Ancillary-Care Obligations

2021 ◽  
Author(s):  
Henry S. Richardson
Keyword(s):  
Human Rights ◽  
Incidental Findings ◽  
Professional Role ◽  
Adequate Account ◽  
Imaging Studies ◽  
Trial Conduct ◽  
Resource Poor ◽  
Medical Researchers ◽  
Ancillary Care ◽  
Study Participants

Medical researchers’ ancillary-care obligations have, until recently, been ignored by the authoritative guidelines on the ethics of medical research. Ancillary care is medical care, often unrelated to what is under study, that is not required by sound science, safe trial conduct, morally optional promises, or redressing research injuries. The question is when medical researchers have moral responsibilities to provide such care if their study participants need it. This question shows up insistently in studies done in resource-poor areas and—as the question of whether to return incidental findings—in genomic and imaging studies. After laying out six desiderata for a fully adequate account of medical researchers’ ancillary-care obligations, this chapter critically evaluates six potential grounds for such obligations—the duty of rescue, human rights, rectificatory justice, professional-role obligations, the researcher–participant relationship, and partial entrustment. It closes by suggesting the possibility of combining two or more of these grounds.

scholarly journals Incidental Findings and Ancillary-Care Obligations

2008 ◽  
Vol 36 (2) ◽  
pp. 256-270 ◽  
Author(s):  
Henry S. Richardson
Keyword(s):  
United States ◽  
Incidental Findings ◽  
The United States ◽  
The Other ◽  
Medical Researchers ◽  
The Common ◽  
Ancillary Care ◽  
Study Participants ◽  
Medical Research Ethics ◽  
Vast Range

This paper explores the convergence of two recent and growing streams of bioethical work and concern. Each has originated independently, but each arises from the fact that the Common Rule that has shaped medical research ethics, as institutionalized in the United States and also abroad, is largely silent about what needs to be done in response to researchers’ positive obligations. One stream concerns what to do about the sometimes vast range of findings that may arise incidentally to performing research procedures. The other asks whether medical researchers owe their study participants any “ancillary care” — that is, medical care that their study participants need but that goes beyond what is required to do the science safely.

scholarly journals What do we know about ancillary care practices in East and Southern Africa? A systematic review and meta-synthesis

2021 ◽  
Vol 6 ◽  
pp. 164
Author(s):  
Blessings M. Kapumba ◽  
Nicola Desmond ◽  
Janet Seeley
Keyword(s):  
Medical Research ◽  
Southern Africa ◽  
Data Extraction ◽  
Empirical Studies ◽  
Ethical Practice ◽  
Ethical Guidelines ◽  
Bias Risk ◽  
Medical Researchers ◽  
Ancillary Care ◽  
Study Participants

Background: Despite growing calls for the provision of ancillary care to study participants during medical research, there remains a noticeable gap in ethical guidelines for medical researchers in resource-constrained settings (RCS). We reviewed recent studies to determine the extent to which ancillary care is provided in East and Southern Africa and to examine the ethical justifications researchers provide to support their views on ancillary care obligations. Methods: A systematic search for qualitative and mixed methods studies on ancillary care was conducted across MEDLINE, Embase, African Wide Information, PubMed, CINAHL Plus, and Scopus. The National Institutes of Health (NIH) Department of Bioethics and H3 Africa websites and Google Scholar were further searched. Studies conducted in East and Southern Africa between 2004 and 2020, as well as those that reported on ancillary care provided to study participants were included. All studies included in this review were evaluated for methodological quality as well as bias risk. NVivo version 12 was used for thematic analysis. Results: Overall, 4,710 articles were identified by the initial search. After the data extraction and quality assessment, 24 articles were included. Key areas presented include ancillary care approaches and the themes of researcher motivation for providing ancillary care and expectations of participants in medical research. The review shows that while some international researchers do provide ancillary care to their study participants, approaches are not standardised without consistent guidelines for ethical practice for ancillary care. We found limited empirical studies in RCS that report on ancillary care, hence findings in this review are based on single studies rather than a collection of multiple studies. Conclusions: This paper emphasizes the value of establishing ethics guidelines for medical researchers in RCS who consider provision of ancillary care to their participants, and the need to account for these ethical guidelines in medical research.

scholarly journals God, New Natural Law Theory, and Human Rights

Religions ◽  
2021 ◽  
Vol 12 (8) ◽  
pp. 613
Author(s):  
Christopher Tollefsen
Keyword(s):  
Human Rights ◽  
Natural Law ◽  
Two Dimensions ◽  
Natural Rights ◽  
Creative Activity ◽  
Adequate Account ◽  
Full Theory ◽  
Natural Law Theory ◽  
Epistemological Dimension

Critics of the “New” Natural Law (NNL) theory have raised questions about the role of the divine in that theory. This paper considers that role in regard to its account of human rights: can the NNL account of human rights be sustained without a more or less explicit advertence to “the question of God’s existence or nature or will”? It might seem that Finnis’s “elaborate sketch” includes a full theory of human rights even prior to the introduction of his reflections on the divine in the concluding chapter of Natural Law and Natural Rights. But in this essay, I argue that an adequate account of human rights cannot, in fact, be sustained without some role for God’s creative activity in two dimensions, the ontological and the motivational. These dimensions must be distinguished from the epistemological dimension of human rights, that is, the question of whether epistemological access to truths about human rights is possible without reference to God’s existence, nature, or will. The NNL view is that such access is possible. However, I will argue, the epistemological cannot be entirely cabined off from the relevant ontological and motivational issues and the NNL framework can accommodate this fact without difficulty.

scholarly journals Data Monitoring Committees: Current issues

2018 ◽  
Vol 15 (4) ◽  
pp. 321-328 ◽  
Author(s):  
Thomas R Fleming ◽  
Susan S Ellenberg ◽  
David L DeMets
Keyword(s):  
Best Practices ◽  
Safety Data ◽  
Data Monitoring Committee ◽  
Data Monitoring ◽  
Marketing Approval ◽  
Definitive Evidence ◽  
Trial Conduct ◽  
Risks And Benefits ◽  
Monitoring Committee ◽  
Study Participants

Maintaining confidentiality of emerging data and ensuring the independence of Data Monitoring Committees are best practices of considerable importance to the ability of these committees to achieve their mission of safeguarding the interests of study participants and enhancing the integrity and credibility of clinical trials. Even with the wide recognition of these principles, there are circumstances where confidentiality issues remain challenging, controversial or inconsistently addressed. First, consider settings where a clinical trial’s interim data could provide the evidence regulatory authorities require for decisions about marketing approval, yet where such a trial would be continued post-approval to provide more definitive evidence about principal safety and/or efficacy outcomes. In such settings, data informative about the longer term objectives of the trial should remain confidential until pre-specified criteria for trial completion have been met. Second, for those other than Data Monitoring Committee members, access to safety and efficacy outcomes during trial conduct, even when presented as data pooled across treatment arms, should be on a limited “need to know” basis relating to the ability to carry out ethical or scientific responsibilities in the conduct of the trial. Third, Data Monitoring Committee members should have access to unblinded efficacy and safety data throughout the trial to enable timely and informed judgments about risks and benefits. Fourth, it should be recognized that a mediator potentially could be useful in rare settings where the Data Monitoring Committee would have serious ethical or scientific concerns about the sponsor’s dissemination or lack of dissemination of information. Data Monitoring Committee Contract Agreements, Indemnification Agreements and Charters should be developed in a manner to protect Data Monitoring Committee members and their independence, in order to enhance the Data Monitoring Committee’s ability to effectively address their mission.

The Invisible Hand Guiding Technology

2011 ◽  
Vol 2 (4) ◽  
pp. 1-15
Author(s):  
Nada K. Kakabadse ◽  
Andrew Kakabadse ◽  
Reeves Knyght ◽  
Linda Lee-Davies
Keyword(s):  
Human Rights ◽  
Radio Frequency Identification ◽  
Qualitative Methodology ◽  
Invisible Hand ◽  
Rfid Technology ◽  
Domestic Life ◽  
Frequency Identification ◽  
Study Participants ◽  
Near Future ◽  
Insight Into

This paper examines attitudes towards Radio Frequency Identification (RFID) technology and explores the wider concerns of the ever increasing prospect of social tagging. Capturing vignettes and narratives from a sample of study participants, the paper highlights concerns about adopting RFID implements now and in the future. The views captured through qualitative methodology act as the platform for a wider argument concerning the human rights and privacy intrusion concerns over IT applications. Intended as an insight into the reality of technology impact, this paper lists a series of questions for leaders to consider over matters of human rights specifically concerning RFID adoption. The authors conclude that caution, naivety and fear are the underlying reasons for society accepting RFIDs without question and that RFIDs will be a part of everyday working and domestic life in the near future.

Ancillary Care Obligations of Medical Researchers

JAMA ◽  
2009 ◽  
Vol 302 (4) ◽  
pp. 424 ◽  
Author(s):  
Neal Dickert
Keyword(s):  
Medical Researchers ◽  
Ancillary Care

Frequency of potential causes of lower back pain and incidental findings in patients with suspected sacroiliitis: retrospective analysis of 886 patients with negative sacroiliac MRI examination for sacroiliitis

2020 ◽  
pp. 028418512096856
Author(s):  
Hasan Emin Kaya ◽  
Ülkü Kerimoğlu
Keyword(s):  
Back Pain ◽  
Lower Back Pain ◽  
Incidental Findings ◽  
Uterine Fibroids ◽  
Mri Imaging ◽  
Imaging Studies ◽  
Lower Back ◽  
Lumbosacral Transitional Vertebra ◽  
Sacral Insufficiency Fractures ◽  
Magnetic Resonance Imaging Mri

Background In a majority of patients with suspected sacroiliitis (SI) who underwent sacroiliac magnetic resonance imaging (MRI), imaging studies may be normal, may depict other causes for pain, or may show clinically irrelevant incidental findings. Purpose To determine the prevalence of possible etiologies other than SI and frequency of incidental findings demonstrated on sacroiliac MRI examinations in a cohort of patients with lower back pain and suspected SI. Material and Methods Sacroiliac MRI examinations of 1421 patients with suspected SI were retrospectively reviewed. In patients without SI findings, other potential causes for lower back pain and incidental findings were documented. Results SI was present in 535 of 1421 patients (37.6%). In 886 of the patients whose MRI studies were negative for SI, other possible causes for lower back pain or incidental findings were seen in 386 (43.5%). The most common musculoskeletal (MSK) finding was lumbosacral transitional vertebra (8.6%) followed by findings suggesting piriformis syndrome (4.2%), spondylosis (3.7%), and sacral insufficiency fractures (1.8%). The most common non-MSK findings were follicular cysts (15.3%) and uterine fibroids (4.9%). Conclusion In patients with suspected SI but negative MRI examinations for SI, some other possible causes for lower back pain and several incidental findings can be seen on imaging. The presence of these findings may explain the patient’s symptoms, and awareness of these conditions may be helpful in patient management and individualizing treatment.

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