Exploitation, benefits and Exploitation, benefits and inducementinducement

Clement AdebamowoClement Adebamowo

ExploitationExploitation

• Claims about exploitation are frequent in the research settingClaims about exploitation are frequent in the research setting• Exploitation is often conflated with oppression, betrayal, Exploitation is often conflated with oppression, betrayal,

coercion, assault, deception and discrimination, It is helpful to coercion, assault, deception and discrimination, It is helpful to distinguish exploitation so that the right remedy can be applied distinguish exploitation so that the right remedy can be applied to itto it

• Arises because of the difference in power, knowledge and Arises because of the difference in power, knowledge and authority between researchers and participants; between authority between researchers and participants; between researchers and sponsors; between local and international researchers and sponsors; between local and international researchersresearchers

• Exploitation is a moralized concept so one of the criterion for Exploitation is a moralized concept so one of the criterion for making a valid claim for exploitation is a moral onemaking a valid claim for exploitation is a moral one

• Moral weight of exploitation refers to the intensity of the Moral weight of exploitation refers to the intensity of the wrongnesswrongness

Moral weight of exploitationMoral weight of exploitation

• Exploitation manifests itself in micro-level transactions but Exploitation manifests itself in micro-level transactions but some argue that it has its roots in macro-level injustice. That some argue that it has its roots in macro-level injustice. That there would be less micro-level exploitation in a society that is there would be less micro-level exploitation in a society that is just at the macro leveljust at the macro level

• Even if this were true, and it most probably is, we are not Even if this were true, and it most probably is, we are not absolved of the need to look at the micro-level issues so that absolved of the need to look at the micro-level issues so that we can determine what must be done at this level and possibly we can determine what must be done at this level and possibly at the macro-level in additionat the macro-level in addition

• Exploitation may be Exploitation may be harmfulharmful or or mutually advantageousmutually advantageous• Exploitation may also be consensual (exploited has given Exploitation may also be consensual (exploited has given

proper informed consent) or non-consensual (as in the case of proper informed consent) or non-consensual (as in the case of fraud or coercion)fraud or coercion)

ExploitationExploitation

• Typically in examining an action – there may be many moral Typically in examining an action – there may be many moral issues at stake – and we tend to focus on the strongest moral issues at stake – and we tend to focus on the strongest moral wrong. For example, a murderer not only kills his victim but wrong. For example, a murderer not only kills his victim but also unfairly uses them. In this situation, we would not focus also unfairly uses them. In this situation, we would not focus so much on the exploitative nature of the act of murder, so much on the exploitative nature of the act of murder, present though it is, but on the murder itselfpresent though it is, but on the murder itself

• Similarly in reviewing research for exploitation, we should Similarly in reviewing research for exploitation, we should have excluded the greater harms of coercion, fraud and harm, have excluded the greater harms of coercion, fraud and harm, where these are present. It is when these are absent that we where these are present. It is when these are absent that we consider those forms of exploitation that may occur within the consider those forms of exploitation that may occur within the context of research where often the transaction is potentially context of research where often the transaction is potentially mutually advantageous or consensualmutually advantageous or consensual

ExploitationExploitation

• This is generally defined as present when A takes unfair This is generally defined as present when A takes unfair advantage of B. This can be understood in two waysadvantage of B. This can be understood in two ways• One way refers to some dimension of the One way refers to some dimension of the outcomeoutcome of the of the

exploitative act or relation; and this too has two elementsexploitative act or relation; and this too has two elements• The benefit to AThe benefit to A• The effect on B The effect on B

• – – wherein we may claim that it is wrong for A to wherein we may claim that it is wrong for A to benefit at all from his or her act on B or that his benefit at all from his or her act on B or that his benefit is excessive relative to that of B within the benefit is excessive relative to that of B within the context of the transactioncontext of the transaction

• Secondly, we may imply that A has been able to turn some Secondly, we may imply that A has been able to turn some characteristic of B or some feature of B’s situation to his or characteristic of B or some feature of B’s situation to his or her advantage – a defect in the her advantage – a defect in the process process of the transaction or of the transaction or agreement between A and Bagreement between A and B

Elements of ExploitationElements of Exploitation

• For the conditions to exist for A to take For the conditions to exist for A to take unfairunfair advantage advantage of B, the transaction must be such that A can take of B, the transaction must be such that A can take advantage of B, at alladvantage of B, at all

• Harmful exploitation does not necessarily mean that B Harmful exploitation does not necessarily mean that B looses something (zero-sum – A gains and B looses). It looses something (zero-sum – A gains and B looses). It may involve a negative-sum (A’s gain is less than B’s loss) may involve a negative-sum (A’s gain is less than B’s loss) or positive-sum (A gains by imposing a loss on B that is or positive-sum (A gains by imposing a loss on B that is less than A’s gain)less than A’s gain)

• Can A exploit B if B is not directly affected by A’s Can A exploit B if B is not directly affected by A’s utilization of B or if B gains from the transactionutilization of B or if B gains from the transaction

• Consider cases of Consider cases of harmless parasitismharmless parasitism – A uses B to his – A uses B to his own advantage but B is not worse offown advantage but B is not worse off

Elements of exploitationElements of exploitation

• Consider situations where there is Consider situations where there is heterogeneity of heterogeneity of preferencespreferences – where the elements of a transaction are – where the elements of a transaction are valued differently by both parties and considered valued differently by both parties and considered advantageous to bothadvantageous to both

• In considering whether there is harmful or mutually In considering whether there is harmful or mutually advantageous exploitation, we must take an all-things-advantageous exploitation, we must take an all-things-considered view in relation to its net effect on Bconsidered view in relation to its net effect on B

• Mutually advantageous transaction is one in which B gains Mutually advantageous transaction is one in which B gains relative to the non-participation baseline even though the relative to the non-participation baseline even though the social surplus generated is unfair to Bsocial surplus generated is unfair to B

• How does this relate to the Kantian interpretation of How does this relate to the Kantian interpretation of exploitation – where A merely uses B as a means to his exploitation – where A merely uses B as a means to his own advantage rather than as an end in itselfown advantage rather than as an end in itself

Elements of exploitationElements of exploitation

• How do we distinguish mutually advantageous How do we distinguish mutually advantageous transactions that are exploitative from those that are nottransactions that are exploitative from those that are not

• Marxists and libertarians agree that there is a “force-Marxists and libertarians agree that there is a “force-inclusive” definition in exploitation inclusive” definition in exploitation

• We can see that force inclusiveness – coercion – need not We can see that force inclusiveness – coercion – need not be present for exploitation to occurbe present for exploitation to occur

• Does consensual exploitation involve some sort of defect Does consensual exploitation involve some sort of defect in consent that does not amount to coercion or fraud?in consent that does not amount to coercion or fraud?

• Coercion compromises the voluntariness of consentCoercion compromises the voluntariness of consent• Fraud compromises the rationality or advisability or Fraud compromises the rationality or advisability or

validity of consentvalidity of consent

Elements of exploitationElements of exploitation

• There are cases of exploitation in which B’s consent is not There are cases of exploitation in which B’s consent is not defective (by coercion or fraud)defective (by coercion or fraud)

• A may take advantage of B’s circumstances to get B to agree to A may take advantage of B’s circumstances to get B to agree to a mutually advantageous transaction to which B would not have a mutually advantageous transaction to which B would not have agreed under better or perhaps more just background conditions, agreed under better or perhaps more just background conditions, where A has no special obligation to repair those conditions and where A has no special obligation to repair those conditions and where B is fully informed as to the consequences of various where B is fully informed as to the consequences of various choices. In this situation B may prefer that he has other range of choices. In this situation B may prefer that he has other range of options but he/she can still make rational decisions based on options but he/she can still make rational decisions based on available optionsavailable options

• Even in such circumstance, we would still have to contrast the Even in such circumstance, we would still have to contrast the cases that are nonconsensual because of fraud or coercion and cases that are nonconsensual because of fraud or coercion and ask what the moral force amounts toask what the moral force amounts to

Moral force of exploitationMoral force of exploitation

• Moral force refers to the various moral upshots or reasons for Moral force refers to the various moral upshots or reasons for action that exploitation might or might not involve for parties action that exploitation might or might not involve for parties to the transaction or for societyto the transaction or for society

• Can people have a right to exploit?Can people have a right to exploit?• Is it wrong to allow oneself to be exploited?Is it wrong to allow oneself to be exploited?• Should we refuse exploitative agreementsShould we refuse exploitative agreements• The moral force of harmful and nonconsensual exploitation The moral force of harmful and nonconsensual exploitation

is straightforwardis straightforward• It is, in such situations, wrong It is, in such situations, wrong prima facieprima facie, to harm and the , to harm and the

state is state is prima facieprima facie justified in prohibiting or refusing to justified in prohibiting or refusing to enforce such transactionsenforce such transactions

In summaryIn summary

• Exploitation is a micro-level concern. It is about harms arising Exploitation is a micro-level concern. It is about harms arising from discrete interactions and not about the larger social and from discrete interactions and not about the larger social and historical issues of injustice etc. These macro-level issues historical issues of injustice etc. These macro-level issues affect but do not replace the main issueaffect but do not replace the main issue

• Exploitation is about interactions – between the researcher and Exploitation is about interactions – between the researcher and the participant or between the researchers and the communitythe participant or between the researchers and the community

• It is about “how much” and not about “what” each party It is about “how much” and not about “what” each party receives. The key issue is fairness, not equal-ness of benefitsreceives. The key issue is fairness, not equal-ness of benefits

• The presence of vulnerability may make exploitation more The presence of vulnerability may make exploitation more likely but does not inherently entail exploitationlikely but does not inherently entail exploitation

In summaryIn summary

• Since exploitation is a micro-level concern, the key Since exploitation is a micro-level concern, the key question is the level of benefits provided to the parties who question is the level of benefits provided to the parties who interact. It does not involve weighing the benefits for those interact. It does not involve weighing the benefits for those who do not participate in the interactionwho do not participate in the interaction

• Determining when exploitation occurs requires Determining when exploitation occurs requires interpretation since the concept of fairness depends on an interpretation since the concept of fairness depends on an idealized market conditionidealized market condition

• Therefore reasonable people can and will disagree about Therefore reasonable people can and will disagree about what constitutes fair. This does not however invalidate the what constitutes fair. This does not however invalidate the judgments madejudgments made

Elements of exploitationElements of exploitation

• In the Kantian view, one treats the other in a way to which In the Kantian view, one treats the other in a way to which he could not possibly consent – there is therefore an he could not possibly consent – there is therefore an element of coercion or fraud. There is an element in which element of coercion or fraud. There is an element in which the autonomy of the individual as a decision maker is the autonomy of the individual as a decision maker is underminedundermined

• Rawls looks at fairness at the macro-level – distribution of Rawls looks at fairness at the macro-level – distribution of rights, liberties and resources for the basic structure of rights, liberties and resources for the basic structure of society with which individual transactions occur. It is not society with which individual transactions occur. It is not applicable at the micro-levelapplicable at the micro-level

Elements of exploitationElements of exploitation

• In considering exploitation, the ethics committee will be In considering exploitation, the ethics committee will be looking at the nature of the transaction between the looking at the nature of the transaction between the researcher and the research participantresearcher and the research participant

• What people are offered before they choose to participate. What people are offered before they choose to participate. This is not related to their autonomy to consentThis is not related to their autonomy to consent

• It also refers to the concept of reasonable availability after It also refers to the concept of reasonable availability after the research is overthe research is over

BenefitsBenefits

• In therapeutic research – benefits may include relief from In therapeutic research – benefits may include relief from disease, diminished suffering or provision of diagnostic disease, diminished suffering or provision of diagnostic informationinformation

• In non-therapeutic research participants join for altruistic In non-therapeutic research participants join for altruistic reasons to benefit societyreasons to benefit society

• In exchange for these benefits, participants accept some risk. In exchange for these benefits, participants accept some risk. Acceptability of these risks reflect the participants goals and Acceptability of these risks reflect the participants goals and values. Payment may influence these calculationsvalues. Payment may influence these calculations

• On the other hand, it may be argued that the financial reward On the other hand, it may be argued that the financial reward is a benefit as valid as the other reasons – it should therefore is a benefit as valid as the other reasons – it should therefore be included in the risk benefit calculus. Excluding it may be included in the risk benefit calculus. Excluding it may therefore violate individual autonomy to determine what therefore violate individual autonomy to determine what monetary value, if any he places on participation in researchmonetary value, if any he places on participation in research

BenefitsBenefits

• Another objection to payment of research participants is Another objection to payment of research participants is that it may entice economically disadvantaged persons and that it may entice economically disadvantaged persons and lead them to bear disproportionate amount of risk of lead them to bear disproportionate amount of risk of research. This contravenes principles of justiceresearch. This contravenes principles of justice

• On the other hand, it may be argued that measures that help On the other hand, it may be argued that measures that help to increase the participation of economically disadvantaged to increase the participation of economically disadvantaged people in research is ethical. This assumes that research is people in research is ethical. This assumes that research is beneficialbeneficial

• This counter-argument is also not compelling from the This counter-argument is also not compelling from the utilitarian point of view. There may be no reason to believe utilitarian point of view. There may be no reason to believe that economically disadvantaged people as a group stand to that economically disadvantaged people as a group stand to benefit rather than benefit to only those who participate benefit rather than benefit to only those who participate

BenefitsBenefits

• Another argument against payment of participants is that Another argument against payment of participants is that this makes the participant a “salaried worker” and this this makes the participant a “salaried worker” and this changes the relationship between the participant and the changes the relationship between the participant and the researcherresearcher

• However payment for labor is not unethical and a person’s However payment for labor is not unethical and a person’s services or capacities are commodities that are regularly services or capacities are commodities that are regularly exchanged for wagesexchanged for wages

• Empirical data shows that payment is a primary motivator Empirical data shows that payment is a primary motivator for participating in non-therapeutic trials for participating in non-therapeutic trials

• In therapeutic trials, health improvement was the primary In therapeutic trials, health improvement was the primary motivator to participate in researchmotivator to participate in research

• In developing countries, payment for lost wages, transport In developing countries, payment for lost wages, transport and other inconveniences make a strong justification for and other inconveniences make a strong justification for paymentpayment

BenefitsBenefits

• Incentives may be necessary to recruit adequate numbers Incentives may be necessary to recruit adequate numbers of research participants however there is limited evidence of research participants however there is limited evidence that this works any better than treatment or access to carethat this works any better than treatment or access to care

• Incentive helps to overcome opportunity costs, inertia, Incentive helps to overcome opportunity costs, inertia, distrust and helps to recruit hard to reach participantsdistrust and helps to recruit hard to reach participants

• Reimbursement for expenses and lost wages help to reduce Reimbursement for expenses and lost wages help to reduce the barrier of financial sacrifice for participantsthe barrier of financial sacrifice for participants

• Payment represents fair compensation for time and Payment represents fair compensation for time and inconvenience of participationinconvenience of participation

• Some argue that payment is a form of coercion. However Some argue that payment is a form of coercion. However coercion includes a threat of harm by definition therefore coercion includes a threat of harm by definition therefore an offer of money cannot be called coercionan offer of money cannot be called coercion

BenefitsBenefits

• Payment may constitute undue inducement which may Payment may constitute undue inducement which may compromise informed consent bycompromise informed consent by• Reducing interest in understanding risks related to Reducing interest in understanding risks related to

researchresearch• Reducing the voluntary nature of the decision to Reducing the voluntary nature of the decision to

participateparticipate• Undue inducement is not well definedUndue inducement is not well defined• No evidence that money alters perception of riskNo evidence that money alters perception of risk• Voluntary decisions can be made even when inducements Voluntary decisions can be made even when inducements

are offeredare offered• Other inducements may be as powerful or more powerful Other inducements may be as powerful or more powerful

than moneythan money

BenefitsBenefits

• Another model for payment is the fair-share model which Another model for payment is the fair-share model which views the participant as a partner in the drug development views the participant as a partner in the drug development processprocess

• Payment is based on a percentage of the per-patient Payment is based on a percentage of the per-patient compensation due the investigator or the institutioncompensation due the investigator or the institution

• Payment would be for completed components of the Payment would be for completed components of the research onlyresearch only

• The criticisms of this model include that payment is based The criticisms of this model include that payment is based on a per payment compensation rather than on level of risk on a per payment compensation rather than on level of risk borne by participants; not all research is about drug borne by participants; not all research is about drug development; too much variation; competition would favor development; too much variation; competition would favor studies with more fundingstudies with more funding

BenefitsBenefits

• Some differentiate between paying healthy participants Some differentiate between paying healthy participants and paying patient-participantsand paying patient-participants

• Healthy participants are often motivated to participate in Healthy participants are often motivated to participate in research by money and receive little or no other benefits research by money and receive little or no other benefits from participation whereas commentators worry about the from participation whereas commentators worry about the vulnerability of patient participantsvulnerability of patient participants

• Illnesses make people vulnerable in many waysIllnesses make people vulnerable in many ways• In fact offering money may help participants more clearly In fact offering money may help participants more clearly

distinguish research from treatment and reduce the risk of distinguish research from treatment and reduce the risk of therapeutic misconceptiontherapeutic misconception

• This may also empower the participant to say no to This may also empower the participant to say no to participation without feeling obligatedparticipation without feeling obligated

InducementInducement

• Inducements are pervasive in life. Inducements are pervasive in life. • Exchange of goods for the purpose of alteration of Exchange of goods for the purpose of alteration of

behavior occurs without raising concernbehavior occurs without raising concern• In fact such inducements may make people take on more In fact such inducements may make people take on more

risky occupationsrisky occupations• So when is inducement So when is inducement undueundue??• CIOMS “Payment in money or in kind to research subjects CIOMS “Payment in money or in kind to research subjects

should not be so large as to persuade them to take undue should not be so large as to persuade them to take undue risks or volunteer against their better judgment. Payments risks or volunteer against their better judgment. Payments or rewards that undermine a person’s capacity to exercise or rewards that undermine a person’s capacity to exercise free choice invalidate consentfree choice invalidate consent

InducementInducement

• Undue inducement requires 4 conditionsUndue inducement requires 4 conditions

• An offered good - Individuals are offered something An offered good - Individuals are offered something that is valuable or desirable in order to do somethingthat is valuable or desirable in order to do something

• Excessive offer – The offer must be so large or in Excessive offer – The offer must be so large or in excess that it is irresistible in the contextexcess that it is irresistible in the context

• Poor judgment – The offer leads individuals to exercise Poor judgment – The offer leads individuals to exercise poor judgment in an important decisionpoor judgment in an important decision

• Risk of serious harm – the individuals’ poor judgment Risk of serious harm – the individuals’ poor judgment leads to sufficiently high chance that they will leads to sufficiently high chance that they will experience a harm that seriously contravenes his o her experience a harm that seriously contravenes his o her interestsinterests

InducementInducement

• Compared with coercionCompared with coercion• Undue inducement dangles a positive good before the Undue inducement dangles a positive good before the

participant – a tempting offer that can cause to bad participant – a tempting offer that can cause to bad judgment and lead harmjudgment and lead harm

• Coercion entails a threat that the person considers a Coercion entails a threat that the person considers a worse circumstances if they do not do the desired worse circumstances if they do not do the desired actionaction

• Compared with exploitationCompared with exploitation• Exploitation involves a person getting too little while Exploitation involves a person getting too little while

undue inducement entails a person receiving too muchundue inducement entails a person receiving too much

InducementInducement

• Differentiating undue inducement from unfortunate Differentiating undue inducement from unfortunate circumstancescircumstances• Distressing circumstances that create limited options do Distressing circumstances that create limited options do

not necessarily compromise autonomy and not necessarily compromise autonomy and voluntarinessvoluntariness

• Tempting offers in desperate situations that have clear Tempting offers in desperate situations that have clear good results are not undue inducementsgood results are not undue inducements

• Irresistible offers become undue inducement when a Irresistible offers become undue inducement when a person’s unfortunate circumstances and compromised person’s unfortunate circumstances and compromised judgments are combined with accepting a seriously judgments are combined with accepting a seriously unfavorable risk-benefit ratio that threatens unfavorable risk-benefit ratio that threatens fundamental interestsfundamental interests

Compensation for research injuriesCompensation for research injuries

• Participants in research may suffer injury becauseParticipants in research may suffer injury because• Research procedure – e.g. falling off the treadmill and Research procedure – e.g. falling off the treadmill and

fracturing a bone; headaches after a spinal tapfracturing a bone; headaches after a spinal tap• Injuries may result from the medication or device being Injuries may result from the medication or device being

testedtested• From failure of the investigator to follow the protocolFrom failure of the investigator to follow the protocol• Failure of the investigator to perform research Failure of the investigator to perform research

associated procedure properlyassociated procedure properly

• Occurrence of serious injury is rare in clinical Occurrence of serious injury is rare in clinical trials/researchtrials/research

Compensation for research injuriesCompensation for research injuries

• International guidelines on provision of compensation for International guidelines on provision of compensation for research associated injuries vary widelyresearch associated injuries vary widely

• Some suggest that sponsors and institutions are obligated to Some suggest that sponsors and institutions are obligated to compensate injured participants, particularly when there is a compensate injured participants, particularly when there is a commercial sponsor, regardless of who is to blame or whether commercial sponsor, regardless of who is to blame or whether participants were paidparticipants were paid

• Another view is that participants were aware of the risks through Another view is that participants were aware of the risks through the informed consent process and voluntarily agreed to the informed consent process and voluntarily agreed to participateparticipate

• There are also practical issues There are also practical issues • It may be difficult to determine whether the medical problem It may be difficult to determine whether the medical problem

is related to research participationis related to research participation• Particularly if it develops months or even years after the Particularly if it develops months or even years after the

researchresearch

Compensation for research injuriesCompensation for research injuries

• The cost of providing compensation includes the need to The cost of providing compensation includes the need to adjudicate claims and resolve disagreementsadjudicate claims and resolve disagreements

• Plans with broad coverage are more costly and difficult to Plans with broad coverage are more costly and difficult to administer than those limited to direct costs onlyadminister than those limited to direct costs only

• Research participants need to be told whether Research participants need to be told whether compensation or medical treatments are available for compensation or medical treatments are available for injuries, if so, what they are and where they can obtain injuries, if so, what they are and where they can obtain further information about themfurther information about them

Compensation for research injuriesCompensation for research injuries

• In the U.S., sponsors and institutions are not required to In the U.S., sponsors and institutions are not required to provide either free medical care or compensationprovide either free medical care or compensation

• In many European countries on the other hand, clinical In many European countries on the other hand, clinical trials insurance is mandated through which participants are trials insurance is mandated through which participants are covered regardless of faultcovered regardless of fault

• In Nigeria, researchers conducting clinical trials are In Nigeria, researchers conducting clinical trials are enjoined to obtain insurance in case of research injuryenjoined to obtain insurance in case of research injury