Model

Brain Bank

Regulations

BNE Consortium

May, 2009

Purpose of the BBR

Theguidelines and recommendations currently in use, 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 their organizational structure,
  • Communicate policies and standard operating procedures.

Although many of these instructionsare frequently put into practice, only few tissue repositories have put them in writing.

When a Brain Bank aims for establishment andfurther professionalization, an internal Regulations document is indispensable. Such a document is an enduring reference regardingorganizational governance. Regulations should be easily accessible to donors, scientists and other stakeholders.

Following the agreements established by ratification of the Code of Conduct and other guidelines for research biobanks, we have prepared a Model Brain Bank Regulations. This document is not a guideline, such asmany prepared by other (more authoritative) instances, but a translation of guidelinesinto practice.

The Model BBR is a framework, which ought to be enriched with content according to the individual situation of the local Brain Bank. The document is to be adopted 'at will' by the Brain Bank.

Contents

Purpose of the BBR

CHAPTER I

Article 1 Definitions

Article 2 Object of the Brain Bank Regulations (BBR)

Article 3 Scope

Article 4 Modification

Article 5<BB> organization

Article 6The purpose of the <BB>

Article 7 The objectives of the <BB>

Article 8 The priorities of the <BB>

Article 9Activities of the <BB>

Article 10Financing

Article 11[Permissions to operate]/ [approvals]

Article 12Reporting

Article 13Cessation of all Brain Banking activities and succession of the resources

CHAPTER II

Article 14 Procurement

Article 15 Donors of the Biological Material

Article 16 Guideline on obtaining Informed Consent or Authorization

Article 17 Special considerations in case of Incompetent Persons

Article 18 Special considerations when residual Materials are collected

Article 19 Consent documentation

Article 20Unconsented Materials and Data

Article 21 Withdrawals

CHAPTERIII

Article 22Data stored at the Brain Bank

Article 23Purposes for which the data is collected

Article 24(Pseudo) anonymized data

Article 25Data on subject rights

Article 26Disclosure of identifying data

Article 27 Authorized individuals

Article 28 Data integrity

CHAPTERIV

Article 29 Distribution of the Material

Article 30 Evaluation of requests

Article 31 Material Transfer Agreement

Article 32 Financial contribution

Article 33 Co-authorship of the employees of the Brain Bank

CHAPTERV

Article 34 Organs and Responsible Persons

Article 35 <Head/management>

Article 36 <Scientific Committee/Request Review Panel>

Article 37 Oversight

Glossary

CHAPTER I

With regard to the organization of the Brain Bank

DEFINITIONS, OBJECT, SCOPE, BRAIN BANK ORGANIZATION, PURPOSE, ACTIVITIES, REPORTING

Article 1 Definitions

BrainNet Europe II-project

Sixth Framework project BrainNet Europe II, funded by the European Commission under contract number LSHM-CT-2004-503039.

Consortium Agreement

Agreement signed on November 20, 2003 between participants in the BrainNet Europe II-project, by which the BNE Consortium was established.

BNE Consortium Partners

Partners of the BNE Consortium, who conduct Brain Banking Activities.

Associated Partners

Allied partners without voting rights, who may participate in meetings and in the activities of the BNE Consortium without liability to the European Commission and without contractual duties.

Brain Banking/ Brain Bank Activities

Activities such as obtaining, handling, processing, storing and distributing Material and Data, including all associated research activities.

Informed Consent

Informed, free, express and documented decision to donate Material and Data for scientific research or other purposes.

Human Biological Material

Human Biological Material including:

  1. Tissues: brain and meninges, pituitary, spinal cord, peripheral nervous tissue and other tissues adjacent to the nervous system such as muscles, lymph nodes and blood vessels;
  2. Fluids: such as cerebrospinal fluid or blood;
  3. Cells derived from all of the above-mentioned, including their progeny and unmodified derivatives.

Authorization

Informed Consent given by a legal representative or the next of kin on behalf of a person unable to give Informed Consent.

Brain Donation Program

A program where an individual can record his or her intent for donation, or provide Informed Consent or provide Authorization for post-mortem donation of the Material and Data to the Brain Bank.

Donor

The source of the Biological Material.

Material and Data

Any Human Biological Material and Donor-related Data.

Directly Identifying Material or Data.

Any Material or any Data which, alone or in combination with associated information, allow identification of the person concerned without disproportionate efforts.

Pseudo Anonymized/Coded Material or Data.

Any Material or any Data which allows identification of the person concerned by authorized individuals only through the use of a key.

Fully Anonymized/Unidentifying Material orData

Any Biological Material or Data which alone or in combination with associated information does not allow identification of the person concerned, without disproportionate efforts.

Information on Hereditary Diseases

Any information which is either predictive of genetic disease or can serve to identify the person as a carrier of a gene responsible for a disease or detect a genetic predisposition or susceptibility to a disease, when scientific proof for validity of that information is present.

Data Processing Equipment

All equipment that reads or writes data from or to digital media.

Data Communication Equipment

All equipment that allows the transport of data to, from or across any local or remote digital network.

Tissue Finder/Tissue Finder Database

An online database built to facilitate Material exchange among the BNE Consortium Partners. The Tissue Finder Database contains descriptions of cases and material available at the individual Brain Banks of the BNE Partners. Data stored in the Tissue Finder Database is either Pseudo Anonymized or Fully Anonymized and does not, with reasonable efforts, allow identification of the Donors by anyone searching the Database. The Tissue Finder Database is only accessible to the Partners of the BNE Consortium, and only via encrypted internet. Partnerscan search for and place requests for Material, which may or may not be granted.

BNE Request Form

Online form by means of which researchers can submit a request for Material and data to the BNE Consortium.

Removable Data Media or Removable Data Storage Media

Any removable media such as USB sticks, floppy disks, tapes, CDs, DVDs that store data not for the specific purposes of backing up data.

Backup media

Any removable media such astapes, CDs, DVDs,USB sticks, floppy disks that store data for the specific purpose of backing up data.

Encryption

Disk Encryption - a process by which hard disk information is encrypted on the disk itself and can only be decrypted by the use of the relevant password. If the passwordis not given, the disk will only show encrypted data.

Network Encryption - a process by which transmitted digital data is not sent "in the clear" but encrypted to render eavesdropping more difficult. Also referred to as https or "Secure Servers".

System logging

A process by which a date, time, originator and action of a user are logged in a logfile, thereby establishing retraceability and allowing systems administrators to retrace what happened to information shouldsuch a search be deemed necessary.

Internal or Local Network

Internal or Local Network - the collection of Computers and Communications cables inside the confines of the Brain Bank.

External Network

External Network - the collection of Computers and Communications cables outside the confines of the Brain Bank (such as the Internet).

Network surveillance tools

Software that allows administrator to observe what actually happens on the cable ornetwork by employing eavesdropping techniques (e.g. Snooper is a commonly employed Network sniffing software alerting administrators to potentially dangerous unwarranted intrusions).
Data subject
Living person whose personal information is collected and processed.

Access

Any access to material and data including

  1. Physical access including access to filing cabinets, archives, freezers, storage rooms where Data or Material are stored; collectively referred to as Physical Access;
  2. Electronic access such as access to electronic files, databases, systems, networks; collectively referred to as Electronic Access.

Commercial exploitation

The sale, lease or commercial licensing of the Material. Commercial exploitation also includes uses of the Material to produce or manufacture products for general sale.

Article 2 Object of the Brain Bank Regulations (BBR)

Regulations should firstly state its own purpose. The question why there is a need for internal regulations of the Brain Bank is answered in this article.

Article 2 Object of the Brain Bank Regulations
These Regulations are adopted by the <BB> in order to:
  1. elaborate on the ethical principles laid down in the Code of Conduct of the BNE Consortium;
  2. describe the organization of the <BB>;
  3. specify the purpose and objectives of the <BB>;
  4. define the policies of the <BB>;
  5. state the guidelines the <BB> adheres to and
  6. […] and […].

Article 3 Scope

The activities thatfall within the scope of the BBR should be specified. For example the scope of the Regulations can be broadened to staff of the contracted laboratory or limited to the employees of the Brain Bank only.

Article 3Scope
Paragraph 1
These Regulations shall apply to all Brain Bankingand related researchactivities carried out within the <BB>.
Paragraph 2
These Regulations [or certain articles or certain chapters] shall [equally] or [under certain conditions] apply to <name persons or organization>.

Article 4 Modification

Thedraft guidelines by OECD (see art. 3.6) emphasize that biobanks should anticipate the need for modification of theirpolicies, protocols and procedures. The Brain Bank should have in place a process for undertaking these modifications within its structure.

Article 4 Modification
Paragraph 1
These Regulations shall be revised every [period], by [organ], in consultation with [organ].
Paragraph 2
[Articles number and number] shall be revised every [period], by [...].

Article 5<BB> organization

The structure of the organization of theBrain Bank should be describedin accordance with principles of transparency and accountability.

Article 5<BB> organization
Paragraph 1
The <BB> [does not] possess legal personality. The <BB> is adepartment of the <name institute or department> which is a <name entity> of the <organization which is a legal entity>. <Organization which is a legal entity> is a <public or private> legal entity, established by <law or act> having its registered seat at <address>.
Paragraph 2
The <BB> name and logo are meant to acquire public acknowledgement and to promote the Brain Bank.

Article 6The purpose of the <BB>

In compliance with art. 14 par. 2 of Rec2005(4) of the CoE (CDBI) and EC Directive 95/46/EC the purposes of collection of human biological material and personal data should be specified.

Art. 2A of the OECD guidelines stipulate that both current and future purposes of human tissue banks should be clearly formulated, and communicated as early and as widely as possible, especially to potential participants (donors) and potential users.

Article 6The purpose of the <BB>
The purpose of the <BB> is to facilitate scientific research by distributing well-documented human material among researchers conducting scientific research in the field of neuroscience.

Article 7 The objectives of the <BB>

In compliance with art. 2A Draft Guidelines of OECDthe objectives should be clearly formulated.

The question of who decides upon the objectives of the Brain Bank and whether such decisions need to be taken in consultation with or with the approval of certain bodies, such as an institute’s board of directors or donor representatives, should be carefully considered.

Article 7 The objectives of the <BB>
Paragraph 1
The objectives of the <BB> are:
  1. the distribution ofwell-documented high quality material to scientific researchers;
  2. increasing public awareness of the importance of the use of human tissues for scientific research on brain function and disease;
  3. [..] and[..].
Paragraph 2
The objectives are decided upon by <organ or organization> in consultation with <organ or organization> and <donor representatives>.
Paragraph 3
The objectives are made public by the means of <…>.

Article 8 The priorities of the <BB>

Priorities are the short-term objectives, and should always be in line with the objectives and purpose of the Brain Bank, as stated in the previous articles. Priorities of the Brain Bank should also be considered in relation to the available funds (income), manpower and conditions set by the stakeholders and funders.

The question of who decides upon the priorities of the Brain Bank and whether such decisions need to be taken in consultation with or with the approval of certain bodies (for example donor representatives) needs careful consideration.

Clear priorities will prevent unnecessary accumulation of unused tissue.

Priorities laid down in the regulations should function as terms of reference for accepting or denying any request for material. Also see article on Evaluation of Requests, Chapter IV.

Article 8 The priorities of the <BB>
Paragraph 1
Priorities of the <BB> are decided upon by <persons, organ or organization>, in consultation with <person, organ or organization>.
Paragraph 2
The priorities of the Brain Bank are announced by means of <…>, every <period>.
Paragraph 3
As from this date, the priorities of the <BB> are:
  • to expand the collectionof <disease groups>;
  • to expandthe collectionof control subjects;
  • to optimize and refine the neuropathological characterization of the tissue;
  • to increase thestandardization of the coded clinical summary of the donors;
  • bioinformatics analysis of the databases;
  • to strive for financial sustainability, stabilityand continuity of the organization>;
  • <customization of services, in order to avoid unused tissue accumulation>.

Article 9Activities of the <BB>

The activities of the Brain Bank should be in line with its objectives and priorities.

If certain activities are performed externallythis may be specified in this article by inserting the words [subcontracted] before the relevant activity. The legal basis of such activities needs to be characterized in terms of scientific collaboration, contracted service, voluntary work and so on. In case of subcontracting, the conditions, including the requirements to the subcontractor, should be addressed. Written appointments, contracts and agreements with service providers should be in place.

Article 9Activities of the <BB>
In accordance with its purpose and objectives the <BB> performs the following activities:
i.recruitment of donors and provision of information about Brain Banking;
ii.donor follow-up;
iii.obtaining and documenting Informed Consent or Authorization;
iv.Material retrieval, by means of [cranial] autopsy;
v.neuropathological and other examination of the retrieved Material;
vi.documenting and anonymizing donor Material and related data <e.g. by making “Minimal Clinical Data Set”>;
vii.storing Material and Data;
viii.reviewing applications for research Material;
ix.distributing Material on the basis of approved applications or <providing access to researchers to Material and Data>.
x.processing post-mortem Material to renderit suitable for research purposes.

Article 10Financing

The Brain Bank should be transparent about the sources of its income. Equally the conditions under which the funds are provided should be clearly established. In certain cases approval of the parent organization will be required to receive funds. Issues connected with surplus income and deficitsneed to be addressed.

Article 10Financing
Paragraph 1
Neither the <BB> nor its affiliated institutions intend to make a profit.
Paragraph 2
The income of the <BB> consists of:
  1. the capital of the <Trust, Foundation etc>;
  2. governmental subsidies;
  3. <contributions made by the European Commission>;
  4. grants by <...>;
  5. financial contributions by the researchers;
  6. amounts which are or will be obtained through donations, testamentary depositions <etc>.
Paragraph 3
All income mentioned under paragraph 1 received in any year by the <BB>, under whatever name, which is not intended to be set aside as capital, shall be used for the activities and accomplishment of the objectives of the <BB>, in line with the priorities of the <BB>.
Paragraph 4
If in any year the funds available for the accomplishment of the objectives are only partly used, the <organ> determines whether and to what extent the balance not used will be <in what way used> or <reserved for the future accomplishment of the objectives of the BB>.
Paragraph 5
If in any year the income of the <BB> falls short of its costs <specify how the deficitswill be covered>.
Paragraph 6
If the deficitsare structural <specify how these structural deficitswill be covered>.

Article 11[Permissions to operate]/ [approvals]

The licenses, registrations, ethical approvals which the Brain Bank has been granted or needs to hold can be specified here.

Article 11[Permissions to operate]/ [approvals]
The <BB> is registered at […] or holds [licenses, approval, registrations], which <should be/are renewed every period>.

Article 12Reporting

Article 12Reporting
Paragraph 1
Annually the <BB> reports to [person, organization].
Paragraph 2
Annually the <BB> will publish a progress report on activities.
Paragraph 3
The financial statement of the <BB> shall be included in the annual report of the Legal Entity>.

Article 13Cessation of all Brain Banking activities and succession of the resources

Provisions in case of cessation of all Brain Banking should be included in the BBR.

Article 13Cessation of all Brain Banking activities and succession of the resources
Paragraph 1
<Organ or person>, in consultation with donor representatives and other stakeholders, may make decisions on cessation of all or part of the Brain Banking activities. Plans to terminate all Brain Banking activities and a call for succession, including any eligibility criteria, will be announced, upon such a decision.
Paragraph 2
Organ or person> in conformity with paragraph 1, shall consider all eligible organizations for the succession of all Brain Banking activities, including the Donor Program.
Paragraph 3
Succession shall be formalized by a transfer agreement signed by both parties, upon which all Material and Data stored at the <BB>, [including all donor registrations] and material transfer agreements shall be transferred to the successor, subject to acceptance of provisions of these Regulations or similar provisions for the governance and management of the succeeded resources.
Paragraph 4
In case no suitable successor is available, all Material and Data stored at the <BB> shall be irreversibly destroyed. All Donors registered at the donor program will receive written notification of the cessation of all Brain Banking activities.
Paragraph 5
Upon succession as specified in paragraph 3 or termination as specified in paragraph 4, the <BB> will cease to exist.

CHAPTER II

With regard to obtaining the Biological Material and Data