Reconsidering the Declaration of Helsinki

Emanuel, Ezekiel J.

doi:10.1016/s0140-6736(13)60970-8

Cited by 61 publications

(34 citation statements)

References 3 publications

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“…Hence, these activities are exempted from clinical research regulations as such. These cases show that neither levels of risk nor of lack of validation are necessary conditions for an intervention to be regarded as research-some arguing it ought to be different (Emanuel 2013).…”

Section: Intention To Benefit Individual Patients ("Practice")mentioning

confidence: 99%

Seizing Opportunity at the Limits of Medicine: An Enhanced Definition of Innovative Practice

Mastroleo¹

2019

Preprint

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The activity of innovative practice relates to seizing opportunities now for patients in desperate situations and the ethical dilemmas around it. Sadly, the term innovation has multiple meanings, adding confusion and misunderstanding to an already difficult debate. This paper aims to enhance the definition of innovative practice in two ways. Fist, we propose to curb ambiguity by replacing the term "innovative practice" with the more precise of "new non-validated practice" and by distinguishing the specific meaning of innovation at stake. To identify this meaning, we analyse the traditional research ethics’ distinction between research, validated practice, and innovation. Second, we propose the following unified definition of "new non-validated practice", that is, the first or recent use of diagnostic, therapeutic or preventive interventions that introduce a significant change (new); with an insufficient level of evidence of safety or efficacy for regular healthcare (non-validated); and with the main aim to benefit patients (practice). To avoid objections to our definition, we analyse its three core elements (significant novelty, insufficient validation for, and patients' best interests) and we present a 2D classification of medical practice that follows from our definition. If sound, our enhanced definition of "new non-validated practice" allows comparing exceptional activities in different fields of medicine that previously have been considered unconnected (e.g. compassionate use of investigational drugs, humanitarian uses of devices, novel off-label uses, etc.).  In turn, it also provides a promising conceptual tool to inform empirical research, discuss responsible access to innovative care and evaluate the regulation of innovative practice (e.g. right-to-try laws).

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Section: Intention To Benefit Individual Patients ("Practice")mentioning

confidence: 99%

Seizing Opportunity at the Limits of Medicine: An Enhanced Definition of Innovative Practice

Mastroleo¹

2019

Preprint

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“…Exclusion criteria were severe heart failure, acute myocardial infarction, severe pulmonary hypertension, chronic obstructive pulmonary disease, moderate to severe renal or moderate to severe hepatic insufficiency. ABI and standardized treadmill test (3.5 km/h; 12.5% ascending slope; S2the maximum walking distance in meters; S1 -free of pain walking distance in meters) were evaluated before and 3 months after initiation of therapy with cilostazol (Pletal ® , Otsuka Pharmaceutical Co. Tokyo, Japan) [16][17][18][19][20].…”

Section: Study Populationmentioning

confidence: 99%

Dynamic Quantitative Contrast-enhanced Ultrasound for Assessment of Cilostazol Induced Pro-angiogenic Therapeutic Effects on Skeletal Muscle Microcirculation in Peripheral Arterial Disease

Hu¹,

Amarteifio²

2016

Vasc Med Surg

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Purpose: To assess the effect of cilostazol on muscular microperfusion in patients with peripheral artery occlusive disease (PAOD) using dynamic quantitative contrast-enhanced ultrasound (CEUS). Materials and Methods: 20 patients with PAOD, Rutherford classification grade I, category III were evaluated performing CEUS with the arterial occlusion paradigm, ankle-brachial-index (ABI) and treadmill walking distance test before and after oral treatment with cilostazol for three months. Microperfusion of the calf skeletal muscle was assessed using quantitative CEUS parameters which were extracted from time signal-intensity curves (TIC). Results: 10 patients had to be taken off medication secondary to side effects. Maximum CEUS signal enhancement prior to therapy was 104 ± 69 ~mL compared to 114±68 ~mL post treatment (P=0.26). tmax was 34 ± 20 s before and 36 ± 23 s post treatment (P=0.51). Maximum slope of the TIC (m2) prior to therapy was 6.06 ± 5.55 ~mL/s and revealed to be 5.12 ± 3.30 ~mL/s post treatment (P=0.62). Area under the curve after the occlusion (AUCpost) was 3975.38 ± 2856.52 ~mL/s prior to cilostazol therapy compared to 4210.98 ± 2816.33 ~mL/s after therapy (P=0.39). The values for ABI and treadmill walking distance test did not differ significantly differ, either. Conclusion: In patients with PAOD, medical therapy with cilostazol seems not to be associated with significant improvement of muscular microperfusion as assessed by dynamic quantitative CEUS. This study demonstrates the feasibility of the CEUS technique to evaluate response to pro-angiogenic drug treatment and confirmation of results in a larger population is warranted.

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“…Finally, restricting the obligation of access to relevant information after research only to the ‘general outcome and results of the study’ seems insufficient. As discussed in the examples taken from the literature of post‐trial access ethics, other information relevant to the health of former participants could also be included, for example, measures to improve the welfare of participants based on the research results, the group they were randomized to in the research study, appropriate incidental findings, newly detected adverse effects or the withdrawal of the drug from the market for safety reasons …”

Section: Interpretation Of Post‐trial Obligations In Doh 2013mentioning

confidence: 99%

Post‐trial obligations in the Declaration of Helsinki 2013: classification, reconstruction and interpretation

Mastroleo¹

2015

Developing World Bioethics

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The general aim of this article is to give a critical interpretation of post-trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki 2013 identifies at least two clearly different types of post-trial obligations, specifically, access to care after research and access to information after research. The agents entitled to receive post-trial access are the individual participants in research studies. The Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above. To justify this interpretation of post-trial obligations, I first introduce a classification of post-trial obligations and illustrate its application with examples from post-trial ethics literature. I then make a brief reconstruction of the formulations of post-trial obligations of the Declaration of Helsinki from 2000 to 2008 to correlate the changes with some of the most salient ethical arguments. Finally I advance a critical interpretation of the latest formulation of post-trial obligations. I defend the view that paragraph 34 of 'Post-trial provisions' is an improved formulation by comparison with earlier versions, especially for identifying responsible agents and abandoning ambiguous 'fair benefit' language. However, I criticize the disappearance of 'access to other appropriate care' present in the Declaration since 2004 and the narrow scope given to obligations of access to information after research.

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Reconsidering the Declaration of Helsinki

Cited by 61 publications

References 3 publications

Seizing Opportunity at the Limits of Medicine: An Enhanced Definition of Innovative Practice

Seizing Opportunity at the Limits of Medicine: An Enhanced Definition of Innovative Practice

Dynamic Quantitative Contrast-enhanced Ultrasound for Assessment of Cilostazol Induced Pro-angiogenic Therapeutic Effects on Skeletal Muscle Microcirculation in Peripheral Arterial Disease

Post‐trial obligations in the Declaration of Helsinki 2013: classification, reconstruction and interpretation

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