Tissue procurement is the process of collecting biological samples for scientific research or medical purposes. This process involves the collection, preservation, and distribution of tissues from human or animal subjects, which are used for diagnostic, therapeutic, and research purposes. 

The main goal of tissue procurement is to collect high-quality, representative samples that can be used to advance medical knowledge and improve patient outcomes. 

Best Practices for the Tissue Procurement Process: Stage by Stage

Pre-Procurement

This stage involves several key steps, including donor identification, consent acquisition, medical history review, screening for infectious diseases, and donor eligibility determination. 

  • Donor identification involves identifying potential donors who meet the criteria for tissue donation, such as age, health status, and cause of death. 
  • Consent acquisition involves obtaining the donor’s informed consent to donate their tissues, which may involve obtaining consent from their family members or legal guardians. 
  • Medical history review involves reviewing the donor’s medical history to identify any conditions or factors that may affect the suitability of their tissues for donation. 
  • Screening for infectious diseases involves testing the donor’s blood and tissues for any infectious diseases, such as HIV, hepatitis, or syphilis. 
  • Donor eligibility determination involves assessing the donor’s overall health status and determining whether they meet the criteria for tissue donation. 

This stage is critical for ensuring that Human tissue samples are safe and of high quality, and that they are suitable for use in medical and research applications.

Procurement

The procurement stage is a critical aspect of tissue donation that involves the gathering of viable tissues for scientific research and transplantation. 

Various procurement methods exist, ranging from surgical procedures to minimally invasive techniques. 

  • Surgical procurement involves the removal of tissues from living donors, whereas post-mortem procurement occurs after the death of the individual. 
  • Minimally invasive procurement methods, on the other hand, involve the collection of tissues through biopsy or other minimally invasive procedures.

Collection of ancillary data, such as genetic information, is essential in the procurement stage and should be performed simultaneously with tissue collection where possible. 

To ensure the quality of the tissue obtained, procurement procedures need to be carried out by highly trained medical professionals using standard surgical and procurement practices. 

Additionally, the development of new and innovative techniques such as ex vivo perfusion of donor organs is critical in ensuring continued improvement of tissue procurement practices. These procedures help increase the number of available tissues for study and transplantation and ensure that the donated tissues meet scientific criteria.

Post-Procurement

The Post-Procurement stage begins after the collection of tissues or organs from a donor and refers to the handling of the specimens following procurement for eventual use in medical research or transplantation. 

The safe and timely transportation of the tissue to the processing facilities is paramount to ensure the preservation of its biological integrity. 

During processing, the tissue is cleaned and decontaminated before being dissected into smaller pieces, which are then subjected to different treatments (such as freezing or fixation using different agents) depending on the intended use of the tissue. 

This stage also involves the storage of the processed tissue, which must be carried out under multiple conditions, depending on the nature and intended use of the specimens. Cryopreservation and liquid nitrogen storage are commonly used for preserving the tissues for future use in research, while low-temperature refrigerators are used for maintaining the vitality of tissues. 

Preparing the tissue for distribution, including labeling, packaging, and transportation, also constitutes an essential component of the Post-Procurement stage. The transport of the tissue must be organized such that undue delays and exposure to high temperatures are avoided, and the tissue is packaged and stored using appropriate materials to prevent damage. 

This stage is critical in ensuring the specimens’ safety, maintaining their quality and viability, and their ultimate success in research or transplant use.

In Research

From oncology to neurology, tissue procurement is an essential tool for researchers to investigate molecular biomarkers, identify therapeutic targets, and develop new therapies. 

Research institutions collaborate with tissue banks to procure the necessary tissues, including blood, whole organs, and post-mortem tissues, to conduct studies. Several methods exist for procuring tissue, including surgery, biopsies, autopsies, and organ donation. 

The availability of high-quality tissue samples with minimal time to procurement is critical to ensure the preservation of different cellular and molecular features within the tissue. 

An international Code of Ethics in Tissue Procurement promotes ethical practices, including the informed consent of donors, confidentially, and equitable distribution. 

Outside of ethical considerations, the quality control and standardization of procurement protocols impact the reliability of research results and reproducibility. 

Hence, the adoption of standardized policies, guidelines, and protocols in tissue procurement is imperative to improving the quality of research and outcomes in various medical fields.

In Drug Development

The process of tissue procurement plays a critical role in drug development as it enables scientists to obtain high-quality biological specimens for research, testing, and analysis purposes. 

Tissues obtained through procurement are essential in investigating molecular and genetic mechanisms of diseases, including cancer, Alzheimer’s, and diabetes, among others, helping in the development of new drugs to tackle these ailments. 

With the high demand for biological specimens, the tissue procurement process has become increasingly critical in the drug development field. 

This process requires collaboration between procurement agencies, healthcare providers, and biotech companies to ensure that the specimens are collected efficiently and ethically, preserving their integrity. 

Biological specimens collected through procurement undergo thorough analysis to identify their composition, including their genetic makeup, which helps in the identification of new drug targets and the selection of appropriate drug candidates for specific illnesses. 

Moreover, the procurement process plays a key role in ensuring the safety and efficacy of new drug therapies by identifying possible side effects and drug interactions before release to the market.

Ethical and Legal Best Practices Regarding Tissue Procurement

Informed Consent

Informed consent is the process by which donors are informed about the nature, purpose, and risks associated with donating tissue. This includes providing details about the intended use of the tissue, such as research purposes, and obtaining explicit permission from the donor for the use of their tissue in these contexts. 

The donor should be fully informed about the goals of the tissue procurement and the possible outcomes associated with the use of their tissue. This allows them to make an informed decision about whether or not to donate their tissue.

Informed consent is particularly important in the context of tissue procurement because it helps ensure that the donor is able to maintain control over their own body and that their wishes are respected throughout the process. 

While the informed consent process is a fundamental component of responsible tissue procurement, it is not a one-time event. Donors must be informed about the status of their tissue after the procurement process, and informed about how the tissue will be used. 

Moreover, the informed consent process should remain open to revisions and updates throughout the procurement process. This is especially important in cases where the intended use of the tissue changes, or when new information becomes available that may alter the donor’s decision regarding the use of their tissue.

Donor Privacy

The donor’s identity and medical information should be kept private, and any disclosure of such information should be done under the law’s confidentiality requirements. Measures should be put in place to prevent unauthorized access to donor information, and procedures for data protection and security training should be mandatory for all personnel involved in tissue procurement.

Donors must receive adequate information and education about how their data will be protected, the extent of disclosure, and the use of their tissues. Additionally, donors must be informed of their rights to withdraw consent if they feel that their confidentiality is at risk. 

Procedures such as anonymization and de-identification of donor tissues must be followed to ensure patient anonymity in research and medical applications. 

To reinforce donor privacy, oversight bodies should be established to provide transparent and impartial reviews of tissue procurement processes and enhance accountability. 

Regulatory Compliance

The regulatory compliance of tissue procurement plays a critical role in ensuring that donated tissues are used for their intended purposes and that the rights and privacy of donors are protected. 

These regulations are in place to protect donors, ensure the quality of donated tissues, prevent the spread of infectious diseases, and prevent tissue misuse or trafficking.

In addition to informed consent and donor privacy, regulatory compliance also encompasses ownership and commercialization of tissues. Tissues donated for research or medical purposes cannot be sold or used for commercial gain without the explicit consent of the donor or their legal representative.

Ensuring regulatory compliance also helps prevent tissue trafficking and misuse. Tissue trafficking refers to the illegal trade of human tissues, which can include the theft of tissues or the sale of tissues without consent. Misuse of tissues can also occur when tissues are used for purposes other than those for which they were intended, such as using tissue from one patient for another without proper testing or consent.

By following established regulations, tissue procurement organizations can help ensure that tissues are used for their intended purposes and that the individuals who donate their tissues are respected and protected.

iProcess as Your Trusted Biospecimen Supplier

iProcess Global Research is a leading supplier of biospecimens, including tissue samples, which are used in clinical research research. 

With over 17 years of experience, we have a global network of over 1,000 sites and have shipped over 100,000 specimens worldwide, working with major pharmaceutical, diagnostic, and research organizations to support cutting-edge research involving biospecimens

Our biospecimens are banked or prospectively collected, and we provide a wide range of specimens including tissues, blood, plasma, serum, swabs, urine, and stools across various disease types including cancer and infectious diseases​​.

Submit a free feasibility request here.

Sources:

Organ procurement in a deceased donor | PMC

Long-term and short-term preservation strategies for tissue engineering and regenerative medicine products: state of the art and emerging trends | PMC

AMA Code of Medical Ethics’ Opinions Relevant to Organ Transplantation and Procurement | American Medical Association