Human Subjects Safety

 

 

 

 

 

The Institutional Review Board (IRB), also known as the ethics committee, is charged with protecting the rights and welfare of human subjects recruited to participate in research protocols at UNC Asheville. The IRB reviews all protocols involving human subjects that UNC Asheville is involved with and has the authority to approve, disaprove or require modifications to protocols.

Institutional Review Board

Additional resources at the University available to investigators include: 

 
118 W.T. Weaver Boulevard
828-251-6887
 
Mental health counseling & resources available to UNC Asheville students.
 
 
 
 
Weizenblatt Hall
828-251-6710
 
Emergency Response

 

Research Involving Human Blood, Fresh Human Tissue, or Body Fluids

All human blood, fresh tissue, or body fluids must be regarded as possibly infected with bloodborne pathogens such as Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV). Therefore, the UNC Asheville Institutional Biosafety Committee (IBC) will review research protocols which involve the use of human blood, fresh human tissue, or body fluids in cllinical research to ensure maximum safety.

All persons working with these substances in Clinical Research must be informed of the potential hazard and instructed in the procedures needed to avoid exposure and infection. It is the responsibility of the Principal Investigator to inform and instruct those persons under his/her supervision.

The UNC Asheville IBC is authorized to inspect research facilities, approve research practices and procedures, and to take actions to ensure a safe workplace.

Project Registration Forms are available on the EH&S Biosafety Website to register research involving human blood, fresh human tissue, or body fluids. 

Review of the project shall include:

  • assessment of the containment levels required; and
  • assessment of the facilities, procedures, practices, and training of personnel involved in the research. 

Biosafety Level 2 is appropriate when work is performed with any human-derived blood, body fluids, tissues, or primary human cell lines where the presence of an infectious agent may be unknown.

 

Research Involving the Exposure of Radiation to Human Subjects

North Carolina Regulations for Protection Against Radiation 10A NCAC 15 has Rules regarding deliberate exposures to individuals for training, demonstration or other non-healing arts purposes. Standing orders are not acceptable in North Carolina.

.0602 (26) "Healing arts mass screening means the examination of human beings using x-rays for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts who is legally authorized to prescribe such x-ray tests for the purpose of diagnosis or treatment. It does not include the use of x-ray tests as a requirement for hospital admission or as a condition of employment."

.0603(G) "Individuals shall not be exposed to the useful beam except for healing arts purposes. Such exposures shall have been authorized by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure of an individual for training, demonstration or other non-healing arts purposes."

The following procedure needs to be followed in order to apply for an exemption to 10A NCAC 15.0603(a)(1)(G) for clinical research studies involving the exposure of radiation to human subjects.

Procedure for Research Projects Involving the Exposure of Radiation to Human Subjects