Any research with human subjects at NC State must go through the NC State IRB. Unauthorized use of external IRBs is not permitted.
IRB Official Forms
- Unanticipated Problem or Adverse Event Reporting Form
- NC State IRB Authorization Agreement Request Form
- NC State Authorization Agreement – Another IRB Relies on the IRB at NC State: After completing the NCSU IRB Authorization Request form, complete the “NCSU Authorization Agreement – Another IRB relies on the IRB at NC State” if you want NC State to serve as the reviewing/approving IRB. This is where another IRB would rely on NC State to review and approve the research.
- NC State Authorization Agreement – NC State IRB Relies on Another IRB: After completing the NCSU IRB Authorization Request form, complete the “NCSU Authorization Agreement – NC State IRB Relies on Another IRB” if you want NC State to rely on the review and approval of another IRB.
- IRB Letter of Intent Form
Example Forms & Templates
- Consent Form Template for NC State Research — Adults: This is the informed consent template to be used for all NC State IRB-approved research with adults. This NC State IRB consent template is appropriate for in-person research and, with modifications to the template, for obtaining consent online, creating opt-out forms, and for research information sheets.
- Parental Permission and Minor Assent Templates: This document includes a Parental Permission Form and three Minor Assent Templates (for ages 7-10, 11-13, and 14-17 years old) to be used with all NC State IRB-approved research with minors. The Parental Permission and Minor Assent Templates are appropriate for in-person research and, with modifications to the templates, for obtaining consent online, creating opt-out forms, and for research information sheets.
Guidance for Application Preparation & Matters of Compliance
- FAQ for Differentiating Between Research and Evaluation
- Post-Award Data Management Checklist: Use this research data management checklist for completing the IRB application, especially if you plan to share your data.
- Information Regarding Class Projects
- Conflicts of Interest in Research
- Incentive Payments and Compensation
- FAQ for Faculty Points of Contact
- FAQ Researchers Enrolling in Their Own Research
- FAQ Risks and Benefits Information and Analysis
- Information about Non-Compliance: 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. Any unapproved departure from your approved IRB protocol or implementation of research with human subjects without appropriate IRB approval is non-compliance. Non-compliance 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 PARTICIPANTS, without IRB approval, is very serious and must be dealt with immediately.
- Things to Consider:
- About Data Security
- When Using Amazon’s Mechanical Turk (M-Turk)
- When Your Data Includes Third parties
- When Creating a Survey
- When Creating Focus Groups
- When Creating Interview Protocol
- When Implementing Photovoice
- When Using Photos and Video/Audio Recording
- When Implementing Food Quality Studies
Research Associated With The Department of Defense (DoD)
Are you performing research with human subjects that is funded by the Department of Defense (DoD) and/or uses any DoD resources or people (including ROTC)? If so, your research is considered supported by DoD and you are subject to additional requirements from the DoD regarding human subjects research (including Exempt, Expedited, and Full Board Approvals).
DoD entities include (but may not be limited to) these groups:
- Air Force
- Air Force Academy
- Coast Guard
- Coast Guard Academy
- Defense Advanced Research Projects Agency (DARPA)
- Defense Intelligence Agency
- Military Academy (West Point)
- Missile Defense Agency
- National Geospatial-Intelligence Agency
- National Guard
- National Security Agency
- National War College
- Naval Academy
- Office of Naval Research
- Pentagon Force Protection Agency
- Tricare Health System
- U.S. Army Corps of Engineers
- U.S. Naval Observatory
Additional Requirements for DoD supported research are noted in the guidance below. These requirements include specific content to be included in study documents and procedures, an additional review process with a Human Research Protection Officer (HRPO) outside of the NCSU IRB office, and possibly a Scientific Merit review. Please read through the guidance below in order to meet all of your additional requirements.
If your research is approved by the IRB under Expedited procedures or via the Full Board, your study will need to undergo a Scientific Merit Review. Scientific Merit review is an independent review and approval that assesses the scientific merit of a study. Please find information regarding the Scientific Merit Review below.
The NCSU IRB office has created a form that can be completed for Scientific Merit reviews. Not all HRPO officers will accept this and they may have their own process, but you can try and use it.
- Scientific Merit Review Form
- Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research
- Limitation on use of humans as experimental subjects
- Department of the Navy, Human research Protection Program
- DoD regulations for Human Subjects Research
Health Insurance Portability and Accountability Act (HIPAA)
- HIPAA Law
- HIPAA Privacy Rule and Its Impacts on Research
- NC State HIPAA SOP (coming soon)
- HIPAA Authorization
Research Associated with the Biomedical Engineering Department
UNC-Chapel Hill and NC State have a joint Biomedical Engineering Department that is supported by both universities. All human subjects research that is biomedical in nature and completed by faculty, staff, and students affiliated with this joint department will submit their IRB applications to UNC-Chapel Hill’s IRB.
Please see this Guidance for more detailed information.
Human Embryonic Stem Cell Research Guidance
The use of human stem cells in research provokes much debate in the United States. This debate centers around the ethical, legal and regulatory aspects and is primarily directed towards the use of Human Embryonic Stem Cells in research (hESC). The regulatory framework governing hESC research is promulgated by Presidential Executive Order, managed by the National Institute’s of Health and relies heavily on existing regulations governing research involving human subjects, substance management and biocontainment. NC State University will facilitate oversight of hESC research by staying abreast of the changing regulatory environment, assess best practices, network with local and regional subject matter experts, and advise the NC State leadership on needed support and actions associated with this important and promising research frontier.
A collection of resources designed to provide a better understanding of issues surrounding Human Embryonic Stem Cell use in research endeavors are available below.
Data Used as Secondary Research
Using data for secondary research means that you are wanting to use information or biospecimens – originally collected for nonresearch purposes – as data for your research project OR you are wanting to use information or biospecimens – originally collected for research purposes other than the project currently proposed – as data for your research project that you are now proposing. Data and materials do not have to exist as of the IRB application you are submitting. They just need to have been/or be collected or generated for purposes other than the research you are proposing (in other words, they would exist or be created regardless of your project taking place).
- How do you as a researcher have access to the data?
- Who gave you permission to access the data for research purposes?
- Is the data subject to HIPAA or FERPA? If so, please detail and address issues of consent as required by HIPAA and FERPA.
- What is the data comprised of and does it have identifiable information on it?
- What is the identifiable information connected to or directly on the data?
- Do you need to retain identifiers directly on the dataset or through the use of a master list? if so, please detail why these IDs or links to IDs need to be retained.
- If you are removing identifying information, when and how is this identifiable information removed and who is removing the information?
- Once identifying information is removed, will anyone on the research team be able to re-identify the data based on access, expertise, or technologies used?
- How is the data transferred to you?
- How are you storing the data?
- Will you be sharing the data with anyone or will anyone be sharing the data with you?
- If so, do you need a data use or material transfer agreement in place for this?
- How will you be disposing of the data?
- Who in your IT office will you be working with to create a data security plan?
- How will you be handling the Informed Consent process for the use of this data for research purposes? Options Include:
- Informed Consent
- Waiver/Alteration of Informed Consent: This means that you would like to request the waiver of the requirement to get informed consent from each individual in your study. In order to qualify for a waiver of consent for the data to be used for secondary research purposes, your research must meet ALL of the following criteria:
- No more than minimal risk to the subjects
- Could not practicably be carried out without the waiver
- The IRB must determined that the research could not practicably carried out without identifiers being associated with the data
- Will not adverse affect the rights and welfare of participants
- Whenever appropriate, the subjects will be debriefed
- Broad Consent: Only useable for secondary research when using identifiable private information or identifiable biospecimens. Broad Consent allows for future research without necessarily knowing what that research will be. This is an option, not a requirement.
Guidance and Education Regarding Secondary Use of Data