The Human Applications Laboratory (HAL) is a facility specifically designed for the production of clinical-grade products. It provides a clean, controlled, and monitored environment for the culture and manipulation of human cells and the manufacture and packaging of gene vectors. The laboratory is part of the University of Michigan General Clinical Research Center (GCRC), which is funded through a competitive grant from the National Institutes of Health. The HAL was originally built in 1992 and completely renovated in 1996.

Because the HAL is funded through the GCRC, it may only be used for the production of materials which are to be used in human clinical trials. These clinical trials usually take place in the GCRC, on the seventh floor of the hospital. The HAL does not provide any resources or materials for use in animal research.

Investigators who wish to make use of HAL resources are required to submit a protocol application to the GCRC. All HAL protocols must be approved by both the GCRC Advisory Committee and the HAL Advisory Committee prior to initiation. (The GCRC Main Office staff will ensure that your GCRC protocol application is routed to both committees.) The HAL Director, Dr. Blake Roessler, should be consulted early in the protocol application process. HAL protocols are usually performed in support of an approved Investigational New Drug (IND) study. The Food and Drug Administration's Center for Biologics Evaluation and Research has published information for submitting an IND application.

Once a protocol has been approved, Dr. Roessler and the HAL staff will work with the investigator to ensure that the protocol is completed to specification. The HAL staff oversees the day-to-day operations of the laboratory and ensures that HAL protocols are performed in accordance with the appropriate regulations and standards. The HAL staff do not perform the bulk of the tissue culture procedures in the laboratory. Instead, investigators generally assign one or more of their own technicians to perform their HAL protocols. The HAL staff will support the investigator's technicians and may fill in for them in the event of illness. Any supplies or specialized equipment needed to complete a protocol must either be purchased by the investigator or negotiated with the GCRC as part of the protocol application.