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1

Lokakarya, dan Pelatihan Tentang Hak-Hak Masyarakat Adat FPIC (Free Prior Informed Consent) REDD dan Penyelesaian Konflik (2009 Manokwari Indonesia). FPIC (Free, Prior, and Informed Consent), REDD (Reducing Emissions form Deforestation and Forest Degradation), dan resolusi konflik: Workshop dan training di Manokwari, Propinsi Papua Barat, 19-21 Mei 2009. Jakarta]: Pusaka, 2009.

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2

Informed consent: A tutorial. [Owings Mills, MD]: National Health Pub., 1986.

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3

Engstrom, Karen M. Health care consent manual: Policies, laws, procedures. 2nd ed. St. Louis, Mo: Catholic Health Association of the United States, 1985.

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4

F, Wilson James. Legal consent forms for veterinary practices. 3rd ed. Lakewood, Colo: American Animal Hospital Association Press, 2001.

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5

Zuber, Thomas J. Office procedure forms. Baltimore: Williams & Wilkins, 1999.

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6

Canadian healthcare forms and policies. Markham, Ont: LexisNexis Canada, 2007.

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7

Miletti, Antonella. Obblighi informativi e tutela della salute del consumatore: Health claims, prescrizioni di forma ed obbligo di informare se stesso. Napoli: Edizioni scientifiche italiane, 2012.

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8

When life ends: Legal overviews, medicolegal forms, and hospital policies. Westport, Conn: Praeger, 1995.

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9

Institute of Medicine (U.S.). Committee on Assessing the System for Protecting Human Research Subjects. Preserving public trust: Accreditation and human research participant protection programs. Washington, D.C: National Academy Press, 2001.

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10

Glazkova, Mariya. Court practice in the mechanism of legal monitoring. ru: INFRA-M Academic Publishing LLC., 2020. http://dx.doi.org/10.12737/25284.

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The manual discusses the role of judicial practice in the implementation of the mechanism of legal monitoring on the Federal, regional and local levels. It justifies significance of judicial practice as an integral part of the legal monitoring, since it is the judiciary, which is constant- Janno being at the turn of sometimes conflicting interests to have the most complete information about the quality of legislation. Describes the theoretical and normative foundations of legal monitoring, its organization and influence on the development of procedural law and the legal system. Special attention given the anti-corruption monitoring. The work is aimed at resolving issues of implementation of legal monitoring in the activities of public authorities, business-structures, public organizations and other civil society institutions in order to make informed proposals on optimization of the Russian legislation. For deputies, employees of state and municipal authorities, representatives of civil society institutions, scientific workers, teachers, postgraduates and students of law universities and faculties.
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11

United States. Congress. House. Committee on Agriculture. PIC and POPS Conventions and the LRTAP POPS Protocol Implementation Act: Report (to accompany H.R. 3849) (including cost estimate of the Congressional Budget Office). [Washington, D.C: U.S. G.P.O., 2006.

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United States. Congress. House. Committee on Energy and Commerce. Stockholm and Rotterdam Toxics Treaty Act of 2006: Report together with dissenting views (to accompany H.R. 4591) (including cost estimate of the Conggressional Budget Office). [Washington, D.C: U.S. G.P.O., 2006.

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13

Rathmell, Anna. Consent. Edited by Patrick Davey and David Sprigings. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780199568741.003.0007.

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In contemporary medicine, the traditional paternalistic model of healthcare has largely been replaced with a model which focuses on patient autonomy and the right of patients to have as much control as possible over decisions relating to their medical care. In English law, this has led to the concept of informed consent and the right of patients to withdraw their consent at any time, even if they have previously given consent or signed a consent form.
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14

Health care powers of attorney: An introduction and sample form. Washington, D.C: Commission on Legal Problems of the Elderly, American Bar Association, Public Services Division, 1990.

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15

Farb, Daniel. Agent GCP and the Bloody Consent Form Library Edition: Informed Consent and Institutional Review Boards in Clinical Trials, for Beginner to Advanced, for ... Also Relevant to Biomedical Ethics. University Of Health Care, 2004.

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16

Farb, Daniel. Agent GCP and The Bloody Consent form Guidebook: Informed Consent and Institutional Review Boards in Clinical Trials, For Beginner to Advanced, For Pharmaceutical ... Also Relevant to Biomedical Ethics. UniversityOfHealthCare, 2005.

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17

Farb, Danile. Agent GCP and the Bloody Consent Form 5 Users: Informed Consent and Institutional Review Boards in Clinical Trials, For Beginner to Advanced, For Pharmaceutical ... Also Relevant to Biomedical Ethics. UniversityOfHealthCare, 2005.

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18

Gordon, Bruce, and Daniel Farb. Agent GCP and the Bloody Consent Form Manual and CD, Informed Consent and Institutional Review Boards in Clinical Trials, For Beginner to Advanced, For ... Also Relevant to Biomedical Ethics. UniversityOfHealthCare, 2003.

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19

van Staden, C. W. Informed Consent to Treatment. Edited by John Z. Sadler, K. W. M. Fulford, and Werdie (C W. ). van Staden. Oxford University Press, 2015. http://dx.doi.org/10.1093/oxfordhb/9780198732372.013.25.

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The chapter clarifies the scope and conditions of informed consent before addressing capacity and incapacity to give informed consent, its clinical assessment, and some clinical examples. It underscores the crucial place of good process in both informed consent and the assessment of incapacity to give informed consent owing to mental disorder. Good process provides for the practical co-production of the necessary conditions of informed consent insofar as incapacity owing to mental disorder does not prevent these from pertaining. By good process, the assessment of such incapacity involves a clinical consideration of (1) the presence of mental disorder as well as the mental contents as affected by mental disorder that (2) are preventing the patient from (3) understanding the intervention, communicating, choosing decisively, or accepting the need for the intervention. By good process understanding may be nurtured, better communication ensured, undue influences identified and managed, and more certainty and acceptance developed and grown co-productively.
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20

Periodontology, American Academy of, ed. Informed consent for surgical periodontics: Information and sample forms. Chicago: American Academy of Peridontology, 1991.

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21

Dwight, Newman. Part III Indigenous Peoples and the Canadian Constitution, C Indigenous Peoples and the Constitution Act, 1982, Ch.16 The Section 35 Duty to Consult. Oxford University Press, 2017. http://dx.doi.org/10.1093/law/9780190664817.003.0016.

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This chapter examines the duty to consult doctrine, which is a particularly significant doctrine under Canada’s section 35 Aboriginal rights clause that is triggered hundreds of thousands of times a year. Since a series of cases in 2004, this doctrine has taken a particular proactive form in which the honour of the Crown leads to government duties of consultation when government decisions potentially impact on Aboriginal or treaty rights. This chapter explains the purposes and origins of this duty, considers its relationship to developing international norms on consultation and FPIC (free, prior, and informed consent), and considers a number of controversies that have emerged on the scope of its application. The chapter also examines the complex relationships of the duty to consult to administrative law contexts before turning to some final comments on potential future directions for the duty.
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22

Read, Stephen L., and James E. Spar. Capacity, Informed Consent, and Guardianship. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780199374656.003.0009.

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Medical decision-making based on informed consent is a fundamental principle of ethical medical practice. When a patient lacks medical decisional capacity and is unable to give truly informed consent, an agent must be sought to act on the behalf of the person. This chapter reviews the principles underlying determination of the capacity to give informed consent regarding healthcare decisions in a clinical setting. Cognitive loss, emotional distress, or disengagement or the perception that the patient is choosing unwisely or as a result of influence may be concerns that lead to consultation. In contrast to the clear standards for medical decision-making capacity, statutory guidance and case law are essentially nonexistent regarding what standard applies to the capacity to create or to change an advance health directive (AHCD) or to change or designate a healthcare agent. In addition to current decision-making capacity, the consultant must address broader issues of functional or management capacity when the patient’s ongoing capacity to manage personal care and health is at issue, as is relevant to the petition for guardianship. A comprehensive forensic geriatric psychiatry consultation will assist with the care of the patient.
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23

Silverman, Henry J. Informed consent in the ICU. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199600830.003.0025.

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The doctrine of informed consent is an important concept in medical care, but presents challenges in the critical care setting, where patients may have diminished capacity to provide their own informed consent. The elements of informed consent include adequate disclosure of information, cognitive capacity of individuals to make decisions, and the voluntary nature of such decisions. Currently, there are no universally accepted procedures regarding capacity assessment, especially in critically-ill patients. Such assessments remain subjective, but this chapter provides some guidelines on the subjective assessment of such capacity. When it is determined that patient lacks decision making capacity to provide consent, several mechanisms exist by which their autonomy can still be respected, including following any existing advance directives or family members or friends’ moral authority to make decisions for patients, based on either the substituted standard or the best-interests standard. Informed consent issues in the emergency clinical situations and in the context of research are also discussed.
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24

Flanigan, Jessica. Pharmaceutical Freedom. Oxford University Press, 2017. http://dx.doi.org/10.1093/oso/9780190684549.001.0001.

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If a competent adult refuses medical treatment, physicians and public officials must respect her decision. Coercive medical paternalism is a clear violation of the doctrine of informed consent, which protects patients’ rights to make medical decisions even if a patient’s choice endangers her health. The same reasons for rejecting medical paternalism in the doctor’s office are also reasons to reject medical paternalism at the pharmacy. Yet coercive medical paternalism persists in the form of premarket approval policies and prescription requirements for pharmaceuticals. This book defends patients’ rights of self-medication. It argues that public officials should certify drugs instead of enforcing prohibitive pharmaceutical policies that disrespect people’s rights to make intimate medical decisions and prevent patients from accessing potentially beneficial new therapies. This argument has revisionary implications for important and timely debates about medical paternalism, recreational drug legalization, human enhancement, prescription drug prices, physician assisted suicide, and pharmaceutical marketing. The need for reform is especially urgent as medical treatment becomes increasingly personalized and patients advocate for the right to try. The doctrine of informed consent revolutionized medicine in the twentieth century by empowering patients to make treatment decisions. Rights of self-medication are the next step.
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25

Publishing, St Anthony, ed. St. Anthony's forms that work: Customizable forms for your medical practice. Reston, VA: St. Anthony Pub., 1997.

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26

Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and Sarah Gibbings, eds. Informed consent in a research setting. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199608478.003.0009.

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Informed consent is a legal requirement for all clinical trials conducted on human subjects. This chapter summarises the process for obtaining consent for non-clinical trial research and goes on to describe the more highly regulated consent process for clinical trials in investigational medicinal products (CTIMPs). The chapter defines consent and discusses the requirements for consent in capable adults. The process for CTIMP studies is outlined together with the required elements of consent to be documented in the patient information sheet and the process to be followed with withdrawal of consent is also described. Consent, assent and the concept of legal representatives in vulnerable groups is discussed including children and incapacitated adults. How to assess capacity is described along with consent in emergency situations. Formally documenting the consent process and how the information is given to the patient is vital. The role of the research team in consent is outlined. The investigator is advised to describe the process of consent and should identify which registered health professionals will undertake the process. In some situations a medically qualified person will be required to determine eligibility prior to enrolment, to discuss the study and assess capacity if necessary. A participant's decision to consent for research may be influenced by 'the research culture' in the country or the health care setting. Transparency and providing information continuously to participants throughout the study will re-assure them and reaffirm their willingness to continue.
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27

Jenkins, Kath. Consent and anaesthetic risk. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780198719410.003.0002.

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This chapter describes the importance of obtaining informed consent for anaesthesia. It covers some ethical points to guide this process. Informed consent requires good knowledge of the risks of anaesthetic practice and their likelihood. The chapter contains a detailed table of perioperative adverse outcomes, linked to real-life examples to aid clarity of communication to the patient. There are detailed suggestions of how to identify the higher-risk patient and estimate their risk of perioperative mortality and morbidity.
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28

Jenkins, Kath. Consent and anaesthetic risk. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780198719410.003.0002_update_001.

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This chapter describes the importance of obtaining informed consent for anaesthesia. It covers some ethical points to guide this process. Informed consent requires good knowledge of the risks of anaesthetic practice and their likelihood. The chapter contains a detailed table of perioperative adverse outcomes, linked to real-life examples to aid clarity of communication to the patient. There are detailed suggestions of how to identify the higher-risk patient and estimate their risk of perioperative mortality and morbidity.
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29

Thomas, David F. M. Disorders of sex development. Edited by David F. M. Thomas. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780199659579.003.0124.

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The aetiology of disorders of sex development (DSD) is multifactorial and includes chromosomal defects, developmental abnormalities of the gonads, and defects of hormonal synthesis and expression. Infants born with ambiguous genitalia require urgent investigation because of the risk of hyponatraemia associated with congenital adrenal hyperplasia (CAH) and to permit an informed decision on gender assignment. CAH is the commonest form of DSD, accounting for around 80% of all infants born with ambiguous genitalia. Despite controversy regarding timing and consent, feminizing genitoplasty in early childhood remains the accepted management for girls with significant clitoromegaly. Surgical reconstruction for 46XY DSD is guided by several factors, notably the size of the phallus and gonadal phenotype. The majority of individuals with disorders of sex development will require ongoing specialist care and long-term multidisciplinary follow-up and support.
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30

Shah, Monica, and David Waisel. Ethics in Pediatric Anesthesiology. Edited by Kirk Lalwani, Ira Todd Cohen, Ellen Y. Choi, and Vidya T. Raman. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780190685157.003.0066.

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Ethical principles affect daily decision-making in pediatric anesthesiology. These medical decisions are interlaced with the ethical components of informed consent and obligations to the child and family. Informed consent in pediatrics includes the concepts of best interest, in which the parents or other surrogate decision-makers choose acceptable treatment for the child, and assent, which enables children to participate in decision-making to the best of their ability. Of equal significance to informed consent, the process of informed refusal requires anesthesiologists to more fully inform children and their guardians about risks and benefits while respecting refusal of assent and avoiding coercion. Pediatric considerations regarding end-of-life therapy are slightly different than adult considerations. To help resolve these ethical dilemmas, ethics committees are available for consultations to assist the medical team, family members, and patients in order to make the best decision for the child.
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31

Saxton, James W., Amanda R. Budak, and Maggie M. Finkelstein. Medicolegal Issues in Bariatric Surgery. Edited by Tomasz Rogula, Philip Schauer, and Tammy Fouse. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780190608347.003.0040.

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Bariatric surgery is more of a service business than any other surgical specialty. From the medicolegal perspective, the risk of a complication becoming a lawsuit can be mitigated by focusing on the relationship with the patient, addressing patient expectations with specific documentation, and prompt, clear communication if a complication occurs. Studies show that when a patient complaint or dissatisfaction is coupled with an adverse event, the patient is more likely to sue. This chapter reviews the current bariatric surgery liability environment and explains how recent changes in the healthcare and liability landscapes have and will continue to affect surgical practice. The chapter introduces three important strategies to increase engagement with your bariatric surgery patient and concurrently impact your liability risk: Five-Star Service, second-generation informed consent form and process, and post-adverse event communication.
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32

Wollschlaeger, Bernd. Opioid Overdose Education, Prevention, and Management (DRAFT). Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780190265366.003.0013.

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In reviewing the elements of opioid overdose education, prevention, and management, this chapter focuses particularly on practical interventions that are available and deserve advocacy; e.g., provision of naloxone to those with opioid use disorder and to possible first responders. It moves from a discussion of the epidemiology of opioid deaths to the more individual topic of patient risk for overdose. Prophylactic interventions in the form of education of the patient’s family and friends, and agreements for treatment with informed consent are described. There follows a discussion of management of the opioid poisoning itself, including use/distribution of naloxone injection. Two figures are included: drug overdose death rates in the United States (2014); a map describing the current states with naloxone or “good Samaritan” laws impacting opioid overdose management. A text box with resources includes directions for initiation of community overdose prevention and intervention schemes.
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33

Veatch, Robert M., Amy Haddad, and E. J. Last. Consent and the Right to Refuse Treatment. Edited by Robert M. Veatch, Amy Haddad, and E. J. Last. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780190277000.003.0017.

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This chapter is concerned with one of the major ethical issues in contemporary health care practice: informed or valid consent. The chapter defines the elements of informed consent—that is, the types of information that need to be transmitted for consent to be adequately informed. The second section looks at cases involving questions of the standards of consent, referring to the question of what standard of reference should be used in determining whether a sufficient amount of a particular type of information has been transmitted: the professional standard, the reasonable person standard, or the subjective standard. The third section examines questions of whether the information transmitted is comprehended and whether the consent is adequately voluntary. Finally, the fourth section addresses whether incompetent patients can be expected to consent and what role parents, guardians, and other surrogates can play in giving approval for medical treatments for those who are legally incompetent to do so themselves.
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34

Flanigan, Jessica. Conclusion. Oxford University Press, 2017. http://dx.doi.org/10.1093/oso/9780190684549.003.0008.

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Arguments in favor of rights of self-medication have revisionary implications for existing drug approval policies and drug prohibitions. Specifically, in order to respect people’s rights of self-medication public officials should not prohibit competent adults from purchasing and using (almost) any drugs. These implications may seem dangerous to some readers, but the current system is dangerous as well, and patients cannot consent to the risks associated with prohibitive policies. Even if public officials adopted policies that respected patient’s rights of self-medication, people who are concerned about the dangers of using pharmaceuticals could still consult a physician, government certification, or other experts before using a drug. In the twentieth century, patients benefited from increasing acceptance of the doctrine of informed consent. Pharmaceutical freedom is the next step.
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35

Carrington, R. W. J. Preoperative planning for total hip replacement, consent, and complications. Oxford University Press, 2011. http://dx.doi.org/10.1093/med/9780199550647.003.007003.

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♦ Preoperative planning is essential to achieve successful results after total hip replacement♦ Obtaining informed consent is important for both surgeon and patient♦ The surgeon must have a comprehensive knowledge of the aetiology and treatment of the common associated complications.
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36

Cutter, Mary Ann G. What Are the Ethical Implications of Understanding and Treating Breast Cancer? Oxford University Press, 2018. http://dx.doi.org/10.1093/oso/9780190637033.003.0007.

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Philosophically speaking, the question “What are the ethical implications of understanding breast cancer?” raises a host of issues, including informed consent, risk assessment, and access to breast cancer care. What we find is that, initially, there are adequate guidelines for informed consent, adequate efforts to develop risk assessment measures, and a decent level of access to breast cancer care in the United States. But things can be improved from an ethical standpoint. Upon reflection, the informed consent process would benefit from a more explicit discussion of uncertainty in breast cancer medicine and the ways breast cancer patients make decisions about their care. Risk assessments would benefit from a more personalized approach. Access to breast cancer care could be improved by continued studies of the diverse forces that limit access to proper breast cancer care.
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37

Ramers, Christian B. Ethical Conduct of Clinical Trials, Institutional Review Boards, Informed Consent, and Financial Conflicts of Interest. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780190493097.003.0052.

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Ethics and conflicts of interest are important considerations when planning and carrying out research. It is the role of the institutional review board to weigh these against protection of the research subject when evaluating research proposals. The ethical considerations when performing research include basic ethical principles (e.g., autonomy, confidentiality, non-maleficence, informed consent, beneficence, justice, and utility), as well as nuances such as appropriate study designs, investigator conflict of interests, and bias in all its forms. To help guide clinicians, a number of professional and governmental organizations have published guidelines and recommendations on various aspects of clinical research (e.g., the American Medical Association, the National Institutes of Health, and the US Food and Drug Administration).
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38

Christopher, Paul P., and Laura B. Dunn. Psychiatric Research Ethics. Edited by John Z. Sadler, K. W. M. Fulford, and Werdie (C W. ). van Staden. Oxford University Press, 2014. http://dx.doi.org/10.1093/oxfordhb/9780198732372.013.11.

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The nature of neuropsychiatric disorders raises questions and concerns that must be addressed for research on these disorders to proceed ethically. This chapter discusses the rationale for both conceptual and empirical ethics work related to psychiatric research, focusing in particular on informed consent, decision-making capacity, and voluntarism. The extant literature regarding the abilities of people with mental illness to provide informed consent to research is reviewed. Also discussed are the ethical implications of co-occurring problems frequently faced by people with mental illness. Finally, the types of conceptual and empirical work that are needed to move psychiatric research ethics forward are discussed.
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39

Dickert, Neal W., and Scott D. Halpern. Research ethics in the ICU. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199600830.003.0024.

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In no context is rigorous clinical research more important than in ICU care. However, clinical research in the ICU poses numerous ethical challenges, some of which are unique or particularly problematic in the ICU setting. Significant barriers exist to informed consent, and existing approaches to consent challenges are limited and lack evidence. Moreover, some studies can only be done in the absence of consent. Additionally, high levels of acuity and variable levels of evidence for both current and innovative treatments often make assessments of equipoise and control group selection particularly difficult. Finally, studies evaluating systems-based approaches to ICU care are integral to advancing the field. However, these studies can be difficult to distinguish from quality improvement activities and require careful consideration given their potential impact on major patient outcomes and the impracticability of informed consent in this context. This chapter discusses these prominent ethical issues in ICU research, and argues that there is a need for further research on ethical dimensions of clinical research in the ICU as well as a need for innovative, context-sensitive solutions.
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40

ABA Commission on Legal Problems of the Elderly., ed. Lawyer's tool kit for health care advance planning. Washington, D.C: ABA Commission on Legal Problems of the Elderly, 2000.

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41

Flanigan, Jessica. A Defense of Self-Medication. Oxford University Press, 2017. http://dx.doi.org/10.1093/oso/9780190684549.003.0001.

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The same considerations that justify rights of informed consent also justify rights of self-medication because paternalism is wrong at the pharmacy and in the doctor’s office. Rights of self-medication require that patients have legal access to medicines without a prescription and without authorization from a regulatory agency. Like informed consent, the right of self-medication does not rely on a single, potentially controversial normative premise. From a consequentialist perspective, patients should be entrusted with making choices for themselves because they are generally most knowledgeable about which decision will further their interests. From a rights-based perspective, medical decisions are often intimate and personal choices that are especially significant to patients. Furthermore, even if a medical choice is not intimate, personal, or especially significant, people are more generally entitled to choose how they live their lives without being subjected to benevolent interference by physicians or public officials.
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42

Abubaker, S. Khalid, Tyler G. Jones, and Philip J. Candilis. Geriatric Psychiatry Research. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780199374656.003.0040.

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Forensic research with older participants carries more ethical challenges than either geriatric or forensic research alone. Concerns with cognitive impairment, informed consent, and voluntariness combine to complicate investigations of criminal and civil competencies, aggression, and the needs of an aging correctional population. Despite the paucity of regulatory guidance, researchers have developed a number of tools for simplifying the complex requirements of forensic geriatric research. Formal assessments for capacity to consent, ongoing consent discussions and enhancements, use of surrogate decision-makers, attention to vulnerability and desperation, and research useful to the subjects themselves are all part of a best practice model that underscores the dignity and personhood of this vulnerable research population. This chapter addresses each of these elements of best practice in geriatric forensic research, as well as research ethics required in conducting geriatric psychiatry forensic research.
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43

Dodds, Chris, Chandra M. Kumar, and Frédérique Servin. Ethics and the law involving the elderly. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780198735571.003.0015.

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The role of ethics in the care of the elderly is discussed, and some of the aspects of importance to anaesthesia are reviewed. Ethical principles are commonly viewed as either consequential, where the risk/benefit balance between necessary harm (surgery) provides improved quality of life, or deontological, where it is simply the action that is judged and not the outcome. The lack of individualized outcome data is identified as a major issue for the consequential process. Consent for surgery (and anaesthesia) is described in the context of the UK, but it is applicable worldwide. The validity of informed consent is reviewed against the criteria of competence, lack of duress, and appropriately provided information. The capacity to give consent and the use of legal alternatives such as health attorneys is detailed. Finally, the debate on excellent palliative care rather than assisted death is reviewed.
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44

Veatch, Robert M., Amy Haddad, and E. J. Last. Death and Dying. Edited by Robert M. Veatch, Amy Haddad, and E. J. Last. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780190277000.003.0018.

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Many of the critical moral decisions related to the care of terminally and critically ill patients actually involve the ethical issues of informed consent or the refusal and withdrawal of consent. Legal as well as most ethical theories consider the moral principle of autonomy to take priority over paternalism. If this is true, then it is acceptable for the substantially autonomous patient, even if treatment is life-sustaining, to decline or to withdraw consent. This chapter begins with the problems associated with definitions of death. In succeeding sections, the cases deal with decisions by surrogates for terminally or critically ill patients who are not competent to make their own choices, looking first at formerly competent patients and then at those who have never been competent. In the final section, the issue is new controversies over limiting the amount of care that is provided to terminally ill patients in order to conserve scarce medical resources.
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45

Gibson, Lorna M., Cathie L. M. Sudlow, and Joanna M. Wardlaw. Incidental findings: Current ethical debates and future challenges in advanced neuroimaging. Oxford University Press, 2017. http://dx.doi.org/10.1093/oso/9780198786832.003.0003.

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The urgency to pragmatically address the challenges of managing incidental findings on neuroimaging is driven by the recent development of very large, population-based imaging studies, and ever-increasing use of imaging within research, clinical, and commercial sectors. Incidental findings are complex and variable. Their clinical significance ranges from benign to life-threatening; detection may be influenced by imaging, reader, and participant characteristics; and feedback may generate follow-up and anxiety. Appropriate management of incidental findings is therefore challenging, but essential in order to minimize negative impacts on participants, health services, individual research studies, and public trust in the wider community. This chapter summarizes current knowledge of the scale of the problem of incidental findings, factors influencing detection, potential impact, and public expectations. It highlights areas where robust, empirical data are needed to inform the design of feasible management policies and improve informed consent processes for the future.
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46

Bruce, Steve. Ethics in Social Research. Oxford University Press, 2018. http://dx.doi.org/10.1093/oso/9780198786580.003.0006.

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It is right that social researchers consider the ethical implications of their work, but discussion of research ethics has been distorted by the primacy of the ‘informed consent’ model for policing medical interventions. It is remarkably rare for the data collection phase of social research to be in any sense harmful, and in most cases seeking consent from, say, members of a church congregation would disrupt the naturally occurring phenomena we wish to study. More relevant is the way we report our research. It is in the disparity between how people would like to see themselves described and explained and how the social researcher describes and explains them that we find the greatest potential for ill-feeling, and even here it is slight.
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47

Sitarz, Daniel. Advance Health Care Directives Simplified (Law Made Simple). Nova Publishing Company, 2007.

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48

Skerker, Michael. A Two-Level Account of Executive Authority. Oxford University Press, 2018. http://dx.doi.org/10.1093/oso/9780190922542.003.0010.

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This chapter will consider whether an inhabitant of a liberal state needs to be informed of all her government’s policies in order for that government to have legitimate authority to compel her actions. Another way of putting this question is whether government authority in a liberal state depends on full transparency. Security actors in a liberal state are charged with maintaining a relatively crime-free and peaceful society because such an environment is a necessary precondition for a person’s full enjoyment of her rights over time. State agents should pick consent-worthy tactics indexed to this consent-worthy end. Since efficacious tactics may be in tension with respect for people’s rights, consent-worthy tactics will be those that are the most efficacious, effective, reliable, proportionate, and rights-respecting available. Transparency is not necessary for legitimacy since legitimate government actions are indexed to the hypothetical consent of a generic person rather than the explicit consent of particular people. Transparency is necessary for inhabitants to ensure that state agents do not err or become corrupt in the pursuit of otherwise legitimate aims. Yet the complete disclosure of government actions will compromise some legitimate security-seeking missions. In these cases, the moral need for secrecy trumps the need for disclosure. Liberal governments then can conceal the existence of certain programs without compromising their authority to implement them. Secrecy opens the door to corruption, but thankfully, these parameters apply to few tactics.
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49

Candilis, Philip J., and Eric D. Huttenbach. Ethics in correctional mental health. Oxford University Press, 2015. http://dx.doi.org/10.1093/med/9780199360574.003.0008.

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Working as a psychiatrist in a jail or prison presents many ethical issues, many unique to the correctional setting. Obligations to the law, professional standards, the community, and public health require a complex appreciation of competing values. It remains an extraordinary commentary on the state of mental health that the largest mental health institutions in the United States are jails and prisons. In daily practice, acknowledging healthcare, individual, and professional values in a robust vision of professionalism means advocating for clinical values and opposing mistreatment. Making the limits of confidentiality clear is a time-honored element of the informed consent process and need not be diluted in the correctional system. Honoring clear boundaries between treatment and forensic evaluation are the crux of this issue: confidentiality warnings and access to counsel cannot be one-off affairs that do not account for the cognitive, educational, or mental health vulnerabilities of the patient in a correctional setting. Developing trust, offering transparency, and delivering clear descriptions of procedural requirements are the lessons of an empirical database that supports this approach and can lead to more collaboration and less violence. This chapter presents a discussion of the critical concerns, including informed consent and coercion, dual agency, appropriate access to care, and managing professional boundaries and standards.
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50

Veatch, Robert M., Amy Haddad, and E. J. Last. Experimentation on Human Subjects. Edited by Robert M. Veatch, Amy Haddad, and E. J. Last. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780190277000.003.0016.

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This chapter examines ethical issues in research involving human subjects. The Nuremberg trials, which exposed to all humankind the outrageous things that could be done in the name of medical science, led to the Nuremberg Code, the first international document from public sources setting out an ethic for research on human subjects. Basic differences are outlined between the goals of therapy for the good of a patient and those of research that focus on attainment of knowledge and the good of society. To protect the interests of human subjects who take part in research, guidelines such as the Declaration of Helsinki have been established for assessing risks and benefits, voluntary consent, protection of privacy and confidentiality, and equity in subject selection. The chapter focuses on the difficulty in calculating harms and benefits to subjects and challenges of obtaining informed consent for participation in research.
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