Guidelines for Research Utilizing Human Subjects

Does My Research Project Require IRB Review and Approval?
Student Research and Faculty Responsibility
The Review Process
Exempt Research Review Categories
Summary: Exemption Categories
Protocols Eligible for Expedited Review

Does My Research Project Require IRB Review and Approval?

All research, including non-Federally funded human subjects research will be reviewed and approved in accordance with federal regulations and UNC Charlotte policy. 

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.

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

(1) Data through intervention or interaction with the individual, or

(2) Identifiable private information.

Intervention includes both physical procedures by which data are gathered (for example, 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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

This requirement applies to ALL research projects regardless of the granting agency or the institution to which they are being submitted for funding, and includes those supported by University funds or those without funding.

Faculty members and staff members should consult the Office of Research Compliance early in the preparation of a grant proposal to receive guidance concerning the use of human subjects.

Students who are required to complete human subjects research as a research requirement for advanced degrees (e.g., thesis or dissertation projects) should contact the Office of Research Compliance in the planning stages of their projects to receive guidance concerning the use of human subjects and to determine the level of review as required by Federal regulations. See “Student Research and Faculty Responsibility” below for more information.

All researchers are responsible for compliance with applicable federal and state laws and with institutional policy.

The following guidance document is intended to provide descriptions of activities and associated determinations regarding the requirements to submit to the IRB for approval.

The IRB has the authority to approve, require modifications in, or disapprove any research involving human subjects conducted under UNC Charlotte's auspices.

Approvals cannot be granted retrospectively for any human research conducted without appropriate IRB review and approval.

Investigators will find additional information and guidance in the University Policy #306, "Research Utilizing Human Subjects."

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Student Research and Faculty Responsibility

Research investigations conducted by students, such as thesis or dissertation research require IRB approval before implementation.  Student class or course projects generally do NOT require IRB approval.   For additional information on how to determine if a student project might require IRB review and approval, go to Student Research Projects. If, after reviewing this information, you still have questions, please contact the Compliance Office at 704-687-1871.

Research projects conducted primarily for instructional purposes within the context of a formal class, and not designed to contribute to generalizable knowledge, do not require review by the IRB.  In these cases, the class or course instructor oversees all projects conducted in conjunction with the class and is responsible for the professional and ethical implementation of these projects.  If a student plans to use a class or course project to also fulfill thesis or dissertation requirements, IRB approval prior to implementing the project and collecting any human subjects data is needed. 

In some cases, instructors may still require that students submit for IRB approval as part of the educational process. E.g., as part of the learning experience in a research methods course.  However, IRB review of these class projects is not mandated by the human subjects protection regulations.

Before submitting an application for IRB review, students and Responsible Faculty are encouraged to review the Guidance: Examples of Activities that Do and Do Not Require UNC Charlotte IRB Review and Approval document.

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The Review Process

Under applicable federal regulations and/or University Policy, the Office of Research Compliance as delegated by the IRB determines which of the following classifications applies to a protocol (listed in order of level of IRB review):

  • Exemption determination (i.e., exempt from a higher level of review)
  • Expedited review by the Committee (i.e., review by one or more members), or
  • Full review by the full Committee at a convened meeting.

Studies meeting an Exempt category are reviewed for Exempt determination by Office of Research Compliance IRB staff. 

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Exempt Research Review Categories

Certain types of research protocols may be exempt from a higher level of IRB review. The Office of Research Compliance as delegated by the IRB is authorized to decide, consistent with applicable federal laws, University Policy guidelines , whether research protocols may be exempt from a higher level of IRB review or subject to Expedited or full review by the Committee.

 After submitting a protocol, if the project meets one or more of the categories for Exemption, an Exemption determintation certificate will be issued to the investigator(s) and the project may be started.

The following guidance document is intended to provide information about the Exempt categories and examples of activities that may meet an Exempt category.

NOTE: Exemption categories may not apply when the research activities include:

  • Prisoners, fetuses, pregnant women or human in-vitro fertilization;
  • The review of medical records if the information is recorded in such a way that subjects can be identified, directly or through identifiers linked to the subjects;
  • Survey or interview techniques which include minors as subjects;
  • Techniques which expose the subject to discomfort or harassment beyond levels encountered in daily life;
  • The deception of the subject

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Categories of research activities eligible for exemption certification are as follows::

Category #1:  Research conducted in established or commonly accepted educational settings, involving normal education practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods

UNC Charlotte Interpretation of category #1:

Established or commonly accepted educational settings include but are not limited to K‐12 schools and college classrooms.  They may also include after‐school programs, preschools, vocational schools, alternative educational programs, and other sites where educational activities occur.  This might also include non‐school settings, such as libraries, training centers or workplaces such as hospitals.  

Normal educational practices include established teaching methods, curriculum content and commonly accepted classroom management techniques that are planned and implemented by the classroom teacher.  These activities typically occur in a classroom or other educational setting. 

Examples include: 

  • Test development
  • Assessment of attitudes about learning or curriculum
  • Evaluation of classroom or school activities
  • Use of educational tools such as computers or smart phones   

Thus, a study that evaluates a novel instructional strategy or curriculum, or that randomly assigned students to different instructional strategies/curricula for comparison, may not be eligible for Exemption determination, since these are not normal educational practices.  Studies that involve surveys and interviews with minors that are outside of normal educational practices may also not qualify for Exemption determination.  

Lastly, studies wherein the Investigator will request a waiver of informed consent (e.g., waiver of parental informed consent) may not be eligible for Exemption.

Even when research meets an Exempt category, researchers using student educational records must meet the requirements of the Family Education Rights and Privacy Act (FERPA).

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Category #2: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (b) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

UNC Charlotte Interpretation of category #2:

Public behavior refers to behavior taking place in a publicly accessible location in which the subject does not have an expectation of privacy (e.g., a public plaza or park, a street, a building lobby, a government building).  If subjects have a reasonable expectation of privacy at the location where the researcher is conducting the observation, the project may not qualify for this Exempt category. 

Children: Research involving surveys or interviews with children or observation of public behavior when researchers interact with the children does not qualify for this Exemption category. 

Many survey/interview projects fall within this Exemption category.  Studies wherein the data are collected  anonymously, which means that no identifiers can be connected to the data, either directly or through a coding system are eligible for Exemption determination. 

Studies that involve interventions are not eligible for this Exemption category.  An “intervention” is a manipulation of the participant’s environment for research purposes.  For example, a study that randomly assigns students to complete an interview and the study intervention includes varying the gender of the interviewer to see whether interviewee responses change, is not eligible for this Exemption category. 

Studies that include linking additional personally identifiable data to collected data may not be eligible for Exemption.  For example, obtaining data from student educational records to link to study collected data. 

Studies involving collection of multiple pieces of information about a person, none of which are identifiable on their own, but may uniquely identify a person when brought together; in this case, the data would be identifiable and would not be considered anonymous.  However, a study such as this may still be eligible for Exemption determination if any disclosure of the data would NOT reasonably place the subject at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation.

Studies that involve the collection of identifiable information that if disclosed could put the subject at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation are not eligible for Exemption.  

Examples may include:

  • Collecting employee feedback about employer/supervisors wherein the employee’s responses are identifiable. 
  • Collecting identifiable information about health history, health diagnoses, medication usage, HIV status, etc...

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Category #3:  Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under (2) of this section, if: (a) the human subjects are elected or appointed public officials or candidates for public office; or (b) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Category #4:  Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

UNC Charlotte Interpretation of category 4:

Existing data means data that is in existence at the time of the protocol application submission.  This Exemption category applies to information that would generally be found in some type of records or repository.  This Exemption category is not applicable to studies that include primary data collection.

Publicly available includes archives in a public library, government or other institutional records where public access is provided upon request, or from a commercial entity if the information is provided to members of the public on request or if the only requirement for obtaining the information is paying a user fee, registering or signing in as a visitor.

Category #5:  Research and demonstration projects which are conducted by or subject to the approval of, department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (a) Public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.

Category #6:  Taste and food quality evaluation and consumer acceptance studies, (a) if wholesome foods without additives are consumed or (b) 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.

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Summary: Exemption Categories

In summary, if the research is determined to meet one or more of the Exemption categories an Exemption certificate will be issued and the Investigator you may begin the research.

If the project is not exempt from a higher level of review, the submission will be processed for either Expedited (limited) or Full board review.

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Protocols Eligible for Expedited Review

Federal regulations (45 CFR 46.110 and 21 CFR 56.110) permit an expedited review procedure for protocols that meet certain eligibility requirements. Under an expedited review procedure, the review may be carried out by the Chair of the IRB or by one or more experienced reviewers from among members of the Committee. In reviewing the research, the reviewers may exercise all of the authorities of the Committee except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedures described in the next section.

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