Presentation at ETHOX: The ethics of clinical research during an epidemic – Lessons from Ebola

Tomorrow, I will be speaking about The ethics of clinical research during an epidemic – Lessons from Ebola at the ETHOX research seminar series. Many thanks to my colleagues at ETHOX for setting this up, and for hosting me as a Caroline Miles visiting scholar this month!

19 May, 2015, 10:30-12:00 pm, Lecture Theatre, Richard Doll Building, Old Road Campus, University of Zurich

New publication: Research led by participants: a new social contract for a new kind of research

Vayena E, Brownsword R, Edwards SJ, Greshake B, Kahn J, Ladher N, Montgomery J, O’Connor D, O’Neill O, Richards MP, Rid A, Sheehan M, Wicks P, Tasioulas J (2015): Research led by participants: a new social contract for a new kind of research. Journal of Medical Ethics (online early)

Abstract

In recent years, there have been prominent calls for a new social contract that accords a more central role to citizens in health research. Typically, this has been understood as citizens and patients having a greater voice and role within the standard research enterprise. Beyond this, however, it is important that the renegotiated contract specifically addresses the oversight of a new, path-breaking approach to health research: participant-led research. In light of the momentum behind participant-led research and its potential to advance health knowledge by challenging and complementing traditional research, it is vital for all stakeholders to work together in securing the conditions that will enable it to flourish.

Now out: The ethics of placebo-controlled trials

van der Graaf R, Rid A: Placebo-controlled trials, ethics of. In: Wright JD (Ed): International Encyclopedia of the Social & Behavioral Sciences, 2nd Edition, Volume 18, Elsevier: Oxford, 2015, pp. 164-173

Abstract

There are often good scientific and ethical reasons for using placebo controls in clinical trials. At the same time placebo use is

controversial, especially when an established effective treatment is being withheld from the control group. This article gives

an overview of the key ethical positions in the controversy around placebo-controlled trials. While some argue that placebo

controls can only be used when withholding or delaying an established effective treatment poses no or negligible risks to

participants, others hold that the risks should be low or acceptable in light of the social value of the knowledge to be gained

from the research. The article also describes different positions on placebo use in trials in low- and middle-income countries

where study participants may not have had access to an established effective treatment outside the trial.

 

Research Ethics Grand Rounds at UNC Chapel Hill

On Thursday, I will be speaking about The ethics of clinical research during an epidemic: Lessons from Ebola during Research Ethics Grand Rounds at UNC Chapel Hill. Many thanks to my colleagues from the Center for Bioethics for setting this up! 19 February, 2015, 12:00-1:00 pm, 219 Brinkhous-Bullitt TraCS Conference Room, School of Medicine, University of North Carolina, Chapel Hill

New publication: Genetic research on biospecimens poses minimal risk

Wendler D, Rid A (2015): Genetic research on biospecimens poses minimal risk. Trends in Genetics (1):11-15 (.pdf)

Highlights

  • There is continuing debate over whether genetic research on biospecimens poses minimal risk or greater than minimal risk to donors.
  • Resolving this debate is important for determining when genetic research on biospecimens is ethically appropriate and when it should be subject to additional requirements and limitations.
  • With standard protections in place, the risks of most genetic research are no greater than the risks of daily life, the risks of routine examinations, and the risks of charitable activities.
  • The risk level of most genetic research on biospecimens, therefore, qualifies as minimal on the three extant definitions of minimal risk.

Abstract

Genetic research on human biospecimens is increasingly common. However, debate continues over the level of risk that this research poses to sample donors. Some argue that genetic research on biospecimens poses minimal risk; others argue that it poses greater than minimal risk and therefore needs additional requirements and limitations. This debate raises concern that some donors are not receiving appropriate protection or, conversely, that valuable research is being subject to unnecessary requirements and limitations. The present paper attempts to resolve this debate using the widely-endorsed ‘risks of daily life’ standard. The three extant versions of this standard all suggest that, with proper measures in place to protect confidentiality, most genetic research on human biospecimens poses minimal risk to donors.

Access to the published paper or penultimate draft

Open letter to NICE

Participants of the KCL/UCL Workshops on Social Values and Health Priority Setting have submitted an advice document to the National Institute for Health and Care Excellence (NICE). The document is an open letter in response to a request by Professor Sarah Garner, Associate Director of R&D at NICE, for the KCL/UCL group to consider issues that should be addressed when updating the 2008 edition of NICE’s Social Values Judgements document. The authors of the open letter make 10 recommendations to NICE. Read the recommendations and the full-length open letter here. More information on the KCL/UCL Social Values Group, of which I am a member (and a co-author of the open letter), can be found here.