The Ancillary-Care Responsibilities of Medical Researchers: An Ethical Framework for Thinking about the Clinical Care That Researchers Owe Their Subjects

2004 ◽  
Vol 34 (1) ◽  
pp. 25 ◽  
Author(s):  
Henry S. Richardson ◽  
Leah Belsky
Author(s):  
Henry S. Richardson

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.


JAMA ◽  
2009 ◽  
Vol 302 (4) ◽  
pp. 424 ◽  
Author(s):  
Neal Dickert

2008 ◽  
Vol 36 (2) ◽  
pp. 256-270 ◽  
Author(s):  
Henry S. Richardson

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.


Healthcare ◽  
2020 ◽  
Vol 8 (1) ◽  
pp. 49 ◽  
Author(s):  
Bas C. Stunnenberg ◽  
Jaap Deinum ◽  
Tom Nijenhuis ◽  
Frans Huysmans ◽  
Gert Jan van der Wilt ◽  
...  

N-of-1 trials can provide high-class evidence on drug treatment effectiveness at the individual patient level and have been given renewed interest over the past decade due to improvements of the initial single patient design. Despite these recent developments, there is still no consensus under what circumstances N-of-1 trials should be considered as part of evidence-based clinical care and when they represent medical research with need for institutional review board (IRB) approval. This lack of consensus forms an obstacle for a more widespread implementation of N-of-1 trials. Based upon the existing literature, we as a group of researchers involved in N-of-1 trials and members of the IRB of a tertiary academic referral center, designed a practical flowchart based on an ethical framework to help make this distinction. The ethical framework together with a practical flowchart are presented in this communication.


2014 ◽  
Vol 100 (4) ◽  
pp. 380-385 ◽  
Author(s):  
Karen A Horridge

Increasing numbers, complexities and technology dependencies of children and young people with life-limiting conditions require paediatricians to be well prepared to meet their changing needs. Paediatric Advance Care Planning provides a framework for paediatricians, families and their multidisciplinary teams to consider, reflect and record the outcome of their conversations about what might happen in the future in order to optimise quality of clinical care and inform decision-making. For some children and young people this will include discussions about the possibility of death in childhood. This may be unexpected and sudden, in the context of an otherwise active management plan or may be expected and necessitate discussions about the process of dying and attention to symptoms. Decision-making about appropriate levels of intervention must take place within a legal and ethical framework, recognising that the UK Equality Act (2010) protects the rights of disabled children and young people and infants and children of all ages to the same high quality healthcare as anyone else.


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