On 3 October 2018, the Central Denmark Region Committees on Health Research Ethics confirmed the following:
On 28 August 2012, the Central Denmark Region Committees on Health Research Ethics, Committee II (RVK M) approved the project “Genetiske og miljømæssige årsager til skizofreni, bipolar sygdom, depression, ADHD, autisme og anorexia nervosa / Genetic and environmental causes of schizophrenia, bipolar disorder, depression, ADHD, autism and anorexia nervosa (the iPSYCH project)”. In accordance with the Act on Research Ethics Review of Health Research Projects (in Danish: Komitéloven), Section 10 (1), the committee granted exemption from obtaining informed consent from participants.
On 1 January 2012, the Act on Research Ethics Review of Health Research Projects (in Danish: Komitéloven) was altered. Among other things, this entailed that research projects which pertain to "particularly complex areas" must in future be reported to the National Committee on Health Research Ethics as first instance cases. The particularly complex areas were determined in the ministerial order of 15 June 2012 on information and consent for participation in health research projects as well as on the notification and supervision of health research projects. The ministerial order stipulates that projects with extensive mapping of the genome shall in future be first instance processed by the National Committee on Health Research Ethics.
The iPSYCH project was reported to RVK M prior to genomic projects being defined as a "particularly complex area".
RVK M’s processing and approval of the iPSYCH project is therefore in accordance with applicable law and practice at the time of notification.
On 12 October 2012, the National Committee on Health Research Ethics adopted the first genomic guidelines. The guidelines stem from the fact that legislatively, no specific position had been taken on the special ethical issues that genomic research involves. The genomic guidelines lay down criteria for feedback to test subjects, the inclusion of minors as test subjects, genetic counselling and criteria for exemption from the requirement for consent. Furthermore, they also lay down narrower frameworks for what genomic data may subsequently be used for and its disclosure. Over the subsequent years, the genomic guidelines have been regularly revised.
In 2013 and 2015, RVK M 2 approved supplementary protocols for the iPSYCH project.
As the guidelines and practice for the processing of genomic projects have changed since the approval of the iPYSCH project, in 2017 RVK M – in consultation with the National Committee on Health Research Ethics – initiated a dialogue with the research group with a view to adapting the IPSYCH project in relation to the applicable guidelines and practice.
This adaptation of the IPSYCH project takes place through a supplementary protocol which was approved in 2018. The supplementary protocol from 2018 does not grant permission for an expansion of the project, but rather alone imposes limitations in relation to the genomic guidelines.