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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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Unsuccessful trial accrual and human subjects protections: an empirical analysis of recently closed trials (Papers: Benjamin Carlisle et al 2014)0

Posted by Admin in on July 1, 2016
 

Abstract

Background
Ethical evaluation of risk–benefit in clinical trials is premised on the achievability of resolving research questions motivating an investigation.

Objective
To determine the fraction and number of patients enrolled in trials that were at risk of not meaningfully addressing their primary research objective due to unsuccessful patient accrual.

Methods
We used the National Library of Medicine clinical trial registry to capture all initiated phases 2 and 3 intervention clinical trials that were registered as closed in 2011. We then determined the number that had been terminated due to unsuccessful accrual and the number that had closed after less than 85% of the target number of human subjects had been enrolled. Five factors were tested for association with unsuccessful accrual.

Results
Of 2579 eligible trials, 481 (19%) either terminated for failed accrual or completed with less than 85% expected enrolment, seriously compromising their statistical power. Factors associated with unsuccessful accrual included greater number of eligibility criteria (p = 0.013), non-industry funding (25% vs 16%, p \ 0.0001), earlier trial phase (23% vs 16%, p \ 0.0001), fewer number of research sites at trial completion (p \ 0.0001) and at registration (p \ 0.0001), and an active (non-placebo) comparator (23% vs 16%, p \ 0.001).

Conclusion
A total of 48,027 patients had enrolled in trials closed in 2011 who were unable to answer the primary research question meaningfully. Ethics bodies, investigators, and data monitoring committees should carefully scrutinize trial design, recruitment plans, and feasibility of achieving accrual targets when designing and reviewing trials, monitor accrual once initiated, and take corrective action when accrual is lagging.

Keywords
Medical ethics, research ethics, clinical trials, trial accrual, recruitment

Carlisle B, Kimmelman J, Ramsay T and MacKinnon N (2014) Unsuccessful trial accrual and human subjects protections: an empirical analysis of recently closed trials. Clinical Trials. 12(1):77-83. doi: 10.1177/1740774514558307.
Publisher: http://ctj.sagepub.com/content/12/1/77.long

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
 

Introduction
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
http://ec.europa.eu/research/swafs/pdf/pub_research_ethics/KI3213113ENC.pdf#view=fit&pagemode=none

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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