Apply Now!
GIVE TO VUU | INTERNATIONAL | CAMPUS POLICE | QUICK LINKS
About VUU

Division of Title III Administration and Sponsored ProgramsHuman

Subjects in Research


Policies and Procedures Governing all Research

The following procedures and regulations govern all research at the University, whether externally or internally funded. Depending on the research topic and conditions necessary for successful project implementation and completion, special circumstances ay be encountered which require extra measures of precautions. Adhering to the apropriate procedures will ensure that the University policies specifically pertaining to the situations, as well as, the minimal federal, sate and local laws and regulations are met. Included are: Human Subjects in Research; Animal Subjects in Research; Biohazards; Hazardous Waste; and Patent and Copyright Policies of the University.


Purpose: To establish local institutional policies and procedures for implementation of federal policy safeguarding the rights and welfare of humans involved as subjects in experimental projects and research. The Special Assistant to the President/Title III Administrator and the Director of Sponsored Programs are the University official responsible for safeguarding the rights and welfare of human subjects involved in research activities. Any project originating at Virginia Union University which uses human subjects, including self-experimentation, is subject to review and approval. The review shall determine that:

  •  The rights and welfare of the subjects involved are adequately protected.
  • The risks to an individual – physical, psychological, or social – as a result of any activity which exceeds the application of accepted routines necessary to meet his needs are outweighed by potential benefits to society.
  •  Legal informed consent is obtained by appropriate and adequate methods. Approval must be obtained before the project is initiated.

All projects involving human subjects and requesting funds from external sources should
have approval of the Institutional Review Board (IRB) prior to submission to the agency, or the protocol must be submitted to the IRB concurrently with submission to the agency. If the project is to be carried out at a facility not associated with Virginia Union University, the PI is obligated to follow that organization’s guidelines as well. This procedure applies to all activities involving human subjects conducted by Virginia Union University personnel regardless of the source of support. The determination of the risk-to-benefit ratio is primarily the application of common sense and sound professional judgment to the proposed activity. Questions concerning what constitutes risk should be addressed to the Chairman of the IRB during the planning stages of the proposal.

 

Procedures:

  • Principal investigators submitting proposals involving the use of human subjects must check Human Subjects in the Project Requirements section of the Proposal Review and Certification Form.
  • Agency requirements for human subjects’ assurance certifications vary.
  • Principal investigators must allow sufficient time for review and approval of the IRB Committee in the proposal submission and internal review/approval process. Clearance is indicated by the appearance of the signature of the IRB Chairman on one of the lines provided for Other Signatures Necessary on the Proposal Review and Certification Form.

Animal Subjects in Research

Procedures: To establish local institutional policies and procedures for implementing federal policy governing the welfare of animals used by University
personnel for research.

An animal is defined to be any living vertebrae organism used or intended for use in research, experimentation, testing, training, teaching or related purposes. The definition includes, but is not limited to, dogs, cats, rodents, primates, large domesticated animals, poultry, wild-captured animals, and aquatic animals used for these purposes. All policies established for laboratory care at Virginia Union University shall meet the standards set forth by the National Institutes of Health (NIH) “Guide for the Care Use of Laboratory Animals” (U.S. Department of Health, Education and Welfare Publication N.

{NIH} 7-23, 1978) and all revisions thereof. Additionally, the University shall uphold federal laws relating to the use of laboratory animals. Federal laws and regulations define and prescribe the rules for obtaining, maintaining, transporting and disposing of animals, other than farm animal, used for research purposes. Failure to comply with these rules and regulations can result in the loss of federal funding for the University. To comply with these regulations, the IRB will implement and administer the University policy on animal welfare. All research, sponsored or non-sponsored, involving animal subjects must be reviewed by the IRB to assure that it conforms to the University’s policies governing animal care and welfare as set forth in the NIH Guide.

  •  Principal investigators must allow sufficient time for review and approval of the IRB in the proposal submission and internal review process. Clearance is indicated by the appearance of the signature of the IRB Chair on one of the lines provided for Other Signatures as Necessary on the Proposal Review and Certification Form.

 


Biohazards

Purpose: To monitor the extent of biohazards use in University research. The term “biohazards” generally refers to chemical carcinogens, mutagens, teratogens, and all microbiological agents and radiological hazards. Common compounds that fall into these groups are asbestos, arsenic, benzene, carbon tetrachloride, chloroform, alfatoxin, urethane, and vinyl chloride. Radioactive materials, x-rays, lasers and microwaves represent common radiological risks. University policies governing the use of biologically hazardous materials shall be set by an appointed Biohazard Safety Official. It is the responsibility of the PI to be fully knowledgeable about the potential risks and to practice proper care and handling of such materials and generating devices. A Biohazards Safety Official review is required for proposal submissions for external funding for projects involving the use and/or handling of biohazards.

Procedures:

  •  PIs proposing to conduct research involving general biohazards should check Biohazards Review in the Project Requirements section
    of the Proposal Review and Certification Form.
  • The Office of Sponsored Programs will refer all proposals for research activity involving biohazards to the University Biohazard Safety Official for review and
    approval. PIs are encouraged to consult with this person early in the proposal development process to identify and resolve potential problems and questions concerning biohazard handling and use.
  •  PIs should allow ample time for review and approval of the Biohazards Safety Official in the proposal submission and internal review process. A signature by the Biohazards Safety Official in the Other Signatures as Necessary section of the Proposal Review and Certification Form may be required before further processing can be completed.

Hazardous Waste

Purpose: To alert the people reviewing the proposal that hazardous waste will be generated during conduct of the project and that provisions have been made for
disposal of this waste in accordance with University regulations.

Procedures: The PI should write a memorandum stating arrangements have been made for disposal of any hazardous waste generated during the project. The PI and the person responsible for disposing of the waste should sign the memorandum. The memorandum should be included with the Proposal Review and Certification form and filed with the proposal.