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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

The Role of Intuition in Risk/Benefit Decision-Making in Human Subjects Research (Papers: David B. Resnik | June 2016)0

Posted by Admin in on February 2, 2017

One of the key principles of ethical research involving human subjects is that the risks of research to should be acceptable in relation to expected benefits. Institutional review board (IRB) members often rely on intuition to make risk/benefit decisions concerning proposed human studies. Some have objected to using intuition to make these decisions because intuition is unreliable and biased and lacks transparency. In this article, I examine the role of intuition in IRB risk/benefit decision-making and argue that there are practical and philosophical limits to our ability to reduce our reliance on intuition in this process. The fact that IRB risk/benefit decision-making involves intuition need not imply that it is hopelessly subjective or biased, however, since there are strategies that IRBs can employ to improve their decisions, such as using empirical data to estimate the probability of potential harms and benefits, developing classification systems to guide the evaluation of harms and benefits, and engaging in moral reasoning concerning the acceptability of risks.

Benefits, human subjects research, institutional review boards, intuition, reasoning, risks

Resnik DB (2016) The Role of Intuition in Risk/Benefit Decision-Making in Human Subjects Research. Accountability in Research
Policies and Quality Assurance 24(1)

We must urgently clarify data-sharing rules – Nature (Jan-Eric Litton | January 2017)0

Posted by Admin in on January 29, 2017

In a little over 12 months, the European Commission will roll out a new legal framework to govern the protection of personal data. There were many debates and discussions about the controversial regulations, which passed last year, and scientists and scientific bodies raised concerns over restrictions that the framework could have placed on the use of research data. We won several concessions, but the fight is not over yet. Scientists must now come together to work out a consistent way to implement the rules, and they must do so quickly.

Once in place, the European regulations will have to be interpreted by lawyers, administrative staff and others across a diverse patchwork of legal systems and cultures. To smooth their introduction and implementation, the European Commission is encouraging organizations that represent data users to prepare formal codes of conduct that would set out — in simple language — what can and cannot be done. Scientists need to help prepare these codes to ensure that the hard-won concessions for research are not lost in translation.

Legal texts are not easily accessible to non-lawyers. By developing codes of conduct that are as understandable as possible, we can help to guide researchers and administrative staff, reduce unnecessary fear about compliance and enhance data sharing for the sake of progress in research.

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Friday afternoon funny – Does a signed consent form mean much?0

Posted by Admin in on January 27, 2017

Cartoon by Don Mayne

Common Rule Reform – A Botched Job – Network Blogger (Robert Dingwall | January 2017)0

Posted by Admin in on January 26, 2017

US social scientists have long complained about the impact of the Common Rule, the main federal regulation governing the ethical review of biomedical and behavioral research by Institutional Review Boards (IRBs). This was first enacted in 1991 and last revised in 2005. In 2011, the relevant federal agencies announced a review, leading to the publication of revised regulations on the very last day of the Obama presidency. An international policy community has closely followed these US debates because of their influence on the frameworks for ethical regulation established elsewhere.

A 2014 report of the National Research Council of the National Academies (NRC) and by the draft regulations issued for consultation in 2016 raised hopes of sensible reform. The final drafting, however, seems to have been distracted by a major controversy over access to biospecimens. There are also signs of haste to enact regulations before the change of administration. Biomedical agendas have once again crowded out proper consideration of social science concerns.

The NRC set out a coherent approach that appropriately identified virtually all social science research as minimal risk. It should be ‘excused’ from ethical regulation on the basis that participants were well able to judge the risk and make their own decisions. A small number of experimental or intervention studies might require IRB review but everything else should just be registered. Specific consent should not be required for most studies – it could be inferred from willingness to fill in a survey or continue with an interview or focus group. Observations in public spaces, including social media, would also be ‘excused,’ as would most re-use of administrative data sets. ‘Vulnerable groups’ would no longer be listed but assumed normally to be capable of judging their own best interests. This approach was largely adopted by the draft regulations, which substituted the term ‘excluded’ for ‘excused’. IRBs would lose their jurisdiction over most social science research, unless it fell within narrow criteria or they could justify calling it in from the registration documents. There were still uncertainties about the status of participant observation or ethnography, but the approach was broadly welcomed by the community.

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