CIOMS_presentation_WMA_-_Delden

CIOMS ethical guidelines for
Biomedical Research:
some issues for the revision
Prof dr JJM van Delden MD PhD
Professor of medical ethics, UMC Utrecht
President CIOMS
j.j.m.vandelden@umcutrecht.nl
What is CIOMS?
• An NGO: international, non-governmental, non-profit
organization
• Forum to consider and prepare advice on
contentious issues in research ethics and safety of
pharmaceuticals…
• … for WHO, public health authorities, academia,
pharmaceutical industry and others.
• Established 1949 by WHO and UNESCO
• Offices located in Geneva, Switzerland
CIOMS BM research ethics guidelines
• Purpose: indicate how fundamental ethical principles
and Declaration of Helsinki can be applied effectively
in medical research world-wide in different:
– cultures, religions, traditions, socioeconomic
circumstances;
– with special attention for low and middle income
countries.
• Content: 21 guidelines plus commentaries (!)
• Use: 2002 Guidelines have been widely used, notably
in developing countries.
– Indication: translation into several languages, including French,
Spanish, Portuguese, Chinese, Arabic, Czech, and Vietnamese.
Revision of CIOMS guidelines
• For many reasons CIOMS decided to revise the 2002
glns:
– changes in other relevant documents
– changes in the field of research
– changes in existing regulations and ethical practices by
health authorities
– developments within research ethics
• Process started in 2012
• So I will show issues to deal with, rather than fixed
positions
Obligations of researchers: overview
1. Pre-trial obligations
2. (Obligations during the trial)
3. Post-trial obligations
Pre-trial obligations: issues
• Responsiveness to health needs & priorities
(CIOMS, DoH)
• Justifying exclusion of groups (CIOMS)
• Not a limitative list
CIOMS guideline 10
• Before undertaking research in a population or
community with limited resources, the sponsor and
the investigator must make every effort to ensure
that:
– the research is responsive to the health needs and
the priorities of the population or community in
which it is to be carried out; and
– any intervention or product developed, or
knowledge generated, will be made reasonably
available for the benefit of that population or
community.
Responsiveness: comments
• Intuitively a good requirement: avoids
exploitation
• Not so clear what it means
• What is a health need/priority? When is research
justifiably called responsive?
• Relation with reasonable availability!
• People in LMIC may want to study diseases
that are no priority
CIOMS guideline 12
Groups or communities to be invited to be subjects
of research should be selected in such a way that
the burdens and benefits of the research will be
equitably distributed. The exclusion of groups or
communities that might benefit from study
participation must be justified.
Justifying exclusion: comments
• Participation in research seems to have become a
good which should be distributed equitably: very
difficult to realize (whose duty?)
• no group (including vulnerable people) should be
deprived of its fair share of the benefits of research,
both direct and indirect
• May mean that we have to do away with the
subsidiarity
Post-trial obligations
• Responsiveness and reasonable availability
(CIOMS)
• Fair benefits approach (NIH, DoH?)
Reasonable availability
• Ensures certain type of benefits is provided
• Identifies addressee
• Prior agreements necessary
• Down side:
– exact level is not defined (how much? How long?)
– applies to Phase III (IV) research mainly, not to
other phases or epidemiological research
Fair Benefits Approach
• Wider range of benefits (e.g. infrastructure)
• Wider applicability (not just phase III)
• Collaborative partnership
• Prior agreement
FB or RA: a heated debate?
• In reality: a lot in common
• Main differences:
– type of benefit made available
– Position of responsiveness as starting point
• In common:
– Sense of obligation “to close the circle” (naïve idea about time line?)
– No clear idea about exact level of benefits required
– Also in RA other benefits than the study product could be part of the
agreement
– Prior agreement through negotiation, about which participants are
informed
• Real ethical question (for both!): why exactly do we have
these obligations? And to whom?
Conclusions
• Ethical concerns augment when conducting
research in LMIC
• Intuitively clear that we owe participants in
developing countries special obligations
• Supercontractual obligations may be
necessary, but need further justification
• Revised CIOMS guidelines (2015?) will provide
yet another provisional fixed point