Jeff_Blackmer_Summary_-_Tokyo

CONSENSUS BUILDING
AND SUMMING UP
Dr. Jeff Blackmer
Dr. Peter Carmel
Biobanks
•  New and evolving field with several unique considerations
•  Issues to consider:
•  Consent – different options, broad vs. specific
•  Different and unique types of harm
•  Privacy and anonymity
•  Feedback to study participants, their families and the
public
•  Stewardship and governance
•  Considerations for the DoH revision:
•  How to deal with the unique and rapidly evolving field in
the current revision
•  Whether to mention “Biobanks” specifically or try and
capture important considerations within the current text
•  Introduce the topic here and elaborate in the next
version?
Insurance/compensation/protection
•  Currently addressed in Paragraph 14 of the DoH
•  Wording needs to be strengthened
•  WG currently working on this issue, will need to decide
how specific and directive the language should be versus
providing general guidance
•  Include the word “insurance” specifically or does this set
too high a threshold in some locations?
•  Local circumstances vary considerably
•  Difficult to capture all options and types of protection/
compensation in one document
Resource poor settings and post study
arrangements
•  Need to clarify and strengthen current provisions on post
trial access during the current revision of the DoH
•  Unique issues and considerations in resource poor
settings
•  Limited access to medication for the average patient –
special type of vulnerability
•  Reliance on trials to get access to medications and
supplies (patients, doctors and hospitals)
•  Disposal of research drugs and materials
•  Access to qualified REC’s
Vulnerable groups
•  We all agree that vulnerability is difficult to define (is it like
art?)
•  Researchers need to be acutely aware of the possibility of
exploitation in the name of science
•  Protection of vulnerable subjects requires a balanced view
and clearly enunciated principles
•  India represents an excellent example of the challenges of
doing important research in vulnerable populations and
the very real possibilities of exploitation
•  Sponsors, regulators and investigators all have a role to
play in the protection of vulnerable subjects
•  The DoH needs to be able to provide clear principles in
this area
Research Ethics Committees
•  Points to consider in revision process:
•  Relationship between DoH and REC’s
•  International research and dual approval
•  Membership of REC’s
•  Training for chairs and members
•  Quality assurance
•  Challenge: Balance between high level guidance for
REC’s versus specific proscriptions or requirements that
will not be implementable locally
Thank you!
•  The Working Group very much appreciates your expertise
and input on these important issues
•  This is very valuable for our subsequent discussions and
work on the next draft of the DoH