Guidelines for Research Utilizing Human Subjects

 

All research, including non-Federally funded human subjects research will be reviewed and approved in accordance with Federal Regulations and UNC Charlotte Policy #306. 

Important:  Revisions to the humans subjects protection regulations, 45 CFR 46, were issued in January 2017 and are effective as of January 21, 2019.  The revised regulations (i.e., 2018 Rule or Final Rule) apply to studies submitted on and after January 21, 2019.  The current regulations (i.e., Pre-2018 Rule or Original Rule) remain in effect for all existing studies reviewed and approved by the IRB prior to January 21, 2019.  The following definitions are the definitions under the 2018 Requirements.

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.

Excluded from the definition of Research are:

  • Most scholarly and journalistic activities that focus directly on the specific individuals about whom the information is collected (e.g. oral history, journalism, biography, literary criticism, legal research, and historical scholarship).
  • 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: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) 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 subjects 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 reasonable 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 reasonable 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.

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.

 

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.

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),
  • Exempt determination requiring Limited 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. Exempt studies requiring Limited Review are reviewed based on the Expedited review procedures. Expedited review is completed by at least one member of the IRB Committee. Studies requiring Full IRB review are reviewed at a scheduled IRB Committee meeting. 

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 Limited, 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 determination 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;
  • 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, unless the subject is told in advance that deception will used.
 
CATEGORIES OF RESEARCH ACTIVITIES ELIGIBLE FOR EXEMPTION CERTIFICATION ARE AS FOLLOWS:
 

Category #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.

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.  

Further, this category is only applicable when the research does not adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction.  A study that requires that students miss instructional time may not be eligible 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).

 

Category #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:  

(i) 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; 

(ii) 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

(iii) 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 to make the determination that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data.

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.  Further, (iii) is not applicable for research that involves children.

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. 

This Exemption category does not include the collection of biospecimens.  Therefore for example, a study that includes, collecting a cheek swab in addition to collecting survey or interview responses is not eligible for this Exemption category.

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 may be eligible for Exemption determination with Limited Review by the IRB.  

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.
 

Category #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:

(a)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; (b) 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

(c) 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 to make the determination that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data.   

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. Provided all such criteria are met. 

Examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

Interventions may be distinct from the data collection method. 

Examples: study comparing test performance of test takers in quiet or noisy surroundings. OR cognitive tests and audiovisual recording is used to collect the data without any educational test, survey or interview procedure occurring.

UNC Charlotte Interpretation of Category 3:

This exemption category is limited to behavioral interventions and does not include physiological data collection such as EEG, wearable devices, blood pressure monitors, or other medical interventions (medical tests, procedures, devices). Therefore, studies including the collection of blood pressure measurements would not be eligible for this Exemption category.

The intervention may be distinct from the data collection method. For example, subjects could be asked to perform cognitive tests and video recording could be used to collect data.

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. 

This category does not apply to research involving children.

 

Category #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:

(i) The identifiable private information or identifiable biospecimens are publicly available;

(ii) 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;

(iii) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under HIPAA [Health Insurance Portability and Accountability Act - 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b)]; or

(iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

UNC Charlotte Interpretation of Category 4:

Secondary research refers to re-using identifiable information and identifiable biospecimens that are collected for some other “primary” or “initial” activity.  This Exemption category applies to information or biospecimens 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.

The use of health information that is private identifiable information (i.e., Protected Health Information from a medical record) may be eligible under this Exemption category when the use is regulated under the HIPAA Privacy Rule.  In other words, if medical records will be used the requirements under HIPAA that include where appropriate, the requirement to obtain a subject’s authorization for future, secondary research use of protected health information or a waiver of authorization is allowed.  Importantly, UNC Charlotte is NOT a HIPAA Covered Entity (CE).  Use of this category of exemption for identifiable health information may require documentation that HIPAA Authorization to release this information was obtained or will be obtained from participants or documentation from the Covered Entity’s Privacy Officer that a waiver of authorization was granted by the Covered Entity.

 

Category #5:  Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal website or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.

 

Category #6:  Taste and food quality evaluation and consumer acceptance studies:

(i) If wholesome foods without additives are consumed, or

(ii) 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.

 

Category #7:  Storage or maintenance for secondary research for which broad consent is required.

 

Category #8:  Secondary research for which broad consent is required.

UNC Charlotte Interpretation of Category 7 and Category 8:

UNC Charlotte will not implement the Exemption #7 or #8 at this time.  These Exemption categories require Broad Consent which in turn requires,

a) that the Broad Consent identify the types of research that may be conducted,

b) researchers and institutions to record and track which participants have provided broad consent and which participants have refused broad consent, and

c) the tracking of the terms of broad consent in order to allow for a determination regarding if the research is within in the scope of the broad consent. 

Therefore, UNC Charlotte has determined that it is not feasible to meet these additional requirements at this time.  The Office of Research Compliance and the IRB may reevaluate this decision at such time that the Office of Human Research Protections provides guidance on the use of these categories and broad consent.  

Investigators may continue to conduct secondary research using identifiable private information or identifiable biospecimens under:

  • Obtaining IRB approval (non-Exempt review) with study specific consent
  • Obtaining IRB approval (non-Exempt) with a waiver of consent
  • Obtaining an Exempt Category #4 determination
  • Obtaining de-identified data such that the study may result in a non-human subjects determination.   

In summary, if the research is determined to meet one or more of the Exemption categories not requiring Limited Review, a Determination of Exemption certificate will be issued and the Investigator may begin the research.

Exempt studies requiring Limited Review are reviewed based on the Expedited review procedures. Expedited review is completed by at least one member of the IRB Committee. Studies requiring Full IRB review are reviewed at a scheduled IRB Committee meeting.

Studies that are not eligible for Exemption determination will be submitted for Expedited review or Full board review.  In reviewing research by Limited Review or Expedited review, the reviewer(s) 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 Full board review procedures.

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.