Brain Bank Regulations
Purpose of the BBR

Current guidelines and recommendations, such as Draft Guidelines for Human Biobanks and Genetic Research Databases by OECD or Recommendation by the Council of Europe (Rec 2005, CoE), instruct new and established biobanks and tissue repositories to:

  • clearly define their objectives,

  • describe organizational structure,

  • communicate policies and standard operating procedures.

Although many of these things are frequently defined in practice, only few tissue repositories have established these in a written form.

When a brain bank aims for further professionalization and establishment, an internal Regulations document is indispensable. Such document should serve as durable terms of reference for organizational governance; Regulations should be accessible and evocable to the donors, scientists and other stakeholders.

The document presented on this webpage is not a guideline, like many prepared by other (more authoritative) instances, but a direct translation of guidelines to practice. The Model BBR merely aims to create a framework, which is ought to be enriched with content, according to the specifics of the local brain bank.

Chapter I here

  • Definitions
  • Regulation
  • Object (why this Regulation)
  • Scope (what does it regulate or when does this Regulation apply)
  • Brain Bank (what is a Brain Bank)
  • Purpose Brain Bank (what does it exist for)
  • Objectives of the Brain Bank (what does it try to achieve)
  • Priorities (what are the priorities of the Brain Bank)
  • Activities (what does it do)
  • Financing (who is paying for it)
  • Reporting (who does it report to)
  • Cessation of all Brain Banking activities and succession of the recourses (what happens when the Brain Bank stops with its acitivities)

Chapter II Donors of the Material (who is the source of the Material) here

  • How and by whom the Material is collected
  • How informed consent and authorization should be obtained and what information should be provided
  • Considerations in case of incompetent persons
  • Considerations in case of residual materials
  • How consent should be documented
  • How consent withdrawals should be documented

Chapter III Data protection and privacy here

  • What personal data is stored at the brain bank
  • Purposes for which the data about persons is collected
  • How data should be anonymised
  • What data can be regarded as pseudo anonymised and fully anonymised
  • The rights of the living individuals whose personal data is processed (data subject rights)
  • To whom personal data shall be disclosed
  • Responsibilities of the Brain Bank with regard to collected personal data
  • Authorized individuals (persons who are authorized to process personal data)
  • Data integrity and security arrangements and electronic data protection measures within the Brain Bank

Chapter IV Distribution of Material and data here

  • Distribution of the material
  • Evaluation of requests
  • Conflict of interest
  • Material Transfer Agreement
  • Financial contribution
  • Co-authorship and co-inventorship policy by employees of the Brain Bank

Chapter V Organs and responsible persons here

  • Provided as example with a structure of organs and persons of the NBB

 

Complete version of the BNE Brain Bank Regulations here

 



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