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Dmitry Khodyakov - One of the best experts on this subject based on the ideXlab platform.

  • From Subject to Participant: Ethics and the Evolving Role of Community in Health Research
    American journal of public health, 2015
    Co-Authors: Elizabeth Bromley, Lisa Mikesell, Felica Jones, Dmitry Khodyakov
    Abstract:

    Belmont Report principles focus on the well-being of the research subject, yet community-engaged investigators often eschew the role of subject for that of participant. We conducted semistructured interviews with 29 community and academic investigators working on 10 community-engaged studies. Interviews elicited perspectives on ethical priorities and ethical challenges. Interviewees drew on the Belmont Report to describe 4 key principles of ethical community-engaged research (embodying ethical action, respecting participants, generalizing beneficence, and negotiating justice). However, novel aspects of the participant role were the source of most ethical challenges. We theorize that the shift in ethical focus from subject to participant will pose new ethical dilemmas for community-engaged investigators and for other constituents interested in increasing community involvement in health research.

  • FromSubjecttoParticipant:EthicsandtheEvolvingRole ofCommunityinHealthResearch
    2015
    Co-Authors: Elizabeth Bromley, Lisa Mikesell, Felica Jones, Dmitry Khodyakov
    Abstract:

    Belmont Report principles focus on the well-being of the research subject, yet community-engaged investigators often eschew the role of subject for that of participant. We conducted semistructured interviews with 29 community and academic investigators working on 10 community-engaged studies. Interviews elicited perspectives on ethical priorities and ethical challenges. Interviewees drew on the Belmont Report to describe 4 key principles of ethical community-engaged research (embodying ethical action, respecting participants, generalizing beneficence, and negotiating justice). However, novel aspects of the participant role were the source of most ethical challenges. We theorize that the shift in ethical focus fromsubject to participantwill pose new ethical dilemmas for community-engaged investigators and for other constituents interested in increasing community involvement in health research. (Am J Public Health.2015;105:900‐908. doi: 10.2105/AJPH.2014.302403)

  • ethical community engaged research a literature review
    American Journal of Public Health, 2013
    Co-Authors: Lisa Mikesell, Elizabeth Bromley, Dmitry Khodyakov
    Abstract:

    Health research has relied on ethical principles, such as those of the Belmont Report, to protect the rights and well-being of research participants.Community-based participatory research (CBPR), however, must also consider the rights and well-being of communities. This requires additional ethical considerations that have been extensively discussed but not synthesized in the CBPR literature.We conducted a comprehensive thematic literature review and summarized empirically grounded discussions of ethics in CBPR, with a focus on the value of the Belmont principles in CBPR, additional essential components of ethical CBPR, the ethical challenges CBPR practitioners face, and strategies to ensure that CBPR meets ethical standards. Our study provides a foundation for developing a working definition and a conceptual model of ethical CBPR.

James Lindgren - One of the best experts on this subject based on the ideXlab platform.

  • Introducing a New Paradigm for Ethical Research in the Social, Behavioral, and Biomedical Sciences: Part I
    Social Science Research Network, 2006
    Co-Authors: Mary Simmerling, Brian Schwegler, Joan E. Sieber, James Lindgren
    Abstract:

    During the past thirty years, considerable attention and resources have been focused on various aspects of the ethics of research involving human participants. However, the presumptive basis on which the entire enterprise of research ethics is based - The Belmont Report - has received little serious scrutiny during this time. Conceptually, The Belmont Report occupies a unique position: because it is outside traditional disciplines that deal with issues of morality and moral reasoning - e.g., moral philosophy, social and political philosophy, legal ethics, and anthropology - it appears to be unassailable to judgments from those disciplines. Yet, despite this separation from these more traditional disciplines, the Report relies on their principles, without necessarily being sufficiently informed by them. Indeed, The Belmont Report's influence is nearly hegemonic in that within IRBs and the broader research ethics community all discussions must start (and sometimes end) with it in order to be considered morally legitimate. The Belmont Report is treated as immutable to appeals to the philosophical requirements of the principles upon which it claims to be based. Moreover, within its implementation, it straddles a line between normative and practical ethics, leaving both unsatisfied. The statutory requirements of the federal regulations governing human subjects research (45CFR46) draw from and underscore Belmont's principles. Belmont is the only statement of ethical principles recognized as a legitimate foundation for ethical review processes in the contract required by the US government for institutions receiving government funds for research. Consequently, almost all U.S. universities and other research institutes hold their research practices to Belmont's definitions of the ethical. IRB review process and professional codes of conduct tacitly or explicitly incorporate the principles of The Belmont Report. IRB reviews are to document that risks to participants are minimized within a study's design (beneficence), that benefits and burdens of research participation are equitably distributed (justice), and that the informed consent of participants is prospectively acquired and documented (respect for persons). We think that the time has come to examine this influential Report and how it might be supplanted by a more cogent, logical, and ethical guide for research. In this Part I of our project, we both discuss some of the valuable ideas in The Belmont Report and examine problems with The Belmont Report's analyses of ethical principles. These suggest that Belmont's core principles must remain foundational for the enterprise of ethical research. However, their specification and application has at times verged from the spirit and philosophical foundations of these principles. We argue that the principled model for ethical decision-making specified and implied in The Belmont Report distorts the philosophical requirements of the ethical principles of beneficence, respect for persons, and justice in both their conceptual specification and practical application. Specifically, we argue that: the conception of beneficence relies on a simplistic conception of benefits and risks that cannot accommodate the various goods and harms that are legitimately given weight in risk/benefit calculations made by research participants; the conception of respect for persons relies on a superficial view of choice; and the conception of justice involves a conceptual mistake that conflates the harms of exploitation with those of disrespect for persons.

Deven Mcgraw - One of the best experts on this subject based on the ideXlab platform.

Elizabeth Bromley - One of the best experts on this subject based on the ideXlab platform.

  • From Subject to Participant: Ethics and the Evolving Role of Community in Health Research
    American journal of public health, 2015
    Co-Authors: Elizabeth Bromley, Lisa Mikesell, Felica Jones, Dmitry Khodyakov
    Abstract:

    Belmont Report principles focus on the well-being of the research subject, yet community-engaged investigators often eschew the role of subject for that of participant. We conducted semistructured interviews with 29 community and academic investigators working on 10 community-engaged studies. Interviews elicited perspectives on ethical priorities and ethical challenges. Interviewees drew on the Belmont Report to describe 4 key principles of ethical community-engaged research (embodying ethical action, respecting participants, generalizing beneficence, and negotiating justice). However, novel aspects of the participant role were the source of most ethical challenges. We theorize that the shift in ethical focus from subject to participant will pose new ethical dilemmas for community-engaged investigators and for other constituents interested in increasing community involvement in health research.

  • FromSubjecttoParticipant:EthicsandtheEvolvingRole ofCommunityinHealthResearch
    2015
    Co-Authors: Elizabeth Bromley, Lisa Mikesell, Felica Jones, Dmitry Khodyakov
    Abstract:

    Belmont Report principles focus on the well-being of the research subject, yet community-engaged investigators often eschew the role of subject for that of participant. We conducted semistructured interviews with 29 community and academic investigators working on 10 community-engaged studies. Interviews elicited perspectives on ethical priorities and ethical challenges. Interviewees drew on the Belmont Report to describe 4 key principles of ethical community-engaged research (embodying ethical action, respecting participants, generalizing beneficence, and negotiating justice). However, novel aspects of the participant role were the source of most ethical challenges. We theorize that the shift in ethical focus fromsubject to participantwill pose new ethical dilemmas for community-engaged investigators and for other constituents interested in increasing community involvement in health research. (Am J Public Health.2015;105:900‐908. doi: 10.2105/AJPH.2014.302403)

  • ethical community engaged research a literature review
    American Journal of Public Health, 2013
    Co-Authors: Lisa Mikesell, Elizabeth Bromley, Dmitry Khodyakov
    Abstract:

    Health research has relied on ethical principles, such as those of the Belmont Report, to protect the rights and well-being of research participants.Community-based participatory research (CBPR), however, must also consider the rights and well-being of communities. This requires additional ethical considerations that have been extensively discussed but not synthesized in the CBPR literature.We conducted a comprehensive thematic literature review and summarized empirically grounded discussions of ethics in CBPR, with a focus on the value of the Belmont principles in CBPR, additional essential components of ethical CBPR, the ethical challenges CBPR practitioners face, and strategies to ensure that CBPR meets ethical standards. Our study provides a foundation for developing a working definition and a conceptual model of ethical CBPR.

Ann Hamilton - One of the best experts on this subject based on the ideXlab platform.

  • The Development and Operation of IRBs: Medical Regulations and Social Science
    Journal of Applied Communication Research, 2005
    Co-Authors: Ann Hamilton
    Abstract:

    A sketch of the development of institutional review boards (IRBs) and the system of human subjects research regulation in the United States is presented, from the Nuremberg Code of 1949 to the Belmont Report of 1979, and continues with several contemporary developments. Conflicts within the system are discussed, particularly those related to the regulatory application of the medical model to social science. Examination of two central documents produced by participants in the IRB regulatory system is presented to illustrate difficulties with current regulation.