Ethics & Compliance
The procurement of biospecimens is considered a highly risky endeavor. One mistake in the compliance process and your entire program may be shut down. iSpecimen goes above and beyond to help ensure compliance.
Ethical Oversight
- All specimens from iSpecimen are collected under the oversight of an IRB/IEC or other appropriate ethics committee. In the U.S., this includes conformance to 45 CFR part 46, HIPAA, 21CFR Part 50/56, and the Uniform Anatomical Gift Act. Specifically:
- Specimens Collected Specifically for Research (“Human Subject Research”) are collected under iSpecimen’s IRB protocol with informed consent or under our partners’ IRB/IEC protocol with informed consent, both of which have been reviewed and approved by iSpecimen’s compliance team.
- Remnant Clinical Specimens are collected under a Non-Human Subject Research determination without consent (45 CFR 46 exemption 4), with a waiver of consent, or with informed consent, depending on the sourcing institution. Researchers can specify the level of consent desired when procuring specimens and only those meeting proper consent requirements will be delivered.
- Cadaver Specimens cadavers are collected under guidelines set forth by the Uniform Anatomical Gift Act with consent provided by the donor or next of kin.
iSpecimen will provide associated compliance documentation with specimens upon request.
Allowable Uses
The iSpecimen Partner Network includes a variety of healthcare providers and partners, each of which may have their own allowable specimen uses. Keeping track of these differences and ensuring proper specimen use is a major source of risk for researchers. iSpecimen tracks this information to ensure only specimens meeting these requirements are delivered. iSpecimen also vets researchers and their programs to ensure specimens only go to those with legitimate research or educational programs.
Patient Privacy
iSpecimen goes to great lengths to ensure a patient donor’s privacy is protected. Our technology automatically de-identifies patient data before we even receive it from our specimen partners, eliminating the PHI leakage that often happens with manual de-identification processes. Our technology undergoes regular, rigorous privacy and security audits to ensure it continues to protect the identity of patient donors and is impervious to hackers. All researchers are contractually bound to never try to re-identify patients, ever.
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