Matsui-Third-panel-comments_matsui_0916

Third panel (Biobank issues and genomics):
Comments on
the draft declaration
Kenji Matsui, MD, PhD
Head, The Office for Research Ethics & Bioethics, and
Head, The Office of Personal Information Protection, NCVC Biobank,
The National Cerebral and Cardiovascular Center of Japan (NCVC)
The WMA Copenhagen meeting
On Health Databases and Biobanks
15. – 16. September 2015
Disclaimer
The views expressed in this talk are my own.
They do not reflect any position or policy of NCVC, the Ministry of
Health, Labour, and Welfare, or the Japanese government.
There is no conflict of interests.
Major problems with the draft decl.
• At least 3 major problems:
• Too broad scope
• Too narrow visions
• No clear definitions of key-concept terms
Drafted scope of the decl.
• Giving additional principles to DoH [1.][2.]
– More specific to issues on health databases & biobanks

• Any use beyond the individual care of patients [4.]:
For research, and [2.]
For other purposes [2.]
e.g.
• For commercial/industry-use purposes
• For public health purposes
• For administrative /policy-making purposes
Problems with the draft decl.
• Too broad scopes
For research, and [2]
For other purposes [2]
• For commercial/industry-use purposes
• For public health purposes
• For administrative /policy-making purposes
• Lack of due considerations to the consequences
e.g.
– ? A dedicated independent ethics committee must approve the establishment of
health databases and biobanks for other purposes than for research [20][18][21]
– ? An appropriately qualified physician should be appointed to safeguard [25]
– ? The privacy of a patient’s information is secured by the physician’s duty [14]
Problems with the draft decl.
• Too narrow: No exceptional circumstances are
appropriately considered.
e.g.
– ? Individuals must be given the opportunity to decide whether their
identifiable information will, or will not be included in … [15]
– ? Individuals must have the right to, at any time and without reprisal,
withdraw their consent… [17]
 Cf. the 2000 Decl. on Ethical Considerations regarding Health
Databases:
– …unless there are exceptional circumstances as described in paragraph
11/…unless exceptional circumstances apply… [the 2000 Decl. 10 & 12.]
– Under certain conditions, personal health information may be included on
a database without consent, for example… [the 2000 Decl. 11.]
Problems with the draft decl.
• Giving no clear definitions of key terms will
only make confusions:
especially,
– What is “identifiable” data? [9][15][17]
 ? fully anonymised; non-identifiable; anonymous; peudo
anonymous [8[[9]
– What is “conditional broad” consent? [18]
 ? blanket consent; open consent [18]
Concluding suggestions
1. Should simply focus on issues on
databases/biobanks for “research” purposes
2. Should see the reality of databases/biobanks
managements (not so many physicians are involved  those
other than patients are included in databases/biobanks)
3. Need careful and due considerations to
exceptional circumstances
4. Need careful and clear wording
5. More important matter for the WMA seems
giving principles on ethical conduct of genetic
medical practices in clinical settings