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Clinical Trials – More Blinding, Less Worry! – Statistically Funny (Hilda Bastian | August 2018)0

Posted by Admin in on October 11, 2018
 

She’s right to be worried! There are so many possible cracks that bias can seep through, nudging clinical trial results off course. Some of the biggest come from people knowing which comparison group a participant will be, or has been, in. Allocation concealment and blinding are strategies to reduce this risk.

Blinding and randomisation are often held up as best practice for clinical trials, but the reality is a lot less certain than many people realise and the ethical challenges aren’t trivial. We’ve included links to a long list of items reflecting on the ethics of trials.

Before we get to that, let’s look at the source of the problems we’re aiming at here: people! They bring subjectivity to the mix, even if they are committed to the trial – and not everyone who plays a role will be supportive, anyway. On top of that, randomizing people – leaving their fate to pure chance – can be the rational and absolutely vital thing to do. But it’s also “anathema to the human spirit”, so it can be awfully hard to play totally by the rules.
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And we’re counting on a lot of people here, aren’t we? There are the ones who enter an individual into one of the comparison groups in the trial. There are those individual participants themselves, and the ones dealing with them during the trial – healthcare practitioners who treat them, for example. And then there are the people measuring outcomes – like looking at an x-ray and deciding if it’s showing improvement or not.
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Ethical Guidelines for Observational Studies0

Posted by Admin in on October 11, 2018
 

Foreword to the 2012 edition
These Guidelines were first released in 2006; the current document is a revision. The Health Committee’s inquiry into improving New Zealand’s environment to support innovation through clinical trials (June 2011) resulted in significant changes to the ethics review process, as reflected in the revised Standard Operating Procedures (SOPs) for Health and Disability Ethics Committees.

This 2012 revision aims to provide consistency with the SOPs. These Guidelines have been updated to remove process guidance, and ensure that policy previously included in the Operational Standard for Ethics Committees is now addressed by these Guidelines. The revision did not fundamentally change the existing ethical standards and principles set out in these Guidelines.

As previously, the Guidelines are directed primarily to investigators, who have the main ethical responsibility for good study conduct. But the Guidelines also continue to be directed to others with a role in health and disability research ethics – particularly the ethics committees that review studies against established ethical standards. The key objectives of developing national ethical guidelines are to…

Contents

Foreword to the 2012 edition iii
Foreword to the 2006 edition iv

1 Introduction 1

2 Guidelines scope and definitions 3
Types of observational research 3
Types of audit or related activity 4

3 Ethics of observational studies 6
Worth of observational studies 6
Ethical requirements of observational studies 6

4 Underlying ethical considerations 8
Respect for people 8
Māori and ethical considerations 8
Justice 9
Beneficence and non-maleficence 9
Integrity 10
Diversity 10
Conflict of interest 10

5 Design of study and protocol 11
Study question 11
Study design 11
Scientifically sound 11
Skills and resources 12
Protocol 12

6 Collecting health information 13
Identifiability of health information 13
Collection of health information directly from individuals 14
Collection of health information from a third party 18

7 Use of information 20

8 Confidentiality of data 21
General considerations 21
Record linkage 22

9 When to reveal information obtained by observational studies 23

10 Communicating study results 24

11 Features of observational studies that pose more than minimal risk 25

12 Additional points 27
Bibliography 28

Appendix:
Joint Health Research Council and NEAC guidance on features of robust peer review for assessing the scientific validity of research 30

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Current Perspectives on Research Ethics in Qualitative Research (Wolff-Michael Roth, Hella von Unger | 2018)0

Posted by Admin in on October 4, 2018
 

Abstract

In this article, we provide a brief introduction to the special issue on research ethics in qualitative research. We describe the general context within which our idea emerged to organize a special issue and present its design and, for purposes of transparency, some particulars with respect to the selection and review process. We sketch some of the common themes that are shared across parts of the paper set, including critical analysis of ethics codes and ethics reviews, the intricacies of informed consent, confidentiality and anonymity in qualitative research and questions of vulnerability.

Keywords
anonymity; confidentiality; ethics codes; ethics reviews; informed consent; knowledge/power; vulnerability

Roth, W., & von Unger, H. (2018). Current Perspectives on Research Ethics in Qualitative Research. Forum Qualitative Sozialforschung / Forum: Qualitative Social Research, 19(3). doi:http://dx.doi.org/10.17169/fqs-19.3.3155
Publisher (Open Access): http://www.qualitative-research.net/index.php/fqs/article/view/3155

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Privacy in User Research: Can You? – Scholarly Kitchen (Lisa Janicke Hinchliffe | September 2018)0

Posted by Admin in on September 23, 2018
 

We may live in the age of privacy nihilism but recognizing one’s reality does not have to mean agreeing to do your own work by its terms. This post is for those publishers, academic and research librarians, and others who conduct research on user behavior in library information systems, who — whether for personal and/or professional ethical reasons or policies — want to do so in ways that prioritize privacy.

Situating Myself and Academic Librarianship

This paper will most obviously be of interest to librarien researchers who are reflecting on the ethics of the use of user data. But its discussion will be of interest to anyone interested in research ethics in quality assurance and service delivery where user data is collected. The piece’s discussion about the important differences between privacy, confidentiality and anonymity are likely to be helpful to anyone thinking about the ethical design, conduct and the reporting of human research.

A bit of my own background is probably useful to contextualize this discussion. My own attention to this topic of privacy and user data came into focus when I led the launch of the Value of Academic Libraries Initiative as President of the Association of College and Research Libraries (ACRL) in 2010-2011. Grounded in The Value of Academic Libraries: A Comprehensive Research Review and Report, my work that year and since then has been heavily focused on advocating for the profession to move to evidence-based claims for library value and for the collection and analysis of individual user data in order to do so. This work has been heavily criticized for its focus on collecting user data and, at times, for facilitating the neoliberal transformation of higher education.
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Given that, I have also had to confront hard questions about how gathering and analyzing user data aligns with the values of my profession. Specifically, the value of privacy as expressed in the ALA Code of Ethics statement that: “We protect each library user’s right to privacy and confidentiality with respect to information sought or received and resources consulted, borrowed, acquired or transmitted.” These questions have not had easy or straightforward answers, particularly as the value of privacy can be in tension with another principle in the ALA Code of Ethics: “We provide the highest level of service to all library users.” I’m grateful to Andrew Asher who joined me in a series of public presentations exploring these issues (e.g., CNI Fall 2014).
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