The above mentioned case involved the use of an organ taken from the plaintiff for research purposes and producing cell cultures from these tissues with subsequent financial gain in the form of a patent and shares. The Supreme Court stated the lack of regulations and experiences regulating the property rights of human tissue and the uncertainty on how tissues should be disposed. In addition, the court also stated that the product formed by processing the tissue no longer carried the original characteristics and therefore should be considered different and a product of human creativity.
In accordance with these rules, institutions should require the completion of consent forms aiming to keep health information confidential and containing comprehensive information related to the specific research project. Consent forms must comply with the legal requirements, clearly identify how and by whom the information will be used and should be signed by the patient.
Some studies have reported that the cost and quality of medical research have been negatively influenced by the bureaucratic procedures required by HIPAA. The investigators conducting this study accepted the importance of the confidentiality, but stated that these rules should not make medical research and innovation difficult.
The College of American Pathologists CAP made a number of suggestions about the use of human tissue in research, education and quality control. These recommendations are intended to balance the privacy requirements with the necessity of conducting research in everyday life.
In the Moore v. UC Regents case, the tissues obtained from the patient generated a significant commercial profit.
The Supreme Court clearly stated that cells obtained for any purpose in medical institutions should not be accepted as the property of the patient. Many organizations and experts recommend certain principles to avoid such conflicts that may occur during or following research with pathology material.
For example, Mohapatra et al. They state that the pathologists may wish to get assurances of the following: 1 Patients have been informed of the risks and benefits, 2 Patients have given consent to use of the sample for research 3 Patients have been informed of any possible commercial interests in this research 4 Tissues already stored by the laboratory are made anonymous or granted institutional review board IRB waivers 2.
Many studies contend that it should be possible to perform research on pathology material leftover from diagnostic or therapeutic procedures with only institutional ethical and scientific approval and without a special consent from the patient. In addition, all consent forms used for the surgery and invasive initiatives should specify whether the tissues obtained from the patient will be used for research purposes.
The patients should be informed and should be told that they have the right to reject if they want If obtaining consent is not practical or possible, the consent of an IRB committee should be enough The purpose of these laws should be the delivery of healthcare services in an uninterrupted manner and in accordance with modern standards, while providing the most fertile environment for sensible research and medical education that can set an admirable precedence.
It is critically important to resolve the problems that may emerge from the uncertainties in legislation that regulates property rights of pathology material in addition to creating the most conducive environment for scientific progress and discovery.
The purpose of the new laws should be to determine the property rights, conditions of use, storage and appropriate disposal of human organs and tissues and specifically pathology material Future laws should balance patient rights with the rights and welfare of the society and promote public health, medical education and scientific research. In summary, the basic principles that should be adopted in future legislation can be summarized as follows: 1. Pathology material obtained from patients and subsequently created paraffin embedded tissues and glass slides should be considered to be the property of the hospital or the governing healthcare organization.
The information that relates to the aforementioned tissues and products created from these tissue should be the property of the patient, legal representative or the legal guardian of the patient.
The pathology department should be responsible for preserving the confidentiality of information belonging to these patients or related diagnostic and prognostic information obtained from these tissues.
The use of this information should be dependent on the consent of the patient except for circumstances where such use is related to direct patient care.
In cases when an informed consent cannot be obtained, the use of these tissues for research purposes should be dependent on IRB approval. The information that has been created or that can be obtained from these tissues should be shared with any healthcare personnel who is directly responsible for the care of that patient without the necessity of obtaining informed consent.
The information that will be used for the care of the patient should only be given to the persons responsible for the care of the patient. Sharing of patient information for any other purpose should be dependent on the informed consent of the patient or the legal representative. The authority to use the pathology material for education or research purposes should be given to the healthcare institution, which should be executed by the pathology departments.
The decisions on the use of pathology material for education or research purposes should be subject to IRB approval. IRBs should only require a signed informed consent when this is practically possible or for prospective research trials.
The general informed consent obtained from the patient before surgery or invasive procedures should be sufficient for the use of this material for educational and research purposes after IRB approval. The requirements for informed consent and the rules and regulations of IRBs should be based on national standards or legislation. The principles and procedures followed by IRBs should also be determined within the national context.
The use of pathology material for commercial purposes should be under the responsibility of the hospital administration or its governing organization. The hospitals and their governing organizations should also regulate the rules of sharing profits that may be gained through commercialization of the research products.
Overwiew of legal issues facing pathologists and laboratories when saving and sending out tissues, slides, and tissue blocks. Pathology Case Reviews , 3 Cornelio v. Stamford Hospital, Conn 45,49 A.
Docked number: Regents of the University of California 51,3d S Government Printing Office. Author information Article notes Copyright and License information Disclaimer. Address for correspondence: Dr. E-mail: ude. Received Sep 22; Accepted Jun This article has been cited by other articles in PMC.
Abstract There are several aspects to a histopathology practice besides the acquisition of biopsy specimens and histopathological diagnosis. Keywords: Archival tissue, biospecimens, informed consent, pathology, storage. Change in color of blue litmus paper to red indicates a switch to acidic pH When paraformaldehyde precipitation is observed at the bottom of the container When the solution shows discoloration.
Footnotes Source of Support: Nil. Ethical, legal, and policy issues: Dominating the biospecimen discussion. Cancer Epidemiol Biomarkers Prev.
Hakimian R, Korn D. Ownership and use of tissue specimens for research. Human tissue ownership and use in research: What laboratorians and researchers should know. Clin Chem. To err is human: Quality management practices in surgical oral pathology, a safety net for medico-legal complications.
J Oral Maxillofac Pathol. Harty-Golder B. Retention and ownership of blocks. Cellular Pathology Technique. London: Butterworths; Fixation; pp. Factors influencing the degradation of archival formalin-fixed paraffin-embedded tissue sections.
J Histochem Cytochem. Dry S. Who owns diagnostic tissue blocks? Lab Med. Stuck between a scalpel and a rock, or molecular pathology and legal-ethical issues in use of tissues for clinical care and research: What must a pathologist know? Am J Clin Pathol. Charo RA. Body of research - Ownership and use of human tissue. N Engl J Med. Wald P. Cognitive estrangement, science fiction, and medical ethics. Svalastog AL, Martinelli L.
Representing life as opposed to being: The bio-objectification process of the HeLa cells and its relation to personalized medicine. Croat Med J. Ness RB. American College of Epidemiology Policy Committee. Indian Council of Medical Research. Kapp MB. Ethical and legal issues in research involving human subjects: Do you want a piece of me? J Clin Pathol. Savulescu J. No consent should be needed for using leftover body material for scientific purposes. Ram N. Tiered consent and the tyranny of choice.
Jurimetrics J. Research ethics. Research practice and participant preferences: The growing gulf. Washington University refused to move the samples and sued to establish ownership.
At trial, patients argued they retained the right to control their tissues, since the informed consent documents gave them the right to withdraw from the research and some forms included the right to request sample destruction. Furthermore, patients stated their trust in Dr.
Catalona was critical to their consent to donate, since they understood their tissues would be used at his direction. Catalona—owned the tissues, and the patients could not force transfer of the samples to another institution. If patients chose to withdraw their consent for the research, the court indicated that federal and state rules gave the university the right to destroy, anonymize, or continue to store without using them in research samples.
In all three cases, the courts expressed concern that biomedical research cannot be performed successfully or efficiently if patients can control how their tissues are used in research, how products from their tissues are used, or how profits from products derived from their tissues are shared. However, based on the prior cases, it would appear that as long as departments fulfill their caretaker roles for tissue blocks and follow federal and institutional human subject research regulations, courts would support research on tissue blocks in pursuit of broader biomedical research initiatives.
In the absence of specific laws or prior case law, it remains unclear if patients have the right to refuse use of their diagnostic tissue blocks for research. All research projects meeting federal criteria for human-subjects research must be reviewed prospectively by Institutional Review Boards IRBs ; these internal institutional committees interpret federal guidelines and apply them to submitted research proposals to ensure compliance with federal research regulations.
Technically, only research that is federally funded or conducted by federal agencies must meet the Common Rule guidelines. In practice, many institutions require all research proposals to meet these criteria. In the past, there has been some uncertainty within the research community concerning whether research on diagnostic tissue specimens requires IRB approval and, if so, the type of review required.
Diagnostic tissue samples are removed from patients during the course of routine and necessary diagnosis and treatment. This protects both potential research subjects and the department. If informed consent is required, departments may want a copy of the signed informed consent form along with the request for the tissues to keep on file.
Pathology department leadership may consider establishing policies regarding disbursement of tissues to outside researchers. Since these policies may affect other clinicians and researchers at the institution, involvement of institutional leaders in this process may be prudent.
State laws governing individual patient privacy, genetic testing, and human-subjects research have resulted in important and significant differences in regulations regarding the collection, storage, and use of human tissues in research between even neighboring states.
Since individual IRBs may interpret federal guidelines for human-subjects research differently, internal institutional IRB approval may be appropriate for any outside requests for tissues, even if the requestors have approval from their own IRBs.
Above all, as the legal caretakers of these materials, pathology departments should ensure that adequate diagnostic tissue remains in storage for future testing, second opinions, or medical-legal cases. In summary, diagnostic formalin-fixed, paraffin-embedded tissue blocks are stored by pathology departments.
Pathology departments are the recognized legal caretakers of these tissues and, as such, must abide by hospital, state, and federal regulations. There are no specific state or federal rules regarding ownership of diagnostic tissue blocks. Departments must follow state laws governing the length of storage typically years and retrieval of materials and should ensure diagnostic tissue remains in the event future testing, outside consultation, or medical-legal cases require it.
Unlike samples specifically collected for research, these diagnostic tissue blocks occupy a unique bioethical niche. These blocks may have research value, especially for clinical and translational research, since they can be linked to information on diagnosis, treatment response, and disease outcome contained within pathology and hospital databases. There are no prohibitions on the use of these tissues in biomedical research, assuming departments follow State laws regarding maintenance of these blocks, ensure diagnostic tissues remain available, and abide by Federal research regulations.
In cases involving only tissues originally designated for research use, courts have not found that patients retain ownership or property rights in their excised tissues. Currently, it is not clear if patients have the legal right to prohibit use of their diagnostic tissue blocks in research. Decisions regarding the appropriate use of these materials should be determined by pathology department leadership, in conjunction with institutional leaders, the IRB, and legal counsel, as needed. Skene L.
Ownership of human tissue and the law. Google Scholar. Andrews L. Who owns your body? J Law Med Ethics. Lebacqz K. Health Care Analysis.
Skloot R. Taking the Least of You. The New York Times Magazine. Google Preview. Rules for donations to tissue banks—What next? N Engl J Med. Harty-Golder B. Retention and ownership of blocks. Epstein JI.
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