Research ethics codes and guidelines for genomics

The SIENNA project conducted a survey of codes and guidelines for human genomics. The survey was submitted to the European Commission in 2018, and lists a large body of codes and guidelines. Here, you will find a link to our full report, and a selection of guidelines we consider important to be aware of. 

The list below builds on Howard H, Niemiec E, Tamborino L, Lanzerath D et al. D2.3 Survey of REC approaches and codes for Human Genomics, 2018, which is a public deliverable report from the SIENNA project. You can download the full report on research ethics committee approaches for human genomics from Zenodo.

Amsterdam Declaration on Genetic and Health Data, Challenges for Tomorrow and Data Protection Oversight of Security and Intelligence: The Role of Data Protection Authorities in a Changing Society

published by the International Conference of Data Protection and Privacy Commissioners in 2015 (International)

Summary of the discussions in the Closed Session of the 37th International Privacy and Data Protection Conference held in Amsterdam, Netherlands on 26 and 27 October 2015 about the challenges arising from society’s increasing ability to collect, analyze and use genetic information with focus on the following observations: Characterization and identification, Risks for data protection and privacy, Necessity for Greater Communication with the Scientific Community. (like this for the other guidelines, too)

Link: Amsterdam Declaration on Genetic and Health Data, Challenges for Tomorrow and Data Protection Oversight of Security and Intelligence: The Role of Data Protection Authorities in a Changing Society

An Update to Returning Genetic Research Results to Individuals: Perspectives of the Industry Pharmacogenomics Working Group

published by the Industry Pharmacogenomics Working Group in 2015 (International)

The ease with which genotyping technologies generate tremendous amounts of data on research participants has been well chronicled. In parallel to these advances come additional ethical considerations and debates, one of which centers on providing individual research results and incidental findings back to research participants taking part in genetic research efforts. In 2006 the Industry Pharmacogenomics Working Group (I-PWG) offered some 'Points-to-Consider' on this topic within the context of the drug development process from those who are affiliated to pharmaceutical companies.

Link: An Update to Returning Genetic Research Results to Individuals: Perspectives of the Industry Pharmacogenomics Working Group

Whole-genome sequencing in newborn screening? A Statement on the continued importance of targeted approaches in newborn screening programmes

published by the European Society of Human Genetics (ESHG); Human Genome Organization (HUGO); PHG Foundation Public Population Project in Genomics and Society (P3G) in 2015 (International)

The advent and refinement of sequencing technologies has resulted in a decrease in both the cost and time needed to generate data on the entire sequence of the human genome. This has increased the accessibility of using whole-genome sequencing and whole-exome sequencing approaches for analysis in both the research and clinical contexts. The expectation is that more services based on these and other high-throughput technologies will become available to patients and the wider population. This statement presents the relevant issues and culminates in a set of recommendations to help inform and guide scientists and clinicians, as well as policy makers regarding the necessary considerations for the use of genome sequencing technologies and approaches in NBS programmes.

Link: Whole-genome sequencing in newborn screening? A Statement on the continued importance of targeted approaches in newborn screening programmes

Framework for Responsible Sharing of Genomic and Health-Related Data

published by the Global Alliance for Genomics & Health in 2014 (International)

This Framework is developed under the auspices of the Global Alliance for Genomics and Health. Its mission is to accelerate progress in human health by helping to establish a common Framework of harmonized approaches to enable effective and responsible sharing of genomic and clinical data and to catalyze data sharing projects that drive and demonstrate the value of data sharing. This Framework provides guidance for the responsible sharing of human genomic and health-related data, including personal health data and other types of data that may have predictive power in relation to health.

Link: Framework for Responsible Sharing of Genomic and Health-Related Data

The Application of Genome Editing in Humans

published by the Federation of European Academies of Medicine (FEAM) in 2017 (International)

Whilst recognising that the further development of new genome editing techniques will have global significance, FEAM develops its own position, thus helping to support the development of an appropriate regulatory and ethical environment and identify future priorities for the funding of research –for the ultimate benefit of the patient.

Link: The Application of Genome Editing in Humans

Ethical issues of CRISPR technology and gene editing through the lens of solidarity

published by the Human Genome Organization (HUGO) in 2017 (International)

The avalanche of commentaries on CRISPR-Cas9 technology, a bacterial immune system modified to recognize any short DNA sequence, cut it out, and insert a new one, has rekindled hopes for gene therapy and other applications and raised criticisms of engineering genes in future generations. Authors place increased emphasis on the principle of solidarity and the public good. The genetic bases of some diseases are not thoroughly addressable with CRISPR-Cas9. Authors see no new ethical issues, compared with gene therapy and genetic engineering in general, apart from the explosive rate of findings. Other controversies include eugenics, patentability and unrealistic expectations of professionals and the public.

Link: Ethical issues of CRISPR technology and gene editing through the lens of solidarity

Human Genome Editing: Science, Ethics, and Governance

published by the National Academies of Sciences, Engineering, and Medicine National Academy of Sciences (NAS) in 2017 (International)

Human Genome Editing considers important questions about the human application of genome editing including: balancing potential benefits with unintended risks, governing the use of genome editing, incorporating societal values into clinical applications and policy decisions, and respecting the inevitable differences across nations and cultures that will shape how and whether to use these new technologies. This report proposes criteria for heritable germline editing, provides conclusions on the crucial need for public education and engagement, and presents 7 general principles for the governance of human genome editing.

Link: Human Genome Editing: Science, Ethics, and Governance

Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations

published by the National Academies of Sciences, Engineering, and Medicine in 2016 (International)

Mitochondrial Replacement Techniques considers the implications of manipulating mitochondrial content both in children born to women as a result of participating in these studies and in descendants of any female offspring. This study examines the ethical and social issues related to MRTs, outlines principles that would provide a framework and foundation for oversight of MRTs, and develops recommendations to inform the Food and Drug Administration's consideration of investigational new drug applications.

Link: Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations

On Human Gene Editing: International Summit Statement

published by the National Academies of Sciences, Engineering, and Medicine in 2015 (International)

Scientific advances in molecular biology over the past 50 years have produced remarkable progress in medicine. Some of these advances have also raised important ethical and societal issues. The scientific community has consistently recognized its responsibility to identify and confront these issues. After three days of thoughtful discussion of these issues, the members of the Organizing Committee for the International Summit on Human Gene Editing have reached conclusions detailed here on this webpage.

Link: On Human Gene Editing: International Summit Statement

Statement on Genome Editing Technologies and Human Germline Genetic Modification

published by the Hinxton Group, an International Consortium on Stem Cells, Ethics and Law in 2015 (International)

The goal of the Hinxton Group is to inform ongoing debates on the scientific, ethical and regulatory issues raised by both research and clinical reproductive uses of this technology and to provide useful guidance to decision-­ÔÇÉmakers regarding use of these technologies in humans, and in particular their use to intervene in the human germline. The focus of our discussions was genome editing in the early stages of human development, when any such intervention might reasonably be assumed to integrate into the germline, and therefore have the opportunity of being passed down to future generations.

Link: Statement on Genome Editing Technologies and Human Germline Genetic Modification

The Alliance for Regenerative Medicine’s (ARM) Position Statement Regarding Human Embryo or Germline Genome Modification

published by the Alliance for Regenerative Medicine (ARM) in 2015 (International)

ARM’s position is that it is neither appropriate nor acceptable to pursue this kind of research at this time, given the highly premature stage of germline modification technology and the many scientific and ethical issues that surround it. The statement emphasizes that this field of research is controversial and its impact on future generations, both long- and short-term, remain unproven.

Link: The Alliance for Regenerative Medicine’s (ARM) Position Statement Regarding Human Embryo or Germline Genome Modification

The ISSCR Statement on Human Germline Genome Modification

published by the International Society for Stem Cell Research (ISSCR) in 2015 (International)

The International Society for Stem Cell Research calls for a moratorium on attempts at clinical application of nuclear genome editing of the human germ line to enable more extensive scientific analysis of the potential risks of genome editing and broader public discussion of the societal and ethical implications.

Link: The ISSCR Statement on Human Germline Genome Modification

Report of the IBC on Updating Its Reflection on the Human Genome and Human Rights

published by the UNESCO International Bioethics Committee (IBC) in 2015 (International)

In response to the rapid advancements in genetics and genomics, and within the framework of its work programme for 2014-2015, the International Bioethics Committee (IBC) decided to update its reflection on the issue of the human genome and human rights, building upon the considerable work done on this topic by the IBC in the past.

Link: Report of the IBC on Updating Its Reflection on the Human Genome and Human Rights