The HEADSpAcE investigators place ethics at the heart of the project. With this aim, a dedicated external Ethics Advisor is part of the International Advisory Board. The European Commission, which is funding the HEADSpAcE project, closely monitors ethics compliance to ensure that the project complies with best ethics practices. All of this work is towards the same objective: maintaining the highest standards of research ethics.
Below, the HEADSpAcE research team shares details on ethics approvals and guidelines.
- HEADSpAcE overall ethics approval
The HEADSpAcE project was approved by the IARC Ethics Committee on 24 September 2019 under reference No. 19-23. This approval covers HEADSpAcE recruitment as well as the use of samples from existing studies such as the Alcohol-Related Cancers and Genetic Susceptibility in Europe (ARCAGE) and the International Consortium on Head and Neck Cancer Genetic Epidemiology (InterCHANGE) studies.
- HEADSpAcE overall ethics approval – Amendment 1
Amendment 1, which was approved in November 2019, added to HEADSpAcE the following recruitment sites, after they obtained their respective local ethics approvals:
- University of Turin (UNITO), Turin, Italy
- Charles University in Prague (CUNI), Prague, Czechia
- University of Glasgow (UGLA), Glasgow, Scotland
- El Bosque University (UnBosque), Bogotá, Colombia
- HEADSpAcE overall ethics approval – Amendment 2
Amendment 2, which was approved in February 2020, added to HEADSpAcE the following recruitment sites, after they obtained their respective local ethics approvals:
- Institute of Oncology “Angel H. Roffo” (IOAR), University of Buenos Aires, Buenos Aires, Argentina
- Centre Léon Bérard (CLB), Lyon, France
European Union deliverables related to ethics and data protection
All the reports listed below were written in close collaboration with the HEADSpAcE Ethics Advisor, Professor Mahsa Shabani, and all were approved by the European Commission.
- Ethics guidelines (D9.2)
The HEADSpAcE ethics guidelines present the roles of the people involved in HEADSpAcE and the frameworks needed to ensure the security of the donor and the biological resources they provided to HEADSpAcE.
- Ethical approvals (D10.1)
Copies of ethical approvals by the responsible local/national Ethics Review Boards were submitted to the European Commission. These were approved by the European Commission in 2020.
- Consent forms and authorization by the donor for secondary use of the sample (D10.2, D10.3)
Consent forms and information sheets were submitted to the European Commission and approved in 2020. Studies existing prior to, and included in, the HEADSpAcE project included authorization by the donor for the secondary use of their samples.
- Compliance with respective national legal framework (D10.4)
HEADSpAcE researchers checked whether special dispensations related to the rights of data subjects or the processing of their health data had been established under their respective national law, and submitted to the European Commission a declaration of compliance with the respective national legal frameworks.
- Data Protection Officer (D10.5)
Each European recruiting centre within HEADSpAcE made the contact details of their respective Data Protection Officer available to the data subjects involved in the research using the consent form or information sheet signed by the data subjects.
Non-European recruiting centres within HEADSpAcE followed the HEADSpAcE consent form template and translated it into the data subjects’ language. The HEADSpAcE consent form template was reviewed and approved by the IARC Ethics Committee. Local ethics approval was requested.
Data from subjects involved in the HEADSpAcE project are centrally hosted by the International Agency for Research on Cancer (IARC) and shared with, but not transferred to, HEADSpAcE researchers, respecting all applicable data protection and data privacy rules.
Several agreements are in place to allow sharing of data among HEADSpAcE researchers. A number of documents add to this and serve as detailed data protection policies:
- Personal Data Protection and Privacy Principles for United Nations System Organizations
- IARC Information Security Policy Extended for Data relating to a Data Transfer Agreement
- Grant agreement 825771
- HEADSpAcE Consortium Agreement
- HEADSpAcE Data and Material Transfer Agreement (DMTA)
- Data management plan (D1.2)
- Ethics guideline (D9.2)
- Protocol for prospective recruitment of 1100 head and neck cancer cases in Europe and South America (D1.4)
- Assessment of ethics risk (D10.6)
The HEADSpAcE researchers, and their respective institutes and Ethics Review Boards, evaluated the ethics risks related to the data processing activities of the project.
- Appointment of an external Ethics Advisor (D10.7)
An Ethics Advisor with the relevant independent expertise to monitor the ethical concerns in this project was appointed.