With the increase of biological and pharmaceutical research, biorepositories are surfacing as a huge, important component. Biorepositories store and catalog a variety of biological samples. They must adhere to stringent regulations when handling and using biological specimens, especially when human samples are involved. Here are some of the legal guidelines biorepository staff much be familiar with and adhere to.
HIPAA Compliance
HIPAA or the Health Insurance Portability and Accountability Act is a US law. It is designed to protect patient’s medical records and privacy. Any business that handles any type of patient information much follow HIPAA regulations and practices to protect patient privacy. Biorepositories store samples were taken from human patients. If there is a breach in patient data or if the biorepository is not compliant with the guidelines set forth in HIPAA, they can be subject to criminal or civil penalties.
Informed Consent and Human Tissue Samples
The IRB (Institutional Review Board) oversees studies at research institutions when they involve human subjects. The review board is set up to help protect people from possible negative consequences when they are involved in research studies. In most cases, specimens collected from research participants or patients require the signing of an informed consent form approved by the IRB. Specimens are often stored in biorepositories for future use. These specimens require signed informed consent documents. It is often difficult to know when specimens will be used in research, donors may be able to withdraw their authorization for tissue sample use.
Patient’s Right to Withdraw from Research
When patients consent to the use of their samples for future research, they retain their right to withdraw that consent. As far as sample management and protocol in general, it can vary between institutions. Biorepositories should outline their best practices and how the specimens will be handled in cases where a patient withdraws consent. For instance, biorepositories may choose to destroy the sample, or they may be able to transfer the sample to a different donor-approved research project. Having a transparent operating procedure to follow for cases where donors withdraw consent, helps protect biorepositories from unintentional violations of HIPAA or IRB regulations.
Custody and Ownership of Samples
The laws vary from state to state and between institutions as they pertain to biological repository sample ownership and custody. In most cases, collected samples are owned by the organization that gathered them. Researchers who collect samples usually retain custody of them since they are using them for a particular study or purpose. Other times, they are in the custody of an IRB-approved biospecimen regulatory body. Biorepositories should have clearly stated guidelines for the ownership, custody, and distribution of samples. They should also have a clear plan for cases when a researcher leaves their institution.
Access to Biological Specimens and Data
Biorepositories also need to tightly control access to biological samples and the data associated with them. This helps ensure both the integrity and security of the specimen. Access to samples should be limited to authorized researchers and specific biorepository staff. Logs should be diligently maintained by biorepository staff. These logs should contain detailed audit trails for each sample including access logs.
Biological research is growing rapidly and as with other technologies, the pace is often faster than regulations. Laws that affect biorepositories are still relatively young and it’s likely that they will change as products, research, and technology continue to advance. Staff members at biorepositories should continue to be aware of regulatory developments as they occur in the future.
