74 found
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  1.  31
    Reframing Consent for Clinical Research: A Function-Based Approach.Scott Y. H. Kim, David Wendler, Kevin P. Weinfurt, Robert Silbergleit, Rebecca D. Pentz, Franklin G. Miller, Bernard Lo, Steven Joffe, Christine Grady, Sara F. Goldkind, Nir Eyal & Neal W. Dickert - 2017 - American Journal of Bioethics 17 (12):3-11.
    Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...)
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  2.  34
    Broad Consent for Research With Biological Samples: Workshop Conclusions.Christine Grady, Lisa Eckstein, Ben Berkman, Dan Brock, Robert Cook-Deegan, Stephanie M. Fullerton, Hank Greely, Mats G. Hansson, Sara Hull, Scott Kim, Bernie Lo, Rebecca Pentz, Laura Rodriguez, Carol Weil, Benjamin S. Wilfond & David Wendler - 2015 - American Journal of Bioethics 15 (9):34-42.
    Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...)
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  3.  40
    The Limitations of "Vulnerability" as a Protection for Human Research Participants.Carol Levine, Ruth Faden, Christine Grady, Dale Hammerschmidt, Lisa Eckenwiler & Jeremy Sugarman - 2004 - American Journal of Bioethics 4 (3):44 – 49.
    Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in (...)
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  4.  19
    Misunderstanding in Clinical Research: Distinguishing Therapeutic Misconception, Therapeutic Misestimation, & Therapeutic Optimism.Sam Horng & Christine Grady - forthcoming - IRB: Ethics & Human Research.
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  5.  70
    A Broader Understanding of Moral Distress.Stephen M. Campbell, Connie Ulrich & Christine Grady - 2016 - American Journal of Bioethics 16 (12):2-9.
    On the traditional view, moral distress arises only in cases where an individual believes she knows the morally right thing to do but fails to perform that action due to various constraints. We seek to motivate a broader understanding of moral distress. We begin by presenting six types of distress that fall outside the bounds of the traditional definition and explaining why they should be recognized as forms of moral distress. We then propose and defend a new and more expansive (...)
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  6.  36
    Does Ethics Education Influence the Moral Action of Practicing Nurses and Social Workers?Christine Grady, Marion Danis, Karen L. Soeken, Patricia O'Donnell, Carol Taylor, Adrienne Farrar & Connie M. Ulrich - 2008 - American Journal of Bioethics 8 (4):4 – 11.
    Purpose/methods: This study investigated the relationship between ethics education and training, and the use and usefulness of ethics resources, confidence in moral decisions, and moral action/activism through a survey of practicing nurses and social workers from four United States (US) census regions. Findings: The sample (n = 1215) was primarily Caucasian (83%), female (85%), well educated (57% with a master's degree). no ethics education at all was reported by 14% of study participants (8% of social workers had no ethics education, (...)
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  7.  9
    Moral Standards for Research in Developing Countries From "Reasonable Availability" to "Fair Benefits".Maged El Setouhy, Tsiri Agbenyega, Francis Anto, Christine Alexandra Clerk, Kwadwo A. Koram, Michael English, Rashid Juma, Catherine Molyneux, Norbert Peshu, Newton Kumwenda, Joseph Mfutso-Bengu, Malcolm Molyneux, Terrie Taylor, Doumbia Aissata Diarra, Saibou Maiga, Mamadou Sylla, Dione Youssouf, Catherine Olufunke Falade, Segun Gbadegesin, Reidar Lie, Ferdinand Mugusi, David Ngassapa, Julius Ecuru, Ambrose Talisuna, Ezekiel Emanuel, Christine Grady, Elizabeth Higgs, Christopher Plowe, Jeremy Sugarman & David Wendler - 2004 - Hastings Center Report 34 (3):17.
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  8.  5
    Factors Associated with Women’s Health Care Decision-Making Autonomy: Empirical Evidence From Nigeria.Pauline Osamor & Christine Grady - 2018 - Journal of Biosocial Science 50 (1):70-85.
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  9.  61
    Moral Distress: A Growing Problem in the Health Professions?Connie M. Ulrich, Ann B. Hamric & Christine Grady - 2010 - Hastings Center Report 40 (1):20-22.
  10.  21
    Dealing With the Long-Term Social Implications of Research.Jeremy Sugarman, Dale E. Hammerschmidt, Christine Grady, Lisa Eckenwiler, Carol Levine & Alan Fleischman - 2011 - American Journal of Bioethics 11 (5):5-9.
    Biomedical and behavioral research may affect strongly held social values and thereby create significant controversy over whether such research should be permitted in the first place. Institutional review boards responsible for protecting the rights and welfare of participants in research are sometimes faced with review of protocols that have significant implications for social policy and the potential for negative social consequences. Although IRB members often raise concerns about potential long-term social implications in protocol review, federal regulations strongly discourage IRBs from (...)
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  11.  27
    Money for Research Participation: Does It Jeopardize Informed Consent?Christine Grady - 2001 - American Journal of Bioethics 1 (2):40 – 44.
    Some are concerned about the possibility that offering money for research participation can constitute coercion or undue influence capable of distorting the judgment of potential research subjects and compromising the voluntariness of their informed consent. The author recognizes that more often than not there are multiple influences leading to decisions, including decisions about research participation. The concept of undue influence is explored, as well as the question of whether or not there is something uniquely distorting about money as opposed to (...)
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  12. Misconceptions About Coercion and Undue Influence: Reflections on the Views of Irb Members.Emily Largent, Christine Grady, Franklin G. Miller & Alan Wertheimer - 2013 - Bioethics 27 (9):500-507.
    Payment to recruit research subjects is a common practice but raises ethical concerns relating to the potential for coercion or undue influence. We conducted the first national study of IRB members and human subjects protection professionals to explore attitudes as to whether and why payment of research participants constitutes coercion or undue influence. Upon critical evaluation of the cogency of ethical concerns regarding payment, as reflected in our survey results, we found expansive or inconsistent views about coercion and undue influence (...)
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  13. Clinical Research: Should Patients Pay to Play?Ezekiel J. Emanuel, Steven Joffe, Christine Grady, David Wendler & Govind Persad - 2015 - Science Translational Medicine 7 (298):298ps16.
    We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.
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  14. The Ethics of Placebo-Controlled Trials: Methodological Justifications.Joseph Millum & Christine Grady - 2013 - Contemporary Clinical Trials 36 (2):510-14.
    The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more controversially, (4) when (...)
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  15.  12
    The Role of the Virtuous Investigator in Protecting Human Research Subjects.Christine Grady & Anthony S. Fauci - 2016 - Perspectives in Biology and Medicine 59 (1):122-131.
    Dr. Henry Beecher, a renowned Harvard Medical School anesthesiologist, sent shock waves through the medical research community and the lay press when he described 22 examples of “unethical or questionably ethical studies” by reputable researchers at major institutions in his now well-known 1966 New England Journal of Medicine article. Beecher concluded this exposé by noting: “The ethical approach to experimentation in man has several components: two are more important than the others, the first being informed consent.... Secondly, there is the (...)
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  16.  10
    Communicating With Pediatric Families at End-of-Life Is Not a Fantasy.Connie M. Ulrich, Kim Mooney-Doyle & Christine Grady - 2018 - American Journal of Bioethics 18 (1):14-16.
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  17.  53
    What Should Research Participants Understand to Understand They Are Participants in Research?David Wendler & Christine Grady - 2008 - Bioethics 22 (4):203–208.
    To give valid informed consent to participate in clinical research, potential participants should understand the risks, potential benefits, procedures, and alternatives. Potential participants also should understand that they are being invited to participate in research. Yet it is unclear what potential participants need to understand to satisfy this particular requirement. As a result, it is unclear what additional information investigators should disclose about the research; and it is also unclear when failures of understanding in this respect undermine the validity of (...)
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  18.  7
    Beyond Open Communication: A Call for Partnership Between Clinical Ethics and Research Ethics Committees.Christine Grady, David Gibbes Miller & Hae Lin Cho - 2018 - American Journal of Bioethics 18 (1):52-54.
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  19.  5
    Bioethics in the Oversight of Clinical Research: Institutional Review Boards and Data and Safety Monitoring Boards.Christine Grady - 2019 - Kennedy Institute of Ethics Journal 29 (1):33-49.
    In this set of contributions to the Kennedy Institute of Ethics Journal celebrating the significant work and contributions of LeRoy Walters, we aim to bring new perspectives to topics that Dr. Walters helped to pioneer and continue his tradition of bringing moral insights and arguments to bear on the development of practical public and professional policies. Dr. Walters is well known for his invaluable service as member and chair of the Recombinant DNA Advisory Committee at the National Institutes of Health. (...)
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  20.  14
    Research on Stored Biological Samples: The Views of Ugandans.David Wendler, Christine Pace, Ambrose O. Talisuna, Faustine Maiso, Christine Grady & Ezekiel Emanuel - 2005 - IRB: Ethics & Human Research 27 (2).
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  21.  7
    Comparative Effectiveness Research: What to Do When Experts Disagree About Risks.Reidar K. Lie, Francis K. L. Chan, Christine Grady, Vincent H. Ng & David Wendler - 2017 - BMC Medical Ethics 18 (1):42.
    Ethical issues related to comparative effectiveness research, or research that compares existing standards of care, have recently received considerable attention. In this paper we focus on how Ethics Review Committees should evaluate the risks of comparative effectiveness research. We discuss what has been a prominent focus in the debate about comparative effectiveness research, namely that it is justified when “nothing is known” about the comparative effectiveness of the available alternatives. We argue that this focus may be misleading. Rather, we should (...)
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  22. Introduction: The Fogarty International Research Ethics Education and Curriculum Development Program in Historical Context.Joseph Millum, Christine Grady, Gerald Keusch & Barbara Sina - 2013 - Journal of Empirical Research on Human Research Ethics: An International Journal 8 (5):3-16.
    In response to the increasing need for research ethics expertise in low and middle income countries (LMICs), the NIH's Fogarty International Research Ethics Education and Curriculum Development Program has provided grants for the development of training programs in international research ethics for LMIC professionals since 2000. This collection of papers draws upon the combined expertise of Fogarty grantees, trainees, and other experts to assess the state of research ethics in LMICs, and the lessons learned over 12 years of international research (...)
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  23.  24
    An Alternative Account of Clinical Ethics: Leveraging the Strength of the Health Care Team.Christine Grady, Amy Haddad & Cynda Rushton - 2018 - American Journal of Bioethics 18 (6):59-60.
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  24.  36
    Does Fear of Retaliation Deter Requests for Ethics Consultation?Marion Danis, Adrienne Farrar, Christine Grady, Carol Taylor, Patricia O’Donnell, Karen Soeken & Connie Ulrich - 2008 - Medicine, Health Care and Philosophy 11 (1):27-34.
    BackgroundReports suggest that some health care personnel fear retaliation from seeking ethics consultation. We therefore examined the prevalence and determinants of fear of retaliation and determined whether this fear is associated with diminished likelihood of consulting an ethics committee.MethodsWe surveyed registered nurses (RNs) and social workers (SWs) in four US states to identify ethical problems they encounter. We developed a retaliation index (1–7 point range) with higher scores indicating a higher perceived likelihood of retaliation. Linear regression analysis was performed to (...)
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  25.  8
    Deciphering Assumptions About Stepped Wedge Designs: The Case of Ebola Vaccine Research.Adélaïde Doussau & Christine Grady - 2016 - Journal of Medical Ethics 42 (12):797-804.
  26.  4
    Comprehension and Informed Consent: Assessing the Effect of a Short Consent Form.Leanne Stunkel, Meredith Benson, Louise McLellan, Ninet Sinaii, Gabriella Bedarida, Ezekiel Emanuel & Christine Grady - 2010 - IRB: Ethics & Human Research 32 (4):1.
    The objective of this study—a substudy to a phase I bioequivalence study—was to compare the effect of standard and concise consent forms on research volunteers’ comprehension of and satisfaction with consent forms, as well as to assess the effect of select volunteer characteristics, such as financial motivations to participate in research, on their comprehension. A 36-item questionnaire measured volunteers’ comprehension, satisfaction, and motivations for participation. Volunteers were randomized to the standard Pfizer consent form or a concise, easier-to-read form. We approached (...)
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  27.  5
    Vulnerability in Research: Individuals with Limited Financial and/or Social Resources.Christine Grady - 2009 - Journal of Law, Medicine and Ethics 37 (1):19-27.
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  28.  14
    Incentives for Research Participants.Neal Dickert & Christine Grady - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford Textbook of Clinical Research Ethics. Oxford University Press. pp. 386.
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  29.  37
    Four Paradigms of Clinical Research and Research Oversight.Ezekiel J. Emanuel & Christine Grady - 2007 - Cambridge Quarterly of Healthcare Ethics 16 (1):82-96.
    The understanding of appropriate ethical protections for participants of biomedical research has not been static. It has evolved over time, with the evolution of biomedical research as well as social values. Since World War II, there have been four major paradigms of research and research oversight operative in the United States. These paradigms incorporate different values and provide different approaches to research oversight and the protection of research participants.
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  30.  10
    The Limits of Disclosure: What Research Subjects Want to Know About Investigator Financial Interests.Christine Grady, Elizabeth Horstmann, Jeffrey S. Sussman & Sara Chandros Hull - 2006 - Journal of Law, Medicine and Ethics 34 (3):592-599.
    Research participants' views about investigator financial interests were explored. Reactions ranged from concern to acceptance, indifference, and even encouragement. Although most wanted such information, some said it did not matter, was private, or was burdensome, and other factors were more important to research decisions. Very few said it would affect their research decisions, and many assumed that institutions managed potential conflicts of interest. Although disclosure of investigator financial interest information to research participants is often recommended, its usefulness is limited, especially (...)
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  31.  19
    Vulnerability in Research: Individuals with Limited Financial and/or Social Resources.Christine Grady - 2009 - Journal of Law, Medicine and Ethics 37 (1):19-27.
    Individuals with limited resources are often presumed to be vulnerable in research. Concerns include the possibility of impaired decision making, susceptibility to undue inducement, and risk of exploitation. Although each of these concerns should be considered by investigators and IRBs, none justifies categorical exclusion of individuals with limited resources.
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  32.  5
    Informed Consent: Practices and Views of Investigators in a Multinational Clinical Trial.Lindsay Sabik, Christine A. Pace, Heidi P. Forster-Gertner, David Wendler, Judith D. Bebchuk, Jorge A. Tavel, Laura A. McNay, Jack Killen, Ezekiel J. Emanuel & Christine Grady - 2004 - IRB: Ethics & Human Research 27 (5):13-18.
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  33.  5
    Science in the Service of Healing.Christine Grady - 1998 - Hastings Center Report 28 (6):34-38.
  34. Points to Consider.Laura Beskow, Christine Grady, Ana Itlis, John Sadler & Benjamin Wilfond - 2009 - IRB: Ethics & Human Research 31 (6):1-9.
    Research ethics consultation is increasingly recognized as a potentially valuable mechanism for addressing the depth and breadth of ethical issues that arise in research related to human health and well-being. However, fundamental questions remain, including: What is “research ethics consultation”? And what is its justification beyond the purposes already served by existing entities? We examine how a research ethics consultation service may differ from or complement the role of an institutional review board by offering a definition of research ethics consultation (...)
     
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  35.  2
    The Limits of Disclosure: What Research Subjects Want to Know About Investigator Financial Interests.Christine Grady, Elizabeth Horstmann, Jeffrey S. Sussman & Sara Chandros Hull - 2006 - Journal of Law, Medicine and Ethics 34 (3):592-599.
  36.  17
    Research Benefits for Hypothetical HIV Vaccine Trials: The Views of Ugandans in the Rakai District.Christine Grady, Jennifer Wagman, Robert Ssekubugu, Maria J. Wawer, David Serwadda, Mohammed Kiddugavu, Fred Nalugoda, Ronald H. Gray, David Wendler, Qian Dong, Dennis O. Dixon, Bryan Townsend, Elizabeth Wahl & Ezekiel J. Emanuel - 2008 - IRB: Ethics & Human Research 30 (2):1.
    Controversy persists over the ethics of compensating research participants and providing posttrial benefits to communities in developing countries. Little is known about residents' views on these subjects. In this study, interviews about compensation and posttrial benefits from a hypothetical HIV vaccine trial were conducted in Uganda’s Rakai District. Most respondents said researchers owed the community posttrial benefits and research compensation, but opinions differed as to what these should be. Debates about posttrial benefits and compensation rarely include residents' views like these, (...)
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  37.  1
    A Hybrid Approach to Obtaining Research Consent.Christine Grady - 2019 - American Journal of Bioethics 19 (4):28-30.
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  38.  5
    Making the Choices Necessary to Make a Difference: The Responsibility of National Bioethics Commissions.Christine Grady - 2017 - Hastings Center Report 47 (S1):S42-S45.
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  39.  26
    A Response to Commentators on “The Limitations of 'Vulnerability' as a Protection for Human Research Participants”.Carol Levine, Ruth Faden, Christine Grady, Dale Hammerschmidt, Lisa Eckenwiler & Jeremy Sugarman - 2004 - American Journal of Bioethics 4 (3):W32-W32.
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  40.  19
    Response to Open Peer Commentaries on “A Broader Understanding of Moral Distress”.Stephen M. Campbell, Connie M. Ulrich & Christine Grady - 2016 - American Journal of Bioethics 16 (12):1-3.
  41.  13
    The Invisible Hand in Clinical Research: The Study Coordinator's Critical Role in Human Subjects Protection.Arlene M. Davis, Sara Chandros Hull, Christine Grady, Benjamin S. Wilfond & Gail E. Henderson - 2002 - Journal of Law, Medicine and Ethics 30 (3):411-419.
  42.  26
    Exploring the Concept of Vulnerability in the Work of the US Presidential Commission for the Study of Bioethical Issues.Michelle Groman & Christine Grady - 2015 - Asian Bioethics Review 7 (2):214-229.
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  43.  22
    Cancer Clinical Trial Participants' Assessment of Risk and Benefit.Connie M. Ulrich, Sarah J. Ratcliffe, Gwenyth R. Wallen, Qiuping Zhou, Kathleen Knafl & Christine Grady - 2016 - Ajob Empirical Bioethics 7 (1):8-16.
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  44.  20
    Adolescent Research Participants' Descriptions of Medical Research.Christine Grady, Isabella Nogues, Lori Wiener, Benjamin S. Wilfond & David Wendler - 2016 - Ajob Empirical Bioethics 7 (1):1-7.
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  45.  7
    Confidentiality: A Survey in a Research Hospital.Christine Grady, Joan Jacob & Carol Romano - 1991 - Journal of Clinical Ethics 2 (1):25.
  46.  5
    Autonomy and Couples’ Joint Decision-Making in Healthcare.Pauline E. Osamor & Christine Grady - 2018 - BMC Medical Ethics 19 (1):1-8.
    Background Respect for autonomy is a key principle in bioethics. However, respecting autonomy in practice is complex because most people define themselves and make decisions influenced by a complex network of social relationships. The extent to which individual autonomy operates for each partner within the context of decision-making within marital or similar relationships is largely unexplored. This paper explores issues related to decision-making by couples for health care and the circumstances under which such a practice should be respected as compatible (...)
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  47.  4
    Autonomy and couples’ joint decision-making in healthcare.Pauline E. Osamor & Christine Grady - 2018 - Bmc Medical Ethics 2018 19:1 19 (1):3.
    Respect for autonomy is a key principle in bioethics. However, respecting autonomy in practice is complex because most people define themselves and make decisions influenced by a complex network of social relationships. The extent to which individual autonomy operates for each partner within the context of decision-making within marital or similar relationships is largely unexplored. This paper explores issues related to decision-making by couples for health care and the circumstances under which such a practice should be respected as compatible with (...)
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  48.  19
    Respondent Burden in Clinical Research: When Are We Asking Too Much of Subjects?Connie M. Ulrich, Gwenyth R. Wallen, Autumn Feister & Christine Grady - forthcoming - IRB: Ethics & Human Research.
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  49.  16
    Making the Transition to a Learning Health Care System.Christine Grady & David Wendler - 2013 - In Mildred Z. Solomon & Ann Bonham (eds.), Ethical Oversight of Learning Health Care Systems. Wiley-Blackwell. pp. 32-33.
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  50.  12
    Genethics.Leslie G. Biesecker, Francis S. Collins, Evan G. DeRenzo, Christine Grady & Charles R. MacKay - 1995 - Cambridge Quarterly of Healthcare Ethics 4 (3):387.
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