Human Research Program: NCCU Investigator Guidelines

Before submitting an institutional review board (IRB) application, first determine if IRB review is required (NCCU IRB Manual) for your project. Review the definition of human research and the guidance below to assist in this determination. In accordance with the Revised Common Rule, IRB review and approval is required for projects that include all of the following:

1. Meet the definition of research;
2. Involve human participants; and
3. Include any interaction or intervention with living human participants or involve access to identifiable private information, including identifiable biospecimens of living individuals.

Note: IRB review and approval are also required for the following studies:

• Research that uses protected health information (PHI) or identifiable biospecimens of deceased individuals.
• Research (i.e., genetic studies) that uses deceased individuals private or medical information to link to identifiable living individuals.

HIPAA’s privacy rule applies to all research involving deceased individuals.

This category applies to research activity considered to be less than minimal risk, and the involvement of human subjects is limited to the categories outlined in 45 CFR 46.101(b). Exempt-level reviews are conducted by the IRB chair. Limited IRB review checks to ensure confidentiality and privacy.

This category applies to research activity involving no more than minimal risk and for minor changes in approved research. The probability and magnitude of harm or discomfort anticipated in the research are not greater than those encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Expedited review involving children is described to be no greater than minimal risk, only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardian are granted. Categories of research that may be reviewed under expedited review 46.110 and 45 CFR 46.404 procedures are the following: Expedited Review Categories. 45 CFR expedited-level reviews are conducted by one or more experienced reviewers designated by the IRB chair from among the members of the IRB.

This category applies to research activity not eligible for exempt or expedited review involving more than minimal risk and/or involving elements, procedures or interventions that require additional provisions or safeguards, as stated by federal regulations and guidance (i.e., protected populations, pregnant women, fetuses, or prisoners). Full Board applications are reviewed by a quorum of members at a convened meeting on the third Friday of the month.

Is the research involving human subjects eligible for exemption under 45 CFR 46.104(d)?

The following graphic charts are intended to aid those who need to decide if an activity is research involving human subjects that must be reviewed by an institutional review board (IRB) and whether informed consent or the documentation of informed consent can be waived under the 2018 Requirements found for the U.S. Department of Health and Human Services (HHS) at 45 CFR part 46, Subpart A.

View All Charts

Before beginning any activity, an NCCU IRB must examine and approve it to determine if it fits any of the criteria for research involving human subjects if conducted at NCCU or under its authority. The University acknowledges that certain student projects conducted to complete their course requirements contain multiple tasks under various circumstances involving human subjects. The university's policy insists that it does not need IRB review for research initiatives in the classroom that aim to educate students on research techniques, with the following exceptions: doctoral dissertations; funded research; research conducted through collaborations outside of NCCU; master's theses, and honors theses. Each of these must be examined and accepted by the IRB before students begin their research.

For classroom assignments involving human subject research that do not require IRB review, faculty and departments are responsible for overseeing the activities. They must ensure students receive proper training and design research projects with appropriate safeguards to maintain ethical standards.

Yes, you will need to complete the following, depending on your role at the university:

Faculty Training

Collaborative Institutional Training Initiative (CITI) Training Certificates:

• Human Research Protections: Social and Behavioral Research or Biomedical Research Modules (refresher required every 2 years)
• Financial Conflicts of Interest

Graduate Student Training

CITI Training Certificates Required:

• Human Research Protections: Graduate Student Module (refresher required every 2 years)
• Financial Conflicts of Interest

Undergraduate Training

CITI Training Certificates Required:

• Undergraduate Student IRB Student Course
• Conflict of Interest Form

Please submit the following:

• Cover sheet

• Form A

• Research protocol, including questionnaires, internet surveys, instructional tools, scripts for phone interviews, etc.

• Informed consent document (required). If applicable, include assent forms, information sheets, and verbal consent scripts.

• Recruitment materials, including final copies of printed advertisements, audio/video taped advertisements, scripts, flyers, letters, and email.

• Investigational drug data, if applicable. Include the investigator’s brochure and/or package insert for previously approved uses of the drug.

• Letters of support or additional approvals from relevant “gatekeepers” (e.g., school principals, facility directors), if applicable.

• Thesis plan, chapters 1 and 2 (NCCU graduate students only)

• CV of the principal investigator

• Conflict of interest certification

• Documentation of training in research with human subjects for all personnel who will directly interact with research participants. Reminder: CITI training must be completed as a NCCU affiliate within the past 2 years.

• Submit applications to the NCCU IRB mailbox at [email protected] 

NCCU IRB Manual 

Links and Videos:

• Frequently Asked Questions: Investigators
• OHRP: What Is Human Subjects Research?
• HRPP Resources
• Cayuse Information

Belmont Report

• The Belmont Report summarizes ethical principles and guidelines for human subject research.
• Human Research Powerpoint

Download the IRB Manual

An "NHR" determination is research involving no communication or involvement with living people, and neither the source nor the recipient of the data or biospecimens can connect them to any specific living or deceased person.

Resource: What Is an NHR in Human Subjects Research?

An institutional review board (IRB) is authorized to validate that specific grants, agreements, or contracts have been granted with a component of human subject research, although the plans for the inclusion of human subjects are still undetermined.

This certificate is only applicable when there is insufficient research data or information, such as when an indefinite element that is essential to the IRB review process has not yet been developed.

At NCCU, reliance agreements are formal documents that allow one institution to cede IRB review to another institution for human subjects research. This is often used when a project involves multiple institutions or when researchers are not affiliated with NCCU but need to conduct research there. ​​​​​​​

• Site Authorization: This agreement is for any external organization that wants to conduct research on the NCCU campus, and their home institution approved their protocol under Exempt Review. 
• IRB Authorization Agreements: An IRB Authorization Agreement (IAA) is a special agreement between two institutions that are engaged in human subjects research to establish a single IRB review. An IAA allows an institution with a Federalwide Assurance (FWA) to extend the applicability of its FWA to cover another institution. In practice, this means an institution’s IRB will be the IRB of Record that reviews the study. These agreements help to minimize the regulatory burden on the IRB review and approval process by limiting the IRB review to one institution. IAAs are sometimes referred to as IRB of Records. When signing the IAA, one institution is designated the lead IRB or single IRB of Record. This specific agreement will be executed following the Expedited and Full Board Review Guidelines. 
• Smart IRB: The SMART IRB master reliance agreement was created to harmonize and streamline the IRB review process for multisite studies. It enables reliance on a study-by-study basis, clearly defines roles and responsibilities of relying on institutions and reviewing IRBs and eliminates the need to sign reliance agreements for each study. NCCU uses the SMART IRB agreement as the basis for all single IRB studies (SMART IRB).
  • NIH policy regarding use of single IRB (sIRB): Effective January 25, 2018, the NIH requires the use of a single IRB [sIRB] for the review of NIH-funded multisite studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. This policy applies to domestic sites only. Under the policy, “multi-site” is defined as two or more sites. For more information, visit the related resources on the NIH website.

IRB approval is for a period of one year. If the research activities extend longer than one year, it is necessary to renew IRB approval. To request a renewal of a previously approved protocol, complete and sign Form B and the Conflict-of-Interest Certification, found in Appendix A of this manual. 

All modifications to a previously approved protocol must be approved by the IRB prior to implementing the changes. To request a modification of a previously approved protocol, complete and sign Form B, found in Appendix A of the manual. Submit Form B electronically to [email protected].