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The Next Phase of Human Gene-Therapy Oversight – The New England Journal of Medicine (Francis S. Collins and Scott Gottlieb | August 2018)0

Posted by Admin in on October 18, 2018
 

The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) have played key roles in the emergence of safe and effective human gene therapies. Now, we are proposing new efforts to encourage further advances in this rapidly evolving field.

The potential to alter human genes directly was first recognized nearly 50 years ago, around the same time as initial groundbreaking advances were being made in recombinant DNA technology. After intense discussions regarding the ethical, legal, and social implications of this technology, conversations were initiated at the NIH that led to the establishment of the Recombinant DNA Advisory Committee (RAC) in 1974. The RAC’s mission was to advise the NIH director on research that used emerging technologies involving manipulation of nucleic acids — a mission that was eventually expanded to encompass the review and discussion of protocols for gene therapy in humans. In 1990, the FDA oversaw the first U.S. human gene-therapy trial, which involved pediatric patients with adenosine deaminase deficiency and was conducted at the NIH Clinical Center in Bethesda, Maryland.

Although no major safety concerns were initially reported, over the course of the 1990s it became evident that many questions regarding the safety and efficacy of gene therapy remained unanswered. These unknowns were brought into sharp focus in 1999 when Jesse Gelsinger died of a massive immune response during a safety trial of gene therapy for ornithine transcarbamylase deficiency.1 This tragic death led to closer scrutiny of the field, including a greater focus on open dialogue and increased regulatory oversight.

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Research with former refugees: Moving towards an ethics in practice (Nisha Thapliyal and Sally Baker | September 2018)0

Posted by Admin in on October 14, 2018
 

Abstract:
Research into issues relating to people from refugee backgrounds has proliferated in line with the explosion in the numbers of people seeking refuge globally. In this think piece, we reflect on what it means to research with former refugees in contexts of resettlement in an academic and social climate dominated by audit culture and austerity politics. Drawing on an interdisciplinary literature and existing institutional ethics standards, we discuss key, often unaddressed, ethical issues which manifest throughout research processes of recruitment, data collection and dissemination. Specifically, we problematise static and decontextualised approaches to engaging with issues of vulnerability, fair selection, informed consent and the burdens and benefits of participation, and point towards the benefits of taking an ethics in practice approach. In doing so, we hope to make a useful contribution to our collective strategic repertoires to carry out ethical research in practice with former refugees.

Thapliyal, Nisha and Baker, Sally. (2018) Research with former refugees: Moving towards an ethics in practice [online]. The Australian Universities’ Review, Vol. 60, No. 2, Sep 2018: 49-56. ISSN: 0818-8068
https://search.informit.com.au/documentSummary;dn=818725514655109;res=IELHSS 

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

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