FREQUENTLY ASKED QUESTIONS

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FREQUENTLY ASKED QUESTIONS What does ispecimen do? Privately held and headquartered in Lexington, MA, ispecimen is a trusted, one-stop source of customized human biospecimen collections.

1 FREQUENTLY ASKED QUESTIONS What does ispecimen do? Privately held and headquartered in Lexington, MA, ispecimen is a trusted, one-stop source of customized human biospecimen collections. Every day at hospitals throughout the country, thousands of specimens such as blood, urine, and other tissues are thrown away once clinical testing is complete. But in the meantime, biomedical researchers are in dire need of human specimens on which to conduct potentially life-saving research for new diagnostics and treatments. ispecimen has developed and deployed unique technology that compliantly matches leftover, de-identified biospecimens from hospitals and labs throughout the country to researchers who need them. Who are ispecimen s customers? Most major organizations developing in vitro diagnostics and therapeutics need specimens for their research. These organizations include diagnostic, biotechnology, and pharmaceutical companies; academic institutions; and government organizations. What is the ispecimen Supply Partner Network? The ispecimen Supply Partner Network is a selected group of hospitals, academic medical facilities, commercial laboratories, practice groups, blood centers, biobanks, and specialty clinics that have agreed to make their specimens available to researchers using ispecimen s technology. We often refer to participants in our supply network as supply partners. How does ispecimen s technology work? ispecimen s technology watches millions of remnant specimens flowing through its supply partners clinical labs and identifies biospecimens that exactly match research requests. When matches are made, the technology direct laboratory personnel to pick, pack, and ship selected specimens and associated data to researchers. What effect does ispecimen s technology have on supply site operations? The ispecimen technology does not change a lab s standard operating procedures until the discard step, at which point a lab technician will either discard a specimen as usual or pack and ship it on behalf of ispecimen. Outside of lab operations, the ispecimen technology requires very little IT support as ispecimen handles most of the up-front IT requirements, including integration of all data feeds, as well as ongoing maintenance. Our experience shows that once up and going, the ispecimen system will require less than an hour of IT support a month on average to allow for upgrades and operational improvements.

2 FREQUENTLY ASKED QUESTIONS How does ispecimen differ from other biospecimen suppliers? Does ispecimen bank specimens? ispecimen differs from other biospecimen suppliers in many important ways. For one, ispecimen uniquely uses technology to watch specimens flowing in real time through our supplier network and match them to researchers requests, which is unprecedented in the biospecimen sourcing industry. Second, ispecimen does not bank or hold human biospecimens we source directly and prospectively from our clinical lab supply partners, many of which are at hospital sites or academic medical centers. Because of our technology and broad supply partner network: o We can provide researchers with broad access to a large volume and variety of highquality specimens at a faster rate. o Our specimens are differentiated by a vast amount of data, made possible through our linkages with Electronic Medical Records and Laboratory Information Systems. ispecimen is able to provide efficiencies in identification, accuracy, timeliness, and quality. Is it legal to use discarded specimens for research without patient consent? Is IRB approval needed? De-identified clinical specimens can be used for research once they are no longer need for clinical care without IRB approval and patient consent since the use of them is considered non-human subjects research. However, if the research will be submitted to the FDA, it generally requires the use of specimens from consented patients. The FDA does allow an exception for in vitro diagnostics development and has provided a guidance and document covering this topic. Even though federal regulations say that we do not need IRB approval or patient consent, ispecimen s proprietary software prevents shipment of specimens for any study until there is an IRB approval, waiver, or exemption in place. Supply partners are able to use ispecimen s commercial IRB or use their own. Further, we encourage our supplying organizations to get consent as a best practice.* *On September 2, 2015 the Department of Health & Human Services (HHS) announced in a Notice of Proposed Rulemaking that, if approved, would require informed consent for the use of de-identified remnant specimens in research, except potentially in certain circumstances. Which regulations cover discard specimens use in research? There are three major federal regulations that govern the use of discarded clinical specimens for research and with which ispecimen s business practices comply: C.F.R., Part 46, Subpart A (known as the Common Rule ); C.F.R., Parts 50 and 56 (concerning research and data submitted to the FDA); and

3 FREQUENTLY ASKED QUESTIONS 3. HIPAA Privacy Rule These rules codify that discarded specimens can be re-purposed into research without patient consent as long as they are de-identified and not drawn for research purposes.* *On September 2, 2015 the Department of Health & Human Services (HHS) announced in a Notice of Proposed Rulemaking that, if approved, would require informed consent for the use of de-identified remnant specimens in research, except potentially in certain circumstances. How does ispecimen protect patient confidentiality? ispecimen is committed to protecting patient privacy and has instituted technology and processes to ensure Protected Health Information (PHI) remains secure and is not released to researchers. First, deidentification software removes PHI from all data feeds and files before leaving our supplying partners data center so ispecimen and our research customers never have access to PHI. Every specimen that is shipped to researchers is also re-tubed and re-labeled so that no patient PHI exists on the specimen. Additionally, all researchers using our specimens sign a Material and Data Use Agreement specifying what they can and cannot do with the specimens, including the prohibition to ever try to re-identify patients should technology and/or available databases enable it in the future. What is the difference between de-identification and anonymization? De-identification is the process of removing all personally-identifiable health information from a data set. When applied to clinical specimens and associated medical record data repurposing, deidentification is the removal of 18 identifiers as specified by HIPAA (e.g. name, birthdate, social security numbers, medical record numbers) prior to data release. De-identification does not include breaking all links back to the original patient. An honest broker who holds the links may be able to re-identify the patient. Anonymization takes de-identification one step further and cuts all links back to the original patient record. Anonymized samples cannot be re-identified by anyone, not even the healthcare system, thus the data provided to the researcher cannot be traced back to the patient. ispecimen technology will perform patient de-identification or anonymization, depending on the needs of our partners. What types of specimens does ispecimen procure and provide researchers? ispecimen procures and provides a range of specimen types to researchers, including liquid specimens such as serum, plasma, whole blood, urine, CSF, sputum, cerebral spinal fluid, and liquid cytology, as well as solid tissue, such as fresh tissue, frozen tissue, fixed tissue, and FFPE blocks and slides. When selecting specimens, researchers can specify laboratory tests and results (more than 10,000 tests across all result ranges), patient demographic information (age, gender), diagnoses (ICD9/10 codes), and procedures. In the future, ispecimen will also include more data such as medical history, medications, social history, and family history.

4 What types of research may be conducted? Specimens are needed for all types of medical research, including the study of different types of cancer, diabetes, heart disease, and Alzheimer s disease, to name a few. They are also critically important for the study of rare diseases. Many of today s most successful diagnostics, medications, and treatments were developed by analyzing thousands of human specimens. Subcategories of research may be for instrument validation, analytical validation, and biomarker discovery, to name a few. What are examples of medical discoveries that have been made through specimen-based research? Numerous medical discoveries have been made through research conducted on human specimens, including learnings about how disease works, diagnostics, procedures, treatments, and medications. Below are examples of just some of these discoveries: Herceptin to treat breast cancer Zelboraf to treat melanoma Iressa to treat non-small cell lung cancer Gleevec to treat gastrointestinal stromal tumors Identification of biomarkers linked to Type 2 Diabetes Identification of biomarkers associated with Rheumatoid Arthritis How do patients respond to the use of their specimens or data for research purposes? Studies show that most patients (53-90% depending on the study 1 ) are willing to support medical research by allowing the use of their clinical discards for the development of new and better diagnostics and treatments. According to the National Institutes of Health (NIH), donating biospecimens may help some patients and their families cope with their disease. Many patients find comfort knowing that their specimens will help researchers make discoveries that can advance medicine and improve the treatment of others in their community. 2 A from 2013 study from BMJ Open revealed that 81% of patients believe donation of human biospecimens is important. 3 A 2014 study from Biopreservation & Biobanking in 2014 found that 90% of tissue donors felt they were contributing and supporting a good cause, and that it feels good to help. 4

5 What do I need to know about intellectual property rights and the chain of custody for remnant specimens? Patient samples are the property of the clinical laboratory during specimen collection and testing. Upon shipment, the specimen belongs to ispecimen per the agreement with the clinical laboratory. ispecimen then transfers ownership to our customers in accordance with our Material and Data Use Agreement. How do researchers benefit by using clinical discards? Researchers benefit in a number of ways: Access a ready supply of specimens that exactly match study requirements. ispecimen procures common and rare samples selected by researchers based upon specific medical data and demographic data. Accelerate specimen procurement rates. ispecimen provides researchers access to millions of specimens that can quickly be moved into research once clinical testing is complete and the specimen is ready for discard. Gain access to higher quality specimens and data that have been collected with full regulatory oversight. ispecimen has developed and deployed technology for specimen selection and annotation as well as compliance management to ensure the right specimen is delivered to research programs in a fashion that completely protects patient privacy. How do hospitals, labs, and other organizations benefit by participating as suppliers of clinical discards? Hospitals, labs, and other supplying organizations benefit in a number of ways: Contribute to biomedical research. By participating in the ispecimen Supplier Program, hospitals, labs, and other participating organizations take an active role in contributing to the acceleration of biomedical research (both internally and externally). By repurposing what has long been discarded as waste, they are creating valuable resources for the scientific community and future discoveries. Gain a new source of revenue. A brand new revenue stream is created when remnant specimens are repurposed in this manner. Supply partners can use this revenue for a variety of important operations, including technology, patient care, and services. Improve patient care. By accelerating biomedical research, new diagnostics and cures will be pursued at a faster rate. Ultimately, this improves healthcare for all. How long does it take to prospectively collect clinical remnants? The amount of time it takes to find specimens that match researchers requirements depends primarily on the rarity of the specimen, test results, and patient phenotype. Researchers looking for common

6 specimens (such as serum with a single analyte result in the normal range) may receive specimens within a few days of the order. Can a researcher follow a patient over time? Some of our hospital partners do allow us to follow patients over time, so should a patient return for additional testing, we would be able to access the specimen and test results. We can also provide updated Electronic Medical Record data for these patients as well. How does ispecimen control for quality? All ispecimen partner labs are CLIA-certified (Clinical Laboratory Improvement Amendments) and regularly audited by the company. ispecimen regulates storage conditions, duration, and transport conditions as defined by our customers specific study requirements. Who is compensated for the use of remnant specimens? Researchers pay a service fee for each specimen that they receive from our supply network and this fee flows back to us and our hospital and laboratory partners. Our partners use this money to not only pay for the actual costs involved in the picking and processing of these specimens but to advance hospital capabilities and services (such as employee training, community outreach programs, advanced medical technology). This ultimately leads to a better patient experience for our community. We operate as a for-profit company and use this money to provide the best possible technology and services to our customers and partners as well as sustain our business. 1 Report of the Public Responsibility in Medicine and Research (PRIM&R) Human Tissue/Specimen Banking Working Group,March 2007; Tool F Patient Attitudes 2 How You Can Help Medical Research: Donating Your Blood, Tissue and Other Samples. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, National Institutes of Health 3 Public views on the donation and use of human biological samples in biomedical research: a mixed methods study, BMJ Open, Celine Lewis, Margaret Clotworthy, Shona Hilton, Caroline Magee, Mark J Robertson, Lesley J Stubbins, Julie Corfield, August 7, Cancer Patient Perceptions about Biobanking and Preferred Timing of Consent, Biopreservation & Biobanking, Braun Kathryn L., Tsark JoAnn U., Powers Amy, Croom Kristen, Kim Robert, Gachupin Francine C., and Morris Paul, April 21, 2014

Breast Specimen Repository & Registry Specimen Allocation and Registry Use Policy

Breast Specimen Repository & Registry Specimen Allocation and Registry Use Policy Background Since its founding in 2001, the FHCRC/UW Breast Specimen Repository (BSR) has greatly enhanced basic and translational