Ethical Aspects of Cancer Registration Clement Adebamowo

Ethical Aspects of Cancer Ethical Aspects of Cancer RegistrationRegistration

Clement AdebamowoClement Adebamowo

General Principles of Ethics in Clinical Research and General Principles of Ethics in Clinical Research and Public Health in NigeriaPublic Health in Nigeria

• As producers of data, cancer registry personnel may not be As producers of data, cancer registry personnel may not be very conversant with the fact that there are important very conversant with the fact that there are important ethical considerations in their workethical considerations in their work

• To explore this, we will start by looking at the classic To explore this, we will start by looking at the classic principles of research ethics, then explore how they relate principles of research ethics, then explore how they relate to cancer registrationto cancer registration

• These are These are • AutonomyAutonomy• BeneficenceBeneficence• JusticeJustice

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Respect for autonomyRespect for autonomy

• Personal self-governance and freedom from controlling Personal self-governance and freedom from controlling influence by others and from personal limitations that influence by others and from personal limitations that prevent choiceprevent choice

• We are more concerned about We are more concerned about autonomous actionautonomous action than than autonomous personsautonomous persons

• Autonomous persons can and do make non-autonomous Autonomous persons can and do make non-autonomous choices due to temporary constraints e.g. due to ignorance choices due to temporary constraints e.g. due to ignorance or coercionor coercion

• Non-autonomous persons sometimes must the resources to Non-autonomous persons sometimes must the resources to make autonomous decisions such as refusals, etcmake autonomous decisions such as refusals, etc

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• A third issue is to be A third issue is to be respected as autonomousrespected as autonomous• Many issues in informed consent are related to thisMany issues in informed consent are related to this

• Manipulative non-(under) disclosure of informationManipulative non-(under) disclosure of information

• Non-recognition of refusal of certain medical Non-recognition of refusal of certain medical interventionsinterventions

• To respect an individual’s autonomy entails:To respect an individual’s autonomy entails:

• Recognize and appreciate the person’s capacities and Recognize and appreciate the person’s capacities and perspective, including his right to hold certain views, perspective, including his right to hold certain views, make certain choices, or take certain actions based on make certain choices, or take certain actions based on personal values and beliefspersonal values and beliefs

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• This is rooted in Kantian philosophy that persons are ends This is rooted in Kantian philosophy that persons are ends in themselves, determining their own destiny and are not to in themselves, determining their own destiny and are not to be treated as a means to other’s endsbe treated as a means to other’s ends

• This principle is the basis for the right to make This principle is the basis for the right to make autonomous decisionsautonomous decisions

• The obligation to obtain informed consent in research and The obligation to obtain informed consent in research and clinical practice is grounded on this principleclinical practice is grounded on this principle

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BeneficenceBeneficence

• Providing ‘benefit’ has often been considered a Providing ‘benefit’ has often been considered a foundational value of clinical practice and therapeutic foundational value of clinical practice and therapeutic researchresearch

• Hippocrates is commonly cites to have states “Hippocrates is commonly cites to have states “primum non primum non nocerenocere” “” “above all, do no harmabove all, do no harm” though modern ” though modern scholarship suggest that he really said “scholarship suggest that he really said “help, or at least do help, or at least do no harmno harm” thereby demanding first, the provision of benefit ” thereby demanding first, the provision of benefit beyond the avoidance of harm beyond the avoidance of harm

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BeneficenceBeneficence

• Frankena arranged the components of this principle in the Frankena arranged the components of this principle in the following hierarchical orderfollowing hierarchical order

• I ought not to do evil or inflict harm (non-maleficence)I ought not to do evil or inflict harm (non-maleficence)

• I ought to prevent evil or harm (beneficence)I ought to prevent evil or harm (beneficence)

• I ought to remove evil or harm (beneficence)I ought to remove evil or harm (beneficence)

• I ought to do or promote good (beneficence) – some I ought to do or promote good (beneficence) – some have doubted whether this is a dutyhave doubted whether this is a duty

• This ordering is attractive as ordinary moral discourse and This ordering is attractive as ordinary moral discourse and some philosophical systems suggest that negative duties some philosophical systems suggest that negative duties are more compelling than positive onesare more compelling than positive ones

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JusticeJustice

• Justice – in the sense of what is fair and what is Justice – in the sense of what is fair and what is deserveddeserved• An injustice occurs when an entitlement is denied An injustice occurs when an entitlement is denied

without good reason or burden imposed undulywithout good reason or burden imposed unduly• Another conception is that equals must be treated Another conception is that equals must be treated

equally.equally.• This plays a role in resource allocation, ensuring that This plays a role in resource allocation, ensuring that

no particular group bears excessive burden on behalf of no particular group bears excessive burden on behalf of others others

• The emphasis on rights in bioethics is another The emphasis on rights in bioethics is another derivative of this principlederivative of this principle

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JusticeJustice

• This is often confused with other moral principles. For This is often confused with other moral principles. For example when withholding of information from patients is example when withholding of information from patients is called called unjustunjust while the correct moral principle is while the correct moral principle is beneficence; when the use of deception in research is beneficence; when the use of deception in research is referred to as referred to as unjustly denying informationunjustly denying information when the moral when the moral principle is respect for autonomyprinciple is respect for autonomy

• Problems like health care resource allocation, claims to a Problems like health care resource allocation, claims to a right to health care, burden of research risks compared to right to health care, burden of research risks compared to benefits are examples of justice issuesbenefits are examples of justice issues

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When principles conflictWhen principles conflict

• Conflict of principles creates a weighting or priority Conflict of principles creates a weighting or priority problemproblem

• Ross proposed finding the greatest duty in any Ross proposed finding the greatest duty in any circumstance of conflict by finding the greatest balance of circumstance of conflict by finding the greatest balance of right over wrong in that particular contextright over wrong in that particular context

• He proposed a distinction between He proposed a distinction between prima facieprima facie and and actualactual dutiesduties

• Prima faciePrima facie duties are those that must always be acted duties are those that must always be acted upon except they conflict with equal or stronger duties in upon except they conflict with equal or stronger duties in that particular occasion. They are always right and always that particular occasion. They are always right and always binding, all other things being equalbinding, all other things being equal

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• So, though firm, they are conditional on not being So, though firm, they are conditional on not being overridden or outweighed by competing moral demandsoverridden or outweighed by competing moral demands

• Actual dutyActual duty is therefore determined by a balance of the is therefore determined by a balance of the respective weights of the competing respective weights of the competing prima facieprima facie duties duties

• Therefore duties and rights are not absolutes but rather Therefore duties and rights are not absolutes but rather strong prima facie moral demands that may validly be strong prima facie moral demands that may validly be overridden in circumstances where stringent opposing overridden in circumstances where stringent opposing demands are presented by a competing moral principle demands are presented by a competing moral principle

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• This does not diminish the value of autonomy but let us This does not diminish the value of autonomy but let us ask with Daniel Callahan “What would it be like to live in ask with Daniel Callahan “What would it be like to live in a community for which autonomy was the central value”a community for which autonomy was the central value”

• The arguments about duties applies to rights tooThe arguments about duties applies to rights too• Many philosophers no longer submit to a thesis of absolute Many philosophers no longer submit to a thesis of absolute

right to life irrespective of competing claims or social right to life irrespective of competing claims or social conditionsconditions

• It is now commonly agreed that we have an It is now commonly agreed that we have an exercisable exercisable rightright not to have our life taken only if there is not a not to have our life taken only if there is not a sufficient moral justificationsufficient moral justification to override this right to override this right

Pertinent issues in cancer registrationPertinent issues in cancer registration

• ConfidentialityConfidentiality• Data sharing and transfer including by e-mail web-based data Data sharing and transfer including by e-mail web-based data

entryentry• Increased used of computers to store private health Increased used of computers to store private health

informationinformation• Linkage of data setsLinkage of data sets• Need to balance individual rights and autonomy with public Need to balance individual rights and autonomy with public

health ethicshealth ethics

DefinitionsDefinitions

• Personal Health Information (PHI) is any information Personal Health Information (PHI) is any information held by a covered entity which concerns health status, held by a covered entity which concerns health status, provision of health care, or payment for health care that provision of health care, or payment for health care that can be linked to an individual. can be linked to an individual.

• De-identified information – PHI where the identifying De-identified information – PHI where the identifying characteristics have been removed. However such characteristics have been removed. However such characteristics still exist and can be reapplied to the characteristics still exist and can be reapplied to the informationinformation

• Anonymized – Identifying characteristics of PHI have Anonymized – Identifying characteristics of PHI have been removed and cannot be reappliedbeen removed and cannot be reapplied

• Anonymous – Identifying information were never Anonymous – Identifying information were never collectedcollected

Ethical Aspects of Cancer RegistrationEthical Aspects of Cancer Registration

• Typically contains identifying characteristicsTypically contains identifying characteristics• Shared with clinicians for patient care purposesShared with clinicians for patient care purposes• Transferred to collaborating or central registries for Transferred to collaborating or central registries for

complete and accurate cancer registrationcomplete and accurate cancer registration• Often contains data about deceased personsOften contains data about deceased persons• Typically, the type of information collected by Cancer Typically, the type of information collected by Cancer

Registries requires informed consentRegistries requires informed consent• However, traditionally, this has not been considered However, traditionally, this has not been considered

necessary because such a requirement will negatively necessary because such a requirement will negatively impact cancer registry workimpact cancer registry work


• The workload on cancer registry staff engendered by such The workload on cancer registry staff engendered by such requirement would be too muchrequirement would be too much

• The repeated physical and psychological burden on The repeated physical and psychological burden on patients and relatives may not be justifiablepatients and relatives may not be justifiable

• It would be burdensome if such requirement were to be It would be burdensome if such requirement were to be transferred to medical stafftransferred to medical staff

• Cancer registry data is used for longer than envisaged by Cancer registry data is used for longer than envisaged by many ethical codes conception of the duration of many ethical codes conception of the duration of effectiveness of informed consenteffectiveness of informed consent

• If some people give consent and others do not give, this If some people give consent and others do not give, this will lead to differential bias in the data collectedwill lead to differential bias in the data collected


• By and large therefore, traditional practice has been that By and large therefore, traditional practice has been that national regulations provide exemptions in the public national regulations provide exemptions in the public interest for the work of the cancer registries becauseinterest for the work of the cancer registries because• Overriding national interestOverriding national interest• Data is used for statistical, historical or scientific Data is used for statistical, historical or scientific

researchresearch• Participants can no longer be informed because they are Participants can no longer be informed because they are

deaddead• We must note that this may change going forward given We must note that this may change going forward given

continued developments in the theory and practice of continued developments in the theory and practice of informed consentinformed consent


• Therefore cancer registration is exempted from rules about Therefore cancer registration is exempted from rules about informing data subjects individually about processing and informing data subjects individually about processing and disclosuredisclosure

• This exemption imposes tremendous burden on cancer This exemption imposes tremendous burden on cancer registries to take extra care on maintaining confidentiality registries to take extra care on maintaining confidentiality of the data that they collectof the data that they collect

• It is for this reason that the IARC has issued Guidelines on It is for this reason that the IARC has issued Guidelines on Confidentiality for Population-Based Cancer RegistrationConfidentiality for Population-Based Cancer Registration

Principles of Confidentiality for Cancer Principles of Confidentiality for Cancer RegistrationRegistration

• The principles relate to confidentiality in the process of The principles relate to confidentiality in the process of collecting, storing, use and transmission of identifiable collecting, storing, use and transmission of identifiable data by cancer registriesdata by cancer registries

• Medical ethics says that “the doctor is not the only Medical ethics says that “the doctor is not the only confidant of medical and non-medical information of confidant of medical and non-medical information of patients” and he/she needs to share this information with patients” and he/she needs to share this information with other medical and non-medical personnel in order to other medical and non-medical personnel in order to provide optimal care for patientsprovide optimal care for patients

• However, the physician has the right to expect that the However, the physician has the right to expect that the persons with whom these information is shared – including persons with whom these information is shared – including cancer registries – observes the same strict rules of cancer registries – observes the same strict rules of confidentialityconfidentiality


• Physicians and the general population will continue to Physicians and the general population will continue to provide information for Cancer Registries to the degree provide information for Cancer Registries to the degree that Cancer Registries maintain the confidentiality of the that Cancer Registries maintain the confidentiality of the data and make appropriate use of itdata and make appropriate use of it

• Confidentiality rules which are consistent with Confidentiality rules which are consistent with international guidelines, national legislations, professional international guidelines, national legislations, professional ethics etc must be put in place to reassurre stakeholdersethics etc must be put in place to reassurre stakeholders

• Legal protection – cancer registration in Nigeria is based Legal protection – cancer registration in Nigeria is based on the authority of the Government to make laws and on the authority of the Government to make laws and regulations regulations for the health and well-being of Nigeriansfor the health and well-being of Nigerians


• Scope of the confidentiality rules extend toScope of the confidentiality rules extend to• Identifiable data on cancer patientsIdentifiable data on cancer patients

• Census dataCensus data

• Interview recordsInterview records

• Death certificatesDeath certificates

• Members of cohort studiesMembers of cohort studies

• Deceased personsDeceased persons

• Indirectly identified dataIndirectly identified data

• Data storage in any manner – paper, computer, web, etcData storage in any manner – paper, computer, web, etc

Measures for Confidentiality in Cancer Measures for Confidentiality in Cancer RegistrationRegistration

• Defined responsibility for Director of Cancer RegistryDefined responsibility for Director of Cancer Registry• Oath of SecrecyOath of Secrecy• Display reminders on the need for and value of Display reminders on the need for and value of

confidentiality in the Cancer Registryconfidentiality in the Cancer Registry• Restrict physical access to the Cancer Registry to Restrict physical access to the Cancer Registry to

authorized personnel onlyauthorized personnel only• Identify and train authorized personnel – including training Identify and train authorized personnel – including training

in ethics and principles of confidentialityin ethics and principles of confidentiality• Active methods of data acquisition, access, protection and Active methods of data acquisition, access, protection and

transport should be in placetransport should be in place• Review of confidentiality and security proceduresReview of confidentiality and security procedures

Thank youThank you

• Institute of Human Virology, Nigeria, Nigerian Institute of Human Virology, Nigeria, Nigerian Malignancy Consortium,Malignancy Consortium,

• Society of Oncology and Cancer Research of Society of Oncology and Cancer Research of Nigeria,Nigeria,

• International Agency for Cancer Research,International Agency for Cancer Research,• West African Bioethics Training ProgramWest African Bioethics Training Program• Centers for Disease Control and Prevention Centers for Disease Control and Prevention

(CDC),(CDC),• and theand the• Federal Ministry of Health of NigeriaFederal Ministry of Health of Nigeria

Documents

Ethical Aspects of Cancer Registration Clement Adebamowo