ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)
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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

A Tool to Help Address Key Ethical Issues in Research – Journal of Medical Ethics Blog (Rebecca H. Li and Holly Fernandez Lynch 2016)0

Posted by Admin in on July 4, 2016

One of the most important responsibilities of a clinical project lead at a biotech company or an academic research team is to generate clinical trial protocols. The protocol dictates how a trial will be conducted and details background information on prior research, scientific objectives, study rationale, research methodology and design, participant eligibility criteria, anticipated risks and benefits, how adverse events will be handled, plans for statistical analysis, and other topics. Many protocol authors use as a starting point a “standardised” protocol template from their funder or institution. These templates often provide standard language, and sections for customisation, sometimes with various “pick-and-choose” options based on the nature of the research. They inevitably cover each of the key topics listed above, but often fail to include ethical principles and considerations beyond the regulatory requirement of informed consent. Indeed, the process of protocol writing has traditionally focused on scientific detail, with ethical analysis often left to institutional review boards (IRBs) and research ethics committees (RECs); unfortunately, robust discussion of specific ethical issues is often absent from clinical trial protocols.

When IRBs and RECs convene to review protocols, they are expected to evaluate whether the study will adequately protect enrolled participants. When the protocol fails to address potential ethical concerns explicitly, reviewers are left to speculate: did the investigator consider the concern, but dismiss it as not relevant in this particular context; did the investigator fail to understand the concern; does the investigator have an appropriate plan in place to resolve the concern, but has left it unstated in the protocol? This uncertainty can contribute to delays as reviewers debate among themselves, and can require lengthy back-and-forth with researchers, including series of protocol revisions and re-reviews until clarity is established. In some cases, it may also be that reviewers with less experience or expertise fail to identify an ethical concern that has not been brought to their attention in a protocol.

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Research ethics needs fine tuning, not rigidity: how to promote evidence in neglected patient populations by rethinking informed consent (Papers: J. Wouter Jukema et al 2015)0

Posted by Admin in on July 2, 2016

Well-conducted biomedical research tells us how best to act in various clinical situations. In order to do so, ethical and legal rules have been developed over time for optimal study conduct, with special attention to the subjects involved in these studies. This includes asking informed consent before including a person in a clinical trial, and protection of fragile and mentally incompetent individuals by restricting and regulating their participation in biomedical research. Apart from the obvious positive effects, these regulations may also lead to unintended restrictions, and as a result not all relevant patient subgroups are sufficiently included in human clinical research. Consequently, important questions on how to optimally treat certain patient groups remain unanswered.

The objective of this ‘current opinion’ article is to explore how therapeutic scientific research and procedures can be better exploited, to advance clinical expertise and to discuss ethical issues that need to be considered in that context. For that purpose, we reflect on the challenges and consequences of patient selection, studies in acute care setting, and comparison of established therapies, in the final part illustrated by discussing some relevant recent clinical trials.

We all appreciate the fact that biomedical research in humans should be guided by high ethical standards, as outlined in the Declaration of Helsinki,1 among which informed consent of the subject before participation in a trial. Nevertheless, we propose that, in order to obtain optimal scientific and clinical data, certain study types should not require (pre-study) informed consent, while still guaranteeing patients essential (ethical) rights and safety.

Jukema JW, Brouwer JR, Lüscher TF, Engberts DP, Quax PHA (2015) Research ethics needs fine tuning, not rigidity: how to promote evidence in neglected patient populations by rethinking informed consent. European Heart Journal. 36(40):2681-5. doi: 10.1093/eurheartj/ehv358.

Research, Risk-Benefit Analyses and Ethical Issues How to ensure research projects meet EU ethics standards A guidance document for researchers complying with requests from the European Commission Ethics Reviews0

Posted by Admin in on June 27, 2016

You have received feedback from an ethics panel… – Any points raised in ethical reviews are not meant to be punishments or attempts to interfere with your research. Rather, they are requests for safeguards to ensure that human subjects, animals or the environment are protected and the public perception of research remains positive. If certain research methods may raise ethical concerns, you should take measures to ensure that widely shared societal values are not compromised. This document will help you to identify some ethical issues, take measures to reassure concerns and address any points raised by an ethics panel.

What is a risk-benefit analysis? – A risk-benefit analysis is something we do in any decision-making process. In its basic form, it is a consideration of the risks in relation to the benefits. Where benefits are great or necessary, we concentrate on reducing the exposure to potential risks (where risks are too high or the benefits insignificant, we take precaution). Central to risk-benefit analyses is the consideration of introducing risk reduction measures.

Risks are not just economic, environmental or systemic. There are also societal or ethical risks (challenges to human values, rights, freedoms) which can have an impact on research directions. If research causes loss of life or well-being, confronts basic freedoms like privacy and free movement or challenges shared values, then this research is seen to be a risk. This is the human element that some researchers can easily overlook or downplay. As our personal worth (human dignity) is not something elastic that can be easily traded off , an ethical risk could interfere with the ability to continue along present research lines and should therefore not be taken lightly.

European Commission (2013) Research, Risk-Benefit Analyses and Ethical Issues How to ensure research projects meet EU ethics standards A guidance document for researchers complying with requests from the European Commission Ethics Reviews. Directorate-General for Research and Innovation Science in society/Capacities FP7. Luxembourg: Publications Office of the European Union doi:10.2777/74325

Facebook’s Research Ethics Board Needs to Stay Far Away from Facebook – Wired (Zoltan Boka June 2016)0

Posted by Admin in on June 26, 2016

CHANCES ARE, YOU’RE on Facebook right now. About 1.7 billion people—almost a quarter of the world’s population—actively use the social media platform . And though it’s free, Facebook isn’t charity. It has a product, and that product is you and me. The company cleared a tidy $5.2 billion from user-directed ads in the first quarter of 2016 alone.

To keep that business running, Facebook doesn’t just need users: It needs active, engaged users. Facebook needs to get in your head, to understand how you’ll respond to a product or an offer or a marketing campaign—and more and more, it’s using internal experiments to predict those behaviors. But using those methods, commonly referred to as neuromarketing, means that Facebook needs to address the same ethical questions other behavioral scientists do.

In 2014, Facebook undertook an experiment on more than half a million of its users, manipulating feeds so some people saw more positive posts while others were exposed to a more negative stream. The moods were contagious: Those who saw more good news wrote happier posts and those who saw more bad news wrote sadder posts. But Facebook didn’t ask its users permission to do this; it has argued that their terms of service allows it to structure what you see. The blowback was massive, with some wondering whether the experiment pushed depressed users towards suicide. In response, Facebook has recently decided to draw on an essential element of ethics in behavioral science: an Institutional Review Board.

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