conflicts of Interest and Conflicts of Commitment<\/a> (opens in a new window), including having an updated Financial Interest disclosure on file, if required.&nbsp;<\/li>\n\n\n\n<li>If Lead PI delegates any of these duties to others, they retain responsibility to ensure they are completed&nbsp;&nbsp;<\/li>\n<\/ul>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"4v7twf\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\"><strong>Co-PI<\/strong><\/h2>\n      <\/summary>\n      <p>\n        \n\n<p>The Co-PI is responsible for any of the delegated responsibilities of the Lead PI.&nbsp;<\/p>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"4v7twf\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\"><strong>Student PI\u2019s Advisor\/Chair\u00a0<\/strong><\/h2>\n      <\/summary>\n      <p>\n        \n\n<p>The student PI&#8217;s Advisor\/Chair is responsible for the following:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The student PI\u2019s Advisor\/Chair is ultimately responsible for all aspects of the student PI\u2019s project as the student is considered learning throughout the process.&nbsp;<\/li>\n\n\n\n<li>Though the student may complete an IRB application, the student PI\u2019s Advisor\/Chair must meticulously review the application before the student PI\u2019s Advisor\/Chair submits the IRB application themselves. The student cannot submit the application themselves.&nbsp;<\/li>\n\n\n\n<li>The student PI\u2019s Advisor\/Chair is expected to work with their student on the research question, study design, and IRB application and submission. Once an IRB protocol is approved, it is expected that the student PI\u2019s Advisor\/Chair provide intentional guidance and support to the student PI throughout the life of the project including data collection, implementation of intervention or interaction, or access and analysis of identifiable or re-identifiable data.&nbsp;<\/li>\n<\/ul>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"4v7twf\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\"><strong>The IRB Office and Full Board<\/strong><\/h2>\n      <\/summary>\n      <p>\n        \n\n<p>The IRB\u2019s scope of authority and responsibility includes:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>IRB office staff receive a completed IRB application and review the application for completeness, consistency, and regulatory and ethical requirements.&nbsp;<\/li>\n\n\n\n<li>IRB office staff provides detailed feedback to researchers in order to ensure that their protocol is ethical and compliant with the federal, state, and university level regulations. Once the application is approvable, the IRB office staff processes that approval.&nbsp;<\/li>\n\n\n\n<li>The IRB office does not design a student\u2019s research nor do they advise students in the capacity of research design as a whole. We only discuss regulatory requirements and ethical practices as related to the participants.&nbsp;<\/li>\n<\/ul>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"4v7twf\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\"><strong>Research Administrators and Support Staff<\/strong><\/h2>\n      <\/summary>\n      <p>\n        \n\n<p>Research Administrators scope of authority and responsibilities may include:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Asking to review the study protocol and materials if assisting with the project&nbsp;<\/li>\n\n\n\n<li>Assisting the PI in the coordinating the review process (PINS\/RED) for any required agreements related to an IRB protocol<\/li>\n\n\n\n<li>If it\u2019s within the scope of the administrator\u2019s authority (such as a data steward or their delegate), releasing data to researchers in accordance with normal practices. In doing this, research admins can ask to review the approved IRB protocol and Informed Consent information.&nbsp;<\/li>\n\n\n\n<li>Processing any compensation provided to participants in accordance with <a href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/fiscal-compliance\/\">Fiscal Compliance<\/a> requirements.&nbsp;<\/li>\n\n\n\n<li>Completing <a href=\"https:\/\/drive.google.com\/file\/d\/15On0UevTEaZz9cXk9pVPdSstZPFgjnbO\/view\">necessary human subjects research training<\/a> should they be considered \u201cengaged\u201d in the human subjects\u2019 research protocol due to their involvement with recruitment and consent of participants; implementation of intervention, interaction, or manipulation of a participant&#8217;s environment, or handling of identifiable or re-identifiable data, this does not include data stewards or their delegates who release data to researchers.&nbsp;<\/li>\n\n\n\n<li>Asking the IRB questions with the Lead PI and Co-PIs copied on the email. Note: if the question is about the rights and welfare of the participants or about ethical issues in the study, please do contact the IRB office via phone or email privately.&nbsp;&nbsp;<\/li>\n<\/ul>\n\n\n\n<p>Unless considered a research team member on the IRB protocol, research administrators should not:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Complete the IRB application on behalf of the Lead PI, Co-PI, or other research team members.&nbsp;<\/li>\n\n\n\n<li>Complete any required training on behalf of the Lead PI, Co-PI, or other research team members. Administrators supporting researchers should only complete the training required for themselves, not anyone else.\u00a0<\/li>\n\n\n\n<li>Make any changes to IRB approved documents.<\/li>\n\n\n\n<li>Handle identifiable data unless approved to do so on the approved IRB protocol.&nbsp;<\/li>\n\n\n\n<li>Participate in the consent or research intervention\/interaction processes unless approved to do so on the approved IRB protocol.&nbsp;<\/li>\n<\/ul>\n\n\n      <\/p>\n  <\/details>\n\n\n    <\/div>\n  <\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Commonly Asked Questions from Research Administrators<\/h2>\n\n\n<div class=\"is-text wp-block-ncst-accordion\" >\n    <div class=\"accordion isLinked\" id=\"ncst-accordion-l8uxs2\">\n          \n<details class=\"wp-block-ncst-accordion-item\" name=\"l8uxs2\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\"><strong>When is IRB approval required?<\/strong><\/h2>\n      <\/summary>\n      <p>\n        \n\n<p>IRB approval is needed for all projects completed by NC State University faculty, staff or students where the project meets the definition for \u201cresearch\u201d and \u201chuman subject\u201d as defined by the regulation <a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46\">45 CFR 46<\/a>. On the homepage for the NC State University IRB website, there is a description of the\u00a0 \u201cLifecycle\u201d of an IRB protocol. You can find details on definitions and scope of IRB authority on our &#8220;<a href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/determining-approval\/\">Step 1: Determining if IRB Approval is Required<\/a>&#8221; webpage.\u00a0<\/p>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"l8uxs2\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\"><strong>What are the training requirements to be able to do human subjects research?<\/strong><\/h2>\n      <\/summary>\n      <p>\n        \n\n<p>All NC State University faculty, staff, and students who wish to engage in human subjects research must successfully complete <a href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/irb-training\/\" target=\"_blank\" rel=\"noreferrer noopener\">human subjects research training<\/a> and provide proof of completion to the IRB before an IRB protocol can be completed. Engagement is defined as anyone who is involved in recruiting and consenting, implementing an intervention with human subjects, interacting with human subjects, manipulating the environment of human subjects, or handling\/analyzing identifiable\/re-identifiable private data about humans.\u00a0<em>Please note: Research administrators should not complete human subjects research training for anyone but themselves. <\/em><\/p>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"l8uxs2\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\"><strong>Where is the IRB application and how do researchers apply for approval?<\/strong><\/h2>\n      <\/summary>\n      <p>\n        \n\n<p>Researchers apply for IRB approval through the electronic system called the <a href=\"https:\/\/www3.acs.ncsu.edu\/hs\/irb.php\">eIRB system<\/a>. You can find details on how to apply for IRB approval on the IRB Lifecycle section \u201c<a href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/preparing-and-submitting-an-application\/\">Step 2: Preparing and Submitting an Application<\/a>\u201d<\/p>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"l8uxs2\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\"><strong>A researcher asked me to input information into the clinicaltrials.gov website. How do I do that?<\/strong><\/h2>\n      <\/summary>\n      <p>\n        \n\n<p>The NC State IRB office will have given the researcher access to clinicaltrials.gov when their study was initially approved. That login information should be used to input information into <a href=\"https:\/\/register.clinicaltrials.gov\/\">PRS<\/a>, the clinicaltrials.gov database.\u00a0 login info. The IRB office has no authority or access to assist with entering information into this system. Please review the <a href=\"https:\/\/docs.google.com\/document\/d\/14UYmLz-VDywHk5lVRYXaPaxbxO3DK5sR\/edit#heading=h.gjdgxs\">NC State IRB unit standards on clinical trials<\/a> and refer to Appendix B and E. For details on using the PRS system itself, please refer to the <a href=\"https:\/\/clinicaltrials.gov\/submit-studies\/prs-help\/prs-guided-tutorials\">PRS Guided Tutorial<\/a>.\u00a0\u00a0<\/p>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"l8uxs2\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\"><strong>A researcher or study has Department of Defense (DoD) funding. What are the additional obligations that I need to help coordinate?<\/strong><\/h2>\n      <\/summary>\n      <p>\n        \n\n<p>All Department of Defense (DoD) affiliated human subjects research requires the researcher to complete additional steps before, during, and after IRB approval with the NC State University\u2019s IRB. Please review the <a href=\"https:\/\/docs.google.com\/document\/d\/16IKH6EbO_rKxTyCcWH7bF0eBPwUMlL-u\/edit#heading=h.gjdgxs\">NC State IRB unit standard on DoD Supported Research<\/a>. The main requirements include provision of a <a href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/irb-forms-and-templates\/\">scientific merit review<\/a> with the Initial IRB application and a secondary review called \u201cHRPO\u201d review once NC State IRB approval is granted. The HRPO review is facilitated by the researcher with their DoD Agency.<\/p>\n\n\n\n<p>For details regarding the additional obligations that are required for DoD sponsored research, please review the content from the IRB Lifecycle section \u201c<a href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/responsibilities-after-initial-approval\/\">Step 4: Responsibilities After Approval<\/a>\u201d<\/p>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"l8uxs2\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\">Can the NC State IRB review research that will be done by a current University faculty\/staff member or student at a business or startup<strong>?\u00a0<\/strong><\/h2>\n      <\/summary>\n      <p>\n        \n\n<p>IRB approval through NC State university is required when an NC State University faculty member, staff member, or student is both acting within the scope of their position and acting on behalf of the University to complete the regulated research with human subjects. When a researcher needs IRB approval for a project and they are not working within the scope of their University position, the NC State IRB office cannot review and approve their project. Please review the \u201c<a href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/determining-approval\/\">Step 1: Determining if IRB Approval is Required<\/a>\u201d webpage for more information. The <a href=\"https:\/\/research.ncsu.edu\/commercialization\/inventors-guide-to-commercialization\/\">NC State University Office of Research Commercialization<\/a> can help researchers identify external IRBs that can review human subjects research beyond the scope of the NC State IRB to review. .\u00a0<\/p>\n\n\n\n<p>If an NC State University researcher will be conducting human subjects research outside the scope of their role but their NC State collaborator(s) work on the project is within their institutional role at NC State, then the NC State IRB may be able to review and approve the project with a formal agreement in place. Please review NC State University IRB&#8217;s <a href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/cooperative-research\/\">Cooperative Research<\/a> webpage and review the criteria related to an individual investigator agreement.<\/p>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"l8uxs2\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\"><strong>A researcher wants to collaborate on human subjects research with people outside of NC State University. What do we need to know to proceed?\u00a0<\/strong><\/h2>\n      <\/summary>\n      <p>\n        \n\n<p>Familiarize yourself with the NC State University IRB&#8217;s <a href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/cooperative-research\/\">Cooperative Research<\/a> page of our website and refer the researcher to the site to start there. Additionally, should the research collaboration lead to a research project that will include the research procedures taking place at \u201cmultiple sites,\u201d please refer the researcher to the guidance for <a href=\"https:\/\/docs.google.com\/document\/d\/1UsO9YUa64ZAxmUru8N1t27Odtnqign7v\/edit#heading=h.a1y6by7kszoy\">Multi-Site Research<\/a>.\u00a0<\/p>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"l8uxs2\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\"><strong>What University level regulations, rules, and guidances often apply to human subjects research?\u00a0<\/strong><\/h2>\n      <\/summary>\n      <p>\n        \n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/policies.ncsu.edu\/regulation\/reg-10-10-03\/\">REG 10.10.03 \u2013 Human Subjects Research<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/policies.ncsu.edu\/regulation\/reg-01-25-09\/\">REG 01.25.09 \u2013 Privacy\/Confidentiality, Release and Security of Protected Health Information<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/policies.ncsu.edu\/regulation\/reg-01-25-17\/\">REG 01.25.17 \u2013 Surveys of NC State Students, Alumni, Faculty, Staff and\/or Administrators<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/policies.ncsu.edu\/regulation\/reg-01-25-18\/\">REG 01.25.18 \u2013 Programs that Involve the Participation of Minors&nbsp;<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/policies.ncsu.edu\/rule\/rul-08-00-18\/\">RUL 08.00.18 \u2013 Endpoint Protection Standard&nbsp;<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/research.ncsu.edu\/administration\/policies-and-guidance\/pi-eligibility\">Principal Investigator Eligibility and Standing<\/a><\/li>\n<\/ul>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"l8uxs2\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\"><strong>What is a data and access security plan (DASP) and when is it required by the IRB?<\/strong><\/h2>\n      <\/summary>\n      <p>\n        \n\n<p>A data and access security plan (DASP) is a comprehensive data management approach created with an NC State University OIT Security and Compliance representative and the protocol&#8217;s principal investigator for a specific research protocol. A DASP is only required for human subject research protocols that access or generate highly sensitive (red) data or ultra sensitive (purple) data as defined by NC State University\u2019s OIT, the IRB office, and in some cases by contract from entities releasing data to NC State University. It is also required when protocols are required to share their research data, such as with National Institutes of Health (NIH) funded studies, and by some data providers that require data use agreements (DUAs) or material transfer agreements (MTAs). <\/p>\n\n\n\n<p>For ease of reference, the IRB defines \u201cred\u201d and \u201cpurple\u201d data below:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Ultra-sensitive or Purple Data<\/h3>\n\n\n\n<p>Ultra-sensitive data includes data where unauthorized disclosure or loss poses the highest risk or impact to the human subjects, university, or its affiliates or where specific data categories require special privileged access management. Examples include data where unauthorized disclosure or loss poses the highest risk or impact to the human subjects, university, or its affiliates or where specific data categories require special privileged access management.&nbsp; Examples include social security numbers, passwords, encryption keys, and biometrics (such as fingerprints and iris scans), admitted behavior that could be considered a felony. Other examples of qualitative data that should be treated as \u201cpurple\u201d data include data that will likely lead to arrest, detention, incarceration, deportation, physical injury, or death of both primary and third party participants. Additional access and handling requirements are required for Ultra-sensitive data because it may be impossible to repair damage caused by its unauthorized disclosure.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Highly Sensitive or Red Data<\/h3>\n\n\n\n<p>Highly sensitive data includes data where unauthorized disclosure or loss poses a high risk or impact to the university, or its affiliates. Examples include data where unauthorized disclosure or loss poses a high risk or impact to the university, or its affiliates. Examples include driver\u2019s license, mother\u2019s maiden name, passport, and immigration number, admitted unlawful behavior that is not considered purple. Other examples of qualitative data that should be treated as \u201cred\u201d data include information that could lead to persecution, harassment or retaliation, information that may or likely will irreparably harm relationships, information that will likely lead to stigmatization where physical or psychological harm may occur as a result of both primary and third party participants, or any data where unauthorized disclosure or loss poses a high risk or impact to all human subjects.&nbsp;<\/p>\n\n\n\n<p>Should a researcher need a data and access security plan (DASP), the researcher will be informed of this during the IRB review\/approval process and directed to complete a \u201cData Access and Security\u201d plan request form via the NC State University \u201c<a href=\"https:\/\/ncsu.service-now.com\/sp\">Service Now<\/a>\u201d portal. Once the request form is submitted, a representative from NC State Security and Compliance will reach out to the researchers to initiate next steps. No \u201cred\u201d or \u201cpurple\u201d data can be generated or accessed until this plan is finalized and a part of the approved IRB protocol. This plan must be congruent with any associated contract or agreement.\u00a0<\/p>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"l8uxs2\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\"><strong>I was asked to release data for an IRB approved study. Can I release it? How do I know what to release?<\/strong><\/h2>\n      <\/summary>\n      <p>\n        \n\n<p>The IRB office does not have jurisdiction over records release permission. They are two different and separate permission processes. Just because a study has IRB approval does not mean that a data steward or their delegate must grant a researcher&#8217;s records release request. The data steward or their delegate can still say \u201cno\u201d to the researcher. Please review the <a data-type=\"link\" data-id=\"https:\/\/docs.google.com\/document\/d\/1lyjsVyn19ugHCcowxVY_kSJUhjf98W-9\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" href=\"https:\/\/docs.google.com\/document\/d\/1lyjsVyn19ugHCcowxVY_kSJUhjf98W-9\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">NC State IRB guidance for data stewards and delegates<\/a>.&nbsp;<\/p>\n\n\n\n<p>A data steward for FERPA records at NC State determines if the records can be released. Things the data steward should consider:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Whether consent was\/will be obtained from research participants to access FERPA records<\/li>\n\n\n\n<li>If the project meets the FERPA exception if permission <\/li>\n\n\n\n<li>If the unit\/department has the bandwidth to provide the data and if so, what level of involvement that will be.&nbsp;<\/li>\n\n\n\n<li>What the process is for releasing the data.&nbsp;<\/li>\n\n\n\n<li>If no direct FERPA permission is sought from individuals, consider the reason the request is submitted and if it is, or is not, in line with the unit\u2019s role, goals, priorities etc.<\/li>\n\n\n\n<li>The Data Steward should ask the researcher for their IRB approval information including the approved protocol and consent form where applicable.&nbsp;<\/li>\n<\/ul>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"l8uxs2\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\"><strong>What are the rules about research incentives and compensation?\u00a0<\/strong><\/h2>\n      <\/summary>\n      <p>\n        \n\n<p>The IRB thinks about incentives and compensation in one of three ways:&nbsp;<\/p>\n\n\n\n<p>\u201cIs the compensation\/incentive unduly influencing or coercive?\u201d<\/p>\n\n\n\n<p>\u201cIs the compensation\/incentive fair across participant groups in a study\u201d&nbsp;<\/p>\n\n\n\n<p>\u201cWhat information is needed from participants in order to disperse compensation and does that information increase risks to participants?\u201d&nbsp;&nbsp;<\/p>\n\n\n\n<p>If the IRB has determined that the information collected from participants to disperse the incentives or compensation increases risk to participants, then the IRB will require a participant protection that limits the information collection and sharing. Should this be the case, and researchers not be able to provide the research office with direct IDs of participants, the IRB will provide the researchers with a letter indicating this limitation.&nbsp;<\/p>\n\n\n\n<p>The IRB expects that in the IRB protocol, the researcher describes the information needed to disperse compensation and to detail the information that their department needs for compensation\/incentive disbursement. This allows the IRB to properly assess privacy and confidentiality risks.&nbsp;&nbsp;<\/p>\n\n\n\n<p>To assist researchers in designing their research with compensation incentives in mind, the NC State IRB office has created the following guidance<a href=\"https:\/\/docs.google.com\/document\/d\/1cC-u1Cy_zvqbNTHXqcCgtP37Ms-tgZs91mk3LwP585s\/edit?usp=sharing\" target=\"_blank\" rel=\"noreferrer noopener\"> incentives and compensation for research participants<\/a>.<\/p>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"l8uxs2\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\"><strong>A researcher needs a data use\/sharing agreement (DUA) to access data for research. What do I tell them?\u00a0<\/strong><\/h2>\n      <\/summary>\n      <p>\n        \n\n<p>Many researchers at NC State University want to access data generated elsewhere (also called \u201c<a href=\"https:\/\/docs.google.com\/document\/d\/1ytvLEFsIgAcZhLtvnFcNNAUyJ72IlJwP\/edit#heading=h.opku75vve966\">secondary data<\/a>\u201d) to use for their own analysis and research projects. In many cases, these datasets are private and sometimes a data use agreement (DUA) is required before the data can be released to NC State University researchers. A DUA details what the data is composed of and how it can or cannot be access and used, among other topics, and are handled by college research offices, not the IRB office. Please review the NC State University <a href=\"https:\/\/research.ncsu.edu\/administration\/data-use-agreements\/\">Research Administration and Compliance \u201cData Use Agreements\u201d Guidance<\/a>.&nbsp;<\/p>\n\n\n\n<p>The NC State IRB will need to know the terms of the Data Use Agreement (DUA) so we can review and confirm that the submitted IRB protocol matches what is expected in the DUA. PIs should upload the executed DUA with their IRB application. The DUA process and the IRB process can happen at the same time. However, until the executed DUA is a part of the approved IRB protocol, no access to the data can occur.&nbsp;<\/p>\n\n\n      <\/p>\n  <\/details>\n\n\n    <\/div>\n  <\/div>\n","protected":false},"excerpt":{"rendered":"<p>Scope of Roles as Related to the Research with Human Subjects and the IRB To assist NC State researchers in understanding their responsibilities when completing research with human subjects, the&hellip;<\/p>\n","protected":false},"author":16,"featured_media":0,"parent":338,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"source":"","ncst_custom_author":"","ncst_show_custom_author":false,"ncst_dynamicHeaderBlockName":"ncst\/default-header","ncst_dynamicHeaderData":"{\"pageIntro\":\"Due to the multiple roles that administrators play at NC State when assisting researchers with their research endeavors, the NC State University IRB office has compiled relevant information and resources applicable to staff in various supporting roles. Below you will find information about topics that commonly intersect with people in administrative roles who support research efforts.\u00a0\"}","ncst_content_audit_freq":"","ncst_content_audit_date":"","ncst_content_audit_display":false,"ncst_backToTopFlag":"","footnotes":""},"tags":[],"class_list":["post-13925","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Administrators Supporting Research - Research Administration and Compliance<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/administrators-supporting-research\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Administrators Supporting Research - 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