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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)

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.

Read the rest of this discussion piece

HHS and 15 other Federal Departments and Agencies Announce Revisions to the US Federal Policy for the Protection of Human Subjects (the Common Rule) – Statement from the HHS0

Posted by Admin in on January 19, 2017

The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies have announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.

This change applies only to research that is reviewed by an IRB/research ethics committee that utilises the HHS framework. Nevertheless it might portend changes to the frameworks in other jurisdictions.

These revisions are an effort to modernize, simplify, and enhance the current system of oversight.
The final rule is being put on public display on January 18, 2017, by the Office of the Federal Register and can be accessed at:…. It is expected that the final rule will be published in the Federal Register on January 19, 2017.
HHS released a Press Release about the final rule that can be accessed at:

National and International Compliance Tools (Papers: Pamela Andanda, et al 2016)0

Posted by Admin in on January 10, 2017

Creating and enhancing TRUSTworthy, responsible and equitable partnerships in international research
A report for TRUST

Executive Summary

The main challenge in the governance of research at the global level is the existence of varying ethics review practices across countries. While differences in approaches per se do not necessarily create a problem, such varying practices can lead to “ethics dumping”; the purposeful exploitation of third country research participants/resources, as well as exploitation based on insufficient ethics awareness.

The TRUST project develops three tools to counter ethics dumping:

1. A Global Code of Conduct for North‐South Collaboration

2. A Fair Research Contracts Webtool, and

3. A Compliance and Ethics Follow‐up Tool.

This report provides the first step towards the Compliance and Ethics Follow‐up Tool. It was produced based on the following activities.

The resource developed which covers the first two activities can be found on pages 18‐32, structured according to the Horizon 2020 ethics review template.

An overview of self‐regulatory mechanisms operated by 13 pharmaceutical companies, as presented in their public sources, can be found on pages 33‐44. An overview of existing compliance tools can be found on pages 45‐54.

Andanda P, Wathuta J, Leisinger K and Schroeder D, a report for TRUST