NIH Recombinant DNA Guidelines Assessment

Has your institution established an Institutional Biosafety Committee (IBC)?*

Required for all institutions conducting recombinant DNA research

Does your IBC include at least 5 members with expertise in recombinant DNA and biosafety?*

Must include biological safety professional and community member

Does the IBC review all recombinant DNA protocols before research initiation?*

Are IBC meeting minutes documented and retained per NIH requirements?*

Minutes must be available for NIH inspection

Are all recombinant DNA experiments conducted at appropriate biosafety levels (BSL-1/2/3/4)?*

Containment level determined by risk assessment

Do your facilities meet physical containment requirements for assigned biosafety levels?*

Autoclave, biosafety cabinets, HEPA filtration as required

Are biosafety cabinets certified annually and after relocation?*

Do you maintain appropriate decontamination and waste disposal procedures?*

Autoclave/chemical decontamination before disposal

Do you conduct risk assessments for all recombinant DNA experiments?*

Consider source organism, vector, host, and expression products

Are experiments involving human gene transfer reviewed for additional oversight?

RAC review may be required for novel gene therapy

Do you identify and implement additional safeguards for high-risk experiments?*

Toxins, drug resistance genes, pathogenic organisms

Do all personnel receive biosafety training before working with recombinant DNA?*

Initial and annual refresher training required

Are training records documented and maintained?*

Do you maintain standard operating procedures (SOPs) for all recombinant DNA work?*

Are accidents, spills, and exposures reported to the IBC and NIH as required?*

Immediate reporting for significant exposures

Is your institution registered with the NIH Office of Science Policy (OSP)?*

Required for NIH-funded recombinant DNA research

Do you submit annual reports to NIH documenting IBC activities?*

Due within 60 days of fiscal year end

Are protocol amendments reviewed and approved by the IBC before implementation?*

Are human gene transfer protocols reviewed by IBC and IRB?

Dual review required for human subjects research

Do you submit gene therapy protocols to FDA (IND) as required?

FDA oversight for most human gene transfer

Are informed consent documents specific to gene therapy risks?

Disclosure of viral vector risks, germline modification potential