Regulation of human epigenetic editing: ensuring international frameworks for governing Human Genome Editing don’t impede vital medical research
In this thoughtful post, Nik Zeps reflects on human genome manipulation in medical research, the ethical guidance in Australia and internationally.
He discusses CRISPR and the furore in 2018 around the ‘genetically modified babies’ in China.
Nik then discusses the degree to which the COVID-19 pandemic has pushed discussions about human genetic manipulation off the media radar.
Nevertheless, there have been important international discussions about the topic, including a new WHO Framework. This topic was recently discussed in a paper by Zeps, Lysaght et al. 2021.
The situation might position the WHO as a major player in the international discussion about human genetic manipulation.
In this post Gary discusses the components of a good internal report from a research ethics committee to the governing body of the host institution.
Such reports should be produced annually.
A constructive report should provide a snapshot of the committee during the reported period.
The report should cover specific matters that are optional and strategic in nature.
In this post, Gary Allen and Nik Zeps explore the human research ethics arguments and imperatives that only allow for the sharing of data, but establish a public good that can make sharing expected and essential.
This expectation should shape the approach to consent, the framing of assurances given to potential participants about confidentiality and e reflected in the application for research ethics review.
Research ethics committees and review bodies should be cognisant of these ethical arguments during the research ethics review of projects
Institutions must have clear policies and guidance material on data sharing.
In this post find out why Gary is cranky about the proposed good practice guide for Australian Research Integrity Advisers.
#SPOILERALERT It is because he believes institutions need a network of collegiate Research Integrity Advisers to nurture and support a community of practice within their institution.
He also thinks mandatory reporting and telling people to speak in hypotheticals are STUPID.
While Gary describes this as a personal opinion, we agree. We don’t see how mandatory reporting will make serving as an RIA would be appealing or encourage anyone to consult them about whether an individual’s practice is appropriate.
AHRECS provides desktop audit and blueprint on Research Integrity within an institution and conducts professional development for RIAs.
Contact firstname.lastname@example.org to discuss.
We are delighted with how busy AHRECS is at the moment in the human research ethics and research integrity spheres in Australia, Aotearoa New Zealand and the United Kingdom. Our current work can be broken down into four categories:
1. Informing the practice of a research institution
2. Fostering and supporting a community of practice
3. Helping with tricky questions
4. Formulating an approach
To discuss any of the above, contact one of our senior consultants, or send an email to Enquiry AHRECS email@example.com.
While our activities are focussed on Australia, Aotearoa New Zealand and…
Element Zero: What’s missing from the National Statement to support Consumer and Community Involvement in health research?
In this great post, Mark, Deborah and Ciara discuss a useful new element for the National Statement that relates to genuine involvement, input and participation for consumers/community members.
Mark Israel, Deborah Hersh and Ciara Shiggins
Advocates in health research of Consumer and Community Involvement – a concept better known in the United Kingdom as Patient and Public Involvement (PPI) – argue that it offers a way of building knowledge that incorporates the experiences and perspectives of a range of stakeholders, including patients and members of the public. Such involvement can improve the experience for research participants, enhance the process of informed consent, aid research impact and dissemination. It might also avoid the waste of resources on findings that have little relevance to end users or that cannot be implemented…
In this post, Dr Gary Allen reflects on the establishment and conduct of constructive audits.
Dr Gary Allen
When research with current ethics approval is periodically monitored, it is typically a passive process. Institutions, often via their research ethics administration, will ask researchers to self-report on the continued ethical acceptability of a project (and compliance with any conditions of approval). It would not be unreasonable to conclude that self-reporting is not the most effective way to identify if there have been problems with approved projects. Indeed, if things have gone wrong, it is at least possible that the most troublesome researchers might not be entirely honest about what has happened or why.
So, what is the alternative?
Conducting random audits of a small number of active projects…
Farida Fozdar responds and reflects upon the February 2021 post by Gary Allen and Mark Israel.
The Tower of Babel (Allen and Israel, 2021) is a compelling image when considering issues to do with translation and interpreting and the ethics of social research. Even when we speak the same language, we may not be ‘speaking the same language’, so to speak (excuse the triple metaphor). Talking past each other occurs in many ways but, in communicating the clear purpose and potential risks of one’s research, clarity is vital. Here, I outline a few issues from personal research experience, arguing that the communities themselves may be best placed to identify ethics issues and solutions to translation and interpreting dilemmas.
When working with those from a language different from that of the researchers, it may be the case that the idea of research is not well understood in the culture of origin…
Professor Jennifer Byrne | University of Sydney Medical School and Children’s Hospital at Westmead
Most institutions have processes for differentiating between Quality Assurance/Quality Improvement (QA/QI) activities and those
Nik Zeps, Consultant, AHRECS Keywords: Ethical Review, International Guidelines, Gene editing technologies, It has
In a notorious scene from Pirates of the Caribbean: The Curse of the Black