Case Studies for Participants in the Jordan RCR Program (Year 4)-2018-2019

• Case Study:

By: Mayis Aldughmi

A RCT aimed to explore the effect of a supervised exercise program and stem cells therapy on motor and non-motor symptoms in people with multiple sclerosis (MS). Study participants will be randomized randomly into one of three groups: Those who take stem cells only (group 1), Exercise only (group 2), and combined treatment of exercise and stem cells (group 3). During the recruitment process, research personnel explained to eligible participants the study design and the randomization process. Subjects were informed about the potential risks and benefits of the study intervention programs (exercise and stem cells). And the research team clarified how stem cell therapy is still under research worldwide, and so they may/might not benefit from this therapy. However, the researchers noticed that most of the subjects approved to participate in the clinical trial for the hope to receive stem cells therapy. Despite explaining to them the randomization process prior to signing the consent, and informing them that they have to agree to be part of any of the 3 groups before consenting. After being randomized into the “Exercise Only” group, many subjects started to complain and some even refused to participate in the clinical trial. As a result, the PI decided to offer stem cell injections for those randomized into the “Exercise Only” group after they finish the clinical trial, to increase recruitment and compliance of the participants.

Case Analysis and Ethical Dilemma

There are several possible reasons why the participants were hoping to receive stem cells therapy: Unfortunately, a lot of patients assume stem cells as “miracle treatment”, and this may be due to the presence of some clinics who are exploiting patients by offering effective stem cell therapies without credible scientific rationale. Other reasons may include: Lack of awareness regarding the benefits of exercise, desperation and pressure from family/friends that may be due to ineffective commonly used treatments for MS. The decision made by the PI may be unethical because he/she is reassuring the participants that stem cells is a therapy that they will benefit from, but they need to wait for a while until they receive it. This contradicts the current evidence and the initial recruitment process in this clinical trial. Also, the decision made encourage the false thoughts participants may have that exercise alone is not beneficial.

It is possible that the consent process was not effective in the first place and may result to a problem in this clinical trial. Where the descriptions of risks and benefits vague or ambiguous? Did the researchers clearly explain the uncertainty inherent in stem cell therapy? Also, blinding the participants to the allocation and type of intervention in the first place may have helped overcoming the issue in this study.

 

• Case study:

By: Jennifer Muhaidat

A researcher was conducting a cross-sectional study to explore the falls profile of community-dwelling Jordanian older adults. The information sheet and the researcher have made it clear to all potential participants that there are no direct benefits to the participants from the study and that their participation will be of great value for the identification of the needs of this population in terms of services and rehabilitation.

After reading the information sheet and having the time and chance to ask any questions, a participant consents to take part. The data collection session took 1 hour and the researcher thanked the participant for her contribution. Before leaving the participant asked then researcher for physiotherapy services for her shoulder pain.

 

Ethical problem

The ethical problem in this case is offering extra services that are not part of the study.

The researcher needs to consider that this might affect the motivation of the participant to participate in future studies.

The ethical problem here is also concerning the researcher’s professional obligation since she is a physiotherapist by training, so should she offer the service?

The researcher will not charge the participant for the service and she will not harm the participant.

Another ethical problem is the possibility of the participant being recruited form a physiotherapy clinic, so treating the participant by the researcher might cause an ethical problem with colleagues.

 

Potential solutions

The most appropriate way to handle this situation is to refer the participant to an independent physiotherapist who is not involved in the research study. This will ensure that that the researcher did not offer any services that could be considered as incentives that were not declared at the planning phase of the study. Moreover, the researcher would fulfill her ethical and professional obligation to help the participant get the service needed.

 

• Case study:

By: Taher Emahbes

Dr Smith is a professor in one of the top universities around the world. He is the director of the public health department and the director of the research department at the university. Dr Smith is conducting public health interventional research on the public. Four post graduate students helping him in conducting the research. The students did all the work in the research including the study design, collecting data, data analysis, writing the articles and reviewing it.

After they finish with the article, Dr Smith reviewed the result and it was interesting and it will be good to publish this article. Professor Smith informs the students that he will submit the paper to a public health conference but his name will be the first because he is the supervisor. He also said to them that all the work they did is a part of the training program to get a Ph.D degree.

He then, informed them that he will publish this paper in high rank Journal but he will be the first author in the research.

The students were confused because what the professor did is un ethical but on the other hand they want to graduate. The students ask themselves questions such as:

Ethical Considerations

• Does the professor know that what he did is un-ethical?
• Are they entitled to refuse his action?
• To whom to speak if they want to complain?
• Should they accept it and lose the credit?
• Do they talk to him and tell him to put his name but not the first, and he cannot be the speaker in the conference?
• Do they tell him that he did not do any work and he should not be in the paper nor speaking in the conference (but then they will face that they will be delayed to graduate because that the supervisor has the authority to extend it)?

 

• Case study:

By: Jamila Abu-Idhail

A senior researcher conducted a follow up, Interventional study among first year nursing university students. The purpose of the study was to enhance the students’ level of knowledge and clinical skills in the laboratory. The researcher used a new educational material for the students with new innovative clinical teaching strategy for two semesters. Then the researcher compared the students’ level of knowledge and their competency in performing clinical skills after adopting the new strategy of teaching with the performance of students that resulted from the old strategy of teaching. After data analysis and getting the results, the researcher found there were no significant results between the students’ performance of clinical skills using the old methods versus the new method of teaching, which means that the new strategy did not affect the students’ skills. However, the level of students’ knowledge was improved.

Ethical problems

At the time of preparing a manuscript to publish the results of the study, the researcher falsified the data. He changed the data of the participants and the results of the test to become significant. At the time of writing the manuscript the researcher wrote highly positive explanations for his new strategy of teaching by relating the results of students’ competence with their falsified academic achievement and clinical training. The researcher was expecting to get a big difference between two times of assessment of the students’ skills, and high level of students’ competence in the skills’ performance by using the new strategy of clinical teaching. However, most of his discussion falsely inflated the new strategy of teaching without references.

Ethical solutions

The reviewers of a journal rejected the manuscript and asked the researcher to be scientific and give some of the weaknesses of the new strategy of teaching. The manuscript was questionable regarding the significant results without supporting documents or data through discussion. So, the researcher continued to re-change the data, but it took around three years to publish the manuscript. Ethically the researcher was not honest, gave false results and overestimated. This researcher –if he was known- he should be resigned from the scientific community and the journal should publicize his unethical act to his institution.

 

 

• Case study:

By: Dania Qutishat

Dania did a qualitative research study that involved a focus group for physiotherapy students. The aim of the study was to explore the attitude and experience of students toward community-based project targeting physical activity. Dania was the responsible for the course that involved the community-based project. The participants were her students in that course.

Ethical issues in the case study

• Participants were students at university.
• Researcher is the course educator.

 

Ethical issues regarding Participants

• Bias as a result to embarrassment and over pressure.

Solutions to address ethical issues-Participants

• Method of data collection
• Timing of conducting the study
• Valid consent
• Voluntariness
• The Right to withdraw from the study at anytime

 

Ethical issues regarding the Researcher

• Conflict of interest (conscious)

 

Solutions to address ethical issues- Researcher

• Rigorous data analysis.
• Follow the data not personal assumptions or expectations.

 

 

 

 

 

• Case study:

By: Rasha Okasheh

Researcher X was examining gait parameters in patients with COPD.

Contextual information (Participants):

• People with COPD are usually physically inactive
• They participated in the study to please their doctor

Contextual information (Study protocol)

• The inclusion criterion was very “tight”, so it was difficult to find participants.
• The assessment tests require the patient to walk
• Patients are offered frequent test
• There physiological parameters are continuously being monitored and participant are being informed about how these are changing

Contextual information (Information to patients)

• Patients were adequately informed about the level of effort involved.
• They were assured that the physician is onsite, there is an emergency plan, and oxygen source is readily available.
• Refreshments were provided.

The problem:

• A large number of patients claimed that they were tired and wanted to stop the test.
• Physiological parameters were within normal.
• Is it OK to nudge them? If yes, what is the best way of doing it?

The solution:

Behavioral interventions “strategies” used in the science of psychology could be implemented to facilitate appropriate adoption and involvement of participants at the beginning VanEpps et al. (2016). More thoughtful consideration to the design and planning “appropriate nudge” during recruitment would have reduced the need to “nudge” during the study. However it could also be helpful to plan strategies to motivate patients during the study and to inform patients that such strategies would be used.

References

VanEpps, Eric M., Kevin G. Volpp, and Scott D. Halpern. “A nudge toward participation: improving clinical trial enrollment with behavioral economics.” Sci Transl Med 8.348 (2016): 348fs13.

 

 

• Case Study:

By: Raed Al-Shami

Dr. B would like to do an experimental study on extracted teeth, testing the efficiency of material X, the material was supported by his own company, while supervising his UG students in the clinic, and he asked the students to keep the extracted teeth in a jar so that he can do the experiment later. The students told the participants that their extracted teeth will be used in a research at the university and they agree. Later on, when the results came out, there was a non-significant effect of material X, but they showed some advantages of the product in comparison to control.

The ethical problems / misconduct:

• The collection of samples before getting an IRB approval for the research. So they will collect the extracted teeth before clarifying to the IRB or even the patient the aim of the research.
• The doctor owns the company so there will be a conflict of interest even if the principal investigator declared it, still a lot of questions will be asked about the validity of the results, knowing that they showed some positive effects although non-significant results just to prove some efficiency of the product.
• Asking the patients orally to agree for doing a research on their teeth just before the surgical procedure, so the patients might think that if they refused to join the research for any reason, then they will be treated differently or not treated at all.

Potential solutions:

Although extracting teeth is a routine procedure in dentistry but once the plan is to perform a research then the P.I should get an IRB approval before attempting any procedure. So once the teeth extracted then you can perform your work on them later. Secondly, since the P.I own the company, he might have some bias and it’s preferable if letting another researcher to do the research so the results will be unbiased to certain degree or to perform the study funded by your company and declare it very well. In addition to get a valid consent from the patient a head of their appointment so the participants feel free to join or not without affecting their desire by any other means.

 

• Case Study:

By: Afef Skhiri

Dr XY is a physician working in a primary health care facility in a governorate from the North of Tunisia. In July 2013 he participated in a national conference on non- communicable diseases .He was very interested with the poster session and even took pictures of different posters. In January 2015, Dr XY submitted an abstract to a national conference on general practice .The abstract title was « the epidemiology of leishmaniosis about 27 cases in the North of Tunisia », the abstract was accepted and he presented it.

An Epidemiologist participated in this conference and he was really upset by the number of leishmaniosis cases in the North of Tunisia. Indeed, leishmaniosis is a tropical disease with high prevalence in the South of Tunisia but it is sporadic in the North of the country.

Furthermore, this epidemiologist was working on the national surveillance system of communicable disease and never knew about these cases. So, he immediately contacted Dr ZY, the health director of the governorate from the North. He wanted an explanation about the underreporting of these cases and to initiate an epidemiological investigation.

• Dr ZY contacted Dr XY and his chief to blame them as they did not declare these cases to the directory of health and to the Ministry of Health.
• The epidemiological investigation found only three real cases (during the last five years).
• It appears that Dr XY copy pasted the poster content, and changed some details like the region and the year of events and falsified data.

 Ethical issues:

• Data falsification: Dr XY falsely reported data to increase his abstracts chance at being accepted; he changed the number of cases from 5 to 27 cases. As a consequence this lead to the involvement of the ministry of health (epidemiological investigation )
• Plagiarism: Dr XY clearly carried out plagiarism, a year and a half after the first poster was presented.

Solutions:

There are hundreds of scientific events every year, and abstract books are often published online or shared, giving oppurtunity to some researchers to violate ethical principles and committing acts of plagiarism.   Possible solutions:

• Author’s Statement: Authors must sign an author’s statement when submitting an abstract. In fact, it is easy to detect plagiarism by software available but it only done for articles
• Sharing abstract books in a protected PDF version
• Disciplinary penalty and blacklisting author’s falsifying data or plagiarism
• Training researchers on Responsible Conduct of Research and on ethics principles
• Sharing abstract books in a PDF version

 

• Authorship Irregularities and Illegal Practices

By: Almuthanna Khalaf Alkaraki

The main supreme goal of publications is scientific progress and scientific contribution to mankind.

Authorship proof individual intellectual efforts and implement self-confidence.

Authorship provides financial benefits such as research fund, academic promotions and work positions. Authorship credits to who deserves. The main question in publication process is “who is the author?”

Illegal Irregularities and Unethical Attitudes:

Pressured Authorship

The listed author uses his or her authority to apply pressure; to be included as a co-author.

Forced authorship

• Listing other professionals who are not involved as true authors.
• Those Professionals can prevent access to materials or instrumentations needed during the study.
• The enforcement may be imposed by department’s head or laboratory manager with a wrong understanding of their rights

International Committee of Medical Journal Editors (ICMJE): Sets three authorship guidelines that define the qualified author:

• Firstly, Author should significantly contribute to the conception and design of a study or data acquisition, analysis or interpretation.
• Secondly, Author should write or critically revise the paper manuscript.
• Finally, all authors should approve the final version of manuscript before publication

Ethical Dilemma-Self-Experience (Problem):

• Study Goal: to investigate the prevalence of certain genotypes as a risk factor for Disease X.
• The study was approved by a local IRB.
• Problem: Physician rejects to provide help in blood sampling, unless he/she is being listed as co-Author.
• Once we did complain to the head of the hospital, he/she was very generous to provide help, and again he/she wanted to be listed as a co-Author.

References

• Anderson PA, Boden SD. Ethical Considerations of Authorship. SAS Journal. Summer 2008; 2: 155 – 158.
• Bennett DM, Taylor DM. Unethical practices in authorship of scientific papers. Emerg Med (Fremantle). 2003 Jun;15(3):263-70.
• International Committee of Medical Journal Editors (ICMJE). Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication. Available at: http://www.icmje.org/index.html. Accessed: December 16, 2013.
• Riancho JA. Authorship of Scientific Articles. Acta Otorrinolaringol Esp. 2007; 58(7):281-3

 

• Reviewers’ Ethical Dilemma in the Research Process

By: Dr Moawiah Khatatbeh

 

The Scenario:

From time to time, academics (researchers) receive calls from their colleagues/friends (a faculty member) telling them about their new submission of a research paper and nominating their colleague’s name as a possible reviewer for that paper as instructed by the journal. They request that In case you get their paper for review ; to just say OK and not to critically review his manuscript.

 

 

What should your answer be?

OK, I will do my best

Or, No, this is not ethical….and let me do my job

 

What is the best practice in this situation? What should you do?

• Refuse the review process for many reasons.
• Review the manuscript carefully; neglecting concerns about the relationship with your colleague.

 

 

Peer-review responsibilities*:

 

• Blind……No conflict of interest
• Alerting the editor about any potential personal or financial conflict of interest and declining to review when a possibility of a conflict exists.
• Complying with the editor’s written instructions on the journal’s expectations for the scope, content, and quality of the review
• Refraining from direct author contact.

 

References:

*https://www.councilscienceeditors.org/resource-library/editorial-policies/white-paper-on-publication-ethics/2-3-reviewer-roles-and-responsibilities

 

 

• Case Study(Authorship):

By: Mohammed  Mehanna

Adam Anderson had recruited several postdoctoral staff at his laboratory where research is mainly concerned with application of nanotechnology in drug delivery to treat prostate cancer. Rayan, one of the postdoctoral, was responsible for the training of PhD candidate, Abyad, on the use of flow cytometry during molecular elucidation of anticancer drug subcellular mechanism. During experimental work, Sam, the laboratory technician, helped and guided Abyad. Several months later, under the supervision of the postdoctoral, the PhD candidate wrote his scientific article and prepared it for submission. Professor Adam, Rayan and Abyad were listed as co-authors in the above sequence. Sam was listed in the acknowledgment section of the article. At this point, Sam was upset and asked Abyad to add him as a co-author as he mentioned, “without my contribution, this work couldn’t be carried and this article couldn’t be even there”. Abyad asked Prof. Adam for his advice and what he should do but Prof. Adam wasn’t aware of the article at all and actually he critiqued the research point form the article title. Moreover, Prof. Adam opposed the authors’ arrangement on the article. What do you think about the authorship of this article?

 

• Case Study

By: Suhaib Muflih

A research team consists of three assistant professors (Drs. A, B, C) at J.U.S.T working on an ambitious research project “Pharmacogenetic Testing:  a cost-effect evaluation.” Shortly, after the first group brainstorming meeting, the goals, responsibilities, and roles were clearly defined. During the second group meeting conducted two weeks later, Dr. A proposed listing his wife (Dr. D) as a co-author on the current project.

The ICMJE recommendations:

Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; Drafting the work or revising it critically for important intellectual content; Final approval of the version to be published; and Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Is it ethical to choose a spouse as a coauthor?

Couple vs. Research Partners           

• The integrity of the contributions of co-authors
• A valid contribution
• Barriers for co-authorship
• Nonacademic collaborators (rather low)
• Recognizing intellectual contribution…
• Similar research interests
• Conflict of interest
• Doubling the academic output
• Subconscious bias regarding the co-authors contribution
• Concerns about loss of impartiality

Coauthors are responsible for others

Discussion:

After presenting the case, the audience expressed positive attitudes regrading having their spouses participate and involve them in the publication process. The majority of the audience agreed on the primary interest of the spouse in promoting the learning process. In addition, the audience members denied the possibility of conflict of interest that might occur between the spouses. Two members emphasized the importance of having a spouse as a coauthor especially if he/she shares the same research interests. However, a few audience members expressed concerns regarding doubling the academic output of spouses that could happen faster than collaborating with other non-spouse researchers.

 

• Case Study

By: Loai Tawalbeh

Dr X wants to conduct a study that assesses the empathy behaviors among health care providers (nurses) for newly diagnosed patients with cancer. In addition, the researcher wants to assess the feelings and the coping mechanisms for the family members of patients whom are newly diagnosed with cancer. How empathic are health care professionals (Nurses) in their treatment of patients whom are newly diagnosed with cancer? What are the levels of stress, anxiety and coping mechanisms used by family members of patients whom are newly diagnosed with cancer?

Ethical aspects and concepts

• First: this case showed that the participants rights are in indirect conflicts with the study demands which posing an ethical dilemma.
• To prove this we have to determine:
• What are the participants rights based on this study?
• What are the study demands?
• What is the conflict?

Participant’s rights:

• Informed consent
• No harms (either psychological, physiological, ——-).

Study demands

• To address the study purposes and to answer the study questions, the researcher would likely want to observe nurses’s behaviors while treating patients.
• Also, the researcher may observe the family member during their patient visit. In addition, they may ask them using questionnaire about the level of stress and anxiety and the possible coping mechanisms that they will use.

So the conflict is:

• Ethical research studies generally involve explaining the study to the participants (part of informed consent).
• If the Dr X informs the nurses that their treatment of patient will be observed.
• If their behaviors are being altered because of their awareness of being observed, the entire value of the study will be undermined.
• Moreover: to assess the family members stress, anxiety and coping mechanisms, the researcher want to assess these concepts intrusively among the family members whom are very vulnerable. Such investigation could be painful and traumatic

Possible solutions, alternatives

• Are there possible solutions for observation (informed consent part)?
• Are there ways to deal with family members at the time of grief and anger? (No harm)
• Informed consent should be obtained and we have to inform the participant that they are being observed.
• Conclusion
• Ethical principles should be applied first
• No risks, no harms, or the benefits should outweighs the minimal risk

 

• Case Study

By: Hiba Al Zou’bi

Alma is a 16 year old student; she has an Askfm public profile. A researcher wants to make a study on bullying at school; is collecting data via the internet from students aged 12-16.

He will collect data from her public profile, then he will send her a friend request and he will ask her the questions as her friend (not as a researcher).

Ethical Questions and Answers

• Is a Human research ethical committee approval needed? Yes, Recommendation: We need to develop universal guidelines for internet-based research, especially with young people.
• Can the researcher use Alma’s profile content without her consent? Researchers generally don’t need consent to use information that is in a public profile.
• But, we are dealing with young?? Some young people may not be concerned about their privacy?? It is better to take the consent.
• If Alma agrees, can we use the information based on her consent alone without her parental consent? Yes, we can, if the research does not involve the collection of identifiable information, such as in our case (counting instances of something).

 

 

 

 

• Case Study

By: Lara Al-Khlaifat

A vulnerable population case study:

A study investigating physical fitness in physiotherapy students was conducted. The study had two aims:

1- To explore the perception of the students on physical fitness using focus groups. The principle investigator (PI) led the focus group and asked the questions.

2- To investigate the effectiveness of a 6-week exercise program on the student’s physical fitness levels.

 

Ethical Problems:

1- Recruitment process: the students might have felt coerced to participate. Although the consent form highlights participation is voluntary and the participants could withdraw anytime, they might still fear to do so in order not to risk their relationship with their professor.

2- The students might have felt coerced to complete the 6-week exercise program although they did not want to.

3- Conflict of interest issue: the PI in the focus group is also the one who provided the learning experience.

4- The student might have answered the questions to the best interest of the research rather than what they really thought only to please the PI.

5- The exercise program was delivered by the PI and a research assistant (RA) who was trained on the delivery of the program. It was noticed that the drop-out rates were higher in the RA classes which could be explained by the students’ need to please the PI.

6- Confidentiality of the data: the identity of the participants in the focus group cannot be hidden from the PI or other participants.

 

Ethical Solution/s( Discussion):

1- Recruitment was performed by the RA rather than the PI to allow the student to decide without restraint if they want to participate in the study.

2- The PI and RA looked for signs that any student might not be happy with his/her contribution in the study and asked them to leave the study without ramifications to avoid coercion to complete the study.

3- The PI could seek recruiting other students whom he does not teach to avoid conflict of interest.

4- Clear explanation of the goals of the study and clarifying that their participation would not affect the learning process could help the students express their ideas freely without the need to please the PI.

5- Clear explanation of the importance of the study and clarifying that their decision to participate would not affect the learning process. In addition to training the RA on the delivery of the program so there would not be any differences among groups.

6- This is a qualitative study design using focus groups where the discussion between participants is important to form ideas. Therefore, hiding the identity of the participants from the PI or other participants is not possible. However, their information can be hidden when analysing the data through coding and limiting the access to the data to the research team.

 

 

 

• Case Study: Return of results to study participants

By:  Majd A. Hamaly

 

MM is a pediatric patient 8 years old, developed symptoms of low grade fever, night sweat and weight loss with a growing mass in her neck. She was diagnosed with Hodgkin’s disease with a Mediastinal mass. Her parents consented to enroll her in a study that examines the reduction of exposure to radiotherapy with patients experiencing a rapid response to chemotherapy. This study was going hand in hand with evaluating the exposure of radiation to predisposing cancer.

MM demonstrated slow response to chemotherapy and according to the protocol she received high dose radiation therapy to the chest. MM lymphoma remind in remission, she continued to follow up with the pediatric oncologist till the age of 18. Afterwards she moved out of her home and stopped seeing an oncology specialist.

At the age of 30 , MM and as part of pink October ; was part of the breast cancer screening program taking place at the nation’s level. MM discovered that she has a breast mass. Along her treatment journey and as part of obtaining the patient history; her oncologist informed her that the study she participated in as a teenager revealed that radiation therapy to the chest for adolescent girls was a predisposing factor to breast cancer.

The aforementioned study recommends that women exposed to such therapy are to start screening mammography earlier with continued follow up at the survival clinic. MM was very angry about this information, and she thought that her breast mass could have been detected at an earlier stage with proper and continuous follow up.

Issues in this case study:

• Should the study team have communicated the results to the participants?
• Who shall decide on the results to be returned?
• What sort of results shall be returned to subjects?
• Shall data be traced back to participants by whoever is doing the return?
• What is the time frame for return?
• To whom shall the results be returned, this is a pediatric patient?
• If investigators decided on the return of results how are they going to reach out to participants, participant moved out of town for example?

 

Discussion and recommended solutions:

Three important aspects shall be tackled in case of results return. First; the nature of data to be returned. Study team shall identify what participants want and don’t want to know. Data that is actionable, clinically relevant shall be returned especially when a potentially serious health condition is identified. Ideally, Informed consent shall clarify to research participants what results they will be receiving and how much of the results will be returned [1]. Second; the timing or reporting. Participants shall be educated about the complex and lengthy nature of research investigation. In addition, an agreement regarding the timeliness of reporting results shall be made with participates before enrollment [2]. Finally the way results are returned; personnel responsible for the delivery of returned results shall be identified weather the principle investigator, the participant’s health care provider or other study team member. Study team shall make sure the participant understands the returned result and explain the probability and uncertainty aspect of some results. Logistics and cost of results return (if applicable) shall be appropriately planned [3].

References:

[1] S.D. MacNeil, C.V. Fernandez, Informing research participants of research results: analysis of Canadian university based research ethics board policies, Journal of Medical Ethics, 32 (2006) 49-54.

[2] C.V. Fernandez, K. Ruccione, R.J. Wells, J.B. Long, W. Pelletier, M.C. Hooke, R.D. Pentz, R.B. Noll, J.N. Baker, M. O’Leary, Recommendations for the return of research results to study participants and guardians: a report from the Children’s Oncology Group, Journal of Clinical Oncology, 30 (2012) 4573.

[3] C.A. Wong, A.F. Hernandez, R.M. Califf, Return of Research Results to Study Participants: Uncharted and Untested, JAMA, (2018

 

• Case Study

By: Sawsan Abuhammad

Professor John ;( who is a cultural diversity instructor in the University of Wisconsin- Milwaukee); wants to study the experience of international students and what barriers they face during their journey to the US. He asked their students in the class if anyone was interested in participating in his study. One Jordanian student expressed her interest in participating in the study. This study was a longitudinal study with four interviews to talk about the experience and the barriers that faced international study. At the first interview, the professor explained the purpose of the study, benefit and risk. The student signed the informed consent. The first, second, and third interviews went very well. After that, the professor tried to contact the student to conduct the last interview. The student did not respond to any of the professor’s attempts of contacting her. After one week, the student dropped her class in response to some issues that happened in her life. Mr. John was shocked at why the student did not respond to any of his trials to contact her and he was worried that the student shared what happened during the interviews with other students in the class, since she sent her friend to ask him to withdraw her interview from the project. Also, he was worried that the student was feeling insecure as she had shared a lot of information with him. Professor John was feeling guilty that may be he was the reason for her dropping the class. Moreover, he wanted her to complete because he got very important data from her that would benefit his research, but he did not know how to do that.

The argument in this case

• Dr John wants the student to continue the study so as to get important data from her.
• Dr John is feeling that he is responsible for what happened with the student.
• The student asked the researcher to withdraw her data from the project by sending her friend.

What happened next?

The professor understood that he did not do anything wrong and he did his best to ensure the participants confidentiality and to ensure that the participants understand what type of questions will be in the interview. Moreover, he provided the participants with contact information if they need to discuss any concerns. He dropped her data from the project after she wrote a letter and signed it that she wanted to withdraw her data from the project.

 

• Case Study: Authorship and Publication

By:Rasha Araybat

Elsa is a PhD student, taking a graduate research methodology course with Dr. Melissa. Elsa is required to come up with an idea, analyze data, and write a high quality paper that is suitable for publication. Elsa discussed an idea with Dr. Melissa and she helped her with the design and analysis of data. Elsa also asked her mentor/graduate advisor Dr. George to be a co-author in the study. Elsa informed Dr. Melissa about her decision and she agreed upon that. By the end of the semester, Elsa wrote the paper, submitted it to Dr. Melissa and she graded her with an A for that class. During the next semester, Dr. George asked to see the draft of the paper. Dr. George thought that the idea and the paper were great and asked for a meeting with Elsa and with Dr. Melissa to collaborate on improving the study. During the meeting, Dr. George provided suggestions to improve the manuscript and reviewed subsequent drafts. One day, Dr. George asked Elsa explicitly to put his name as a last (senior author of the paper). Because of her ignorance of the authorship order, Elsa thought that the last author is the one who did the least work and she agreed upon that. Now Elsa submitted the paper for Dr. Melissa and she was totally upset with the authorship order and confronted Elsa with that. Elsa apologized for her ignorance, updated the authorship order, and made Dr. Melissa the last author. Elsa constantly felt that Dr. George is trying to push her not to list Dr. Melissa in the paper, but Elsa resisted. Elsa was busy with her dissertation and put the paper aside for a while. Once she had her degree and appointed as an assistant professor in other university she continued working on the paper and she maintained contact only with Dr. George who asked her to list him as a corresponding author on the paper and submit to X journal. On one of his email to Elsa, Dr. George said, “it is not necessary for Dr. Melissa to approve the last draft because we need to submit the paper ASAP, and the data is getting old, and anyway the editors will defiantly ask for revisions, so the manuscript will be changed.” Elsa submitted the paper without informing Dr. Melissa or letting her approved the final draft of the manuscript. Dr. Melissa still was the last author of the paper as she requested previously. Against all expectations, the editor of the journal was very happy with the article and wanted to publish it directly without sending it to peer-review. Dr. George sent an e-mail to Dr. Melissa to congratulate all the co-author of this great news. However, Dr. Melissa was upset that she did not approve the final draft of the manuscript.

Questions for discussion

• If you were in the position of Dr. Melissa, would you feel happy that the paper was accepted and published rapidly or would you feel upset that the paper was published without you approving the final draft of the manuscript?
• What is/are the ethical problems entitles in this study? Who should set the standards for authorship order, the student, the student’s graduate advisor (Dr. George), or the instructor of the course (Dr. Melissa)
• Elsa insisted on keeping Dr. Melissa as the last author on the paper even though Dr. George (the advisor) did not like that. So why do you think Elsa did not send Dr. Melissa the final version of the paper? Whom to blame in this situation? Who is being unethical here? Elsa, Dr. George, Dr. Melissa, or maybe the editor of the journal?
• Do you think the student was exploited by his/her advisor?

 

Possible solutions:

• The order of authorship on the publication should be a joint discussion of the co-authors.
• Each journal should make it explicit that everyone read and approve the final manuscript and send a confirmation email to each one of them separately
• Graduate students should be instructed about the authorship order and RCR
• The university should strengthen their regulations about the rights of their students
• Elsa should have sent an email for Dr. Melissa explaining the whole situation along with the final draft.
  • Case Study:Authorship

By: Hadeia Ahmed Mashaqbeh

John is a PhD student who had completed his thesis work and wrote the first manuscript of his work, John sent the manuscript to his supervisor Jace to edit and submit it to a peer-reviewed journal.

Thomas is another faculty member who helped Jace in editing John’s thesis; in return Thomas becomes a second author. John reluctantly agrees that he will be the third author, Jace is the first author.

Thomas at that time needed to publish an article with him being the first author for the purpose of promotion. Jace decided to help Thomas, he informed John that Thomas would be the first author; and he didn’t wait for John’s reply since his authority order didn’t change.

John’s response was aggressive and he had sent an email message insulting Jace and Thomas, then he informed the faculty members about his case. John’s response annoyed the faculty members and they decided not to help John.

The article was submitted and published. John didn’t give any further reaction because he was afraid about delaying his graduation.

Case analysis and arguments present in the case:

• The authority relationship; how to decide the order of author’s contribution.
• If the author order didn’t change, could the other authors exchange places between each other!
• When should the discussion on authority be performed? Before starting work, when they start the manuscript writing, or just before submitting the article.
• Good supervisory and authorship can help in solving and minimizing research ethical problems.

Possible solutions:

• John takes the PhD degree and now he can withdraw the published article.
• The regulatory policies in the universities should protect the right of authors in special cases such as students.
• Training researchers more about the ethical principles of authorship and responsible conduct of research.
• • Case Study

By: Hisham Altayb

During the past few months, there was an increase of diarrheal incidence in area X.  Most of the cases were children admitted to the local hospitals.  Dr. Mohammed wants to study the possible causative agents and source of infection.  He noticed that the source of drinking water in this area is common. He proposed to collect water samples from the river (the main source of drinking water), water refining station and from patients homes. Also his next step is characterizing the isolated bacteria from children diarrheal samples. While Dr. Mohammed started to collect samples from homes, he noticed an old man being treated very badly by his sons, the old man asked the doctor for help, and said “I want to get out”; but the sons told the doctor that this was none of  his business, they told him to do his job and leave.

The main levels of ethical concern in this case scenario are:

• The collection of the samples from an environment related to human health
• Protection of homes privacy and confidentiality
• Publishing of sensitive data related to human health and awareness of people at risk
• The security considerations (might mean that he can’t publish his findings, this would be putting him at risk)
• Water is crucial for human health; this ethical issue is a matter of survival for humanity.
• Ethical considerations pertaining to especially vulnerable children.
• Security issues about sensitive data: Is it ethically to report child or elderly abuse in homes if found; or do we have to keep the privacy of homes.

Suggested solutions

• For water samples collection, I think initially the researcher must obtain ethical approval from the proper authorities.
• Also an informed consent must be obtained from the home residents and from the children’s parents.
• The informed consent must be well prepared to include all issues related to children and the homes privacy and confidentiality.
• Awareness of public or water consumers about the current problem is a good idea.
• For elderly abuse in homes, I think this is a matter of humanity, its best to report this to the specialized authorities.

 

 

 

 

 

• Case Study: Effects of a writing intervention for Palestinian Adolescents victims of political violence in Gaza Strip
  By: Abdel Aziz Mousa Thabet

The aim of this study was to investigate the efficacy of expressive writing as a therapy for adolescent affected by war and trauma in the Gaza Strip.

The participants were recruited from four schools in Gaza City, the first group consisted of 28 girls, the second group consisted of 25 boys which were chosen as the intervention group, and the group consisted of 30 boys and girls as the control group. The research team received a list of pupils in the target age group from the 4 schools, and conducted a random selection of participants.  Out of 28 girls in the first assessment, 27 girls completed the post assessment scales, while 18 boys from 25 completed the scales. While 12 boys and 15 girls from the control group were assessed post intervention.

Before starting the intervention, the three groups were assessed using the 4 scales (Gaza Traumatic Event Checklist (GTEC), Impact of Events Scale-8 items version
Child Depression Inventory (CDI), and Revised Children’s Manifest Anxiety Scale).

After finishing the three days intervention, the three groups were assessed using the same scales.

Ethical Questions from the case

• Did the research follow the ethical procedure in conducting such research?
• What are other ethical issues in dealing with such a study?
• Did the researcher follow the known method of comparing more than one group exposed to therapy and control group?
• In your opinion what will be the best way to evaluate such intervention in children?

Ethical Discussion: In this study there were many ethical issues

• We did not get the parents’ consent form. For such a sample we should have the parents agreement of their children’s participation in the study.
• The sample division into three groups with two experimental and one control was unethical. Such study had to have experimental groups and the control group had to be waiting list group and receive the same intervention and to be left alone.
• We should have followed up with the three groups; three and six months later

 

• Case Study

By: Rana Obeidat

A researcher was conducting a survey study among colorectal cancer patients in Jordan. Data is being collected from two hospitals in the country (i.e. a teaching hospital and one affiliated with Jordan Ministry of Health). An ethical approval has been formally obtained from the two clinical settings. During data collection in one of the two settings, an attending oncologist has forbidden the data collectors from asking his patients to participate in the study.The researcher had a meeting with the oncologist and showed him the IRB approval document. The oncologist claimed that he should have been sent a formal request to approve data collection from his patients even if the researcher has obtained an IRB approval .The oncologist insisted on his refusal of data collection from his patients.

Case Analysis: The analysis of this case is formulated as a question and an answer format

• Is there a threat to patients’ health/safety?

No, as the study is a survey study with less than minimal risk, there is no clinical intervention or invasive procedures that would justify the physician’s refusal of data collection from his patients.

• Does the attending physician have the right to forbid data collection from his patients?

No, as the physician does not own either the patient him/herself or the patient’s data. Only the patient can agree or disagree to participate in a research study.

• Does the physician own his patients’ data?

No. Only the patient owns his/her data.

• Who has the right to decide on behalf of the patient to participate in a research study?

Only the patient or his legal guardian if the patient does not have decision making capacity.

• Should the researcher seek approval from each treating physician before commencing data collection from their patients? If yes? What type of approval?

No. the researcher does not have to seek formal approval from each attending physician before commencing data collection from his/her patients.

• What could have caused the physician to react in this way?

A possible explanation for the physician’s reaction would be that he was not informed about the study. There is an obvious lack of professional communication from the hospital’s administration which should have had informed all attending physicians about studies that would involve data collection from their patients. Or, the physician might have reacted this way because he/she wanted to be listed as a co-author in future publications that will emerge from the study.

 

Suggested Solutions:

Short term/immediate solutions:

• The researcher should meet the attending physician, explain the details of his study, and discuss with the physician his reasons for refusing data collection from his/her patients
• File a complaint to the hospital administration if the physician insisted on his refusal
• Recruit patients through other physicians/clinics

Long term solutions:

Raising awareness among health care professionals about ethical conduct of scientific research (e.g., the role of the IRBs, valid consent, and authorship criteria). The hospital’s administration (e.g., head of medical department) should send all physicians a notification /memo of each study that would involve data collection from their patients.

 

• Case Study

By: Abdelraouf Elmanama 

A group of researchers have started a phase 3 clinical trial on a drug that was proven to reduce blood sugar levels in lab animals as well as in humans in both phase I and II. The design is double blinded randomized controlled trial. All necessary legal and ethical approval were obtained. Participants were happy by the data presented to them and consented willingly. Everything was going smoothly until one of the researchers read a piece of information that shocked him and he felt depressed. The FDA has cleared and approved a new class of diabetic drugs that is superior to all other available drugs. He was not able to ignore this information.

He gathered the research team and the administration of the company and informed them about the FDA drug. They were all feeling confused by the news!

Ethical issues raised by the team

1. Should they ignore the news and continue the trial since all participants consented and only one month was remaining for the trial?
2. Should they discontinue the trial because it is unethical to deprive participants from using a more effective drug?
3. Should they just inform the participants of the new drug and give them the choice?
4. Will your answers to the above question be different if the clinical trial was on a cancer drug?
5. Will your answers to the above questions be different if the clinical trial was on AIDs drug and AIDS patients?
6. Is it really wise to answer any of the above questions (yes or no) immediately?
7. Will your answer be different if you are one of the researchers?

 

Discussion

The main point in this case is the approval of an effective diabetic drug while the team was experimenting a new drug that they have developed. The questions raised here is whether to ignore this fact and continue with their experiment might seem unethical, however, taking into consideration that new drugs will not hit the market as soon as they are approved and only one month remains to finish the trial it might be wise to continue the trial normally.  Informing study subjects about the new drug is optional since they will not be able to benefit from the drug during the period of the study. Questions 4, 5 and 6 were added to this case just to highlight the importance of the type of disease we are dealing with which might very much influence our decisions. In addition, we emphasize the need to gather more data and information about the case. AIDS and cancer are two different diseases and also different from diabetics in terms of severity, life expectancy, complication and mortality rates. Thus, one-month period can make difference on the health of study subjects. Question 7 was raised to highlight the possibility biased decision by researchers who are involved in the experiments, since they exerted efforts and have expectations.

 

• Case Study

By: Faisal Alzahrani

A virologist working in Saudi Arabia was a professor of microbiology and was working in a private hospital laboratory in Jeddah at the same time. Several years ago, a committee of the Ministry of Health opened an investigation with this him because he conducted research on blood tests he had taken from a patient who died two years ago at the hospital where he worked. He contacted a research center in Germany and sent them blood test results from this patient. He even expressed to German researchers his suspicion of a virus behind the patient’s death. The hospital reported that the cause of death was kidney and lung failure.

The professor continued to conduct research without taking ethical permission, even after the death of the patient. He sent samples to the Ministry of Health asking for help in reaching a clear scientific interpretation of the cause of the deadly disease. He also sent samples to a global scientific center in Europe. The European center responded to the professor by saying that a cornea virus was present in the cells of the patient to which it was sent. This was the first case diagnosed globally, the first scientifically proven case that the Corona virus killed humans by entering cells and causing respiratory and kidney failure.

Difficult Ethical Decisions:

The problem is that this researcher faces two dilemmas: either he saves the public health and conducts scientific research in an unethical way without having IRB. The other is to ignore a potential viral epidemic because he does not have ethical approval to conduct such scientific research in the right way.

Ethical dilemma and arguments present in the case:

• Failure to obtain ethical approval to conduct research on patient samples
• The external lab will obtain the intellectual rights of the research
• He may be subject to a criminal charge and that he constructed the virus inside the laboratory and published it
• Violation of laws and regulations of the country
• It may be that he caused the spread of the disease in the medical sector that has been observed significantly

 

• Case Study: A case study of sabotage

By: Mariam AbdEljalil

Sally is a 32 year old PhD student who is working at the pharmacokinetics lab of a prestigious university in the United Kingdom. She is developing a liquid chromatography–mass spectrometry method to measure the blood level of a group of immunosuppressant from dried blood spots (DBS). Her work aims to reduce the amount of blood withdrawn regularly from transplanted patients (especially pediatric patients) during the routine process of therapeutic drug monitoring (TDM), reduce discomfort, allow TDM to be performed via the regular postal service.

She started developing a method utilizing drug-spiked blood withdrawn from volunteers, and in a very short period the method was optimized and validated according to the appropriate guidelines. Sally’s supervisor was very happy with her rapid progress and told her to start recruiting patients.

A week later she started recruiting patients and receiving DBS cards via the post, and she analyzed every 10 cards together. Unfortunately, the analysis result showed erroneous peaks (indicating contamination) that made the interpretation of the immunosuppressant concentration inaccurate. She analyzed another 5 cards and found similar results. She started to investigate the possible source of such peaks by eliminating one possible source at a time, but despite all her efforts she could not identify the source of contamination. Out of desperation, she didn’t log into the lab’s system the cards of two patients; instead she mailed them directly to a professional company asking them to help her with her analysis.

To her surprise the samples analyzed at the company showed no contamination and their results were similar to her initial analysis utilizing spiked blood. This made her suspect that someone is tampering her samples when they are stored in the lab to confirm this thought she analyzed three cards immediately after she received them and found no traces of contamination in her samples.

Possible solutions:

1) Say nothing and store samples more securely; the problem with this solution is that the person who is sabotaging her samples will not get caught

2) Convey her suspicions to her supervisor and take responsibility for her actions. This is the most appropriate solution, although she could be accused that she is unable to analyze the samples correctly. Furthermore, she will have to face disciplinary action for taking patients samples outside the lab without permission

3) Act like COLUMBO and do her own detective work. Although some would say that they will do it, it is not really realistic in a busy lab.

 

 

 

 

 

 

• Case Study: Scientific Research Collaboration

By: Ola Al-Sanabra 

Ali a biochemist from Jordan has set collaboration with Professor Smith a hematologist and scientist from Switzerland. They were to conduct a research regarding the effect of delivering coated miRNA-181 on CLL cells survival. Dr. Ali was responsible for developing nanoparticles that coated the miRNAs; while Professor Smith’s lab was to study the effect of delivering these nanoparticles on CLL cells survival.

One of the things included in this collaboration was to send Dr. Yasser a postdoctoral from Dr. Ali’s lab to get six months training on the techniques that will be used in this research. Afterwards he will be able to transfer this knowledge to Jordan and conduct research independently. As a preparation for the research, Yasser started his training by Dr. Max who is a postdoctoral in Prof. Smith’s lab for a month. Also, Prof. Smith scheduled a 10 minute weekly-based meeting as a research meeting for all. However, during this month of training Max has taken a week off without arranging this with Yasser. At the same time he has frequently faced a problem of rescheduling the meeting with Prof. Smith.  After one month both of them started to perform the experiments alongside. During this time Max was using some of Yasser’s results and presenting them in the meetings with Prof. Smith. Furthermore, he has asked Prof. Smith to exclude Yasser’s name from any publication for this study or to be named in the paper before Yasser name. Yasser contacted Dr. Ali to let him know about the difficulty that he has faced. However, Dr. Ali hesitated to do anything because he does not want to lose this collaboration.

Ethical Practices:

 

• Mentoring: Lack of commitment and responsible supervision from the mentors.
• Collaboration guidelines: There are no specific written regulations for collaboration
• Showing disrespect towards a colleague by taking his results and presenting them
• Authorship: There is no previous agreement regarding the arranged author names in the published papers.
• Conflict of interest: keeping the collaboration

Solutions:

• Have written regulations for the agreements for any collaboration
• Clarify the roles for each investigator involved in the collaboration from the beginning
• Make it clear from the beginning about the names of authors; and how they will appear on the published papers.
• Responsibility of the collaborators: Guarantee proper training for the individuals involved in any collaborative study even if there is inequality in individuals’ competence.
• Make a documented record for the mentoring meetings and have a regular progress report.

 

 

 

 

 

• Case Study

By: Rania Mahafdeh

• A 14-year-old youth is suffering depression; he does not want to discuss his problems with his parents. He requests help from a community health center, the center provides him with the counseling to discuss his personal problems without telling his parents. The researchers from the center invite the fourteen year old to be a part of a randomized controlled trial that studies if a new drug can help in the treatment of depression. The 14-year-old youth does not want to involve his parents, and the researchers say that parental consent is not needed for the 14-year-old to access treatment so they do not need to obtain parental consent for him to participate in the research.

 

Ethical Problems:

 

• Is the researcher’s view correct? No, the researcher’s view is not correct.
• The 14-year-old does not have a good level of competence to allow independent access to treatment, and his consent does not authorize participation in a randomized controlled trial of an experimental drug.
• The risks of the research are not expected because it is an experimental trial. For this, the effectiveness and safety from the drug is unknown, so the consent from a14-year-old does not protect the welfare of the researchers and the welfare of the participants.

 

 

Ethical Solutions and Discussion:

• The regulatory definition of children depends both on the local laws and on the specific treatments or procedures that will be involved in the research. The location in which the research will be conducted allows 14-year-olds to consent to the treatment and the IRB may require some additional protections if they feel that the adolescents who will be involved in the study are vulnerable.

 

 

• Case Study:

By: Nahla Gamal Eldin

Dr R is a student of oncology at University X. One of the university requirements needed to be promoted to a higher degree is to conduct her master thesis. Unfortunately she is running out of time and she needs to finish her thesis in almost one year with all items, literature review, data collection, analysis and discussion, finally writing the report and publishing her findings. So the department assigned supervisors to mentor her all through. So she started communicating with them to choose the topic of her thesis. And finally after a lot of arguments and internet search, they reach a consensus about the following topic; Assessment of dietary and life style habits among breast cancer cases: A case control study .So she should take her cases from the oncology unit in the university hospital and her controls from other department probably the ophthalmology unit. However, Dr R was so much worried about finishing data collection as fast as she can so she decided to take her controls from her friends and neighborhood. Her supervisor asked her first to calculate sample size to conduct her research , she went to her friend -a statistician- and asked her to calculate as least as possible sample size  number , her friend did as well and told her if 50 cases and 50 control will be appropriate , she agreed and was happy to this . She told her supervisors that the sample size was calculated and that the appropriate sample required is 100. so she started  to collect data through a standardized questionnaire about life style and dietary factors in cancer patients and collected the responses from only 20 cases and one of her friends told her that she can fabricate the other responses according to what is collected ,it won’t differ a lot ( her friend said). She actually did this. She sends her data to a statistician to analyze, however he gave her the results which was very depressing to her. All of the results are not significant, how come? Only one finding is significant. My supervisors won’t accept this anymore because all the literature said there is a significant relationship between most of the variables?!! She said to the statistician

He told her that he can modify in the raw data to make it significant, she was so happy to hear that and of course agreed

All through the time she was writing her introduction in which she found an exactly the same topic of her except it was on cancer colon patients and she began to copy the literature from this paper. Something so good in order to be able to finish this horrible task. She said

Unfortunately, a document was sent to her from the IRB in her university asked for the consent which is needed to accept her proposal, something which made her so angry but in one minute she said oh no problem I will sign all the informed consents, who will know??

She made it and signed it and now everything is ready for her thesis discussion!!!! Finally at the step for publication which is a formal requirement for her promotion, one of her supervisors insisted to write her name as the first author. Dr R was forcefully agreed upon this in order to end this horrible status!

 

• Case Study

By: Dr. Reema Karasneh

• A research team has agreed on the conception and design of a research project. The proposal was submitted to the IRB to obtain the approval for conducting the research. The research team has obtained the IRB approval in addition to the required fund for conducting the research. After completing the research project, one of the researchers whose name was listed as a co-author in the submitted proposal was found to have a contribution that would not fulfil the authorship guidelines of the International Committee of Medical Journal Editors (ICMJE).
• Questions
• Should his name be listed as a co-author in the submitted manuscript?
• Or should the proposal be amended and resubmitted to the IRB and the funding agency?
• Should the researcher be acknowledged?
• What if findings were novel?
• What if he has objected his removal from the author list?
• Solution
• In the ideal situation, the research team should have agreed on who is the PI, the order of listed co-authors, and their contributions prior to conducting the research project.
• The research team may agree on acknowledging the researcher with the minimum contribution rather than listing him/her as a co-author.
• However, in this case, IRB and the funding agency should be notified about the actual contribution of each author.

 

 

 

• Case Study

By:Lubna Gharaibeh

• Dr Eman is conducting a study that evaluates the venous thromboembolism prophylaxis (VTE) in hospitalized patients, the physician’s practice is assessed and whether it coincides with guidelines or not is determined. Collection of data involved reviewing the medical files and interviewing patients for information. Once the data collection sheet is filled the score is obtained and depending on the score the level of risk of thromboembolism is determined.
• Hospitalized patients are randomly selected, and Dr Eman approaches a female patient, she explains to the patient the purpose of the study and that information about the patient medical condition and VTE risk factors will be obtained from her medical files and personal interview. The patient signs the consent form and Dr Eman starts to ask questions in a room that contains 5 other patients. Questions involve history of previous abortions, genetic diseases, and other personal questions. The patient looks uncomfortable answering these questions while other patients are listening, Q1: what can the researcher do to provide some privacy to the patient? Dr Eman finishes the interview and the patient asks the researcher whether the physician’s practice is correct and whether she should receive VTE prophylaxis or not. Q2: should the researcher provide information about the physician’s practice to the patient?
• Discussion :
• Privacy of the patient:
• Protection of patient privacy is very important during research, the patient in our case agreed to answer Dr Eman’s questions but not to share that information with other patients in the room. The researcher should take this into consideration, she could use the cubicle curtains to provide a certain degree of privacy, and she could choose a time when other patients have visitors and occupied in conversation so that they can’t hear the interview. If the patient can move the researcher could ask the patient if she would prefer to conduct the interview in a private room.
• Providing information to the patient concerning the physician’s practice
• The researcher is not entitled to provide information to the patient concerning his/her medical condition or the physician’s practice since the researcher is not part of the medical team. The researcher should tell the patient that the final decision regarding whether the patient should receive VTE prophylaxis or not is to the physician because he/she knows better the patient’s medical condition.
  • Case Study:

By: Zaid Alatany

• Research misconduct investigation has focused on two papers about a simple new method for creating stem cells. The papers describing the method, called stimulus-triggered acquisition of pluripotency, were published in the prestigious journal Nature in January 2014. But they were retracted in July after Nature discovered that the papers included plagiarized writing, misidentified images, and misreported data.
• Haruko Obokata, the lead author, who performed the studies and wrote the manuscripts, was found guilty of falsifying data. Yoshiki Sasai, leader of the Riken research group, was a co-author on both papers had been responsible for overseeing Obokata’s research, and he was criticized for his poor supervision.
• Haruko Obokata stated “the mistakes do not affect the conclusion of the papers, and moreover the experiments have been conducted accurately and the data exist.”
• Ethical Problems:
• Manipulating the image data of two different gels and using data from two different experiments.
• Misinterpretation of autofluorescence as real signal
• Ethical Solution/s( Discussion):
• In July 2014, Obokata was allowed to join Riken’s efforts to verify her original results under monitoring by a third party. She tried to replicate her own study using genetically manipulated mouse spleen cells that glow green if a gene indicative of pluripotency is activated. She failed to reproduce the ‘STAP cell’ to back up her claimed discovery.
• Obokata announced her resignation from Riken in December 2014.
• Obokata had offered to retract her doctoral dissertation following allegations that she may have copied and pasted some segments of her dissertation from publicly available documents posted in the U.S. NIH website.
• in October 2014, an investigative panel appointed by Waseda University gave Obokata one year to revise her Ph.D dissertation or lose her degree. One year later, the university announced that it was revoking Obokata’s Ph.D.

 

• Case Study: Responsible authorship and publication

Authorship versus Contributor ship: Risk and Benefits

By: Amal Al-Bakri

Nadia is a PhD student under the supervision of Prof Majeda and co supervised by Prof Salah. She successfully defended her thesis in October, 2017. After finishing her dissertation, Nadia prepared a manuscript presenting the main findings of her work which she emailed to her supervisors for revision and comments. After receiving her email, the main supervisor sent her an email inquiring about the paper authorship. Nadia put herself as first author and included her supervisors but two extra names were added to the manuscript. Nadia justification for the two extra names is as follows: One of the added authors is a student who was doing his internship at the hospital and helped her in data and sample collection and patients follow up. I promised this student authorship for his major contribution and based on that agreement the student used to stay late and do excessive work, she explained. Second, due to shortage in recruited patients within the study, I had to approach Dr Khalid (Specialist) for permission of including his patients in the study. This is a common practice at the hospital and without his consent the study would have not been completed.

The main current issue is that clinical studies on admitted patients will not take place without breaching authorship criteria and researchers faces the dilemma of what is more important authorship ethics or human health?

The Solution

According to the main supervisor the inclusion of these two extra authors contradicts with the International Committee of Medical Journal Editors (ICMJE) definition of authors and authorship cannot be gifted and promised. The institute carries the ethical responsibility towards students performing research and researchers to highlight the principles of Responsible Conduct of Research. Accordingly, the supervisor explained to these extra authors that their contribution does not merit the authorship criteria and they were acknowledged for their help.

 

• Case Study: Data Falsification and fabrication

By: Meimouna Sidi Deoula

We are aware that the high consumption of fruits and vegetable with a low consumption of meat and fat could protect our body against cancer specifically (Bowel cancer, Breast cancer and Colon cancer). This information has been confirmed by many epidemiological studies. However, the majority of these studies have been conducted in developed countries in which there are high potential and funding for studies. On the other hand, a little information about this relationship in developing countries is available.

Hence, Prf. X belongs to the laboratory of research in public health in country M. Professor X wants to investigate the association between fruit intake and bowel cancer in his country. Note that his country is different socioeconomically and culturally and religiously from developing countries.

Prf. X wrote the protocol for the study (which included the type of study, sample size, plan of statistical analysis and prepared and validated the FFQ” Food Frequency Questionnaire”). This FFQ included some fruits and vegetable that is specifically and widely consumed in his country.

Ali is a Ph.D student under the supervision of Prf. X; note that Ali has never been trained in public health and ethical research. In contrast, Prf. X did not inform Ali about the procedure of this survey, he sent him directly to collect data from the patients without explaining to him the necessity to apply the ethics of scientific research.

This includes the consent of the patient to participate in the study. Ali was interested in the number of participants included in the study, so he tries to deceive the patients and collected a high number of data from them.

When Ali reached the step of analysing the data, he found some missing data which he filled in, instead of going back and obtaining the real data from the participants in the study.

 

Ethical Issues:

• Ali makes a fabrication of data because he is afraid of his supervisor.
• After the analysis Ali found no significant association between fruits intake and bowel cancer in this country X.
• In addition Prf. X did not accept these results and told Ali to change them to be similar to the results in the literature.

 

 

• Case Study: Fouchier and Kawaoka Dual Use Research

By: Jwan Ibbini

The real life story I’m presenting here has been documented extensively as an example how life science research can have a dual use potential, and is prone to misuse. In 2011 the scientific communities awake on a fir-storming debate whether to publish or not the research findings of virologists working on avian influenza virus H5N1.

The US National Institute of Health (NIH) independently funded two research teams one led by Ron Fouchier in Rotterdam- Netherland and the other led by Yoshihiro Kawaoka in the USA. Both groups came to a similar finding, that the H5N1 virus could develop a mutation enabling the virus to become transmissible among mammals through airborne infection, which makes this virus a threat to the general public. Fouchier submitted his research finding to Science, While Kawaoka submitted similar results at about the same time to Nature. The editorial board of both journals decided to ask NIH to review the manuscripts, which then asked the US National Science Advisory Board for Biosecurity (NSABB) to screen both papers; as potential threat is seen from publishing detailed manuscripts that can be used to develop this mutant and then harm the general public.

Ethical dilemma and arguments present in the case:

The researchers claim their right to publish their work but the debate was fired weather to:

• Ignore the findings and never publish the work.
• Publish the work in full details.
• Publish the research finding while removing sensitive information.
• Who would have access to sensitive information?
• Would hidden information restrict the development of other useful research such as vaccine development?

The recommendations came to publish the papers highlighting the conclusion and major outcome, and modifying the methodology and other details that would allow the replication of their work by criminals or terrorists. Moreover, it was recommended that funding agencies should review what is now called the gain of function research (research involving microbial alteration and manipulation to gain a new function) for potential dual use is also debatable; also whether we should worry about scientific freedom in the future.

There is no one straight answer to all of the raised questions, but it is generally believed that responsibility can be enhanced by awareness/ education as well as ethical review and a well-established biosecurity code of conduct.

 

• The Below are not fit for publishing:
• • By: Mohanad Odeh

In Brief:

Participant would like to participate without signing the consent form. He offered verbal agreement OR requesting the researcher to sign instead of him.

Scenarios for discussion:  

Real case: Patient at Antrim hospital claimed that she cannot read the Patient Information Leaflet (PIL).

What if:

Patient claim he cannot reading

Or

Patient express phobia of signing medical related papers

Or

Patient create fake obstacle to avoid participation … etc

 

• By: Sanaa Abujilban

Ethical Dilemma

• The best way to test the effectiveness of an intervention is to administer the intervention to some participants but
• Withhold it from others to see if differences between the groups emerge.

What is the Dilemma?

• Experimental Group: exposed to potentially hazardous side effects
• Control Group: denied a beneficial treatment

Suggested Solutions?

• Delayed treatment for the control
• Stuck with the guide of clinical trials

 

• Case Study (Ethics of Peer Reviewers: Conflict of Interest)

Lina  Al-Ebbini

During my study, one of my Professors exploited me to review papers on his behalf. He asked me for reviewing too frequently, sometimes two papers weekly, knowing that I was a lot to do for my research and my study. I was busy and have no time for such work. The big problem is that he asked me sometimes to do reject for papers prior of reading them. I should say this is not ethical, but I don’t have power at that time to say ‘No’. I need to graduate. So, what I did is reviewing the papers and sending my concerns to him without giving a decision of acceptance or rejection.

Arguments present in the case:

According to the discussion with my partners, one argument was to don’t do reviewing on time, to be lazy so the Professor will not ask me again for reviewing process. Another solution was to talk to the head of the department or to the office of International students about the problem.