LAW 2516 Lecture Notes - Lecture 8: Biobank, National Health And Medical Research Council, Data Security
23 May 2018
School
Department
Course
Professor
BIOMEDICAL RESEARCH
CONSENT, CONTROL AND OWNERSHIP
OVER BIOLOGICAL MATERIALS
CONTEXTS
Researcher taking tissue directly from participant
1. Standard of disclosure
a. When doctor seeks informed consent to med
treatment: must disclose risks that a reasonable
person in the patient’s position would deem to
be material Rodgers v Whittaker
b. Researchers: not taking tissue to treat you,
taking tissue to achieve their alternative goal-
thus standard should be as high/ higher
because they have a different set of interests
than treating the patient
2. Biobanks
a. Biobank = research platforms that hold human
biological materials (blood, saliva, plasma)
and associated date sets (health and
demographic information)
• Integral research resource that provides
samples and data to study disease and the
interactions between genes and the
environment
→ Can be private or disease-specific
→ Can be open to all researchers to study
all types of diseases
b. Examples: biobank UK, over $90 million
pounds invested, worlds largest publicly
funded population bank
c. Benefits of biobanking
• Advancement of scientific knowledge:
ability to study wide variety of diseases
and enhance understanding of genetics at a
population wide level
• Efficiency: individual researchers don’t
have to collect own samples
• Coordination: ability to utilise smaller
biobanks under biobanking framework
d. Concerns
• Data security & privacy
• Re-identification risks
• Value, sustainability and affordability
• Governance challenges
• Public trust- dependent on public coming
forward to donate, have to maintain trust
• Consent
3. Consent
a. What challenges does the need for informed
consent pose for biobanks?
• P’s consent must be voluntary after
receiving the following information:
→ Research for which specimens will be
used
→ How specimens will be stored, used,
disposed of
→ Identifiability of specimens
→ Whether specimens and/or data will be
distributed to other researchers
→ Potential commercial applications of
research using the specimens and to
whom any financial benefits will be
distributed
→ Rights to withdraw, and implications
regarding date already collected
b. Timing of consent
• At the time the P gives biological
materials to BB, the BB has no idea which
researchers will come into contact with
their bio material in the future
• Cannot actually inform P of who will
access their materials
c. Consent models
• Recontact P to regain consent each time
new researcher accesses BB? - NO.
impractical
• Dominant model =‘broad consent’: if P
gives tissue to BB, BB discloses current
processes of researches using their tissue,
but also informs P of risk of future
researchers accessing materials – offers no
guarantee that privacy won’t be breached/
samples won’t be identifiable by new
researcher
• Australian framework- NHMRC
• Other consent models- dynamic consent
→ application on phone – gives
notification when R wants to access
their genetic material/ info at BB
d. The right to withdraw
• Fundamental principle of research ethics,
participants have a right to withdraw from
study- reflects ongoing nature of consent.
Respects autonomy
→ But BB context complicates this
Impossible to withdraw sample if
they are anonymised
Generally, can exercise right to
prevent sample being used in
future studies, but cannot do
anything about data already
collected
e. Incidental findings
• P gives sample to BB, R discovers
something incidental to their research –
duty to inform?
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