Descriptions for the various registrations required by the IBC and/or Biosafety Office are listed below. Forms for these registrations may be downloaded here.
Recombinant or Synthetic Nucleic Acid Molecules | Infectious Agents and Pathogens | Toxins | Gene Transfer or Pathogens in Human Subjects | Human Tissue Registrations | Human Tissue - Clinical Focus | Human Tissue - Research Focus
All research involving Recombinant or Synthetic Nucleic Acid Molecules (naturally-derived or synthesized DNA or RNA) on campus must be accompanied by a valid Recombinant or Synthetic Nucleic Acid Molecules Registration. This is an NIH Requirement. An investigator does not need to file a separate registration for every project performed or funded in the laboratory if the projects involve similar recombinant or synthetic nucleic acid molecule activities. Clearly distinct projects such as "expression of signal transduction molecules in cell lines to assay function" and "expression of modified viral stocks to assay modes of infection" would require separate registrations. Be advised, however, that the NIH expects the investigator to identify the genetic elements or nucleic acid molecules that will be inserted into a given vector or host and to report the identity of constructs designed to replicate or express recombinant protein. Recombinant or Synthetic Nucleic acid Molecules that can be used to express a biological toxin must also be registered for that toxin (see below). Experiments involving Recombinant or Synthetic Nucleic Acid Molecules that are not exempt as defined in the NIH Guidelines are submitted to the Institutional Biosafety Committee (IBC) for review and assignment of Biosafety Containment Levels (BSL levels). IBC approval must be received prior to the commencement of the research project.
Human Subjects Research Involving the Introduction of Recombinant or Synthetic Nucleic Acid Molecules, Potential Infectious Agents or Pathogens, or Biological Toxins in Human Subjects
Investigators who wish to introduce recombinant or synthetic nucleic acid molecules, potential infectious agents or pathogens, or biological toxins into human subjects must receive IBC approval in addition to IRB approval. The IBC evaluates the protocol for patient, staff, and environmental safety issues in their review. The following documents are required by the IBC for review of a Human Subject protocol:
- Recombinant or Synthetic Nucleic Acid Molecules registration form, if applicable.
- Infectious Agent/Pathogen registration form, if applicable.
- Biological Toxin registration form, if applicable
- Human tissue registration form.
- Investigator's brochure (usually the same one submitted to the IRB)
- Sponsor's Protocol
- Appendix M, if applicable, with Hopkins-specific responses. Please note that many studies include an Appendix M written by the sponsoring company for a PI at some other institution. The answers provided (who is doing the work, where will it be done, how many patients, etc.) may or may not reflect what will be done here at JHMI. In these cases, the IBC requests that the investigator provide answers to the Appendix M questions that specifically address the Hopkins component(s) of the project.
- Any RAC communications/approvals
- Any FDA communications/approvals
- IRB comments/approvals
- The following human body fluids:
semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids.
- Any unfixed tissue or organ (other than intact skin) from a human (living or dead).
- HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV.
Human Tissue Registrations are reviewed upon receipt by Biosafety Office personnel. Investigators should expect to receive written confirmation of human tissue registration within a week of document delivery to the Biosafety Office.
Human tissues and body fluids in the clinical setting are handled under "Universal Precautions" or "Standard Precautions". These definitions do not neatly fit into the common biosafety containment levels of laboratory-based research. For this reason, clinical human tissue registrations are handled as a separate category. A clinical researcher only needs to possess one clinical research registration. There is no need to complete a registration for every clinical study as long as the list of personnel on the registration who may come in contact with the human tissues is inclusive for all studies.
Since Question 8 of the Human Tissue Registration Form deals specifically with personnel, it is important that this section is filled out completely and accurately. The PI's name should always be listed. Then, if the blood draw/sample acquisition is done by the GCRC or Express Testing, or the nursing staff on CMSC 9 (for example) the PI can enter this on the next line of question 8. If the PI has an assistant or assistants who will handle or ship the tissue, these names should be listed in question 8 along with any additional investigators who may come in contact with the human tissue. Since human samples in clinical research are derived in standardized manners (blood draws, tissue samples, etc.), Clinical investigators do not need to complete question 9a-f of the form.
Human tissues (including human-derived cell lines) and human body fluids used in the laboratory setting are handled with BSL2 containment practices which include the use of a biosafety cabinet (or other approved containment procedures) for manipulation of the material. An investigator only needs to have one human tissue registration for laboratory-based research. Investigators who maintain research laboratories and also oversee clinical studies should maintain a clinical-focus and a laboratory-focus registration given the differences between BSL2 and universal or standard precautions. Since research laboratory practices are not standardized and prone to creative influence, laboratory-focus human tissue registrations must include answers to question 9a-f.