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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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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Practical, Epistemological, and Ethical Challenges of Participatory Action Research: A Cross-Disciplinary Review of the Literature (Papers: Danielle Lake and Joel Wendland | 2018)0

Posted by Admin in on October 9, 2018
 

Abstract
This article extends recent discussions on the practical, epistemological, and ethical challenges of participatory action research (PAR) for community-engaged scholars through a cross-disciplinary literature review. It focuses on how practitioners across fields define power, engage with conventional research approval processes, and manage risk. The review demonstrates that PAR can be a valuable research approach for community-engaged scholars, but problematic practices and disparities must be addressed. For instance, although PAR practitioners consistently articulate a commitment to empowering the community and shifting structures of oppression, contradictions around how to define and respond to power, engage with standard IRB practices, and cope with high levels of risk are prevalent. We conclude by offering a set of recommendations, highlighting the need for more transparent and self-reflexive methods; transdisciplinary practices; metrics designed to assess risk, inclusion, and power-sharing; ongoing dialogues across disciplinary and institutional divides; and inclusive authorship and open-access publishing practices.

Keywords: participatory action research, ethical challenges, interdisciplinarity, institutional

LAKE, Danielle; WENDLAND, Joel. Practical, Epistemological, and Ethical Challenges of Participatory Action Research: A Cross-Disciplinary Review of the Literature. Journal of Higher Education Outreach and Engagement, [S.l.], v. 22, n. 3, p. 11-42, sep. 2018. ISSN 2164-8212. Available at: http://openjournals.libs.uga.edu/index.php/jheoe/article/view/2093>.

What information and the extent of information research participants need in informed consent forms: a multi-country survey (Juntra Karbwang, et al | 2018)0

Posted by Admin in on October 7, 2018
 

Abstract

Background
The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research.

Methods
This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important).

Results
Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be ‘moderately important’ to ‘very important’ for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively).

Conclusions
Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF.

Keywords
Consent forms, Informed consent, Disclosure, Information, Ethics, Research subjects

Karbwang, J., et al. (2018). “What information and the extent of information research participants need in informed consent forms: a multi-country survey.” BMC Medical Ethics 19(1): 79.
Publisher (Open Access): https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-018-0318-x#Decs

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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