I. Applying for research testing

Before a study can be submitted to the Committee on Clinical Investigations (the Medical Center's institutional review board), the protocol, including Part H, must be reviewed by the Director of Laboratory Medicine (or designee). Part H includes a table for breakdown of the laboratory testing included in the research protocol. A BIDMC grant or special fund number must be specified in the application. Names/locations of specialty laboratories must be specified for all tests to be performed by outside vendors.  Please note that the hospital applies a discount to testing charged to grant accounts. Consult the Office of Sponsored Programs for the current applicable discount rate.

NOTE: Hard copies of applications for signature should be brought to Keith Boehmer (Yamins 309, ext. 7-3648) at least 48 (working) hours before needed.

The menu of research tests offered through the BIDMC clinical laboratory is the same menu used for clinical purposes. Consult the laboratory manual on the CareGroup web site for the list of tests and associated specimen requirements.

Clinical tests in the protocol not performed in our Clinical Laboratory will be sent to a reference laboratory, and the hospital's discount may not apply in such circumstances.

If the proposed testing is projected to have a significant impact on the laboratory (i.e., a substantial volume of specimens), discussion of the plan should take place between the PI and the Lab Director prior to submission of the application. Special processing or testing requirements may not be possible for the clinical laboratory to carry out, or may require additional resources from the research grant; for this reason, any special aspects of the lab testing protocol must discussed in advance with, and approved by, the Lab Director.

If the protocol is sponsored by the hospital's Clinical Research Center (CRC), the cost of the testing is covered but the investigator must still complete Part H.

Please note that when testing is sent to a research laboratory linked to the project, handling and sending is the responsibility of the PI. These specimens should not go through the clinical laboratory.

Requests are approved provided that the type, volume and frequency of testing does not interfere with the routine patient care testing of the laboratory.

II. Ordering lab tests for a research study

Research testing is performed in the main laboratory and is identified and appropriately charged using the 5-digit (XXX.XX) special fund number assigned to the study at the time of IRB approval and grant receipt.

III. Research tests and results

Specimen processing and testing are performed using routine (as opposed to STAT) turn-around times. Specimens are logged into the Laboratory Information System and the results are available through Clinical Computing. Resources for special processing are limited; however, excess serum or plasma from research specimens may be retrieved for other uses up to twenty-four hours after routine processing. The laboratories are unable to provide long-term storage of research specimens. The lab does not test non human specimens.

IV. Listing of Reference Ranges for all tests

The laboratory is often asked to provide a list of reference ranges for all tests run in-house. We periodically produce such a list. You may download the most recent version (January 2009) in .pdf format by clicking here .

Questions regarding laboratory support for clinical research protocols should be directed to Keith Boehmer or Lynne Uhl, MD at 617-667-3648.

Revised/reviewed 1/12/2009