Research Utilizing Human Subjects

I.  Policy Statement and Purpose

This policy summarizes the framework for UNC Charlotte’s compliance and oversight of Research involving Human Subjects in accordance with regulations and accepted ethical and professional standards.   

The purpose of this policy is to describe requirements related to Human Subjects Research and IRB review. All Human Subjects Research requires review by the Institutional Review Board (IRB) or review as delegated by the IRB, prior to commencing.

II.  Definitions

As used within this Policy, the following terms have the meanings provided below.

Research:  A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research 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. (45 CFR 46.102d)

UNC Charlotte applies the following definition to research activities initially approved, waived, or determined to be exempt before January 21, 2019.

Human Subject (Pre-2018 Rule): 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.

UNC Charlotte applies the following definition to research activities initially approved, waived, or determined to be exempt on or after January 21, 2019. This definition also applies to any study initially approved under the Pre-2018 Rule and transitioned to the 2018 Rule.

Human Subject (2018 Rule):  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. (45 CFR 46.102f(e)(1))

Identifiable Biospecimen: A biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

Identifiable Private Information: Private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

Institutional Review Board: An institutional review board established in accordance with, and for the purposes expressed in, 45 CFR 46. The IRB is charged to ensure that Human Subjects Research is conducted in compliance with applicable regulations, University policy, and ethical and professional standards regarding research with Human Subjects, and the IRB has the authority to approve, require modifications in, or disapprove any research involving Human Subjects conducted under University auspices.

Interaction: Includes communication or interpersonal contact between investigator and subject.

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.

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). 

III.  Applicability

This Policy applies to all UNC Charlotte faculty, staff, students, and employees conducting Human Subjects Research, in which the University is engaged.  

IV.  Procedures

Implementation procedures are described in the Guidelines for Research Utilizing Human Subjects, which is updated periodically by the Office of Research Compliance.

A. Institutional Review Board

Human Subjects Research shall not commence before IRB review and approval.  The IRB is charged with monitoring the ethical propriety of such research. The IRB is charged with ensuring that all such Research is conducted in compliance with applicable regulations, University policy, and ethical and professional standards regarding research with Human Subjects. The IRB has the authority to approve, require modifications in, or disapprove any research involving Human Subjects covered by this policy.

The Vice Chancellor for Research appoints the members of the IRB in accordance with federal regulations governing the composition of Institutional Review Boards for Research utilizing Human Subjects. The IRB consists of at least five members, with varying experience and expertise as well as diversity of race, gender, cultural backgrounds, and sensitivity to such issues as community attitudes to promote complete and adequate review of research activities commonly conducted at UNC Charlotte. The IRB includes at least one member whose primary concerns are in scientific areas and one member whose primary concerns are in nonscientific areas, as well as at least one member who is not otherwise affiliated with UNC Charlotte (nor part of the immediate family of a person affiliated with UNC Charlotte).

Members of the IRB shall be appointed for staggered terms of three years. Members may be reappointed for additional terms.  No member of the IRB may participate in the IRB review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.

B. Student Research and Faculty Responsibility

Research investigations conducted by students, such as thesis and dissertation research and many independent research projects, require the approval of the IRB prior to execution. It is the responsibility of all investigators supervising such research to ensure that approval of the IRB is obtained. Small research projects conducted primarily for instructional purposes within the context of a formal class, and not designed to contribute to generalizable knowledge, may not require review by the IRB, provided the instructor is prepared to accept professional and ethical responsibility for all research projects conducted in conjunction with the class. Under these conditions, it is the instructor's responsibility to monitor the ethical propriety of these projects, applying the criteria listed in Section D. However, if the instructor is not prepared to ensure ethical propriety, or if the instructor has reservations concerning a particular project, review by the IRB is required.

C. Exemptions

Certain categories of research may be determined to be exempt from Expedited or Full Board IRB review. The IRB is authorized to determine, consistent with applicable law and regulation, those categories of research proposals that may be subject to an Exempt determination or Limited Review by the IRB. 

D. Criteria for IRB Approval

The IRB reviews proposals for Research in accordance with federal regulations governing research with Human Subjects and must determine that all of the following criteria are satisfied: .  

• Risks to subjects are minimized and are reasonable in relation to anticipated benefits of the Research;
• Selection of subjects is equitable given the purposes and the setting of the Research;
• Appropriate informed consent will be sought from each subject or the subject's legally authorized representative, and such consent will be appropriately documented unless waived by the IRB;
• The Research plan makes appropriate provision for monitoring the data collected to insure the safety of subjects;
• Appropriate provisions are made to protect the privacy of subjects and to maintain the confidentiality of data;
• When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects. ; and
• All investigators named in the protocol, including students, must have completed approved training on the use of Human Subjects in Research.

E. Investigator’s Right of Appeal from Initial IRB Decision

It is the policy of The University of North Carolina at Charlotte that the final decision regarding approval or disapproval of all Research proposals subject to the IRB review rests with the IRB. Any investigator who disagrees with an IRB decision may request a hearing of appeal at any duly convened meeting of the IRB, during which relevant evidence and arguments may be presented on behalf of the investigator. The investigator may also request that the Provost be informed of the appeal. However, final decision rests with the IRB.

F. Procedures for Review of Research

Consistent with applicable law, regulation, and policy, the IRB shall establish procedures for reviewing and approving Research proposals, making Exemption determinations, and for continuing periodic review, when applicable, of Research proposals initially approved. It is the University investigator's responsibility to comply with procedures established by the IRB and to keep the IRB informed of any proposed changes in the Research that may affect risk to Human Subjects.

G.  Committee Records

Documentation of IRB activities is maintained by the Office of Research Compliance for at least three years following the completion of Research and includes, but not limited to, the following:

• Copies of all Research proposals reviewed, approved consent documents, etc.;
• Documentation of actions taken through procedures of Exemption determination, Limited Review, Expedited review, and Full Board review;
• Minutes of meetings in sufficient detail to show attendance; actions taken; vote on these actions for, against, and abstaining; basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution;
• Records of continuing review activities if applicable to a study;
• A list of IRB members as well as a copy of each member's professional vita; and
• Written operating procedures for the IRB.

V.  Roles and Responsibilities

The Vice Chancellor for Research is responsible for overseeing the implementation of this policy and delegation of responsibilities. It shall be the responsibility of the Office of Research Compliance to provide administrative support for the IRB and to keep it advised of current regulations governing Research with Human Subjects.