Human gene transfer research protocols must be submitted to the NIH Recombinant DNA Advisory Committee (RAC) for review prior to local IBC approval. No research participant may be enrolled in a clinical study until the RAC review process is completed and IBC and IRB approvals and applicable regulatory authorizations are obtained.

1. Response to Appendix M of the National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules (7 copies).
2. Copy of RAC review and any comments (7 copies).
3. Investigator's Brochure and Protocol (2 copies).
4. IRB-approved Informed Consent Form (7 copies).
5. Standard Operating Procedures [SOP] for the planned protocol in a document separate from the Response to Appendix M (7 copies) including:

1. Required documents are forwarded to committee members for preliminary review.
2. Following preliminary review, additional information may be requested prior to the IBC meeting.
3. The IBC will approve, disapprove, or withhold approval pending revisions. No protocol will be approved until PI submits documentation that protocol has been reviewed by the RAC.

(See Policies Appendix A: Standard Operating Procedures for Preparation of Human Gene Transfer Products, and Appendix B: Standard Operating Procedures for Administration of Human Gene Transfer Products, for detailed description)

Include description of the following:

A. Facilities:
List all buildings and rooms where the genetically engineered virus will be stored, prepared, administered, and where in-patients will be housed following treatment. Infection Surveillance and Environmental Services will inspect and approve all facilities.

B. Personnel:
List all personnel (e.g. physicians, pharmacists, nurses) involved in the handling and administration of the genetically engineered virus and the care of participating subjects. Provide names, titles, and departments of personnel.

i. The PI must arrange for Environmental Services or Infection Surveillance to provide Biosafety Training covering the hazards of working with genetically engineered virus and the necessary safety procedures before final IBC approval.

ii. The PI also must arrange for Environmental Services to provide any required Respiratory Protection Training and Fit-Testing before final IBC approval.

C. Standard Operating Procedures (SOPs):
The SOPs must incorporate the manufacturer's recommended precautions and address the specific conditions at NYU Medical Center as described below

i. SOPs must include specific procedures for the following:

a) Work with virus in the Pharmacy (or preparation area)
b) Transport within the Medical Center, and to off-site locations
c) Administration of virus
d) Post-administration subject care (in-patient and out-patient)
e) Post-administration handling of subject samples and specimens
f) Autopsy
g) Spills
h) Accidental personnel exposures

ii.The SOPs should identify the type of Infection Control Precautions (e.g. Standard Precautions, Contact Precautions, Respiratory Precautions) required for the protocol. In addition, SOPs should describe clearly all equipment (e.g. biosafety cabinets), safe work practices, protective equipment (e.g. gloves, gowns, goggles, masks), and personal protective equipment (e.g. respirators) needed to protect staff, subjects, and family members.

The PI is responsible for complying with NIH OBA reporting requirements. Annual data report forms are forwarded by NIH OBA directly to investigators. Investigators also must file a copy of their NIH OBA annual report with the Administrative Chair of the IBC. The PI is responsible for reporting any serious adverse event immediately to the IRB, IBC, Office for Human Research Protections (if applicable), and NIH OBA, followed by submission of a written report filed with each group.

Detailed reporting requirements are identified in Appendix M of the NIH Guidelines.