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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 DNA | Infectious Agents and Pathogens | Toxins | Gene Transfer or Pathogens in Human Subjects | Human Tissue Registrations | Human Tissue - Clinical Focus | Human Tissue - Research Focus

Recombinant DNA

All research involving Recombinant DNA or RNA on campus must be accompanied by a valid Recombinant DNA 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 DNA 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 that will be inserted into a given vector or host and to report the identity of constructs designed to express recombinant protein. Recombinant DNA experiments that are not exempt as defined in section III-E of the NIH Guidelines to Recombinant DNA Research 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.

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Infectious Agents and Pathogens

All Infectious Agents and Pathogens on campus must be registered through the Biosafety Office. Organisms listed as Select Agents may require additional effort (see Select Agent Policy, HSE 505 for details) This is a JHI Policy requirement. Each pathogen should be registered on a separate form. The only pathogens that can be combined on a single form are "like agents". For example, an investigator wishing to study Methicillin-resistant Staphylococcus may register this strain and a control strain of Staph. on one registration. Likewise, someone wishing to register multiple forms of lentiviral vectors may register on a single form. One may not, however, register lentiviral vectors and adenoviral vectors on the same form. All Pathogen registrations are reviewed by the IBC for the use of appropriate safety procedures and facilities. IBC approval and designation of appropriate BSL levels is necessary before commencement of the research project.

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Toxins

All Biological Toxins and Host Organisms on campus must be registered through the Biosafety Office. Registration of Select Agent Toxins is mandatory and may require additional effort including CDC notification (see Select Agent Policy, HSE 505 for details). All toxin registrations are reviewed by the IBC and approval is necessary before commencement of the research project.

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Gene Transfer or Pathogens in Human Subjects

Investigators who wish to introduce pathogens or recombinant genetic material 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 Gene Transfer protocol:
1. Recombinant DNA registration form, if applicable.
2. Pathogen registration form, if applicable.
3. Human tissue registration form.
4. Investigator's brochure (usually the same one submitted to the IRB)
5. Sponsor's Protocol
6. 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.
7. Any RAC communications/approvals
8. Any FDA communications/approvals
9. IRB comments/approvals
See Links for further information from the JHMI IRB and BSPH CHR websites regarding research involving human subjects. Click this link to view the BSPH Policy on the JHU IBC and Biosafety Office.

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Human Tissue Registrations

OSHA requires bloodborne pathogen training for all individuals who may come in contact with human blood, bloodborne pathogens, and other potentially infectious materials (29CFR part 1910.1030). Other potentially infectious materials are defined by OSHA as:
1. 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.
2. Any unfixed tissue or organ (other than intact skin) from a human (living or dead).
3. 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.

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Human Tissue - Clinical Focus

Human tissue in the clinical setting is handled under "Universal Precautions" or "Standard Precautions". These definitions do not neatly fit into the common BSL levels of laboratory-based research. For this reason, clinical human tissue registration is handled as a separate category. A clinical researcher needs to possess only one clinical research registration. There is no need to register every clinical study as long as the list of personnel who may contact human tissue is inclusive for all studies. Remember, the goal of the task is to register people for blood-borne pathogen training. OSHA does not care how many studies an Investigator oversees.

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.

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Human Tissue - Research Focus

Human tissue in the laboratory setting is handled with BSL2 containment practices which include the use of a biosafety cabinet for manipulation of the tissue. Human cell lines count as human tissue. 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 difference 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.

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