Work Package 6

Title of Work Package: Ethics

Objectives: WP6 aims to assess, address and monitor the unique ethical challenges associated with the research in TIRCON. Specifically, challenges arising from research on rare disorders, lethal childhood disorders, and conditions that impair cognition of prospective study participants will be addressed. In addition, confidentiality, privacy, and ethical procedures that will be mandatory in the course of TIRCON will be defined. All questions related to ethical issues related to this project from participants will be addressed as well.

Tasks

• Risks and contingency plan: Elaboration, verification and approval of a detailed risks and contingency plan related to all work packages
• Overview of the national legal frameworks: Collect and analyze procedures and legal frameworks addressing ethical issues, confidentiality, and privacy at national level from all participating countries
• Addressing specific challenges
  • For rare disorders, especially those with a genetic component, patient identity is more difficult to protect than for conditions abundant in the population. Special attention will be paid and the necessary measures taken to protect identities and shield privacy
  • All partners responsible for patient ascertainment and informed consent will be sensitized to issues of coercion
• Informed Consent Forms (ICF)
  • Preparation, translation into national languages and adaptation into a child-friendly version of the ICF related to WP1, WP2, and WP4
  • Assessment will be made of study participants’ capacity to consent prior to seeking informed consent
• Seeking ethics approval
  • All scientific partners will seek ethics approval following national or local standards through their respective ethics authorities related to WP1, WP2, WP3, WP4
  • The partners in charge of or participating in WP3 and WP5 will seek authorization by their respective authorities concerning the use of animals: All appropriate ethical permits for animal studies are already in hand, or will be in place in each centre at the start of the project.
  • Seeking approval by national/local data protection authorities
• Data Protection and Data Safety monitoring in WP1, WP2, WP3 and WP4
  • Beyond the unique issues noted above, standard operating procedures will be followed for clinical trials
• Clinical trial monitoring
  • Beyond the unique issues noted above, standard operating procedures will be followed for clinical trials