“An inability to obtain high-quality biosamples is a growing problem in labs, eating away at progress in medicine like an undetected malignancy.”
- Wired Magazine, “Libraries of Flesh: The Sorry State of Human Tissue Storage,” 5/24/10
General
What regulations cover discarded specimens?
Is it legal and ethical to use discarded specimens for research?
What do I need to know about intellectual property rights, other rights and patient consent?
What is the chain of custody on specimens?
How is patient confidentiality protected?
How are IRB approvals managed? Why is this important?
Are all specimens shipped via iSpecimen covered by an IRB approval?
How does iSpecimen control for quality?
What are some examples of studies that have used discarded specimens?
Researchers
Can I use discarded clinical specimens for my research?
Can I follow a patient over time?
How do I get discarded specimens with clinical data?
Labs and Hospital
Will iSpecimen’s system interfere with lab operations?
How much up-front and ongoing IT support will iSpecimen’s system require?
How will iSpecimen’s system affect research we do at our hospital?
How will this affect the quality of patient care in our hospital?
Can the technology be used to help with accountable care initiatives?
What will the PR impact be if our patients know we’re re-using their specimens and data?
General
What regulations cover discarded specimens?
Research on patients and healthy subjects is federally regulated on the basis of the “Common Rule,” described in the Code of Federal Regulations (CFR). Anonymous discarded specimens are exempt from the “Common Rule” as described in an FDA guidance (see next question). The confidentiality of patient information is also described in the CFR.
How can discarded specimens be used in an approved and ethical manner?
Discarded specimens can be used for research as long as there is Institutional Review Board (IRB) oversight and approval of the research protocol. IRBs and hospitals are interested in ensuring that patient care and confidentiality are not harmed. This can be done if the specimen is no longer needed. There is an FDA guidance document on the use of discarded specimens for diagnostic test approval that provides further detail.
What do I need to know about intellectual property rights, other rights and patient consent?
Patient samples become the property of the hospital. Patients may
be informed that any unused tissue or specimen may be used for research. The hospital can then discard samples as medical waste or distribute them for research as long as safety and confidentiality regulations are followed. Once a specimen is obtained for you by iSpecimen, it is your property and any resulting research and inventions are yours.
What is the chain of custody on specimens?
Upon specimen collection, the collecting facility owns all rights to the specimen. Upon retrieval, the specimen belongs to the customer per agreement with collecting facility. Complete chain of custody for each specimen is available upon request.
How is patient confidentiality protected?
When the specimen can be discarded, it is anonymized so that the clinical sample cannot be linked to a patient by name or other identification. iSpecimen can arrange to have as much or as little clinical data accompany the specimen as necessary for your research. Because of the procedures used by iSpecimen, there is no way to track a specimen back to a patient.
How are IRB approvals managed? Why is this important?
iSpecimen works only with CLIA certified laboratories in institutions with an IRB (“Covered entities”). iSpecimen has set up IRB approved protocols for collection of a variety of discarded specimens that should be satisfactory for most research. If your research has additional requirements, iSpecimen can arrange for IRB review and approval at appropriate hospitals. The length of time to obtain IRB approval will depend on the type of research and the hospital.
Are all specimens shipped via iSpecimen covered by an IRB approval?
Yes. iSpecimen’s proprietary software prevents shipment of specimens for any study until there is an IRB approval or waiver in place.
It is important to note that IRB review and approval plays a crucial role in protecting your research and patient rights. By having IRB-approved protocols iSpecimen ensures that there is documentation that all parties are aware of and agree to how clinical samples are used for research.
How does iSpecimen control for quality?
The hospital labs used by iSpecimen are all CLIA certified. Once samples have been analyzed they are stored for a defined period of time under standard conditions set up by the lab. Additionally, the needs of your specific study are taken into consideration. If discarded specimens will not meet your needs, then iSpecimen will work with you to arrange for collection of samples meeting your requirements. This may require patient consent.
What are some examples of studies that have used discarded specimens?
The power of the iSpecimen is that investigators can collect large numbers of specimens together with almost any type of specified clinical data. iSpecimen allows investigators to ask and answer questions that could not be addressed before. Here are some examples:
Asthma: The iSpecimen system was used to confirm genetic predictors associated with a high risk of hospitalization. This is of benefit because such patients could receive care to reduce their risk. In one study, blood samples from >97,000 patients were screened and stratified based on aspects of their medical history such as concurrent medication, pulmonary function test results along with many other variables.
Rheumatoid Arthritis: The iSpecimen system was used to explore the relationship of genetic markers of Rheumatoid Arthritis based on Genome Wide Association Studies (GWAS) and determined which markers were worthy of further study. More than 4,000 samples from patients were used along with hundreds of control samples to define further alleles associated with Rheumatoid Arthritis.
Superior Diagnostic Tests:The iSpecimen system was used to evaluate a new Troponin I assay. Discarded samples from patients who initially had “negative” Tn I results followed by “positive” results were selected and tested with a new assay to see if it was more sensitive in detecting myocardial infarction.
Researchers
Can I use discarded clinical specimens for my research?
Many studies can be done with clinical specimens that would otherwise be discarded. Some examples are studying pharmacokinetics of fluconazole in infants and what types of immune cells infiltrate breast cancers. Using discarded specimens is permitted provided certain regulatory conditions are met.
Can I follow a patient over time?
Some research benefits or requires following a patient over time. While such samples could be de-identified, they cannot be completely anonymized because of the need to match specimens over time with a particular patient. iSpecimen can act as an “honest broker” to protect the privacy of the patient while ensuring that you receive samples from the same patient over time. To ensure patient confidentiality, such arrangements would require IRB approval and, possibly, patient consent.
How do I get discarded specimens with clinical data?
iSpecimen’s core technology can track specimens in real time as they are collected. It keeps track of specimen type, collection time and combines this information with the patient’s electronic medical record which consists of concurrent medication, diagnoses and past medical history.
Labs & Hospitals
Will iSpecimen’s system interfere with lab operations?
No. The lab will operate as normal up through discard, at which point the technician will either discard the specimen as usual or pack/ship it.
How much up-front and ongoing IT support will iSpecimen’s system require?
iSpecimen handles most of the up-front IT requirements and on an ongoing basis; our experience suggests the iSpecimen system will require 3-5 hours of IT support a month.
How will iSpecimen’s system affect research we do at our hospital?
The iSpecimen system will greatly enhance your research programs because now you will have greater access to specimens and data that normally would cost hundreds to thousands of dollars per sample. Additionally, the service will increase the competitiveness of the organization to attract outside research and grant opportunities.
How will this affect the quality of patient care in our hospital?
There will be no operational impact on patient care, but over time, advanced research will provide an overall enhancement to patient care.
Can the technology be used to help with accountable care initiatives?
iSpecimen’s solution will enable you to more easily track quality of care metrics and measure improvements delivered over time. Additionally, advanced research will provide an enhancement to patient care and positively affect these metrics.
What will the PR impact be if our patients know we’re re-using their specimens and data?
Specimens enable researchers to find better ways to treat patient illnesses. Patients and the hospital group will be advancing medicine through the use of what previously was waste. Most patients are happy with this type of eco-friendly re-use as long as they cannot be personally identified, which the iSpecimen solution ensures.