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Presented at an online workshop on biobanking by Omar Hasan Kasule MB ChB (MUK), MPH (Harvard), DrPH (Harvard)
INTRODUCTION TO SETTING UPO BIOBANKS[1]
· Biobanks can be used for research or clinical purposes
· The goals of each biobank must be clarified
· Strict accreditation standards and operating procedures must be followed
· A sufficient budget must be available for space, equipment, and personnel
· IT infrastructure to deal with the information[2]
· Long term strategic planning to ensure sustainabiluty[3]
SUMMARY OF ETHICAL ISSUES IN BRAIN BIOBANKING -2· Autonomy and informed consent: 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.
· Brain donation as a gift: 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
· Brain harvesting: The brain can be harvested only after ascertaining legal death
AUTONOMY AND INFORMED CONSENT-1: The duality of nafs and jasad· Research objective Research on any part of the brain for useful medical purposes is allowed under the principle of necessity, dharurat
· Property rights: The law of property applies to useful products made from brain tissues but not to knowledge derived from research on the brain
· Protocols and guidelines Protocols of brain banks must be respected according to the principle of custom, ‘aadat
· Confidentiality: Confidentiality of the brain donors must be observed strictly.
· 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.
AUTONOMY AND INFORMED CONSENT-2: questions on autonomy after death
AUTONOMY AND INFORMED CONSENT-3: prospective/ proxy autonomy after death· Does the nafs have responsibilities for and accountability on the jasad after death?
· Does the nafs during biological life have the prospective autonomy to make decisions on what to do to the body after death?
· Does the autonomous right of decision devolve to the family after death?
· My view is that there is continuing responsibility and accountability after death
· 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.
· Either pre-mortem will by the deceased or post-mortem proxy decision by the waliy a decision to donate the brain to a brain bank can be made.
BRAIN DONATION
BRAIN HARVESTING· 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, يشترط ان يكون الواهب عاقلا بالغا (Majallat Article No. 859).
· The donation can be withdrawn at any time before the brain is harvested if the donor changes his mind because according to the law, a donation becomes effective only when the donated thing is taken by the recipient, لا يتم التبرع الا بالقبض (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, التابع تابع (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, ذكر بعض ما لا يتجزآ كذكر كله (Majallat Article No 63)
THE RESEARCH OBJECTIVE· Brain harvesting must be done only after proper informed consent as is required by the doctrine of autonomy.
· According to the principle of certainty, قاعدة اليقين (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, حفظ النفس, 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.
PROPERTY RIGHTS· Brain banks can be established and used by institutions actively engaged in research.
· The objective of banking must be clear and sincere as research according to the principle of intention, قاعدة القصد (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 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, قاعدة الضرورة, harvesting and using brains for necessary research is allowed because necessities permit the prohibited, الضرورات تبيح المحظورات (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.
PROTOCOLS AND GUIDELINES FOR BRAIN BANKS· 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, الضرورة لا تبطل حق الغير (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.
CONFIDENTIALITY· 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,العادة محكمة (Majallat Article No 36).
· If consensus guidelines or protocols are not available, regulations issued by regulatory authorities can be used.
NOTES· 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.