Aligning Regulations and Ethics in Human Research

Dresser, Rebecca

doi:10.1126/science.1218323

Cited by 11 publications

(11 citation statements)

References 9 publications

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“…Risks to FIH trial volunteers must be justified by the social value of the information such trials are expected to produce 6 7. The social value of study information is a function of the level of improvement the hoped-for intervention will provide to patients 8.…”

Section: Background Considerationsmentioning

confidence: 99%

“…Furthermore, when recruiting any individual with HIV for FIH trials, researchers must ensure that study materials and discussions alert prospective subjects to the trial's knowledge-seeking purpose and the low likelihood of direct health benefit. Study teams should also adopt measures to assess and improve subjects' comprehension of these study facts 6 7…”

Section: Subject Selection and Risk Minimisationmentioning

confidence: 99%

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First-in-human HIV-remission studies: reducing and justifying risk

Dresser

2016

J Med Ethics

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Interest and excitement surround the possibility of developing measures that produce sustained or permanent HIV remission in infected individuals. First-in-human (FIH) trials are one step in exploring this possibility. Initial human trials raise the usual ethical issues associated with human research, and a set of distinct issues. Because the potential direct benefits to FIH trial volunteers will be either small or non-existent, trial risks must be justified by the social value of the information the trials are expected to produce. To minimise and justify risks, researchers must have solid preclinical evidence that FIH trials will be safe and produce information relevant to human health improvements. Researchers must also adopt adequate study safeguards to protect FIH subjects. An ethically defensible study population must be selected as well.

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Section: Background Considerationsmentioning

confidence: 99%

Section: Subject Selection and Risk Minimisationmentioning

confidence: 99%

First-in-human HIV-remission studies: reducing and justifying risk

Dresser

2016

J Med Ethics

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“…Our proposals would certainly require additional institutional resources and, perhaps, cause a slight reduction in patient participation in clinical research 25. These, however, are prices worth paying in order to make an attitude of respect for the patients the overriding value in human experimentation.…”

Section: Practical Suggestionsmentioning

confidence: 99%

Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension

et al. 2013

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We explored the comprehension of the informed consent in 77 cancer patients previously enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at the San Raffaele Scientific Institute in Milano. We asked participants to complete an ad hoc questionnaire and analysed their answers. Sixty-two per cent of the patients understood the purpose and nature of the trial they were participating in; 44% understood the study procedures and 40% correctly listed at least one of the major risks or complications related to their participation in the trial. We identified three factors associated with comprehension of the informed consent: age, education and type of tumour/investigator team. We suggest several possible improvements of how to obtain informed consent that will increase patient awareness, as well as the validity and effectiveness of the clinical trials.

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“…In the fall 2012 class a student suggested a commentary in the Nature magazine (Corbyn 2012), which references a PNAS study documenting that most of the retractions in lifesciences journals are due to fraud and not errors (Fang et al 2012). Another student in the same class suggested a policy forum in the Science magazine, tackling the misalignment of regulations with ethical considerations in human research (Dressler 2012). A third student suggested a CNN article about lessons drawn for U.S. nuclear safety from the Fukushima meltdown (Aldrich 2012).…”

Section: Web Linksmentioning

confidence: 97%

Connecting Past with Present: A Mixed-Methods Science Ethics Course and its Evaluation

et al. 2015

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We present a graduate science ethics course that connects cases from the historical record to present realities and practices in the areas of social responsibility, authorship, and human/animal experimentation. This content is delivered with mixed methods, including films, debates, blogging, and practicum; even the instructional team is mixed, including a historian of science and a research scientist. What really unites all of the course's components is the experiential aspect: from acting in historical debates to participating in the current scientific enterprise. The course aims to change the students' culture into one deeply devoted to the science ethics cause. To measure the sought after cultural change, we developed and validated a relevant questionnaire. Results of this questionnaire from students who took the course, demonstrate that the course had the intended effect on them. Furthermore, results of this questionnaire from controls indicate the need for cultural change in that cohort. All these quantitative results are reinforced by qualitative outcomes.

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Aligning Regulations and Ethics in Human Research

Abstract: New U.S. rules should ensure assessment of subjects' understanding, compensation for injury, and standards of study quality.

Cited by 11 publications

References 9 publications

First-in-human HIV-remission studies: reducing and justifying risk

First-in-human HIV-remission studies: reducing and justifying risk

Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension

Connecting Past with Present: A Mixed-Methods Science Ethics Course and its Evaluation

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