Institutional Biosafety Committee (IBC)

The standards for research and clinical laboratories are published by the Centers for Disease Control, the Biosafety in Microbiological and Biomedical Laboratories (BMBL).

A Human Cell LINE is defined as in vitro or animal passaged (e.g., nude mouse) cultures or human cells that fulfill traditional requirements of a cell line designation. That is, the cells are immortalized cells, transformed by spontaneous mutation or natural or laboratory infection with an immortalizating agent such as Epstein-Barr virus (EBV). EBV is a bloodborne pathogen. It should be noted that human cervical carcinoma cells or other transformed human cell lines like HeLa cells are sometimes adulterated with laboratory pathogens accidentally introduced by cultivation with other cell cultures, or physically contaminated by other cell cultures handled in the same lab. In order to handle human HeLa cells, without having to comply with the requirements of the bloodborne pathogens standard (BPS), human HeLa cells should be documented to be pure HeLa cells and shown to be free of bloodborne pathogens by testing.

Characterization of human cells, for inclusion or exclusion from compliance with the BPS, would include screening of the cells lines or "strains" for viruses characterized as bloodborne pathogens by the Standard, including human immunodeficiency viruses, hepatitis viruses or EBV, if the cells are capable of propagating such viruses. Most cell lines are screened for human mycoplasmas and are free of bacterial and mycotic contaminants. Testing may include antigenic screening for viral or agent markers, co-cultivation with various indicator cells that allow contaminants to grow, or using molecular technology (polymerase chain reaction or nucleic acid hybridization) to identify latent viruses capable of infecting humans such as Herpesviruses (e.g., EBV), or papilloma members of the Papovavirus group, etc. Cell lines that are procured from commercial vendors or other sources with documented testing to be free of human bloodborne pathogens and which have been protected by the employer from environmental contamination may be excluded from the BPS.

Human cell STRAINS are defined as cells propagated in vitro from primary explants of human tissue or body fluids which have finite lifetime (non-transformed) in tissue culture for 20-70 passages. Human cell "strains" must be handled as potential biohazards unless characterized by testing to be free of blood borne pathogens).

In order for research with human specimens, cells, cell lines, or data to involve human subjects,

1. The specimens, cells, or data:

• must be or must have obtained from individuals who are alive; AND
• must be or must have been obtained by an investigator conducting research

AND

2. The investigator EITHER:

• must be obtaining or must have obtained specimens, cells, or data through interaction or intervention with living individuals; OR
• must be obtaining or have obtained individually identifiable private information.

IF providers of coded human specimen, cells, cell lines or data:

1. Obtained or will obtain the specimens or data, AND
2. Can link the specimens or data to living individuals, AND
3. Will also collaborate on other activities related to the conduct of a proposed research project with the investigators who obtain the specimens or data;

THEN both the providers and recipients will be considered to be involved in the conduct of the research and are conducting human subjects research.

Research that proposes the use of human cell lines available from the American Type Culture Collection or a similar repository is not considered human subjects research because the cells are publicly available and all of the information known about the cell lines (perhaps, including the donor) is also publicly available.

Research that proposes the use of established cells from a donor whose identity cannot be readily ascertained by the investigator is not considered to be human subjects research, either for example, because there are written policies and procedures prohibiting release of identifiers and/or an agreement specifying that identifying information will not be shared with the investigator.

Research with Primary cells: If you are taking blood or other cells from living individuals for research purposes in order to create a cell line, the research involves human subjects.

IF the repository/database obtains the specimens/data without identifiers, OR

IF the repository/database obtains the specimens/data with identifiers but is prevented, by law*, from providing identifiers that link to living individuals and the repository/database plays no collaborative role in the proposed research,

THEN studies using the specimens/data from the repository/database are not human subjects research.

If your proposed studies meet these criteria, you should check “No” in Item 4, and you should consider including an explanation of why your research does not involve human subjects in the Human Subjects section of your application

If your proposed studies do not meet these criteria, you are proposing human subjects research. You should check “Yes” in Item 4 and complete the Human Subjects section of your application.

*Because NIH is not a covered entity, NIH cannot comment on the adequacy with which institutions address HIPAA requirements. NIH, therefore, cannot recognize the HIPAA Privacy Act as the law preventing the release of identifiers.

An approach to infection control.  According to the concept of Universal Precautions, all human blood and certain human body fluids are treated as if known to be infectious for HIV, HBV, and other bloodborne pathogens.

All sources for definitions are available from the Center for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), or the Occupational Safety and Health Administration (OSHA).