How is tissue used for research

Lab Med ; 40 : 69 — Doerr A. Genomics Law Report American College of Medical Genetics. Position statement on importance of residual newborn screening dried blood spots. The Havasupai case: research without patient consent. Harmon A. Indian tribe wins fight to limit research of its DNA. New York Times Apr Uniform anatomical gift act. Hakimian R , Korn D. Ownership and use of tissue specimens for research. JAMA ; : — 5. Cooper S. Informed consent and malformed consent.

American Thinker. The Havasupai Indian tribe case: lessons for research involving stored biologic samples. The charitable trust as a model for genomic biobanks. N Engl J Med ; : — 4. Oxford University Press is a department of the University of Oxford. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide. Sign In or Create an Account. Sign In. Advanced Search. Search Menu. Article Navigation.

Close mobile search navigation Article Navigation. Volume Informed Consent. Specimens Obtained Postmortem. Future Considerations. Oxford Academic. Michelle LE Powers. Department of Pathology and Immunology. K Scott Gronowski. BJC HealthCare. Ann M Gronowski. Euclid, St. Louis, MO Fax ; e-mail gronowski wustl. Select Format Select format. Permissions Icon Permissions. Table 1. Important cases regarding specimen ownership.

Reason for case. Beleno v. SACAFB, United States District Court for the Western District of Texas Parents sued state for use of leftover blood samples that were collected for newborn blood screening and were used in research for which parents had not given consent. Case settled out of court. State destroyed all existing leftover specimens. Adams v.

King County , P. Family sued, contending that donor's consent was limited to transplantation. Court held that family had a claim based on their interest in proper treatment of body; not a property interest. Washington University v. Catalona , F 3d 8th Cir. Court held that donors made a gift of their samples and did not retain a right to direct that they be transferred elsewhere.

Havasupai Tribe v. Arizona State University , Case No. CV, Superior Court of Arizona, Maricopa County Native American tribe filed lawsuit claiming samples given to local universities for diabetes research were used for studies on inbreeding, schizophrenia, metabolic diseases, alcoholism, and population migration.

Greenberg v. Plaintiffs sued after learning that research institution was licensing the test. Patients have no property right in tissue voluntarily donated for medical research. Mansaw v. Midwest Organ Bank , U. Court acknowledged father's property interest, but held that it was minimal.

York v. Jones , F. Later the couple sought to have the prezygote transferred to another medical school for implantation. Moore v. Regents of University of California , P.

Patient sued after learning that research institution had developed cell line and realized economic benefit. Court held that patient did not have property right in excised tissue, but could pursue a breach of fiduciary duty claim. Open in new tab. Table 2. What laboratorians and researchers should do before conducting research on human tissue specimens. Understand and be in compliance with state and federal laws. List the components of a quality consent form [see Mello and Wolf 20 for different approaches to the informed consent].

Inform research participants as much as possible about how their specimens will be used now and in the future. Have protocols and consent forms reviewed and approved by an IRB committee. If additional uses are identified, additional consent should be obtained, specimens should be deidentified, or an IRB waiver of consent should be obtained. The Human Tissue Act defines 'relevant material' as any material from a human body that consists of, or includes, cells.

This includes blood except where held for transplantation. Hair and nail from living persons are specifically excluded, as are gametes and embryos outside the body, which are covered separately by the provisions of the Human Fertilisation and Embryology Act.

Researchers should contact the HTA if they require further advice. Under section 16 7 of the Human Tissue Act, 'storage' does not include storage incidental to transportation. The HTA defines storage as incidental to transportation if human tissue is held for a matter of hours or days and no longer than a week pending transfer to a another organisation.

Where this applies, a licence is not required. However, where a researcher holds human tissue for a short period for the purpose of a project to conduct analysis prior to discarding the human tissue , this is storage for a scheduled purpose i. Such storage requires either a licence from the HTA or ethical approval for the project. Ethical approval will give authority to store the human tissue for the duration of this project only. Before the end of the project, if the human tissue has continuing value you will need to do one of the following to make it lawful to store the tissue for further research use:.

The diagnostic archive does not require a storage licence for research. The licensing requirement would apply only where an archive planned systematically to store human tissue for research use. Researchers sourcing human tissue from diagnostic archives require specific project approval from a REC. Yes, provided it also obtains a licence from the Human Tissue Authority to store human tissue for prospective research use.

It could then seek generic ethical approval for projects to which it releases tissue. The import or export of human tissue is not in itself a licensable activity under the Human Tissue Act However, once human tissue is imported, its storage or use for a scheduled purpose including research is subject to licensing by the Human Tissue Authority unless it is for a specific research project with ethical approval from a Research Ethics Committee.

It is preferable for imported human tissue to be stored in a licensed establishment where possible, and if so there is no requirement for NHS REC approval to undertake research. In the HTA Code of Practice and Standards on Research Code E there is detailed guidance for individuals and establishments involved in import of human tissue for research paragraphs If an application to a REC is required, the researcher should provide assurances to the REC that the human tissue has been obtained ethically and in accordance with the legal requirements of the donor country, including specific consent for research if appropriate.

Provided appropriate assurances are given, no further detailed review will be undertaken of the consent arrangements in the donor country. There is no legal requirement for licensing or ethical approval. The REC will confine its review to the activities to be conducted in the UK, in particular the arrangements for informed consent. It will not undertake detailed scrutiny of overseas research projects.

Over the past century, animal research has played a vital role in scientific and medical advances. But following advances in technology and scientific processes, it is now possible to use human tissue to replace some use of animals in research.

This allows scientists to study diseases in the tissues that are actually affected rather than simulating a model in animals. During this time, the number of new drugs and biologics applications submitted to FDA has declined significantly and many drugs also fail in Phase 2 the first time they are used to treat the disease.

To address this, drug companies are turning to the use of human samples at all stages of the drug discovery and development pipeline to fast track drug discovery. Human tissue is biological material that comes from a human body and consists of or includes human cells. Relevant materials include whole human bodies or internal organs, large pieces of tissue, surgically removed tissue such as tumours, skin, teeth, bone and small samples of body fluids such as blood. Tissue used in research can be obtained from healthy, living donors or during post-mortems on those who have recently passed away or donated their tissue after death.

Human tissue can also be obtained as part of disease diagnosis, treatment or surgery. This can include tissue obtained from surgical biopsies, removed tumours, organ transplants and blood transfusions. Research using human tissue can expand our fundamental understanding of human biology and can help us develop disease diagnosis techniques, future therapies, and treatment protocols. Conducting research with human tissues enables faster development of more effective, safer drugs and an enhanced understanding of the basic disease processes that affect humans.

Register to be a tissue donor at OrganDonor. Other organizations such as the National Disease Research Interchange and International Institute for the Advancement of Medicine also accept tissue from both living and post-mortem donors.

Individuals can donate blood, tissue from surgery such as tumors or diseased organs , or organs after death, including those that cannot be used for transplant. Once you have registered to be a donor, it is important to discuss this decision with your family to ensure that they are aware of your wishes. The use of human tissues in scientific research has improved health care by leading to discoveries in disease progression, drug development, and medical procedures.

Organs-on-chips, 3D bioprinting , and other methods that use human tissues instead of animals produce results that better translate to human health. Human tissue is typically obtained post-mortem from people who are organ donors, as surgery remnants, and via blood or other bodily fluids. But accessibility is often cited as one of the main barriers of using human tissues and cells for scientific advancement. The roundtable speakers—scientists, policy experts, physicians, and leaders from U.

The Human Tissue Roundtable led to the development of the following recommendations and the Physicians Committee is working to achieve them.