Roy G Spece

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Scholarly Contributions

Books

• Spece, R. G., & Shapiro, M. (2019). The Constitution of Bioethics: Criminal Law.
• Spece, R. G., & Shapiro, M. (2019). The Constitution of Bioethics: First Amendment. Lexington Press.
• Spece, R. G., & Shapiro, M. H. (2019). THE CONSTITUTION OF BIOETHICS IN VIVO. Lexington Press.
• Spece, R. G., & Shapiro, M. H. (2019). THE CONSTITUTION OF BIOETHICS: Equal Protection.
• Spece, R. G., & Shapiro, M. H. (2020). THE CONSTITUTION OF BIOETHICS IN VIVO. Lexington Press.
• Spece, R. G., & Shapiro, M. H. (2020). THE CONSTITUTION OF BIOETHICS: Equal Protection. Lexington Press.
• Spece, R. G., & Shapiro, M. H. (2020). The Constitution of Bioethics: Criminal Law. Lexington Press.
• Spece, R. G., & Shapiro, M. H. (2020). The Constitution of Bioethics: First Amendment. Lexington Press.
• Spece, R. G. (2017). (Implicit) Consent to Intimacy (long-term care residents). 50 Ind. L. Rev. 907.
• Spece, R. G., Shimm, D. S., Buchanan, A., & Buchanan, A. E. (1996). Conflicts of interest in clinical practice and research. Oxford University Press.
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  Part I: A Theoretical, Interdisciplinary. and Comparative Perspective. Roy G. Spece, Jr. and David S. Shimm: Introduction. 1: E.L. Erde: Conflicts of Interest in Medicine: A Philosophical and Ethical Morphology. 2: Roy G. Spece, Jr, and David S. Shimm: Discovering the Ethical Requirements of Physicians Roles in the Service of Conflicting Interests as Healers and as Citizens. 3: Geoffrey C. Hazard, Jr.: Conflicts of Interest in the Classic Professions. 4: Allen E. Buchanan: Is there a Medical Profession in the House?. 5: Charles W. Wolfram: A Trans-Substantive Approach to Conflicts of Interest. Part II: Clinical Practice. 6: Roy G. Spece, Jr. and David S. Shimm: An Introduction to Conflicts of Interest in Clinical Practice. 7: Nancy J. Moore: Entrepreneurial Doctors and Lawyers: Regulating Business Activity in the Medical and Legal Professions. 8: Marc A. Rodwin: Physicians Conflicts of Interest in HMOs abnd Hospitals. 9: Mark A. Hall: Physician Rationing and Agency Cost Theory. 10: E. Haavi Morreim: Conflicts of Interest for Physician Entrepreneurs. 11: Jay A. Katz: Informed Consent to Medical Entrepreneurialism. 12: Jean M. Mitchell: Physician Joint Ventures and Self Referral: An Empirical Perspective. Part III: The Pharmaceutical Industry's Influence on Clinical Practice and Referrals. 13: Roy G. Spece, Jr., Davis S. Shimm, and Michele Y. Burpeau-DiGregorio: Conflicts of Interest in Relationships Between Physicians and the Pharmaceutical Industry. Part IV: Clinical Research. 14: Roy G. Spece, Jr., and David S. Shimm: An Introduction to Conflicts of Interest in Clinical Research. 15: Edward J. Huth: Conflicts of Interest in Industry-Funded Clinical Research. 16: Baruch A. Brody: Conflicts of Interest and the Validity of Clinical Trials. 17: Thomas L. Kurt: Regulation of Government Scientists' Conflicts of Interest. 18: Leslie Francis: IRBs and Conflicts of Interest

Journals/Publications

• Spece, R. G. (2018). DISCRIMINATION AND BALKANIZATION (EMPIRICAL STUDY OF LIKELY RESPONSES TO VARIOUS UNIVERSITY ADMISSION PROGRAMS. various.
• Spece, R. G. (2020). Chiropractic Manipulation: Junk Science and Tort Reform. Being submitted to numerous publications.
• Spece, R. G. (2020). Medicare Set-Asides as Impediments to Settlement. Submitted to numerous publications.
• Spece, R. G. (2020). Revisiting, After Half a Century, The First Amendment Argument Against Coercive Use of "Mind"/Brain/Thought Tampering. Being submitted to numerous publications.
• Spece, R. G., & Abraham, M. (2021). Black Lives and Bioethics. Submitted to numerous publications.
• Spece, R. G., & Witte, R. (2021). What Is Protected Thought. Submitted to numerous publications.
• Spece, R. G. (2021). COVID-19 CONTROL: DISRUPTING DOCTOR-PATIENT RELATIONSHIPS. Nebraska Law Review, 100(1), 150-209.
• Spece, R. G. (2021). COVID-19 CONTROL: DISRUPTING DOCTOR-PATIENT RELATIONSHIPS. Nebraska Law Review.
• Spece, R. G., & Hilton, J. K. (2017). SAYING YES TO SPOUSAL INTIMACY: A PROPOSED EVIDENCE-BASED BALANCING TEST TO DETERMINE CAPACITY OF MARRIED LONG-TERM CARE RESIDENTS WITH DEMENTIA TO CONSENT TO SEX WITH THEIR SPOUSES. Indiana Law Review, 50(3), 35.
• Younggren, J. N., Spece, R. G., Spece, J. R., & Hilton, J. K. (2017). Implicit) Consent to Intimacy. Indiana law review, 50(3), 907-942. doi:10.18060/4806.1156
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  This paper discusses the capacity of long-term care residents - even some with dementia - to consent to intimacy with their spouses or partners, the health and legal implications of prohibiting or allowing such intimacy, and a set of procedural and substantive policies that protect residents’ rights and interests while minimizing abuse risk. The policies provide, in part, that (1) residents are presumptively competent; (2) consent can be by way of explicit oral or written direction upon admission, a prior written statement, or, for those without a written statement and unable or unwilling to verbally communicate their wishes, by failure to object to intimacy with their spouse/partner either verbally or physically (“implicit consent”); (3) if there is no prior statement or a directive upon admission and the facility reasonably has substantial doubts about a resident’s competency, it shall arrange or require a competency evaluation using a described domain-specific and risk-sensitive approach; (4) all residents retain the right to revoke prior consent orally or physically regardless of competency, but a prior directive that intimacy cease if the resident becomes incompetent shall not be disregarded; (5) residents should be encouraged to include in any specific oral or written statements their wishes should they become legally incompetent as well as a surrogate decision-maker who can intervene and make decisions about intimacy in circumstances specified in the policy; (7) unless it becomes obvious -- to a surrogate or a qualified employee of the facility designated to make such judgments and informed through the medical records that shall contain entries by staff educated to observe for indications of abuse under the state of the art -- that the resident might lack the capacity to object orally or physically or the resident communicates a desire to revoke consent, the facility shall facilitate the resident’s and spouse/partner’s privacy; (8) if it reasonably appears that the resident might lack capacity and is suffering harm, the appointed surrogate or qualified employee can request the spouse/partner to confirm the resident has not verbally or physically refused intimacy, and intimacy must cease if there is no confirmation; (9) if there is confirmation, the surrogate, or the facility’s appointed s qualified employee when there is no surrogate, should bring the matter to court if the surrogate or qualified employee determines that it is in the resident’s best interests to cease intimacy, best interests being determined by considering the resident’s past relevant representations, other indications of the resident’s critical and experiential interests, and the resident’s physical and emotional well-being; and (10) the court should determine best interests using the same criteria.
• Spece, R. G., & Yokum, D. (2015). Scrutinizing Strict Scrutiny. Vermont Law Review, 40(2).
• Macklin, R., Shepherd, L., Dreger, A., Asch, A., Baylis, F., Brody, H., Churchill, L. R., Coleman, C. H., Cowan, E., Dolgin, J., Downie, J., Dresser, R., Elliott, C., Epright, M. C., Feder, E. K., Glantz, L. H., Grodin, M. A., Hoffman, W., Hoffmaster, B., , Hunter, D., et al. (2013). The OHRP and SUPPORT - Another view. New England Journal of Medicine, 369(2), e3.
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  PMID: 23803134;
• Spece Jr., R. G. (2013). Direct and enhanced disclosure of researcher financial conflicts of interest: the role of trust.. Health matrix (Cleveland, Ohio : 1991), 23(2), 409-424.
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  PMID: 24341077;Abstract: In earlier writing, I recommended direct disclosure of major researcher financial conflicts of interest in per capita funding arrangements--the practice of providing researchers with a fixed sum for each subject recruited and enrolled in a study. This Article adds a recommendation for enhanced direct disclosure. The enhancement in the disclosure is a summary of why per capita and excess payments are being discussed and further includes whether the sponsors of the research and the researchers have claimed that there are no excess payments. The reason per capita payments are being discussed is because of the risk--with special caution when sponsors and researchers are not willing to claim that there are no excess payments--of introducing bias into researchers' decisions regarding study design, implementation, and interpretation, as well as concerning whom to enroll or keep in studies. Researchers' claims that there are no excess payments do not vitiate the risk of such payments. Nevertheless, a special admonition when sponsors and researchers do not claim the absence of excess payments would hopefully encourage them to eschew excess payments. My recommendations are required by the rights to bodily integrity and autonomy embedded in informed consent. Several arguments have been made against my recommendations, many of which relate to supposed effects on trust. My rights-based recommendations should not be rejected because of objections based on propositions that (1) are conceptually unclear because of a failure to unbundle different kinds and degrees of trust and (2) have not been empirically proven even where concepts are clarified. In some instances, the required strong empirical confirmation cannot be made because of practical or ethical restraints, including the fact that some of the necessary studies would require invasion of the right to informed consent. Finally, I suggest and partially apply an organizational method to generate empirical questions and guidance for future research in this area. Even the few hypothetical scenarios addressed demonstrate how complex--and sometimes practically or ethically impossible--the empirical studies must be to adduce proofs sufficient to overcome the imperative of informed consent.
• Spece, R. G., & Bernstein, C. (2007). Scientific misconduct and liability for the acts of others. Medicine and Law, 26(3), 477-491.
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  PMID: 17970247;Abstract: We argue that two ambiguities in [U.S.] Public Health Service ("PHS") misconduct regulations make them so vague that they are unconstitutional and unfair: (1) they provide no guidance concerning when one can be held responsible for others' actions; and (2) they simultaneously are intended to allow misconduct findings only when there are "significant departure[s] from established practices of the relevant research community" but even if one complied with customary standards of practice in her research community, thus providing confusion rather than guidance. The effect of these ambiguities is not only to leave researchers without notice as to proscribed or prescribed conduct but also to give officials discretion to apply the regulations arbitrarily and discriminatorily. The regulations' effect is illustrated by applying them, hypothetically, to facts relating to the central charge in the misconduct case pressed by the University of Arizona in 1997 through 2003 against then Arizona Regents' Professor Marguerite Kay. © YOZMOT 2007.
• Spece, R. G., & Bernstein, C. (2007). What is scientific misconduct, who has to (dis)prove it, and to what level of certainty?. Medicine and Law, 26(3), 493-510.
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  PMID: 17970248;Abstract: This article traces the regulation of [U.S.] Public Health Service ("PHS")-funded research from changes begun with the proposal (1999) and then adoption (2000) of a basic, Uniform Federal ("research misconduct") Policy. It argues that the PHS misconduct regulations deny due process of law and are fundamentally unfair because they fail to specify the level of culpability for guilt, force accused researchers to prove that they are innocent, and, although admittedly quasi-criminal, adopt a standard of proof that tolerates nearly a 50 percent probability of false convictions. The regulations' infirmities will be demonstrated by applying them to facts relating to the central charge in the misconduct case pressed by the University of Arizona in 1997 through 2003 against then Arizona Regents' Professor Marguerite Kay, which facts are set forth in our companion piece in this theme issue. © YOZMOT 2007.
• Spece, R. G., Spece, J. R., & Marchalonis, J. J. (2006). Sound Constitutional Analysis, Moral Principle, and WlSe Policy Judgment Require a Clear and Convincing Evidence Standard of Proof in Physician Disciplinary Proceedings. Indiana Health Law Review, 3(1). doi:10.18060/16467
• Spece Jr., R. G. (2003). Conflicts of interest affecting those who participate in staff privileges matters. HEC Forum, 15(2), 188-227.
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  PMID: 12918285;
• Spece Jr., R. G., & Marchalonis, J. (2003). What should the standard of proof be in scientific misconduct proceedings relating to public health service-funded research?. Cellular and molecular biology (Noisy-le-Grand, France), 49(4), 565-577.
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  PMID: 12899448;Abstract: This article discusses the nature and purposes behind the three standards of proof commonly used in the United States. It summarizes the analytical constructs or standards of review courts commonly use to determine the constitutional validity of standards of proof (as well as other procedural protections) in physician disciplinary proceedings. It applies these constructs to the context of scientific misconduct and an illustrative case, and shows that sound policy and morals as well as procedural due process and equal protection provisions of the United States and some state constitutions require the use of the clear and convincing evidence standard of proof in scientific misconduct proceedings. That standard is necessary to protect scientists from misuse of scientific misconduct charges and proceedings, entailing, as they do, vast discretion in bureaucratic officials as well as staggering costs. The imminent rule making proceedings at the federal level will provide a special opportunity to right a wrong that long has been long visited upon academic scientists throughout the United States.
• Spece Jr., R. G., & Marchalonis, J. J. (2001). Fourth Amendment restrictions on scientific misconduct proceedings at public universities.. Health matrix (Cleveland, Ohio : 1991), 11(2), 571-626.
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  PMID: 11683049;
• Spece, R. G., & Weinzierl, J. (1998). First Amendment protection of experimentation: a critical review and tentative synthesis/reconstruction of the literature.. Southern California interdisciplinary law journal, 8(1), 185-228.
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  PMID: 15085843;
• Shimm, D. S., & Spece, R. G. (1993). Ethical issues and clinical trials. Drugs, 46(4), 579-584.
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  PMID: 7506646;
• Spece, R., Shimm, D. S., & Spece, R. G. (1993). Ethical issues and clinical trials. Drugs, 46(4).
• Shimm, D. S., & Spece, R. G. (1992). Rate of refusal to participate in clinical trials.. IRB; a review of human subjects research, 14(2), 7-9.
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  PMID: 11651246;
• Spece Jr., R. G. (1992). Should HECs be designed primarily to assist the health care team and institution rather than the patient? - Yes: HECs should be designed primarily to assist the health care team and institution. Hec Forum, 4(3), 199-203.
• Spece Jr., R. G., & Meyer, H. B. (1992). Point and counterpoint. Should HECs be designed primarily to assist the health care team and institution rather than the patient?. HEC forum : an interdisciplinary journal on hospitals" ethical and legal issues, 4(3), 199-203, 205.
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  PMID: 10120024;
• Shimm, D. S., & Spece Jr., R. G. (1991). Conflict of interest and informed consent in industry-sponsored clinical trials. Journal of Legal Medicine, 12(4), 477-513.
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  PMID: 1800586;
• Shimm, D. S., & Spece Jr., R. G. (1991). Industry reimbursement for entering patients into clinical trials: Legal and ethical issues. Annals of Internal Medicine, 115(2), 148-151.
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  PMID: 2058862;Abstract: • Pharmaceutical manufacturers commonly contract with clinical investigators for pre-market testing of new products. The per-patient reimbursement offered to the investigator generally exceeds the per-patient costs incurred by the investigator. This excess represents a windfall that can be used to pay for travel, equipment, or supplies, or to fund research for which the investigator cannot obtain funding through peer-reviewed granting channels. This excess raises a potential conflict of interest, because it may lead the investigator to propose experimental treatment for a patient when the patient might be better served by conventional treatment or by no treatment at all. Not only does this situation pose a conflict of interest, it also is a conflict of which few patients are aware and fewer are informed. We propose that all experimental subjects be informed of the source, amount, and mechanism of funding for the experimental treatments they undergo. Further, we propose that payments from pharmaceutical manufacturers for pre-market testing of drugs go to the medical school dean rather than to the individual investigator. With this money, the dean can defray the direct as well as the indirect costs of the clinical study; the remainder, which would otherwise go directly to the investigator, should be placed in a funding pool for which the entire medical school could compete. This solution largely eliminates conflict of interest, addresses informed consent, and reasonably balances the interests of the experimental subject, the clinical investigator, the pharmaceutical manufacturer, and the academic institution.
• Spece, R., Shimm, D. S., & Spece, R. G. (1991). Conflict of interest and informed consent in industry-sponsored clinical trials. The Journal of legal medicine, 12(4).
• Spece, R., Shimm, D. S., & Spece, R. G. (1991). Industry reimbursement for entering patients into clinical trials: legal and ethical issues. Annals of internal medicine, 115(2).
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  Pharmaceutical manufacturers commonly contract with clinical investigators for pre-market testing of new products. The per-patient reimbursement offered to the investigator generally exceeds the per-patient costs incurred by the investigator. This excess represents a windfall that can be used to pay for travel, equipment, or supplies, or to fund research for which the investigator cannot obtain funding through peer-reviewed granting channels. This excess raises a potential conflict of interest, because it may lead the investigator to propose experimental treatment for a patient when the patient might be better served by conventional treatment or by no treatment at all. Not only does this situation pose a conflict of interest, it also is a conflict of which few patients are aware and fewer are informed. We propose that all experimental subjects be informed of the source, amount, and mechanism of funding for the experimental treatments they undergo. Further, we propose that payments from pharmaceutical manufacturers for pre-market testing of drugs go to the medical school dean rather than to the individual investigator. With this money, the dean can defray the direct as well as the indirect costs of the clinical study; the remainder, which would otherwise go directly to the investigator, should be placed in a funding pool for which the entire medical school could compete. This solution largely eliminates conflict of interest, addresses informed consent, and reasonably balances the interests of the experimental subject, the clinical investigator, the pharmaceutical manufacturer, and the academic institution.
• Spece Jr., R. G. (1988). AIDS: due process, equal protection, and the right to treatment.. Issues in law & medicine, 4(3), 283-344.
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  PMID: 3069801;
• Froede, R. C., & Spece Jr., R. G. (1987). Forensic and medicolegal aspects of transplantation.. Contemporary anesthesia practice, 10, 1-29.
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  PMID: 3555993;
• Spece, R. G. (1978). A purposive analysis of constitutional standards of judicial review and a practical assessment of the constitutionality of regulating recombinant DNA research.. Southern California Law Review, 51(6), 1281-1351.
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  PMID: 11661658;
• Spece, R. G. (1978). Preserving the right to treatment: a critical assessment and constructive development of constitutional right to treatment theories.. Arizona law review, 20(1), 1-47.
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  PMID: 11664134;

Presentations

• Spece, R. G. (2022, Summer). COVID-19: Lessons Learned on Legal & Policy Challenges
  . 45th ANNUAL HEALTH LAW PROFESSORS CONFERENCE. Phoenix, AZ: American Association of Law, Medicine & Ethics.

Creative Productions

• Spece, R. G. (2023. An Empirical Investigation of Racial Divisiveness and Explicitness in College Admission Programs.
• Spece, R. G. (2023. Chiropractic Manipulation: Junk Science and Tort Reform.
• Spece, R. G. (2023. Medicare Set-Asides as Impediments to Settlement.
• Spece, R. G. (2023. Revisiting, After Half a Century, The First Amendment Argument Against Coercive Use of "Mind"/Brain/Thought Tampering.
• Spece, R. G., Torrealba, F., Downing, C. G., & Ibanez, R. M. (2013. Comparing Certain Aspects of U.S. and Costa Rican Medical Malpractice Compensation Systems: Bad News for Costa Ricans and Medical Tourists to Costa Rica?". 30 Ariz J. Int'l & Comp. L. 187.