1. Ethical Aspects of Cancer Registration Clement Adebamowo

2. 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 workAs 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 registrationTo explore this, we will start by looking at the classic principles of research ethics, then explore how they relate to cancer registration These areThese are AutonomyAutonomy BeneficenceBeneficence JusticeJustice

3. 3 Respect for autonomy Personal self-governance and freedom from controlling influence by others and from personal limitations that prevent choicePersonal 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 personsWe 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 coercionAutonomous 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, etcNon-autonomous persons sometimes must the resources to make autonomous decisions such as refusals, etc

4. 4 Respect for autonomy A third issue is to be respected as autonomousA third issue is to be respected 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 interventionsNon-recognition of refusal of certain medical interventions To respect an individual’s autonomy entails: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 beliefsRecognize 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

5. 5 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 endsThis 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 decisionsThis 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 principleThe obligation to obtain informed consent in research and clinical practice is grounded on this principle

6. 6 Beneficence Providing ‘benefit’ has often been considered a foundational value of clinical practice and therapeutic researchProviding ‘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 harmHippocrates 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

7. 7 Beneficence Frankena arranged the components of this principle in the following hierarchical orderFrankena arranged the components of this principle in the following 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 have doubted whether this is a dutyI 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 onesThis ordering is attractive as ordinary moral discourse and some philosophical systems suggest that negative duties are more compelling than positive ones

8. 8 Justice Justice – in the sense of what is fair and what is deservedJustice – 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 undulyAn injustice occurs when an entitlement is denied without good reason or burden imposed unduly Another conception is that equals must be treated equally.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 othersThis 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 principleThe emphasis on rights in bioethics is another derivative of this principle

9. 9 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 autonomyThis 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 issuesProblems like health care resource allocation, claims to a right to health care, burden of research risks compared to benefits are examples of justice issues

10. 10 When principles conflict Conflict of principles creates a weighting or priority problemConflict 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 contextRoss 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 dutiesHe 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 equalPrima 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

11. 11 When principles conflict So, though firm, they are conditional on not being overridden or outweighed by competing moral demandsSo, 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 dutiesActual 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 principleTherefore 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

12. 12 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”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 tooThe 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 conditionsMany 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 rightIt 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

13. Pertinent issues in cancer registration ConfidentialityConfidentiality Data sharing and transfer including by e-mail web-based data entryData sharing and transfer including by e-mail web-based data entry Increased used of computers to store private health informationIncreased used of computers to store private health information Linkage of data setsLinkage of data sets Need to balance individual rights and autonomy with public health ethicsNeed to balance individual rights and autonomy with public health ethics

14. 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.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 informationDe-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 reappliedAnonymized – Identifying characteristics of PHI have been removed and cannot be reapplied Anonymous – Identifying information were never collectedAnonymous – Identifying information were never collected

15. Ethical 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 complete and accurate cancer registrationTransferred to collaborating or central registries for complete and accurate cancer registration Often contains data about deceased personsOften contains data about deceased persons Typically, the type of information collected by Cancer Registries requires informed consentTypically, 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 workHowever, traditionally, this has not been considered necessary because such a requirement will negatively impact cancer registry work

16. Ethical Aspects of Cancer Registration The workload on cancer registry staff engendered by such requirement would be too muchThe 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 justifiableThe 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 staffIt 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 consentCancer 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 collectedIf some people give consent and others do not give, this will lead to differential bias in the data collected

17. 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 becauseBy 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 interestOverriding national interest Data is used for statistical, historical or scientific researchData is used for statistical, historical or scientific research Participants can no longer be informed because they are deadParticipants 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 consentWe must note that this may change going forward given continued developments in the theory and practice of informed consent

18. Ethical Aspects of Cancer Registration Therefore cancer registration is exempted from rules about informing data subjects individually about processing and disclosureTherefore 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 collectThis 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 RegistrationIt is for this reason that the IARC has issued Guidelines on Confidentiality for Population-Based Cancer Registration

19. 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 registriesThe 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 patientsMedical 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 confidentialityHowever, 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

20. 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 itPhysicians 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 stakeholdersConfidentiality 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 NigeriansLegal 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

21. Principles of Confidentiality for Cancer Registration 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

22. Measures for Confidentiality in Cancer Registration 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 confidentiality in the Cancer RegistryDisplay reminders on the need for and value of confidentiality in the Cancer Registry Restrict physical access to the Cancer Registry to authorized personnel onlyRestrict physical access to the Cancer Registry to authorized personnel only Identify and train authorized personnel – including training in ethics and principles of confidentialityIdentify and train authorized personnel – including training in ethics and principles of confidentiality Active methods of data acquisition, access, protection and transport should be in placeActive methods of data acquisition, access, protection and transport should be in place Review of confidentiality and security proceduresReview of confidentiality and security procedures

23. Thank you Institute of Human Virology, Nigeria, Nigerian Malignancy Consortium,Institute of Human Virology, Nigeria, Nigerian Malignancy Consortium, Society of Oncology and Cancer Research of Nigeria,Society of Oncology and Cancer Research of 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 (CDC),Centers for Disease Control and Prevention (CDC), and theand the Federal Ministry of Health of NigeriaFederal Ministry of Health of Nigeria