Ethics & Compliance
The procurement of biospecimens can be a highly risky endeavor, especially when it comes to compliance. The iSpecimen Marketplace® efficiently and thoroughly manages critical aspects of compliance at every stage of the biospecimen procurement process, helping to mitigate risks and instill confidence.
Reducing Risk, Ensuring Compliance
Attention to Detail is the iSpecimen Way—Especially when it Comes to Patient Protection.
From specimen collection to sourcing patient data, we ensure that our suppliers meet all specimen-handling regulations. We process every order with patient privacy as the top priority, obtaining consent from donors and automatically de-identifying patient data upon reception.
Here are six ways iSpecimen incorporates gold standard practices into our specimen procurement process:
Strict adherence to exacting regulations
All specimens 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.
For research use only
Specimens extracted 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 consent requirements
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 informed consent, depending on the sourcing institution. Only specimens meeting the specified consent requirements will be delivered.
Special guidelines for cadaveric specimens
Cadaver specimens are collected under guidelines set forth by the Uniform Anatomical Gift Act with consent provided by the donor or next of kin.
Our partner network includes a variety of healthcare organizations, each may have their own allowable specimen uses. Ensuring proper specimen handling doesn’t have to be risky. Our team tracks and manages this information to help ensure project requirements are met.
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 can happen with manual de-identification processes.