NIH Guidelines, Module 2

The NIH Guidelines are applicable to:

  • Research conducted at or sponsored by an institution that receives any support for recombinant or synthetic nucleic acid research from the NIH;
  • Research that involves testing in humans of materials containing recombinant or synthetic nucleic acid molecules developed with NIH funds.

Attention!

UNT receives NIH support. Therefore, all recombinant or synthetic nucleic acid molecule work conducted at UNT must be in compliance with the NIH Guidelines.

Non-Compliance Consequences

  • Non-compliance with the NIH Guidelines can result in:
    • Suspension, limitation or termination of NIH funding for UNC-Chapel Hill.
    • A requirement of prior NIH approval of all recombinant or synthetic nucleic acid projects at UNC.

Roles and Responsibilities

The NIH Guidelines never will be complete or final since all conceivable experiments involving recombinant or synthetic nucleic acid molecules cannot be foreseen. Therefore, each institution (and the Institutional Biosafety Committee acting on its behalf) is responsible for ensuring that all research with recombinant or synthetic nucleic acid molecules conducted at or sponsored by that institution is conducted in compliance with the NIH Guidelines.

-Section IV-A. Policy, Roles and Responsibilities, NIH Guidelines

Institutional (UNT's) Responsibilities

UNT is responsible for:

  • Establishing and implementing policies for the safe conduct of recombinant or synthetic nucleic acid research;
  • Establishing an Institutional Biosafety Committee;
  • Assisting and ensuring compliance with the NIH Guidelines by investigators;
  • Ensuring appropriate training for IBC members and staff, PIs and laboratory staff;
  • Reporting any significant problems, violations of the NIH Guidelines, or any significant research-related accidents or illnesses to NIH Office of Science Policy.

Institutional Biosafety Committee Responsibilities

The IBC is responsible for*:

  • Reviewing, approving and overseeing recombinant or synthetic nucleic acid research conducted at UNC to ensure compliance with the Guidelines;
  • Periodically reviewing recombinant or synthetic nucleic acid research;
  • Setting containment levels;
  • Reporting significant problems, violations of the NIH Guidelines or any significant research-related accidents or illnesses to the NIH Office of Science Policy.

*See UNT Biosafety Manual for more complete description

The Biosafety Officer is responsible for*:

  • Conducting periodic inspections of laboratories working with recombinant or synthetic nucleic acid.
  • Reporting any significant problems, violations of the NIH Guidelines, or any significant research-related accidents or illnesses to the IBC.
  • Developing emergency plans for spills and personnel contamination.
  • Investigating laboratory accidents.
  • Providing advice on lab security.
  • Providing technical advice to PIs and IBC on research safety procedures

*See UNT Biosafety Manual for more complete description

The Principal Investigator (PI) is responsible for*:

  • Full compliance with the NIH Guidelines
  • Determining which category their experiments fall under.
  • Determining if experiments require IBC approval.
  • Experiments that require prior IBC approval cannot be conducted until IBC approval is obtained.
  • Experiments that require registration (Section III-E) must not begin until the appropriate paperwork has been submitted to the IBC.
  • Making the initial determination of containment levels required for experiments.
  • Notifying the IBC of any changes to recombinant or synthetic nucleic acid experiments previously approved by the IBC.
  • Immediately reporting any significant problems, violations of the NIH Guidelines or any significant research-related accidents and illnesses to RMS (940.565.2109) and the IBC.
  • Having an updated Laboratory Biosafety manual on file with BSO and in their Laboratory.
  • Describing practices required to ensure safety in the Schedule F and training laboratory staff.
  • Describing appropriate medical surveillance required for work with recombinant or synthetic nucleic acid in the Schedule F.

*See UNT Biosafety Manual for more complete description

Principal Investigator's Responsibilities for Human Use Protocols

  • Principal investigators must report any serious adverse events associated with the use of recombinant or synthetic nucleic acid in humans to the IBC.
  • A serious adverse event is an event occurring at any dose that results in any of the following outcomes: death, life threatening event, in-patient hospitalization, disability/incapacity, or congenital anomaly/birth defect.
  • An adverse event is associated with the use of a gene transfer product when there is a reasonable possibility that the event may have been caused by the use of that product.

NIH Responsibilities

  • Managing the RAC.
  • Conducting and supporting training of IBCs.
  • Review of human gene transfer protocols.
  • Review of certain basic recombinant or synthetic nucleic acid experiments:
    • Deliberate transfer of drug resistance trait to microorganisms not known to acquire the trait naturally, if it could compromise disease control
    • Cloning of toxin molecules with LD50<100 ng/Kg bodyweight
    • Nucleic acid from restricted agents transferred to nonpathogenic prokaryotes or lower eukaryotes
    • Nucleic acid from nonpathogenic prokaryotes or lower eukaryotes transferred to restricted agents
    • Use of infectious or defective restricted poxviruses in presence of helper virus