Case Analyses (Ethics Discussion) for Participants in the Jordan RCR Program Year 2 (2016-2017)

  • Ethical Issues Related to Online Consent- Based Research

By: Zeinab Alsubeh

The wide spread of internet, along with high prevalence of using personal laptops, smart phones, and other smart devices, have opened a new approach for conducting research studies. Internet- based studies could offer several advantages over the traditional method. They are easier to conduct, need less effort, save time, allow for recruiting large sample size, and more cost effective. Therefore, many researchers tend to conduct internet- based studies that would be submitted to target population via different methods; such as social media, email, websites, etc.

One of the main ethical issue related to internet-based studies is the ability to obtain free and informed consent. In online consent form, researchers usually face the following problems:

  • Inability to perform direct interaction or face to face discussion about research topic with each subject.
  • Can’t make sure that each participant has read the entire text of consent form.
  • Inability to assess the extent of participants understanding of the consent form, even if they fully read it.
  • If the participant aware about his rights to cancel his consent and withdraw his data at any time, even after submitting the response!.
  • How to reassure participants that their privacy and confidentiality will be protected, how the collected data will be stored, and who has access to it!

The following points are suggested to solve or avoid these issues with online consent:

  • Build up a consent form that consists of several stages, each stage discuss a major point or item of the study, and participant needs to check a box under each stage to confirm that he fully read and understand this part.
  • Researcher should list his detailed contact information in the consent form, such as work address, telephone number, or email. Therefore, any participant can contact him for questions, or if he decide to withdraw from study.
  • Supplement the consent form with a link that includes answers for the most commonly asked questions.
  • Using electronic signature for studies that are associated with more than minimal risks, or discussing sensitive topic.
  • Recording and uploading a video or audio file, in which researcher can verbally clarify a major points related to study.
  • If applicable, online face to face interaction with target population can be conducted.
  • Steps taken to guarantee subject privacy, confidentiality, and data security should be clearly stated in the consent form.

 

  • Nanotechnology and human/environmental health

By: Yazan Akkam

There is a belief that nanotechnology will give us more “god-like” powers, consequently; nanotechnology products have been granted a label to never become a harmful. As a result, nanotechnology became the fast growing field in this century 1.

Unlike any other science, nanotechnology has been involved in many disciplines, consequently, -on daily bases- humans are expected to get in contact with nanotechnology products ; cosmetics, food, and pharmaceuticals.

Currently, most nanomaterials are sold everywhere in the world despite the “Material Safety Data Sheets’ don’t show the toxicity, carcinogenicity, and fate in the nature. Up-to-date, there are no restrictions on the big manufacturing companies to produce nanomaterials, and they are amassing billions of dollars in wealth. For instance; the products incorporating nanotechnology contribute approximately $1 trillion to the global economy by 20152.

The trend of making new nanomaterials hasn’t changed yet as the number of research studying the toxicity of existed nanomaterials is very few compared to the synthesis and the use of engineered nanomaterials3. So, the huge financial benefits blindfold both the society and the scientists form potential toxicities of the manipulated nanomaterials.

Up to Date, Jordan doesn’t have any regulation or legislation on the production, synthesis, or handling of nanomaterials. However, there are multiple labs in Jordan are synthesizing and using nanomaterials in their research .Moreover, Nanomaterials product are also emerging into Jordanian markets.

The characteristics of same nanomaterial – including toxicity – can be changed according to the method of synthesis and the size. So we should start building legislations to control: who synthesized the nanomaterials, how to be synthesized, how to be handled, and how to be disposed.

It is unethical to make money and expose humanity to potential danger, scientist and companies should be forced to study the toxicity of each manipulated nanomaterials.

References:

[1] Sadik, O. A., Zhou, A. L., Kikandi, S., Du, N., Wang, Q., and Varner, K. (2009) Sensors as tools for quantitation, nanotoxicity and nanomonitoring assessment of engineered nanomaterials, J. Environ. Monit 11, 1782-1800.

[2] Roco, M. C. (2011) The Long View of Nanotechnology Development: The National Nanotechnology Initiative at 10 Years, J Nanopart Res 13, 427-445.

[3] Wang, Y., Santos, A., Evdokiou, A., and Losic, D. (2015) An overview of nanotoxicity and nanomedicine research: principles, progress and implications for cancer therapy, J. Mater. Chem. B 3, 7153-7172.

 

  • Industry-Sponsored Research; Ethical Considerations

By: Wesam Ismail

Industry serves as the major funder of research nowadays. According to recent reports and surveys, it is estimated that almost 70% of clinical trials are funded by pharmaceutical companies1. Moreover, some researchers are receiving monetary payments by these companies for research consultations; a financial conflict of interest might be noticed.

Drug discovery and development process is very important to improve human and public health and make advances in diseases control. The discovery processes are known to be very costly where the for-profit companies fight to compensate for their expenditures and grow their revenues by marketing and selling their products, and there is no better than positive research outcomes to serve the mission.

The Bright Side

Pharmaceutical companies share the social responsibility of backing research that would improve the public health; they are able to offer invaluable amounts of money for medical research which will improve our knowledge and management of many diseases.

In 1993, American College of Clinical Pharmacy (ACCP) published a guideline known as “Pharmacists and the Pharmaceutical Industry—Guidelines for Ethical Interactions”2, which is now updated to include all industry sectors, to protect pharmacists and researchers from being trapped in ethical problems when dealing with industry.

So, What Is the Problem?

The relationship between industry and researchers has some benefits, and sometimes inevitable. But, business interest is known to induce certain types of bias; a number of meta-analyses were done on general medicine literature revealed that studies which were sponsored by industry were more likely (almost 4 times more) to report pro-industry conclusions, which may be violating the “uncertainty principle”3.

These high rates of positive outcomes could be contributed to many proposed factors, like for example, improperness of study designs, under-reporting of negative results, the misleading way of analyzing and presenting data and writing conclusions, and directing funds toward projects that most likely will produce positive outcomes3,4.

What Should Be Done?

Even there is no obvious violations of any rule in these sponsored researches, but this raise many questions; should we ignore these researches? Should the industry funding be stopped? How can journals guarantee the date and conclusions accuracy? Is it ethical to continue the same way?

Of course we cannot stop the funding, but at least we can control the system by:

  • Scrutinizing the industry-funded researches and outcomes; chiefly by journal editors.
  • Steering the fund to special organizations rather than direct contact with researchers and individuals
  • Training researchers more about the ethical principles of responsible conduct of research and declaring conflicts of interest

 

References

1- Baird P. Getting it right: industry sponsorship and medical research. Can Med Assoc J May 13 2003;168(10):1267–9.

2- American College of Clinical Pharmacy, Hatton RC, Chavez ML, Jackson E, Maurey

J, Barriere SL, Couchenour R, Evens RP, Gunning K, Hume AL, Hutchison LC, Matzke

GR, Noviasky JA, Rospond RM, Kelloway JS, Stevenson JG, Vanderveen RP,

Verme-Gibboney CN, Walters D. Pharmacists and industry: guidelines for ethical

interactions. Pharmacotherapy. 2008 Mar;28(3):410-20.

3- Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry

sponsorship and research outcome and quality: systematic review. BMJ. 2003 May

31;326(7400):1167-70.

  • Chopra SS. Industry Funding of Clinical Trials: Benefit or Bias?. 2003;290(1):113-114.

 

  • Use of Children as Research Subjects

By: Wesam Ahmed

Involving children in clinical trials has been the subject of much debate in research. Keeping in mind that much of the pediatrics therapeutic data is actually derived from studies performed on adults, hence the term “therapeutic orphans” may be used to describe children because their age group lacks sufficient therapeutic studies.

Why pediatric clinical research is important?

1) Differences in physiology, pathology, pharmacokinetics, and pharmacodynamics between adults and children, in such a way that extrapolation of therapeutic data of adults for pediatric population is not appropriate.

2) Several age groups for pediatrics (newborn, infants, toddlers, adolescents)

Challenges and ethical issues:

1) Clinical research involves minimal, moderate, or high risk to the subjects. It also worth mentioning that categorizing which is minimal risk and which is high risk is not always attainable.

2) It is not clearly defined at which age children should be allowed to be involved in the consent or assent process.

3) Parents are more reluctant than their children for enrolling them in trials, because they fear harming them.

 

Solutions and suggestions:

1) There should be a balance between individual benefit versus group benefit. In fact, children can participate only if a benefit to the children will result, while preserving the child’s well being, integrity, dignity, and confidentiality.

2) Only pediatric studies that are well designed, properly analyzed, well documented, and based on good science can be performed. This can be achieved by following good clinical practice (GCP) guidelines.

3) Such studies are required to be performed in specialized institutions that are child-friendly with pediatric infrastructure and trained personnel.

4) Investigators should not place any undue influence or coercion on the parents for the children to participate, instead they should be provided  with sufficient information regarding the advantage and disadvantage of the outcomes of the study, and be given enough time to decide whether to let their child participate or not.

5) The child should have the right to withdraw any time from the project.

6) Many recommend an age of seven years to involve children in the assent process.

7) Building ethics committee specialized in reviewing and evaluating research projects on pediatrics. This committee can either be independent or as part of the IRB.

 

  • Confidentiality in Qualitative Research

By: Wejdan Khater

The National Institutes of Health Guidelines for the Conduct of Research Involving Human Subjects mandates that confidentiality of the participants to be   maintained and maximized (Kaiser, 2009). However, maintaining confidentiality can be challenging in qualitative research. The issue of maintain confidentiality in qualitative research has been raised in the literature (Kaiser, 2009). More specifically, researcher in some challenging situations may feel the need to break participants’ confidentiality. Interviews in qualitative study may reveal data that would not be discovered through quantitative research such as mistreatment, malpractice, child abuse, or other criminal behavior by the interviewee. In such situation researcher is challenged whether to report this data or not. However, the situation is far complex than just reporting or not. Maintaining confidentiality in qualitative research in such situations might lead to serious legal problems or harmful consequences to participants themselves or to the public (Houghton, Casey, Shaw, & Murphy, 2010). Unfortunately, these challenges are not adequately addressed in the literature on research ethics and research methods (Kaiser, 2009).

When proposing solution for these special situations evaluating the consequences of such cases is very essential. Legal and regulatory frameworks can provide the solution for this situation (Wiles, Crow, Heath, & Charles, 2006). The law requires researchers to break the confidentiality if participants disclose having committed or being about to commit a crime (Wiles, Crow, Heath, & Charles, 2006).  Further, researcher explicitly should include the undisclosed criminal/harmful behaviors as information that she/he would not consider as confidential (Houghton, Casey, Shaw, & Murphy, 2010). Further, some argue that training and education are needed to improve researcher ethical and legal knowledge about confidentiality disclosures in qualitative research (Elger, Handtke, Wangmo, 2015). In summary, promises of confidentiality in qualitative studies need to be weighed against protecting participants and the public considering legal and ethical considerations.

References :

Elger S., handtke V & Wangmo T (2015) Informing patients about limits to confidentiality: A qualitative study in prisons. International Journal of Law and Psychiatry, Volume 41, July–August 2015, Pages 50-57

Houghton, C, Casey, D; Shaw, D & Murphy, K (2010).. Ethical challenges in qualitative research: examples from practice. Nurse Researcher.  Vol. 18 Issue 1, p15-25

Kaiser K. (2009). Protecting Respondent Confidentiality in Qualitative Research. Qual Health Res, November 19: 1632-1641

Wiles R., Crow, G., Heath, S & Charles V.  (2006). Anonymity and Confidentiality. Paper presented at the ESRC Research Methods Festival, University of Oxford, July 2006 Email contact: raw@soton.ac.uk

 

  • Ethical Controversy Surrounding Research in the Intensive Care Unit.

By: Shoroq Altawalbeh

Research involving critically ill patients presents special ethical challenges, largely due to the fact that critically ill patients frequently are unconscious and unable to consent for research participation1. Even if they are conscious and can understand and judge the benefits and risks of participation, they frequently unable to give informed and independent consent due to their vulnerability and dependency on health care professionals for their care1,2. Consenting their family members or other surrogates is also not free of ethical challenges. They may give consent just because they might believe that the care their relatives will be better if they give consent, mainly due to their inability to distinguish between research and clinical care1,2.  Obtaining consents from surrogates is rather complicated by the consideration of what happens when the actual patient regains capacity. The debate is whether the patients are obligated to continue in the research project if their continuation is decisive in answering the research question, and what happens if harm does result2.

Beyond challenges in the consenting process, other ethical considerations in conducting research in such vulnerable community include: weather a higher standard of  information disclosure than in other populations  is required 2, the issues of discriminating adverse effects of study procedures from complications of the underlying illness3, and finally, the difficulty of protecting research participants from risk especially when patients receive care that differs significantly from what they would have received outside of the trial4.

The best strategy to overcome or alleviate such challenges is to heightened awareness to principles of ethics. Challenges must be acknowledged and confronted by all persons involved in the research and thorough the whole process3 5. Researchers should recognize the differences between clinical research and clinical practice and should clearly communicate this differentiation to participants or their surrogates3,5. In line with this, consents should be obtained by persons involved in the research other than the practitioner clinicians even though they might serve as investigators in the research3. Risks and benefits should be clearly explained to potential participants or their surrogate who is legally committed to be a trusted guardian to the patient. Finally, oversight is necessary to ensure ethical standards and to enhance protections of vulnerable subjects in a continuous and uniform manner3,5.

 

References:

  1. Luce JM. Is the concept of informed consent applicable to clinical research involving critically ill subjects? Crit Care Med 2003;31:S153–S160.
  2. Laura Hawryluck. Research ethics in the intensive care unit: current and future challenges. Crit Care. 2004; 8(2): 71–72.
  3. Luce JM, Cook DJ, Martin TR, Angus DC, Boushey HA, Curtis JR, Heffner JE, Lanken PN, Levy MM, Polite PY, Rocker GM, Truog RD. The ethical conduct of clinical research involving critically ill patients in the United States and Canada: principles and recommendations. Am J Respir Crit Care Med. 2004 Dec 15;170(12):1375-84.
  4. Miller FG, Silverman HJ (2004) The ethical relevance of the standard of care in the design of clinical trials. Am J Respir Crit Care Med 169:562–564
  5. Silverman HJ, Lemaire F. Ethics and research in critical care. Intensive Care Med. 2006 Nov;32(11):1697-705. Epub 2006 Aug 8.

 

  • Ghost Authorship

By: Osama Alshogran

Authorship is one of the major aspects of scientific integrity and research

misconduct. There are multiple issues and concerns usually raised when we come to

include author list in the research manuscript. Generally speaking, to be included as

an author in a paper, usually a substantial intellectual, experimental, or technical

contribution is required (1). Providing credit to somebody who has not participated in

the study by including him as an author, or denying somebody who deserves to be

an author and not including him, are major ethical issues of authorship. This, in fact,

is common, at least in our community, and usually researchers attribute that to the

urgent need and pressure of publication, or the inability (financial or so) to acquire

the facilities required for conducting research. Well, these are invalid excuses.

I would like to focus in this essay on what is called a “ghost author”, which reflects an

individual who significantly contributes to the study but does not receive any credits

by listing him as an author or even in the acknowledgment (2, 3). For instance, why

don’t we include undergraduate or junior students in the author list despite having

them running he experiments and drafting part of the manuscript? Also, why do we

include expert researchers in the author list without having them contribute, at least

partially, to the research paper? Is this will increase the likelihood that the paper will

be accepted (i.e., honorary authorship, 4)? A study of Gotzsche PC et al, which

analyzed 44 industry-initiated clinical trials found an evidence of ghost-authorship in

75% of them (5). In fact, most of these authors were statisticians. This is

unacceptable and a breach of honesty.

In my opinion, in order to prevent such attitude we have to improve researchers

knowledge and perceptions about unethical issues related to ghost-authorship and

its consequences. Also, institutions should develop restrict policies and guidelines

that would ensure that authorship is properly recognized. We also should not be

hesitant to report the cases involved, and serious punishments should be developed.

References:

  1. Bavdekar SB. Authorship issues. Lung India. 2012 Jan;29(1):76-80.
  2. Hamilton CW, Donnelly J, Gertel A, Marchington J, Woolley K. Ghost authorship. Home

Healthc Now. 2015 Jun;33(6):346

  1. Sokol DK. The dilemma of authorship. BMJ. 2008;336:478.
  2. Kressel HY, Dixon AK. Where is the Honor in Honorary Authorship? Radiology. 2011;

259:324-327

  1. Gøtzsche PC, Hro´ bjartsson A, Johansen HK, Haahr MT, Altman DG, Chan A-W. Ghost

 

  • An ethical controversy and its potential solution and alternatives.

By: Noor Al Mortdai

An orthodontist and a dental nurse agreed to conduct a research for the purposes of following up a group of patients after inserting a new device to straighten the teeth. The principal investigator used a personal computer to save his patients data. For each patient there is a large data file stored on a laptop including the patient’s profile that was accumulated. The clinician used to use the laptop either at home or clinic in order to avoid losing the data and tracking each case easily. The clinician was the principal investigator of the research.

A dental assistant who works with clinician on the same research was very concerned about this situation and considered it as unethical to have the data of a laptop where the clinician’s family and/or colleagues can see the data as well as a conflict to the commitment of the proposal method. Furthermore, she noticed that the clinician doesn’t follow the disinfection and sterilization protocols that should be in the clinic such as changing the gloves after treating each patient and disposable sheets on the dental chair menu.

She asked the clinician to have the data on the desktop in the clinic for the privacy and confidentiality of the patients. She also asked the clinician to follow the safety and disinfection protocols to avoid patient’s infection. The clinician refused to listen to her because he though this won’t effect on the teeth.

Ethical Challenges:

  • Poor data storage
  • Health insurance cost in case of treating the infection issues raised by the side effect of the research.
  • Do the dental assistant needs to take an action and report that to the institution in order to ensure the privacy of the patients is adequately protected?
  • Do the dental assistant needs to not raise up the problem in order to keep smooth communication with the research team during the research and the future?
  • Do the dental assistant needs to address the issue the problem that might affect adversely on the university/and or staff reputation?
  • What is the best way to monitor this clinician’s future behavior without irreparably damaging his career?

Proposed Solutions:

The dental assistant needs to talk again to the clinician about this behavior and told him that she can’t proceed in this research unless he follows the ethics of conducting the research and following the standard protocols approved by the ethical board.

Also, she needs to ask the clinician to check the school’s/institution web site for guidelines of research and consequences of reporting the issue.

Specific people who work for the research have access to the laptop and controlling this might be by using the finger print of the users

 

References:

https://www.aps.org/programs/education/ethics/upload/Ethics-Case-Studies-Teacher-Edition.pdf

http://www.bath.ac.uk/research/pdf/ethics/ethical-dilemmas.pdf

 

  • Effect of Jordanian cultures on implementing research ethics principles, while conducting researches in the field of public health and epidemiology.

By: Mohammad Malkawy

Introduction:

Jordan population has faced various demographic changes that significantly affect its structure and introduced the globalization features among many aspects of daily life deeds.

Although of these changes, Jordan society kept major features that characterized people for decades. For example Jordan people reside at different geographical location share some common social habits that organise their life and in some cases control and judge the way they will respond in many situations. For example, marriage ceremony and death occasion have some rituals that should be followed. Moreover, concrete considerations towards elderly people, parents, women and guests based on respect and dignity are well established (Al-Zyoud 2010).

All these cultural characteristics and behaviours have impacted the research progress carried out by public health researchers and epidemiologist in Jordan. Researches addressing issues like tobacco use, alcohol consumption, drug use, breast cancer prevention, and human sexuality have faced many obstacles in conducting the study and producing a reflective results using private data (Wahsheh et al. 2012).

In this project few hypothetical cases will be tailored to address some of the major impacts of the Jordanian culture on conducting a public health research. Principles like, respect of autonomy, beneficence, privacy and confidentiality will be challenged.

Case No.1

Researcher X is a Jordanian student who is running a research on the effect of pollution on DNA damage of people residing in different locations in Jordan.

His study aimed to investigate the relations between personal exposure to gaseous, particulate emissions, and polyaromatic hydrocarbons from different sources like power stations, industry factories and vehicles on each area and the occurrence of DNA strand breaks. In order to conduct the study he should carry on surveys and collect urine samples from both adult male and female subjects in different locations in Jordan.

While he headed down south to Al-Tafelah to collect samples, the head of the tribe prevented collection of samples from women, though the researcher informed him earlier. He agreed to provide samples under two conditions, one is that he will be the moderator of sample collection and the another, is not to provide any information about the female samples.

Ethical controversy:

Respect of autonomy: the head of the tribe take the decision over the females in his tribe and decided not to give samples at the beginning and then decided to give sample without any extra information.

Solutions:

  • The procedure of collecting data should insure privacy and anonymity and explaining who will access the data.
  • Pseudonymous identifier will be used and no clear information on the sample with restricted access to the data.
  • Medical education by the authorities like Ministry of health, universities and medical students for people with different cultural background will promote and adopt healthy behaviours.

Alternatives

  • Searching other females that are willing to give information and samples
  • Exclude the location from the study.

Case No.2

Researcher X is a Jordanian Assistant professor, who is running a research on the breast cancer prevention and self-examination (BSE) among Jordanian women.

Her study aimed to develop educational programs through investigating the effect of self examination of breast cancer among women in Jordan. She wanted to correlate the knowledge of the BSE with age and education level.

Through her study she prepared a survey where she had to ask women about how often they practice BSE and their motivation.

Ethical controversy:

  • Protecting the privacy of the participants and the confidentiality of collected data.

Solutions:

  • Protect the privacy and confidentiality of the participants, a document this in the consent forms.
  • Prepare consent forms for anonymous surveys.

Alternatives

  • Using medical record for patients diagnosed with breast cancer as an alternative to directly contacting individuals of interest.

References:

  • Al-Zyoud MSN (2010) The Impact of Globalization on Jordan Society Dirasat: Educational Sciences 36
  • Wahsheh MA, Geiger BF, Hassan ZM (2012) Considering Cultural and Religious Perspectives When Conducting Health Behavior Research with Jordanian Adolescents Annals of Behavioral Science and Medical Education 18:14-20 doi:10.1007/bf03355175

 

  • Embryonic Stem Cell Research: Ethical Controversy and Islamic Point of View

By: Mohammed Alazzani

Embryonic stems cells provide hope for new medical therapies. However, embryonic stems cell research (ESCR) has been challenged by a moral dilemma in which two moral concepts should be considered. The first one is the obligation to prevent or alleviate suffering of many peoples from diseases that are incurable. The second ethical principle is the duty to respect the value of human life.  Respecting both moral concepts in the case of ESCR is difficult if not impossible; obtaining embryonic stem cells for the research purposes means destroying a potential human life, and, on the other hand, conducting ESCR could leads to stem-cells based therapies could alleviate the suffering of many patients. This made ESCR one of the largely debated researches that require difficult decision-making process.

One of the strongly controversial issues in ESCR is the moral status of the embryo. The opinions ranges from that the embryo has full moral status from fertilization onwards and, thus, his/her respect and dignity as a potential person should be protected, to the opinions that the embryo has no moral status at all.

ESCR is controlled by restricted regulations by many countries, and its conduction is prohibited among several religions. Islam religion also has given great importance to the life of human embryo. Islam has different view on the moral status of the embryo, the embryo does not have full status until day 40 after fertilization in which it prohibited after this age to make any research.

According to the Sharia’s law of Islam it is not permitted to destroy an embryo for just the sake of research only.  However, there is a great importance for scientific research in Islam, and Islam emphasizes the importance of helping others, the hope for producing medical therapies for treatment of incurable diseases reinforce many Muslims’ point of view for stem cell research. Therefore, it is allowed according to Sharia’s law that, during in vitro fertilization (IVF) for reproduction, ESCR is permitted only on remaining embryos no longer needed for reproduction and would otherwise have been destroyed after obtaining full consent from donors. Alternatively, adult stem cell research is less controversial and can be conducted.

References:

  1. Ilkilic, I. & Ertin, H., 2010. Ethical aspects of human embryonic stem cell research in the islamic world: positions and reflections. Stem Cell Reviews, 6(2), pp.151–161.
  2. http://www.eurostemcell.org/factsheet/embyronic-stem-cell-research-ethical-dilemma

 

  • Obtaining Consent in Geriatric Research: Dementia Research

By: Mera Abaneh

Dementia is a very common condition in geriatrics population.  The research on dementia is going on and being supported by many agencies to provide beneficence for this group of patients.  In order to conduct a research projects, investigators need to obtain informed consent from participants as the case with any research projects. However, in this case patients with dementia may not be able to provide the consent given the nature of their disease. The consent is usually obtained through a surrogate person (e.g. family member or caregiver). ¹ The issue here is whether this surrogate person has the right to decide on behalf of patient with dementia to participate in the study. Moreover, what are the bases of choosing surrogate person?  Would this person really is considering only the patient best interest regardless of any pressure by research team members, organizations, or incentives coming with the research project?  How could the dementia patient have a voice in deciding to withdraw from the study?  I think this is very controversial topic and many questions don’t have clear answer. Imagine the situation for a single dementia patient who is widowed and his son and daughter have opposing views regarding participating in the study, which one the investigator should consider? Who is considering patient interest?  Although the literature is discussing this issue and the argument is still out there, however, the variation in dementia level and consequently patient’s cognitive capacity necessitate the need to design a detailed ethical protocol for research in dementia research.  Consulting with a third party to decide the best way to obtain consent for research is one step that could go beyond the IRB approval.  In summary, obtaining valid consent in dementia research is debatable especially in terms of feasibility for researchers and patients and their surrogates.

 

¹ Whitehouse PJ (2000), Ethical issues in dementia. Dialogues in Clinical Neuroscience.

 

  • Data Sharing and Reuse: Citation and Co-authorship

By: Maysa Almomani

Sharing data is important for the integrity of science due to related benefits of replication, data preservation, scientific progress, data integrity and public trust. It is a human rights that everyone has the right to get the benefits of scientific progress [1].

Sharing data and crediting sources are basic ethical principles. However, failure of existing ethical guidelines, associated with increasing demand and resources for data sharing raises significant ethical dilemmas for data generators and data users. The degree to which researchers are willing to share data depends mainly on the responsible conduct of investigators who reuse the data [1].

The lack of clarity regarding intellectual property and ownership rights makes it difficult to determine who has the right to decide how data should be shared [2]. Researchers may feel unhappy to work extensively on writing proposal, obtaining funding and ethical approvals, collecting data, and producing the first publication, to then have their data quickly “shared” with investigators. It is a major issue because one study may produce series of publications, but data sharing may be required as soon as the appearance of the first publication [3].

To solve this problem, there is a need for balanced approach of sharing data by giving the initial investigators adequate time to publish their main findings with certifying the accuracy and clarity of the data. Timely data sharing is an ethical commitment for scientists and aids both science and society [1].

Also, it is essential to develop formal ethical guidelines that support a culture of data sharing. Data providers should be offered co-authorship if their data are integral part of the manuscript or meet other conditions of authorship. If data provider doesn’t accept co-authorship, the use of the data and publication can be proceed with citing data sources through formal citations or acknowledgment [1].

References:

[1]      C. S. Duke and J. H. Porter, “The Ethics of Data Sharing and Reuse in Biology,” Bioscience, vol. 63, no. 6, pp. 483–489, 2013.

[2]      S. Bull, P. Y. Cheah, S. Denny, I. Jao, V. Marsh, L. Merson, N. Shah More, L. N. T. Nhan, D. Osrin, D. Tangseefa, D. Wassenaar, and M. Parker, “Best Practices for Ethical Sharing of Individual-Level Health Research Data From Low- and Middle-Income Settings.,” J. Empir. Res. Hum. Res. Ethics, vol. 10, no. 3, pp. 302–13, 2015.

[3]      N. Pearce and A. H. Smith, “Data sharing: not as simple as it seems.,” Environ. Health, vol. 10, no. 1, p. 107, 2011.

 

  • The Ethical Consideration of Gene Patent

 By: Loai Alzghoul

 Gene patent refer to gain an intellectual property rights over pieces of the human genome, or to patenting a newly discovered unique segments of DNA, which perhaps code for a certain disease or a certain protein. There are several ethical issues with gene patenting, but the most concerns are 1) validity of patents on naturally occurring DNA sequences, and 2) accessibility and promoting human health

1) Validity of patents on naturally occurring DNA sequences

Many people see that genes are our common heritage, and DNA is a product of nature, not human initiative, that why they believe that DNA is intimately related to species identity and no parts of it should be controlled by corporate interests. Also, patents on human genes pose a threat to human freedom, equality and dignity, especially that, genetic patenting was preceded with obtaining gene samples prior consent, but since this consent was on individual levels not national or community levels.

On the other side, patented gene differs from its natural form, as it is no longer part of a chromosome, and it has been isolated and purified to get only the protein-encoding part of a gene, not the regions without apparent function. This isolation changes it from its natural manner as no isolated gene sequence occurs in nature. And for the human dignity and freedom part, people who are pro gene patenting see that we share many of our genetic materials with even low level animals including insects and warms, and since mankind has been long obtaining property of several nature  products such as land and animals , there is no point of making human DNA a different thing.

2) Accessibility and promoting human health

Since patenting DNA have issues with decreasing respect for human dignity and freedom, these issues might overlooked if the end result were an increase in human well-being. Yet, this stills a hot issue for debate regarding gene patenting. Since companies that hold gene patents have exclusive rights over these genes, many people fear that they might decide to not allow other companies to look at these genes, which will obstruct research and discoveries. Furthermore, even after discovering new tests or drugs,  gene patenting processes such as licensing arrangements and other fees might lead to too expensive medical tests and treatments that is not available for who need them.

Recently, there is many ways of finding genes. Including short sequences that are 25 to 30 nucleotides in length which can be used to identify genes but provide no information about the entire gene, or its product and function. In addition, using software, some researchers can search gene database and placing theoretical information about the any DNA sequence. And to date, there are thousands of gene patent applications filed at the U.S. Patent Office that were results of these processes. This increases the fear of many people that some companies will try to gain out of nature with no significant additive to the information pool about these genes.

On the other side of the argument, almost everybody agrees that intellectual property protection was necessary to encourage investment in the development of new drugs, and gene patenting should not be different than that at all. Gene patenting might Encourages research and development in private industry, as pharmaceutical and biotech companies invest hundreds of millions of dollars in identifying genes to be used in developing diagnostic tests and drugs. Without patents, it is unlikely that companies will invest in developing these drugs.

Alternatives and potential solutions

Unfortunately there is no alternative for gene patenting, but the solution should be having a clear roles and guidelines for it. My opinion is that although there is ethical dimension of gene patenting but still it is necessary and we should have it. The specific question should be is “How to?” And setting the bar at a reasonable level in terms of when to give a patent, such as if only they isolate the gene and give information about its function and protein.

 

  • Who Owns a Patient’s Medical Record?

 By: Laila Akhu-Zaheya

The medical world is far from black and white. The areas of gray are not far and few in between, and as such, certain aspects can be viewed from multiple perspectives.

The owner of a patient’s medical record for example, is a bone of contention amongst those in the medical profession. Who owns a patient’s medical record? Ethically, is it the doctor, as it is the doctor who has taken the oath to uphold a patient’s wellbeing, and cannot do so if the medical record is not entirely at his disposal and available at all times.

Some may say the owner, in terms of ethics, is the patient, but this is a theory that can result in more harm than good. Patients, for whatever reason, may feel the need to conceal something from their physician, a dangerous decision for both the doctor and the patient, as it could result in a life-altering, even life-threatening event.

It is important to understand the reason for such conflict. The doctor-patient relationship is perhaps the most important, most intimate, and most intrusive of relationships, but it is the nature of the relationship and it is an important feature. While the patient may feel as though their privacy is being invaded, the good more than outweighs the bad.

The patient moreover, is protected by so many assurances of confidentiality and privacy that it is not as if the medical community is completely ignoring their concerns. Those guarantees of confidentiality and privacy are specifically designed and enforced in order to put the patient at ease, in order to make them feel comfortable in sharing anything and everything with their doctor, because it is necessary. Information is the thread that preserves the well-being of the patient; it is the difference between life and death.

Doctors should be the patient’s protectors, but it is important to transfer and convince patient about this, the doctor cannot accomplish such a feat on their own.

 

  • Ethical perspective: Niqab (face-veil) has an impact on research

 By: Jihad Alzyoud

         “The sight of niqab-drapped women, invites inferences of femininity, modesty and religiosity; but blocks inferences of immaturity, indifference, anger, boredom or contempt” [1].

Niqab is a religious symbol that many Muslim women wear especially in Middle East countries. In a recent paper, a question was raised if wearing niqab is a barrier to have justice in court [1]. In another study, the credibility and perception of Muslim women wearing Niqab were also investigated. A conclusion outcome should not lead to bias or challenge manner and accountability [2].

This led us to the question if face-veil has impact on research. Two situations we addressed, first the researchers were women wearing Niqab and we are doing a research project in a Muslim country especially in rural areas and the potential population were women. Second, if the researcher is a male involved in the above research.

The question raised here, will veiled women participate if the researcher were male or female? Would this mean that male researcher would unintentionally exclude these women (exclusive population)? In addition, will veiled women response will differ from unveiled women. Another point of view would the face-to-face interviews have the same quality of data with/without face-veil even if the researcher is female.

Research includes interviews which necessities random sample selection and eye contact and in case of face-veil it might potentially undermined the quality of data collected or randomness. Is it ethical not include them or is it a discrimination

Potential solutions: one possible solution is to run the interviews by females, however, still the veiled women in comparison to unveiled may have different responses. Another possible solution is change the design of methods by introducing a questionnaire instead of interviews, however, this is also may affect the richness of data.

  1. Allen, A.L., Veiled Women in the American Courtroom: Is the Niqab a Barrier to Justice?, in The Rule of Law and the Rule of God. 2014, Springer. p. 189-205.
  2. Kelley-Hollwell, V.J.-A., Perceptions and behaviors that encourage or impede advancement or attainment of leadership positions in higher education by Muslim women wearing hijab. 2009, University of Missouri–Columbia.

 

  • Conducting Research on Elderly People with Mental Health Issues

 By: Heyam Dalky

Conducting research on human subjects carries many challenges in most cases; however such more concerns and attention are to be considered when studying elderly people mental health related issues.

Elderly population is commonly considered as vulnerable due to many factors such as, their physical and psychological health deterioration due to age. None the less, ethical principles should be applied and applied in a careful manner when it comes to studies on mental health issues of elderly. Such concerns, for example; is the consent form and the issue of who has the right to sign, is he the elderly himself, or his guardian or caregiver? The autonomy and respect of person’s rights and wishes put us in front of two controversy cases:

  1. An elderly who refuses, or even not being informed about taking part in the study?
  2. A caregiver who-assumes because of his role-has the right to say, think and even decide for the elderly?
  3. The fully competent (cognitively) elderly with physical limitation (decrease in hearing, vision, mobility?

This lead to another related issue of more importance in research among elderly people is “integrity of elderly people”. Showing respect and maintain integrity in approaching elderly people for research purposes is a request.  Researchers have to be careful when studying elderly people, they should care about the limitations they might have due to aging. To some degree, this might necessitate a researcher to have special training on conducting research among elderly people. For example, special communication skills are needed.

Elderly people is of importance to study worldwide, specially that this population portion of is getting higher in most countries. So, more studies related to their various aspects of their health and common illnesses are needed in this population group. Of the ethical principles that concern responsible conduct of research (RCR) in this special population is the concept of “research with human subjects”. Do no harm or be beneficial is what researchers have to keep in mind when studying or involving elderly people in research studies. Exposing them to harm intentionally or non-intentionally at the emotional, physical, economical, or even social levels; is a matter of concern too.

Thus, specialized researchers in elderly population are needed. Attention to their special needs, maintaining and keeping their integrity during all aspects of conducting a study is a big challenge and an important aspect of RCR among this population.

 

  • Recruiting vulnerable minorities in phase one nontherapeutic drug trials

By: Hanin Makhlouf

Recruiting vulnerable minorities in clinical studies is usually challenging, and requires special attention, particularly with participants who explicit multiple vulnerabilities as war refugees whose number has increased dramatically all over the world in the past few years. Vulnerable persons are “those who are relatively (or absolutely) incapable of protecting their own interests”, according to the Council for International Organizations of Medical Sciences (CIOMS).

Almost all ethical challenges in this case can be attributed into two of the four fundamental principles of bioethics, justice and respect of autonomy. To conduct an ethical research a valid consent is a necessity, war refugees in accordance to their socioeconomic status and dependency on others they suffer from an explicit imbalance in powers, which make them certainly neither autonomous nor competent to give a valid consent to enroll or withdrawal from the study.

It’s also a form of injustice to conduct a clinical trial on a specific population over another, especially that this type of studies which in order to be more informative and give reliable results, should be applied to more than one population, to eliminate any possible genetic or environmental factors.

According to the declaration of Helsinki research involving human beings, benefits must overweight the burdens, in phase one clinical trials, risks by far exceeds benefits for the tested group and this makes them vulnerable to harm, further more if this drug later on proved to be effective this research is primarily expected to benefit people outside the tested population, unless it’s made reasonably available for the tested community, to somehow balance benefits to risks.

This kind of research is mainly done by the pharmaceutical companies, any result obtained from these kind of trials might never see the light based on the fact that industry are never obligated to share the result they obtain.

 

  • To Consent or not to Consent…

By: Hana Abu-Hassan

I am a family medicine practitioner and still do some clinical work in the UK; where

GP surgeries operate on computer-based systems. A widely used ‘QRISK calculator’,

predicts the 10-year risk for cardiovascular disease. It uses the Framingham risk

equation [1] and the adjustments as suggested by the Joint British Societies’ (JBS2)

paper [2] and the JBS Cardiovascular Risk Assessor. [3]

In 2010 the National Institute for Health and Clinical Excellence (NICE) decided it

could no longer recommend that the Framingham risk equation be used, as it tends

to over-estimate risk by approximately 5% in UK men. [4]

QRISK requires the entry of patients’ postcodes. In fact there is a website on the

Internet where patients can independently calculate their risk without the direct

involvement of their GP.

A statement on the website: ‘The QRISK®2 algorithm has been developed by doctors

and academics working in the UK National Health Service and is based on routinely

collected data from many thousands of GPs across the country who have freely

contributed data for medical research. It is updated annually each April, refitted to the

latest data to remain as accurate as possible.’ [5]

GP’s routinely use the QRISK calculator all across the UK with the built in postcode

section without informing their patients, that they have become participants in

medical research. We are now aware, and credit goes to the QRISK calculator that

certain postcodes have higher cardiovascular disease risks. The aforementioned fact

carries many implications, especially if the wrong parties (such as health or life

insurance companies) take hold of such data; and patients are made aware that their

postcode has a higher predictor, without any justification.

Potential solutions that arise at first glance are: a message on the computer screen

prompting the GP to take consent from the patient when using the postcode. On first

time registration, GP surgeries could inform patients that their medical records might

be used for research purposes. GP’s could use the Internet version of the calculator

and hand type the QRISK percentage into the records, hence avoiding postcode entry

that happens by default through the computer system.

I believe the NHS has to take initiative into resolving the confidentiality and consent

issues arising from such a widely used measurement; as it is part of the NICE

guidelines, and is a national issue.

  1. Anderson KM, Odell PM, Wilson PW, et al; Cardiovascular disease risk

profiles. Am Heart J. 1991 Jan;121(1 Pt 2):293-8.

  1. No authors listed; JBS 2: Joint British Societies’ guidelines on prevention of

cardiovascular disease in clinical practice. Heart. 2005 Dec;91 Suppl 5:v1-52.

  1. JBS CV2 risk assessor; Heart UK.
  2. Collins GS, Altman DG; Predicting the 10 year risk of cardiovascular disease

in the United Kingdom: independent and external validation of an updated

version of QRISK2. BMJ. 2012 Jun 21;344:e4181. doi: 10.1136/bmj.e4181.

  1. https://www.qrisk.org/2016/

 

  • Anti-aging Research from Ethical and Religious Perspectives

By: Enas Mokhemer

In the light of the significant progress in the field of “anti-aging “research, it is considered as one of the most controversial cases in society. Although, development of techniques for genetic manipulation of what’s called long-life genes (ex. – telomerase) and the cloning of stem fetal cells which possess an astonishing reproducing capacity, are performed between the walls of medical research laboratories, the progress of this filed of research is in the mercy of many effective points of control including, the financials support providers, the political force, the institutions of religion. Some arguments are focusing on the problem of justice and the gap between society classes, the rich and poor, others are focusing on the huge political power that comes with controlling such technology. The argument of several religions (Judaism, Islam, Buddhism) seem to be in harmony as it supports  using the new means of anti-aging to the ultimate purpose of well-being in society, as long as they are not directed towards achieving the abstract concept of  immortality.

From my point of view, the aging process is viewed medically as a progressive decline of cellular function, which is the ultimate underlying cause of several morbidities; therefore the approach of slowing down that decline is attempting and medically justified.  I believe that there should be an ethical reference that controls the practice, but not the development of this technology. The beneficial reward of ant-aging research in the field of fighting cancer and congenital disorders using stem fetal cells cannot be argued. Using those same means in  less beneficial goals or even the fact that they might be the reason to start destructive wars of power does not make them  less brilliant,  it  would be  just the user to blame not the tool.

References:

  • Pijnenburg, M. A M and C. Leget. “Who Wants To Live Forever? Three Arguments Against Extending The Human Lifespan”. Journal of Medical Ethics 33.10 (2007)
  • Davis J K. Collective suttee: is it unjust to develop life extension if it will not be possible to provide it to everyone? Ann N Y Acad Sci 20041019535–541.541

 

  • There are two sides to every story: Name game

By: Eman Al-Zboon

The adage “there are two sides to every story” applies to disability issues. One of current controversy issues in special education is the “Labeling Issue” or “The Name Game”. This issue refers to whether students with disabilities SWDs should be labeled at all and what the suitable label should be used: disabled, idiot, retarded, student with disability, or student with special needs. However, the researchers in the field of disability studies need to adopt an ethical framework to the application of labeling.

Opponents of labels argue that labels permanently stigmatize the student. They believe that researchers, parents, teachers and administrators lower their expectations of a labeled student. Furthermore, labeling lead to deny the opportunities of students with disabilities to be in the mainstream program with their peer without disabilities. Labels may cause others to hold low expectations for a students with disabilities and differentially treat her on the basis of the label, which may result in a self-fulfilling.

Supporters of labels such as learning disabled, blind, deaf, deaf-blind, or autistic believe that these labels offer a common ground for researchers to discuss practices and share knowledge about particular disabilities. In addition, labeling is required to be included for special education services based on the educational laws in many countries. Labeling helps make students with disabilities’ needs more visible to policymakers and the public.

The possible solutions for this controversy issue is  labeling students with disabilities according to the curriculum and skill areas they need to learn. Another alternative is using general labeling based on students with disabilities needs. Finally, researchers should use label which is acceptable by international convention for rights of persons with disabilities. This convention demands using “person with disability” label instead of “disabled person” label.

 

  • Ethical controversy: the role of incentives in human research participation

By: Basima Almomani

Valid informed consent requires voluntary participation and this means it should be free of coercion and undue influence. Incentive is a benefit offered to participants, monetary or non-cash, in order to motivate the participation in research either by increasing the number of participants or speeding up the process of recruitment. It is different from reimbursing participants to compensate minor expense as a result of participating in research (e.g. transportation costs of parking). Ethical concerns are raised that incentives are a form of power, particularly large ones, and it can be also used as coercive offer or undue influence. This is considerably sensitive especially in conducting human research that involves invasive procedure such as in obtaining organ for transplantation and blood transfusion. Incentives may also compromise the dignity of human subject by securing patients’ participation in clinical researches. Another raised issue is whether the participants would accept higher risk in exchange for higher incentives. However, no sufficient evidence found an association between size of risk and size of incentive.

Incentives whether prepayment or promised ones, have the potential to affect individuals’ opinion to participate. The use of incentives is challenging particularly with the increasing demand to involve different group of population in research (e.g. children, elderly, women …) and with the sponsoring research by industry. In my opinion, incentive can work against the principle of beneficence in human research if they are used inappropriately in term of type and amount. It is always very important to consider the element of voluntarism for obtaining valid consent. To justify using incentives in research and protect against any harm, both researchers and IRB committees have a responsibility to eliminate unnecessary risks and preserve human dignity.

References


  1. Eleanor Singer     and Mick P. Couper . Do Incentives Exert Undue Influence on Survey Participation? Experimental Evidence. J Empir Res Hum Res Ethics. 2008 Sep; 3(3): 49–56. .
  2. Ruth W. Grant and Jeremy Sugarman. Ethics in Human Subjects Research: Do Incentives Matter? Journal of Medicine and Philosophy, 29(6): 717–738, 2004

 

  • Genetically modified foods: scientific, ethical and religious considerations

By: Amal Sallam

 Genetically modified foods (GM foods) are still a subject of debate between groups accepting and others refusing.  According to the WHO, GM foods are crop plants created for human or animal consumption using genetic engineering, in which selected individual genes are transferred from an organism into the plant to enhance desired agronomic traits1. From a scientific point of view, groups supporting GM foods claim that GM foods can achieve food security all over the world, solve malnutrition problems by acquiring resistance to insect damage, viral infections, and tolerance towards certain herbicides besides protecting the environment1,2. Groups that oppose rely on three main debated issues which are the potentials to provoke allergic reactions, gene transfer and outcrossing1,3,4. To overcome fears of health hazards, the product must pass a test of “substantial equivalence,” that refers to its relative safety compared to its traditional counterpart besides evaluating efficacy, quality, and safety. According to WHO, individual GM foods and their safety should be assessed on a case-by-case basis; it is not possible to make general statements on the safety of all GM foods. Protocols for testing GM foods have been evaluated by FAO and WHO.

From the ethical and moral points of view which are always related to religious beliefs, the group totally refusing GM foods claims that humans are not permitted to interfere with God’s creation. The other group accepting claim that GM foods have the potential to solve many of the world’s hunger and malnutrition problems, and help protect the environment consequently useful for the humanity, so these foods are permissible, but producing transgenic plants for biological experiments that are not obviously leading to an advantage to humanity may not be permitted. Finally, scientific considerations side by side with ethical and religious considerations should be reflected in researcher’s decisions and experimental studies.

Abbreviations:

WHO: World Health Organization.

FAO: Food and Agriculture Organization of the United Nations.

References:

(1): World Health Organization, frequently asked questions on genetically modified foods- May 2014

(2): Food and Agriculture Organization, 2014.

(3): Engel, K-H, Frenzel, TH and Miller, A. “Current and future benefits from the use of GM technology in food production”. Toxicology Letters, 127: (2002) 329-336.

(4): Dona, A and Arvanitoyannis, I. “Health riska of genetically modified foods”. Critical Reviews in Food Science and Nutrition, 49: (2009) 164-175

 

  • Drug Re-purposing

By: Ahmed Alhusban

Drug re-purposing is a new trend in translational research where the aim is to test currently approved agents for new indications. During this process, the drug needs to go through the different stages of drug development. Interestingly, in animal studies some of the repurposed drugs would show impressive effects in the newly tested indications. Moving toward clinical phases necessitates the preparation of a proposal to allow their testing in humans. During this process, the investigator needs to provide support for his hypothesis using available literature. In certain cases, the investigator would retrieve studies that provide strong support of his hypothesis. Unfortunately, some of these are “too good to be true” or would come from investigators known to generate “positive results” only. Alternatively, the investigator might retrieve literature supporting his hypothesis but the methodology used to generate them has certain flaws. In this case, the investigator has to make an ethical decision about whether to use this evidence or to ignore it.

To overcome this problem the investigator can assume that since it is published in a peer-reviewed journal then it has went through critical revisions and would not have been published unless it is true. Although valid in some cases, this argument assumes that the reviewer had access to all research details, which is not the case in all journals.  On the other extreme, the investigator can simply ignore this evidence. This would introduce bias and may threaten the progress of his research.

Alternatively, the investigator can cite relevant work and provide critical appraisal for the results leaving it to the reviewer to decide. Although valid, this might kill a highly promising drug. Accordingly, it might be necessary to have a centralized scientific body to review human research before publication. This body should have full access to all research aspects.

 

  • Ethics of stem cell research- Islamic view

By: Ahmed Al-Delaimy

The challenging issue in embryonic stem cell research argues that do researchers consider embryo has its moral status and have the full condition to be protected! Or would they deal with the embryo in any stage as any other tissue in the body.

Different religions view the status of the early human embryo in different ways. In Islam the ethical principles in stem cell research related with saving life, reducing suffering from diseases and development of science. It also makes a distinction between potential life and actual life protection. In addition cells in vitro fertilization technique differs from inside the body of a human being. But at the same time Islam forbid and against the misuse of embryos and stem cells.

In Islam a “Hadith” by the prophet Muhammad says; in forty days after fertilization ‘Allah’ sends it an angel that gives it form and the information of sensory organs. This organogenesis peaks precisely at 42 days from fertilization. In another ‘Hadith” it was said that after 120 days (after three main stages the embryo goes through: sperm then clot then lump) after conception the embryo would have spiritual life.

The Quran describes the stage of embryonic life:

“Then we made the sperm-drop into a clinging clot, and we made the clot into a lump [of flesh], and we made [from] the lump, bones, and we covered the bones with flesh; then we developed him into another creation. So blessed is Allah, the best of creators”.

From these texts “fatwa” was established by scholars, the rights of the human embryo/fetus (harma) increases as it transformed from one of these stages to the next.

So Islam encourages international guidelines (for example taking valid consent from cell donors and not allowing money profits) in this field of research to establish strict rules in dealing with embryo including stem cell research.

 

  • Research misconduct: a raising global problem

By: Ahmed Al-Azayzih

Research misconduct is defined as “fabrication, falsification, and plagiarism, and does not include honest error or differences of opinion” according to National Institute of Health (NIH) definition. This definition is almost similar among the majority research institutions and bodies worldwide.

There have been many reported cases of research misconduct throughout the history. This behavior can lead to negative consequences on all parties involved in such act, for example, the investigators involved in misconduct might lose their funds and careers as well as the loss of scientific body reputations and respect. Furthermore, it does raise the concern about research integrity and trust among public.

Career demands and ease of falsification and fabrications are among the main motivators for researchers to commit research misconduct. Although, many research administration bodies have implemented several administrative actions against those who commit such attitudes, many cases are still not evaluated and assessed and necessitates further regulatory actions, for example, submitting the same manuscript to different journals at the same time is not included clearly under the definition of the research misconduct, although it is considered as unethical act.

In my opinion, there is an urgent need to reform and improve the precautionary measurements and actions to prevent research misconduct from happening, as it can save the time and needed to assess the misconduct. Precautionary measurements can involve various elements including 1 holding continuous educations about major ethical issues for all persons involved in research projects, 2all manuscript should be evaluated for the pictures and figures manipulation software before submitted to peer-review, 3the principal investigator should provide the grants provider, institution, and the potential publishing journals with the raw data utilized to make the final results and figures. 4Also, it is very important to hold continuous educational programs for researchers, especially the junior researchers about statistical applications and to correct the wrong statistical concepts.

In conclusion, research misconduct is considered as major problem that faces the scientific environment and it does need an urgent resolution through implementing various precautionary actions to limit such behavior.

 

  • Early Marriage

By: Adnan Al-Hindi

Background

Early marriage (or child marriage) one of the common practices in some Arab, Asian and African countries, this is related to different factors and cultures. In our |Isalm the sexual relationship is attained by (legal marriage or legal wedding). Others are considered as un-legal.  Normally marriage is occurring after 16 years old in Arab countries or after ending of university education. In 2006, Pan Arab Project of Family Health conducted a survey and found that approximately 10% of young girls between the ages of 15 to 19 years old are married and 50% of 20 to 24 years old are married.

 The problem/questions emerged:

  1. Is there is a significant difference in research results regarding girls in early marriage vs normal age of marriage?
  2. Is the research results are affected by the physical, social and psychological consequences of child marriage on the girl and the family?
  3. Is the research results are affected by cultural and religious commitments to the early marriage?
  4. Is the research results are affected by health side effects on those girls?
  5. Is child marriage a violation of human rights and is prohibited by a number of international conventions and other instruments? [1].
  6. Is it ethical to enforce children for marriage due to different factors?
  7. Are there a relation between early marriage and divorce?
  8. Are families aware and understanding for the risk/consequences of early marriage?
  9. Who is responsible for this condition, the mother or father, society, culture, traditions?
  10. If these girls participate in a research will they give true/accurate answers?

 Suggested solutions

  1.  The probability to change the cultures and traditions.
  2. Stating new laws to set the minimum age of marriage
  3. Improving the life of families and more chances of education for girls.

 References:

[1] UNFPA, State of the World Population, 2005

[2]. http://iheu.org/child-marriage-violation-human-rights/

[3].https://staff.najah.edu/sites/default/files/Early%20Marriage%20in%20Palestine.pdf

 

  • Data fabrication, reviewer’s misconduct and irreproducibility

By: Aceil Al-Khatib

Dr. A. who is an assistant professor at a university noted that a heavily cited article by (Dr. X.) reported the use of a certain test to determine the prevalence of a micro-organism in the mouth. Given the importance of the topic and knowing that the test was not available at the time the study was conducted, she decided to replicate the study. The results of her twice repeated findings showed differences in positive results in comparison to those reported in Dr. X’s article. She completed the manuscript and submitted it to the same journal in which that article was published. The editor invited two reviewers one of whom, apparently, was Dr. X. (as an expert in the field). The outcome was a rejection on the grounds of: “incredible findings that are not in agreement with previously published research”. Six months later, a similar article by Dr. X. was published in a different journal, with sections copied verbatim including spelling mistakes, from Dr. A’s rejected article, but after manipulating statistical results conflicting with Dr. X’s article.

This case sheds light on an association between data fabrication and irreproducibility, and raises many ethical challenges: First, the fabrication of data by Dr. X. Second, a conflict of interest leading to reviewer’s misconduct, as exemplified by rejecting an article challenging a fabricated published article by Dr. X. And third, plagiarism of an author’s article by an unethical reviewer. Consequently, the honest author was deprived of a publication credit and two fabricated articles remain published and possibly cited by other misled researchers.

Published fabricated studies continue to divert funds to sponsor irreproducible research and contaminate the scientific literature.

The problems of irreproducibility, conflict of interest, reviewer’s misconduct, and plagiarism can be prevented by adopting open-data and open-peer-review policies, and the use of plagiarism detection tools.