Institutional Human Subject Research Policy

PC 12 – Human Subject Research – “All human subject research must have approval from the Institutional Review Board prior to its initiation.”

HTRC only handles human biospecimens for IRB approved or exempted research protocols.

Human Biospecimen Policy

The HTRC’s policy regarding the procurement, processing and allocation of biospecimens is mandated by the University of Chicago (UC). 

HTRC is the custodian of the human biospecimens that are stored in the biorepository.  However, the biospecimens are owned by the University.  If an investigator places human biospecimens into the biorepository and subsequently leaves the institution, the human biospecimens become the property of the biorepository or a new principal investigator (PI).  Cancer biospecimens may not be taken from the repository without permission from the University of Chicago Cancer Center (UCCCC) Biospecimen Committee.

Human subject specimens and data may not be sold for profit.  The costs to use the biorepository and providing biospecimens (including collection, processing, storage and distribution) are subsidized by the Biological Sciences Division (BSD), and the recharge fees are based on recovery of operating expenses.

Consent or waiver of consent is required for the storage and future use of data/human biospecimens entered into research repositories.

Once an investigator places human biospecimens in the biorepository, the specimens may be stored for a time period as specified by the investigator or indefinitely, until the biospecimen is requested for withdrawal by an investigator. 

Any University of Chicago investigator may request for withdrawal of biospecimens, even from other investigators’ biobanks, as long as they receive approval from the biobank’s principal investigator(s) (if still at the University).  HTRC does not release biospecimens to external investigators or private companies who are not collaborating with current UC investigators.   All biospecimen distribution requires a signature by investigators or their designees who submitted the request.

Once a biospecimen is withdrawn from the biorepository, the sample may not be re-stored, as HTRC is no longer able to guarantee the condition of the sample after it leaves our custody.  If the investigator would like the sample to be re-stored in the biorepository, then the sample will be registered and stored as a separate new sample (different sample ID).  Investigators are responsible for applicable sample re-registration fees.  One exception to this re-storage policy is when HTRC staff or investigators request FFPE blocks or OCT frozen samples to be pulled for HTRC’s Histology team to create sections for controls, pathology verification or screening.  These samples do not leave HTRC’s custody during the entire process to ensure that they are handled in appropriate conditions.  Investigators are responsible for applicable processing and sample re-storage fees.  Sample audit trails are maintained during this process as sectioning details for all samples are documented in our LIMS.

Please CLICK HERE to read the Institutional Policy Regarding Biospecimen Allocation and Collection.

Service Policies

All requests are handled in the order in which they are received. It is the responsibility of the investigator to manage their own time to ensure deadlines are met.

A re-stocking fee will be applied to any slides not picked up from Histology within 90 days.

Billing is submitted at the completion of services.

Specimen Acceptability Criteria

1. HTRC will only handle and process research specimens for IRB-approved/exempt protocols with a HTRC service agreement signed by the protocol’s Principal Investigator (PI).  HTRC does not handle any diagnostic specimens requiring clinical diagnoses. Only specimens listed on the service agreement will be processed.
2. For protocols requiring consent, the study subject must be entered into LabVantage along with documentation of consent.  For exempt protocols that do not require consent, HTRC staff will be responsible for documenting necessary subject information into LabVantage and also de-linking the biospecimen after processing (when applicable).
3. Specimens must have a container label with all the following information: At least two unique subject identifiers (Subject’s First and Last Name or initials, Unique study subject ID, Medical Record Number or Date of Birth); IRB protocol number; and specimen description/site (for tissues).
4. Specimens must be submitted with a completed Biospecimen Collection Form that includes all the following information: Same two unique identifiers as listed on specimen container label, IRB protocol number, Sender/CRC name, Sender/CRC contact information, Collection date, Collection time, Specimen type (tissue, saliva, red top blood, lavender top blood, etc.), and specimen quantity (for each specimen type).
5. The subject identification, IRB protocol number and specimen information on the container label and collection form must match.
6. Specimens must be sent in the proper container and packaging: sealed, leak-proof primary container and sealed biohazard bag (secondary packaging).  Each bag should contain samples from one case only. Different sample types (blood, urine, saliva, etc.) should be in separate bags.  Appropriate packing material must be used to prevent specimen from breaking/leaking. All paperwork should be in a separate compartment from the specimen.
7. Specimens should be sent to HTRC as soon as possible after collection on the same day.  Avoid batching specimens to the end of the day!  HTRC is not responsible for the quality of samples affected by delayed processing if specimens are delivered over 2 hours after collection.
8. Specimens should be sent to HTRC prior to the cut-off time for same-day processing. Cut-off time for biofluids drop-off at Billings P-524 is 4:00pm. Cut-off time for tissue drop-off at CCD 2-470 is 5:00pm. Exceptions to the cut-off time may be arranged in advance for unexpected occurrences (at the discretion of HTRC’s Scientific Director).
9. Specimens must be of sufficient quantity (size or volume) to be processed. Examples of insufficient quantity include: leaky specimens or desiccated specimens, empty containers, blood volume of less than 1mL for DNA isolation, and diagnostic tissue entirely submitted for clinical diagnosis.
10. Specimens must be of sufficient quality to be processed. Examples of insufficient quality include: grossly contaminated tissue or saliva; hemolyzed, lipemic or icteric blood; and tissue specimens with inadequate or inappropriate preservative for the intended testing.

Reagent and Container Labeling Policy

HTRC is committed to providing quality biospecimens to investigators at University of Chicago.  Please help us to ensure the quality of samples by appropriately labeling all reagents and containers provided to HTRC staff.

If you are providing a large bottle of reagent to be used for your protocol, please make sure that the reagent bottle is labeled with the following information:

• IRB protocol number
• Reagent name
• Storage requirements (temperature)
• Expiration date

Printed safety data sheets must be provided for all reagents so that HTRC staff is aware of any handling requirements and safety risks.

If you are providing empty containers (vials, tubes, etc.) for tissue samples, please make sure that EACH container is labeled with the following information (Just labeling the tube rack/box/bag that is holding the containers is NOT sufficient as HTRC staff handles numerous protocols and the vials will get separated from the holder):

• IRB protocol number

If you are providing pre-filled containers (vials, tubes, etc.) with reagent for tissue samples, please make sure that EACH container is labeled with the following information (Just labeling the tube rack/box/bag that is holding the containers is NOT sufficient!):

• IRB protocol number
• Reagent name
• Expiration date (This can be written on the bag holding each batch of cryovials with the reagent expiration date.)

Scheduling and Usage Policy

All users must be trained by an HTRC staff member prior to use of the equipment, regardless of experience. Any usage of equipment should be scheduled using the online scheduler. If equipment is being used without a reservation, the user will be prohibited from using this equipment in the future. You may not begin using equipment until the start of your reservation. Once your session has ended, you must cease all use of equipment or make a new reservation (as available online). The user that made the reservation is the only individual that may use the scheduled equipment. No user substitution is allowed. All users are responsible for disposing of waste, trash, and biohazardous materials in the proper receptacle. HTRC staff should be notified if a user has been injured during use of the facility’s equipment.

Damage Policy

Damage to an instrument or instrument malfunction must be reported to core staff immediately. Failure to do so may compound damage and expense. Minor damage may be covered by the core. Instruments require regular service and repair and these costs are built into the normal rates. However, PIs will be responsible for covering significant damage to equipment resulting from user negligence.

In the event of damage to an instrument that clearly resulted from a user’s failure to adhere to established operating protocols then the user’s principal investigator will be expected to pay for repairs not covered by service contracts. The technical director will notify the lab’s PI of the incident and charges.

Please CLICK HERE to read the HTRC Usage Agreement.

Please view our Frequently Asked Questions for more information.