Research Utilizing Human Subjects

University Policy 306, Research Utilizing Human Subjects

Executive Summary: 

All UNC Charlotte research involving human subjects must be conducted in accordance with accepted ethical and professional standards. The University's Institutional Review Board for Research on Human Subjects (“IRB”) must review such research before its execution and must monitor the ethical propriety of such research. The IRB is charged to ensure that all such research is conducted in compliance with federal regulations regarding research with human subjects, and it has the authority to approve, require modifications in, or disapprove any research involving human subjects conducted under University auspices. Implementation procedures are described in the Guidelines for Research, which is updated periodically by the Office of Research Compliance.

I.  Statement of Policy

It is the policy of The University of North Carolina at Charlotte that all UNC Charlotte research involving human subjects must be conducted in accordance with accepted ethical and professional standards. All such research (unless it is specifically exempt from review as provided herein) must be reviewed and approved by the University's Institutional Review Board (IRB) for Research with Human Subjects prior to its execution. That committee has been charged with monitoring the ethical propriety of all research involving human subjects that is conducted under University auspices. It is further charged with insuring that all such research is conducted in compliance with federal regulations regarding research with human subjects. It is the policy of The University of North Carolina at Charlotte that Institutional Review Board (IRB) for Research with Human Subjects has the authority to approve, require modifications in, or disapprove any research involving human subjects conducted under UNC Charlotte auspices.

II.  Definition of Terms

As used in this Policy, the term "research" refers to any systematic investigation, including "demonstration" or "service" programs, designed to develop or contribute to generalizable knowledge (45 CFR 46.102d). The term "human subject" refers to any living individual about whom an investigator (whether professional or student) obtains (a) data through interaction with the individual or intervention with the individual's environment or (b) identifiable private information (45 CFR 46.102f).

III.  Student Research and Faculty Responsibility

Under these definitions, major research investigations conducted by students, such as thesis research and many independent research projects, clearly require the approval of the IRB prior to execution. It is the responsibility of all investigators supervising such research to insure 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 V. However, if the instructor is not prepared to insure ethical propriety, or if the instructor has reservations concerning a particular project, review by the IRB is required.

IV.  Research Exempt from IRB Review

Certain categories of research proposals may be exempt from review. The IRB is authorized to determine, consistent with applicable law and regulation, those categories of research proposals that may be subject to limited review or may be exempt from review by the IRB.

V.  Criteria for Approval of Research Not Exempt from Committee Review

The IRB reviews proposals for research in accordance with federal regulations governing research with human subjects. The IRB may also apply in its deliberations such codes of professional ethics as the IRB may deem appropriate. It is the policy of The University of North Carolina at Charlotte that in order for any research proposal to be approved, the IRB must determine that all of the following requirements are satisfied:
  1. Risks to subjects are minimized and are reasonable in relation to anticipated benefits of the research;
  2. Selection of subjects is equitable given the purposes and the setting of the research;
  3. Appropriate informed consent will be sought from each subject or the subject's legally authorized representative, and such consent will be appropriately documented;
  4. The research plan makes appropriate provision for monitoring the data collected to insure the safety of subjects;
  5. Appropriate provisions are made to protect the privacy of subjects and to maintain the confidentiality of data;
  6. Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, appropriate additional safeguards have been included to protect the rights and welfare of these subjects; and
  7. All investigators named in the protocol, including students, must have completed approved training on the use of human subjects in research. 

VI.  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. 

VII.  Composition of the IRB

The Vice Chancellor for Research and Economic Development appoints the members of the Institutional Review Board (IRB) for Research with Human Subjects 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 backgrounds to promote complete and adequate review of research activities commonly conducted at UNC Charlotte. It is made up of persons of both sexes and includes at least 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. 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. 

VIII.  Procedures for Review of Research

Consistent with applicable law and regulation, the IRB shall establish procedures for reviewing research proposals not exempt from review, to include procedures for continuing periodic review 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. 

IX.  Committee Records

Documentation of IRB activities is maintained by the Office of Research Services for at least three years following the completion of research and includes the following: 
  1. Copies of all research proposals reviewed, approved consent documents, etc.;
  2. Documentation of actions taken through procedures of expedited review;
  3. 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;
  4. Records of continuing review activities;
  5. A list of IRB members as well as a copy of each member's professional vita; and
  6. Written operating procedures for the IRB. 

X.  Administrative Support

It shall be the responsibility of the Office of Research Services to provide administrative support for the IRB and to keep it advised of current regulations governing research with human subjects. 
 
(References: 45 CFR 46; 45 CFR 50; 45 CFR 99)
 
Revision History: 

Initially approved August 21, 1981
Revised August 28, 1995
Revised February 26, 2001
Revised June 5, 2002
Updated October 29, 2004

Authority: Chancellor

Responsible Office:  Academic Affairs

Related Resources:

<a data-cke-saved-href="https://research.uncc.edu/departments/office-research-compliance-orc/human-subjects/guidelines-research" href="https://research.uncc.edu/departments/office-research-compliance-orc/human-subjects/guidelines-research" ;="" line-height:="" 25.00788116455078px;"="">Guidelines for Research