Omar Hasan Kasule MB ChB (MUK), MPH (Harvard), DrPH (Harvard) EM: omarkasule@yahoo.com. Faculty of Medicine King Fahad Medical City Riyadh Saudi Arabia.

Abstract

For the purposes of this review, articles on brain banks over the past 10 years were retrieved from the PUBMED data base and were read to identify ethical issues. All ethical issues thus identified were then analyzed from the perspective of the principles of the Law, qawa’id al shari’at. The final list is as follows: autonomy and informed consent, brain donation as a gift, brain harvesting, research objective, property rights, protocols and guidelines, and confidentiality. The analysis reached the following conclusions: 1. A living donor has prospective autonomy to donate the brain after death to a brain bank. This right transfers automatically to the relatives upon his or her death. 2. Brain donation is covered under the laws of gifts, hiba. Thus, the decision can be reversed before harvesting and donation of an inseparable part of the brain. In addition, harvesting and donation of an inseparable part of the brain is treated as donating the whole brain 3. The brain can be harvested only after ascertaining legal death 4. Research on any part of the brain for useful medical purposes is allowed under the principle of necessity, dharurat 5. The law of property applies to useful products made from brain tissues but not to knowledge derived from research on the brain 6. Protocols of brain banks must be respected according to the principle of custom, ‘aadat 7. Confidentiality of the brain donors must be observed strictly.

Introduction

Some neuronal diseases cannot be studied using animal models and require availability of human tissue in good condition. The decrease in post mortem rates made brain banking a necessity to obtain brain tissue for research and teaching.[1] The tissue was obtained from pre mortem donation programs[2] or from post mortem donation by the bereaved families[3] and then sent to the banks where they supplied research material to researchers in the local institution or in other institutions even outside the country. Both pathological and normal brains were collected at these brain banks depending on the specific focus of the brain bank; some were set up for research in defined and specific areas and others not so much. Many epidemiological studies have been made possible with the help of brain bank data, for example the establishment of a causal relation between alcohol and traumatic injury.[4]

Brain data banks in various cities focuses on certain areas in research: Sao Paolo on aging,[5] Christchurch on cancer,[6] Sydney on neuropsychiatric and alcohol-related conditions,[7] Bethesda on psychiatric disease,[8] and New York on HIV[9] and autism.[10] For efficiency and to have access to a wider diversity of tissues, some data banks operate in consortia[11] and have had to use electronic tracking for the distribution of research material.[12]

The proliferation of brain banks has led to calls for standard operating procedures, protocols, regulations, and laws to ensure high quality storage and to prevent abuses such as commercialization[13]^,[14]. Strict quality controls are needed in brain banking[15] because post mortem material deteriorates and is of limited use in research.[16]

Harvesting, banking, and using brain tissue has special sensitivity because the brain is the repository of human cognition, intellect, memory, and identity. It regulates human behavior and its sophistication distinguishes humans from animals. Pre-mortem donation of brain tissue by the patient raises fewer problems than post-mortem donation by relatives. In either case ethical issues relating to end of life decisions are involved because the earlier a patient is declared brain dead, the earlier the brain can be harvested while still viable for research.

Ethical issues arise in the collection, storage, and use of the tissues. A lot of research has been done on the operation and use of brain banks but very little has been done on the associated ethical issues. A paper published in 2004 listed ethical issues of brain banking as commercialization, confidentiality, informed consent, and quality of research[17]. These remain the main issues today.

Methods

A list of potential ethical issues was drawn up by review of publications on brain banking. The list was used as key words to search for publications in the PUBMED on ethics of brain banking. The key words used in conjunction with ‘brain bank’ were: ethic, commercialization, financial gain, conflict of interest, confidentiality, informed consent, autonomy, donation, procurement, harvesting, infection / communicable disease, data safety, disclosure, research. Ethical issues related to brain banking were then analyzed from the perspective of purposes of the Law, maqasid al shari’at[18] and principles of the Law, qawa’id al fiqh[19].

Results of the search:

The search revealed a paucity of publications on the ethical issues of brain banking. No articles were found with a focus on the following ethical issues: commercialization of brain banks, autonomy, procurement, and harvesting. A model for individual autonomy in brain tissue donation was proposed in an Australian paper[20]. One article mentioned confidentiality as an ethical issue.[21] Two articles discussed consent.[22] Six articles discussed donation.[23] One article discussed data safety.[24] Two articles discussed research ethics.[25]^,[26]

Autonomy and informed consent

A human has a dual nature, a spiritual entity called ruh or nafs, and a physical component called jasad. The essence of the human is the nafs, which is permanent. The jasad is temporary. At death or shortly before it, the nafs is separated from the jasad. Human biological life belongs to Allah and the nafs is just a custodian. As a custodian the nafs must take good care of the jasad including decisions on what can be done to the body as medical or surgical treatment as well as organ harvesting or donation. The nafs has the autonomy to make these decisions based on the responsibility above. Therefore, nothing can be done to the body during biological life without informed consent. Controversy arises after death and this can be summarized as one basic question: does the nafs have responsibilities for and accountability on the jasad after death? My view is that there is continuing responsibility and accountability after death which in turn raises two questions: (a) does the nafs during biological life have the prospective autonomy to make decisions on what to do to the body after death? (b) Does the autonomous right of decision devolve to the family after death? I think that the nafs has prospective autonomy after death which is the same autonomy that it exercises in making a will, wasiyyat, about allocating wealth to permitted relatives, payment of debts, funeral preferences, and endowments, waqf. From this perspective a living person can decide to prospectively donate his or her brain to a brain bank for purposes of research. This autonomous right automatically transfers to the legal guardian, waliy, during terminal illness when the patient loses legal competence. The waliy will continue enjoying this right after death. In either way, pre-mortem and post mortem decisions to donate a brain to the bank can be effected.

Brain donation

Principles of the Law on gifts, hiba, regulate the process of donation of brain tissue to the bank. It is a condition that the person making the donation decision is of legal age and is legally competent, yushtaratu al yakuuna al waahibu aaqilan baaligan (Majallat Article No. 859). The donation can be withdrawn at any time before the brain is harvested if the donors change their mind because according to the law, a donation becomes effective only when the donated thing is taken by the recipient, la yatimmu al tabaru’u illa bi al qabdh (Majallat Article No 56). When the donation decision mentions the brain, it includes the brain and all its appendages unless a specific exclusion is made according to the principle that parts follow the whole, al tabi’u tabi’u (Majallat Article No. 47). A donation decision that mentions a part of the brain that cannot be easily separated from the rest or if separated will be unusable is considered as donation of the whole brain according to the principle that mentioning an inseparable part is like mentioning the whole, dhikr ba’adhu ma la yatajaz’u ka dhikr kullihi (Majallat Article No 63)

Brain harvesting

Brain harvesting must be done only after proper informed consent as is required by the doctrine of autonomy. According to the principle of certainty, qa’idat al yaqiin (Majallat Article No 4) harvesting must be carried out after legal death. Certification of death must not be done under the pressure of early harvesting to obtain a viable brain because the purpose of preserving life, hifdh al nafs, takes precedence over the purposes of research. To ensure that no ethical infractions occur the team of physicians involved in harvesting and banking brains should not be involved at all in the certification of death. Under no circumstances should brain tissue be harvested before legal death on the assumption that the patient is certain to die.

The research objective

Brain banks must be established and used by institutions actively engaged in research. The objective of banking musts be clear and sincere as research according to the principle of intention, qa’idat al qasd (Majallat Article No 1). All activities and processes at the bank must conform to declared intentions. It is unethical to establish a brain bank for reasons other than research. A bank whose objective is cryo-preservation of brains with the hope that one day the owners will come back to life is acting unethical. A bank that is run on a commercial basis, selling tissues for research, is also unethical. The Law protects the dignity of the body before and after death and removing organs and storing them for any purpose would, in normal circumstances, be frowned upon. Under the principle of necessity, qa’idat al dharurat, harvesting and using brains for necessary research is allowed because necessities permit the prohibited, al dharuraat tubiihu al mahdhuurat (Majallat Article No. 21). It is justified to remove the brain and use it for research necessary to find new therapies to preserve life instead of burying it with the body.

Property rights

Life belongs to Allah and the human is a temporary custodian. The custodial duty confers upon the human interests and rights in the body and its parts. The necessity of research does not abrogate those rights, al dharurat la tubtilu haqq al ghair (Majallat Article No 33). We have already mentioned the right of autonomy to make decisions on harvesting, banking, and using brain tissue for research. There are in addition financial rights if the brain tissue is used to develop products that are patented and are commercialized; the surviving family members have a right to get royalties. In my view these commercial rights apply to products made directly from the specific banked tissue such as a commercial cell line. The rights do not apply to products made using basic knowledge acquired from research on banked tissue.

Protocols and guidelines for brain banks

All institutions involved in harvesting, banking, and using brain tissue must follow consensus guidelines and protocols in conformity with the principle of custom under which what is customarily accepted has the force of law, al ‘aadat muhakkamat (Majallat Article No 36). If consensus guidelines or protocols are not available, regulations issued by regulatory authorities can be used.

Confidentiality

Extra caution is needed in dealing with confidentiality of information obtained from study of individual brains because of the relation of brain pathology to human behavior. Disclosure of diagnostic information can cause confusion to some and embarrassment to others. If a diagnosis unknown in life is diagnosed after death, some parties affected by decisions made in the life of the patient may seek court redress to reverse the decisions. Confidentiality needs to be maintained for the human dignity of the patient. Information from brain banks can never be published with personal identifiers.

Conclusions

We can draw two main conclusions from the analysis above. Little has been published in the general literature about ethical issues of brain banking. Principles of Islamic Law can adequately be used to analyze and resolve many ethical issues relating to brain banks.

KEY WORDS: brain bank ethics research

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