Health Research Ethics, religious perspective of basic ethical principles and country experience with focus on informed consent,

By: A.I.Arbab University of Oslo, Institute of Health and Society I am going to discuss the basic ethical principles that should be taken into consideration when conducting research involving human subjects from Islam point of view or Islamic perspective and lastly will reflect on Sudan country experience in health research ethics focusing on informed consent. Background: Research is a designed activity developed to contribute to knowledge which can be generalized and Biomedical indicates that research related to human health, including both medical and behavioral studies1. Research involving human subjects is an ancient human practice; however serious concern about it and its consequences relatively appeared after abuses of human subjects and crimes against humanity in the recent past. The important event that pushed research ethics to the front position happened at the Nuremberg trials in 1947, where the Military Tribunals condemned the Nazi experiments on war detainees in the tribunals review of crimes against humanity2.Thus a global concern start growing about ethics in health research and more than seven Global Forums have been held up to now tackling the issue of ethics in research involving human subjects. The basic ethical principles: Ethics is the study of morality-careful and systematic reflection on and analysis of moral decisions and behavior3.The basic principles of ethics were first found in the pyramids texts from approximately 3000 B.C and they echoed throughout Pharaonic era. Following the

Pharaonic era, different consecutive religions like Judaism, Christianity till Islam promoted good deeds and morals4. The discussion and the resolution of moral dilemmas and conflicts all the way through the history have been different in time, place, the cultural tradition and the faith of society. And definitely no longer homogeneous traditional societies exist with one faith and one culture and this because of the migration and mass movement of people from continent to continent and from country to country. This new reality required new sets of ethical principles to resolve the new moral dilemmas5. Beachump and Childress, who are American philosophers wrote a book called Principles of Biomedical Ethics in 19796, where they formulated four ethical principles , which were: respect to autonomy, beneficence, non-maleficence and justice. These four principles tested by researches conducted in different cultures and societies and found to be valid and applicable as ethical behavior regulated these cultures and societies. Islamic perspectives of the basic ethical principles In this part I will explore the roots and traces of these four principles in Islamic traditions. Examine these roots to find whether they are contradicting the basics principles of ethics for research involving human subjects stated in the Declaration of Helsinki, which issued by the World Medical Association in 1964; since this declaration has influenced the formulation of international, regional and national legislation and codes of conduct. It is impossible to explore the roots of these basic ethical principles without giving a reader a background on how ruling of Islam formulated and what are the basics of it. Islam is a comprehensive system that covers all aspects of human life in regard to spiritual and civil aspects of individuals and communal life7. The instructions of everyday activity of life that good Muslim need to follow called Sharia. Sharia has primary sources and secondary sources. The primary sources of Sharia are the Holy Quran, which believed to be the very word of God by all Muslims; the Sunna and Hadith, which are the authentic tradition and sayings of
1

the Prophet Mohamed (peace be upon him);Igma, which is the unanimous opinion of Islamic scholars and last is analogy (Qias), which is reasoning used to rule events the not tackled by Quran and Sunna . The secondary sources of Sharia are: Istihsan (the choice of one of several lawful options as most suitable in a given situation); views of Prophets companions; current local custom if lawful; public welfare; and finally rulings of previous divine religions if they do not contradict Islamic rulings. Sharia is not rigid; it is flexible to accommodate and adapt emerging situation in different times and places and can accept different honest opinions if it will not contradict the spirit of its primary sources and it is directed to the benefit of humanity8. Worth to say that even if the action is forbidden allowed to be undertaken if the alternative would cause harm4. Moreover what is forbidden today may become allowed in the future if science proves that the alternative would be harmful to human beings. The progress and development of Fiqh (jurisprudence) managed to establish certain guiding principles to help to drive rulings. The role of Fiqh can be showed examples like: harm should be removed, the lesser of two harms should be chosen, and the public interest should take priority over private benefit. The goal of Sharia can be summarized in the preservation and protection of self (life, health,procreationetc), mind (prohibition of alcohol, drugs; freedom of thought,etc), religion (freedom of faith, non compulsion in religion, rituals of worship), ownership (sanctity of private ownership, legitimate commercial relationships, prohibition of stealing, fraud and usury) ,and honor ( purity, marriage and laws of family formation and chastity)9. The Muslim ethics is a systematic reflection from a theological perspective, both on moral actions and practices of those in the Muslim community. It also reflects the character, traits, virtues, dispositions and intentions out of which those actions and practices come10, 11. The primary sources of Sharia seem quite congenial to the four basic principles of medical ethics

as elucidated by Beauchamp and Childress12 and in ethics for research involving human subjects. In regard to the principle of autonomy, respect for persons in Islam is not restricted to the existing human being but also extends to the foetus before birth. According to Prophet Mohamed if a pregnant woman who admitted adultery, punishment will be postponed until she delivers her baby and ceased nursing him. In Quran said: No one is punished for the sins of others13. In regard to the principle of beneficence, the Quran has encouraged doing good and even ordered it for individuals and for nations at large14. If one does good, he is rewarded with good15 .Instructions to do good have been mentioned in several hadith of the Prophet Mohamed (peace be upon him). Beneficence not restricted only to human beings but also to animals and the environment. The Prophet Mohamed (peace be upon him) said: The Muslim makes no implementation or planting which results in feeding of a human being, an animal or a bird for which he gets no reward till the day of the hereafter16. The Prophet (peace be upon him) also said: that one may avoid punishment in the hereafter or bad deeds by planting a palm tree17. The non-maleficence principle been mentioned in Qurn in several verses and strongly stressed by Prophet Mohamed (peace be upon him) as an order from God to be followed by people and not merely as an advice to them18. The Prophet said: Dont sever relations, dont plot, dont hate, and dont envy each other and be brothers in worship16. Islam encourages beneficence and non-maleficence not only in deeds but also in feelings. The Prophet (PBUH) said: one should care for the feelings of his neighbours and should not hurt them by his deeds, tongue and hand19.Instructions in Islam are not restricted to human beings, it includes also animals. The Prophet said: that a woman entered Hell for the sake of a cat she imprisoned till death. She neither fed the cat nor offered her a drink or set her free20 and also said: God had forgiven a man for offering a drink to a thirsty dog21.

The principle of justice has been stressed by Quran and Hadith of the Prophet Mohamed (PBUH). Justice ordered by Quran for all without discrimination on racial, social, political or financial bases22. The Prophet (PBUH) orders justice among members of the family, the society, and the nation at large23. More than that the Prophet (PBUH) has advised Muslims that members of society should share equitably in food, money, love and care23. And this today known in the world as basics observing human rights. To conclude this part, it is clear from the above discussions based on quote from Quran and Sunna of Prophet Mohamed (PBUH), constituting major part of the Sharia are not in contradiction with the four basic ethical principles formulated by the two American philosophers Beachump and Childress, who claim that these principles are universal and applicable to any culture and society, these principles have always existed in different moral traditions in different ways5, of which Islamic tradition, teaching and rulings presented as good example. In addition to that the teaching of Prophet Mohamed and his companions inspires to conduct medical research. Prophet Mohamed stated that there is a cure for every disease and we should search for it. Islam put emphasis on seeking knowledge and benefits from it and also Islam advice on dissemination of knowledge and prohibits hiding it; as mentioned by the Prophet (PBUH) whoever withholds knowledge arrives in the judgment day leashed a leash from fire24. The Prophet of Islam (PBUH) said: that he was sent to complete the epitomes of ethics4. Country experience: Historical background At the beginning of the twentieth century, health research in the Sudan developed as primarily as a function of the colonial British administration in 1903, when Welcome Tropical Research Laboratories (WTRL) were established as part of Gordon Memorial College25. Ethical issues in medical profession in Sudan are governed by Sudan Medical Council (SMC).

In 1935, medical research became the responsibility of the Research Section of the Sudan Medical Services (SMS). In 1970, the National Council for Research (NCR) was established. It was under the responsibility of the Ministry of Higher Education and Scientific Research. In the Ministry of Health research was responsibility of the Directorate of Statistics and Research and then under the Directorate of laboratories and Research25. In 1996 the Ministry of Health in collaboration with WHO established the Health System Research Programme (HSP). In 1997 HSP changed to Health System Research Unit (HSRU). In 1998, HSRU changed into the Research Directorate (RD) affiliated to the office of Undersecretary25. First medical school established in 1924, Stack Medical Research laboratory established 1927. Training on research started in 1963 and until 1975 there was only one university. According to the Federal Ministry of Health Mapping Survey conducted in 2003 institutes and specialized centers involved in research including health are 34. The ethical review started in Sudan as an initiative of a group of physicians in 19979 at Stack Laboratory but lacked political support and died in infancy. Only in 2oo2 the minister of health issued a ministerial decree formulating the National Research Ethical Committee, which drafted the National health research policy including research ethics and after that research ethics guidelines drafted and finally endorsed in 200626. Informed consent in health research involving human subjects: Sudan experience Informed consent has gained the most attention among researcher. International guidelines like CIOMS require some form of informed consent in research involving human subjects that is based on the principle that competent individuals are entitled to choose freely whether to participate in research. It protects the individuals freedom of choice and respects in the individuals autonomy, it must always be complemented by the approval of an independent review of an ethical research committee27. The Nuremburg Code (1947), the first international code concerning research ethics, and Declaration of Helsinki (1964) made the consent of research participants and essential
5

principle of research ethics28,29. Researchers have a responsibility to provide potential research subjects with information about the proposed researched, including the procedures and goals of the study, anticipated benefit and potential risk (if any). Consent must be informed understood and voluntary, includes the right to withdraw from the study without penalty, protect privacy and maintain confidentiality. Researchers should test the understanding of participants to make sure that they comprehend the implications of their participation in the study30. Consent should be documented either the subject imply by voluntary actions, express consent orally or sign a consent form. Generally, the subject should sign a consent form or in the case of incompetence, a legal guardian or other duly authorized representative should do so27. Investigator should never initiate research involving human subjects without obtaining each subjects informed consent, unless they have received explicit approval to do so from an ethical review committee. If the research design involves no more than a minimal risk and not greater than expected with routine medical examination and the requirement of individual informed consent would make the conduct of the research impracticable (for example, where research involves only data from subjects records). In this case the ethical review committee may waive some or all of the elements of informed consent. In some cultures an investigator may enter a community to conduct research or approach prospective subjects for their individual consent only after obtaining permission from a community leader, a council of elders, or another designated authority. Such customs must be respected27. It is important to remember renewing the informed consent of each subject in long-term studies at pre-determined intervals. Exception to the requirement for informed consent applied to emergencies in which the researcher anticipates that many subjects will be unable to consent like head trauma, stroke and cardiopulmonary arrest, especially when there is no time to locate a person having authority to give permission. However in some cases like epilepsy or alcohol binges; informed consent can be taken from prospective subject while fully capable of informed
6

consent. In some situation incompetent person may be vulnerable to exploitation for financial gain by guardians, therefore guardian should be offered no recompense other than a refund of travel and related expenses. Special justification is required for inviting vulnerable individuals (children, persons with mental or behavioral disorders, women of reproductive age or pregnant women)to serve as research subject, and if they are selected, the means of protecting their rights and welfare must be strictly applied27. The Sudan Medical Council (SMC) controlling issues within the medical profession in Sudan. Informed consent starts to be seriously required in research involving human subjects after the endorsement of the National Research Ethics Guidelines (NREG) in 2006 and formulation of National Research Ethical Committee (NREC). In Sudan no any evaluation for ethics in health care and research done. One study conducted recently to evaluate the current practice of Sudanese researchers in obtaining informed consent from human involved in biomedical research. The outcome of this study as follow: a sample of 153 Sudanese researcher were invited to participate in a study exploring the knowledge and attitudes of Sudanese researchers on obtaining informed consent from study subjects involved in health research. Only 95 were interviewed, with response rate of 62%. Forty seven respondents (49.5%) of the surveyed researchers reported that they obtain informed consent from study subjects, whenever they conduct a research study. Most of the surveyed researchers (11) reported that they obtain informed consent because they respect the study subjects autonomy (20.9%), other respondent (11) do so because it is required by the study sponsor (17.7%), 6 respondents (9.6%) because required by the ethics review committee. Only 12 respondents (19.4%) used to seek written consent. Other factors that prevent researchers from getting informed consent include cultural diversities, lack of communication due to language barriers and high illiteracy rate among Sudanese citizens. In conclusion, it is clear that informed consent is not consistently obtained in health research involving human subjects in Sudan. What so ever the reasons it is clearly that the situation of informed consent is challenging , discouraging and characterized by lack of knowledge about
7

the importance of informed consent and lack of ethical culture among Sudanese researchers ,health education authorities, health system and policy within which research carried out. Bioethics component needed to be integrated within the health research system in the country and efforts to increase the awareness of researchers about ethical issues and informed consent in particular are critically important. To do so can be achieved through training on ethics inside and outside the country is crucial, workshops, seminars, participating in national and international conferences30. Responsible policy-makers in the medical profession in the country have to decide on what is ethically acceptable guided by the international guidelines, tailored to suit the social, cultural, traditional and religious values of the people, which not contradicting with the basic principles of bioethics.

References: 1. Medical research Ethics-Lesson-1, Ahmed Bedru Omer, Knut W. Ruyter Version January 6, 2009 23. 2. Evelyne Shuster. Fifty years later: The Significance of Nuremberg Code. The Eng J M; November 13,1997.1436-1440. 3. World Medical Association (2005): Medical Ethics Manual, The World Medical Association, B.P. 63, 01212 Ferney-Voltaire Cedex, France . 4. Raafat Y Fifi, International Journal of Surgery (2007)5,292-296. 5. Sahin Aksoy and Ali Tenik: The four principles of bioethics as found in 13th century Muslim scholar Mawlanas teachings. BMC Medical Ethics,2002,3:4 6. Beachump TL, Childress JF: Principles of Biomedical Ethics.Oxford University Press, New York 1994 7. B. Andrew Lustig (Ed.), Bioethics Yearbook:Volume 5,171-188,1997 Kluwer Academic Publishers.Printed in the Netherlands 8. Serour,GI:1991,Research findings on the role of religion in family planning 9. Hathout, H, Lustig, B.A:1993, Bioethics Developments in Islam,in Lustig, A,et al (ed),Bioethics Yearbook volume 1,103-117. 10. Serour, GI (1994), Islam and the Four Principles in Ed. R.Gillon, Principles of health Care Ethics,John Wiley & Sons Ltd., London 75-91 11. Serour,GI.(1994),Religous Approaches to Bioethics.Paper presented at 2nd World Congress of Bioethics, Buenos Aires,Argentina,Oct.24-26 12. Beachump TL, Childress JF: Principles of Biomedical Ethics,3rd Ed.Oxford University Press, New York 1989 13. Quran ,Surat Al-Bakara 2:272;Sura Younis 10:99 14. Quran,Surat Al-Bakarah;Surat Aal-Omran 3:104 15. Quran,Surat Al Zalzalah 99:7-8 16. Hadith Shareef, reported by Anas 17. Hadith Shareef, reported by Adre Ibn Halem 18. Quran ,Surat Al-Nahl 16:90;Surat, Al-Ahzab 33:58
9

19. Hadith Shareef, reported mentioned by Gabber and reported by Muslim;reported by Abdullah Ibn Amir Ibn Glass 20. Hadith Shareef, reported by by Ibn Omar 21. Hadith Shareef, reported by Boukhary 22. Quran ,Surat Al-Nahl 16:90;;surat Al Heg 22:71; Surat Al-Hegret 49:9 23. Hadith Shareef, mentioned by Omar Ibn El-khatab,reported by Imam Ahmed 24. Hadith Shareef 25. Dya Eldin ME, Developing World bioethics ISSN1471-8731(print):1471-

8847(online); volume 4, Number 2,2004 26. Dr Al Fadil SM, WHO/Sudan pps to the first Meeting for EM and Arab Forum on Bioethics in Research, Cairo, Egypt,12-14 Aug.2008 27. Prof. Suad MS et al:Guidelines for Ethical Conduct of Research Involving Human Subjects,2008, Sudan Currency Press. 28. Weinding P. The Origin of Informed Consent: The International Scientific Commission of Medical War Crimes, and Nuremberg Code. Bulletin of the History of Medicine.2001;75(1):37-71 29. World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects.Helsinki1965,as amendment Tokyo 2004. 30. Dya Eldin ME, Phoebe R. Bernan: Sudanese Journal of Public Health:April 2007,vol.2 (2)

10