Heather_Widdows

Revising the
Declaration of Helsinki
Professor H. Widdows
www.birmingham.ac.uk/heatherwiddows
Purpose & aims of research
“The primary purpose of medical research involving
human subjects is to understand the causes,
development & effects of diseases & improve
preventive, diagnostic & therapeutic interventions
(methods, procedures & treatments)” (Para 7, DoH)
“build a major resource that can support a diverse
range of research intended to improve the
prevention, diagnosis, & treatment of illness & the
promotion of health throughout society” (UKB EGF
2007, p.3).
To address the problem
1.  Challenges of genetic material &
information
–  Shared & identifying
–  Problematic for consent & confidentiality
2.  Further challenges of biobanking
–  Future-orientated
–  Not a research project but many
–  Withdrawal problematic
3.  Detailed redrafting to meet these challenges
Shared not individual
“The key feature of
genetic information
is that it is typically
information about a
family, or even…
about a larger
community not just
about an individual
patient”
(Brock, 2001, p34)
Identifying (& into the future)
1.  Comparison with genetic database
2.  Triangulation
3.  New technology & improved techniques
“DNA is itself uniquely identifiable”
(McGuire, 2008, p75)
1. By comparison (a bit like fingerprints)
“By analogy, for example, one could publish a set
of fingerprints along with clinical phenotypes on
the web, but these would be of limited use without
knowledge of whose fingerprints they are. This
argument is unacceptable for genomic data in a
rapidly changing environment where 1)
genotyping is becoming very accessible &
inexpensive, 2) the ability to collect & share
personal information is increasing, & 3) the ability
to use genomic data to infer individual
characteristics is largely unexplored & potentially
powerful”
(Lin et al 2004, p.183)
2. Triangulation
“a number of physical attributes can now be
inferred from DNA analysis, such as gender,
blood type, approximate skin pigmentation, &
manifestations of Mendelian disorders”
(Lowrance & Collins, 2007, p.601)
Therefore identification by elimination is less
difficult than one might imagine
3. Improved technology & technique
Evidence to date suggests:
– Technology moves faster than expected
– Data that was once ‘un-identifying’
becomes ‘identifying’ in an instant
– Identifiable individuals (& those related
to them) are profoundly vulnerable
– To be ethical we should plan for
identifiability
Biobank challenges & informed consent
1. Future-orientated
o  Cannot be informed as projects unknown
at the point of consent
‘clinical research has specific aims, the aims of
biobank research may be vague or non-
existent at the time of the participants’
donation to the biobank’
(Skolbekken et al.2005, p336)
Biobank challenges & informed consent
2. Large-scale research resource/library
o  Informed consent is always to a specific
research project
o  Biobank is not a research project
o  But consent is used as if it were
o  To seek consent as envisaged by the DoH
would make Biobank research impossible
o  Therefore new approaches needed
Biobank challenges & informed consent
3. Withdrawal
o  DoH requires withdrawal without reprisal
o  Withdrawal hard for biobanks
o  UK Biobank withdrawal:
–  No further contact
–  No further access
–  No further use
o  “UK Biobank would destroy their samples (although
it may not be possible to trace & destroy all
distributed anonymised sample remnants) & would
only hold their information for
archival audit purposes”
(UKB EGF 2007, p.9)
Different risks
o  Risks of medical research which informed
consent protects from:
–  Direct harm
–  Physical harm
–  Breaching of bodily integrity
–  Balancing risks & benefits
o  Risks of biobanking research which informed
consent does not protect from:
–  Identification
–  Stigma
–  Discrimination
–  Unwanted knowledge about disease & status
–  Cultural & economic harms
Suggested changes to next
version of Declaration of
Helsinki…..
2. Although the Declaration is addressed primarily to
physicians, the WMA encourages other participants in medical
research involving human subjects to adopt these principles. All
scientists involved in biobanking research should understand
using participants’ samples and data is research on human
subjects.
9. Medical research is subject to ethical standards that promote
respect for all human subjects and protect their health and
rights. Some research populations are particularly vulnerable
and need special protection. These include those who cannot
give or refuse consent for themselves and those who may be
vulnerable to coercion or undue influence. Vulnerability
includes possible discrimination against families or wider
communities, as a result of genetic research.
11. It is the duty of physicians who participate in medical
research to protect the life, health, dignity, integrity, right to self-
determination, privacy, and confidentiality of personal
information of research subjects. Given the potential identifying
nature of genetic material, promises of confidentiality should be
proportionate and attention given to protection
in instances of unintended identification.
14. The design and performance of each research study
involving human subjects must be clearly described in a
research protocol. The protocol should contain a statement of
the ethical considerations involved and should indicate how
the principles in this Declaration have been addressed. The
protocol should include information regarding funding,
sponsors, institutional affiliations, other potential conflicts of
interest, incentives for subjects and provisions for treating
and/or compensating subjects who are harmed as a
consequence of participation in the research study. The
protocol should describe arrangements for post-study access
by study subjects to interventions identified as beneficial in
the study or access to other appropriate care or benefits. In
instances where this is not possible – such as biobanking –
ethics committees or other mechanisms for ensuring that
participant interest and affected others are respected
throughout the lifetime of the biobank or for the duration
which the data and samples are utilised must be put in place.
16. Medical research involving human subjects must be
conducted only by individuals with the appropriate scientific
training and qualifications. Research on patients or healthy
volunteers requires the supervision of a competent and
appropriately qualified physician or other health care
professional. The responsibility for the protection of research
subjects must always rest with the physician or other health
care professional and never the research subjects, even
though they have given consent. This includes thought for
third parties in instances, such as much genetic research,
where the research is likely to impact upon family members or
wider populations.
18. Every medical research study involving human subjects
must be preceded by careful assessment of predictable risks
and burdens to the individuals and communities involved in
the research in comparison with foreseeable benefits to them
and to other individuals or communities affected by the
condition under investigation. It should be recognised that
genetic research may have implications for family members of
enrolled research subjects.
o 23. Every precaution must be taken to protect the privacy of
research subjects and the confidentiality of their personal
information and to minimize the impact of the study on their
physical, mental and social integrity. Given the potential
identifying nature of genetic material, promises of
confidentiality should be proportionate and attention given to
protection in instances of unintended identification.
24.In medical research involving competent human subjects,
each potential subject must be adequately informed of the
aims, methods, sources of funding, any possible conflicts of
interest, institutional affiliations of the researcher, the
anticipated benefits and potential risks of the study and the
discomfort it may entail, and any other relevant aspects of the
study. The potential subject must be informed of the right to
refuse to participate in the study or to withdraw consent to
participate at any time without reprisal. Special attention
should be given to the specific information needs of individual
potential subjects as well as to the methods used to deliver
the information. After ensuring that the potential subject has
understood the information, the physician or another.
appropriately qualified individual must then seek the potential
subject’s freely-given informed consent, preferably in writing.
If the consent cannot be expressed in writing, the non-written
consent must be formally documented and witnessed. In
instances where this is not possible – such as biobanking
research – ethics committees or other mechanisms for
ensuring that participant interest and affected others are
respected throughout the lifetime of the biobank or for the
duration which the data and samples are utilised must be put
in place.
25. For medical research using identifiable human material or
data, physicians must normally seek consent for the
collection, analysis, storage and/or reuse. There may be
situations where consent would be impossible or impractical
to obtain for such research or would pose a threat to the
validity of the research. In such situations the research may be
done only after consideration and approval of a research
ethics committee. In instances of biobanking or other long-
lived projects attention must be given to development over
time to ensure continued ethical justification.
Thank you!
www.birmingham.ac.uk/heatherwiddows