How does compliance process work in the Human Brain Project and what are the main challenges for compliance management for the next years? We continue our Question & Answer series with Ethics Support task leaders. This time it is William Knight, task leader for Compliance Management.
Q1: What are the aims of Compliance Management?
The primary role of the Compliance Management task is to ensure that all research activity in the Human Brain Project (HBP) adheres to EU legal and ethical requirements.
Q2: What are the main activities of Compliance Management?
I manage the compliance process. This involves speaking directly to HBP staff across the subprojects about the research activity taking place at in their tasks, and working with them to complete the Ethical Issues and Approvals Survey. This survey gives the Principal Investigator the chance to identify any ethical issues raised by their task, and to provide the local regulatory approvals they have acquired to account for these issues. Once these are received, I pass the survey and any supporting documentation on to our internal ethics experts for review.
Our internal ethics experts work with the study team to address any queries and questions and once they are resolved then we can consider the compliance process complete. This whole process is tracked in the Ethics Registry – a database of all tasks in the HBP, their assigned task leader, the ethical issues raised by the activity in that task and the status of any local regulatory approvals.
Further detail can be found in this short video presentation on the subject of Compliance in the Human Brain Project, and our Compliance Management and Informed Consent Standard Operating Procedures, which can be found alongside a host of useful guidance at the HBP Ethics Support website.
It is important to note that Ethics Support is not a Research Ethics Committee. We do not give ethical approval. It is simply our task, as part of Compliance Management, to ensure that local authorisation is given for research to take place at a location and to track, monitor and report on the compliance status of all tasks in the project. For that reason, we rely heavily on our task leaders, research staff and other ethics support structures such as the Ethics Rapporteurs to liaise with their local authorising bodies for regulatory approval. It is for this reason that we consider dialogue to be a vital part of compliance management in the HBP.
Q3: Who are the main collaborators of Compliance Management within and beyond the HBP?
As my task involves ensuring that every task in the project has regulatory approval, I liaise with a wide range of staff across the project. In particular, I work closely with Ethics Rapporteurs, as they are a vital link between the Ethics Support services and the study staff on the ground. I am in regular contact with the Project Coordination Office in Subproject 11 ‘Management & Coordination’ and the European Commission to report on the compliance status of the project.
Q4: What are the main achievements of Compliance Management so far?
By the end of previous funding period (SGA1, 1st Specific Grant Agreement: April 2016-March 2018), we ensured that every task within the project reported their compliance status, and those tasks presenting key ethical issues all completed the compliance process and ensured that they had compliance documentation recorded in the Ethics Registry.
The compliance process for current funding period (SGA2, 2nd Specific Grant Agreement: April 2018-March 2020) commenced in Summer 2017, well in advance of the start of this phase of the project, and we are now beginning to bring together those task leaders who identified potential issues in their task, but are yet to provide compliance documentation.
Q5: What are the main challenges of Compliance Management for the next years?
Our compliance processes ensure that HBP research has local authority approval. This process works well when we are dealing with research staff in a traditional research environment, but as we move towards the majority of work being on the HBP Joint Platform, we must consider the role of research compliance in that structure. Compliance Management must be more closely interlinked with the data curation processes going on in Subproject 5 ‘Neuroinformatics Platform’.
When the Joint Platform becomes operational, our main concerns regarding compliance will switch from ensuring that HBP research has local approval, to ensuring that the data accepted into our platform from external users is compliant with the legal and ethical requirements set in place by the project. The shape that this collaboration will take is still under development, but it will surely involve a closer working relationship between the Ethics Support services and the infrastructure management processes in place across the project.
Additionally, our compliance processes are designed to ensure compliance with EU law – but what role does Compliance Management play when we are looking to accept data from outside the jurisdiction of the EU? Is it feasible to track the compliance of datasets produced in China, South America and India? There may be research occurring outside the EU that comes from a defensible ethical position, but nonetheless does not adhere to EU requirements. In light of these considerations, what requirements will the HBP expect datasets to follow and what form will the internal processes take to ensure they are compliant with these requirements? One possible answer to these questions is to consider what equivalencies can be drawn between EU and non-EU compliance practices, and this is an avenue of research we will examine in forthcoming work.
Q6: Anything else?
If there are queries regarding ethics compliance in the HBP then they can be directed to the hbp.compliance@dmu.ac.uk email account, where the Ethics Support team can pick them up.
William Knight is Research Fellow and Compliance Manager for the Human Brain Project based at the Centre for Computing and Social Responsibility, De Montfort University, Leicester, UK.