FAQ RE: Service
Why should I work with Incite-Bio?
It’s been reported that 70% or more of banked specimens may fail for any given application. This attrition rate can be very costly in terms of time, money and wasted resources. Incite-Bio addresses this problem by providing customized prospective specimen collection, fit for your specific needs.
What does custom procurement cost?
Incite-Bio has built an efficient and cost effective system that allows it to provide custom fit-for-purpose specimens at a prices comparable to those of most commercial bio-bank samples. Contact us for a free estimate.
How long does it take for the prospective collection of annotated human specimens?
You may be surprised at how rapidly custom samples can be procured. The specific time for procurement however will depend on the availability and rarity of the specimens you seek. Incite-Bio has a streamlined the process to match your sample requirements with the right clinical sites and to expedite the approval and procurement of special or rare samples.
How do you control for quality?
Incite-Bio closely manages sample collection, processing, storage conditions, storage duration, and transport conditions as defined by your specific study requirements.
What is the typical process?
Contact us so that we may learn your needs. Once we have defined your specific requirements we will evaluate the accessibility of your specimens and whether there is a need for additional patient consent. We will then provide you with an estimate of cost and an estimated schedule for procurement and delivery. If you are satisfied, cut us a Purchase Order and we will get right to work. That’s it. It is that simple.
What types of specimens can Incite-Bio provide?
A variety of specimens including biological fluids such a serum, plasma, whole blood, urine, CSF, sputum, ascites fluid, cerebral spinal fluid, and liquid cytology samples are available through Incite-Bio’s clinical lab and hospital network. Solid tissues including most tumor types and matched normal samples can also be obtained. Each specimen is collected to meet your specific needs whether based on medical condition, diagnosis, specific test results, analytical ranges, patient demographics or handling methods and procedures.
From what types of medical conditions can you procure samples?
Cancer, Skin Disorders, Metabolic Disorders, Autoimmune Disorders, Neurological Disorders, Infectious Diseases, Hematological Conditions, Cardiovascular Disorders among many others. We are also able to collect samples from healthy donors and pre-conditioned donors evaluated through specific clinical tests such as: A1C, High Cholesterol, High Triglycerides, High Blood Pressure and Increased CAVI Scores (Cardio Ankle Vascular Index), etc.
Can you customize the sample collection according to client specifications?
Yes. In fact, most of our bio-specimen collections are acquired to meet custom client specifications after IRB approval or waiver of the sampling.
What is the size of your typical blood, serum and plasma samples?
- Whole Blood 1 mL
- Serum 0.5 mL
- Plasma 0.5 mL
- Costume volumes per project need.
FAQ RE: Regulations
What regulations govern bio-specimens for research?
Research on patients and healthy subjects is regulated by the US Food and Drug Administration (FDA) as recorded by the Code of Federal Regulations (CFR) Title 21, Part 50, Protection of Human Subjects. As long as they are de-identified, discarded clinical specimens are exempt from requiring informed patient consent as defined by what is called the “Common Rule” in 45 CFR, Part 46, Subpart A. Also the Health Insurance Portability and Accountability Act (HIPAA) under the “Privacy Rule” defines the requirements for the protection of patient confidentiality and privacy and the requirement for de-identification of clinical samples. Together, these rules govern the use of discarded specimens which allow for their use for research purposes without patient consent, as long as they are de-identified and are not collected for the sole purpose of using them for research.
Are all specimens you provide covered by an IRB approval?
All specimens are procured under IRB approval or waiver. Although discarded de-identified clinical specimens do not require IRB approval according to HIPAA, since according to the US federal regulations under 45 CFR they are considered “Non-Human Subject Research”. Incite-Bio believes that patient/donor privacy rights and protections are crucial and is therefore committed to ensuring IRB or appropriate waivers in applicable and in place for all its network laboratory partners.
What is an IRB or Ethics Committee?
An Institutional Review Board (IRB), also known as an Independent Ethics Committee or Ethical Review Board, is a committee that has been formally designated to approve, monitor, and review bio-medical and behavioral research involving humans. The IRB conducts risk-benefit analyses in an attempt to determine whether or not research should be done. IRB committees are composed of least five members consisting of experienced, diverse, experts and community volunteers, including scientists and non-scientists. IRBs are maintained by independent commercial entities as well as hospitals, health centers, and university institutions. Incite-Bio works with IRBs from these various institutions.
What is HIPPA?
HIPAA is the acronym for the Health Insurance Portability and Accountability Act that was passed by the US Congress in 1996. HIPAA provides the ability to transfer and continue health insurance coverage for millions of American workers and their families when they change or lose their jobs. Within HIPAA there is also what is called the Privacy Rule. This Privacy Rule establishes national standards to protect individuals’ medical records and other personal health information.
How do patients respond to the use of their specimens and de-identified data for research?
Studies show that that the majority of patients are willing to allow their specimens to be used for medical research.
Do patients need to consent before their specimens can be used for research?
According to US federal regulations, patient consent is not required provided the specimens are de-identified, in other words, as long as the patient is not identifiable as the source of the specimen. Incite-Bio ensures that only specimens that comply with research requirements and all applicable regulations are released to researchers. However at Incite-Bio we believe that even discarded specimens should have consent from patients. We therefore have an ongoing program to get all of our Network partners to put in place procedures for informed consent, even in cases of discard specimens.
Can a researcher follow a patient over time?
Incite-Bio has the ability to procure specimens over a period of time with the consent of patients and IRB approval. These projects may require additional time for additional approvals.
Can clinical discards be used for non-clinical research?
Discard annotated human specimens can be used for non-clinical studies such as instrument sensitivity calibration and optimization, biomarker discovery, and assay development and validation.