All protocols which utilize the GCRC must first be approved by the Committee on Clinical Investigation (CCI), the Beth Israel Deaconess Medical Center Institutional Review Board. The application and instructions (Guidelines) are available in hard copy as well as on diskette in both PC and Macintosh formats from the CCI offices, Dana 905, East Campus 667-4272.

CCI meetings are held once monthly on each campus, and are staggered so that there is a meeting on either campus every two weeks. The schedules for application deadlines and meetings are available from the CCI office. An integral part of the application is the request for use of the Clinical Research Center ( Section I) and the information necessary for the Office of Clinical Trials and Research (Section J). Other information in the application is utilized by CRC staff to provide essential information about the study.

If the study is funded or supported by industry, it is important to work with the staff in the Office of Clinical Trials and Research, Lowry Medical Office Building, Suite 5A, (632- ) which will assist with budgeting, protocol submission and contract negotiation..

It is preferable that each protocol be approved by the CCI before requesting approval for CRC use through the Scientific Advisory Committee. Each protocol must be reviewed and signed by the administrative personnel in the GCRC. The original protocol plus twenty-five copies must be received in the CCI office by 5:00 p.m. on the deadline day. It is usually easiest to prepare an additional 30 copies for the Scientific Advisory Committee of the CRC (SAC) at the same time, and have them delivered to the Administrative Office of the CRC (GZ-800). The CRC also requires five copies of the pharmaceutical company or multi-center protocol, and three copies of any questionnaires, forms, etc. being used.

The Committee on Clinical Investigations reviews the protocol primarily for ethical standards and risks and benefit to research subjects, the informed consent form and procedure, the selection of subjects and provisions for maintaining confidentiality of information on subjects and data. In contrast, the Scientific Advisory Committee (SAC) of the GCRC, primarily reviews the protocol for scientific merit and appropriate utilization of GCRC resources.

All studies which utilize GCRC resources must be approved by the GCRC Scientific Advisory Committee. SAC consists of representatives from various Departments, Divisions and Scientific disciplines, from both within and outside the Beth Israel Deaconess Medical Center. Scientific Advisory Committee meetings are scheduled once monthly. The schedule of meetings and deadlines is available from the Administrative Office (GZ-800). Please contact Phillip Balasa (667-3664) for detailed information.

Following protocol submission, he Principal Investigator (PI) is invited by letter to attend the meeting to briefly explain the study and answer any questions for Committee members. If the PI is unable to attend the meeting, it is necessary that a Co-Investigator or other knowledgeable collaborator attend the meeting. Protocols may be deferred until the next meeting if there is no representative available to attend the meeting and answer questions.

The Committee votes in closed session following the presentations, and a letter is sent to the Principal Investigator disclosing the decision of the Committee, and requesting any additional information or other requirements necessary before the study may begin.

Modifications to protocols: copies of changes, modifications, amendments to the protocol which are submitted to CCI also must be submitted to the CRC, along with copies of correspondence to and from the Chair. This includes annual reviews and approvals, and the yearly dated consent form. In some cases, modifications to protocols may require re-review by the Scientific Advisory Committee.

Research subject classification: Research protocols are classified for GCRC purposes into one of three types:

A Pure research: studies initiated by the investigator. Usually funded by the NIH or foundations, but may have support from industry;

 

B Subjects who are hospitalized for a medical problem supported by third-party payments but participating in a research study (medically necessary admission);

 

D Subjects involved in industry-initiated studies (clinical drug trials).

 

Additionally, some medically necessary, non-research patients may be admitted to the GCRC ( "C" patients) on a bed available basis.

In cases where the classification seems unclear, the Scientific Advisory Committee will make the determination.

For investigator-initiated studies ("A" patients), the GCRC will support the full cost of admission to the hospital or the use of an outpatient "bed." Specifically, this means that there will be no charge for bed use, nursing care, or nutritional support. The GCRC also will support some laboratory work including routine chemistries and other more specialized tests such as radioimmunoassays. These tests must be "negotiated" with the administrative staff to ensure equitable distribution of limited funds.

When there is industry support for "A" studies, the GCRC will not provide duplicate support. Clear documentation of investigator initiated studies with industry support is required for the GCRC files. Studies for which documentation does not exist can be classified as "D".

For "B" patients, the GCRC may be able to support the cost of testing which is not medically necessary, but required strictly for the research portion of the protocol. This may be "negotiated" on a case-by-case basis with the administrative staff.

There will be charges for all "D" (industry-initiated) services provided by the GCRC. It is advantageous to meet with the Administrative Manager before submitting the budget to the pharmaceutical company to ensure that all necessary charges have been included. Since charges to industry must be the same for all investigators throughout the institution, no reduction of applicable charges can be made.

  V. Policy and Procedure for Investigational Drug Dispensing* Investigational Drug   Studies