Introduction
Neurobiobanking entails the storage of tissues from the central nervous system (CNS). The CNS is made up of the brain hemispheres and spinal cord. The tissues stored may include the whole brain or a section of the brain. Most of the tissues in neurobiobanks are obtained at post-mortem. The tissues may be stored after fixation in a suitable fixative or kept frozen. Although rare, brain biopsies obtained from living persons are retrieved for diagnostic purposes to discover the presence, cause or extent of a disease.Footnote 1Non-CNS tissues in biobanks include blood fractions. Blood is made up of platelets, red blood cells, white blood cells and plasma. Substances that are extracted from any of these components are known as blood fractions.Footnote 2Genomics research involves probing into the cause of a disease through the study of genes. Neurobiobanking implies that the genes in the tissues obtained from the brain and spinal cord can be examined to determine the presence, cause or extent of a disease. The disease of interest in this instance is stroke. Strokes are highly prevalent in Sub-Saharan Africa and are known to increase the risk for dementia and depression, and can lead to disability and death.Footnote 3The severity of a stroke is also known to have been influenced by racial differences.Footnote 4This suggests that genetic factors unique to specific racial groups could have some roles to play.
Research on strokes using genetics and neurobiobanking has highlighted some ethical, legal and social implications (ELSI). Blood donation, brain donation, blood storage, re-use and sample sharing, data sharing, return of individual results, disclosure of incidental findings, pattern and causes of preference for informed consent, governance and regulation, and biorights are some of the legal problems presented. This aspect is examined in this study. In this study, some of the legal issues involved in stroke neurobiobanking and genomics research are examined to assess the extent to which the law mirrors people’s expectations. Thus, the legal issues involved in each distinct aspect of blood and brain donation, blood storage, re-use, sample and data sharing; return of individual results; disclosure of incidental findings; pattern and determinants of preference for informed consent; governance and regulation; and biorights are examined to assess the extent to which the law mirrors people’s expectations.
The justification for this study lies in its relevance in determining appropriate legal interventions. For example, if the existing law mirrors people’s expectations, the need for statutory intervention may be minimal. Where statutory intervention is even required, the nature and extent of the intervention may be informed by the extent to which the existing law mirrors people’s expectations. For example, a positive symbolic statute where people are also legislators together with the stateFootnote 5may be adopted as opposed to an instrumental statute where the state legislates without necessarily taking cognizance of people’s expectations.
This study is limited to Ghana and Nigeria. It does not cover the whole of Sub-Saharan Africa. However, it is envisaged that the findings would apply substantially to other communities in sub-Saharan Africa because of identical sociocultural background. This article is divided into seven sections. The first section introduces the article. The second section discusses some preliminary issues. These issues constitute the context for the study. They are the research method, study location and population and literature review. The third section examines the theoretical framework adopted in this article. The fourth section presents the first part of the research findings. This part of the research findings is with respect to blood donation; brain donation; blood storage, re-use and sample sharing; and data sharing. The fifth section presents the second part of the research findings. The second part of the research findings is with respect to return of individual results; disclosure of incidental findings; pattern and determinants of preference for informed consent; governance and regulation; and biorights. The sixth section applies the theoretical framework to the research findings. The seventh section concludes.
Preliminary issues
Preliminary issues that are required to be addressed, as previously indicated, are the research method, study location and population, and literature review.
Research method, study location and population
A qualitative survey was conducted among community-dwelling lay persons from the seven existing SIREN (Stroke Investigative Research and Education Network) sites in Ghana and Nigeria.Footnote 6Five of these sites were communities in Nigeria from Abeokuta, Ibadan, Ilorin, Kano and ZariaFootnote 7and two were communities in Ghana from Accra and Kumasi.Footnote 8A Community Advisory Board (CAB) was established for each of the sites. CAB membership at each site ranged between six to nine individuals and included stroke survivor(s), faith-based leader(s), community leader(s), public health leader(s), ethics committee representative(s) and profession-based organizational leader(s) including the media and legal practitioners.Footnote 9The CAB in each of the seven sites served as a liaison with each community. Each CAB guided the investigators in explaining the research to the residents and facilitated participant recruitment and sustainable and responsive interactions with the community as well as facilitating feedback of research findings to the community.Footnote 10Participants were recruited from each site and included stroke survivors, caregivers, healthy controls, providers, hospital administrators, researchers, public health practitioners, ethics committee members, religious and community leaders, and laypersons.Footnote 11Qualitative approach was used to obtain input from the communities.Footnote 12This involved Focus Group Discussions (FGDs) and Key Informant Interviews (KIIs). The FGDs and KIIs explored the perspectives of those that were recruited on the legal issues identified above.Footnote 13As previously mentioned, the legal issues involved include blood and brain donation; blood storage, re-use and sample sharing; data sharing; return of individual results; disclosure of incidental findings; pattern and determinants of preference for informed consent; governance and regulation; and biorights. In each site, four FGDs were conducted among SIREN stroke survivors, SIREN stroke caregivers, CAB members and SIREN stroke free controls while ten KII participants were recruited in each site among healthcare providers, hospital administrators, researchers, public health practitioners, ethics committee members and religious and community leaders. For the FGDs, participants were purposefully selected to maintain a careful balance for age, gender, socioeconomic status, types / levels of disabilities and caregiver support.Footnote 14Participants were 18 years or older and did not have any condition that could limit FGDs such as dementia.Footnote 15They were included from all the sites.Footnote 16
Literature review
There are existing works on ELSI with respect to stroke biobanking and genomics research in Sub-Saharan Africa. Some of these works will be examined and what this research seeks to do differently will be highlighted. Adigun et al in “Symbolic Legislation and the Regulation of Stroke Biobanking and Genomics Research in Sub-Saharan Africa” examine how genomics research and stroke biobanking can be regulated through legislation in Sub-Saharan Africa.Footnote 17They argue for a legislative intervention through a positive symbolic approach. In this approach, the statute will be enacted broadly to address policy issues while detailed rules including decided cases, cases settled out of court and the ethical guidelines prepared by Human Heredity and Health in Africa (H3 Africa) will be stated in an accompanying explanatory note. Adigun et al in “Legal implications of stroke biobanking and genomics research in Sub-Saharan Africa” (“Legal implications”) examine the legal implications of stroke biobanking and genomics research in Sub-Saharan Africa. They argue that laws from the perspectives of human rights, common law and intellectual property are implicated in stroke biobanking and genomics research. However, they recognize that there are still gaps to be filled which may have to be done through legislation.Footnote 18Adigun et al in “Human rights implications of stroke biobanking and genomics research in Sub-Saharan Africa” examine human rights implications of stroke biobanking and genomics research in Sub-Saharan Africa. While in “Legal implications” they examine laws that are generally implicated, in this instance, they engage in details of human rights that are implicated. They argue that the right to dignity of the human person, the right to privacy, the right to freedom of information, the right to freedom from discrimination, the right to own property, the right to self-determination and the right to health may be implicated and that the courts may have to balance any of these rights against another which may be challenging.Footnote 19
Singh et al examine the level of awareness and willingness to donate or share biological samples in Ghana and Nigeria. They report that participants have lower levels of awareness about brain sample donation for research and low levels of willingness to donate brain samples compared to blood samples.Footnote 20Uvere et al document capacity-building experiences of researchers during the development, pretesting and validation of data collection instruments of the African Neurobiobank for Precision Stroke Medicine-(ELSI) Project. They find that capacity-building is a necessary step toward ELSI-related genomic research implementation in African countries where scholarship of ELSI of genomics research is emerging.Footnote 21
What this article seeks to do differently is to assess the extent to which the law mirrors people’s expectations with respect to stroke neurobiobanking and genomics research. While previous studies have examined some of the legal issues involved in stroke biobanking and genomics research, none of these studies has examined the extent to which the law mirrors peoples’ expectations.
Having examined preliminary matters, the theoretical framework adopted for this study will now be examined as previously intimated.
Theoretical framework
The theoretical framework adopted for this study is the general jurisprudence of law and society developed by Tamanaha.Footnote 22The general jurisprudence of law and society has five basic elements. First, it recognizes social arena as an analytical tool. Secondly, it challenges the assumption that law brings about social order. Thirdly, it argues that social order is substantial coordination of behaviour. Fourthly, it argues that law is just a source among sources of substantial coordination of behaviour. Fifthly, it argues that law is not necessarily a mirror of society which functions to maintain social order.Footnote 23Each of these elements merits further elaboration.
In general jurisprudence of law and society, a social arena is an analytical tool whose boundaries can be determined based on the purpose of the study. Thus, a social arena may be delimited in such a way that its boundaries will be the same as that of a nation state, a local business community or an international group of merchants.Footnote 24In a nutshell, the social arena as an analytical tool is flexible as it can be determined in terms of geography, type of activity, type of group, or a combination of some or all of them. A social arena may be localized while another one may transcend state boundaries. A social arena may be tied to a group while another may cut across several groups.Footnote 25
The assumption that law brings about order and that securing order is the sole purpose of the law is challenged in the general jurisprudence of law and society. In Leviathan,Footnote 26Hobbes argues that in the state of nature, life was “nasty, brutish and short”Footnote 27and that people submitted their unbridled freedom to do whatever they liked to a despot who brought about the order through law. With this, the law precedes social order and helps bring it about. Tamanaha contends otherwise. He argues that there must be some social order in existence and that law can only contribute to it.Footnote 28A riotous situation reinforces this argument since law practically plays no role.Footnote 29In some instances, the law can even disrupt social order.Footnote 30In a nutshell, social order precedes law and identifying law with social order is misconceived.
The general jurisprudence of law and society conceives the idea of order as a substantial coordination of behaviour. It strikes a balance between factual order and normative order. In a factual sense, order connotes regularity of conduct, patterns of behaviour, predictability and stability.Footnote 31In this sense, there is the absence of conflict, chaos, randomness, chance and unpredictability. The absence of conflict is the opposite of Hobbes’s state of nature. In the normative sense, there is an order based on a body of norms shared by a group. In general jurisprudence, both conceptions of the order are considered flawed. Factual order is considered to include too much while normative order is considered to exclude too much. In the factual sense, not all regularity is of importance to be investigated. In the normative sense, sources of order apart from what is normative are excluded.Footnote 32In addition, a normative conception of the order has the problem of treating the society as being completely homogeneous. But, in reality, a society may be ordered and still exhibit conflicts between individuals and groups.Footnote 33With substantial coordination of behaviour, there is a balance between leaving out too much and taking in too much; and a social arena can be ordered and still accommodate conflict between individuals and groups.Footnote 34
Sources of substantial coordination of behaviour in an ordered social arena include an unarticulated substrate such as shared habits, modes of action, customs, practices and unthinking rule-following;Footnote 35shared norms with accompanying guilt when disobeyed and roles; and goal-oriented behaviour among people of identical interest.Footnote 36They also include consent grounded in a mutually agreed course of action; behaviour motivated and instinctively induced by love, altruism and sympathy; and behaviour induced by coercion.Footnote 37Coercion may take the form of self-help, revenge, gossip, shunning, imposition of fines, exile, imprisonment and death. It may be applied by various entities ranging from family, friends and colleagues to the state legal apparatus.Footnote 38All these sources mingle with one another and cannot be separated. Also, they bring about coordination of behaviour between groups, between institutions, between groups and institutions, and between individuals interacting outside groups and institutions.Footnote 39
In the sources of coordination stated above, the law was only mentioned once and was noted in relation to coercion. But the law as a source of coordination transcends a coercive one. Law includes state law, customary law, religious law, international law,Footnote 40transnational law, indigenous law and natural law.Footnote 41Considering typologies of law, it follows that law may not necessarily mirror the society. Since there is an existing social order, it follows that law may not necessarily be geared towards securing social order. The extent to which law contributes to the maintenance of social order may be difficult to measure with quantitative exactitude. However, it is feasible to arrive at a qualitative measure such as none, low, moderate, high or extremely high.Footnote 42
Law versus what people want: research findings I
The first part of the research findings on law versus what people want in Nigeria and Ghana, as previously indicated, will be presented here with respect to blood donation; brain donation; blood storage, re-use and sample sharing; and data sharing.
On blood donation
What people want: Nigeria
In Nigeria, there is evidence that awareness and willingness for blood donation is high. However, some could not differentiate between blood donation for research and transfusion. Reasons why people are willing to donate blood include the desire to save others, the desire to know one’s problem, the assurance that analysis will be done locally and the capacity of local researchers will be built, and the availability of storage facilities. Other reasons are the perceived belief that not donating blood can cause a problem and a positive disposition for care.
Some barriers to the willingness to donate are identified. They are cultural and religious beliefs, the fear of misuse of blood for rituals, lack of knowledge with respect to the quantity of blood to be donated and being sick. With respect to religious belief, some religious groups such as Jehovah’s Witness will not donate blood.Footnote 43However, not all religions go against blood donation. A Muslim participant said that “[r]eligion is not against it. There is a saying from the Prophet that suggests that blood walks / moves”.Footnote 44Another Muslim participant said thus: “I supported it, there is even a verse in the Qur’an that says when you preserve or save life; you will be rewarded by the Almighty Allah. I am willing to participate in such type of research”.Footnote 45
What the law is: Nigeria
In Nigeria where people cannot differentiate between blood donation for research and transfusion, it implies that the situation can give rise to the tort of misrepresentation.Footnote 46A tort is any wrong known to law other than that occasioned by contract. Misrepresentation as a tort occurs when someone makes a statement to another person and that other person acts contrary to their interest. Misrepresentation as a tort may be fraudulent, negligent or innocent.Footnote 47It is fraudulent when the maker of the statement does not have belief in the statement made. It is negligent when the maker of the statement is careless with the statement made. An innocent misrepresentation is a form of misrepresentation that is neither fraudulent nor negligent.Footnote 48Since a genomics researcher is a person to whom blood will be donated, it implies that such a researcher must supply sufficient information to the donors before the donors part with their blood. In a nutshell, the donor is protected by law. If there is a fraudulent and negligent misrepresentation, the remedy is damages which will be awarded against the genomics researcher. It is also possible that the blood donated may be ordered to be returned. With respect to innocent misrepresentation, there will be no damages to be awarded. But the blood may still be ordered to be returned in line with the principle of restitutio in integrum. This principle tends to restore parties to their original condition as much as possible which in this context is the condition before blood donation.
With respect to barriers to blood donation, they may yield different legal implications. Someone who believes that their blood may be used for rituals has their belief protected by law in Nigeria. The Constitution of the Federal Republic of Nigeria 1999 (Nigerian Constitution) protects the right to freedom of religion, thought and conscience.Footnote 49If a person refuses to donate blood as a result of any of these beliefs, such a person is protected by law. This person can only be persuaded to part with their blood with an adequate supply of information to avoid misrepresentation. But while the law in Nigeria protects beliefs that appear unreasonable or unfavourable to genomics research, it also protects those that are favourable to genomics research. Thus, the belief of a Muslim that favours genomics research is also protected.
If the person whose belief is not favourable to genomics research is persuaded to donate blood and the person does, then the doctrine of constructive trust is automatically imported between the genomics researcher and the donor.Footnote 50This means that the person, that is, the genomics researcher, to whom blood is donated is in a trust relationship with the donor. What the doctrine of constructive trust means is that a person in whom a trust is reposed must not betray that trust as a matter of law. While law and morals are different from each other, this is one area where they are connected. This implies that the beliefs of the donor must be protected whether reasonable or not and their expectations must be met.
With respect to fear of stigmatization, it appears that illness that may be discovered while blood is being tested and the stigmatization that goes with it are the issues. In this respect, apart from the doctrine of constructive trust that protects the donor, the doctrine of breach of confidence under common law also protects the donor.Footnote 51Under this doctrine, information is protected if it has the quality of confidence, is imparted in a situation that imports an obligation of confidence and there is an unauthorized use or disclosure of that information to the detriment of the person who gave the information.Footnote 52Information about the donor’s health condition appears to have the quality of confidence because it is private. The situation also imports obligation since the donor wants it protected. Since its disclosure leads to stigmatization, then it is detrimental to the donor. In addition, the Nigerian Constitution recognizes and protects the right to privacy.Footnote 53
What people want: Ghana
In Ghana, there is also evidence of willingness to donate blood.Footnote 54Factors that promote willingness include assurance that blood donated will be safe. The fact that blood has been donated before for other purposes also encourages donating blood for genomics research.Footnote 55
While there are factors promoting a willingness to donate blood, there are also barriers. The unavailability of storage facilities and past experience in handling blood donated which invariably led to waste are barriers.Footnote 56The fear of misuse of blood for ritualsFootnote 57and that of stigmatization if a disease is detected are also barriers.Footnote 58
What the law is: Ghana
On the issue of waste, the law appears silent. With respect to the fear of stigmatization, the Constitution of Ghana protects the donor. It recognizes and protects the right to privacy.Footnote 59The doctrine of breach of confidence under common law also protects the donor.Footnote 60With respect to the fear of misuse of blood for rituals, the doctrine of constructive trust earlier mentioned also applies.
On brain donation
What people want: Nigeria
While awareness is high with blood donation in Nigeria, this is not the case with brain donation as awareness is low. Participants could not differentiate between donation for research and brain transplantation.Footnote 61Some barriers to brain donation are identified. They are the belief to remain whole,Footnote 62religion, brain donation as occult practice, difficulty in discussing the issue with the family, perception of the society, special attachment to the brain and time of burial. With respect to religion, a Muslim participant stated thus: “May God be with us, the issue being discussed now, for Muslims, we won’t allow it. This is because I want to go back to God complete”.Footnote 63A Christian participant also maintained an identical position. The participant said “[l]et us be sincere, donation of brain is not easy. I cannot do it as it is against my religion (Christianity) and culture (Kogi)”.Footnote 64On brain donation as occult practice, a participant stated thus: “People will assume you belong to a cult that is why you want the brain removed. As an individual, I don’t buy the idea at all. It is of no use at all”.Footnote 65On special attachment, a participant said that “[i]t is not right, the brain is vital”.Footnote 66With respect to the time of burial, a Muslim participant said that in “Islamic religion, we bury our dead soon after death as soon as possible, we don’t give any room for thought or for any individual to consider such”.Footnote 67
What the law is: Nigeria
What someone chooses to do with their brain is purely personal and it is protected in Nigeria. As previously noted, there is the right to privacy in Nigeria. As a human right, it also applies even after one’s death and can be enforced by the family of the deceased.Footnote 68What someone chooses to do with their brain is also protected under the right to freedom of thought, conscience and religion.Footnote 69Thus, the belief of a Muslim that a deceased person must be buried almost immediately after death leaving little or no time to possibly remove the head or have the head opened and have the brain extracted for research is also protected as an expression of religious belief. It is noteworthy that what the texts of a religion say do not matter. It is also not what the adherents of a particular religion generally believe. What is significant is what each person within the fold of a religious group believes. Since human rights subsist even after one’s death, it follows that the belief of the deceased until death is what matters. Therefore, the next of kin who will take the decision on behalf of the deceased will have to take a decision in line with the belief of the deceased.
What people want: Ghana
In Ghana, awareness of brain donation is also low, just as it is in Nigeria. However, unlike in Nigeria, there is a willingness for brain donation.Footnote 70But, despite this willingness, there is a misconception that only those that are educated should donate their brains.Footnote 71
What the law is: Ghana
A person’s decision to donate their brain is also a matter of personal choice and it is protected under the Constitution of Ghana as the right to privacy. A person’s thought which informs the choice is also protected as the right to freedom of thought.
Blood storage, re-use and sample sharing
What people want: Nigeria
Many participants in Nigeria do not show concern about the use of blood after donation. They leave the decision to researchers.Footnote 72Nonetheless, some participants desire to know where the blood samples will be kept. They want the blood samples to be stored in a safe place to avoid being wasted. Some participants want them stored in a safe place to avoid being stolen. Some want them stored because storage opens doors for knowledge generation,Footnote 73while some support storage because it enhances future research by having something to fall back on.Footnote 74
What the law is: Nigeria
On the use of blood after donation, even though most participants in Nigeria do not show concern about how their blood is used, the law can intervene in certain instances. The very fact that they do not care does not mean their right under the tort of misrepresentation, the doctrine of breach of confidence and the doctrine of constructive trust is extinguished. But it must be exercised within the period prescribed by law through a statute of limitation. A statute of limitation is a statute which stipulates the period within which an action can be filed. The action here is a civil cause. What is civil is what is not criminal. Civil causes are cases which are not criminal. Since the rights being considered are civil, it means that they can only be exercised within the period prescribed by law.Footnote 75One dramatic aspect is where the use of blood violates the human right to privacy of the donor. In this respect, someone apart from the donor can file an action to remedy the violation. This is because human rights actions can be filed by anyone in Nigeria even if the person does not have any interest involved. Thus, a non-governmental organization or a human rights activist can file an action on behalf of the donor.Footnote 76This makes it different from an action based on the tort of misrepresentation, breach of confidence or constructive trust where only the donor who can be said to have had their right violated can file an action. In addition, there is no statute of limitation with respect to the period within which the violation can be remedied.Footnote 77This is also another important difference between an action founded on misrepresentation, breach of confidence or constructive trust and one founded on human rights.
With respect to blood storage, a donor can have a remedy only if it is a condition upon which the donor gave their blood. In this respect, the tort of misrepresentation and the doctrine of constructive trust can come to apply. But a breach of confidence will not apply since there is no leakage of information detrimental to the donor.
Where blood has been wasted, retrieval is not possible. But the donor may be entitled to nominal damages. Nominal damages are awarded for the symbolic purpose of ventilating or acknowledging the grievance of the donor. It is not meant to punish the person who is in the wrong or compensate financially for an injury sustained.Footnote 78Therefore, the amount to be awarded may not be substantial.
What people want: Ghana
In Ghana, there is support for blood storage.Footnote 79Participants want to be informed of any future use of their blood.Footnote 80
What the law is: Ghana
The doctrine of constructive trust and the principle of breach of confidence apply with respect to future use of blood. Where there is wastage of blood, nominal damages may be awarded.
Data sharing
What people want: Nigeria
People in Nigeria support data sharing because it is considered synonymous with sharing of ideas and can be done locally and internationally.Footnote 81A participant stated thus: “Two heads are better than one, one researcher may see what the other researcher did not see so I believe that sharing of data is very good”.Footnote 82While participants support data sharing, however, they want confidentiality to be maintained.Footnote 83Also, participants want data sharing to be discussed by researchers, participants and an overseeing body.Footnote 84In addition, the participants do not want data to be commercialized. According to one participant: “It is to be done for non-commercial use”.Footnote 85
What the law is: Nigeria
With respect to data sharing, genomics researchers appear to be protected in Nigeria. The Nigerian Constitution recognizes and protects the right to freedom of expression.Footnote 86Data sharing can be considered to be a form of expression. With respect to the confidentiality of donors, the Nigerian Constitution also recognizes and protects the right to privacy as previously mentioned. This implies that while genomics researchers can share data as a form of expression, they cannot violate the right to privacy of donors. With respect to donors who want to be informed right from the beginning that data collected from their samples will be shared, the tort of misrepresentation may apply and the samples collected may be retrieved by the donor with the possible award of damages. This can be avoided if all necessary information is supplied to donors from inception.
On the issue of the non-commercialization of samples collected, the position of the law is a bit complex. The position of the donor on non-commercialization can be sustained if genomics researchers agree beforehand with donors. The tort of misrepresentation will apply in this instance. Where there is no prior agreement, there are various possibilities. First, under the doctrine of constructive trust, the genomics researcher to whom biological samples are donated can be regarded as the trustee and legal owner of the samples while the donor is the beneficiary and equitable owner. This implies that the samples are properties. But there is no statutory enactment or judicial pronouncement in Nigeria that a biological sample is a property. However, there is nothing to suggest that they cannot be regarded as a property for the purpose of genomics research under the doctrine of constructive trust.Footnote 87What constitutes a property is what the society regards as a property and it changes with time. It is not fixed in time and space.Footnote 88At present, patients placed under oxygen often pay for it. Indirectly, oxygen is regarded as a property. In a nutshell, biological samples can be commercialized. But the doctrine of constructive trust is to avoid unjust enrichment. This means that while biological samples can be commercialized, they must not unjustly enrich genomics researchers to the detriment of donors. Thus, the genomics researcher can sell the samples as a form of commercialization and if it has been done, the donor is only entitled to a part of the amount that will prevent the genomics researcher from being unjustly enriched. However, the donor cannot recover the samples except where the sale has not been done.
Secondly, where there is no prior agreement on the non-commercialization of biological samples, the law may import guardianship between the genomics researcher and the donor.Footnote 89In this respect, the genomics researcher cannot commercialize the samples. This implies that an inequitable dealing on the part of the genomics researcher will entitle the donor to damages and recovery of the samples. It is noteworthy that what constitutes unjust enrichment or inequitable dealing depends on the circumstances of each case.
What people want: Ghana
In Ghana, people also support data sharing.Footnote 90But people also want confidentiality to be taken into consideration. Thus, they want their data to be de-identified.Footnote 91Some participants want data-sharing plans included in the consent form.Footnote 92While some participants do not want their data to be shared without their consent, some members of ethical committees feel that it is not always necessary to inform the participants and that once members of ethical committees are carried along, it is sufficient.
What the law is: Ghana
With respect to data sharing, the Constitution of Ghana recognizes and protects the right to freedom of expression.Footnote 93On the confidentiality of donors, the Constitution of Ghana also recognizes and protects the right to privacy of donors. Therefore, while genomics researchers can share data as a form of expression, they cannot violate the right to privacy of donors. With respect to donors who want to be informed right from the beginning that data collected from their samples will be shared, the tort of misrepresentation may apply and the samples collected may be retrieved by the donor with the possible award of damages.
Law versus what people want: research findings II
The second part of the research findings on law versus what people want in Nigeria and Ghana will be presented here, as previously indicated, with respect to return of individual results; disclosure of incidental findings; pattern and determinants of preference for informed consent; governance and regulation; and biorights.
Return of individual results
What people want: Nigeria
Participants support the return of individual research results. But whether to return the result or not should be based on individual preference. They also believe that research results should be communicated by diverse means ranging from face-to-face communication to phone contacts.Footnote 94Participants believe that research results should be communicated by experts or professionals.Footnote 95The return of research results promotes motivation, continuous participation and trust.Footnote 96Some participants believe that giving results to participants is the right of the participants.Footnote 97Some participants believe that there is a need for counselling before research results are returned.Footnote 98
What the law is: Nigeria
In Nigeria, a genomics researcher can only be obliged to give results if it is part of what is agreed on from the beginning. This means that failure of the genomics researcher to give it may lead to a tort of misrepresentation if the donor gave the samples on the understanding that he / she will receive feedback. Where it is not expressly agreed beforehand but the context tends to show that the return of research results is envisaged, then under the doctrine of constructive trust, a genomics researcher may be compelled to return results. With respect to counselling, the genomics researcher may be liable in tort if failure to counsel leads to an adverse consequence. There is what is called the eggshell rule.Footnote 99The rule is that if someone has a skull that is as fragile as an eggshell and another person hits the person’s skull and breaks the skull, that person who breaks the skull is liable in tort. Even though ordinarily a person’s skull is not expected to be as fragile as that of an eggshell, such a person must be taken as he / she is. This implies that if there is no counselling and the donor to whom the research result is returned faints or develops hypertension or dies because of shock occasioned by the result, the genomics researcher may be held liable. It does not matter that the donor to whom the research result is returned should ordinarily not have fainted, developed hypertension or died. This is because he / she must be taken as he / she is.
Disclosure of incidental findings
An incidental finding is slightly different from the return of research results. In returning a research result, what is communicated to the donor is within the range of what is reasonably envisaged or expected. It is the outcome of the research but may have implications for the donor or participant. But in an incidental finding, what is not expected or envisaged is discovered.
What people want: Nigeria
Participants in Nigeria support the return of incidental findings.Footnote 100They believe that a disclosure plan or framework should be developed or maybe further explored. They also believe that the sensitivity of the result should be considered in disclosure. Participants state that incidental findings should be made confidential and that its disclosure should be done face to face.Footnote 101But some believe that disclosure does not necessarily have to be done face to face and that various methods can be used depending on the sensitivity of the information.Footnote 102Participants believe that incidental findings should only be disclosed if the result can be attended to.Footnote 103
What the law is: Nigeria
In Nigeria, the right to privacy is protected under the Nigerian Constitution. In addition, the doctrine of breach of confidence also protects privacy under the common law. With respect to communicating what does not have a solution, the eggshell principle will also apply. Thus, any consequence arising from such communication may make the genomics researcher liable.
What people want: Ghana
In Ghana, participants want to know their results and do not want a third party to be involved.Footnote 104Participants also want experts to be employed in the communication of incidental findings. They believe that the method to be used depends on the weight, that is the perceived severity or seriousness, of the findings.Footnote 105
What the law is: Ghana
In Ghana, the right to privacy is protected under the Constitution of Ghana.Footnote 106In addition, the doctrine of breach of confidence also protects privacy under the common law. With respect to communicating what does not have a solution, the eggshell principle also applies.
Pattern and determinants of preference for informed consent
What people want: Nigeria
In Nigeria, the majority of researchers involved in stroke neurobiobanking and genomics research prefer broad consent. Their choice of broad consent is informed by the complexity involved in re-consenting.Footnote 107
What the law is: Nigeria
Concerning broad consent, the preference of the genomics researcher is not the determining factor in law. While broad consent understandably favours the genomics researcher, what constitutes the determining factor is the agreement reached by the genomics researcher and the donor. If the donor agrees that the genomics researcher can make use of their samples as he / she considers appropriate, then the donor is bound by that agreement. However, the donor reserves the right to withdraw. Therefore, if the researcher uses the biological sample and the donor is not satisfied, the donor can have it retrieved since the donor reserves the right to withdraw. But the donor cannot claim damages since the research is covered by the broad consent. Where the researcher has expended a lot of effort and money, the doctrine of estoppel may apply.Footnote 108The doctrine of estoppel states that if a person creates a factual situation and communicates it to the other person and the other person acts on it and has his / her position changed, the person who creates the factual situation cannot deny it again and is bound by it. In this respect, the donor may be prevented from retrieving the samples and other information extracted from them. This is because the expenditure of efforts and money has changed the position of the genomics researcher.
What people want: Ghana
In Ghana, some members of the ethics committee observe that the educational level of participants influences the consent process. According to a member of the ethics committee: “You see the informed consent process, generally, when you are dealing with educated people, people are a bit more careful to go through the steps, but I have realized that when they are dealing with people who are not highly educated, a lot of the things are lost in translation”.Footnote 109
What the law is: Ghana
What the genomics researcher and the donor agree substantially determines the respective rights of the parties. Where translation creates a problem, the tort of misrepresentation may apply.
On governance and regulation
What people want: Nigeria
Most people in Nigeria are not aware of any regulations in place but agree that regulations should be developed by stakeholders. They believe that governance is needed to guide against misuse.Footnote 110Some participants are of the view that “there should be rules and regulations governing biobanking, to avoid other people using the opportunity for rituals with the samples taken for the biobanking”.Footnote 111In the words of another participant:
“So governance becomes quite important in this, in terms of defining the clear roles, mode of operation of such biobanks and how they are regulated, the role of the authorities, and the individuals that store them, monitoring and evaluation of such biobanks and a clear cut chain of the whole events and which authority should have a big role to play in this.”Footnote 112
What the law is: Nigeria
Considering the preceding discussion, there are some laws regulating genomics researchers. So far, reference has been made to the tort of misrepresentation, breach of confidence, the doctrine of constructive trust, human rights and estoppel. Therefore, it is going to be incorrect to assert that there is no law governing genomics research in Nigeria and Ghana. However, there is no comprehensive legislation in Nigeria and Ghana on genomics research and neurobiobanking.Footnote 113
What people want: Ghana
There is also support for the regulatory bodies in Ghana. According to a participant: “I agree with that because if there’s something and there is nothing governing it, it becomes needless. So if a committee can be formed to see to it, it would help a lot. If it exists and there’s no law governing it or nobody is monitoring, it seems it wouldn’t help”.Footnote 114
What the law is: Ghana
The tort of misrepresentation, breach of confidence, the doctrine of constructive trust, human rights and estoppel also apply in Ghana. Like Nigeria, there is no comprehensive legislation governing genomics research and neurobiobanking.
On biorights
What people want: Nigeria
In Nigeria, the majority do not know biorights. According to a participant: “Bioright is an extension of human right because I have the right to protect what I think is mine”.Footnote 115Religion influences participants’ views of the biorights. A Muslim participant said: “So it is not allowed in the sharia for all this: do not excorticate, take my brain when I am dead, take my heart when I’m dead, it’s not allowed. So, it shows that that right will cease immediately the person dies and it’s shifted to another person especially the family members”.Footnote 116Some participants are of the view that once consent is given, the rights of the participants end. They see giving consent as a transfer of rights.Footnote 117Some other participants feel otherwise.Footnote 118But some of the researchers involved believe that the type of consent determines the level of control and ownership.Footnote 119
Some participants stated that there should be equitable distribution of rights between participants and researchers. According to a participant: “There should be human right law; whoever donates his specimen should be entitled to the discoveries because he is the owner of the specimen that brought about the discoveries”. A participant stated that “[i]f there is any profit, it should be shared 50-50”.Footnote 120Similarly, another participant stated that “[p]articipants should have 50% right on it, he / she should be informed on anything to be done on it”.Footnote 121Some participants believe that control of sample use is not a norm in Nigeria.Footnote 122
What the law is: Nigeria
Biorights in this context relates to the bundle of rights that subsists in a biological sample from the perspective of the donor and the genomics researcher. Considering the preceding discussion, there are instances where the donor may have their right to the biological sample whereas in other instances, the donor may not.
What people want: Ghana
In Ghana, some people believe that the agreed purpose should be honoured. Some people feel that they do not have control over the use of their samples after donation.Footnote 123However, some people feel that their samples are still theirs even after donation.Footnote 124
What the law is: Ghana
In light of the preceding discussion, there are instances where the donor may have their right to the biological sample whereas in other instances, the donor may not.
Discussion of research findings
To discuss research findings, the general jurisprudence of law and society will be applied to the research findings, as previously intimated.
Application of the theoretical framework to research findings
As previously discussed, the general jurisprudence of law and society developed by Tamanaha has five basic elements. First, it recognizes the social arena as an analytical tool which is flexible in terms of geography, activity or group. Secondly, it contends that law does not necessarily bring about social order although it may contribute to an existing social order. Thirdly, it argues that social order is substantial coordination of behaviour even though there may still be a conflict between individuals and groups. Fourthly, it maintains that law is just a source among sources of substantial coordination of behaviour. Lastly, it contends that the law may not necessarily be a mirror of the society.
The social arena in this instance, in terms of geography, is the SIREN sites in Ghana and Nigeria. The social arena transcends cities within Nigeria having extended beyond one. It also extends beyond one in Ghana. The social arena also transcends state boundaries since the sites are in Nigeria and Ghana. In terms of activity, the social arena is on stroke research and education. In terms of the group, the social arena is made up of stroke survivors, caregivers, healthy controls, providers, hospital administrators, researchers, public health practitioners, ethics committee members, religious and community leaders, and laypersons.
There is an existing social order around stroke investigation and education. SIREN can be regarded as an existing social order. In terms of the preceding findings, there is evidence of people’s willingness to donate blood to enhance genomics research on strokes even though barriers in terms of religious belief and stigmatization remain.Footnote 125In terms of consent, although genomics researchers want broad consent which may not always be agreeable to participants, nonetheless the fact of their willingness to work with participants cannot be denied.Footnote 126The willingness of participants and researchers to achieve a common goal reflects social order. With respect to the contribution of law to this social order, the law places a premium on what researchers and participants agree.Footnote 127The contribution of law to this social order is its recognition of the agreement between participants and researchers and its readiness to have it enforced with the state’s machinery.
There is evidence of substantial coordination of behaviour in the social arena investigated. As previously noted, substantial coordination of behaviour can be brought about through shared habits; modes of action; customs; practices; roles; goal-oriented behaviour among people of identical interest; consent grounded in a mutually agreed course of action; and behaviour motivated and instinctively induced by love, altruism and sympathy. In this instance, participants and researchers have their roles to play. The participants essentially donate biological samples while researchers make use of the samples for the agreed purpose. Participants and researchers have identical interests in investigating stroke and mitigating its incidence. This also constitutes modes of action and practices. There is evidence that participants are motivated by altruism. But substantial coordination of behaviour does not rule out the possibility of conflict between groups and individuals. In this instance, there is also evidence of conflict despite substantial coordination of behaviour. While genomics researchers appear to prefer broad consent, educated participants appear not to be comfortable with it.
With respect to the attribute that law may not necessarily be a mirror of the society, analysing this attribute considering the above findings directly speaks to what this study seeks to achieve while preceding analyses constitute the context. As previously stated, what this study seeks to achieve is to examine the extent to which the law reflects people’s expectations in stroke neurobiobanking and genomics research. Regarding blood donation, people are willing to donate blood in Nigeria and Ghana although some cultural and religious beliefs remain as barriers. Interestingly, the law preserves people’s willingness by placing a premium on their agreement with researchers and through the tort of misrepresentation, the doctrine of constructive trust and the doctrine of breach of confidence. At the same time, the law also recognizes their cultural and religious beliefs with their limiting effects on stroke neurobiobanking and genomics research through the human right to freedom of religion. In a nutshell, law mirrors people’s expectations and reflects their ambivalence. While participants show a willingness to donate blood in Nigeria and Ghana, they are not willing to donate their brains in Nigeria. Their unwillingness is borne of religious and cultural beliefs, and their impact on their family life. Their unwillingness is preserved by law through the human right to religious belief and the right to privacy. Just as it is with blood donation, the law also mirrors people’s expectations in respect of brain donation.
On blood storage, re-use and sample sharing, participants in Nigeria and Ghana want their samples preserved for research purposes but do not care how it is used after donation. Thus, while participants want their samples preserved, they do not care so much if lost to failure to keep them safe. This attitude is recognized by law through the award of nominal damages which is not intended to punish but to register displeasure. In this respect, the law mirrors people’s expectations. On data sharing, participants want their data shared but the confidentiality of those data must be maintained. The law preserves their willingness to share data through their right to freedom of expression and at the same time preserves the confidentiality of their data through their right to privacy. Again, the law mirrors people’s expectations.
Participants want research results returned to them but prefer to be counselled before they are returned. Law recognizes and enforces agreement in which the return of research results is incorporated. The eggshell rule under the law of tort preserves people’s expectations of counselling. Thus, any injury occasioned for failure to counsel is remedied under this rule. In this respect, the law also mirrors people’s expectations. Similarly, on incidental findings, participants want them communicated confidentially and only if there is a solution to what is discovered. The right to privacy preserves confidentiality while the eggshell rule preserves the need to communicate only what is discovered for which there is a solution. In a nutshell, the law mirrors people’s expectations.
As previously stated, researchers tend to prefer broad consent which does not appear agreeable to participants. Law appears to have struck a balance between them. It recognizes agreement between researchers and participants. Where there is no clear agreement, it protects the interest of the participants through the doctrine of constructive trust. Where a researcher has expended much effort and money, the doctrine of estoppel may apply to prevent participants from withdrawing their samples and data relating thereto. In this instance, what the people want is ambivalent and the law reflects this ambivalence. On governance and regulation, people appear to prefer a comprehensive legislation on stroke genomics research and biobanking. To the extent that the existing laws are not legislation directly and comprehensively regulating stroke genomics research and neurobiobanking, it can be stated that the law does not reflect people’s expectations. With respect to biorights, some people want their right to subsist on their biological samples after donation while some do not think they have any right after donation. Some believe that agreement between participants and researchers will determine whether a right subsists after donation. Others believe that the right on biological samples should be equitably distributed.
Conclusion
This article examined the legal issues involved in blood donation; brain donation; blood storage, re-use and sample sharing; data sharing; return of individual results; disclosure of incidental findings; pattern and determinants of preference for informed consent; governance and regulation; and bio- rights in Nigeria and Ghana, to assess the extent to which the law mirrors people’s expectations. In examining these issues, a qualitative method was adopted. In addition, the general theory of law and society was adopted as the theoretical framework and applied to the findings made. It was found that the law to a high level mirrors people’s expectations; and that there was an existing social order to which the law was a contributor. It was therefore argued that any need for the intervention of the law must take cognizance of these findings.
Ethical consideration
Ethical approval was obtained from the Review Board of each of the participating institutions in SIREN: the University of Ibadan; Federal Medical Centre, Abeokuta; University of Ilorin; Aminu Kano Teaching Hospital, Kano; Ahmadu Bello University, Zaria; University of Ghana, Accra and Kwame Nkrumah University of Science and Technology, Kumasi. The confidentiality of the data obtained was ensured. The data was de-identified and kept confidentially.
Acknowledgements
This research was supported by Grant U01HG010273 of the National Institutes of Health (NIH) while the SIREN Study and the Systematic Investigation of Blacks with Stroke using Genomics (SIBS Genomics) Study were supported by Grants U54HG007479 and R01NS107900 respectively from the National Institutes of Health (NIH) as part of the H3Africa Consortium.
Competing interests
None
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