Case Analyses (Ethics Discussion) for Participants in the Jordan RCR Program Year 3 (2017-2018)

• Prenatal genetic diagnosis (PGD) for nonmedical purposes (Sex Selection)

By:Maha Al-Keilani

 

The last decade has been a period of several controversies in research bioethics, one important example is the controversies regarding prenatal genetic diagnosis (PGD) for nonmedical purposes. Although autonomy, justice, beneficence, and non-maleficence, remain the four basic principles that guide the resolution of such ethical dilemma in medicine (1), they still are not sufficient to solve it. The main purpose of PGD was simply to improve the chances for a successful pregnancy and to avoid sex-linked genetic diseases. Nevertheless, the advancements in this technology opened windows for the application of it for nonmedical purposes such as sex selection that usually reflects social, cultural, or economic reasons.

Although proponents consider PGD for nonmedical (elective) sex selection as a parental autonomy and a way to achieve family balance, opponents consider this technology as a causative of inherent sex discrimination and sex imbalance (2).

Jordan community is often motivated by gender stereotype, with the preference of male gender (3). Such male gender stereotyping has several negative consequences on the mother, born babies, siblings, and society, making the PGD for nonmedical sex selection a morally reprehensible procedure.

Up to 2010, there was no Jordanian law that controls the practice of PGD for sex selection, until the release of article 10 (paragraph A) that prohibits it for reasons other than prevention of sex-linked diseases. However, there is no regulatory agency to enforce this law. On the other hand, PGD use in Jordan is not restricted, thus, religious and cultural beliefs remain the major tools for the assessment of morality of PGD for nonmedical sex selection. For example, a study by Al-Akour et al. (2009) revealed that about 26% of pregnant women reported preference of male born child, and 13.5% of women believed that “sex selection should be legally acceptable”.

On the other hand, the prohibition of PGD for elective sex selection may hinder further researches that mainly aim to study the physical, psychological, and social consequences of this technology on the mother and the baby.

 

References:

• Beauchamp TL, Childress JF. 1983 Principles of Biomedical Ethics. Oxford University Press, New York, USA
• Shelby Deeney. Bioethical Considerations of Preimplantation Genetic Diagnosis for Sex Selection, 5 WASH. U.JUR. REV. 333 (2013).
• Al-Akour et al. Sex preference and interest in preconception sex selection: a survey among pregnant women in the north of Jordan. Hum Reprod. 2009 Jul;24(7):1665-9.

 

• The use of addicts as participants in research

By: Samah Al-Shatnawi

Addiction, “a stigmatized disorder”, as a topic of research makes ethical issues particularly significant and critical. It is worth noting that there is a strong connection between research and ethical issues in this field. Most of these ethical issues are related to the extent to which addicts are mentally competent or incompetent by their substance use behaviors and/or disorders. The complexity of addiction as a mental health problem highlights the significant needs of research to uncover and clarify most of these issues and to find ways in which researchers might deal with addicts in an ethical manner.

Regarding the use of addicts as participants in research, several ethical issues should be addressed, including: issues related to the consent (informed, valid) process, capacity, and voluntariness; and other issues related to risks versus benefits to participants. First of all, the standard requirement for ethical research is that all subjects have given their consents to take part in the study, which mandates that the consent process should be informed and valid. This should imply that the content within the consent form should fit the participant’s capacity (level of the mental competence among addicts) in order to participate in research voluntarily. Possibly, the most common ethical concern with the involvement of drug addicts as research participants has been related to their ability in providing a valid consent, either because of their lack of competence or their involuntary participation. The main reasons for this actually lie in the nature of addiction. Addicts’ desires and/or cravings to substance use along with the effects of intoxication and/or substance withdraw might cause a problematic understanding of the research and its consenting process. Thus, decisions taken by addicts regarding their participation in research might be inappropriate and significantly jeopardize the ethical conduct of research. Since the seriousness of such ethical problems might vary between different research projects, it’s preferable to consider a wide range of features when deciding on how to obtain a valid consent from addicts. These features might include the nature of research, the setting and/or context in which consent is obtained, complexity of the information that addicts might need to understand the consenting process, type of incentives to enhance participation, and the easiness of withdrawal from research studies. For instance, even when addicts are unable to provide valid consent, research may still be conductible with additional security steps within the research process or protocol.  These safeguards can include: proxy consent, assured minimal risk to addicts, and potential benefits for participants.

Second comes; the issue of risks versus benefits to research participants. Worldwide, addiction is one of the most sensitive conditions that are highly associated with stigma. Facing and overcoming stigma is a major challenge within research. Stigma can be imposed by society, community, working environment, friends, and/or family members and can cause major risks and harms through discrimination. Thus, for a participant to disclose his/her addiction problem is a serious issue to which anonymity and confidentiality parameters of research may play a significant role. Furthermore, researchers must know their responsibilities and must have a plan for what to do if their research results uncover information about activities that are illegal or may cause harms to others such as the possession or supply of illegal drugs, theft, and/or prostitution that addict may be engaged in to fund their addiction.

In Jordan, similar to other middle-eastern countries, addiction is culturally unaccepted, however, it is evolving rapidly. Thus, instead of ignoring addiction and its devastating consequences, researchers must comprehend several aspects of research to tackle the severity of addiction as a problem among these communities while addressing different ethical issues related to this condition.

 

References:

1- Scott, C. K., & White, W. L. (2005). Ethical issues in the conduct of longitudinal studies of addiction treatment. J Subst Abuse Treat, 28 Suppl 1, S91-s101. doi:10.1016/j.jsat.2004.10.012

2- Souleymanov, R., Kuzmanovic, D., Marshall, Z., Scheim, A. I., Mikiki, M., Worthington, C., & Millson, M. P. (2016). The ethics of community-based research with people who use drugs: results of a scoping review. BMC Med Ethics, 17(1), 25. doi:10.1186/s12910-016-0108-2

 

• Challenges concerning “informed consent” in less developed countries:

By: Alaa AbouElfetouh

Ideally, society benefits from research. When improper and unethical incidents that violated the rights of those who voluntarily joined a study occurred, the idea of informed consent arose. Informed valid consent stands for the protection of the rights of unsuspecting, less informed subjects who might be unethically used by researchers who “know better”. Valid consent includes adequate information to be explained to subjects before asking them without coercion to join a study in their capacity. In developing countries with high levels of illiteracy, the subjects come from different socio-economic levels including low levels of education. In Egypt, lots of patients from major cities and rural areas close by are presented to tertiary university hospitals for medical treatment. Many of these patients are farmers without much education, especially older ones. The younger generation is usually better educated, and sometimes accompanies their elders to help with the paperwork of patient admission in a hospital. The challenge in recruiting such patients for a study is the message researchers should convey in an understandable way to obtain consent. This might be easy in developed countries where people, while not understanding the intricacies of research, recognize its impact. In developing countries, a better educated relative accompanying the patient will facilitate the job of the researcher.

A related issue is the research on isolates from patients’ specimens obtained under the discretion of the physician for treatment purposes. Is it still essential to obtain patients’ consent to store these isolates in banks for future studies, knowing that the specimen itself was destroyed after isolating the infectious agent? These studies might still include some epidemiological data of the patients without identifiers. Nevertheless, it is very challenging to explain to patients, most of which with low levels of education that invisible microbes will be isolated from their blood or sputum or urine and will be stored for experiments on antimicrobial resistance, another alien concept. Is it the responsibility of researchers to educate people in scientific issues to understand the basics about research? If not, then we make the researchers accountable for faults that weren’t theirs. Another way of thinking is that researchers are usually decent people that wouldn’t harm others to advance their own means, but will they do it for the sake of humanity? Will it be ethical? The answer is probably no and that is why institutional review boards (IRB) were created. Will it be enough in the case just mentioned to obtain an IRB approval instead of patients’ consent? I would believe so.

A valid consent usually grants autonomy where patients can drop out of the study at any point. This is to protect the subjects from any harmful effects or misconduct on the part of the researcher. However, I don’t believe the researcher’s rights were stated in the consent if the subject dropped out because he changed his mind or had some agenda that wasn’t fulfilled. The researcher can’t use the data that were generated during the consent period which might have negative consequences on the study not to mention wasted resources. In the case of the isolates detailed above, does a “change of mind” on the subject’s part mean that those isolates can’t be used anymore? Is it ethical on the part of the subject to drop out of a study for no reason? I believe we have a duty towards society. This duty is not quite obligatory and looking at it from the Islamic perspective (fard kefaya), someone needs to do it on behalf of others or else everyone is sinful. If a subject took it upon himself to be this someone, does he have the right to let everyone down? The answer is obviously yes, but I would still consider it unethical. I look at the consent as a contract between the researcher and the subject, the researcher protecting the subject’s rights and the subject cooperating as best he can. I am calling for revision of consent concept to include protection of the researchers and the society rights not just the subjects’.

 

References:

Krogstad D J, Diop S, Diallo A, Mzayek F, Keating J, Koita O A, and Touré Y T. 2010.  Informed Consent in International Research: The Rationale for Different Approaches. Am. J. Trop. Med. Hyg. 83(4): 743–747.

Satyanarayana Rao K H. 2008. Informed Consent: An Ethical Obligation or Legal Compulsion? J. Cutan. Aesthet. Surg. 1(1): 33–35.

 

• Ethics in The Age of The Genetic Revolution

By: Samer Swedan

Rapid advances in the field of molecular biology and human genetic analysis in recent years have sent the costs of performing whole-genome or extensive genetic studies to the realm of research laboratories worldwide. Such techniques include exome sequencing, DNA microarrays, and next generation sequencing. Instead of relying on conventional PCR-based genetic analyses to identify a limited number of genes present among study subjects, researchers nowadays have the power and convenience to use the aforementioned advanced techniques enabling them to identify a wide range of mutations or SNPs or other potential genetic anomalies among subjects in one convenient experiment.

On one hand, this advancement would enable better clinical diagnosis and prognosis, and would provide a better and a more complete genetic picture of the subject to the researcher, enabling performing genetic association studies and estimating risks of development and progression of various conditions and diseases. On the other hand, subjects being enrolled into a study with a goal of testing the association of a certain gene or a few genes with a particular medical condition would additionally be providing researchers extensive genetic information about themselves that extends well beyond the scope of the genes of interest being investigated in the study. The extensive genetic knowledge gained about the subjects presents an ethical dilemma as it raises many issues. For example, any potential leaks of information about a particular subject, would potentially put the subject and his family into significant harm including stigmatization by the society (a serious issue in Arab countries like Jordan), and discrimination by employers and health insurance agencies, etc. Furthermore, a researcher might be morally pressured into informing the subject regarding the discovery of serious genetic anomalies that might lead the subject or his offspring to develop serious medical conditions or even death, unless early interventions are applied. Alternatively, the subject might not be interested in knowing such information as it may lead to anxiety, depression, suicide, or may change his views on future marriage or having offspring. Another point complicating the issue is that not all genetic anomalies would necessarily translate clinically as many phenotypes are multi-factorial, hence informing the subjects might lead to unnecessary consequences. Of course, some subjects may receive the information with a more positive attitude and utilize it to plan future medical interventions. Nonetheless, the researcher would still be perplexed regarding the provision of the information, as undoubtedly many subjects would react negatively to the information.

So, what is the solution? I believe one way to address this issue is by providing the subjects during the recruitment stage not only information about the study and its goals, but also to explain that the study would involve the use of genetic techniques capable of detecting a wide range of genetic anomalies. Henceforth, the subject would be better informed and would be capable of reaching a better decision regarding participation, and whether or not he would like to be informed upon the identification of significant genetic anomalies. Another solution is anonymizing subject names during data collection, hence no particular subject could be latter associated with particular findings.

 

• Ethical debate about genome editing using CRISPR/CAS9 Technology:

By: Mohammed Alsaggar

CRISPR/CAS9 technology is a natural prokaryotic immune defense system against foreign genomic sequences, such as viruses, works to prevent modification of bacterial genome. Advances in molecular biology and recombinant DNA technologies made it possible to exploit this method for manipulating DNA sequences in targeted germline and somatic cells. As for now, CRISPR/CAS9 technology is widely applied for biomedical research and food industry purposes, such as generation of animal models of human diseases, genetically modified corps with more economic and nutritional values, and for tissue engineering and regenerative medicine.

While the method holds great promise for clinical applications to prevent and treat human diseases, there has been significant ethical debate about genome editing, especially when it comes to germline cells. As with other disciplines of research, the beneficial outcomes of CRISPR/CAS9 should outweigh the risks associated with it. However, off-target editing would result in mutations that may inactivate essential gene functions, or trigger unwanted gene functions like tumorigenic activities. Given the hereditary nature of modified genomes and the possibility of passing mutations across generations, whole phenotypes and even organisms may appear or disappear, which significantly impacts ecosystem equilibrium. Therefore, arguments now are to hold on with applications of CRISPR/CAS9 technology until further elucidation and improvement of safety issues.

The most serious ethical dilemmas are associated with genome editing of human germline, as these changes or mutations are transmittable into future generations, which leads to changes in the identity and beings of human species. In addition, it is ethically debatable on how to implement informed consent when future generations are the affected population. A more recent application of genome editing technology is production of human organs in animal bodies by replacing animal tissues with human one at embryonic stages. This so called chimeric animals technology raises further ethical concerns for genome editing on how to treat these engineered animals as having human organs, (are they animals or half humans?) and would that imply violation of nature order or not.

In summary, genome editing with CRISPR/CAS9 technology has certainly demonstrated significant promise for biomedical research, industry and clinical practice. However, the risks associated with this technology are significant enough to violate the non-maleficence principle of scientific research. As personal view, applications of CRISPR/CAS9 technology in biomedical research, especially on germline cells should be postponed until further safety and ethics assessment, particularly at long run. In addition, funding or research on genome editing should be highly restricted and carefully reviewed by ethical committees, besides science committees.

References:

1. Doudna, J.A. and E. Charpentier, Genome editing. The new frontier of genome engineering with CRISPR-Cas9. Science, 2014. 346(6213): p. 1258096.
2. Fu, Y., et al., High-frequency off-target mutagenesis induced by CRISPR-Cas nucleases in human cells. Nat Biotechnol, 2013. 31(9): p. 822-6.
3. Champer, J., A. Buchman, and O.S. Akbari, Cheating evolution: engineering gene drives to manipulate the fate of wild populations. Nat Rev Genet, 2016. 17(3): p. 146-59.
4. International Summit on Human Gene Editing A Global Discussion.” National Academies of Sciences, Engineering, and Medicine. 2015.
5. Hermeren, G., Ethical considerations in chimera research. Development, 2015. 142(1): p. 3-5.

 

• Research ethics principles faced in dealing with electronic medical information

By: Linda Tahaineh

In 2009, Jordan Ministry of Health launched Hakeem, the first national program to automate medical information. Since then Hakeem was implemented in more than 100 hospital and healthcare center all over Jordan. Electronic Health Solutions (EHS) the company overseeing Hakeem stated in its website that one of the benefits of Hakeem program is “Creation of a comprehensive database of patients that will be made available to authorized researchers for use in scientific studies in addition to support decision makers in setting health strategies and policies aiming solely at improving healthcare delivery in Jordan” ¹

A number of research ethics principles are faced in dealing with electronic medical information. One of the main principles in research ethics is autonomy. Patients have the right to own their medical information. Up to the author’s knowledge, patients in Jordan are not educated or consented that their medical information can be used for research purposes.

Another concept of research ethics is beneficence, Hakeem will allow the government and other research institutions in Jordan to conduct studies and the results of such studies can be used in future planning and development of disease prevention programs. Such studies can be used in applying to grants to international institutions or other governments of developed countries. These grants will fund initiatives that will improve the healthcare system especially that Jordan faces financial restraints due to immigration and other issues.

Justice is an important concept in research ethics, the data provided by Hakeem are mainly from governmental hospitals and healthcare centers. This may imply that patients who have higher socioeconomic class and attend private hospitals will not have their data studied.

Finally, privacy and confidentiality; can the data provided to researchers be re-identified? The EHS is obligated to have strategies to ensure privacy and confidentiality of patients’ electronic health information.

References:
1. Electronic Health Solutions. URL: http://ehs.com.jo accessed 2017 August 15.

3. Sulmasy LS, López AM, Horwitch CA, et al. Ethical Implications of the Electronic Health Record: In the Service of the Patient. J Gen Intern Med. 2017;32(8):935-939.
4. Sittig DF, Singh H. Legal, ethical, and financial dilemmas in electronic health record adoption and use. Pediatrics. 2011;127(4):e1042-7.

 

• Researchers Ethical Dilemmas:

By: Oriana Awwad

The Declaration of Helsinki (1964) and more recently the Belmont Report (1979), both addressed the basic principles for the conduction of an ethical research. These include respect of the person autonomy, maximizing possible benefits while minimizing possible harm and fair and equal distribution of clinical research burdens and benefits.

Beside the rules and the much progress that has been achieved in the field of ethics in research, researchers continue to face ethical dilemmas. In such situations, different opinions exist in regard to an ethical problem, without reaching an agreeable solution. However, good arguments arise from both sides.

Example of a current ethical challenge is the presence of biobanks. Biobanks comprise organized collections of human biological samples that might be associated with personal health information and are used for different biomedical researches.

The research community has been divided regarding the utilization of such human biological samples for the benefit of multiple researches. The debate regarding this issue focused primarily on how to balance between progress and confidentiality.

The presence of human biological samples could facilitate the conduction of researches, as the collection of human samples, represents, most of the times, one of the major obstacles in research. The availability of information collected from a large number of individuals might be very useful to determine links among diseases, lifestyle, environment, and genes.

Thus, biobanks play a significant role in advancing medical science resulting in health information useful for the whole society. For this reason they have been highly supported by the governments.

However conflicts have arisen and centered on how best to obtain consents from the research participants, breaches of confidentiality and the degree/nature of control that participants retain over donated samples and health information.

Disagreements include whether human sample donors should give broad consent for use of samples rather than specific consent for each research study. Some people view that the presence of such organization might threaten confidentiality addressing the informational risks that accompany biospecimen research primarily through standardized data security measures.

In addition, the research participants have an ongoing right to control their research samples. Thus, what about if A had information that could be potentially life-saving for B, has A the moral obligation to offer that information to B?

The perception toward biobanking in Jordan was investigated (Ahram et al., 2012) showing approval to the use of biospecimens in research and agreement to donate both biospecimens and relevant information for biobanking. In addition, the first biobank has been established in Jordan in 2014 where different challenges were faced to incorporate all current international guidelines for biobanking (Barr et al., 2014).

Beside the positive perception and achievements in Jordan, a lot must be done to educate the public about research and bioethics and to ensure the best-in-class continuous practice in biobanking.

References:

• Ahram M, Othman A, Shahrouri M. Public perception towards biobanking in jordan.

Biopreserv Biobank. 2012 Aug; 10(4):361-5.

 

• Barr MP, Souan L, MacGabhann P, et al. Biopreserv Biobank.The establishment of an ISO compliant cancer biobank for Jordan and its neighboring countries thorough knoelwdge transfer and training. 2014 Feb; 12(1):3-12.

 

• New Technologies Ethical Dilemma:

By: Fadwa Alhalaiqa

Inventing and introducing new technologies (such as electronic health record, virtual care (telehealth), telemedicine, robotics, and communication technologies including social media) play a significant role in health promotion and improving quality of care. It could be used for consultations, communication and intervention for healthy or ill people.  Also it help in providing  greater  availability of services  and access to health care providers,  reduce health care accessibility ‘s disparities, less travel time consequently lower costs and quality improvement. Nowadays many initiatives are conducting to invent new technologies so serve health.   All of these uses and advantages follow the ethical principles of beneficence (do good).  However, using these technologies  in research raised many ethical issues  and  principles, such as privacy, confidentiality,  in accurate or obsolete data, design issues ( information overload and usability, linking patient and personal information to achieve interoperability for individual records ), and security (Fleming ; Kaplan and Litewka 2008). Quality and accuracy of online data also another main concerns for the researchers particularly when use big data in medical field and telecommunication (Cai and Zhu 2015). Therefore, quality assessment framework and assessment process for big data are required.

Another ethical dilemma is informed consent by being aware of risk and benefit. New technologies may have new kinds of risks so consent implies consenting to risk impossible to anticipate. It seems ethical that those giving consent also should be aware of this.  For example when using counselling telephone based some people might think the voice that they heard as a member of their family as someone who really cared about them , meanwhile other might heard a high voice that might let them to feel guilt. Those participants built psychological responses (personal relationship with a telephone based system, feeling guilt).

Wearable technologies that could be attached or carried by participants are associated with ethical issues; this technology is used to monitor individual behavior (for example fitness tracking by bracelets and clip on devices) could violate the participants privacy since it record and track their behaviors.

One of the greatest innovations is  brain to brain interface (BBI) which allow direct communication from one brain to another without speech (Rao, Stocco et al. 2014). University of Washington research in 2014 used BBI by allowing person to give one way commands to the other.  To detect brain activity of the sender they used electroencephalography, meanwhile transcranial magnetic stimulation coil that controls receiver’s movement.  This violates many ethical principles (privacy, confidentiality, non-maleficence, security and autonomy); for example how can we protect a person from having accidental information removed or shared from their brains (i.e. hackers).  What about ownership rights in the case that two persons share an idea (autonomy). Additionally, the responsibility and accountability of the action obligated by the recipients of a thought should apply in whom particularly if a separate thinker is saying the actions?

Islam asks Muslims to go through teaching and innovation in order to serve people and serve the community; so technologies are allowed to be used.  Allah asks people to maintain and promote their health “لاضرر ولاضرا”. Allah asks to protect the human body from harm “when individuals die, Allah will ask him how he used and dealt with his body in his life” “عن جسده فيما ابلاه

From the Islamic point of view the human brain is appreciated; Allah differentiates between the human and animal brain in which people think , consider and feel what Allah creates; by these activities person faith and believe in Allah .  Each person in Islam is responsible for his actions (وَلا تَزِرُ وازِرَةٌ وِزْرَ أُخْرى [فاطر: 18]).  So Allah at the Day of Judgment will deal with people based on his/her action. Additionally based on Islamic belief “Allah make individual has choices and able to choose his action” “Allah do not draw a path for people to go throw with taken their desire to do so, people are not stylized their will. So Brain to brain interfaces is sensitive issues in Islam. However, these technologies could be used as intervention for unhealthy people.

As a researcher we have to consider that even if we use same technology there will be different consequences in different circumstances. Additionally they have to consider religion point view when apply technologies into practice. So researchers have to take in account the ethical issues that might be appeared. Additionally, measures that confirm security, privacy and confidentiality should be apply. Such as policy and regulations of using these technologies with people for research purposes.  Valid informed consent based on adequate information (risk and benefit and alternatives), capacity and voluntariness should be followed by researchers.

References:

– Cai, L. and Y. Zhu (2015). “The Challenges of Data Quality and Data Quality Assessment in the Big Data Era.”              Data Science Journal 14: 2.

– Fleming, D. “Telehealth: the ethical challenges of a new technology.” Center for health ethics, Health management and informatics. University of Missouri.

 

– Kaplan, B. and S. Litewka (2008). “Ethical Challenges of Telemedicine and Telehealth.” Cambridge Quarterly of Healthcare Ethics 17(4): 401-416.

 

– Rao, R., A. Stocco, et al. (2014). “A direct brain to brain interface in humans.” PLOS ONE 9(11): e111332.

 

• Ethics of using Animals in Research:

By: Moustafa Kardjadj

Animals are used in research or experimentation in place of human subjects for various reasons such as; disease treatment and prevention, treatment of injuries, basic medical testing, medical diagnosis, vaccinations tests, anesthesia, etc. Nowadays, there exists a wide spectrum of views on this subject, ranging from those concerned with animal “rights” to those who view animals only as a resource to be exploited.

An important part of the debate over animal rights centers on the question of the moral status of an animal. Most people agree that animals have at least some moral status that is why it is wrong to abuse pets or needlessly hurt other animals. This alone represents a shift from a past view where animals had no moral status and treating an animal well was more about maintaining human standards of dignity than respecting any innate rights of the animal. One common form of this argument claims that moral status comes from the capacity to suffer or to enjoy life. In respect to his capacity, many animals are no different from humans. They can feel pain and experience pleasure. Therefore, they should have the same moral status and deserve equal treatment.

Defenders of animal experimentation usually argue that animals cannot be considered morally equal to humans. They generally use this claim as the cornerstone of an argument that the benefits to humans from animal experimentation outweigh or “make up for” the harm done to animals. The first step in making that argument is to show that humans are more important than animals. If animals do not have the same rights as humans, it becomes permissible to use them for research purposes. Under this view, the ways in which experimentation might harm the animal are less morally significant than the potential human benefits from the research.

There is a middle ground for those who feel uncomfortable with animal experimentation, but believe that in some circumstances the good arising out of experimentation does outweigh harm to the animal. Proponents of the middle ground position usually advocate four basic principles that they believe should always be followed in animal research. These basics are called the 4Rs; replacement, reduction, refinement and rehabilitation.

Replacement: Refer to methods which avoid or replace the use of animals and these can be absolute by using in silico (computer based programs) and in vitro methods (human volunteers) or relative replacement (e.g., invertebrates, such as fruit flies and nematode worms).

Reduction: Refers to methods, which allow researchers to obtain comparable levels of information from fewer animals, thereby minimizing animal use (e.g. improved experimental design, modern imaging techniques, sharing data, and resources).

Refinement: Refers to improvements in procedures, which minimize pain, suffering and distress and allow general improvement of animal welfare (e.g., improvement in the living conditions of research animals, anesthesia and analgesia for pain relief).

Rehabilitation: Refers to after-care and/or rehabilitation of animals post-experimentation. All researchers using experimental animals have a moral responsibility to the animals after use.

References:

– Festing S, Wilkinson R. The ethics of animal research. Talking point on the use of animals in scientific research. EMBO Rep. 2007; 8:526–30. [PMC free article] [PubMed]

 

– Pereira S, Tettamanti M. Ahimsa and alternatives: The concept of the 4^th R. The CPCSEA in India. ALTEX. 2005; 22:3–6. [PubMed]

 

• Research Ethical Dilemma:

By: Nasr Al-Rabadi

The Jordanian society is a very closed and conservative one, as many people get to know each other based on their family names or the local region which they come from. All Jordanians are proud of their origin and family names. Despite of this pride, there is no discrimination in the society upon these characteristics as no one thinks of himself/ herself to be better than the others. Alternatively, it reflects their loyalty and attachment to their origin.

In this conservative society, any behavior of one member of specific family or region could be reflected on the other members. This behavior can bring either pride or shame to the whole family or the members originated from the same region. This issue can even affect the marriage relationships as well. Most of the marriages in Jordan are arranged marriages, where the couples are anticipated to suit each other based on the known characteristics of their families or original region. As well, most of our people are preferring the marriage to be from the same family to have more mutual cultural backgrounds and characteristics which are believed to ease the couple’s relationship after this arranged type of marriage.

The best medical practice is encouraging us to study the genetic characteristics of the people who are provided with the medical services. Especially in those cases, where the genetic profile can affect the treatment outcome or can predict the incidence and prognosis of diseases. This should be helpful in Jordan giving that the people preferred to marry from the same family or region. As such, research can take place to understand the characteristics of specific families or specific people living in local areas of the country. Thereafter, defining the best medical practice.

While this kind of informative research is encouraged, it can cause ethical problems related to publishing its outcome. If it was found that specific disease do excessively exist in one family or region, then, this may bring shame to that family. To be clearer, some diseases “especially psychological diseases” can be perceived as defects and can add negative characteristics to that family and their pride. In addition, this may affect the other families’ choice to marry from them. Moreover, Most of the clinical researches in Jordan are conducted in single medical center. These centers are attracting people from specific region or area. Therefore and unintentionally, the outcome of any research from specific center may be interpreted in the future as general characteristic to the people living at that area or region.

We believe that research studies should take into consideration these social characteristics and critical scenarios. The informed consents cannot be ethically validated without explaining the possibility of these scenarios to research subjects. Many researchers may not realize and consider these consequences when conducting their research. On the other hand, most of the Jordanians may not accept enrolling in some clinical trials if they understand that such scenarios may happen.

We should always obtain a valid consent when conducting research. This is an ethical must which cannot be avoided. Moreover, even if the Jordanian law is protecting the researchers after the study subjects signed the informed consent and even if the local publications are not currently attracting the public media, we should be aware that this problem may occur in the future. This is true as there are many examples in the literature about similar scenarios. Thus, more public educational efforts, confidentiality and more sensitive conduct of research should always take place to encourage Jordanians to participate in research with their fully awareness of its consequences.

 

Plagiarism Dilemmas:

By: Ahmed Abusiniyeh

Copying the original work of others, text that they had written, without their permission, plagiarism, is the most common problem among graduate students around the world. This mainly occurs during their thesis writing due to different reasons. For example, students may don’t have a sufficient background about the topic they are writing about, or there is lack of writing ability among some of them. Furthermore, the web is one of the major reason that encouraging plagiarism, students not even copy-past from online articles but also from different sources which are freely available on the internet. Many thesis and articles were rejected because of plagiarism, which have a negative impact on scientific research. In the points of view, piracy of other’s work is one of the most non-ethical issues that it needs to be corrected because it’s considered just as infringement on others intellectual property.

One of the false thoughts is that some students, even some researchers, assume that if they rearrange a few sentences or few words or added a few sentences, then they have absolved themselves from the need to properly acknowledge the original source. Merely editing the original text and/or changing a few words does not abruptly make the student the author of an original work and free him of his intellectual obligation.

Plagiarism is one of major dilemma that impacts the quality of research among graduate students in Jordan. The case that there is a shortage from the academic institute itself and the supervisor toward such kind of problems. It’s the supervisor responsibility to aware his students to such non-ethical issue. Weakness in the English language is the other main reason that may lead to such case, therefore, the student goes to the easy way, which is plagiarism. The concept of copywriting is missing among many of graduate students as they find it easy for them just copy others work and insert it in their thesis, which saves time and efforts in their belief. It is very important that the student have a good background about the topic he is writing about before start writing. So, the students must confess the fact, halt plagiarizing, and prepare for more background work.

The academic institutions need to carry over their responsibilities toward this problematic issue. There is a huge demand to incorporate ethical courses into the university curriculum to emphasize the importance of research ethics to the students, especially plagiarism. In addition, workshops and conferences are the other ways that may help in fighting plagiarism through enhancing the student’s awareness about such significant issues and how they can be addressed from different viewpoints. Anti-plagiarism software is another option that may reduce plagiarism when checking out the student’s thesis during the proofreading process.

 

• Is our knowledge of bioethics sufficient?

By: Kamal Al-Shami

Generally, most people think that ethics are rules to distinguish between right and wrong, such as the Golden Rule (Do you accept what we do to others for yourself). Ethical norms are learned in different social settings like at home, school, and religious institutions during different stages of human maturation. Most societies have legal legislation that governs behavior, but ethical norms are broader than those governed by law, which is the applying of ethics are belong to the person himself and the extent to which he or she is aware of their importance.

One of the most important areas in which the learning and application of ethics is important ; are the fields of scientific research in particular biomedical researchers. Ethical dilemmas have been encountered in many areas of medical research and have at times been the subject of much controversy. But unfortunately, how to deal with these dilemmas has not received much attention in the literature. The main reason that makes ethical dilemmas are difficult problems is the lack of sufficient knowledge of the researcher of ethics and the appropriate ways to deal with an ethical dilemma, especially in subjects which are so very confusing not only at the level of medical scientific research committees but also for the society.

Besides the knowledge, belief, and experience of the researcher; the decision of which issue is ethical or not is also affected by religious beliefs as well as cultural aspects. One example of such ethical dilemma is using somatic gene therapy versus germline gene therapy.  Somatic gene therapy involves introducing a good gene into the patient’s cells to treat complex disorders, but it will not change the chance of passing the disease to patients’. While, germline gene therapy involves modifying the genes in sperm or egg cells, which will then pass the genetic changes to next generations.

Although it has a potential for preventing inherited disease, this type of therapy is controversial. Because gene therapy involves making changes to the body’s genetic material, it raises many unique ethical concerns including; What is the best way to distinguish good from bad uses of gene therapy, Who has the authority to decides which traits are normal and which constitute a disability or disorder, Will the high costs of gene therapy make it available only to the wealthy, widespread use of gene therapy make society less accepting of people who are different (discrimination), Should people be allowed to use gene therapy to enhance basic human traits such as height, intelligence, or athletic ability?

Unfortunately, the distinction between gene therapy for disease genes and gene therapy to enhance desired traits, such as height or eye color, is not clear-cut. No one would argue that diseases that cause suffering, disability, and, potentially, death are good candidates for gene therapy. However, there is a fine line between what is considered a “disease” (such as the dwarfism disorder) and what is considered a “trait” in an otherwise healthy individual (such as short stature).

In conclusion, the huge increase in the quantities of medical research and the problems that researcher faced, especially the ethical issues as the one discussed previously, consider a great challenge and this is due to the limited knowledge of the researchers about research ethics. Establishing of such programs (RCR) will increase researchers’ capabilities of dealing with and solving moral problems in such research. Consequently, research ethics courses will not benefit the researcher only but also patients as well as increase research quality.

References:

1. Moral and Ethical Issues in Gene Therapyby Dr Donald M.Bruce
2. Ethical aspects of gene therapyby Alex Mauron, Associate professor of bioethics
3. Ethical Issues in Human Gene Therapyby LeRoy Walters, Kennedy Institute of Ethics, Georgetown University

 

• Researchers Ethical Dilemmas:

By: Manar AlAzzam

Researchers in different fields encountered ethical dilemmas in many aspects of their research. Such ethical dilemmas been the subject of much controversy especially in several instances where the researchers confronted with these dilemmas have little to no knowledge of how to tackle these issues. It is also empirical to notice that the researchers’ values, beliefs, experiences, and cultural background may interfere with ethical-decision making process.

In performing research there are a number of ethical principles is being implicated by the use of human subjects. These ethical principles require; doing good (beneficence), causing no harm (non-malfeasance), ensuring autonomy, dignity, bodily integrity, privacy, in addition to respect to human subjects involved in the research study. Such ethical principles imply that the researcher should attain informed consent, lessen the risk of harm on the participants, protect the confidentiality, anonymity and privacy of the participants, as well as ensuring the participants that they have the right to withdraw from the research study at any time with no consequences.

Greatest attention has been geared toward the moral-ethical debates  in research studies that used lived person, however, little attention has been given to involving dead human body in research. It has been reported that research involving the dead, particularly “heart-beating” cadavers, possibly will enable the testing of possibly innovative and “life-saving” medical treatments and procedures. The argument concerning these issues is embedded in the fact that in some instances using the human dead body involves an intrusive manipulation of the corpse. Which implies harm to the integrity of the dead body which contradicts the value of respect to the human cadaver; subsequently it symbolizes a “post mortem projection” of the individual alive. Nevertheless, the essential ethical dilemma is how to weigh the moral goods of such treatments and procedures against the needs to respect the human body (even after death), minimize harm, and the right to personal physical integrity.

Moreover, another great issue in this case is the informed consent and how to ensure the autonomy of participating in the research study. It is argued that in cases where there is no pre-mortem decision the family members consent should be pursued for using the cadavers in research studies. In doing so the deceased’s body should be protected from disrespectful incompatible research/treatment that might contradict the family’s postmortem preferences, values and believes. Moreover, such consent should improve public trust in the science of research.

From the Islam religious point of view, human body, “dead or alive”, is honored so it will be improper to interfere with it or dishonor it in any way that might violate the sacredness of it. Therefore, many scholars have acknowledged that using cadavers inappropriately cannot be considered permitted nevertheless of its benefits. Besides, in using the dead body; the body will be “stripped naked” which is not permitted in Islam unless it is appropriately justified. Furthermore, many rituals prescribed by Shariah will be denied (ritual bath (ghusl), shrouding (kafn), promptly burying)
Jordan is considered an Islamic Country which means that the dominant religion is Islam. Hence, the Islamic beliefs might have a great influence on the ethical decision making process among Jordanian researchers as well as families in terms of using human dead body in research. In summary, awareness should be raised about this imperative issue and studying it from different perspectives should be incorporated by decision makers and research committees in the country.

References:

Atighetchi D. Islamic Bioethics: Problems and Perspectives. New York: Springer; 2007.

Jones D.G., The Human Cadaver: An Assessment of the Value We Place on the Dead Body, Perspectives on Science and Christian Faith, No. 47, March 1995, pp. 43-51.

Sachedina A. Islamic Biomedical Ethics. New York: Oxford University Press; 2009.

 

• Supervisor researcher problem:

By: Mariam Abbas Ibrahim

The supervisor of students in any type of research should participate in choosing the idea or even improve it to put the research in the best track, with putting the budget and cost in mind specially when supervising undergraduates in a work deals with genetic analysis and molecular biological techniques. The problems really showed up when the trials consume the samples and reagents and the students could not be able to find a fund to start from beginning and collect a new samples, start the abstraction and do the analysis to complete the chosen research topic and trying to find another one which needs less budget and definitely much less time. As the researchers from any level might met in the research laboratory, some of them are about to finish and others are just going to start, the late desperate students usually tend to get a help from senior researchers who almost done their practical work and still have human samples which were taken for a certain research issue with informed consent. So the students who are in a harry of time are going to use the samples without taking a new informed consent from patients as the samples are already in their hand as a help from the finished researcher although they are going to analyze totally different biomarkers and not related at all to that which analyzed from finished researcher under certain informed consent from the volunteers. They even might not mention the sampling issue to their supervisor and the supervisor might not even ask them because he thought it is obvious. The ethical problem will be even bigger when the supervisor is going to publish the work as an article in a journal. It looks like all participants in this scenario were included in a research non ethical issue even if they were unwitting. The solution of such problem should be start from supervisors who should give all information about research ethics and ethical considerations to their students to improve their research knowledge and outcomes.

 

• Consenting patients in acute critical illnesses:

By: Nidal Eshah

Informed consent is a basic requirement for almost all research studies including human subjects. However, in some circumstances obtaining this consent would be impossible. An example for such situation is studying patients suffering from acute critical illnesses.¹ During critical illness, the patient will not be able to give the informed consent.¹ This might hamper exploring this area, negatively affect its development, and deprive next patients from the benefit of emerged knowledge came from the scientific research.

Researchers interested in this area, started to think in substitutes for the traditional way of obtaining the informed consent.^1,2 Thus several studies conducted to assess the perception of stakeholders about the accepted consent in similar situation.³ Such studies reported three main format: third-party, differed, or waived consent.³

In relation to the third-party consent, studies described several eligible sources who can take the decision to take part in the research studies when the patients are too vulnerable to take such decision.^4,5 The most accepted third-parties were the guardians, guardianship court, independent bioethics committee, and less likely the intensivist not participating in the research study.^1,4,5

Differed consent is an alternative format that used in specific situations where the patient or the third-party is not available or not able to give the consent before starting an emergency therapeutic experiment without delay.² After stabilizing the patient, a regular consent should then be requested from the legal guardians, or from the patients themselves.²  Waived consent is the least popular form,² and applied to urgent situations where there is no possibility to get consent from the patient himself, or from the guardians.^2,4

In conclusion, informed consent is a basic right to the patients in all health care settings. However, consent from patients in acute critical illnesses might be taken by specific alternative format.

References

• Halila, R. (2007). Assessing the ethics of medical research in emergency settings: how do international regulations work in practice?. Science and engineering ethics, 13(3), 305-313.
• Maitland, K., Molyneux, S., Boga, M., Kiguli, S., & Lang, T. (2011). Use of deferred consent for severely ill children in a multi-centre phase III trial. Trials, 12(1), 90.
• Gobat, N. H., Gal, M., Francis, N. A., Hood, K., Watkins, A., Turner, J., … & Nichol, A. (2015). Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness. Trials, 16(1), 591.
• Różyńska, J., & Czarkowski, M. (2007). Emergency research without consent under polish law. Science and engineering ethics, 13(3), 337-350.
• Duffett, M., Burns, K. E., Kho, M. E., Lauzier, F., Meade, M. O., Arnold, D. M., … & Cook, D. J. (2011). Consent in critical care trials: a survey of Canadian research ethics boards and critical care researchers. Journal of critical care, 26(5), 533-e11.

 

• Ethics in Bio-Medicine

Fahmi Alashwal

Ethics are essential aspect in our life, especially in the field of bio-medicine. For instance, the ethical dilemma of abortion is considered one of the most common issues discussed in bioethics. Abortion for fetus can happen for a lot of reasons such as medical reasons, fatal abnormalities, poverty, abusive relationship and gender-selective abortion. The decision of abortion is influenced by religion, socio-economic status and personal values. In this light, some people consider the fetus as part of woman’s body so abortion of the fetus is an issue related to the autonomy of woman. That means pregnant woman has the right to decide whether or not to have an abortion regardless of the reasons. On the other hand, others consider the fetus as a human being and so he has the right to life. So the doctor faces the dilemma of killing the fetus (taking away his right to life) or respecting the autonomy of the mother (her right to choose). That’s why a bio-ethical course is essential for all physicians.

Regarding the influence of religion and culture on abortion, in most Arab countries, abortion is generally forbidden after 4 months of pregnancy unless continuing the pregnancy threatens the life of the mother. It’s forbidden because Muslims believe that the life of fetus begins with ensoulment (approximately 120 days after conception). Before ensoulment, it can be allowed to end pregnancy in case of severe genetic disorders. However, after the soul is breathed into the fetus, even with mild genetic disorders, still it’s forbidden in some Arab countries. This issue need to be reconsidered, because when a malformed fetus is born, there is a significant burden on parents. For example, hospitalization and medical care can cause a huge financial harm on the parents. In addition to the stigma associated with the born of malformed children. So whether to end  the life of malformed fetus or not is still an ethical dilemma.

In brief, different factors may influence and affect the ethical dilemma regarding abortion decision in pregnancy women, and physicians should be ethically educated to provide a proper pre-abortion counseling for the pregnancy women.

Reference:

• Hessini, L. (2007). Abortion and Islam: Policies and Practice in the Middle East and North Africa. Reproductive Health Matters, 15(29), pp.75-84.
• Jotkowitz, A. and Zivotofsky, A. (2010). The ethics of abortions for fetuses with congenital abnormalities. European Journal of Obstetrics & Gynecology and Reproductive Biology, 152(2), pp.148-151.
• Patil, A.B., Dode, P. and Ahirrao, A., 2014. Medical Ethics in Abortion.
• Alamri, Y.A., 2011. Islam and abortion. Journal of the Islamic Medical Association of North America, 43(1).

 

• Ethical issues related to the use of genetically engineered animals

By: Ata Ali

   Ethics are generally the principal rules that effectively set the way by which all of us behave in any setting. These principles can lead to distinguish between right and wrong and establish the norms and standards for social interaction. While there is broad agreement on the principles that are applied on some ethical issues in the whole world, there are still some ethical issues that will create dilemmas among people from different cultures and/or religions.

Many topics have created controversy and debate among researchers on one side and different communities and public influential leaders on the other side. One of these topics is the use genetically engineered animals (GEA) in research, livestock, and food industry. This use has increased significantly in recent years, which brings ethical issues that are related to animal welfare and the environmental wellbeing.

There are many definitions and terminology to describe genetically engineered animals such as, genetically modified, genetically altered, genetically manipulated, transgenic, and biotechnology-derived. In general, any animal which undergoes an induced change in its DNA can be considered as genetically engineered animal. Furthermore, cloned animals can be contained under the umbrella GEA.

Ethical issues arise from the use of GEA include and not limited to the invasiveness of the methods used to develop these animals, the need to use large number and the environmental effect. For these reasons, it is a must to establish ethical committees to decide whether it is necessary or not developing these GEA. And to evaluate the methods that will be used to develop these animals and to predict the effect that will be induced on the environment.

In Arab and Islamic communities in general, the idea of intentional manipulation of the genetic material of any living being might be forbidden and it might be considered as a sin. On the other hand, developing these animals especially those related to human diseases’ models might be the only solution to understand the nature of these diseases and investigating any possible treatment for them. So, it is an essential role for any ethical committee to build a bridge and reduce the gap between the scientific bodies and religious authorities and local communities. Furthermore, we as scientists have an essential role in spreading the knowledge about GEA between our students, which will lead to the awareness of local communities about these issues.

References:

Elisabeth H. Ormandy et al., Genetic engineering of animals: Ethical issues, including welfare concerns. Can Vet J. 2011 May; 52(5): 544–550.

 

• Mitochondrial donation: the ethical issues

By: Iman Amrani

On February 3rd, 2015, the UK parliament voted in favor of the draft “Human Fertilization and Embryology (Mitochondrial Donation) Regulations” which allows the British researchers to pursue a novel in vitro fertilization (IVF) procedure involving mitochondrial DNA (mtDNA) donation. So far, no other country has introduced laws to approve this new technique.

The world’s first child resulting from this new technique also known as “mitochondrial transfer (MT) technique” or “mitochondrial replacement therapy” (MRT) was born on April 6th, 2016. The boy’s Jordanian parents travelled to Mexico where a US-based fertility specialist has carried out the procedure. This event attracted intense media coverage, with ‘three-parent baby’ dominating the headlines.

This special form of IVF consists on removing the nuclear DNA (nDNA) from an oocyte provided by a woman with dysfunctional mtDNA and placing it into another oocyte provided by a woman with “healthy” mtDNA after its nDNA has been removed. The final fertilized egg thus contains three genetic materials: nDNA from the mother and from the father and mt DNA from the oocyte donor.

Dysfunctional mtDNA can result in a clinically heterogeneous group of disorders called “mitochondrial diseases”. Both sexes can be affected but only women are at risk of transmitting the mutation to their children. At present time, there is no effective cure for this type of diseases and available therapies are mostly limited to symptomatic relief.

The purpose of the MRT is thus to prevent the transmission of pathological mutations in mtDNA from affected women to their biological offspring and to allow these women to have “healthy” children to whom they are genetically related.

Despite its promising outcomes, MRT has raised many social and bioethical issues. The general concerns are mainly about the safety of both the offspring and the donor, the child’s autonomy and identity, the harms for society, the ethics of introducing heritable genetic modifications, and the “slippery slope” concerns.

Some examples of the safety issues pertaining to the offspring is the possibility of carryover of dysfunctional mtDNA and the associated long-term risks in the next generations, the nuclear-mitochondrial mismatch and possible epigenetic modification of nDNA, and the abnormal embryo or foetal development.

The autonomy issue lies in how to provide “consent” to accept risks on behalf of a child who does not exist. Another ethical concern lies in the psychological impact of MRT. Children conceived using this technique would have identity problems related to their perception of having “three parents”. Currently no empirical evidence exists about the psychosocial wellbeing of these children, which makes it difficult to determine if any of these worries will eventually materialize.

The possibility of introducing heritable genetic modifications is another major and controversial concern. Should manipulation of mitochondrial genetic material be viewed differently from germline modification of nDNA?

An additional worry is related to what is known in bioethics as the “slippery slope”: that once the door is open to germline genetic manipulation, it is only a matter of time before it is used for human enhancement instead of therapeutic purposes.

Taken together, these ethical issues raise serious concerns about the potential “benefit” and “harm” of the MRT. Although, there has been some success relating to this procedure, it is still in its early experimental stages. Therefore, ethical and safety problems of the MRT need to be resolved, and in depth understanding of the biological mechanisms and results need to be gained before any further clinical application of this technique can be approved.

References:

1. Appleby JB. The ethical challenges of the clinical introduction of mitochondrial replacement techniques. Med Health Care Philos 2015,18:501-514.
2. Bredenoord AL, Braude P. Ethics of mitochondrial gene replacement: from bench to bedside. BMJ 2010,341:c6021.
3. Brandt R. Mitochondrial donation and ‘the right to know’. J Med Ethics 2016,42:678-684

 

• Ethical Issues in dealing with Dead human subjects

By: Mehdi Ben Khelil

Medical and scientific researches are vital for humanity in order to evolve and to answer emerging issues related to public health. Researchers are eager to discover revolutionary findings and without a solid rampart which is represented by ethics principles, they may forget about preventing abuse of their research subjects especially humans but also animals. When it comes to live patients the limits may be clear for researches to act respecting patients’ autonomy, acting with beneficence and without maleficence and respecting justice. However, when it comes to working with dead people to collect and analyze post-mortem samples, these limits would be rather blurred.

In fact, in countries with Islamic background, working with dead people is culturally sensitive.

The population the Prophet Muhammad quotation: “Breaking the bone of a dead person

is akin to breaking the bone of a living person” represented an at first sight limitation even to perform autopsies for the determination of the causes of death. When it comes to scientific research, using human corpses and/or post-mortem analysis, and in addition to the cultural barriers, researches faces other ethical dilemma. We can cite at least two big ethical issues in relation with performing post-mortem research.

First, the valid consent, which represents a compulsory condition, would not be possible to collect from the person himself. I occidental countries, corpses donation is a common procedure. However, in Arabic and other Muslim countries such a procedure will be unacceptable as it will delay the burial and religious rules would privilege a quick burial as soon as possible after death. The alternative of collecting consent from guardians of the corpse may also be problematic. In fact, the guardians may have conflicts of interest with the researchers, or with the research subject or with the dead person himself. In the same idea, the researcher may find himself in a situation where the guardians will give paradoxical consent. In more specific situations, performing research on an unknown person corpse, would suggest the absence of any form of consent which is an unethical behavior. The issue with collecting consent from guardian may also be difficult when it comes of certain vulnerable persons at their life (e.g. children, alienated persons…) who would not be able to give valid consent at their life.

The second ethical issue we have chosen to analyze is represented by research in the field of molecular biology and genetics. In fact, here again, the burden in unclear, between performing DNA analysis to compare traces observed in a crime scene, or for a purpose of identification of an unknown corpse and that of performing a research about a coding or non-coding gene. The guide of the researcher should be their duty of fairness by performing post-mortem research only if there will be a benefit for humanity. The second guide should be their duty of beneficence by respecting the corpse, the willing of the person before his death and preventing any kind of harm including an unnecessary delay for burial or an unnecessary collection of a big biological sample or of an organ.

These two examples of situations of ethical dilemma are not exhaustive and the list could be very much longer.

The keys to act correctly are represented by building trust between the researcher and the corpse guardians, to communicate efficiently about the purpose of the research, to try to know the decision of the dead person when he was alive, to look for potential conflict of interest among the potential guardians of the corpse, to prevent harming the person after death, to act with beneficence and with fairness in a way that guarantee a positive input for humanity.

References

1- Gurley ES et al.  Family and community concerns about postmortem needle biopsies in a Muslim society. BMC Medical Ethics 2011, 12:10.

2- Rispler-Chaim V: The ethics of postmortem examinations in contemporary Islam. Journal of Medical Ethics 1993, 19(3):164-168.

3- TOMASINI F. Is post-mortem harm possible? understanding death harm and grief. Bioethics 2009; 23(8): 441-449.

4- Van Assche K. Governing the post mortem procurement of human body material for research. Kennedy Inst Ethics J. 2015; 25(1): 67-88.

 

• Informed Consent in Retrospective Studies

By: Nour Al-Sawalha

There are several ethical dilemmas that are related to informed consent. It is a well-known practice that interventional or prospective studies require the acquisition of informed consent from all participants. However, researchers, from Jordan and worldwide, consider any retrospective study does not require informed consent. This concept is based on the facts that the researcher does not obtain any new sample from the study’s subjects, the data that are being collected and analyzed are parts of the routine diagnosis and management, and data are anonymous. Therefore, the study’s subjects are exposed to minimal risk, if any. In addition, researchers might find it hard to obtain informed consent for retrospective studies especially if there are dead cases, which complicate the scenario.

In depth analysis of the requirement of informed consent reveal a controversy issue. The absence of informed consent in some retrospective studies will affect the autonomy of the study’s subjects and their rights as well as privacy might be violated. It is well-known that for any research to be ethical, four principles should be applied; autonomy, beneficence, non-maleficence, and justice. If the collected data include private and sensitive information that could lead to the development of stigmatization, then an informed consent should be sought. Otherwise, autonomy is not only affected, but also beneficence and non-maleficence principles are not valid anymore.

Results of HIV test, drug abuse, sexual transmitted diseases and psychology assessments are examples of such private details. The same concept is also applied for results of genetic tests, which is a very sensitive issue in Mediterranean culture. The results could identify the subjects and reveal the risk of developing certain diseases, such as mental diseases, which eventually lead to genetic discrimination. Genetic discrimination will harm the subject himself and his family for generations, especially knowing that the Jordanian community is a small one and most people would know each other.

In conclusion, from the ethical perspective, obtaining the informed consent should be based on the study’s nature and the details of the collected information and not only on the general type of the study.

References:

1. Stefánsson E, Atladóttir OY, Gudbjornsson B. Are ethics rules too strict in retrospective clinical studies? Acta Ophthalmol. 2008 Sep;86(6):588-90.
2. Kıraç FS, Is Ethics Approval Necessary for all Trials? A Clear But Not Certain Process. Mol Imaging Radionucl Ther. 2013 Dec;22(3):73-5.

 

• Use of corpses for scientific research: without the consent of the deceased: is it ethically acceptable?

By: Nadia Alkadmiri

The use of corpses for scientific purposes takes a great interest for teaching, anatomy and scientific research. The corpse has a status peculiar to itself, based on traditions, pity and moral values, and not only on the matter of which it is composed being an object and not a subject.

Since 1 January 2014, the Law on Research on Human Beings (LRH), definitively defines research on human diseases as well as the structure and functioning of the human body, practiced on people deceased. It may be practiced if the person concerned has, during his lifetime, consent to the use of his body for research purposes. In the absence of a document attesting to the deceased’s consent or refusal, the body or parts of it may be used for research purposes with the consent of relatives of the deceased. In accordance with the requirements of biomedical ethics, any physical act on person whether during his lifetime or after his death, requires its consent. This requires informed information, which covers all the important points relating to the intervention including the type, extent and consequences of the intervention. Can this consent prove to be sufficient and is it likely to be limited to solve the problem of compliance? Some practices go through consent (experimentation), others go without (Presumed consent)?

What will be our ethical approach if the relatives give the consent of the deceased to in practice deeds for scientific purposes and deceased never would have done if it was alive?
For unknown deceased, is it sufficient to have the prosecutor’s consent to take samples and use them for research projects? Do we respect the pain of the family of the unknown deceased? Do we respect the dignity and pity of a corpse? If we limit ourselves to a simple informed consent granted by the relatives or the public prosecutor to carry out acts without the consent of deceased person, can we say that we work within the framework of the respect of ethics?

If the corpse is considered to be a physical entity which is transformed into an object for experimental purposes, this consent seems sufficient for the interest of the scientific community. But if it is considered as a moral and spiritual entity, is consent sufficient in the absence of the agreement of the deceased himself?

References:

• Senate of the Swiss Academy of Medical Sciences. Use of corpses or part of corpses in medical research and pre-graduate, postgraduate and continuing training.2014
• Carole Peter-Decarsin. The dead body: the subject or object of the autopsy or the birth of the corpse at the death of the man. DEA 1995.
• UNESCO, 2011. Casebook on Human Dignity and Human Rights, Basic Bioethics Program, Case Study Series No. 1, UNESCO, Paris, 144 p.

 

• Surrogate motherhood and ethical and religious consideration:

By: Ruba Darweesh

Infertility is a condition that is affecting a huge number of individuals all over the world, and it is described as “a disease of the reproductive system that is defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse” [1]. The consequences of such condition usually resulted in different psychological and social impacts. Such impacts make the available techniques for decreasing and prevention of infertility of great importance. There are so many means of Assisted Reproductive Technologies (ART), and their use in different countries depends on ethical, religious, cultural, medical and political debates.

One type of ART is the surrogacy or surrogate motherhood, which is usually used in the conditions of uterine infertility, recurrent miscarriages, multiple failures of In Vitro Fertilization (IVF) or maternal diseases during gestation [2, 3]. Surrogacy mainly happens in two different forms: complete or partial surrogacy [2]. Complete surrogacy happens when two gametes from the “genetic couple” or “commissioning couple” are used for fertilization, via IVF, and then followed by transfer the produced embryo(s) to another woman’s uterus, which called the “surrogate mother” or “the host”. The surrogate mother in this case is obliged to return the baby to the couple upon delivery [2, 3]. On the other hand, partial surrogacy happens when a strange woman is inseminated with the sperm of a man under the condition to return the baby to the sperm owner after delivery [2]. Because of the presence of a third party, surrogacy will result in a different “abnormal” structure of the family that creates the controversy. Moreover, many complications may happen, such as that the surrogate mother refuses to give up the custody of the baby directly after birth, or the parents refuse to take the child if the child has any abnormality, in addition to the long-term psychosocial effects on the child [3]. Such complications, in addition to others, increase the religious controversy that surrounds such methods of ART.

In Islam, only the wife’s and the husband’s gametes, homogenic insemination, are allowed to be used and only if this happens during the marriage time. Otherwise heterogenic insemination, which includes a third party, is strictly forbidden and “haram” which is explained by the respect of the female body and the motherhood through social and biological consideration, in addition to the fear of the jeopardy of genealogical and heritage line of the family [4, 5]. On the other hand, the Catholic Church is strictly prohibiting all forms of ART, especially if surrogacy and heterogenic insemination is involved (McCormick, 1992). In Judaism, surrogacy is not forbidden, however certain legalization should be taken into consideration, such as the child born as a result of surrogacy will belong to the father who gave the sperm and to the woman who gave birth [6, 7] according to the law that was passed by the Knesset, in 1996, which describes the practice of surrogacy in Israel [2, 7]. In conclusion, the debate that is related to the ethical-, cultural-, and religious-aspects of surrogacy is still present, and depends on the type, details and all conditions involved in the surrogacy procedure.

References:

1. Organization, W.H. Revised glossary on Assisted Reproductive Terminology (ART). 2009 2017 [cited 2017 August 6]; Available from: http://www.who.int/reproductivehealth/publications/infertility/art_terminology2/en/.
2. Fasouliotis, S.J. and J.G. Schenker, Ethics and assisted reproduction. Eur J Obstet Gynecol Reprod Biol, 2000. 90(2): p. 171-80.
3. McCormick, R.A., Surrogacy: a Catholic perspective. Creighton Law Rev, 1992. 25(5): p. 1617-25.
4. Husain, F.A., Reproductive issues from the Islamic perspective. Hum Fertil (Camb), 2000. 3(2): p. 124-128.
5. Arbach, O., Ethical considerations in Syria regarding reproduction techniques. Med Law, 2002. 21(2): p. 395-401.
6. Hirsh, A.V., Infertility in Jewish couples, biblical and rabbinic law. Hum Fertil (Camb), 1998. 1(1): p. 14-19.
7. Benshushan, A. and J.G. Schenker, Legitimizing surrogacy in Israel. Hum Reprod, 1997. 12(8): p. 1832-4.

 

• Conflict of interest

By: Manel Ben Fredj

The aim of each researcher is to conduct a good quality research with the necessary of human and material resources. For that reason, many of them applied for funding in order to conduct their researches under the best possible conditions.  However, the acceptance to be funded may expose the researcher to risk of conflict of interest with the funding organization. A conflict of interest is a situation in which a researcher is involved in multiple interests which create a risk that findings may be unduly influenced by secondary interests. It is a challenge to carry out reliable research without being influenced by the funding and sponsoring institutions which may threat the scientific integrity. Therefore, funding the biomedical research is one of the most important ethical issues given the threat of a conflict of interest and the continued increase of industry support in research in last years. The relationship between the researcher and the sponsor should be organized by standard guidelines and clear contracts that determine the rights and duties of each part. Those contracts serve to avoid any misunderstanding that may encounter both parties in the future and to prevent an eventual loss of time, efforts and/ or resources.  Maybe the presence of a neutral third party can be recommended to play the role of judge in case of conflict between both parties. This can be useful also to make researchers more confident and protected against any type of abuse of authority from the sponsors.

The literature is particularly rich of examples about this ethical issue. The consequences of a conflict of interest are serious and in many cases even the disclosure of a potential existence of a conflict is not enough to cure the problem. The consequences includes the lost of investment, withdraw publications and negative reputation.

Each researcher have to receive training in research ethics which make him more conscious and attentive regarding the risk of  conflict of interest and many other ethical issues.

• Researchers Ethical Dilemmas:

By: Omar Alomari

The last era has witnessed a great expansion in all aspect of humans’ daily life.  Medical field is not an exemption. New medical research has helped the communities and increased their quality of life but with conducting research new challenges were raised. One of the ethical issues that researchers can face is encountering patients who express their suicide attempts to the researchers and ask them not to tell others. This leaves the researchers in ethical dilemma.

Ethical dilemma is defined as when the individuals are in a position where they have to choose between mutually exclusive alternatives that both of them initially appear right. In relation to ethical principle, the ethical dilemma can rise when incompatibility between two ethical principle are exist. In another words, when one ethical principle is violated by the other. In this case the researchers are left in place where either to respect participant’s decision or not to disclose their feelings. This put the participant in great risk to commit a suicide or disclose participant’s suicide attempts and compromise the trust relationship that established between the researcher and participant.

The researcher should choose between the three ethical principles autonomy, non-maleficence and beneficence and they cannot consider one without violating the other. In this context, if the researcher respects the participants’ autonomy, they would violate the other principles non-maleficence and beneficence. However, when the researcher respects beneficence, the ethical principle non-maleficence comes to augment it.

Generating ethical decision is never mad easy and it’s more complicated than this as too many factors come to play in regards to each decision. For example, the religions of both of the participant and researcher have a significant impact on this. That is, if they are both Muslims the researcher would stop him immediately as in Islam is forbidden to commit a suicide as from Islamic perspective our bodies are not belonging to us but it belongs to Allah and Allah command to us to save them as much as possible.  Another factor is related to the personal nature of the researchers. That is, the researchers’ maybe doctors or nurses and they swear the oath of doing good, protecting the patients and conducting action to benefit the others. In this case, the fine distinct between the mind of researcher and personal nature of nurses and doctors may melt and they would disclose information to protect the participant as this is what they study and train for.

To sum up, making an ethical decision is never mad to be easy because many factors come to play when consider it. Arabic world need for specialised ethics comities that support and solve any ethical dilemma rise during practice.

References:

Beauchamp I, Walters L. Contemporary issues in bioethics. 6 ed., vol. 25 (8). Belmont, CA: Wadsworth; 2003. p. 178e80.

 

• Incidental Findings

By: Rana Aljaber

Incidental finding  (IF) is defined as  an observation of potential clinical significance concerning research participant, unexpectedly discovered in the course of conducting research and is beyond the aims of the study .The term of IF is used to both anticipatable and unanticipatable finding , which may have potentially serious implications for a participant’s medical health, psychological well-being, employment, and insurance coverage as well for researchers and their institutions , so this issue raises ethical, legal, and regulatory concerns .

The current challenge for this ethical dilemma is to identify specific criteria to determine when it is ethically obligatory to disclose and not disclose IFs to patients or participants since some information revealing a condition likely to be life threatening or genetic information that can be used in reproductive decision making while other information revealing a non-fatal condition but can’t be avoided.

The dilemma in this issue is when the information revealing a condition that is not likely to be of serious health or reproductive importance or can’t be ascertained, some researchers will not disclose that to research participant.

The Bioethics Commission found four ethical principles to be particularly applicable to the ethical assessment of IFs: respect for persons, beneficence, justice and fairness, and intellectual freedom and responsibility.

Limited guidance is available for dealing with such dilemma; however we can adapt some of the ethical approaches to IFs proposed in many articles and end up with general recommendations that can help in solving this issue:

• Researchers should anticipate and plan in advance for IFs and how they will report and respond to these IFs.
• Evidence-based best practices are needed to guide decisions regarding disclosure of IFs.
• Patients’ preferences about disclosure of IFs should be taken into account.
• Good counselling on each condition included in the list of possible IFs.
• Researchers should consult IRB to explore more options ,If monitoring and reporting IFs are not feasible.

References:

– Pinato DJ, Stavraka C, Tanner M, Esson A, Jacobson EW, et al. (2012) Clinical, Ethical and Financial Implications of Incidental Imaging Findings:Experience from a Phase I Trial in Healthy Elderly Volunteers. PLoS ONE 7(11): e49814. doi:10.1371/journal.pone.0049814 .

– Anticipate and communicate Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts , Washington, D.C.December 2013 , http://www.bioethics.gov

– Martin Hoffmann MA, Two basic ethical problems of incidental findings in population-based, non-intervening magnetic resonance imaging (MRI) research, Journal of Evaluation in Clinical Practice ISSN 1365-2753.

– Mohammed Ghaly , Eman Sadoun, Fowzan Alkuraya , Genomics in the gulf region and Islamic ethics ,

A Special Report in Collaboration with the Research Center for Islamic Legislation and Ethics.

– Management of incidental findings detected during research imaging, a report by Representatives of research imaging Centers, professional Societies, Regulatory Bodies, Funding organizations, Royal Colleges involved in research imaging and patient organizations in the UK .

 

• Confidentiality of personal health information used for research

By: Saddam Aldemour

When patients seek health care they are assumed to give implied consent for the carers to access their health records. The Data Protection Act also permits the use of “sensitive personal data” for medical purposes (including medical research) without consent, provided the user is subject to the same duty of confidentiality as a healthcare professional. Explicit consent is mandatory to be taken from the participant to use a personal data for medical research especially for multicenter or secondary research when people who are not part of the original clinical team need access to the data.

As the participant, no longer be available and explicit consent could not be obtained, the alternative to seeking this consent is to preserve the confidentiality of the data subjects through anonymization.

In order to develop a model of confidentiality practice, there should be a balance between public concerns regarding unprofessional disclosure of participant data with the need for access to data for research. Recently there are report from the Academy of Medical Sciences use a personal data in medical research conduction.  If the data have been anonymized and the person cannot be identified through linking the information to other publicly available data, in Europe and the US, data protection and therefore the need for consent, does not apply.

Databases that do retain linkage to the original data subject can give rise to legal complications. However, some time it is difficult to conduct a research if all identifiers are stripped from the data. Research related to genetic and family issues have a major contribution to increase our knowledge of diseases and losing the ability to link family members may make research difficult. Some of information such as names and dates of birth are needed to cross reference each subject.   In addition to attitudes, and commitment of persons who manage a research database are as important as the policies and measures used to protect the privacy of it is data subjects. Staff required a program of training to access the data.

In conclusion, Public confidence in medical research must be maintained and boosted, since most medical research depends on volunteers. Firstly, however, we must understand what the contemporary public concerns are and work towards a consensus that can balance these appropriately against the benefits of using data for research. This is essential before good confidentiality practice in research can properly be defined.

References:

• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1513443/
• Academy of Medical Sciences. Personal data for public good: using health information in medical research. London: Academy of Medical Sciences, 2006.
• Directive 95/46/EC of the European Parliament and of the Council of Europe of 24 October 1995, on the protection of individuals with regard to the processing of personal data and on the free movement of such data. Official Journal of the European Communities 1995; L281/31.
• Health insurance portability and accountability act, 1996. Washington, DC: US Government Printing Office, 1996.

 

• Tissue engineering ethical dilemma

By Walid Alzyoud

One of the ultimate goals of the modern tissue engineering is to work on restoring a normal physiological function either at the tissue level or at the whole organism level which is conceptually a good behavior not a bad one. It represents a hot bioethical topic these days the one is related to utilize the therapeutic uses of medicine in cosmetic uses. So the medical doctor who can use surgery for therapeutic goals as in burns is the same who can use surgery for cosmetic goals as in skin grafts for the sake of a full-face transplantation.

This actually led us to several bioethics related questions. For example, should the tissue replacement be restricted to those patients who have severe facial burns? How can we have a determinant distinction if it is a face disfiguring damage or not in such a case? What about the newly changed nature of human face identity? Can any person use any face? Can a Hispanic person, for example, have a full-face transplant from a Chinese donor? Can an ugly person have a full-face transplant just because he likes to be beautiful and who can determine who is ugly and who is not?

By the way, this amended identity issue is not relatively a brand new ethical concern, it is only highlighted recently. According to different human race cultures, heart or brain transplantations, as examples, might lead to the same concerns about the human identity even at spiritual or moral levels; this is in countries that have solid inherited social and ethical systems such as India, Philippine or China… Etc.

Taking all of those ethical aspects together, and in the presence of such a great transplant technology, it is a must to measure how the market and profit may force the direction of research and technology to move toward a specific direction rather than others. In other words, it is important that the values of personal interest as profit and efficacy not to predominate the values of general interest as healing, compassion and solidarity. Powerful applications related to tissue engineering and technology are forming a growing nucleus of an inevitable global conflict of interests between the driving market for this technology versus the serious needs for new spare parts tissues and organs especially in an aging population. At the end, the scientific community is immediately invited to have a global ethical summit where such emerging issues have to be fully characterized.

Reference:

Lanza, R. P. (Robert P., Langer, R. S., & Vacanti, J. (2014). Principles of tissue engineering.

 

• Children Assent and Parental Permission in Research on Children

By: Rawan Ababneh

The ethics of research with children is a balance. On the one hand, the focus is on ways of preventing and reducing harms in research and ensuring adequate protection of children and young people. On the other hand, there is concern about the risks and harms of silencing and excluding children from research about their views, experiences and participation.

According to UCL Research Ethics Committee Research, involving children and young people should only be conducted where:

• The research question posed is important to the health and well-being of children. However, a research procedure which is not intended directly to benefit the child subject is not necessarily either unethical or illegal. Such research includes observing and measuring normal development and the use of ‘healthy volunteers’ in controlled experiments;
• The participation of children is indispensable because information available from research on other individuals cannot answer the question posed in relation to children.
• The study method is appropriate for children.
• The circumstances in which the research is conducted provide for the physical, emotional and psychological safety of the child.

All proposals involving research on children should be submitted to a research ethics committee for approval.

We have two definitions that should be recognized:

Assent: In the US and UK guidelines it is defined as ‘affirmative agreement to participate’ and mere failure to object is not deemed assent. The term “assent” gives recognition to the role for children that lies between no involvement in discussions and full decisional authority. There is no requirement for a signature. Some people take the view that obtaining a signature from children can detract from “the important goal of engaging the child in discussion”. • Assent is not authoritative i.e. it is not sufficient to authorize participation in research.

Dissent: Means that children’s objections and distress get taken into account even when the child is incapable of taking part in discussions or deciding. When the concept of dissent is recognized, it is more likely that the harm of overriding a child’s preference will be included in the calculation of benefit and harm. Dissent can be about a child wanting to withdraw from research.

In addition, the related question as to when a child develops the capacity to provide meaningful and developmentally appropriate child assent (or dissent) must be addressed. For example, when does a child develop the capacity to understand that a proposed intervention does not offer him or her any prospect of direct benefit?

Parental Permission : Means the agreement of a child’s parent(s) or guardian to the participation of their child or ward in a clinical investigation. Parental permission is held to the same standards as informed consent and is required (absent a waiver) for research involving children. The purpose of parental permission is to protect a child from assuming unreasonable and unjustified risks given his or her immaturity. To accomplish this task, a parent must receive all of the necessary information and be afforded the same opportunity to make a voluntary choice.

The conflicting question is that Is parental consent always needed?

Parental consent generally provides additional protection when a young person is not able to understand or appreciate what research entails or the young person is not willing to properly consider information, but there are also situations where seeking parental consent is (i) inappropriate or (ii) offers no protection. For instance, (i) where parents are neglectful or abusive – however, consent from another adult might be appropriate where that adult is a person who has responsibility for the child or young person’s safety, security and wellbeing, (ii) in some situations asking for parental consent may be risky rather than protective.

Considerable disagreement remains about many fundamental components of assent, including: the age at which investigators should solicit assent from children; how to resolve disputes between children and their parents; who should be involved in the assent process; the relationship between assent and consent; the quantity and quality of information to disclose to children and their families; how much and what information children desire and need; the necessity and methods for assessing both children’s understanding of disclosed information and of the assent process itself; and what constitutes an effective, practical, and realistically applicable decision-making model.

 Conclusion:

In recent years, there have been attempts to use a more standard measurement to determine children’s understanding of research. In determining whether children are capable of assenting, the IRB must take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research.

References:

• National Children’s Bureau: Guidelines of Research London NCB 1993
• Roth-Cline M, Nelson RM. Parental Permission and Child Assent in Research on Children. The Yale Journal of Biology and Medicine. 2013;86(3):291-301.
• Anne Greig and Jane Taylor: Doing Research with Children (Sage Publications) 1999 p.148
• National Institutes of Health Inclusion of Children as Participants in Research Involving Human Subjects http://grants.nih.gov/grants/funding/children/children.htm
• A handbook for Human Research Ethics – 4 – Committees and Researchers 2010

 

• Is it ethical to use placebo in clinical research for cancer pain management when current evidence based treatments exist?

By: Fadia Mayyas

The “gold standard” for evaluating the efficacy of a new therapeutic drug is randomized double blinded placebo controlled trial.

The unethical use of placebo in clinical trials in the developing countries has been reported in Africa, Asia and India, and possibly still being conducted!

Generally speaking, placebo controls may be justified to prove efficacy of a new drug in the absence of effective therapy, in diseases that have spontaneous remissions, or have an uncertain and unpredictable course; when existing treatments have minimal efficacy or have serious adverse effects. Use of placebos may also be justified to assure blinding of health care providers and patients to reduce bias. When clinical trials meet these criteria, they must also fulfill additional criteria to be ethical including patients consenting, and an assurance that placebo patients are not more likely to die than those in the active drug group. In addition, studies should assure that placebo participants are not more likely to suffer irreversible defect/ reversible serious harm, morbidity, disability, or even severe discomfort.

The use of placebo as a control in cancer studies for pain management possess major ethical issues especially when evidence based- standard treatment exists, and if not given could increase patient suffering of pain. From an ethical point of view, there is no medical justification for the use of placebos to evaluate or treat cancer patients who are in pain especially for those at end of life. Use of a placebo to determine whether the patient at end of life is really in pain or for example to diagnose substance abuse or addiction is under no circumstances appropriate.

the American Bar Association (ABA) and the American Pain Society (APS) advocate federal state and governments to fully support the right of patients suffering from pain to be informed of, choose, and receive effective pain and symptoms management, even if such management might result in physical dependence, analgesic tolerance, or even shortens the patient’ life. The Declaration of Helsinki argues that all research participants should be entitled to a “standard of care”. Thus, when clinical researchers cannot offer the standard of care by offering a placebo instead, they break their commitment to their patients by denying them the right to proven treatment.

In my opinion, substituting placebo for accepted forms of pain therapies is undertreating the patient. Although placebo efficacy in pain management has been previously reported, the ability for placebo to control pain occurs in fewer patients and for shorter duration than do active pain therapeutic modalities. Additionally, placebos are associated with side effects and potentially precipitate hyperalgesia or withdrawal in patients previously treated with pain medications. Moreover, the physician-patient relationship might be irreparably damaged if the patient knew that he received a placebo instead of an active treatment.

In fact, the use of placebo can act as a “suicidogenic,” whereby individuals in pain who are given inadequate medication for pain control may be prompted to hasten their death.

It is therefore inappropriate and unethical to substitute a placebo for a medication that is known to be effective, because using placebo in conditions associated with morbidity and mortality violate the principle of beneficence/non-maleficence even when patients are consented.

However, placebo-controlled cancer trials might be in some circumstances scientifically feasible, ethically justifiable, and may be necessary or recommended to meet regulatory standards for drug approval. Using cross-over design or randomized withdrawal trial designs, requiring inclusion of state-of-the-art palliative care, and developing valid and acceptable surrogates for survival are critical strategies to address some of the ethical dilemmas associated with placebo-controlled trials.

References

1. Michels K B, Rothman KJ. Update on unethical use of placebos in randomized trials. Bioethics.2003 Apr;17(2):188-204.
2. Howick J. Questioning the methodologic superiority of ‘placebo’ over ‘active’ controlled trials. Am J Bioeth. 2009 Sep;9(9):34-48.
3. American Bar Association Resolution. Available at: http://www.abanet.org/poladv/congletters/106th/pain091400.html and http://www.abanet.org/poladv/congletters/106th/pain072800.html. Accessed March 3, 2005.
4. The Principles of Analgesic Use in the Treatment of Acute Pain and Cancer Pain. 5th ed. Glenview, Ill: American Pain Society; 2003.
5. Karen J. Nichols, DO; Katherine E. Galluzzi, DO; Bruce Bates, DO; Benneth A. Husted, DO; Jimmie P. Leleszi, DO; Kenneth Simon, DO; Dennis Lavery; Cleanne Cass, DO

AOA’s Position Against Use of Placebos for Pain Management in End-of-Life Care. The Journal of the American Osteopathic Association, March 2005, Vol. 105, 2S-5S.

 

• Genetically Modified Foods

By: Abdulhabib Alqubaty

There is a controversy over the use of Genetically Modified foods safety and the risks arising out of them. Despite the existence of regulatory bodies in the United States of America and the European Union is working on the development of basic criteria and organization of the work of the companies producing this type of foods. Furthermore, recording of any damage resulting from the use, but that many of the world’s least developed countries do not possess such bodies.

Food-producing companies seek profit without taking into account the damage that may infect peoples consumed genetically modified food. It is possible that productive partnerships re-export products that had already been rejected by the regulatory bodies in developed countries to the least developing countries, which do not possess such regulatory bodies. It is also possible that the production of these foods do not pass basic procedures stipulated by the governing bodies of the Organization export to poor countries. Furthermore, it is possible that the companies producing genetically modified products without signs that they genetically modified foods.

From the moral point of the organization and regulatory bodies imposing to the companies that produced the genetically modified foods to develop trademarks on their products, but many of peoples in the least developed countries do not know how to distinguish between the genetically modified foods and the natural products, due to the absence of voter information programs in these countries

Although no proof that there is damage to health on users of the Genetically Modified Food many ethical matters must be done such as, continuous observation for any damage that may result from the consumption of genetic food and the allocation of part of the profits of the companies for

1. Financing of scientific research on the effects if these foods.
2. Treatment damages in case they occur
3. Production information programs to inform communities about the trademarks of genetically modified products

 

• Three-parent IVF Technology

By: Tamam M. El-Elimat

There are a number of devastating maternal inherited disorders that may result from mutations of the mitochondrial DNA (mtDNA). mtDNA accounts for only 0.1% of the total human DNA, while nuclear DNA accounts for 99.9%. Currently, three-parent IVF technology, which is also known as mitochondrial replacement therapy (MRT), can be used to prevent transmission of mtDNA diseases into offspring. Two techniques can be implemented in three-parent IVF technology: maternal spindle transfer (MST) and pro-nuclear transfer (PNT). In MST, the nuclear genetic material of a donor oocyte with healthy mitochondria is replaced with that of a mother oocyte with mutated mitochondria. The resultant oocyte can then be fertilized by a sperm of the father in vitro and transferred to the mother’s uterus. In either technique, the resultant embryo would carry nuclear DNA from his father and mother, and mtDNA from the oocyte donor. Hence, the child would have genetic contributions from three persons. Male child is chosen to minimize the risk of transferring the mtDNA disease to his offspring.

The three-parent IVF technology has raised several ethical and social issues. For example, if the conceived child is female, then the resulted changes, whether good or deleterious, will be passed to next generations. Moreover, the resultant child would have genetic material from two women of different lineages, which will affect the identity, kinship, and ancestry of the person as well as his/her descendants.

One of the major advantages of the three-parent IVF technology is that it will enable women with mtDNA mutations to have genetically related kids-free of the disease. Opponents of this technology argue that for a woman to have a genetically related kid does not constitute enough social value to justify spending medical moneys to develop the technology, and hence renders its development unethical.

Advocates of the three-parent IVF technology claim that it is a lifesaving technology. However, it is neither considered as a cure or treatment for kids with mitochondrial disease nor prevent them from dying due to the disease. Rather it helps to create a healthy baby. However, saving existing lives is different from creating healthy lives.

If three-parent IVF technology got approved in the future, it would be a costly technique that will be available for women who can afford the high-cost and hence violating the equitable access of people to medical services.

There is no guarantee that the application of this technology will be restricted to the prevention of mitochondrial inherited diseases transmission. There is a possibility that the acceptance of this technique could be a slippery slope toward cloning and genetic enhancements “designer babies” with uncontrolled genetic manipulations.

Religious views play very important role in biomedical decision making especially when it related to embryos and genetic manipulations. In England, and after legalizing the three-parent technology, the church has opposed the process as one of the approved procedures involve destruction of a human embryo. Moreover, church advisers on medical ethics think that more research is needed to ensure the safety and efficacy of mitochondria transfer.

In Islam, the genetic material of any child should come solely from his parents, i.e. the sperm from his father, the egg from his mother, and the embryo should grow inside the uterus of the mother. In the three-parent IVF technology, there is a small portion of the DNA is coming from a third person. Regardless how small, this is impermissible in Islam and could mix lineages.

Interestingly, the first family who has their kid born using the three-parent IVF technology was Muslim Jordanian. The child was born in Mexico and the parents refused to use the pro-nuclear transfer as it involves destruction of an embryo, rather they made their choice to use maternal spindle transfer. However, this technique is not legalized yet in Jordan and is not allowed in Islam.

References

1. John Zhang, Hui Liu, Shiyu Luo, Zhuo Lu, Alejandro Chávez-Badiola, Zitao Liu, Mingxue Yang, Zaher Merhi, Sherman J Silber, Santiago Munné, Michalis Konstandinidis, Dagan Wells, Jian J Tan, Taosheng Huang. Live Birth Derived from Oocyte Spindle Transfer to Prevent Mitochondrial Disease. Reproductive Biomedicine Online 34 (2017) 361-368.
2. National Academies of Sciences, Engineering, and Medicine. 2016. Mitochondrial replacement techniques: Ethical, social, and policy considerations. Washington, DC: The National Academies Press. doi: 10.17226/21871.

 

• GMO Ethics:

By: Abdelwahab Ben Othmen

الهندسة الوراثية و التحديات الاخلاقية

لا تخلو الهندسة الوراثية المطبقة على الحيوانات و النباتات   من اضرار جانبية  على صحة الانسان  فمن دلك ندكر مثلا الحساسية التي تصيب الانسان عند تناوله اطعمة معدلة وراثيا و دلك بسبب تواجد اكثر من مصدر للجينات في منتج واحد علاوة عن انتاج بروتينات مجهولة.

المدافعون عن الهندسة الوراثية يقولون بان هده التكنولوجيا مكنتنا من انتاج الانسولين و عدة اطعمة محتوية على مظادات حيوية و لقاحات يمكن توزيعها بطريقة اسهل من حملات التلقيح متناسين ان هده الطريقة قد تساهم في تطور سلالات مقاومة للمظادات الحيوية لدى المجتمعات الفقيرة حيث يسعى هؤلاء العلماء لتطبيقها.

مثال 1: البعوض المعدل جينيا و مدى تاثيره في الصحة العامة

يسعى علماء الهندسة الوراثية لادخال جينات في بويضات هده الحشرات لمقاومة بعض الامراض الوبائية كالملاريا. تؤدي هده التغيرات الجينية الى تغيير تصرفات و بيولوجيا البعوض و من ثم فقدان هويتها في وسطها الطبيعي و السؤال الدي يطرح نفسه مادا سيكون مصير هده الجينات الطائرة و مدى تاثيره على الصحة العامة لدى المجتمعات البشرية؟ عادة ما تكون هده الحشرات معدلة وراثيا بجينات لا تمكنها من العيش طويلا (جينات قاتلة) مما يؤدي الى تناقص اعدادها بصفة جماعية و بدلك يعود البعوض غير معدل جينيا للتكاثر بسرعة  و هدا ما يقودنا الى اعادة التفكير بهكدا طريقة.

مثال 2: تجربة صيينية لاعادة صياغة الجينوم البشري

تركت التجربة التي قام بها علماء صينيون سنة 2005 جدلا واسعا في اوساط الباحثين الطبيين في ميدان الهندسة الوراثية البشرية. لا تخلوا هده التجارب التي تستخدم تقنيات متقدمة CRISPR  لتعديل الجينات البشرية من مخاطر اجراء تغييرات دائمة في الخلايا البشرية البدائية و ان ثمة مخاطر غير معروفة على مصير الانسان الوراثي حيث بينت هده التجارب في بعض الاحيان طفرات وراثية غير مرغوب فيها.

ان استعمال تقنية الهندسة الوراثية لا يزال في بداياته و التاثير على المدى الطويل لهده التكنولوجيا لا يزال مجهولا لدلك يجب توخي الحدر في اجراء هده النتجارب و سن القوانين الاخلاقية المنضمة لدلك.

يجب على منظمات الصحة العالمية  ان تشجع الابحاث المتناولة لاختبار الاثار الجانبية لهده التجارب و تمييز المنتوجات المعدلة وراثيا بملصقات خاصة.

 

• Ethics From an Islamic Perspective

By: Zouhour Ouanes

الاخلاقيات من منظور الشريعة الاسلامية

منذ العصور الاولى عرفت الاخلاقيات كمبدا اساسي  في جميع المجالات المتعلقة بالانسان عامة و في مجال الطب خاصة فاستنبط الغرب النظم الاخلاقية في المجال الطبي كقسم ابقراط و الاعلان العالمي لحقوق الانسان و مبادىء الشرف النبيلة الا انه في يومنا الحاضرلا زالت عدة اشكاليات تطرحت وتثيرجدالا واسعا من الناحية الاخلاقية. و من هنا من الممكن ان تشكل معايير الرسالة الاسلامية نموزج تتم الاستعانة به في المنظومة القيمية العلمية, اذ تشكل الاخلاق الاسلامية معيارا مناسبا لجميع الاجناس البشرية و الصالحة لكل زمان و مكان بما انها رسالة موجهة لكل الامم و هي خاتم الرسالات السماوية و من اعجازها انها صالحة لكل زمان ومكان ومن هذا المنطلق الرجوع الى اساس الشريعة الاسلامية الاساسية و هي القران و السنة من ثم الاجماع و القياس او الفرعية كالاستنباط و الاستدلال تعتبر السبيل الامثل للبت في حل المشكلات الاخلاقية المعاصرة و التي تنبني بالاساس على مقاصد الشريعة الاسلامية و هي حفظ الدين و النفس و العقل و النسل و المال و هي مقاصد تتنزل في نفس السياق العلمي والطبي بحيث تكون هده الاهداف حجر الاساس لبناء مدونة سلوك تستمد روحها من الديانة الاسلامية و تكون منفتحة على المستجدات في المجال البحثي و التي لا تتعارض في حقيقة الامر مع مقاصد الاخلاقيات عند الغرب كالعدالة, السرية, الامانة و غيرها بالعكس فهي من اوكد المقاصد التي نصتها الشريعة الاسلامية في اكثر من موقع من القران الكريم و السنة النبوية الشريفة و لعل القاعدة الاسلام :”درئ المفاسد قبل جلب المصالح” احسن دليل على ذلك و التي تعتبر ان ازالة المخاطر و السلبيات يكون في سلم الاولويات لانها تبعد الشرور و تكون اللبنة الاساس للمجتمع الاسلامي و اذا نزلنا هذا المبدا على الاخلاقيات العلمية نجد ان ابعاد مخاطرالبحث على الاشخاص يعتبر من اوكد الواجبات العلمية التي يجب الاخذ بها.

و بناءا على ما سبق, نعتبر انه من الممكن ان تشكل منظومة الشريعة الاسلامية سياقا ملائما لاعادة النظر في المواضيع الاخلاقية التي تثير جدلا واسعا في وقتنا الحاضر باعتبارها معايير قيمة صالحة للبشرية جمعاء في كل مكان و زمان.