Summary_DoH_-_Blackmer

Consensus
building/summing
up
Dr. Jeff Blackmer
Dr. Urban Wiesing
General
• Document should be better organized for ease of use and
readability
• Should have universal applicability
• Basic ethical principles and standards that can be applied
worldwide
Vulnerable groups
• Clarify and strengthen existing language
• Build on current paragraphs
• Don’t try and develop comprehensive lists
Biobanks
• Need to clarify consent requirements
• Open consent versus wide consent with the right to
withdraw
• Whether to address the issue of disclosure of incidental
findings (specific to biobanks or in general)
• Don’t need specific paragraph on the topic
Post study arrangements
• DoH needs to continue to address this issue
• Importance of continuity of care from the research to the
community setting
• Burden of providing access should be shared (and agents
should be identified)
• Benefits to host communities should be fair and not
restricted by responsiveness requirement
Research Ethics Committees
• Important role for DoH in presenting basic principles and
minimum standards
• Balance this with being too specific/proscriptive
• Clarification of role of local REC compared to remote
REC’s when study sponsor is not local or trial is multi-
national
Enhancement
• Consensus that, while important, issue is either
sufficiently captured by relevant current articles or may
even fall outside of the framework of the DoH
Positions of international
organizations
• Important role of DoH as high level principle-driven
international standard
• Need to continue to strive for balance between sufficient
detail to assist researchers and others versus too much
detail that would undermine local circumstances
• Important role of REB’s, need to also involve them in
discussions of post trial access and benefits
• Post trial access must be made transparent and
described prior to approval
• Responsible agents must be identified
• No consensus on best approach to use to determine
most appropriate post trial benefits/access
• Any additions or changes to the DoH should only be
made where there is a sound and compelling ethical
rationale for doing so
• Should only revise provisions that create problems
Insurance/compensation/prot
ection
• Paragraph 14 may not be strong enough
• Should consider a more definitive commitment to some
form of protection and allowances for “fair
compensation” in the case of complications or adverse
outcomes
• May benefit from a separate paragraph
Unproven interventions/off
label use
• Paragraph 35 – complex issue
• Delete paragraph? Part of paragraph? First sentence?
• Important distinction between “unproven” and “off-
label”
• Strengthen requirement to tie it to research and more
clearly reflect the purpose of the paragraph
• Move up in document (Para 4/5)?
Broad consent – Paragraph 25
• Broad/general consent is acceptable to most subjects
• “Broad consent is ethically acceptable”
• Option of tiered consent
• Need for last sentence?
• Change “reuse” to “single or multiple uses”; timeline?;
“future uses”
Research in children
• No consensus on need to include children separately in the
DoH
• Concepts of assent/dissent/cognitive abilities (Para 28)
• Encourage research in populations under-represented in
research (Para 5)