Case Analyses (Ethics Discussion) for Participants in the Jordan RCR Program (Year 4)-2018-2019

 

• Case Analyses

By: Hadeia Ahmed Mashaqbeh

Sara is a master student in the microbiology department, she decides to start her study about probiotic bacteria, the plan is to isolate the bacteria from real yogurt samples to use in the study; her advisor suggests collecting samples from different dairy producing factories and shops that are located in the same area the student lived in.

The student was surprised that some of the yogurt samples did not contain any probiotics or any living organism (not a yogurt), she informed her advisor about this finding, he asked her to keep silent and eliminate these findings from the study.

Sara followed her supervisor’s instructions, but she felt guilty when she saw people buy these products, so she decided to tell her family, friends and neighbors.

Ethical Discussion

• This study deals with dairy products; collecting samples may need special consideration.
• Factory or shop owners should be informed about the research protocol.
• The student started to collect the samples, she bought a small amount of yogurt from each site, and when the worker refuses to sell her a small quantity she tells the worker that she needs it for research, without giving them any details. Sara used an unformal way to publish her findings and she thought that this is the safest option.
• Another ethical point here was that the researcher knew where she got each sample; and is able to specify the source of samples. Is it ethically accepted that the researcher who will analyze the sample is able to know the factory and the shop’s name that sold the dairy product?

 

• Case Analyses

By: Zaid Altaany

Science- Hub is a web site with a number of domain, that has a hundred of millions of academic paper and articles that allow researcher to access and download the paper for free. This web site has been founded by Kazakhstani graduate student in 2014 as a reaction to the high cost of research papers, she collected all paper from different sources and upload it in here web site and releases it for free. Science – Hub web site also stores papers in its own cache to speed up future request. However, the researchers usually have to pay for an access fee to get some of the published paper.

The same issue here is taken the paper for the science hub and then uploads it on research gate and releases it for public.

Is it ethical to use that web site to get an access for the paper and not to pay, or you have to pay in order to download the paper that you want to read.

In my personal opinion this action is not ethical due to copyright issues.

• Case Analyses

By: Afef Skhiri (this is an imaginary case, but the facts are real)

An associate professor and his two residents from the Public Health department of a Medicine university designed a study on risk behavior among students.

The sample comprised of one class per level. They decided to choose the class with the lowest points during the first semester and to exclude students of other nationalities.

The questionnaire included sections on demographic characteristics, smoking, alcohol drinking, drug consumption and sexual behavior and practices. Most questions were closed ended and some were open ended questions. The questionnaire was self-administered and anonymous .

 

The data was collected during the public health course by their professor and the residents .All Students had 20 minutes to complete the questionnaire .No information was provided about the the aim of the  study and no consent was required  .The residents picked up the questionnaires and were able to read the answers and comment on some of them with the students.

Students having an internship on the PH department had to enter the data survey as an activity .The residents showed them how to enter data on SPSS and they started working on the data base .Some of them were from the students sample of the survey and they read all their colleagues answers and even recognized the writing style of some of their colleagues.

 

The trainees replaced the missing data on sexual behavior section with a negative answer as they wanted finish their work. They returned the database to the associate professor and their internship was validated.

The residents analyzed the data and wrote the article .Few months later, the article was finished and the associate professor sent it to the head of the department, who is the person to decide about the authors name.

The head of the department put the name of the associate professor as first author .he decided to put  the name of an assistant professor as the second author as a gift because she had a newborn   three month ago, even though she had been away for six months and had absolutely no idea about  ​​the study. Only one resident had its name on the paper as he is his favorite one.

The associate professor contacted the ethics committee for approval of the study, which declined.

Thus, he contacted the editor of a scientific journal that is one of his good friends to accept the article. The article was being reviewed a week later and published three months later.

What are the different ethical issues of this case??

 

• Case Analyses : IRB: A Misused Tool

By: Amal Al-Bakri

 

Introduction:

Clinical research is vital for medical progress and our understanding and treating diseases. Human clinical studies were reported since the experiments of Louis Pasteur and Edward Jenner towards the development of vaccines. Both were lucky that no serious adverse effects were associated with their experiments. Nevertheless, repeated incidences of unethical research using humans led to the development of legislations and standards to control clinical trials. Although the Japanese doctors conducted live experiments on prisoners of World War II was not subjected to any legal sequences, nevertheless the Nazi experiments subjected 23 Nazi doctors and scientists to trial in Nuremberg from December 9, 1946 to August 20, 1947.  This led to a set of standards known as the Nuremberg Code to be created as the first framework for the principles that cover human research. In 1964 an expansion of Nuremberg Code was adopted as the Declaration of Helsinki. The Declaration of Helsinki introduced the concept of an independent committee, which evolved into the institutional review board (IRB) system used in the US (1). Currently all research involving humans has to get an IRB approval so as primarily to protect the right, safety and wellbeing of humans involved in clinical trial. IRB composition and membership is defined and it includes scientists and nonscientists (1).

 

Ethical Problem and Misconduct

Although the essential role of IRB is to protect human subjects, nevertheless this can become an intentionally or unintentionally misused tool such as disapproving studies due to the lack of understanding of the science behind it (2) or due to undeclared conflict of interest and benefit among its members. This had been reported as conditional approval for some studies with the requirement of the addition of specific IRB member and others to the study team as a condition of study approval.

 

The solution

1. The Scientific and financial aspects of a study should be reviewed initially and independently by specialized committee. This is followed by revision of the ethical part of the study by the IRB committee which should be renamed as Ethical Review Board and limit its role to reviewing the ethical part of the study; benefits and risks (2).
2. The development and implementation of a code of ethics to be signed by all members describing misconducts and conflict of interest.

References

Kim WO^. Institutional review board (IRB) and ethical issues in clinical research.

Korean J Anesthesiol. 2012 Jan;62(1):3-12. doi: 10.4097/kjae.2012.62.1.3.

Kotsis SV¹, Chung KC.  Institutional review boards: what’s old? What’s new? What needs to change? Plast Reconstr Surg. 2014 Feb;133(2):439-45. doi: 10.1097/01.prs.0000436846.00247.73.

 

 

• Case Analyses : Determine the Prevalence of tobacco use among street children

By: Meimouna Sidi Deoula

Poor country X has a lot of street children, which suffer from many different diseases and need many studies to improve their health. Therefore, Dr. X decided to conduct a cross-sectional study to determine the prevalence of tobacco use among street children. The eligibility criteria of this study are: Age 10 years old to 17 years old, Capability to give consent and ability to communicate and carry out the interview

The protocol of this study was explained to the street children and informed consent was obtained orally and recorded by audio cassettes prior to starting this study.

Ethical Problems

The population study are very vulnerable (children and without their parents). Therefore, among the ethics question discussion on the day of presentation were:

Do you think that the consent obtained orally and recorded by audio cassettes were enough?

Do you think that the street children able to give the informed consent for themselves?

Ethical Solution/s( Discussion)

The investigator must accompany a member from the child protection organization during the day of the interview.

 

• Case Analyses : Authorship and Mentoring

By: Suhaib Muflih

Back in 2015, Mr. SO was a 3^rd year PhD student at Y-USA School of Pharmacy. Mr. SO was on a Jordanian scholarship and very interested in the area of individualized medicine (IM). After completing the PhD course requirements, he collected signatures from four professors appointed by his advisor (Dr. A), to serve on his PhD graduation committee. Because of the unfamiliarity of the committee members with IM, three proposals were rejected. Moreover, Dr. A convinced Mr. SO to switch topics and offered him a list of several research topics unrelated to the original ones. Mr. SO brought this concerning issue to the department chairman’s attention. Unfortunately, no constructive advice was provided. Three months later, Mr. SO and Dr. A agreed to change the committee members due to their lack of expertise in the IM field, which was highly required by Mr. SO’s sponsoring school. Once more, Mr. SO collected signatures from the new committee members who were very helpful and supportive. Next, Mr. SO was able to write a 40-page proposal about IM and secured the Institute review board’s (IRB) letter of acceptance. Subsequently, data collection process was initiated and several manuscripts were prepared for publication. Finally, the defense date was scheduled and an invitation was emailed to everyone. Shockingly, Dr. A conducted a meeting an hour before Mr. SO’s big presentation and requested to keep the old committee members justifying that by the lack of a signed withdrawal form, which was not included in the program policy manual. Dr. A stated that the new committee members would not be allowed to examine Mr. SO’s PhD candidacy. Dr. A added that, the old committee members deserve to be on the publications.

 

Ethical dilemma and arguments:

• Submitting several proposals to the advisor and committee members: this indicated lack of guidance and resulted in wasting too much time and money.
• Choosing committee members by the advisor: the school should rely on the student to select committee members familiar with his research interests.
• Studying in an unsupportive environment: the student was less likely to gain a unique learning experience and research skills before substituting his committee members.
• Authorship and contributor -ship: obviously the old committee members were not contributing significantly into the research manuscripts and therefore did not meet the ICMJE criteria for authorship. ⁽¹⁾
• Even though some forms and policies could be missing from the PhD program student handbook, the student should have collected withdraw notifications from the old committee members through other means (e.g., via email).

 

Mr. SO refused to change his new committee members as he felt that it would be totally unethical to discredit the people who significantly helped in providing guidance and setting milestones for his research project.

 

(1). International Committee of Medical Journal Editors. (2016). Defining the role of authors and contributors. Accessed on 07/17/2018. Retrieved from http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html

 

• Case Analyses :

By: Jennifer Muhaidat

A researcher is conducting a cross-sectional study to assess the functional capacity, quality of life and physical activity levels of community-dwelling older adults. There is no direct benefit to the participants except for the contribution to knowledge and the future improvement of services. No incentives or compensations were provided. An information sheet explaining all study details and the expected risks and benefits was provided to all potential participants and they were given the time and chance to ask any questions. The voluntariness of participation was explained and highlighted in both the information sheet and the consent form.

The researcher noticed that several participants, who consented to participate in the study, appeared to be pushed to participate by their children. The researcher emphasized the voluntary nature of participation and the right to withdraw at any point without any consequences. However, the participants did not clearly state their lack of interest or refusal and they consented but seemed slightly unhappy to take part. The researcher proceeded to collect data from them.

 

Ethical issue

These incidents raise the issue of coercion and undue influence to participate in research studies.

 

Potential solutions

The reasons behind the family pressure need to be investigated. If the family has certain expectations of benefits or services from the research, the researcher needs to clarify this misunderstanding. Since the included participants in the study are cognitively intact and have the capacity to consent, the researcher should talk to the potential participants directly and explain the voluntary nature of participation and the right to refuse.

Prevention of such incidents can be addressed by increasing awareness about the nature of research studies. This necessitates the explicit statement of benefits, risks, harms and incentives and the inquiry of participants and family expectations from research before consenting to participate.

 

 

• Case Analyses : Mentoring Graduate Students

By: Rana Obeidat

 

Case presentation: I have a friend who was doing her PhD at a Jordanian university. She has started her studies almost five years ago and she originally planned to finish and graduate within 3 years (i.e. the period most students finish PhD studies in nursing here in Jordan). She was supervised by a well-known scholar in nursing here in Jordan who is a well-published scholar and one of the most cited researchers not only in Jordan but in the Arab area. One year ago, she finished her data collection, analyzed her data, and finished writing all the chapters of her dissertation. She sent the dissertation to her advisor to review and provide her with a feedback as to revise and prepare herself for her final defense. She waited several weeks for feedback from her advisor and never got one. She asked for a meeting with the advisor to discuss her situation and that she needed a feedback to revise and submit her dissertation to the Graduate school. Though publication in a scientific journal that is indexed either in Scopus or Social Sciences Citation Index is not a requirement for graduation in the university, the advisor insisted on her that she had to publish at least one manuscript from her dissertation in a journal indexed in one of these databases before he would give her approval to defend her dissertation. Thus, she had to spend almost 5 years in the program before she could finally publish, defend her dissertation, and graduate.

Case Analysis: In my opinion, the advisor/mentor conducted an ethical behavior in this situation. I believe that the advisor was using his power to use this student as well as other PhD students for his own benefits. He compelled students to publish from their dissertation studies as to increase the number of his publications and ultimately his citations.

 

v  Case Analyses: Substance use among street children in the Gaza Strip

By: Abdel Aziz Mousa Thabet

Abstract

Aim The aim of the study was to investigate the prevalence of substances abused  among street children  in the Gaza Strip.

Design a Cross-sectional study

Settings:  Street children standing in front of traffic lights and begging people for money.

Participants A total number of 500 children will be selected from unknown number of children in streets of Gaza city.

Measurements Participants will complete an anonymous self-report questionnaire of two parts; the first part of   questions relating to socio-economic information including age, sex, place of residence, cause of being in street,  health status and the second part with be about types of substance abused including inhalation, tramadol, hashish, and other types such as hypnotics, sources and reasons of abusing .

Results:  Results showed that 300 street children had been reached, % has ever used nonprescription substance over the past twelve months; % abused tobacco (smokers).  The Study revealed   % abused psycho-stimulants, % abused sedatives,   0.99% abused cannabis, % abused inhalants, % abused tramadol, and % abused hallucinogenic.

Discussion:

The above mentioned study had many ethical issues

1. The sample size and selection for such groups is very difficult and most of them are boys due to culture issues, sampling will be snow pole type in which we will see children and will ask about others they know.
2. Due to legal issue and police problems, they may refuse the interview and data will be missing
3. The place of data collection for such target and such topic of drug addiction in streets will be appropriate.
4. Level of abusing alcohol and other drugs may be inappropriate in this culture due to religious issues
5. The impact of war on children ability to cope with using drugs is not accepted in our society.
6. The consent form issue is another big issue, from who we will take the permission to conduct the study, where are the parents to take agreement.

 

 

 

• Case Analyses :

By: Faisal Alzahrani

 

A committee from the Ministry of Health opened an investigation with an expert and his contract was terminated. Because he was following 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 Saudi hospital said the cause of death was kidney and lung failure.

The professor continued to conduct tests 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, asking them to confirm that he reached the patient died of the virus. 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.

The Ministry of Health sent a team to investigate this expert. The investigation team accused him of violating the laws by sending samples to an outside party without permission and moral consent. After the investigation, the Egyptian professor was dismissed, and his services were dismissed, and he was sent to Egypt.

After a few weeks, the Corona virus spread and became a global issue. There were large deaths, including a large number of workers in the health sector. As a result, a royal order announced that Dr. Abdullah bin Abdulaziz al-Rabeeah was relieved of his post as minister of health. Then extensive investigations were opened.

 

 

• Case Analyses : Authorship misconduct

By: Lara Al-Khlaifat

A research exploring the perception of patients diagnosed with knee osteoarthritis on exercise was conducted using focus groups. After obtaining ethical approval from the research ethics committees at the hospital and the University, the study commenced.

Participants were recruited from both the physiotherapy department and an orthopedic clinic at a local hospital. The recruitment process involved informing potential participants about the study and if they were willing to participate, they would sign an informed consent form and their contact details were recorded. Their consent would allow access to their medical records to confirm that they meet the inclusion criteria of the study. If that was the case, they were informed of this and a date for the focus group was scheduled.

To recruit participants from the physiotherapy department and the orthopedics clinic, the head of the department and the involved physician asked to be added to the authors’ list when a paper is to be submitted for publication. This is a clear case of authorship misconduct. The approval of the research ethics committee at the hospital provided access to the patients’ medical records after they consent to participate in the study. Therefore, ideally the head of the department and the physician should only be informed of the study and facilitate the recruitment process. However, this was not the case.

To be included in the authors’ list, each author should meet the International Committee of Medical Journal Editors (ICMJE) guidelines for authorship [1]. These guidelines clearly define the authors as those involved in study design, data analysis and manuscript preparation. Therefore, it would be unethical to consider the head of the physiotherapy department and the physician as authors to the paper since their contribution to it was minimal. However, this situation is common specially in academia where publications are linked to promotions.

A feasible solution to this ethical problem could be to arrange an urgent meeting with all possible co-authors to discuss the study and involve them in the preparation of the manuscript by dividing tasks.

References:

1. Defining the role of Authors and Contributors. International Committee of Medical Journal Editors. Available from: http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html [Accessed 13th July 2018]

 

 

• Case Analyses :

By: Loai Issa Tawalbeh

Dr X is a beginning nurse researcher who had an agreement with his colleague Dr Y to carry out a study about the effect of cardiac education on both social support and adherence to healthy lifestyle among patient with CAD. The agreement was to list his colleague as a coauthor in his current study. Therefore, Dr Y agreed to conduct a future research and list Dr X as a coauthor in that study.

Dr X started writing the research proposal, giving the conception of the design, collecting and analyzing the data, writing the results and the discussion part. Dr X copied a few separate sentences to support the discussion of his results from a paper that was published, without providing proper citation but it was unintentional.

Dr X completed his research and published it in a scientific high impact journal including Dr. Y as a coauthor.

A few months later, Dr Y completed his study and published it in a journal without including Dr X as a coauthor in his study as they had agreed upon initially.

One year later, Dr X discovered a wrong inversed statement in the results of his study that concluded a negative relationship between social support and adherence to healthy lifestyle. The data collection occurred soon within the last six months.

Ethical Questions:

1-How should Dr X respond to Dr Y since he refused to include his name as a coauthor in his research study?

2-Is it ethical that Dr X listed Dr Y as a coauthor without any active participation?

3-Is it ethical that Dr Y refused to list Dr X as a coauthor in his current research study?

4- Does copying a few separate sentences in this published study constitute plagiarism?

5- What obligation does Dr X have to correct the error in the published article?

Solutions:

1-From the beginning of the process they should not have made such an agreement: authorship must fulfill important criteria (study conception, data analysis and writing the manuscript). So it is not ethical to have such an agreement.

2- Copy of few separate sentences in this published study constitutes plagiarism and the articles must be retracted. These few sentences must be cited according to the original author.

3-The author has a professional obligation therefore he must retract the paper since it contained a major error. The error must be corrected. After correction the author may resend the article to the same journal.

 

• Case Analyses :

By: Mohammed  Mehanna

Adam Anderson 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 staff was responsible for the training of PhD candidates Abyad. He trained 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 staff, 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 Analyses :

By: Lara Al-Khlaifat

A research was conducted where the perception of patients diagnosed with knee osteoarthritis on exercises was explored. This was a qualitative study design using focus groups. Participants were recruited from both the physiotherapy department and the orthopedics clinic in a local hospital. After obtaining the ethical approval from the hospital IRB committee and the research ethics committee at the University, data collection commenced.

The recruitment process involved informing the patients about the study and if they were willing to participate, they would sign an informed consent form and their contact details were recorded. Their consent would allow access to their medical records to determine if they meet the inclusion criteria of the study. If that was the case, they were informed of this and a date for the focus group was scheduled.

To recruit participants from the physiotherapy department and the clinic, the head of the department and the involved physician asked to be added to the authors’ list when a paper is to be submitted for publication. The IRB ethical approval provided access to the patients’ medical records after they consent to participate so ideally the head of the department and the physician should only be informed of the study and facilitate the recruitment process. However, this was not the case.

To be included in the authors’ list, each author should meet the ICMJE guidelines (icmje.org) for authorship which means each author should be involved in study design, data analysis, and manuscript preparation. Therefore, it would be unethical to consider the physicians as authors to the paper since their contribution to it was minimal. A possible solution would be to meet with them and discuss the study and involve them in the preparation of the manuscript before submission.

 

 

• Case Analyses :

By: Mayis Aldughmi

Assistant professor Sarah and her research assistant Adam are working on a research project where they collect data from patients in neurology clinics located in Jordanian hospitals.

Adam will be responsible for collecting and storing the data. He will collect data on hard copy files in the clinics, and then store them electronically. Sarah wanted him to store the data periodically every week. But her institution does not provide a secure shared drive that can be accessed on campus. Sarah decided to create a study folder on a secure online program (like Dropbox) and give access to Adam. Now Adam can easily store the data electronically from any place and device he wants.

Although Adam de-identified the data stored using subject ID numbers and initials. Sarah asked Adam to create another file with the names and phone numbers of all the subjects and their ID numbers, so that they have a reference in case they wanted to gather more information from the subjects in the future.

After the data collection ended, Sarah deleted the identified data file from the online program. But the problem was that Adam has downloaded all the files on his personal computer during data collection. He did not have a conversation with Sarah regarding this matter.

There are several aspects of research misconduct in this case:

– The thought of storing research data online is controversial. How do we know if this is safe enough? If we delete the program, how do we guarantee that the data is not available somewhere?

– Sarah may have referred to her institution and the IRB first and informed about the issue on storing data. She was mistaken on not informing her research assistant to delete all the downloaded files on his computer. Was it safer if she asked him to access the program only from the lab/office computer? There was clear lack of proper communication between the PI and the research assistant.

– The problem with secured online programs is that data can be accessed from any device anywhere. Also, all files must be downloaded on the device to make edits. What if the device was stolen? What if subjects disapprove that? Were they even informed in this case study?

– If the institution has shortage in resources and does not have enough regulations on data privacy. How do the IRB and researcher handle this?

 

 

 

• Case Analyses :

By: Dania Qutishat

Salma is a research assistant who has started her job recently. She is involved in a study that explores the quality of life of young people diagnosed with mental problems in Jordan.

She is responsible for recruiting participants. She goes to a mental health clinic, talks to the patients and give them information sheets. Those who agree to participate will inform the clinic later. She was also responsible for data entry of basic information of the participants. This included name, age, occupation, marital status, diagnosis and family history.

One day, as she was in the clinic, she recognised one of the patients who happened to be her cousins’ fiancé, they were about to get married in a few months. The guy didn’t recognise who she was as he met her only once. He was so enthusiastic about the study and later agreed to participate. As she was responsible for data entry, she came to know that he had schizophrenia and two of his family members had the same diagnosis. Salma was aware that her ethical responsibility implies preserving confidentiality, but she felt sad for her cousin who didn’t have a clue.

Another incident encountered was that one of the patients was too friendly, he agreed to participate on the spot without even reading the information sheet. He started to ask personal questions and showed up outside the clinic everyday since then. Salma felt insecure, but she had no idea how to react.

Conclusion: New research assistants need to have proper training on how to report and manage ethical issues that might be encountered. Special attention need to be considered for studies that involve sensitive issues and vulnerable population. Responsible mentoring by the main researcher is an ongoing process to discuss and sort out issues that may arise along the way.

 

 

• Case Analyses : Authorship rights and dispute

By: Abdelraouf Elmanama 

A principal investigator (PI) had agreed to collaborate with a colleague from a different university to work in a research project funded by an agency. The PI also included his Master student in the project and promised him that he can use the results in his Master thesis if he performs all the laboratory work. The project has ended successfully and the results were promising. The PI and his collaborator agreed to publish the results and while discussing who will be the first author, the PI has mentioned the name of Master student as one of the authors. The collaborator, was surprised and started to question whether he has the right to be listed as one the authors and that this issue was never been agreed upon. They decided to raise this issue to Institutional Review Board IRB.

The IRB has reviewed all documented including the researcher agreement and the funding contract as well as the Master student proposal. And they concluded that:

1. No agreement between the PI and the collaborator on having a third person.
2. The funding contract did not include a third person
3. The Master student has done a substantial amount of the laboratory investigation and he is willing to write and approve a manuscript (technically he is eligible for authorship). He was not paid.

 

A meeting was held with the three investigators and the case was discussed. The IRB blamed the PI for not explaining and discussing the issue at earlier stages of the project with his collaborator.  The rights of authorship to the Master students were also explained to the collaborator and to please him, they suggested that he can be the first author since his efforts were equal to that of the PI.

 

 

 

• Case Analyses :

By: Rasha Okasheh

The notion of ‘Researcher safety’ is under investigated. Relevant policies and guidelines are developed on the level of the institution amid an acute lack of standardized national or international policies.

A more complex issue is the safety and psychological wellbeing of the researcher versus the autonomy, confidentiality and the ‘ethical obligations’ towards the participants.

The critical incident emerged during a study exploring the experience of “miners” of a certain health condition. The study’s methodology relied primarily on individual interviews and focus group discussions. The study was approved by the IRB of the research institution and the IRB of the health authority. Participants we recruited through community support groups and local specialized health services vendors. A full personal resume and identity check for the researcher conducting the research were provided and approved.

The focus group took place at a local community center, conveniently accessible to participants. Interviews were conducted inside a private room in the health facility. During one of the focus group discussions, the female researcher (who wore a scarf) was inundated by aggression and racism. The participants claimed that they were not expecting to be interviewed by a “terrorist.” They also complained about the identity of the researcher not being disclosed beforehand. The researcher was able to contain the situation and execute the focus group discussion. However, the discussion did not sufficiently fulfill the enquiry. This has created a risk situation where a non – ethnically matched interview resulted in a psychological trauma to the researcher.

The ethical dilemma:

Is the participants’ complaint about disclosing the identity of the researcher valid? How should it be addressed?

Does the researcher have the right to file a civil complaint against the racist behavior encountered? Would that undermine the confidentiality agreement with the participants?

 

 

• Case Analyses: Authorship of a deceased author

By: Reema Karasneh

I was faced with an unusual problem in research.  I was involved in a research project in which I mainly contributed in conducting statistical analysis, and data interpretation for the work. One of the research group members who had substantial contributions to the conception and design of the work and data acquisition passed away before conducting statistical analyses and even before starting the initial stages of writing the manuscript. The research group was discussing his authorship. Some were in favor of including his name as a co-author claiming that his contribution was valid and sufficient to merit authorship. However, few others were worried that the death of our colleague might affect the publication of the manuscript in case he was considered as a co-author. They claimed that our colleague (the deceased author) will not be able to approve the publication as he will not be able to proofread the final published paper. Furthermore, he will not be able to ensure that questions related to the integrity or accuracy of any part of the work were appropriately investigated and resolved when responding to critics of the paper or to queries related to it in post publication peer review. Therefore, they agreed that our colleague should be only favored as an acknowledged entity by mentioning his contribution in the acknowledgment section. I have tried to resolve this issue and thought that we (the research group) may include our deceased colleague as a co-author and include in a footnote that this author was deceased and indicate the date of death. Also, we may explain this dilemma to the journal editor at the time of submission. However, by reviewing authors’ instructions in several journals, I found that no clear instructions are provided on how to credit deceased colleagues in the manuscript submitted for publication.

 

• Case Analyses :Plagiarism

By: Hiba Wazeer AlZoubi

XXX wants to write his PhD research proposal, but he was approaching the deadline. He was trying his best to finish writing by the assigned date, and he read and reviewed many articles about his proposal but the deadline is the next day and he couldn’t complete the proposal, so he decided to copy two sentences from an article very similar to his topic and pasted them in his proposal.

These two sentences were just a few words, and containing simple information regarding the definition of the disease clinically and histopathological defining criteria only. They were not ideas or special opinions related to the author.

Ethical Problem: Is copying these two sentences considered as Plagiarism?

Ethical Solution:

Plagiarism is the “wrongful appropriation” and “stealing and publication” of another author’s “language, thoughts, ideas, or expressions” and the representation of them as one’s own original work, so in this case this is considered as Plagiarism.

You must put these definitions in quotation marks to indicate clearly that they are not your own words and add a footnote to give credit to the original author.

 

• Case Analyses : Finger print consent

By: Mohanad Odeh

New service will be launched in a hospital – outpatient clinics. This service will be delivered for the first year as quasi experimental study, intervention patients will be matched through propensity score matching with a control group.

 

The service is a comprehensive medicines management intervention, led by clinical pharmacists. Eligible patients are those who had more than two chronic diseases and were prescribed more than ten medicines (polypharmacy patients). Some exclusion criteria are listed as well. Patient will be recruited during their hospital stay. Pharmacist intervention (on monthly basis for one year) will be delivered in a medicines management outpatient clinic after discharge.

 

The service includes wide range of interventions: medication review, personally tailored medication plan based on adherence level, believes about medication and life style. Medicines will be changed, deleted or added based on individual needs. Non-pharmacological plans will be also considered.

 

Outcome assessment includes wide range of parameters, primary outcome will be hospital unplanned readmissions. Other outcomes are disease specific, patient related and healthcare system related outcomes.

 

Challenge – Controversy:

Will finger print be accepted on the consent form? For those patients who cannot read.

 

Finger print is used to be accepted in many countries. However, the researcher will not have evidence that the patient had received the information in the proper way; researcher will not have an evidence against the claim that patient may had a wrong perception, or even misleading information.

 

Solution and alternatives:

Excluding patients, who cannot read, will prevent this group of patients’ from receiving the new service.

The following solutions may be used:

1. A) Accept the signature of patient’s guardian in case that the patient cannot read.
2. B) Use the audio record – consent form. Two pathway communications in explaining the study is recorded, then the verbal agreement and verbal consent process is documented.

 

 

 

• Case Analyses :

By: Sawsan Abuhammad

Reem is a nursing community professor in Jordan University of Science and Technology planned to study the experience of sexual violence in the graduate students. She asked their master students in the class if anyone interested in participating in his study. One student called Alia expressed her interest in participating in the study. This study was a longitudinal study with four interviews to talk about the experience of sexual violence. at the first interview, the professor explained the purpose of the study, benefit and risk. The student signed the informant consent. The first and second interviews were gone very well. After that, the professor tried to contact the master student to continue interviewing. The student apologized two times after scheduling appointment. After one week of cancelling the appointment. The student came to Dr Reem and asked her to withdraw from the study. Dr Reem notice several injuries in the face and hands of the student. She asked the student is anyone hurt you. The student started crying and asked Dr Reem why she shared the interview with other people.  The student told Dr Reem that someone told her husband that she was talking about their sexual relationship to others. Her husband felt very bad and hurt her.  Dr Reem knows very well no one have an access to information except herself and her research assistant. Dr Reem expected that the research assistant shared the information with someone or the record reach someone. She planned to change the research assistant and file a complaint against her for breaking confidentiality. However, the dean of the school prevents her and told her this accident would ruin the nursing school reputation. Dr Reem still worries about the safety of other participant if the same story happened with them and she did not want to make confront the dean.

The problem is Dr Reem feeling that the researcher assistant is broke the confidently of the participant that may cause harmful effect on them. Moreover, she is in a conflict with the dean regarding reporting the accident and stops the research assistant from working.

Dr Reem needs to report the research assistant to the responsible area and ignore the dean’s recommendation for not stopping RA from working, because this will cause harmful effect on the researchers and this is against the ethics of research. Next time, she needs to save the records in a safe closed space.

 

• Case Analyses :

By: Jamila Abu-Idhail

A Jordanian qualitative study is being conducted in governmental hospitals. The aim of the study is to identify midwifery practices in the labor room during childbirth and assess their consistency with WHO evidence-based midwifery care.

One data collection method is observation of the current midwifery practices in the labor room. Observations will be recorded by taking notes. The investigator who is a health care provider (nurse or midwife) is the observer. The focus of the observations is on midwives and their practices with giving birth women.

Ethical Problems:

Discussion:

The research proposal received ethical approvals from the Hashemite University Ethical Committee, and the Research Ethical Committee of the Ministry of Health, Jordan. A consent form was signed by the midwives, who were working on A- shift for one month. Furthermore, the consent form was signed by participating women who were interviewed in the postpartum ward. During the observational process, no private data was documented. The researcher was the only one who collected the observational data. Video recording was not used because of the sensitivity of the place and issue. The only method of recording was recorded notes by using pen and paper. If any woman developed any complication or something dangerous occurred, physicians would be called urgently but the researcher would not interfere, her role was to keep recording

Confidentiality of data/records was maintained. We ensured that no one has access to the data. The participants were promised not to discuss the issues arising from an individual interview with others in ways that might identify them. As well as not disclosing what the participant has said in an interview. Finally, anonymity was respected for individuals and/or places in the dissemination of the study to protect their identity.

 

 

 

• Case Analyses :

By: Taher Emahbes

The case (Public health risk assessment of the migrants on general population):

• Dr X was conducting a research that aims to determine the risk of migrants on general people. The researcher recruited medical interns to collect the data as a part of the training process of the interns in public health.
• The study was done at detention campus were the illegal migrants stay. It consisted of giving questionnaire, performing clinical examinations and investigations for the migrants. the researcher was looking for diseases that could affect general population for example HIV, TB, HCV,….etc.

 

Ethical issues:

• The issue here was that the researcher (which has powerful government connection) forced the immigrants to participate in the study!!
• No body explained to migrants why they are doing this research?!!!
• The Interns who are collecting data had to participate and face the danger of getting any communicable disease so they can finish their training!!
• No IRB ethical approval was obtained!!

 

Solutions:

• The investigators should obtain consent from the migrants and the interns as well as the government to conduct the research
• Ethical approval should be obtained before the study conducted
• Migrants should be protected by the government.
• There should be regulations or policies to protect those group

 

It was difficult to stop the study because the investigator convinces the government that this is important and those migrants were illegally entered to the country so the country has the right to collect any data.

 

 

• Case Analyses :

By: Hisham Altayb

Mona is a PhD student; she wants to collect samples from gastric biopsies remnants of patients suffering from gastritis, and gastric cancer to study the role of H pylori infection. She prepared her proposal and ethical consent according to international ethical guidelines, to be approved by the ethical committee in the ministry of health in her region. After approval from the health authorities, she has permission to collect samples from hospital X according to the ethical guidelines.

When she met Dr. Adil the person in charge in X hospital he refused to let her meet the patients for consent approval and sample collection; unless she agreed to add him in the author list of the published papers from this project. She said what is your contribution? Can you help me in data collection and processing? No I can’t I am so busy. But I can tell my patients to cooperate with you. Also if you came back tomorrow in my clinic, I have a lot of patients there, you can collect more than 20 samples per day. In addition, my colleague Dr. Samir has a clinic there he can help you in sample collection from his patients. Be sure that if you don’t agree to add us in the authors list, you can’t begin sample collection.

She agreed to add them in the authors list, because she wants to finish her PhD degree and collect samples quickly without reluctance from patients. At last she collects all required samples easily and finished her degree.

Afterwards she published two papers without their names, because she believes that they had no role and contribution in her study, they just gave her the remnants of gastric samples, and gave her access to their patients, to collect required information.

When they found out they sent a complaint to the journals which stated that they have a right to be listed as authors.
 

• Case Analyses :

By: Tareq Mukattash

 

A dean of a pharmacy school in a private university takes advantage of his/her position in taking advantage of faculty staff and administrative staff to help with her personal research. Many cases have been discussed among faculty members through the last years. No complaints have been field as faculty and administrative staffs are afraid that their dean would not support renewing their contract for the coming year.

This breach of ethical practice has been noticed in many cases:

1- Taking advantage of administrative staff to collect data for his/her studies and enter those on databases (SPSS and EXCEL). The final publication will not have the name of those as co-authors or contributors.

2- The dean would usually chair research committees. He/She would reject studies and proposal submitted by faculty members that do not have a good personal relation with him/her.

3- The dean would take advantage of his/her position to force members of staff to include his/her in their proposals and publication to expedite and facilitate the approval of those studies.

4- The dean would suggest the names of members of staff as reviewers for his/her own papers. He/She would then force them to accept reviewing his/her manuscripts and finally accept them.

5- The dean would force himself/herself as a co-supervisor on the majority of postgraduate students or he/she will contribute in refusing their proposals.

6- Members of staff started adding the dean on their own manuscripts, sometimes as a first or corresponding author.

 

This situation has been taking place for years and the situation is increasing in complication with time passing. This is a clear breach of ethical codes through taking advantage of power.

 

 

 

 

• Case Analyses :

By: Anaan Jarab

A graduate PhD student in the final stage of dissertation is working on novel photonic materials. He applied for several postdoctoral positions and was invited for an interview in a prestigious research institution in a city where he would love to live. After completing the seminar on his research project, the department chair asks for detailed information about the novel material-preparation technique developed in the dissertation research. The student is currently working on a patent application with an agreement with other research members for keeping details confidential until submitting a research article about this work for publication. It has been agreed that the research advisor will be giving the first major presentation on the developed technique at a major international conference soon. The student answer to the interviewing committee was that he and his colleagues are currently preparing a manuscript for publication and a patent application, and he would be glad to send them an early preprint when it is available. The interviewing committee did not show a pleasant feeling to his response. After the seminar, the Chair confirmed on the importance of teamwork and sharing information for good work environment and therefore pushes harder for the information he was looking for in order the applicant being a candidate for hiring.

What should the student do?

 

• Case Analyses : Dual Use Research

By: Jwan Ibbini

Over centuries science had only one mission: to make better societies. As good as it may seem the previous sentence may not be very accurate. And that corrective actions were made after mistakes and wrongdoing in many fields. Which can be part of the trial and error cycles of REsearch.

What is the problem?

Global health and welfare relies on the advancement life sciences. On the other hand, it can be argued that the same knowledge can be misused either deliberately or unintentionally, hence the term biosecurity starts to emerge. Therefore for the last decade or so the idea of dual use research has emerged after few incidents here and there. One example can be mentioned in 2002 when researchers reported the reconstruction of Polio de novo pathogenic virus from commercially available oligonucleotides. Here we are presenting the need to protect pathogens from being misused or the divergence of scientific research to military or terroristic action.

What needs to be done?

Establishing the Biological and Toxic Weapon Convention (BTWC) in 1972 did not guarantee the safety and security of all science and technology outcomes. How can we establish the web of prevention? How can we filter research with dual use action? Would research monitoring counteract research freedom? And so other measures are recommended such as:

• Establishing a national body to discuss this issue.
• Include dual use research into the scientific training on ethics for scientists and policy makers and journal editors
• Creating channels of communication with security and law enforcement community.
• Need to develop codes of conduct at the levels of individuals, institutions, financing bodies and monitoring agencies.
• Establish a clear and transparent oversight over life science research that guide and not hinder progress.

References:

• Whitby S, Novossiolova T, Walther G and Dando M (2015) Preventing Biological Threats: What You Can Do. A Guide to Biological Security Issues and How to Address Them. University of Bradford, Bradford Disarmament Research Centre. 446p.
• Need to develop codes at the levels of individuals, institutions, financing bodies and monitoring agencies.
• – Organizations can tailor the practical implementation of the codes to their own need.

 

 

• Case Analyses : Authorship

By: Lina El-Ebbini

During my study, Professor X gave me an idea to do a research for my thesis. I started gathering information, training on software for simulation purposes, designing the Professor’s idea, optimizing the design, and finally getting interesting results that I analyzed and evaluated. Then the Professor asked me to write my work as a paper and the paper should be accepted to allow me to graduate.

I wrote a draft of the paper and sent it to the Professor; including the order of authors’ names (Professor X, My name, co-advisor name) according to each one’s contribution. The day of submission, I noticed that my advisor had reordered the authors’ names (Professor X, co-advisor, another two names of his friends, and lastly my name). I was shocked and asked him:” Why didn’t you put the names according to the contribution? It is my work, my design, my analysis, my evaluation and my writing. I did everything. His response was: “This is not your decision”. At that time, I saw everything black in front of my eyes, he made me depressed. His behavior was unethical.

On the other hand, after few days, I returned to our submitted manuscript and noticed that I had a typo mistake somewhere during my writing. I told my supervisor about that. Unfortunately, he reproached me in a way that let me weep. The problem is that he does not know that he and the other co-authors have a responsibility too. However, I told him that things will be corrected once we receive the reviewers’ comments. In fact, I was optimistic about my work and had a sense that it would be accepted.

Moreover, the Professor postponed my graduation for another semester till the paper was published. He refused to let me graduate even though we received a primary acceptance from the journal along with reviewers’ comments. At the end, I realized that he was using me during that semester to help him to get a promotion; I had also helped him in writing three other papers.

 

The solutions to the above unethical issues that I faced during my study are as follows: there should be specific rules regarding authorship for graduate students in terms of the order of names and the case of the thesis for graduation; if it should be submitted as a paper or accepted. Moreover, there should be strict rules for professors’ promotion. In other words, a limited number of papers in which graduate students participate.

• Case Analyses : Bio-banking: An Ethical Perspective

By: Majd Hamaly

 

Bio-banking is the collection of human specimens or samples stored for future use in research. Bio-banks present a great potential for scientific advancement in areas of medicine and biomedical research. Many Residual samples collected from the patients for clinical reasons are stored and used later for reasons different from those they were collected for. Some issues that might rise with repurposing clinical specimens include the use of anonymized samples, incidental findings that arise with the research projects and the consenting procedure [1, 2].

In this work I will be presenting ethical issues related with the emergence of bio-banks as a case study for the Responsible conduct of Research summer course. First issue is the informed consent procedure, what sort of consent shall be utilized for the purpose of bio-banking? A broad consent can cover for the later use of bio-specimens. Nevertheless, if the patients were not consented re-consenting shall take place. Re-consenting will be associated with other complications as well as in case of anonymized samples, accessibility to patients who have donated the samples and the case of dead patients [3]. The waiver of informed consent for the use of bio-specimens, cases when informed consent can be waived and the regulating body for that waiver is very important to ensure adequate protection for samples and patients [4].

Another issue is the confidentiality and privacy, the extent to which samples will be anonymized is to be addressed. Would the researcher be able to track trace the sample back to the donor. In case of complete anonymization, the approach of results return to participants and de-anonymization shall be carefully tackled [5] .

A final point to touch on is the handling of incidental findings, genetic research that uses banked sample may reveals serious finding with actionable implications to the samples donors. A study by Johnson et al demonstrated that most of the screened bio-banks (85) had no clear policy regarding the return of result to individual participants and handing incidental finding [6]. All in all, there is a clear need for the development of global and institutional policies to address the above mention items –among other- in order to ensure and ethical and safe utilization of bio-banked specimens.

References:

[1] M. Capocasa, P. Anagnostou, F. D’Abramo, G. Matteucci, V. Dominici, G.D. Bisol, F. Rufo, Samples and data accessibility in research biobanks: an explorative survey, PeerJ, 4 (2016) e1613.

[2] T. Edwards, R.J. Cadigan, J.P. Evans, G.E. Henderson, Biobanks containing clinical specimens: defining characteristics, policies, and practices, Clinical biochemistry, 47 (2014) 245-251.

[3] H.T. Greely, The uneasy ethical and legal underpinnings of large-scale genomic biobanks, Annu. Rev. Genomics Hum. Genet., 8 (2007) 343-364.

[4] M.G. Hansson, The need to downregulate: a minimal ethical framework for biobank research, in: Methods in Biobanking, Springer, 2011, pp. 39-59.

[5] M.G. Hansson, Ethics and biobanks, British journal of cancer, 100 (2009) 8.

[6] G. Johnson, F. Lawrenz, M. Thao, An empirical examination of the management of return of individual research results and incidental findings in genomic biobanks, Genetics in medicine, 14 (2012) 444.

 

 

 

 

 

• Case Analyses : Publish or perish

By: Mariam AbdEljalil

A research team from two different universities in Jordan decided to conduct a mutual research in the field of surgical antibiotic prophylaxis. Shortly after the recruitment-phase one of the teams finalized the manuscript and sent it to the second team for review. The second team noticed great weakness in the scientific language, and mistakes in statistical analysis and hence results and conclusions. For this reason, the second team requested to hold submission until all issues are resolved. The first team explained that they had to publish as soon as possible because one of the team members was threatened to lose his job if he does not publish, and that they have already submitted to a journal. The first team could not do anything about this issue as there was no written agreement; furthermore the paper was accepted quickly in a predatory journal.

Ethical problems

• Publishing inaccurate scientific information for personal benefit
• Ignoring the rights of research partners in analyzing, drafting and accepting the final version of the manuscript
• Publishing in predatory journals that follow the model of “pay to publish”

Why are scholars facing such problems? Because of the “publish or perish” mantra

“Publish or perish” is a term that has been linked to scholar’s research, to demonstrate the enormous pressure they face to maintain their career via publishing their research findings^1,2. A high rate of successful publications is not only beneficious for the scholar himself, but also for his institution, for the purposes of global rating and attracting funds. Nevertheless, such policy can force scholars to head towards low quality quickly publishable research instead of high quality, focused organized research that may take time to be published². Furthermore, such policy gave an opportunity for predatory journals that publish research with little or no peer review in exchange of money, to grow and thrive in a tremendous fashion³.

What can be done?

1. a) Encourage coining laws by institutions and funding bodies that focus on quality rather quantity of research.
2. b) Utilizing written research agreements between universities to determine obligations and duties of each party.
3. c) Many researchers are not aware of the concept of predatory journals. For this reason they could easily fall a victim of an email promising them fast publication, especially when they are in need. Educating researchers about predatory journal, in terms of how they can identify them is hence of prime importance some suggestions can be found in the following reference⁴.

References:

1         Doyle J, Cuthill M. Does ‘get visible or vanish’ herald the end of ‘publish or perish’? High Educ Res Dev 2015; 34: 671–674.

2         Rawat S, Meena S. Publish or perish: Where are we heading? J Res Med Sci 2014; 19: 87–9.

3         Memon AR. Predatory Journals Spamming for Publications: What Should Researchers Do? Sci Eng Ethics 2017; : 1–23.

4         Günaydın GP, Doğan NÖ. A Growing Threat for Academicians: Fake and Predatory Journals. J Acad Emerg Med 2015; 14: 94–96.

• Case Analyses : Plagiarism

By: Almuthanna Khalaf Alkaraki

Plagiarism is stealing (publishing) someone else ideas, expressions, and thoughts; without giving credits to the original scientific work. Plagiarism is considered as break of journalistic ethics and sort of academic dishonesty. Plagiarism software checkers are now available online for academic use.

Internet-based plagiarism-detection service at my School is not present. Good news we heard before six months that they did purchase Turnitin software to be used for Plagiarism detection. After three months of waiting for Turnitin profiles. I did ask my boss, if we can use the service. He/she was happy to tell me that “the school did not buy the software”. His argument was that this service will cause headache for faculty staff. Because in his/her opinion there are trouble maker’s in the faculty staff; those “Trouble makers” will start detecting plagiarism for other colleagues in our school. I was disappointed at that time.

I remember a case that happened with me seven years ago. In my first month of my Ph. D., I received an email from my Professor that I he needs me to stop by his office as soon as possible. Once I was there, he told me that I plagiarized an assignment from someone else. The assignment was: to write a material and method chapter for a paper. At that time, I was shocked. What is the meaning of plagiarism? This the first time that I had heard about this new term. Was it shameful to do this? What should I do? In my opinion “at that moment”; was how I can make the methodology chapter differ from my colleagues? The idea of both is still the same!!! Why should I rewrite the sections in a new way?  Again, I am not stealing.

In addition, I noticed that the curriculum of my graduate School (for Both MSc and BSc), was lacking an Ethics course. I was not trained to deal with plagiarism and different ethical issues. After a while, my Jordanian head of the department sent an email that they are updating the curriculum, and he did ask me if I have any suggestions. It is my chance now to add at least one credit hour ethics course for graduate students as a core course. I did prepare the course description. It was appreciated from the head of the department.  My suggestion was approved; but unfortunately when the curriculum appeared my suggestion for the ethics course was not included.

The best solution for this real dilemma is by increasing the ethical awareness among faculty staff in Jordan. In addition, adding such kind of ethics courses to school curriculums will give the chance for students to be more educated in such subjects. Moreover, workshops and training should be held at Jordanian schools on a yearly basis; to install the phenomena in the Jordanian academic community.

 

• Case Analyses :

By: Moawia Khatatbeh

Last year I started a research in collaboration with some of my colleagues who were faculty members and 4 of my students were engaged in the research process. I told the students that they will be listed as coauthors when we submit the manuscript because they actually did significant efforts in data collection and data entry, in addition to their significant contribution in writing the introduction and the methodology of the paper.

After completing writing the manuscript, I sent it to my colleagues for review. But one of them replied to me and said that students should not be listed as coauthors and he added that an acknowledgement is enough for them justifying that the students will not get any benefit from the publication.

Ethical Problem:

The students have made significant efforts in the manuscript qualify them to be listed as coauthors; however, one of the team thought that they should not be as they are still students and they will get no benefit of the publication authorship.

 

Ethical Solution/s (Discussion)

In fact, as the principal investigator (P.I), I discussed the issue with my colleague and told him that it is their right to be listed as coauthors for the significant efforts they did in our research, and ethically, they should be listed in our authors list even if they would not get benefits of this and I argued that our students will get personal satisfaction and improve their future career rewards. Luckily, my colleague understood the situation and he agreed and the manuscript was published and students were listed as coauthors.

To ensure good publication ethics, anyone who makes significant contribution in any publication should be listed in the authors’ list.

The role of P.I was critical in this case.

 

• Case Analyses :

By: Rania Mahafdeh

The Alzheimer’s Caregiver Study:

A group of researchers are studying the most effective form of day care services that can provided by caregivers for persons with Alzheimer’s disease (AD). The study involved three groups: two treatments and one control. The first group will consist of treatment of AD with 4 hours of “day care” for the AD patients for five days per week. The second group composed of a treatment with 8-hour “day care” for three times per week for the AD patients. The control group will not have “day care” and they will be interviewed every month for the 3 month period to measure stress. The data collected will include the baseline assessment of the AD person, using mental status tests and collecting information from medical records and the consent form will be obtained from the family member of the AD patients.

 

Ethical Problems:

 

The AD patients will be a part of a research group. The AD patients in the control group may not receive a day care services. This is a bioethics case and there are number of ethical problems based on (Beecher 1966 NEJM): withholding available treatment (day care services), risks to subjects outweigh benefits and putting subjects at risk because the patients will not be given the sufficient level of care and that will be harmed on their health.

Ethical Solutions and Discussion:

 

Based on the Belmont Report, there are three principles essential to the ethical conduct of research with humans: Respect for persons, Beneficence and Justice. These are the fundamental principles of bioethics. For this, the investigators should respect for individual rights and the investigators should avoid any bias while doing the research without guaranteeing the rights of the patients to receive the minimum level of day care services. Additionally, the investigators should discuss the risks and the benefits of research as part of the informed consent process in order to minimize the possibility of therapeutic misconception. According to the Belmont Report, “Special provisions may need to be made when an individual’s comprehension is severely limited or when a class of research participants is considered incapable of informed decision making (e.g. children, people with severe developmental disorders, or individuals suffering from dementias)”. Based on that, the IRB should put additional protection for vulnerable subjects who unable to protect them.

 

References:

• Belmont Report.

–          Scenario of the Case Study: www.onlineethics.org

• Case Analyses :

By: Nahla Gamal Eldin

Dr Ahmed is a junior faculty staff member; he wants to conduct a research to study the effect of a new drug versus old drug on hypertensive patients, so he starts recruitment of the study subjects from his city which is a rural area in upper Egypt and his neighborhood. He knew about the importance of informed consent so he started to sign the informed consent from the study participants, while giving them a short brief upon the research process. He convinced them that the new drug will be for sure a very good drug for lowering hypertension other than traditional drugs while convincing the other group that the new drug won’t differ from the new drug.

• He got the approval from the IRB. He conducted his research and analyzed the results. Unfortunately, the pharmaceutical company of the new drug offers Dr Ahmed a sum of money to favor the results of the new drug and that it significantly differ from the old drug in lowering hypertension
• What do you think of the ethical issues in this scenario?
• What do you think of possible solutions?

Ethical problems:

• First: Dr Ahmed made an unfair selection of participants based on his city
• Second: Not valid consent
• Third: Conflict of interest

Ethical Solutions (discussion):

• First: selection of study participants should be based on randomization and not of certain area which is the poor city in this case people are not educated enough so they are willing to take any drug for free. In this case it’s based on socioeconomic status not randomly as it should be.
• Second: He should have obtained an informed consent with correct information given to all study population. In this case, he convinced the participants about his preference to take the new drug which is completely wrong; he should only inform them about the nature of the research, the benefits and the risks. I think that the IRB should make sure that this process is carried out correctly.
• Third: Conflict of interest. Dr Ahmed must refuse strongly manipulating data in favor of a certain drug. Every institution should have conflict of interest policy to govern these similar situations.

 

 

• Case Analyses : Conflicts of Interest: Autism and Vaccination

By: Rasha Arabyat

Dr. Amy is an associate professor in the School of Public Health. Dr. Amy is also mentoring students in doing various research projects related to epidemiology.

One of her doctoral students, Mary, wants to conduct a case-control study about the association between vaccines and autism. Mary has a 4-year old child with autism and has a strong belief that vaccines are what caused her kid the autism. She also believes that pharmaceutical companies are holding many epidemiological studies from the public that link autism to vaccination. Part of her eagerness to do the research and ultimately changing federal policies regarding mass vaccination comes from her strong conviction that vaccines are doing more harm than benefits.

Mary approached Dr. Amy with her idea and suggested doing it for her dissertation. Dr. Amy is unaware of Mary’s beliefs against vaccination and she did not know that Mary have a child with autism. Dr. Amy agreed on the study and consequently Mary started collection and analyzing of data. Mary finished data analysis and started writing her manuscript. The conclusion of the dissertation is that vaccination is associated significantly with autism. Dr. Amy approved the final draft and set a date for the defense.

At the day of defense, Amy first started with presenting a general literature review, and reported findings from questionable papers and parents’ testimonial. Most parts of her presentations were sensational and lacking scientific evidence. She presented the results of her study showing that those with autism were having higher odds of being vaccinated compared to those who have no autism. She indicated that the results were highly significant.

The dissertation committee questioned the quality of data, and asks to go over the raw data again with Dr. Mary to make sure that their analysis is correct before approving her dissertation. That is when Amy says, “Well, I altered the data to get positive results.” Dr. Mary is shocked. Amy says” The government is poising us with vaccine, and causing our children to have autism and disabilities. They are not telling us the truth about vaccines. Someone have to speak up.”

 

 

• Case Analyses :

By: Rana Abu Farha

 

A graduate student at a Jordanian university began a review the previous literature to write his research proposal, but unfortunately he realized that most of the needed studies could not be obtained as a full text and need a subscription by his institution.

The student felt sad and he tried to contact his colleagues studying abroad to help him get the required papers. One of his colleagues advised him to use a website called Sci-Hub which is a website containing millions of international academic research paper that could be accessed illegally without any article viewing charge.

Before starting to use this website, the student discussed with his supervisor the difficulty in finding suitable publication to build his theory, methods, and projects on, as many sources of information are not available. The student informed the supervisor about this website and he was surprised that the supervisor refused to use this illegal website.

But under the pressure of the lack of open access suitable resources the supervisor agreed to use the website and he began using it for himself and he started to encourage all graduate students to use it.

Discussion:

In Jordan, many sources of peer reviewed journal are still not available. This situation carries more challenges to academic and research staff as the subscription in databases is done through the institution solely and subjective.

The latter situation put researchers under pressure to find suitable sources of knowledge and even places more pressure on supervisors, especially in private universities.

Supervisors are increasingly directing their students to Sci-Hub website creating a controversy and a dilemma in using non-authorized sites to access data. The current discussion should be placed from the angle between withholding information and knowledge from junior researchers with minimal funding sources and accessing this information through an unauthorized method.

 

 

• Case Analyses : Salami slicing (data fragmentation)

By: Lubna Gharaibeh

Dr Eman finished collecting the data needed for her study; she started preparing the manuscript for the article. The study is an evaluation of the appropriateness of Venous Thromboembolism (VTE) in hospitalized patients; the outcomes are the extent of agreement of physician’s practice with the guidelines and the incidence of pulmonary embolism, deep vein thrombosis, myocardial infarction, or bleeding in the 6-month follow up period. Dr Eman remembered that she needed two articles with her name listed as first author for her upcoming promotion, so she decided to write and publish two articles not one from this data. She used the same demographic data for both articles but one of the articles had the extent of agreement with institutional and international guidelines as an outcome and the other article had the incidence of VTE events as an outcome.  Is this data splitting acceptable?

Discussion

Dr Eman’s management of data is called Salami Slicing, it is different from redundant publication which is using the same data, hypothesis, methodology or results in two publications. Salami slicing is dividing the data in a large study into more than one publication (1). This leads to a misconception by the readers that the information from each article comes from a different sample. This segmentation of data specifically affects systematic reviews and meta-analysis when the articles are considered as different studies with different populations, but the data came actually from the same sample. This will ultimately affect the whole biomedical scientific database which can lead to guidelines that influence clinical practice.

The ‘publish or perish’ trend in the academic career that gives more weight to the number of publications rather than quality is one possible reason for the desire among researchers to increase the number of their publications (2). It is difficult to detect salami slicing in publication since there is no software for its detection. It usually does not contain plagiarism, so it also escapes software checking.

Salami slicing or dividing a study into several parts is not always incorrect, for example approaching data and results from different points of views and for different population of readers, a biochemist and a clinician perspective, are acceptable. Publications of new and important findings in follow up investigations can have information from the previously published results. In the previous cases, transparency in communications with the editor is essential; the author must explain and justify reasons for slicing data and must indicate which information was previously published (3). The Committee on Publication Ethics (COPE) recommendations on handling salami slicing states that it is adequate to have separate articles if the hypotheses were independent questions, and that dividing data into different papers based on splitting outcomes is not legitimate (4). The Office for Research Integrity (ORI) guidelines on salami slicing (data fragmentation) indicates that authors of complex studies should not split data if its contribution to scientific knowledge is better served as one whole study (5).

References

1. Karlsson J, Beaufils P. Legitimate division of large data sets, salami slicing and dual publication, where does a fraud begin? Knee Surgery, Sports Traumatology, Arthroscopy. 2013;21(4):751-2.
2. The cost of salami slicing. Nature Materials. 2005;4:1.
3. Smolčić VŠ. Salami publication: definitions and examples. Biochemia Medica. 2013;23(3):237-41.
4. Salami publication. Committee on Publication Ethics. 2005;  https://publicationethics.org/case/salami-publication acssessed on July 2018
5. Roig M. Avoiding Plagiarism, Self-plagiarism, and Other Questionable Writing Practices: A Guide to Ethical Writing. The Office for Research Integrity (ORI). 2015; https://ori.hhs.gov/plagiarism-15#DataDisaggregation

 

• Case Analyses : Postgraduate mentorship in Jordan

By: Ola Al-Sanabra

A postgraduate student has conducted a research as her master degree project. During this she was self-taught of the basic techniques that were the core for her project. As the research progress there was a increasing need of her mentors support

to solve research problems. In addition, her mentors have directed her to other doctors to get a simple help such as using certain device in their labs. After she finished her degree was the time to write the paper by herself. This was not easy due to the difference between writing a thesis and a published paper knowingly that there is no experience on this for her. However, she wrote the paper in a very good way with a little editing from her main supervisor. Before they decided to submit it for publication her supervisor asked another colleague of him to read it and give his opinion in it. The colleague doctor took a one-month to do this without changing anything in it. After this the main supervisor was asking the student to put his colleague name as first author in the paper because he was looking for a future collaboration with him.

 

Ethical considerations in this case including: 1- lacking of mentor responsibility: The mentor did not have any regular recorded meetings with his student. In addition, the student face different problems without getting any support or help from his mentor.

2- Conflict of interest: There was not any previous agreement between the mentor and his student regarding the names of the authors that will be the published paper that was an outcome of the student work. Also, advantage of his student work and use it in benefit to establish collaboration with another colleague.

3- Authorship issue: Putting someone name without any contribution effort in this published paper such as: writing the paper, editing or analyzing the data. Moreover, there was no previous agreement between both of them about who is first author of this published paper.

 

The solution for such misconducts will be:

• Both the mentor and the students should have a partnership, clarity and responsibility relationship
• Implementing a training of the basis of mentoring process specifically to the young mentors. These training programs including skills in encouraging students for self-developing and to become creative during conducting their research, How to face students struggling problems and how to solve them and giving support and know the ethical issues during conducting the research and after and make sure that their students informed with these ethics.
• Have a written regulations regarding the responsibility of both the mentors and the students that includes the bylaw the agreement of the publication issues for their work
• The university implanting a schedule recorded mentor-students meeting. This could be weekly base or monthly base.
• Both the supervisor and the student should have a plan and agreement about the authorship regarding the publication of their research work.

 

 

 

These Cases are not suitable for publishing (Not clear)

 

• Case Analyses : Research Misconduct

By: Zaid Altaany

Science- Hub is a web site with a number of domains that has hundreds of millions of academic papers and articles that allow researchers to access and download the paper for free. This web site was founded by Kazakhstani; a graduate student in 2014 as a reaction to the high cost of research papers; she collected all papers from different sources and uploaded them to her web site and releases it for free. Science – Hub web site also stores papers in its own cache to speed up future requests. However, the researchers usually have to pay for an access fee to get some of the published papers.

The same issue here is taken the paper for the science hub and then uploads it on research gate and releases it to the public.

Is it ethical to use that web site to get access for the paper and not pay; or you should have to pay in order to download the paper that you want to read.

In my personal opinion this action is not ethical due to copyright issues.

 

 

• Case Analyses :

By: Raed Al-Shami

Mr. T is a graduate master student who did a research about the effect of biomaterial X on bone regeneration in dogs and wants his work to be published but his advisor, Prof. B, is not helping him.

Mr. T tried many times to contact his advisor to start writing the paper but every time the advisor keeps ignoring his requests. Last time Prof. B told Mr. T that the article was already written and it’s under review in one of the journals but he did not mention anything else to confirm, so Mr. T did not trust his advisor anymore according to his bad experience.

Mr. T decided to rewrite the article with the help of another colleague; Mr. V. Mr.T finishes writing the manuscript and sends it to another journal without telling his advisor because he will refuse to add Mr. V as a coauthor.

Another student of Prof. B when performed their study, measuring the effects of coffee consumption on students’ performance, the study involves surveying 100 of professor’s students in the university, some students were having exams at that time, so they did not read the questionnaire carefully, and they just tackled the answers very quickly. In addition some of the participants wanted to refuse to join but they were afraid that if they did that their professor will be upset. Lastly, when Prof. D asks Mr. T to share the work protocol and the subsequent steps to another colleague to begin similar projects, which Mr. T think he can do such studies later on, Mr. T refused to share their data, because Mr. Ts’ original paper is not published yet and may be another colleague will publish it sooner thus depriving him of recognition and priority.

The ethical problems:

• Sending the article to another journal at the same time.
• Adding another coauthor without telling the corresponding author.
• Conflict of interest between the professor and its projects on his students.
• Informed consent from the participants (students) could be biased.
• Selection of the time to distribute the questionnaire to the participants.
• Refusal of data sharing.

 

 

• Case Analyses (Confusing)

By: Sanaa K. Abujilban

Mr. X and Mr. Y were supervising a student (stu # 2) in 2016-2017. Mr. Y was the first supervisor and Mr. X was the co-advisor. The student was not an active one and it took her a year to prepare the mini proposal and the literature. When she was about to start her data collection, at that time Mr. X started to work with another colleague Mr. L  (who had a previous conflict with Mr. Y) with another student in 2018 (stu # 3). Mr. Y was upset and said to Mr. X “your new project is similar to one of our previous studies’ student (stu # 1) in 2015”, because he did not want Mr. X to work with Mr. L. Mr.X explained that it is a different one, but Mr Y was not convinced  and complained to the Faculty of Higher Education. They called Mr. L and said you needed to solve it between you in a friendly manner. Mr. Y said “let us change the variables and the setting to solve the problem”. So Mr. X and Mr. L discussed with the student and agreed with that, so the problem supposedly ended.

However, what happened then is that Mr. X was surprised when he received an email from the Faculty of Higher Education saying that he was changed from being a co-advisor for the student # 2 by the student herself.  So, Mr. X called the student and she said: “that was done by the first supervisor”, and she was surprised too, because she received an email saying that the new co-advisor is Prof. M.

So, What Is the Problem?

Student’s supervision is a vital process for education and learning process in order to produce new researchers. Both, students and supervisors are benefited from it. But, sometimes personal issues are raised during the supervision processes and affect it. In this case, previous conflict between Mr Y and Mr L raised the problem which resulted in removing Mr X from the supervision.

Mr. X worked a lot with the student (stu #2). He spent hours correcting and guiding her.

 

What Should Be Done?

There is no obvious violation of any rule of supervision, the process is affected and the student might suffer.

What is Mr. X supposed to do?

• Report Mr. Y to the Faculty of Higher Education? Or
• Forget that and not work with Mr. Y anymore?

Solution:

Have an agreement from before about continuity of supervision and the situations in which ending the supervision is possible early on in the research process.