Transcript Legal and Ethical Aspects of Cancer Registration

Ethical Aspects of Cancer
Registration
Clement Adebamowo
General Principles of Ethics in Clinical Research and
Public Health in Nigeria
• As producers of data, cancer registry personnel may not be
very conversant with the fact that there are important
ethical considerations in their work
• To explore this, we will start by looking at the classic
principles of research ethics, then explore how they relate
to cancer registration
• These are
• Autonomy
• Beneficence
• Justice
Respect for autonomy
• Personal self-governance and freedom from controlling
influence by others and from personal limitations that
prevent choice
• We are more concerned about autonomous action than
autonomous persons
• Autonomous persons can and do make non-autonomous
choices due to temporary constraints e.g. due to ignorance
or coercion
• Non-autonomous persons sometimes must the resources to
make autonomous decisions such as refusals, etc
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Respect for autonomy
• A third issue is to be respected as autonomous
• Many issues in informed consent are related to this
• Manipulative non-(under) disclosure of information
• Non-recognition of refusal of certain medical
interventions
• To respect an individual’s autonomy entails:
• Recognize and appreciate the person’s capacities and
perspective, including his right to hold certain views,
make certain choices, or take certain actions based on
personal values and beliefs
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Respect for autonomy
• This is rooted in Kantian philosophy that persons are ends
in themselves, determining their own destiny and are not to
be treated as a means to other’s ends
• This principle is the basis for the right to make
autonomous decisions
• The obligation to obtain informed consent in research and
clinical practice is grounded on this principle
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Beneficence
• Providing ‘benefit’ has often been considered a
foundational value of clinical practice and therapeutic
research
• Hippocrates is commonly cites to have states “primum non
nocere” “above all, do no harm” though modern
scholarship suggest that he really said “help, or at least do
no harm” thereby demanding first, the provision of benefit
beyond the avoidance of harm
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Beneficence
• Frankena arranged the components of this principle in the
following hierarchical order
• I ought not to do evil or inflict harm (non-maleficence)
• I ought to prevent evil or harm (beneficence)
• I ought to remove evil or harm (beneficence)
• I ought to do or promote good (beneficence) – some
have doubted whether this is a duty
• This ordering is attractive as ordinary moral discourse and
some philosophical systems suggest that negative duties
are more compelling than positive ones
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Justice
• Justice – in the sense of what is fair and what is
deserved
• An injustice occurs when an entitlement is denied
without good reason or burden imposed unduly
• Another conception is that equals must be treated
equally.
• This plays a role in resource allocation, ensuring that no
particular group bears excessive burden on behalf of
others
• The emphasis on rights in bioethics is another
derivative of this principle
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Justice
• This is often confused with other moral principles. For
example when withholding of information from patients is
called unjust while the correct moral principle is
beneficence; when the use of deception in research is
referred to as unjustly denying information when the moral
principle is respect for autonomy
• Problems like health care resource allocation, claims to a
right to health care, burden of research risks compared to
benefits are examples of justice issues
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When principles conflict
• Conflict of principles creates a weighting or priority
problem
• Ross proposed finding the greatest duty in any
circumstance of conflict by finding the greatest balance of
right over wrong in that particular context
• He proposed a distinction between prima facie and actual
duties
• Prima facie duties are those that must always be acted
upon except they conflict with equal or stronger duties in
that particular occasion. They are always right and always
binding, all other things being equal
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When principles conflict
• So, though firm, they are conditional on not being
overridden or outweighed by competing moral demands
• Actual duty is therefore determined by a balance of the
respective weights of the competing prima facie duties
• Therefore duties and rights are not absolutes but rather
strong prima facie moral demands that may validly be
overridden in circumstances where stringent opposing
demands are presented by a competing moral principle
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When principles conflict
• This does not diminish the value of autonomy but let us
ask with Daniel Callahan “What would it be like to live in
a community for which autonomy was the central value”
• The arguments about duties applies to rights too
• Many philosophers no longer submit to a thesis of absolute
right to life irrespective of competing claims or social
conditions
• It is now commonly agreed that we have an exercisable
right not to have our life taken only if there is not a
sufficient moral justification to override this right
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Pertinent issues in cancer registration
• Confidentiality
• Data sharing and transfer including by e-mail web-based
data entry
• Increased used of computers to store private health
information
• Linkage of data sets
• Need to balance individual rights and autonomy with
public health ethics
Definitions
• Personal Health Information (PHI) is any information
held by a covered entity which concerns health status,
provision of health care, or payment for health care that
can be linked to an individual.
• De-identified information – PHI where the identifying
characteristics have been removed. However such
characteristics still exist and can be reapplied to the
information
• Anonymized – Identifying characteristics of PHI have
been removed and cannot be reapplied
• Anonymous – Identifying information were never
collected
Ethical Aspects of Cancer Registration
• Typically contains identifying characteristics
• Shared with clinicians for patient care purposes
• Transferred to collaborating or central registries for
complete and accurate cancer registration
• Often contains data about deceased persons
• Typically, the type of information collected by Cancer
Registries requires informed consent
• However, traditionally, this has not been considered
necessary because such a requirement will negatively
impact cancer registry work
Ethical Aspects of Cancer Registration
• The workload on cancer registry staff engendered by such
requirement would be too much
• The repeated physical and psychological burden on
patients and relatives may not be justifiable
• It would be burdensome if such requirement were to be
transferred to medical staff
• Cancer registry data is used for longer than envisaged by
many ethical codes conception of the duration of
effectiveness of informed consent
• If some people give consent and others do not give, this
will lead to differential bias in the data collected
Ethical Aspects of Cancer Registration
• By and large therefore, traditional practice has been that
national regulations provide exemptions in the public
interest for the work of the cancer registries because
• Overriding national interest
• Data is used for statistical, historical or scientific
research
• Participants can no longer be informed because they are
dead
• We must note that this may change going forward given
continued developments in the theory and practice of
informed consent
Ethical Aspects of Cancer Registration
• Therefore cancer registration is exempted from rules about
informing data subjects individually about processing and
disclosure
• This exemption imposes tremendous burden on cancer
registries to take extra care on maintaining confidentiality
of the data that they collect
• It is for this reason that the IARC has issued Guidelines on
Confidentiality for Population-Based Cancer Registration
Principles of Confidentiality for Cancer
Registration
• The principles relate to confidentiality in the process of
collecting, storing, use and transmission of identifiable
data by cancer registries
• Medical ethics says that “the doctor is not the only
confidant of medical and non-medical information of
patients” and he/she needs to share this information with
other medical and non-medical personnel in order to
provide optimal care for patients
• However, the physician has the right to expect that the
persons with whom these information is shared – including
cancer registries – observes the same strict rules of
confidentiality
Principles of Confidentiality for Cancer
Registration
• Physicians and the general population will continue to
provide information for Cancer Registries to the degree
that Cancer Registries maintain the confidentiality of the
data and make appropriate use of it
• Confidentiality rules which are consistent with
international guidelines, national legislations, professional
ethics etc must be put in place to reassurre stakeholders
• Legal protection – cancer registration in Nigeria is based
on the authority of the Government to make laws and
regulations for the health and well-being of Nigerians
Principles of Confidentiality for Cancer
Registration
• Scope of the confidentiality rules extend to
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Identifiable data on cancer patients
Census data
Interview records
Death certificates
Members of cohort studies
Deceased persons
Indirectly identified data
Data storage in any manner – paper, computer, web, etc
Measures for Confidentiality in Cancer
Registration
• Defined responsibility for Director of Cancer Registry
• Oath of Secrecy
• Display reminders on the need for and value of
confidentiality in the Cancer Registry
• Restrict physical access to the Cancer Registry to
authorized personnel only
• Identify and train authorized personnel – including training
in ethics and principles of confidentiality
• Active methods of data acquisition, access, protection and
transport should be in place
• Review of confidentiality and security procedures
Thank you
• Institute of Human Virology, Nigeria, Nigerian
Malignancy Consortium,
• Society of Oncology and Cancer Research of
Nigeria,
• International Agency for Cancer Research,
• West African Bioethics Training Program
• Centers for Disease Control and Prevention
(CDC),
• and the
• Federal Ministry of Health of Nigeria