Ethics of Research Biobanks: Islamic Perspectives

Abstract

Research biobanks can offer great benefits for science and healthcare. However, many ethical challenges arise from their use. These challenges have different perspectives in Muslim countries when research biobanks are created. We propose principles for good practice related to the research biobanks in Islamic countries, focusing on issues related to confidentiality, informed consent, children's participation, and others. These issues were explored according to Islamic fatwas and Usul Al Fiqh, and we provide principles for good practice for policy makers involved in the creation of research biobanks, researchers, and anyone who has to deal with stored tissue specimens taken from Muslims. The actual implementation of the principles will vary according to different jurisdictions.

Introduction

Research biobanks are fundamental in clinical research at the present time and are expected to play an increasingly important role in the future. They support studies of the relationships among genes, the environment, and other factors to facilitate an understanding of the mechanisms and pathology of disease and give directions to appropriate treatments.¹ However, research biobanks come with many ethical challenges, especially related to the respect of the participants' autonomy, protection, and financial issues.^2,3

Research biobanks are beginning to appear in many countries in the Middle East, such as Saudi Arabia and Qatar, where Muslims form the majority of the population. However, the Islamic aspects of the related ethical issues have not yet been studied sufficiently. Studying Islamic perspectives on research biobanks is also vital in other countries, including western countries where Muslim minorities form a significant part of society and Islamic rules are not well known by the staff of biobanks or indeed Muslims themselves. There is a lack of literature that explains the ethical issues of biobanks from an Islamic point of view, and we believe that this article makes a new and important contribution to this subject. Our research aims to help Muslim and western scholars to understand Islamic rules regarding research biobanks and the similarities and differences between these rules and other (especially western) perspectives. We also developed an Islamic opinion on research biobanks to be used as a reference in Islamic countries, especially in the areas of informed consent, children's participation, and confidentiality.

Research Question and Methods

The ethical principles of medical research and research biobanks are a reflection of society's ethos and morals. The ethics of research on a Muslim population are also influenced by Islamic perspectives.

A problem that may be noticed here is how the age of Islamic resources such as the Quran (the holy book) and the Sunnah (the sayings, actions, approvals, or descriptions of the Prophet Muhammad), both of which date to more than 14 centuries ago, may say something about recent matters still being under discussion and negotiation today. Such problematic issues can be solved from an Islamic point of view through knowing the mechanisms of the rules stated in Islam. This can be seen similar to other religions when they state an opinion about new matters such as cloning, removing a ventilator, or other contentious issues.

Even though the Quran and the Sunnah, the main resources of Islamic jurisprudence, do not mention medical research, biobanks, or other new developments, Muslim jurists use many mechanisms to derive rules about new matters and issues as Islamic resources. This process is called al-Ijtihad, which means, “to make every effort to reach the correct decision.” Al-Ijtihad is one of the principal characteristics of Islamic jurisprudence. Although al-Ijtihad considers both the Quran and the Sunnah, it also uses many tools for evolving juristic decisions, such as analogy, consensus, equitable preference, customs, and the public interest; all these, including the Quran and the Sunnah, are called “Usul Al-Fiqh” (source methodology in Islamic jurisprudence).^4,5 There are many juristic rules called “al-Qawa'id al-Fiqhiyyah” concluded from “Usul Al-Fiqh” that are also used in matters of daily life, such as: “Hardship begets facility,” “Harm must be eliminated,” “Necessity makes the unlawful lawful,” “A greater harm is eliminated by means of a lesser harm,” and so on.⁴

Another problem comes from the differences among many Muslims doctrines (such as Sunnis and Shiites and others), and when we say “Islamic perspectives,” we must acknowledge a diversity of perspectives. However, in this article, we choose to talk about the Sunni School, although similarities exist among different Muslim doctrines with regard to new juristic issues. The Sunni school represents the large majority (87%–90%) of Muslim populations.⁶ Although many minor differences are found among the Sunni groups, especially in issues related to praying, fasting, and others, it is different when dealing with new issues, such as organ donation, in vitro fertilization, and medical research, especially when decisions are made by the juristic councils that are formed from (and have representatives of) all Sunni groups. Juristic councils' decisions, which we rely on in this article, are cumulative opinions among the majority of scholars in each juristic council.

To explain and evaluate Islamic opinions about research biobanks, we first surveyed the most prevalent ethical challenges in research biobanking through a review of the literature. The following were among the most relevant sources: Hens et al. about children's research biobanks⁷ and Trommelmans et al. as well as White and Gamm about informed consent.^8,9 Next, we used the results of a number of empirical studies we had previously conducted in the Middle East about biobanking ethics to highlight Muslims' perspectives.^10–13 Also, another two theoretical studies—one about research ethics guidelines in Muslim countries and the second an analysis of Saudi biobank governance—were conducted and used to explore the real factual situation.^{14
15} Then, we reviewed Islamic institutional and individual fatwas^* that may be connected directly or indirectly to research biobanks and the ethical challenges therein. The fatwas of the International Islamic Fiqh Academy (IIFA), the Islamic Fiqh Council (IFC), and statements of the Islamic Organization of Medical Sciences (IOMS) are reviewed.¹⁶ We also used “Usul Al-Fiqh,” including the Quran, the Sunnah, and other resources, to analyze their Islamic opinions regarding research biobanking. We differentiated between two things, issues about which Islam has a position and issues about which Islam does not have any position, and are therefore left to biobanking experts. Finally, we developed a model of Islamic ethical standards that can be used by biobanks in Islamic countries.

Before highlighting the ethical perspectives of research biobanking in Islam, a few simple questions are relevant, namely: what is the position of Islam toward medical research itself, and moreover, does Islam allow the establishment of research biobanks?

Islam and Medical Research

Islamic teachings do not limit scientific progress or development; on the contrary, they encourage progress. Many Quranic verses and Prophetic Hadiths insist on both learning and teaching. Some Muslim interpreters of the Holy Quran have discussed the importance of learning new sciences when they interpret the verses of the story of Moses and how he learned from the good man.¹⁷ The IIFA stated in the introduction of its decision 94 (10/2) on human cloning and in decision 142 (15/8) that Islam does not put any obstacle in the way of research and requires respect for human dignity and privacy, as long as it is beneficial research for humanity.^18,19 Also, in its decision about human resource development 164 (18/2), it encourages doing research.²⁰ This comes in line with a saying of Prophet Muhammad: “Seeking knowledge is the duty of every Muslim.”²¹

According to Muslim scholars, Muslims must fulfill two kinds of obligations. The first kind is a full obligation for every individual (e.g., to know how to pray or fast). If a person does not meet these obligations, he or she is sinful, regardless of other actions. This kind of obligation is called “Fard al-‘ayn” (individually required duty). The second kind of obligation is a partial obligation that is a partial imposition. A certain social class must meet this kind of obligation. If this obligation is not met, the entire community is considered sinful. This type of obligation is called “Fard al-kifaya” (collective duty); if fulfilled by a certain number of individuals it relieves others from performing it. The presence of doctors in a society is an example of this second type of obligation; having some doctors is in the public interest, but not all individuals have to be doctors.^4,5

Medical research might be in the public interest because it contributes to a better quality of life and decreases human suffering. Therefore, medical research represents the second type of obligation.

Although the teachings of Islam support medical research in general, we can identify some limits that regulate and define the boundaries of research for certain cases, in which unintentional violations may occur. For any new matter, including medical research, to be permitted in Islam, five things must be protected, namely religious principles, life, money, intelligence, and offspring. Islam aims to preserve these five items. These five things are called “Maqasid al-Sharia” (Purposes of Sharia).⁴

Islamic resources show that Islam relies on a sense of responsibility, with a special dimension of concern for social transactions (muamalat) with other parties. The Prophet Mohammad said, “Every one of you is a guardian, and responsible for what is in his custody.”²² The meaning of this statement is that everyone in a profession has full responsibility for their profession; they must be good leaders and work for the benefit of their followers. We may apply this statement to medical research and biobanks thus: researchers and biobank staff are responsible for their research and their subjects, and they are responsible to society.

Research Biobanks Ethics

The literature presents many challenges facing research biobanks, such as informed consent, respect for confidentiality, and informed consent and children participation in biobanks. The following sections of this article will discuss these challenges from an Islamic point of view.

Confidentiality and privacy

Confidentiality and privacy are crucial in all human relationships and medical matters, including medical research, and all medical workers and researchers have confidentiality and privacy as a major ethical concern and duty.^23–25 International ethics guidelines, such as the Declaration of Helsinki and the Belmont Report state the importance and obligation of respecting privacy and medical confidentiality.^26,27 Research biobanks contain huge numbers of samples and personal and genetic data, and offer easy and safe access to computerized medical information needed for research.^1,28 The concept of disclosure of an individual's information to a research participant has been much discussed and debated since the 1990s. Confidentiality is built on the concept of trust, which is considered to be absolutely vital to conduct research.^23,29 Genetic information holds a special importance because it is related to sensitive issues that may not only be attached to one person himself but also to the person's relatives. It is essential to have a balance between the necessity of giving access to information for research purposes on the one hand and the obligation of respecting privacy and confidentiality on the other hand. Any disclosure of medical information in clinical research or clinical practice must be made according to informed consent by the participants to allow researchers to access or disclose any information related to them.^30,31 However, in some situations, disclosing medical information without consent may be necessary to avoid greater harm, as in cases of clear individual or societal benefits such as the notification of infectious diseases, for example AIDS.³² Confidentiality and privacy are not only limited to information provided by research participants or taken from their samples or data but also extends to the research results.^33,34

Even though sample and data information are supposed to be collected on an individual basis, in practice, it is not. All family members share similar genetic profiles; moreover, in some societies where the tribal system is still strong, as in many Muslim societies, the tribes have, to some degree, cognate genes. Discrimination, stigmatization, and harm will not be individual, but familial, and maybe tribal.³⁵ Furthermore, people who do not wish to be involved in research biobanking will be indirectly involved to some extent, through samples collected from their close relatives.

Many fatwas released by juristic councils have shown that respecting medical confidentiality is an important issue, including such general fatwas as fatwa No. 79 by the IIFA,³⁶ fatwa (8/1) 33, and fatwa (8/1) 35 by the Islamic Fiqh Academy in India,^37,38 as well as fatwas specific to clinical research such as fatwa No. 1 (15) by the IFC,³⁹ and fatwa No. 161 (17/10) made by the IIFA.⁴⁰ Besides these juristic fatwas, confidentiality is clearly stated in the document issued by the IOMS.⁴¹ Besides these institutional fatwas and opinions about the importance of medical confidentiality, there are many individual fatwas issued by scholars like In Baz (the former Grand Mufti in Saudi)⁴² and writings by doctors like Albar and Chamsi Pasha.⁴³ Despite the importance given to confidentiality by institutional and individual fatwas, a justification for breaching confidentiality can be accepted in some situations, especially when the harm of maintaining confidentiality overrides its benefits, such as reporting HIV-positive individuals to competent authorities to protect their relatives and the community.^{36–38,44–46}

Informed consent

Confidentiality in research is built on disclosure of personal information to the research team by each participant. This disclosure must be voluntary for the participants and be obtained by using a completed informed consent form, preapproved by an Institutional Review Board. However, obtaining informed consent from participants is a very complicated and controversial topic.^47–49 A vast body of literature has been published discussing the significance, limitations, and inadequacy of informed consent in promoting voluntary participation in research.^50–52

Some fatwas related to informed consent in clinical research, released by the IIFA, have included decision No. 67 (5/7) about medical treatment⁵³ and decision No. 161 (17/10) about the juridical regulation of biomedical research on humans.⁴⁰ According to these two decisions, informed consent is an obligation in all research. It must contain sufficient understandable information. Decision-making must be voluntary, and the decision maker must be able to make the decision. Implied consent has the same value as expressed consent. According to IIFA decision No. 142 (15/8), a doctor is responsible in case harm occurs in the absence of informed consent.¹⁹ The IOMS agreed to these juridical decisions and provided more details about the obligation of informed consent and its required elements, such as benefits, risks, confidentiality, and other issues.⁴¹ Many authors like Albar, Chamsi Pasha, and others^43,54,55 have discussed about informed consent and agreed that it is an obligation in research.

Research on children

Obtaining samples from children for the biorepository is both crucial and problematic at the same time. Considering children's vulnerability and their need for greater protection, the inability to provide consent raises many ethical questions regarding their participation in research, in that very little or no direct benefits and some inherent risk may be associated with it. There are many concerns about the proper age for a child being able to give consent, about who should give consent for minors, and also about the significance of each child's assent.⁵⁶

Few Islamic fatwas by juristic councils have discussed medical research and the role of children, apart from an opinion expressed by the IOMS. There is a paucity of individual writings about this fundamental topic, but they are unoriginal in that they copied parts of IOMS opinion.^43,54,55

Three positions were found about conducting medical research on minors. Two have opposite extremes: a complete prohibition by fatwa IIFA 67 in 1992,⁵³ because it is not in the best interests of the child, a complete permission by the IFC's fatwa in 2002,⁵⁷ regarding stem cells, and the fatwa by Dar-Alifta Al-Misrriyah No. 598 in 2008.⁵⁸ However, the most famous opinion selected by the IOMS and accepted by IIFA in fatwa 161 in 2006 is that research on children is not allowed unless it is in the best interests of the child or there is a public need for such research, without causing any harm to children. A priori, it is essential that guardian consent is obtained as well as the approval of the appropriate ethics committee.^40,41

Discussion

Confidentiality, research biobanks, and Islam

Respecting privacy and confidentiality is a basic issue in Islam and around the world. Many related institutional and individual fatwas are issued in this regard. By using one of the principles of “Usul Al-Fiqh” (Source methodology in Islamic jurisprudence), called “Qiyas” (analogy), privacy and confidentiality are important in clinical practice and research and can be applied to research biobanks as well, considering that research in biobanks is research on stored tissues, which is a type of investigational medical research. Moreover, the confidentiality of information in biobanks is possibly even more important than in clinical research, because longitudinal studies last for decades and deal with genetic information. This information is not only about individuals but also familial and tribal, and any leak of information may lead to major harm. However, disclosure of information may be justified for a number of reasons, especially to avoid greater harm, such as potential health dangers to at risk relatives who share the same genes. Many juristic rules in Islam can be used to allow such information disclosure such as: “Necessity makes the unlawful lawful”, which allows disclosure of information which is unlawful, but when it becomes necessary it becomes lawful according to the case of preventing public harm as stated by the fatwa of IIFA.⁴⁰ Disclosing information if necessary is used by the governance of the Saudi biobank, which permits this disclosure in risky cases where there is clear clinical proof of harm, after making necessary consultations by a special committee called the “Confidentiality and privacy committee”.⁵⁹ Interviews with professionals from the Middle East support this Islamic opinion about the importance of confidentiality in research on stored tissues and disclosure can only be accepted for justified reasons,¹⁰ which also is supported by the guidelines of research ethics in a number of Muslim countries in the Middle East.¹⁴

Even though there are no fatwas about preventing genetic discrimination and stigma in genetic research on stored tissues, there are many juristic rules “Qawa'id al-Fiqhiyyah” which can be applied, such as: “Harm must be eliminated”, “Harm may neither be inflicted nor reciprocated,” and “The greater harm is repelled by, the lesser harm”.⁵⁹ These juristic rules clearly prevent harm. It is not a surprise to learn that professionals in the Middle East agree that discrimination and stigma should not be accepted in genetic research.⁹ The Saudi biobank also prevents any action that may lead to discrimination or stigma; this action has also been agreed by the research ethics regulations in many Muslim countries, including Saudi Arabia and Qatar.^59,60

Fatwas or juristic rules about confidentiality are usually stated in general terms, but they do not address or purport to have any interest in the mechanisms involved. We did not find any information that stated definitive recommendations about security systems or which type of coding should be selected (Table 1).

Table 1.

Islamic Position About Confidentiality in Biobanking Research

	Islamic position
	Available supported fatwa	Compatible with Usul Al-Fiqh methods
Respect of confidentiality	Yes	Yes
Justified disclosure of information	Yes	Yes
Prevent discrimination	No	Yes
Prevent stigmatization	No	Yes
Type of security system	No	Neutral
Type of coding	No	Neutral

Informed consent, biobanks, and Islam

Many juristic fatwas, the statements of IOMS, and numerous authors mandate getting informed consent to allow participation in clinical research,^{40,41,43,54–56} that is also applicable to biobanks. Informed consent must be voluntary without any coercion. This opinion matches many juristic rules such as, “A person's right is not to be revoked without his permission” and “Man's right is not to be used without his permission.” Voluntary participation requires using understandable informed consent and the ability to understand.^40,41,43 Using written consent rather than verbal consent is preferred because it helps research participants to understand informed consent more clearly.⁴³

There is no preference in Islamic fatwas with regard to using one-time consent for all research conducted on the same samples, rather than a separate consent for each research investigation. This issue is left to the system of each biobank. The Saudi biobank, as an example, chooses to use a one-time consent. The same is applicable to the degrees of withdrawal used by many biobanks such as the United Kingdom and Saudi biobanks; consent can also be left to the governance of the biobank (Table 2).

Table 2.

Islamic Position About Informed Consent in Research Biobank

	Islamic position
	Available supportive fatwa	Compatible with Usul Al-Fiqh methods
Obligation of informed consent	Yes	Yes
Voluntary	Yes	Yes
Ability to decide	Yes	Yes
Enough information	Yes	Yes
Understandable information	No	Yes
Withdrawal	No	Yes
Degrees of withdrawal	No	Neutral
One time consent	No	Neutral

Children's participation in biobanks and Islam

The position taken by the IOMS, IIFA in its fatwa 161, and many authors seems to be applicable as well to children's participation in research biobanks. All conditions mentioned by IOMS are presented, namely the best interests of the child or a public need for such research, no harm, guardian consent, and requiring the approval of the appropriate ethics committee.^40,41

Children's participation in biobanks is crucial, and even though there may be no direct initial benefits to the participating child, there are benefits for future generations and the community of children. This public benefit justifies the children's participation, as stated by IOMS and IIFA 161.^40,41 Moreover, the risk in biobank participation is considered to be minimal, since the physical risk is limited to just a needle puncture at worst, when collecting samples from participants during their hospital visits. The risk of confidentiality breaches can be avoided by using good coding and effective security systems. Allowing children's participation in biobanks not only matches the fatwas of IIFA and the positions of IOMS but also this approach is compatible with the juristic rules of Usul Al-Fiqh, such as “do no harm” and “necessity makes the unlawful lawful,” considering that children's participation in research biobanks is necessary compared with the minimum risks involved.^7,61 Islamic resources do not define an age for children's participation in research, which is instead left to the governance of each biobank. The Saudi biobank, for example, accepts children aged 10 years or older.

A guardian's consent is needed to allow a child to participate in a biobank, and this is well supported by Islamic fatwas, such as fatwas IFC 3/17, IIFA 161, and Dar-Alifta Al-Misrriyah (598), besides the opinion of IOMS and the authors cited in this study.^{28,40,41,43,57} However, these fatwas do not define who can fulfill the role of guardian, which can be estimated from other resources that discuss guardianship with regard to issues such as orphans or marriage, namely: father, then a grandfather, and then a brother.⁶² While this way of guardianship is selected by some authors to be used in medical issues such as surgery,⁶³ some argue that mothers know and are concerned more about their children. It is remarkable that the Saudi biobank accepts consents from any of the two parents.⁵⁹

Juristic fatwas do not mention child assent; however, IOMS refers to the importance of a child's assent when he/she is able to give it. According to Al-Mausoha Al-Feqhia (Juridical Encyclopedia), a child older than the age of 7 years may be able to understand, and their assent can be accepted if it is according to their best interests.⁶² With respect to the best interests of the child, no major harm, child assent, and guardian consent make participation in biobanks acceptable.

No fatwas refer to the necessity of research ethics approval, but this is mentioned by IOMS and matches the spirit of Islamic law by following the means that guarantee child protection by requiring a review by experts (Table 3).

Table 3.

Islamic Position About Children's Participation in a Research Biobank

	Islamic position
	Available supported fatwa	Compatible with Usul Al-Fiqh methods
Allowing research on children	Yes	Yes
At which age a child can participate	No	Neutral
Guardian consent	Yes	Yes
Child assent	No	Yes
Best interest of child	Yes	Yes
Reconsent at adulthood	No	Yes
Who is the guardian?	No	Yes

Financial compensation and return of results

The IFC at its eleventh session, in resolution III, objected to the sale of blood.⁶⁴ From henceforth, it was not permissible to establish research biobanks, based on the purchase of samples from participants and would only allow voluntary unpaid donations. This in particular, has been denied by Prophet Mohammad who took charge of blood products. It was narrated that Abu Juhayfah said: the messenger of God forbade the price of blood.⁶⁵ The inadmissibility of the sale of samples and purchase carries moral, spiritual, and psychological values. However, donating blood (and organs) is allowed.

As for the benefits and business profits resulting from scientific research and medical applications, they are most likely to be subject to the terms of the contract, and the agreement among the donor, researchers, and biobank. The IFC in its fatwas about genetic research and stem cell research encouraged researchers to return research results to participants, when that is possible. However, this is just a recommendation, and all issues are subjected to agreement between all parties participating in the research biobanks, which may differ from one another (Table 4).

Table 4.

Islamic Position About Compensation, Ownership, and Return of Results in the Research Biobank

	Islamic position
	Available supported fatwa	Compatible with Usul Al-Fiqh methods
Forbidding the selling blood samples	Yes	Yes
Donating blood samples	Yes	Yes
Return of results	Yes	Neutral

Conclusions

Confidentiality, informed consent, and child participation are considered important challenges in research biobanks. Despite differences in religion, culture, and other factors, ethical solutions have many similarities.

Islam highlights a clear interest in respecting confidentiality and preventing any kind of discrimination or stigmatization. Islam does not express any opinion regarding the coding method and security system, since these are practical issues that must be decided by each biobank.

Informed consent is considered to be an obligatory requirement for an individual to participate in a research biobank. This participation must be voluntary, and the informed consent must contain enough information and a suitable environment to allow the participant to make an informed participation decision. Withdrawal of consent is a right for every participant. Islam does not express any opinion on the degrees of withdrawal or whether collecting a one-time consent is sufficient or whether consent must be obtained for every research study.

Islam allows child participation in biobanks, but requires that no harm can be tolerated, that a guardian gives consent, and that the child gives assent if he/she is able to do so. No certain age is set for participation. Fathers are the preferred choice to give consent for minors.

Principles of Biobanks Good Practice: Islamic Perspectives

1. Islam allows the establishment of research biobanks, as long as autonomy is respected and harm is prevented.

2. Confidentiality must be respected.

3. No discrimination is allowed.

4. No stigmatization is allowed.

5. Informed consent is an obligation before participation.

6. Informed consent must contain all information needed to allow a participant to make a well-informed decision.

7. Participation must be voluntary.

8. One-time consent is not mandatory.

9. Withdrawal of consent is a right of every participant.

10. Degrees of withdrawal are determined by the biobank concerned.

11. Children can participate.

12. No harm to participating children is allowed.

13. A guardian's consent is essential, with fathers preferred.

14. The assent of the child is preferred when the child is able to do so.

15. A child must give consent upon becoming an adult to continue participating.

16. Selling blood samples is forbidden; however, donations are allowed.

17. Return of results is possible and is subjected to the biobank governance and acceptance of donors.

Authors' Contributions

All authors contributed to writing this article. Both conceptualized and designed the study, and G.A. wrote the first draft. Both authors revised it and approved the final version.

Footnotes

Author Disclosure Statement

No conflicting financial interests exist.

*

Fatwa is an Arabic word used in Islamic jurisprudence and means a religious opinion concerning Islamic law about a specific new matter issued by an Islamic scholar according to general Islamic perspectives that depends on primary Islamic resources such as the Quran and the Sunnah, consensus and analogy, as well as other secondary resources. The mufti (the person who issues a fatwa) must be well informed about both Islamic jurisprudence and about the matter of the fatwa to be issued.

References

Khoury

, Millikan

, Little

, et al. The emergence of epidemiology in the genomics age. Int J Epidemiol, 2004; 33:936–944.

Greely

. Human genomics research. New challenges for research ethics. Perspect Biol Med Spring, 2001; 44:221–229.

Hansson

. Combining efficiency and concerns about integrity when using human biobanks. Stud Hist Philos Biol Biomed Sci, 2006; 37:520–532.

Al-Zarga

. Sharh al-Kwae'd al-Fekehea (Enlightenment of Juristic Rules). Damascus, Syria: Dar al-Qalam; 1989.

Al-Zoheily

. Al-Fiqh Al_islami Wa Adellato (Islamic Jurisprudence and Its Evidence). Damascus, Syria: Dar Al-Fikr; 1985

Miller

. Mapping the Global Muslim Population: A Report on the Size and Distribution of the World's Muslim Population. Washington, DC: Pew Research Center; 2009.

Hens

, Nys

, Cassiman

, et al. Genetic research on stored tissue samples from minors: A systematic review of the ethical literature. Am J Med Genet A, 2009; 149A:2346–2358.

Trommelmans

, Selling

, Dierickx

. The importance of the values attached to cells for a good informed consent procedure in cell donation for tissue engineering purposes. Cell Tissue Bank, 2009; 10:293–299.

White

, Gamm

. Informed consent for research on stored blood and tissue samples: A survey of institutional review board practices. Account Res, 2002; 9:1–16.

10.

Alahmad

, Al Jumah

, Dierickx

. Confidentiality, informed consent, and children's participation in research involving stored tissue samples: Interviews with medical professionals from the Middle East. Narrat Inq Bioeth, 2015; 5:53–66.

11.

Alahmad

, Hifnawy

, Abbasi

, et al. Attitudes toward medical and genetic confidentiality in the Saudi research biobank: An exploratory survey. Int J Med Inform, 2016; 87:84–90.

12.

Alahmad

, Hifnawy

, Dierickx

. Ethics of children's participation in a Saudi biobank: An exploratory survey. Genet Med, 2015; 18:806–813.

13.

Alahmad

, Dierickx

. Return of research results in the Saudi biobank: An exploratory survey. Genet Test Mol Biomarkers, 2017; 21:166–170.

14.

Alahmad

, Al-Jumah

, Dierickx

. Review of national research ethics regulations and guidelines in Middle Eastern Arab countries. BMC Med Ethics, 2012; 13:34.

15.

Alahmad

, Al Jumah

, Dierickx

16.

Alahmad

, Dierickx

. What do Islamic institutional fatwas say about medical and research confidentiality and breach of confidentiality?. Dev World Bioeth, 2012; 12:104–112.

17.

Kathir

. Tafsir Ibn Kathir. English Translation by Shaykh Safiur Rahman al-Mubarakpuri et al. of., 1990: 184.

18.

International Islamic Fiqh Academy (IIFA). Decision About Human Cloning. 94 (10/2). Jeddah, Saudi Arabia: International Islamic Fiqh Academy (IIFA); 1997.

19.

International Islamic Fiqh Academy (IIFA). Decision About Doctor Guarantee. 142 (15/8). Muscat, Oman: International Islamic Fiqh Academy (IIFA); 2004.

20.

International Islamic Fiqh Academy (IIFA). Decision About Human Resource Development. 164 (18/2). Putrajaya, Malaysia: International Islamic Fiqh Academy (IIFA); 2007.

21.

Al-Albany

. Sahih Al-Jamea (Hadith No. 3913). Beirut, Lebanon: Al-Maktab Al-Islami; 1990.

22.

Al-Bukhari

. Al-Sahih Aljamea (The Correct Total) Hadith No. 583. Beirut, Lebanon: Dar Ibn Katherr Yamamah; 1987.

23.

Giordano

, O'Reilly

, Taylor

, Dogra

. Confidentiality and autonomy: The challenge(s) of offering research participants a choice of disclosing their identity. Qual Health Res, 2007; 17:264–275.

24.

Gere

, Parry

. The flesh made word: Banking the body in the age of information. BioSocieties, 2006; 1:41.

25.

Ryen

Ethical issues. In Seale

, Gobo

, Gubrium

, Silverman

, eds. Qualitative Research Practice. London: Sage; 2004:218–235.

26.

World Medical Association (WMA). World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA, 2013; 310:2191.

27.

National Institutes of Health (NIH). The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Disponível em: http://ohsr od. nih. gov/guidelines/belmont. html# gob2. Acesso em 26, 2011.

28.

Ethikrat

Biobanks for Research: Opinion. Berlin: German Ethics Council; 2004.

29.

Smith

. The limits of sharing: An ethical analysis of the arguments for and against the sharing of databases and material banks. Account Res, 2011; 18:357–381.

30.

Wendler

. Consent for research with biological samples: One-time general consent versus a gift model. Ann Intern Med, 2012; 156:596–598.

31.

Woodward

. Confidentiality, consent and autonomy in the physician-patient relationship. Health Care Anal, 2001; 9:337–351.

32.

Beauchamp

, Childress

. Principles of Biomedical Ethics. 7th ed. New York: Oxford University Press; 2013.

33.

Godard

, Marshall

, Laberge

. Community engagement in genetic research: Results of the first public consultation for the Quebec CARTaGENE project. Community Genet, 2007; 10:147–158.

34.

Renegar

, Webster

, Stuerzebecher

, et al. Returning genetic research results to individuals: Points-to-consider. Bioethics, 2006; 20:24–36.

35.

Baumann

. Proxy consent and a national DNA databank: An unethical and discriminatory combination. Iowa Law Rev, 2000; 86:667.

36.

International Islamic Fiqh Academy (IIFA). Decision About Medical Confidentiality. 79 (8/10). Bandar Seri Begawan, Brunei Darussalam; 1993. Available at: www.iifa-aifi.org/1972.html (accessed March 2, 2018).

37.

Islamic Fiqh Academy-India. The Ethics and Duties of a Doctor. 33 (8/1). India; 1995. Available at: http://ifa-india.org/arabic.php?do=home&pageid=arabic_seminar8. (accessed March 2, 2018).

38.

Islamic Fiqh Academy-India. The ADISE and Its Rules. 35 (8/1). India; 1995. Available at: http://ifa-india.org/arabic.php?do=home&pageid=arabic_seminar8. (accessed March 2, 2018).

39.

Islamic Fiqh Council (IFC). Genetic Research and Stem Cell Research. Vol. 1. 1998.

40.

International Islamic Fiqh Academy (IIFA). Decision About Juridical Regulation of Biomedical Research on Human. 161 (17/10). Amman, Jordan; 2006. Available at: www.iifa-aifi.org/2223.html (accessed March 2, 2018).

41.

Islamic Organization of Medical Sciences (IOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects-Islamic View. Islamic Universal Charter of Medical Health Ethics. Kuwait: Islamic Organization for Medical Sciences; 2005: 129–301.

42.

Ibn Baz

Fatawa Ibn Baz. Available at: https://www.binbaz.org.sa/noor/291 (accessed March 2, 2018).

43.

Chamsi Pasha

, Albar

. Akhlaqiat al-Bouhoth al-Tibia (Medical Research Ethics). Damascus, Syria: Alkalam Press; 2008.

44.

Ahmad

. Ifsha'a Al-Sirr Al-Tibbi wa Atharoh fi Al-Fikh Al-Islami (Breaching of Medical Confidentiality and its Affect in Islamic Jurisprudence): Collage of Shariah and Law. Cairo, Egypt: Al-Azhar University; 2007.

45.

Arafea

. Sirr al-Mehna Wa Iltezam al-Tabeeb be Akhlaqiat al-Teb (Profession Confidentiality and Doctor's Observance to Medical Ethics). al-Mutlaka al-Sihhi. 2001: 16–18.

46.

Mubarak

. Hal yakshif al-Tabib sirr al-Maridh (Does the Doctor Expose Patient's Secret?). al-Multqa al-Sihhi. 2002: 22–25.

47.

Clayton

. Informed consent and biobanks. J Law Med Ethics Spring, 2005; 33:15–21.

48.

Helgesson

. Children, longitudinal studies, and informed consent. Med Health Care Philos, 2005; 8:307–313.

49.

Secko

, Preto

, Niemeyer

, Burgess

. Informed consent in biobank research: A deliberative approach to the debate. Soc Sci Med, 2009; 68:781–789.

50.

Simon

, Unützer

, Young

, Pincus

. Large medical databases, population-based research, and patient confidentiality. Am J Psychiatry, 2000; 157:1731–1737.

51.

Boulton

, Parker

. Informed consent in a changing environment. Soc Sci Med, 2007; 65:2187–2198.

52.

Burgess

. Proposing modesty for informed consent. Soc Sci Med, 2007; 65:2284–2295.

53.

International Islamic Fiqh Academy (IIFA). Decision About Medical Treatment. 67 (7/5). Vol 67. Jeddah, Saudi Arabia: International Islamic Fiqh Academy (IIFA); 1992. Available at: www.iifa-aifi.org/1858.html (accessed March 2, 2018).

54.

Fadel

. Ethics of clinical research: An Islamic perspective. J Islamic Med Assoc North Am, 2010; 42:59–69.

55.

Abu Matar

. Altajarob Alimia Ala Jism Alinsan (Scientific Experiments on Human) [Master]. Gaza, Palestine: Islamic Jurisprudence, Islamic University in Gaza; 2011.

56.

Burke

, Diekema

. Ethical issues arising from the participation of children in genetic research. J Pediatr, 2006; 149(1 Suppl):S34–38.

57.

Islamic Fiqh Council (IFC). Stem Cells. 3 (17/2003). Majallat Al-Mojamma Al=Feqhi Al-Islami. 2004; 17:293–295.

58.

Dar-Alifta Al-Misrriyah. Using stem cells in scientific experiments. 598. Egypt;. 2008. Available at: http://dar-alifta.org/AR/ViewFatwa.aspx?ID=11343&LangID=1&MuftiType=0 (accessed on March 3, 2018).

59.

King Abdullah International Medical Research Center (KAIMRC). The Governance of Saudi Biobank. Riyadh, Saudi Arabia; 2011 [Not Published].

60.

Qatar. Guidelines, regulations and policies for research involving human subjects. In: Ministry of Health. Guidelines, regulations and policies for research involving human subjects. Doha, Qatar; 2009.

61.

Hens

, Dierickx

. The use of stored tissue samples from minors for genetic research: Interviews with professionals. New Genet Soc, 2010; 29:329–342.

62.

Kuwait. Al-Mausoha Al-Feqhia (Juridical Encyclopedia). Vol. 45. Kuwait: Ministry of Awqaf and Islamic Affairs. Al-Mausoha Al-Feqhia (Juridical Encyclopedia). Kuwait: State of Kuwait; 2006.

63.

Shankeeti

. Ahkam Al-Jeraha Al-tebia (The Rules of Medical Surgery). Jeddah, Saudi Arabia: Maktabet Al-Sahaba; 1994.

64.

Islamic Fiqh Council (IFC). Transfusion of Blood from a Woman to a Child Under Two Years Old, 3 (11/1989). Majallat Al-Bohouth Al-Islamia. 1992; 35:343–344.

65.

Al-Bukhari

. Al-Sahih Aljamea (The Correct Total) Hadith No. 1980. Beirut, Lebanon: Dar Ibn Katherr Yamamah; 1987.