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  1. Shawneequa L. Callier, Christine Grady & Michael L. Gross (forthcoming). Herbert J. Bonifacio is an Adolescent. Hastings Center Report.
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  2. Ezekiel J. Emanuel, Christine Grady & Jerry Menikoff (forthcoming). Case Study: Is Longer Always Better? Hastings Center Report.
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  3. Christine Grady, Isabella Nogues, Lori Wiener, Benjamin S. Wilfond & David Wendler (forthcoming). Adolescent Research Participants' Descriptions of Medical Research. Ajob Empirical Bioethics:00-00.
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  4. Sam Horng & Christine Grady (forthcoming). Misunderstanding in Clinical Research: Distinguishing Therapeutic Misconception, Therapeutic Misestimation, & Therapeutic Optimism. IRB: Ethics & Human Research.
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  5. Connie M. Ulrich, Sarah J. Ratcliffe, Gwenyth Wallen, Qiuping Zhou, Kathleen Knafl & Christine Grady (forthcoming). Cancer Clinical Trial Participants and Assessment of Risks and Benefits. Ajob Empirical Bioethics:00-00.
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  6. Connie M. Ulrich, Gwenyth R. Wallen, Autumn Feister & Christine Grady (forthcoming). Respondent Burden in Clinical Research: When Are We Asking Too Much of Subjects? IRB: Ethics & Human Research.
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  7. Christine Grady (2013). Reflections on Two Decades of Bioethics: Where We Have Been and Where We Are Going. American Journal of Bioethics 13 (1):8-10.
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  8. Christine Grady & David Wendler (2013). Making the Transition to a Learning Health Care System. In Mildred Z. Solomon & Ann Bonham (eds.), Ethical Oversight of Learning Health Care Systems. Wiley-Blackwell 32-33.
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  9. Emily Largent, Christine Grady, Franklin G. Miller & Alan Wertheimer (2013). Misconceptions About Coercion and Undue Influence: Reflections on the Views of Irb Members. 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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  10. Jeremy Sugarman, Dale E. Hammerschmidt, Christine Grady, Lisa Eckenwiler, Carol Levine & Alan Fleischman (2011). Dealing With the Long-Term Social Implications of Research. American Journal of Bioethics 11 (5):5-9.
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  11. Leanne Stunkel, Meredith Benson, Louise McLellan, Ninet Sinaii, Gabriella Bedarida, Ezekiel Emanuel & Christine Grady (2010). Comprehension and Informed Consent: Assessing the Effect of a Short Consent Form. 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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  12. Connie M. Ulrich, Ann B. Hamric & Christine Grady (2010). Moral Distress: A Growing Problem in the Health Professions? Hastings Center Report 40 (1):20-22.
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  13. Laura M. Beskow, Christine Grady, Ana S. Iltis, John Z. Sadler & Benjamin S. Wilfond (2009). Points to Consider: The Research Ethics Consultation Service and the IRB. IRB: Ethics & Human Research 31 (6):1.
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  14. Laura Beskow, Christine Grady, Ana Itlis, John Sadler & Benjamin Wilfond (2009). Points to Consider. 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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  15. Christine Grady (2009). Vulnerability in Research: Individuals with Limited Financial and/or Social Resources. Journal of Law, Medicine & 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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  16. Shlomo Koyfman, Mary Mccabe, Ezekiel Emanuel & Christine Grady (2009). A Consent Form Template For Phase I Oncology Trials. IRB: Ethics & Human Research 31 (4):1-8.
    We reviewed 272 phase I oncology trial consent forms and then created an improved informed consent template in both English and Spanish by redesigning and rewording the consent form to be specific to phase I trials, to avoid repetition, and to use simplified language, identifiable sections framed by first-person questions, and tables to present information. The resulting consent form template is shorter than average and considerably easier to read . The template also meets the recommended eighth-grade maximum reading level for (...)
     
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  17. James Lavery, Christine Grady, Elizabeth Wahl & Ezekiel Emanuel (2009). Correction in Response to the Review of Ethical Issues in International Biomedical Research. Developing World Bioethics 9 (3):167-167.
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  18. Marion Danis, Adrienne Farrar, Christine Grady, Carol Taylor, Patricia O'Donnell, Karen Soeken & Connie Ulrich (2008). Does Fear of Retaliation Deter Requests for Ethics Consultation? 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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  19. Neal Dickert & Christine Grady (2008). Incentives for Research Participants. In Ezekiel J. Emanuel (ed.), The Oxford Textbook of Clinical Research Ethics. Oxford University Press 386.
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  20. Ezekiel J. Emanuel & Christine Grady (2008). Commentary. Hastings Center Report 38 (3):10-12.
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  21. Ezekiel J. Emanuel, Christine Grady & Jerry Menikoff (2008). Is Longer Always Better? Hastings Center Report 38 (3):10.
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  22. Christine Grady, Marion Danis, Karen L. Soeken, Patricia O'Donnell, Carol Taylor, Adrienne Farrar & Connie M. Ulrich (2008). Does Ethics Education Influence the Moral Action of Practicing Nurses and Social Workers? 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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  23. Christine Grady, Marion Danis, Karen Soeken, Patricia O'Donnell, Carol Taylor, Adrienne Farrar & Connie Ulrich (2008). Response to Peer Commentary on “Does Ethics Education Influence the Moral Action of Practicing Nurses and Social Workers?”. American Journal of Bioethics 8 (4):1-2.
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  24. 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). Research Benefits for Hypothetical HIV Vaccine Trials: The Views of Ugandans in the Rakai District. 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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  25. David Wendler & Christine Grady (2008). What Should Research Participants Understand to Understand They Are Participants in Research? 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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  26. Alister Browne, Katharine Browne, Ezekiel J. Emanual, Joseph J. Fins, Colin Gavaghan, Christine Grady & Leonard C. Groopman (2007). William Andereck, MD, is an Internist at California Pacific Medical Center in San Francisco, California, Where He Chairs the Ethics Committee and is Founder and Codirector of the Program in Medicine and Human Values. R. Blake Brown, Ph. D., is a Social Science and Humanities Research Council Post-Doctoral Fellow at Saint Mary's University and a Research Associate at The. [REVIEW] Cambridge Quarterly of Healthcare Ethics 16:1-2.
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  27. Julia Slutsman, David Buchanan & Christine Grady (2007). Ethical Issues in Cancer Chemoprevention Trials: Considerations for IRBs and Investigators. IRB: Ethics & Human Research 29 (2):1-6.
    Cancer chemoprevention trials test the efficacy of pharmaceutical agents in preventing cancer in at-risk research subjects who are neither patients diagnosed with the disease nor typical healthy volunteers. Such trials present unique challenges to investigators and IRB reviewers when evaluating risks and benefits, assessing informed consent, and compensating subjects. Investigators and IRBs should pay particular attention to the criteria used to define at-risk subjects and carefully assess the strength of the evidence supporting them, as this is critical to evaluating the (...)
     
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  28. Ezekiel J. Emanuel & Christine Grady (2006). Four Paradigms of Clinical Research and Research Oversight. Cambridge Quarterly of Healthcare Ethics 16 (01):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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  29. Christine Grady (2006). Ethics of Vaccine Research. In Ana Smith Iltis (ed.), Research Ethics. Routledge
     
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  30. Christine Grady, Elizabeth Horstmann, Jeffrey S. Sussman & Sara Chandros Hull (2006). The Limits of Disclosure: What Research Subjects Want to Know About Investigator Financial Interests. Journal of Law, Medicine & 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. David Wendler, Christine Pace, Ambrose O. Talisuna, Faustine Maiso, Christine Grady & Ezekiel Emanuel (2005). Research on Stored Biological Samples: The Views of Ugandans. IRB: Ethics & Human Research 27 (2).
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  32. Carol Levine, Ruth Faden, Christine Grady, Dale Hammerschmidt, Lisa Eckenwiler & Jeremy Sugarman (2004). A Response to Commentators on “The Limitations of 'Vulnerability' as a Protection for Human Research Participants”. American Journal of Bioethics 4 (3):W32-W32.
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  33. Carol Levine, Ruth Faden, Christine Grady, Dale Hammerschmidt, Lisa Eckenwiler & Jeremy Sugarman (2004). The Limitations of "Vulnerability" as a Protection for Human Research Participants. 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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  34. 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). Informed Consent: Practices and Views of Investigators in a Multinational Clinical Trial. IRB: Ethics & Human Research 27 (5):13-18.
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  35. Connie Ulrich & Christine Grady (2004). Beneficent Deception: Whose Best Interests Are We Serving? American Journal of Bioethics 4 (4):76-77.
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  36. Arlene M. Davis, Sara Chandros Hull, Christine Grady, Benjamin S. Wilfond & Gail E. Henderson (2002). The Invisible Hand in Clinical Research: The Study Coordinator's Critical Role in Human Subjects Protection. Journal of Law, Medicine & Ethics 30 (3):411-419.
  37. Christine Grady (2001). Money for Research Participation: Does It Jeopardize Informed Consent? 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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  38. Christine Grady (2001). Thinking Further About Value: Commentary on" A Taxonomy of Value in Clinical Research". IRB: Ethics & Human Research 24 (6):7-8.
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  39. Christine Grady (1998). Science in the Service of Healing. Hastings Center Report 28 (6):34-38.
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  40. Leslie G. Biesecker, Francis S. Collins, Evan G. DeRenzo, Christine Grady & Charles R. MacKay (1995). Genethics. Cambridge Quarterly of Healthcare Ethics 4 (03):387-.
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  41. Christine Grady (1994). Hiv Preventive Vaccine Research: Selected Ethical Issues. Journal of Medicine and Philosophy 19 (6):595-612.
    This paper explores three selected issues which present ethical challenges unique to the development and testing of preventive HIV vaccines. The issues are: when to move forward with large scale efficacy testing of vaccines, how to incorporate behavioral interventions into the study of vaccine efficacy, and how to plan for and mitigate social harms associated with participation in an HIV vaccine trial. Careful and ongoing consideration must be given to the ethical implications of these decisions. Proposed solutions include planning for (...)
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  42. Christine Grady (1993). Ethical Issues in the Development and Testing of a Preventive Hiv Vaccine. Dissertation, Georgetown University
    This dissertation explores the ethics of human subjects research with particular attention to how clinical research on vaccines differs from research on therapies. The major differences are rooted in the fact that the benefits of vaccines and vaccine research accrue to the community to which vaccines belong by inducing herd immunity and thereby protecting both vaccinated and unvaccinated individuals. Therapeutics have no corresponding benefit to the community, the primary beneficiary is the individual. The ethical justification for conducting vaccine research in (...)
     
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  43. Christine Grady, Joan Jacob & Carol Romano (1991). Confidentiality: A Survey in a Research Hospital. Journal of Clinical Ethics 2 (1):25.