TECHNO-BORNE ORGANS (by Naira Matevosyan)

TECNO-BORNE ORGANSTECNO-BORNE ORGANS

HLTH 952: BIOTECHNOLOGY & THE LAWHLTH 952: BIOTECHNOLOGY & THE LAW

Candidate for Masters of Science in JurisprudenceCandidate for Masters of Science in Jurisprudence

INTRODUCTION: - 3 - 3 ➢ Demand & supply – 4➢ Risks intrinsic in organ donations – 4➢ Donor organ storage & transport - 5➢ Donor organ costs & transplantation coverage – 6

SYNTHETIC BIOLOGISTS CREATE HUMAN ORGANS: - 8 SYNTHETIC BIOLOGISTS CREATE HUMAN ORGANS: - 8 MEDICAL ADVANTAGES: - 12MEDICAL ADVANTAGES: - 12MEDICAL RISKS : - 14MEDICAL RISKS : - 14PSYCHOSOCIAL RISKS: - 16PSYCHOSOCIAL RISKS: - 16POLICY SPECIFICS: - 17POLICY SPECIFICS: - 17 Coordination Framework and Committee - 18 Licensing and “march-in rights” - 18

LEGAL ISSUES: 19LEGAL ISSUES: 19 Patenting rights and trade secrets - 20 Property rights - 21 Patient's privacy - 22 Advance directives for autopsy - 25 Research integrity - 26 Publishing an invention - 27

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INTRODUCTIONINTRODUCTION-Organ transplantation is an effective, often the ultimate, therapy for the end-stage organ failure. Cornea, skin, bone-marrow, kidneys, lungs, liver, heart, pancreatic islet, and spleen are the most demanded. In the U.S., next to 28,000 organ replacements are performed annually - with 120,000 people on the waiting lists. Majority of the organ subscribers die before the donor organ becomes available.

- The growing organ shortage has led to an international organ trade, named “transplantation tourism.” This form of trade results in inequitable allocation of deceased organs. It also raises ethical concerns.

- Most of the donor organs are alleged to be procured from executed prisoners, a practice which itself is criticized by the international community [1, 2]. [1, 2].

((1) Tianjin KC (2005). A transplant Mecca' that attracts patients from 19 Asian countries . Chusonilbo, 1) Tianjin KC (2005). A transplant Mecca' that attracts patients from 19 Asian countries . Chusonilbo, January 30. Available at: http://www.chosunonline.com/article/20050130000046January 30. Available at: http://www.chosunonline.com/article/20050130000046

(2) Ghods AJ, Nasrollahzadeh D (2005). Transplant tourism and the Iranian model of renal (2) Ghods AJ, Nasrollahzadeh D (2005). Transplant tourism and the Iranian model of renal transplantation program: ethical considerations. Experimental & Clinical Transplantology, 3:351-4transplantation program: ethical considerations. Experimental & Clinical Transplantology, 3:351-4

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DEMAND & SUPPLYDEMAND & SUPPLY

-According to the Organs WatchOrgans Watch, major organ importers are Australia, Canada, Costa Rica, Israel, Japan, Oman, Saudi Arabia and the U.S.A.- Commonly known organ exporters are India, Pakistan, China, Colombia, Bolivia, Brazil, Iraq, Israel, the Republic of Moldova, Peru, Iran, and Turkey.- A progressing frequency of medical complications are consistently reported, including the transmission of the HIV, hepatitis B and C, and tuberculosis [3-5][3-5]. Many organ recipients embrace a path of lifetime immunosuppression to stave-off the organ rejection at the cost of lowering their overall immune defense.

(3) Inston NG, Gill D, Al-Hakim A, Ready AR (2005). Living paid organ transplantation results in unacceptably (3) Inston NG, Gill D, Al-Hakim A, Ready AR (2005). Living paid organ transplantation results in unacceptably high recipient morbidity and mortality. high recipient morbidity and mortality. Transplant Proceedings;Transplant Proceedings; 37: 560-2. 37: 560-2.

(4) Ivanovski N, Popov Z, Cakalaroski K, et al (2005). Living-unrelated (paid) renal transplantation - Tten (4) Ivanovski N, Popov Z, Cakalaroski K, et al (2005). Living-unrelated (paid) renal transplantation - Tten years later. years later. Transplant Proceedings;Transplant Proceedings; 37: 563-4. 37: 563-4.(5) Kennedy SE, Shen Y, Charlesworth JA, et al (2005). Outcome of overseas commercial kidney (5) Kennedy SE, Shen Y, Charlesworth JA, et al (2005). Outcome of overseas commercial kidney transplantation: an Australian perspective. transplantation: an Australian perspective. Medical Journal of Australia;Medical Journal of Australia; 182: 224-7 182: 224-7 44

ORGAN STORAGE & TRANSPORTORGAN STORAGE & TRANSPORTCurrently there are two preservation approaches:

- Static- Static - - simple static cold storage (SCS);

-- Dynamic Dynamic -- hypothermic machine perfusion (HMP), normothermic machine perfusion (NPM), oxygen persufflation [6].[6].

Both SCS and HMP are clinically approved for kidneys. Only SCS is approved for liver, lungs, pancreas, and heart. The remaining methods are in various stages of preclinical studies.

SCS relies on the cooling effect alone [7][7].. By contrast, HMP depends on activating residual metabolism, largely dependent on energy generation needed for the oxygen supply for aerobic metabolism delivered by vascular perfusion [8][8].. SCS is a technically simpler and cheaper than HMP (the latter costs ~ $ 3,000 in the U.S.) [9].[9].

((6) Semenza GL (2000). Surviving ischemia: adaptive responses mediated by hypoxia-inducible factor 1. 6) Semenza GL (2000). Surviving ischemia: adaptive responses mediated by hypoxia-inducible factor 1. Journal of Clinical Journal of Clinical InvestigationInvestigation; 106:809 -811 ; 106:809 -811

(7) Lee CY, Mangino MJ (2009). Preservation methods for kidney and liver. Organogenesis; 5:105-112 (7) Lee CY, Mangino MJ (2009). Preservation methods for kidney and liver. Organogenesis; 5:105-112 (8) McAnulty J (2010). Hypothermic organ preservation by static cold storage methods: Current status and a view to the (8) McAnulty J (2010). Hypothermic organ preservation by static cold storage methods: Current status and a view to the

future. future. Cryobiology;Cryobiology; 60(3 suppl):S13- S19 60(3 suppl):S13- S19 55

DONOR ORGAN COSTS & TRANSPLANTATION COVERAGEDONOR ORGAN COSTS & TRANSPLANTATION COVERAGE

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TRANSPLANTATION COVERAGE BY THE GOVERNMENTTRANSPLANTATION COVERAGE BY THE GOVERNMENTFederal and state governments may fund the organ transplant under Medicare and Medicaid. Pursuing a Social Security Disability (SSAD) preapproval is a good idea for seeking a full coverage under Medicare. Since the former President William Clinton's Administration, Medicare paid for post-transplant anti-rejection therapy at 100% for life of the organ-recipient. After the enactment of the 2010's Patient Protection & Affordable Care Act, Medicare remains available to retirees over age 65, disabled people, and those with End-Stage Renal Disease (ESRD).

Medicaid covers transplants only for approved, select diagnoses and only when performed by approved Centers of Excellence. Medicaid services are reimbursable only if the recipient is eligible for Medicaid during the month of service. Proof of donor eligibility and Treatment Authorization Requests (TAR) from the DHHS are required for major solid organs and bone marrow transplants. Providers must submit a Service Authorization Request (SAR) for < 21-year old patents who are eligible for the Genetically Handicapped Persons Program (GHPP).

Donor and transplant recipient services are billed on separate claims. Presently, only liver, kidney and lung transplants require hospitalization of both donors and recipients. Occasionally, per complications, a bone marrow donor may also require hospitalization. When the living donor and recipient are at different hospitals, both hospitals must be designated as Medicaid Centers of Excellence for the specific organ transplant involved.

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SYNTHETIC BIOLOGISTS CREATE HUMAN ORGANSSYNTHETIC BIOLOGISTS CREATE HUMAN ORGANS

With advances of nanotechnology and regenerative medicine, number of solutions become available, including the ability to regenerate whole organs using stem cells, bioprint tissues, and create (harvested, clone) organs. Synthetic biologists even promise to feed us with Petrie-dish-generated steak. This one, perhaps, isn't an attractive idea; however, good news is that custom-designed human organs (cornea, heart, joints, kidneys, liver, lungs, spleen, teeth) are becoming available 'off the shelf.'

(11) Endy D (2005). Foundations for Engineering Biology. A, C, T, and G refer to the four essential nucleotide (11) Endy D (2005). Foundations for Engineering Biology. A, C, T, and G refer to the four essential nucleotide base pairs that make up DNA: adenine, cytosine, thymine, and guanine. 438 Nature, 449, 449 base pairs that make up DNA: adenine, cytosine, thymine, and guanine. 438 Nature, 449, 449

(12) Paradise J, Fitzpatrick E (2014). Synthetic biology: Does re-writing nature require re-writing regulation? (12) Paradise J, Fitzpatrick E (2014). Synthetic biology: Does re-writing nature require re-writing regulation? 88 88 Penn State Law Review; 117:1Penn State Law Review; 117:1

Synthetic biology utilizes biological “parts” to build cells and entire organisms that can either mimic what occurs in nature or be programmed with wholly novel characteristics [11, 12].[11, 12].

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MAKING AN ORGANMAKING AN ORGAN

I. Organ Harvesting: Isolation of a three-dimensional (3D) bio-scaffold material vacant of any cells, then using stem cell technique to plant the patient's own cells unto the scaffold. A stem is coaxed into, becoming a mature hepatocyte, osteocyte, or myocyte. About $10-$30 million U.S. dollars is needed to harvest one organ [13].[13].

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(13) Badylak S (2015). Grow your own. (13) Badylak S (2015). Grow your own. McGowan Institute for Regenerative MedicineMcGowan Institute for Regenerative Medicine , University of , University of Pittsburgh and UPMCPittsburgh and UPMC

Emerging arrays are vast; however, there are three main techniques involved:

MAKING AN ORGANMAKING AN ORGANII. Tissue Engineering & Polymerization: Modified natural and synthetic

polymers are used to replace damaged portions of the organs/tissues (cornea, skin, cartilage, lymphatic nodes, pancreatic islet). Those cells capable of initiating and sustaining a regeneration process are “switched on” through growth factors, so that they generate new functional tissue of the required variety. Collagen-based biopolymers, combined with synthetic crosslinkers or copolymers, form effective scaffolds for developing prototype artificial corneas, skin, or cartilage for replacements [14].[14]. The tissue engineering strategy is cheaper in both investment and recurring costs. Endothelial keratoplasty sham costs $880 per transplant. In contrast, utilizing donor tissue procured from the eye banks for keratoplasty requires U.S. $3,710 per transplant [15].[15].

(14) Griffith M, Hakim, MA, Shimmura SM et al (2002). Artificial Human Corneas: Scaffolds for (14) Griffith M, Hakim, MA, Shimmura SM et al (2002). Artificial Human Corneas: Scaffolds for Transplantation and Host Regeneration. Cornea; 21 (p): S54-S61Transplantation and Host Regeneration. Cornea; 21 (p): S54-S61

(15) Tan T-E, Peh GSL, George BL, et al (2014) A Cost-Minimization Analysis of Tissue-Engineered Constructs (15) Tan T-E, Peh GSL, George BL, et al (2014) A Cost-Minimization Analysis of Tissue-Engineered Constructs for Corneal Endothelial Transplantation. for Corneal Endothelial Transplantation. PLoS ONEPLoS ONE; 9(6): e100563; 9(6): e100563

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MAKING AN ORGANMAKING AN ORGAN

Emerging techniques promise a creation of new nucleobase pairs in addition to the naturally occurring pairs, A-T (adenine- thymine) and G-C (guanine- cytosine). A third base pair could dramatically expand the number of aminoacids that can be encoded by DNA, from existing 20 aminoacids to a theoretically possible 172 [16].[16].

(16) Bradley FJ (2014). Life engineered with expanded genetic code. (16) Bradley FJ (2014). Life engineered with expanded genetic code. San Diego Union San Diego Union Tribune.Tribune.

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IIII. DNA Synthesis: This is either natural or artificial creation of deoxyribonucleic acid (DNA) molecules in various contexts: DNA replication (in vivo amplification), polymerase chain reaction (enzymatic synthesis), and gene synthesis (physically creating artificial gene sequences).

TBO ADVANTAGESTBO ADVANTAGES - absence of risk for infection transmission by the donor organ

- absence of risk for histocompliance and other conflicts

- absence of the need for expensive immunosuppression therapy

- absence of risk for microbiological contamination in the donor organ (a possibility of latent viruses and fungi)

- absence of risk for delivery of mixed-up organs or wrong cells

- absence of side effects from the artificial preservants , and the donor organ's histological changes in preservation or transport (ischemia and re-perfusion injury, oxidative stress and inflammation, inhibition of Na+/K+ATPase causing oedema, increase of cytosolic Ca2,anaerobic glycolysis, magnesium crystal precipitation, redox reaction).

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TBO - ADVANTAGES (continued)TBO - ADVANTAGES (continued)- independence from the long waiting lists

- combating the “transplant tourism”

- reduction of the healthcare costs

- organ customization for the recipient's age, gender, race, ethnic group, energy level, HLA, blood group and Rh factor

- time management - reduced time between the organ prescription and transplant surgery

- peace of mind in the patient

- peace of mind in the patient's relatives

- reduction of malpractice suits for transplantation failures

- others.1313

MEDICAL RISKSMEDICAL RISKSHowever, there are risks associated with:

1. - Modification of cells during the processes of cell amplification or differentiation, especially those involving genetic manipulation: gene transfer of anti-oxidative molecules, gene transfer of anti-apoptotic molecules, gene transfer of cytoprotective (heat shock) proteins, gene transfer of HO-1-inducing molecules, gene transfer of cytokines and cytokine antagonist, blockade of T cell co-stimulation.

2. - The scaffold and its interactions;

3. - Underachievement with respect to the quality of synthesized or regenerated tissue because of failures to understand the specific bio-fitness requirements of tissue engineering scaffolds.

4. - Potential toxicity of the process additives, residues, as well as patient-specific responses (allergies).

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MEDICAL RISKS (continued)MEDICAL RISKS (continued)5. Risk associated with:

6. - Performance of the final product, such as the regeneration process not yielding tissue with adequate mechanical or physical properties (especially in engineered blood vessels or valves).

7. - Maintenance of the created organ in vivo. In traditional organ transplant scenario, the post-surgical screening at minimum includes the white blood cell (WBC) count, blood gas count, hematocrit, coagulation cascade , creatinine index, electrolytes, phosphates, chlorides, CT scan, utrasonography, MRI, and others. Having no observational data on the side effects from the created organ cannot inform the default physiological cutoffs for each parameter that would indicate on transplantation success in the patient.

- The ability of synthetic biology products to self replicate when released into the environment. This study informs the need to explore cross-impact of the TBO and its neighboring organs in the animal models.

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PSYCHOSOCIAL RISKPSYCHOSOCIAL RISKIn traditional transplantation, both donors and recipients may encounter issues with adjustment, ability to adhere to post-transplant medical directives, sexual dysfunction, and job resuming difficulties [17, [17,

18]18].. While donors may suffer hypochondriac phobia (associated with absence of the organ), the recipients may suffer intrusive resistance to the “newcomer” in their body.

Preparing to die is easy for some, and grueling for others. Additionally, wait-listed candidates may develop medical contraindications to transplantation (sudden infection, serious stroke, hemodynamic instability).

Such issues could be eliminated by transplanting a TBO with the patient's own genetic package. This situation, however, can also trigger psychological limbo, similar to the the “iron-man-3 syndrome.”

(17) Engle D (2001). Psychosocial aspects of the organ transplant experience: what has been (17) Engle D (2001). Psychosocial aspects of the organ transplant experience: what has been established and what we need for the future. established and what we need for the future. Journal of Clinical PsychologyJournal of Clinical Psychology; 57(4):521-49. ; 57(4):521-49.

(18) DiMartini, Crone C, Fireman M, et al (2009). Psychiatric aspects of organ transplantation In (18) DiMartini, Crone C, Fireman M, et al (2009). Psychiatric aspects of organ transplantation In critical care. critical care. Critical Care Clinics; Critical Care Clinics; 24(4): 949-x24(4): 949-x

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POLICY SPECIFICSPOLICY SPECIFICSIn 1986, the U.S. Coordinated Framework established a biotechnology oversight through the Environmental Protection Agency (EPA), Department of Agriculture & Animals (USDA), Food & Drug Administration (FDA), National Institutes of Health (NIH), National Science Foundation (NSF), and Occupational Safety & Health Administration (OSHA) – to monitor the genetic engineering sector. The Framework also established a Coordinating Committee to ensure timely and regulatory decision making, inter-agency communication, jurisprudence over the biotechnology products, and keeping track of the changing scene in biotechnology [18][18]. This narrowed Committee (USDA, APHIS, EPA, FDA) has a narrow regulatory scope [19][19]: - it only applies to entities receiving federally funded research grants;- federal oversight is not triggered until development of a commercial product;- some laboratory or animal studies are not regulated because they do not result in

a product of commercial interest.(18) Stepp DL (1999) . The history of FDA regulation of biotechnology in the twentieth century. (18) Stepp DL (1999) . The history of FDA regulation of biotechnology in the twentieth century. Food Food

Drug Law;Drug Law; 46:1 -16 46:1 -16 (19) Wozniak CA, Waggoner AF, Reilly S (2012). An Introduction to Agricultural Biotechnology (19) Wozniak CA, Waggoner AF, Reilly S (2012). An Introduction to Agricultural Biotechnology

Regulation in the U.S. Biopesticides and Pollution Prevention Division, Office of Pesticide Regulation in the U.S. Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. Programs. The U.S. Environmental Protection AgencyThe U.S. Environmental Protection Agency 1717

POLICY SPECIFICS (continued)POLICY SPECIFICS (continued)With remarkable promises on the way, we need to determine whether a

man-made organ - with identical genetic package as that in the recipient - is a subject of scientific novelty, commercial interest, or public health interest ? It could be one, both, or could be all. Additional hurdles are debated as to the NIH and NSF rejoining to the Coordinating Committee, to the system back what it was before Bayh-Dole Act, and for monitoring the scientific process and non-commercial products.

Licensing an invention is another bailiwick. The Bayh-Dole Act and Stevenson-Wydler Act have enabled not only collaborations between the federally funded researchers, but also commercialization of the institutions. Such an influx of economic success drives the institution to focus on funding an invention for a financial benefit - as opposed to altruistic brainstorming. This may negate the “upstream” research.

Under certain circumstances, the government can require the university to grant a license to a third party, or the government may take title and grant licenses itself (using its "march-in rights"). This might occur if the invention was not brought to practical use within a reasonable time, if health or safety issues arise, if public use of the invention was in jeopardy.

LEGAL ISSUESLEGAL ISSUESIn traditional donor-organ transplantation practices, tort or malpractice claims include fraud and misrepresentation, deficient informed consent, conspiracy, breach of the patient's privacy, intellectual and private property disputes, and health insurance constraints. The overwhelming majority of claims concern to the health insurance coverage (see Fig. 1):

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By contrast, the TBO transplant eliminates grounds for claims about misusing unfit donor organs, or the waiting-list discrimination. Anticipated legal issues are discussed further.

PATENTING RIGHTS & TRADE SECRETSPATENTING RIGHTS & TRADE SECRETSAn invention or betterment can be patentable if it presents:(1) Patentable subject matter [35 U.S. Code §101 ]

(2) Utility [35 U.S. Code §102]

(3) Novelty [35 U.S. Code § 103]

(4) Nonobviousness [MPEP Guide 2141]

(5) Specification [35 U.S. Code §112].

Under the 2106 Patent Subject Matter Eligibility [R-11.2013] requirement, there are two matter determinations and both must be satisfied. The claimed invention:(1) must be directed to one of the four statutory categories (process, machine, manufacture, composition of matter), and 2) must not be wholly directed to subject matter encompassing a judicially recognized exceptions: laws of nature, physical phenomena, abstract ideas, theories, mathematical algorithms [see Bilski v. Kappos 20102010; Diamond v. Ananda M. Chakrabarty 1972,1972, Parker v. Flook 19781978]. 2020

PATENTING RIGHTS (continued)PATENTING RIGHTS (continued)

In addition, under the PTO 2164.01 the patent should allow enablement: “Any analysis of disclosure requires a determination of whether the filed disclosure contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention” [see Mineral Separation v. Hyde 19161916].

Several questions raise of the TBO patentability under the matter, process, and novelty criteria. Isn't the TBO a natural phenomena even though it is man-made? Each organ and each transplant is unique. But does it grant the TBO a novelty status?

Making a TBO is a process of genetic engineering that includes DNA isolation, random digestion (DNA with restriction enzymes), or recombination. Ergo, succeeding in a patent claim greatly depends on how skillfully the matter and process are separated and specified in the patent application.

(20) Minerals Separation, Ltd. v. Hyde, 242 US 261 - 1916 (20) Minerals Separation, Ltd. v. Hyde, 242 US 261 - 1916

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PROPERTY RIGHTSPROPERTY RIGHTSThe TBO is both inventor's intellectual property and patient's (recipient) private property. Such a dual status may trigger extensive legal conflict. In resonance to the Myriad's decision, the American College of Medical Genetics and Genomics (ACMG) raised an issue of property rights, reflecting that the DNA (whether native or cDNA) conveys special genetic information that “should not be anyone's private property, and that developing a patent thicket of gene sequences could prevent easy commercialization of genetic diagnostics” [21, 22]. [21, 22].

(21) Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 12-398 (2013) (21) Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 12-398 (2013)

(22) ACMG Applauds Supreme Court Decision on Gene Patents (2013). (22) ACMG Applauds Supreme Court Decision on Gene Patents (2013). www.acmg.net/docs/GenePatientsDecision.pdfwww.acmg.net/docs/GenePatientsDecision.pdf

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PATIENT'S PRIVACYPATIENT'S PRIVACYA successful TBO transplant could become a

“threat” to the patient's privacy. The recipient may become a subject of mass-media magnifying monitor and a target for countless research studies to the public benefit. To be protected from privacy breaches, or to prevent such violations, the patient may exercise his 1st and 14th Amendment rights, as well as his privilege under the Health Insurance Portability and Accountability Act of 1996 (HIPPA) and the Patient Safety & Quality Improvement Act of 2005 (PSQIA). The patient or his proxy should carefully study the Informed Consent form prior the surgery, and decide whether to agree or disagree signing the section specifying the patient's informed obligations to serve in addressing post-surgical scientific inquires for the public good.

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ADVANCE DIRECTIVES FOR AUTOPSYADVANCE DIRECTIVES FOR AUTOPSY Advance Directives and Uniform Anatomical Gift Acts vary from state to state. At

the core, Advance Medical Directives, Living Will, or Durable Power of Attorney (DPOA) help protect the rights of an adult (> 18 years) person and communicate his choices if he becomes physically or mentally unable to do so.

The principal competing interests are: (1) the wishes of the deceased during his lifetime concerning the disposition of his body; (2) the desires of the surviving spouse or next of kin; (3) the interest of the state in determining by autopsy, the cause of death in cases involving crime or violence; (4) the need of autopsy to determine the cause of death when private legal rights are dependent upon such cause; and (5) the need of society for bodies, tissues and organs for medical education, research, therapy and transplantation. These interests (mostly concerning the cornea donation) compete with one another to a greater or less extent (see Brotherton v. Cleveland 19911991; Brown v. Delaware Val. Trans. Program 19921992; Lyon v. US 1994;1994; Perry v. Saint Francis Hosp. & Medical Center 19951995)).

It is wiser to complete both documents (Living Will and DPOA) to provide comprehensive guidance regarding the postmortem autopsy and the TBO donation. Examples of combined documents include Five Wishes and MyDirectives. Department of Pastoral Care is available to assist with the choice and preparing of an advance directive. 2424

RESEARCH INTEGRITYRESEARCH INTEGRITYThe National Science Advisory Board for Biosecurity (NSABB) is a federal

agency formed to provide advice, guidance, leadership in research in biosafety and biosecurity. Expert of the NSABB are selected by the Department of Health an Human Services (DHHS) on a 4-year run.

The key role players in safe biotechnology, as defined by the National Research Council (NRC), are the NSABB, NIH, DHHS, Institutional Biosafety Committee (IBC), Biological Toxins and Weapon Convention (BWC) of 1975, and the U.S. Patriot Act of 2001. The NIH, NSF, FDA, EPA, USDA, Department of Justice, Department of Commerce, Department of Education, Department of Housing, Veteran Administration (VA), Consumer Products Safety Commission, Social Security Administration (SSA), and Homeland Security and Recombinant DNA Advisory Committee (RAC) are concerned of the impact of rDNA and ethical issues. These are entities who directly or indirectly monitor the provision of the Common Rule. Under a federal statute (42 USC 282), the RAC governs bioethics, human subject research, biotechnology.

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RESEARH INTEGRITY (continued)RESEARH INTEGRITY (continued)The Common Rule also identifies the Dual Use Research of Concern

(DURC). The DURC in life sciences can be reasonably anticipated to provide information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, the environment, materiel, or national security. The U.S. Government’s oversight of DURC is aimed at preserving the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research [23].[23].

In some extreme cases, the synthetic biology products may be reviewed under the DURC category and monitored by the NRC and RAC.

(23) (23) Kraemer JD, Gostin LO (2012). The Limits of Government Regulation of Science, Kraemer JD, Gostin LO (2012). The Limits of Government Regulation of Science, 335 SCI. 1047 335 SCI. 1047

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PUBLISHING AN INVENTIONPUBLISHING AN INVENTIONThe synthetic biologists who create TBO should consider striking a

balance between publishing an invention of the national interest and the patient's privacy. Disclosure of a private health information poses an economic and psychosocial harm. Individuals could lose their jobs, health insurance, housing, suffer emotional distress - if a sensitive information becomes a public knowledge.

Despite of the 1st Amendment rights, the government strongly discourages the publishers exposing scientific information about issues linked to bioterrorism (Lassa fever, Cholera, Anthrax, Ebola, Nipah virus, Hanta virus, Marburg virus, Plague, Botulism, others) and defense strategies. The 1st Amendment too, comes with limitations as to the scientific scholarship. Restraints include: scientific expression, prior restrains on publication, classification and security clearance.

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DISCLAIMERDISCLAIMER

This presentation shall not be utilized as a medical This presentation shall not be utilized as a medical or legal advice. or legal advice.

The author declares no commercial or strategic The author declares no commercial or strategic interest (or conflict of interest) with entities or interest (or conflict of interest) with entities or individuals whose names were mentioned or individuals whose names were mentioned or omitted.omitted.

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