What NC State Researchers Need to Know

Studies approved by the IRB before January 21, 2019 are reviewed and approved by the IRB using the Common Rule. Studies approved by the IRB on or after January 21, 2019 are reviewed and approved by the IRB using the Final Rule. Changes to the IRB regulations make the IRB approval process easier for facilitating ethical and compliant research. Major changes are noted on this site.


Where can I learn more about the Final Rule and what it means for NC State and my research?


Final Rule Updates (also called 2018 Requirements/Regulations)

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research:

  • Scholarly and journalistic activities (g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
  • Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
  • Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
  • Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research:

  • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
  • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens

Intervention includes both physical procedures by which information or biospecimens are gathered (e.g.,venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes 

Interaction includes communication or interpersonal contact between investigator and subject 

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g.,a medical record)

Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information

An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests

Written, or in writing, for purposes of this part, refers to writing on a tangible medium (e.g., paper) or in an electronic format

Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes

Changes in categories and new categories:

  • Exemption Category d(1): Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods
    • Children can be involved in studies under this exemption
  • Exemption Category d(2): Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
    • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
    • Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
    • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review
    • Children can be involved in studies under this exemption if the research only involves educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed
  • Exemption Category d(3): Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
    • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
    • Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
    • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review

For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing

If the research involves deceiving the subjects regarding the nature or purpose(s) of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purpose(s) of the research.  Keep in mind that this is referring specifically to studies involving deception that are being (or trying to be) classified as exempt, not all studies involving deception.

  • Exemption Category d(4): Secondary research for which consent is not required. Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
    • The identifiable private information or identifiable biospecimens are publicly available
    • Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects
    • The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164 (HIPAA)
    • Data about children can be included in studies under this exemption
  • Exemption Category d(6): Taste and food quality evaluation and consumer acceptance studies:
    • If wholesome foods without additives are consumed, or
    • If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture
    • Children can be involved in studies under this exemption
  • Exemption Category d(7): If you would like to store or maintain secondary data including identifiable private information or identifiable biospecimens for potential secondary research the following must occur:
    • Broad Consent (from each participant) to house and use the data in this manner is required. This includes a tracking mechanism for individual Broad Consent
    • The IRB must conduct a Limited Review
    • Data about children can be included in studies under this exemption
    • Please see NC State IRB policy and application regarding Repositories
  • Exemption Category d(8): For secondary research where broad consent is required. If you would like to use existing identifiable private information for research purposes AND you want your project to qualify for Exemption the following must occur:
    • You must provide the IRB with information regarding how the data were originally collected/generated AND the Informed Consent/Broad Consent that was obtained at the time of collection/generation
    • You must provide information regarding if the Informed Consent for the original collection/generation was signed or if a consent signature was waived by an IRB.
    • You must agree not to return individual results to participants
    • The IRB must conduct a Limited IRB Review
    • Data about children can be included in studies under this exemption

Expedited review is a type of review that is carried out by an IRB staff member and an IRB Full Board member. This type of review is instead of a Full Board review or an administrative review that leads to exemption. In order for a study to undergo Expedited Review, the study must be no more than minimal risk to participants and involve only procedures listed in the following categories. Studies approved under Expedited Review, are subject to the regulations of 45 CFR 46. These studies do not undergo Annual Renewal unless specified by the IRB Office or Full Board.

Category 1: Clinical studies of drugs and medical devices only when condition (1) or (2) is met.

  1. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
  2. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

  • from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
  • from other adults and children [2], considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

Category 3: Prospective collection of biological specimens for research purposes by noninvasive means. Examples: hair and nail clippings in a nondisfiguring manner; deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; permanent teeth if routine patient care indicates a need for extraction; excreta and external secretions (including sweat); uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; placenta removed at delivery; amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; sputum collected after saline mist nebulization.


Category 4: Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
Examples: physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject=s privacy; weighing or testing sensory acuity; magnetic resonance imaging; electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

Note: eye trackers, body scanning, kinects, eeg caps, etc fall under this category for review


Category 5: Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). This category will require either getting Informed Consent or requesting a Waiver/Alteration of Informed Consent.


Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes.


Category 7: Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.


Category 8: Continuing review of research previously approved by the convened IRB as follows: where (

  • the research is permanently closed to the enrollment of new subjects and all subjects have completed all research-related interventions and the research remains active only for long-term follow-up of subjects; or
  • where no subjects have been enrolled and no additional risks have been identified; or
  • where the remaining research activities are limited to data analysis.

Only studies reviewed and approved by the convened IRB Full Board and some studies reviewed via expedited procedures, will undergo Annual Review.


Category 9: Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

This can be used for studies that:

  • initially require review by a convened Full Board and
  • are minimal risk and
  • do not initially fit into an Expedited Review category.

When a minimal risk study is reviewed by the IRB Full Board, the convened Full Board will determine if that study is eligible for Expedited Review thereafter. This includes amendments that do not change the risk profile of the approved study.

Pregnant Women, Human Fetuses and Neonates Involved in Research: Each of the exemptions may be applied to research with pregnant women, human fetuses and neonates if the conditions of the exemption are met

  • Research Involving Prisoners as Subjects: The exemptions at this section do not apply to research subject to subpart C, except for research aimed at involving a broader subject population that only incidentally includes prisoners
  • Research involving Children: The exemptions at paragraphs (d)(1), (d)(4), (d)(5), (d)(6), (d)(7), and (d)(8) of this section may be applied to research with children if the conditions of the exemption are met
    • (d)(2) only may apply to research with children involving educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed

Limited Review is a new level of IRB review. This review is for determining certain types of studies to be Exempt. Limited IRB review specifically looks at the adequacy of the protections for the privacy of participants confidentiality and the use of Broad Consent. This is completed by a Full Board member. This review entails the board member reviewing and approving the following:

  • Ensuring that broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained;
  • Ensuring that broad consent is appropriately documented or waiver of documentation is appropriate; and
  • Ensuring that if there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data

All levels of review are noted here:

  • Administrative Review: This review is pre-reviewed and completed by IRB office staff or IRB Full Board members (though usually office staff). This review is used for Exemption categories d.1 – d.6. Amendments must be submitted for any changes. Notifications of unanticipated problems, adverse events, participant complaints, and non-compliance must be shared with the IRB.
  • Limited IRB Review: This review is pre-reviewed by IRB staff and completed by IRB Full Board members. This review is used for Exemption categories d.7 – d.8. These studies do not undergo Annual Renewal. Amendments must be submitted for any changes. Notifications of unanticipated problems, adverse events, participant complaints, and non-compliance must be shared with the IRB.
  • Expedited Review: This review is pre-reviewed by IRB staff and completed by IRB FUll Board members. All studies reviewed at this level are subject to all of the regulations in 45 CFR 46. These studies DO NOT undergo Annual Renewal unless determined otherwise. Amendments must be submitted for any changes. Notifications of unanticipated problems, adverse events, participant complaints, and non-compliance must be shared with the IRB.
  • Full Board Review: This review is pre-reviewed by IRB staff and completed by the IRB Convened Full Board. All studies reviewed at this level are subject to all of the regulations in 45 CFR 46. These studies undergo Annual Renewal. Amendments must be submitted for any changes. Notifications of unanticipated problems, adverse events, participant complaints, and non-compliance must be shared with the IRB.

All research records should be kept by the PI for a minimum of 3 years after study completion. If you have questions or  unsure about what is considered a “research record” please reach out to ncsuirboffice@ncsu.edu.

Approval for studies reviewed and approved via expedited procedures no longer need to undergo Annual Review unless specified by the IRB. This means study approval for studies approved after 1/21/19 no longer expire.

All human subject data repositories (information or bio-specimens) must undergo IRB review and approval.

Cooperative research projects are those projects covered by this policy that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy:

  1. Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States.
  2. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research.
  3. The following research is not subject to this provision:
    1. Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or
    2. Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.
  4. For research not subject to bullet points 1,2, and 3 of this section, an institution participating in a cooperative project may enter into a joint review arrangement, rely on the review of another IRB, or make similar arrangements for avoiding duplication of effort.

Definition: a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

Obligation to post Informed Consent: For each clinical trial conducted or supported (funded) by a Federal department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available Federal Website that will be established as a repository for such informed consent forms. For example clinicaltrials.gov