Research Testing for Clinical Trials

The hospital laboratories may be asked to participate in research studies in several ways:
  1. Perform laboratory tests on patient samples, on animal samples, or on other materials, such as solutions or devices
  2. "Spin and save" samples for research studies
  3. Provide excess clinical samples--with or without patient identifiers--to researchers
    Note: all human studies require HIC approval
  4. Provide test result data

Approval
Allow two weeks for pricing-only requests and three to four weeks for approval of research studies.

Participation
Laboratory participation is not guaranteed, but will depend on both study requirements and laboratory resources. A Clinical Laboratory Manager may contact you to determine feasibility or work out the study logistics.

Separate samples required

Separate samples must be submitted for research and for routine clinical testing. It is not possible to bill individual tests performed on one sample to different accounts (i.e. some tests to an OnCORE account and other tests to the patient’s insurance).

Blue Requisition required for individual patient samples

Failure to use the blue requisition may result in the patient being billed instead of the OnCORE.

Research testing is confined to weekdays during the day shift

Please remember that the Clinical Laboratories’ first responsibility is patient care. Since staffing is limited on evenings and weekends, research testing can usually only be accommodated on weekdays during the day shift. Exceptions require pre-approval.

Changes in study requirements

If test or specimen requirements change during the course of your study, the individual clinical laboratory coordinator must be notified and must determine whether these changes can be accommodated. If work increases, the charge may also increase.

Storage of research samples

Storage space in the clinical laboratories is limited.
Research samples should be picked up within 24-48 hours.

HIPAA Tracking

Excess clinical samples taken for use in research need to be recorded by the researcher in a HIPAA Tracking book when two conditions are met: 1) the samples have identifiers; and 2) the patient has not given prior informed consent. The Clinical Laboratories are required to keep this information on file for 6 years.

CAP and CLIA Licenses

If needed, copies of the clinical laboratories CAP and CLIA licenses can be obtained by sending an email with fax information to the Research Coordinator.

A. Billing Instructions

Billing mechanisms must be in place BEFORE requesting laboratory services. Set up an OnCORE account so your grant will be billed instead of the patient.  Fill out the OnCORE and submit by email or fax to:

Charise Berghaus
Account Coordinator
Email: Charise.Berghaus@ynhh.org
Phone: (203) 688-9003
Fax: (203) 688-3330

B. Human Studies

To obtain clinical laboratory tests or services for human research studies, submit:
Request for Human Subjects Research Form
The HIC number and HIC approval letter must be provided.

If excess clinical samples are requested, submit an additional form:
Excess Clinical Samples (HIPAA) Form
An HIC signature is required if the samples will have identifiers or codes of any kind.

Individual patient samples submitted for testing are charged to an OnCORE account. You must obtain a Blue Requisition form from the Laboratory Medicine Research Coordinator

 to submit the individual. Enter the Account number prominently at the top left.

For pre-aliquoted samples brought to the lab for batch testing, contact the individual laboratory for details.

C. Non-Human Studies

To obtain clinical laboratory tests for non-human research studies, obtain a OnCore as above and submit the Request for Non-Human Research Form.

Primate samples are not accepted.

D. Pricing only

To aid in preparation of budgets, a pricing estimate can be requested using the Request for Pricing Only Form.  This estimate is based on handling and testing that is identical to a routine clinical sample.  Any deviation from the routine will incur additional charges.

Forms described in B or C above must be submitted and approved before sample submission and testing can begin.  Prices are valid for the current fiscal year only.

E. Phlebotomy only

Obtain a OnCore account, PTAEO number, and HIC approval, and submit Request for Phlebotomy Only Form to june.stevens@ynhh.org. Arrangements for specimen pickup and drawstation location must be made in advance. The phlebotomists will not centrifuge, deliver or mail specimens.

Billing will be done quarterly at a minimum. If the PTAEO changes, it is the responsibility of the researcher to notify june.stevens@ynhh.org in advance of the change.

Phlebotomy service for research studies is not guaranteed, but will depend on both study requirements and laboratory resources.

Research Testing Coordinator

June Stevens

Address:
Yale-New Haven Hospital 
20 York Street , PS 228 
New Haven, CT 06510 
Phone: (203) 688-7735 
Fax: (203) 688-7340

For copies of CAP or CLIA certificates e-mail Rita.Napierkowski and provide your email address.

Important

Research samples will not be accepted or spun, or research results released, until:

  • The ONCORE is in place
  • Documentation of HIC and HIPAA approvals have been provided
  • The study has been approved by Lab Medicine