Case Studies for the Participants in the Jordan RCR Program Year1(2015-2016)

1) Case Study: Authorship Dispute

By: Dr. Nafez Abutarboush

A faculty member at the University of Jordan (JU) is leading an intriguing project in collaboration with two laboratories at Jordan University of Science & Technology (JUST) and Hashemite University (HU). The collaboration has been established for the past 10 years. Their work was highly cited and some of their publications were in Science, PNAS, & JBC. While finishing his final work and before leaving the lab to be hired at Yarmouk University (YU) as a faculty member on a tenure track, a postdoc from JU lab recommended an idea, designed the experiments, performed the solution biochemistry experimental work, and wrote a preliminary manuscript describing his findings and discussing them. During the year after, the collaborators finished their experiments in crystallography (JUST) and EPR (HU). Afterwards, the final version of the manuscript has been prepared by the professors at YU and JU. The corresponding author (JU) has arranged the list of authors’ order accordingly having his former postdoc the first author and sent the final manuscript to all listed authors.

The professor at HU refused to discuss the manuscript claiming that authorship was unfair and that the manuscript needs further biochemical solution studies and also further major adjustments. He insisted on having his graduate student as the first author claiming that their results are valuable and they made the manuscript clear and informative.

Although the new professor at YU feels he deserve first authorship and it is important for his promotion, he refused to interfere in the dispute so as to save the collaboration of his previous mentor, however, he contacted him expressing his opinion and left the issue for him to decide insisting that he will be fine if he was not the first author.

JU professor neither accepted the recommended changes on the manuscript nor further experimental studies. The professor at JUST was involved to solve the authorship dispute but she did not succeed and she is convinced of JU professor argument.

Solutions:

  • Publishing the manuscript according to HU professor argument. This denies the professor at YU his first authorship with possible impact on his career but preserves the productive collaboration.
  • Publishing the manuscript according to JU professor argument without HU professor results. This ends the collaboration with HU lab and weakens the manuscript (Salami Publication) with possible court involvement.
  • Blocking the submission process which leads to loss of effort, time and money that was spent hardly on the project, hiding necessary data, and unfair for the funding agency.
  • The manuscript was planned to be submitted to JBC and finally was submitted to FEBS letters and published with neither involvement of HU professor and student nor their data.
  • This seems the best solution to be taken in the aforementioned conditions. However, as being insisted all the time, authorship should be discussed always before the project starts along with the planning process.

 

2) Case Study:

By: Dr.Khulood Shattnawi

Description of the Case:

 For my PhD I conducted an ethnographic study that involved participants’ observation in two neonatal intensive care units (NICU). The purpose of my study was to explore why so few mothers breastfeed when their babies are admitted to NICU, and to gain an understanding of the impact of this for the mothers and staff involved. During the course of this research, I witnessed actions done by the health care team (HCT) that I viewed as ethically unacceptable or inappropriate.

Examples of these actions are:

Delaying or ignoring some interventions for the newborn babies such as giving feeds on time, forgetting the use of expressed mother’s milk, and improper performance of some caring activities.

Ignoring infants’ cry for an extended period of time.

Power control, which demonstrated by placing parents in a subordinate position to the HCT, mainly when it comes to their infants’ care plan, or when parents need to seek permission to visit their infants… etc.

On addition to these actions that are considered inappropriate or unethical, the researcher may witness illegal actions as well.

 Ethical Questions:

 These situations raise many questions:

  • Should the researcher share her disapproval with the HCT?
  • Should the researcher report the participants’ actions to the management department/ authorities? And is she obligated to do so?
  • Can the researcher record these actions in her field notes to be part of her data?
  • How can the researcher deal with confidentiality and anonymity?
  • Is the researcher betraying the confidence of her participants if reporting their actions?
  • Is the researcher exposing her HCT participants to harm when reporting their actions? And what about the other participants (families and children) who are affected by the HCT actions?
  • How could this affect the researcher’s relationship with her participants?
  • How could reporting these actions alter the research setting?
  • If choosing not to report, am I considered complicit with them?

 Possible Answers:

 The researcher’s decisions are about revealing or concealing participants’ malpractice or unethical behavior to authorities.

  • If the researcher report unethical behaviors to authorities, she will probably alter the research setting by producing different reactions from her participants to her presence in the future, and thus she could not use the altered observations as a valid data for her research.
  • The researcher is also betraying their confidence as she already promised for anonymity and confidentiality when they signed informed consents.
  • By reporting unethical or illegal actions in her research, the researcher may expose her participants to harm if readers identify them. Therefore, it is important for the researcher to weigh the benefits for her research against the risks on her participants of each situation and decide on whether to document such actions or not.
  • If the researcher chooses to document illegal action, she should ensure removing any minute identifiable information about her participants. However, documenting illegal action may expose the researcher to legal questioning especially when field notes may be considered legal documents in such situation.

 

3) Case Study:

By:Dr. Sukaina Alzyoud

A research team aims to conduct a Randomized Clinical Trial for smoking cessation among pregnant women. The trial will include administering Nicotine Replacement Therapy [NRT] (such as Gum, Nasal spray, etc.), varenicline tartrate and bupropion hydrochlorid. Although NRT, varenicline and bupropion have been shown to be more effective than placebo for smoking cessation in non-pregnant adults, there are limited data on their efficacy in pregnancy. Moreover, there is considerable uncertainty regarding the benefits and risk associated with the use of these smoking cessation pharmaco-therapies during pregnancy. Several clinical trials have tested the safety of NRT use during pregnancy and found that NRT use was no worse than ad libitum smoking in terms of maternal and fetal hemodynamics and nicotine exposure. However, the literature indicated that although NRT did not reduce smoking during pregnancy, it increased the birth weight and gestational age. Some of the challenges in this type of studies were recruiting sufficient numbers of pregnant women. Also, some studies had a high number of participants who withdraw from the study.

Ethical Questions:

  • Does the uncertainty in this cessation method give a window for the team to conduct the study?
  • Will the benefits of the study allow exposing both mother and baby to the risk of Nicotine therapy?
  • Will the mother consent be enough or should the partner\husband consent too?
  • What are the plans to deal with side effects of NRT?

 

4) Case Study:

By: Maram Quttina

A researcher wrote two separate grant proposals for two projects related to each other. One has been accepted and the other is still under review. The two projects share to a great extent the methodology of analyzing the samples. The researcher started to distribute a consent form and collect samples for the approved project. While the researcher was collecting the samples he was taking an extra one for the project being reviewed. The researcher claimed that he will save time by analyzing the samples for both projects, he will not introduce the patient for another invasive sample collection, he will take advantage of the material brought for analysis samples before they get expired, it is hard to find more participants that meet research criteria in his project, and maybe patients will refuse to give a sample next time.

The researcher’s act is not ethical for the following reasons:

  • The consent form is an integral part of the research so he is collecting an extra sample for a totally different research and the patient may not accept to be in the second one so the consent form of the first research is like a cover for the second one and by that he is invading the privacy of the participant and showing disrespect.
  • The researcher’s claim about the material is not a critical issue because even if the material is expired he will have a separate grant for his second research and so he will get the material that is required for his research.
  • The researcher’s claim about the time is not justified, it is not like he is in a competition and he needs to finish his research quickly.
  • The researcher’s claim about the invasive way of getting samples and that it is hard to get a participant is also not justified because if he was able to find participants for his first research he will be able to find participants for his second one, and his deceptive and untruthful action will bring him only trouble.

Alternative solution: To wait for a decision on his second grant proposal, and then start collecting samples.

 

5) Case Study:

By: Dr. Abeer Rabbaba’h

Data Falsification Case Study:

Ms. Emily is 27 -year old freshly graduate researcher from Pluto University of Science and Technology (PUST). She finished the entire university requirements to get the PhD degree in biomedical sciences.  Ms. Emily was lucky in getting an acceptance in a fellowship program from a highly reputable center. She is preparing herself to move on in a research dealing with understanding the downstream signaling pathway of adrenergic receptors in a WX234 knock out animal model, which is considered to be an extension of her thesis project.

One day, when Ms. Emily was working in the laboratory, she received an e-mail from her PhD advisor updating her with the reviewer responses regarding her first author thesis paper. One of the reviewers asked to provide a better western blot image showing the difference in the bands better than the one submitted.  She was too busy with her new job to redo the blots and she replied, “I’m too busy to come over and repeat the experiment, would you please ask one of the laboratory members to redo the experiment based on an instructions present in my laboratory notebook”.

Mr. Erick a graduate student there tried to reproduce the data but unfortunately he couldn’t be able to prove that the data is reproducible using the same technique that Ms. Emily used previously.  The advisor struggled out since the gel used to confirm the WX234 knock out model that had been received from a collaborator at Mars University (MU) and is a critical point for the entire project. They tried to confirm the model using PCR but again the knock out model couldn’t be confirmed. Upon contacting Ms. Emily regarding that, she admitted that she falsified the data and switched WB images because she wanted the project to proceed faster.

Ethical dilemma and arguments present in the case:

  • Submitting the manuscript to a different journal and ignoring the whole scenario about project integrity.
  • Stop the project and don’t publish the manuscript at all and consider that this project never happened (Loss of time, effort and expenses).
  • Ignore the situation and restart the project from scratch.
  • Contacting the collaborators at MU and ask them to do the confirmation from their side and use MU confirmation results for the publication.
  • Withdraw the thesis from the university database and report what happened to the head of graduate committee at PUST (taking into consideration that she may lose her degree along with her new job).

 

The advisor decided to report this event and he withdrew the thesis accordingly. The graduate committee decided to disqualify Ms. Emily since PhD granted to Ms. Emily due to her thesis work, which they discovered that she intentionally falsified the data. The graduate committee considered her event as crossing all research ethics and values, ignoring the major principles of transparency, veracity, accountability and responsibility and this is definitely unacceptable. Ms. Emily lost not only her degree and job, but also the trust of her advisor and committee.

 

6) Case Study 1:

By:Dr. Saleem Banihani

 I will be presenting here a case that is real and happened with me in one of my clinical trials at JUST.

The first proposal that I have submitted to the research deanship at JUST was to investigate the effect of fresh pomegranate juice on the level of fasting serum glucose and its regulating hormones in type 2 diabetic patients.  Briefly, in this study, I proposed to recruit about 150 patients with type 2 diabetes fasted 12 hours, and before they take their medication in the early morning, I will be giving them a fresh pomegranate juice at 1.5 mg/kg of total body weight, then withdraw a blood from them every 1 hour for 3 hrs. time frame. The first decision of the IRB committee was “This study requires FDA”, which means, it requires from me to apply this study on healthy volunteers first, publish the results, then investigate the effect of this sugary juice on diabetics to avoid any harm to them. Given that, I explained in my proposal the last knowledge in this context, which is that “pomegranate juice does not worse the diabetic parameters in rats and may decrease fasting blood sugar”.

After I’ve seen the decision of the IRB, I applied an objection that pomegranate juice is part of our food and many diabetic patients drink fresh pomegranate juice, in addition to the evidence in the literature, which shows that fresh pomegranate juice does not worse the diabetic parameters in type 2 diabetic rats. Moreover, I’ve explained that I’m looking for a hypoglycemic effect of pomegranate juice in humans, but not hyperglycemic. Furthermore, I clarified that if I have to recruit healthy volunteers I may cancel the whole study as I will exceed the research budget! Owing to my objection, there was about 60% of the IRB committee members agreed to pass this proposal! And the second decision by the head of the committee was to allow me to run this study as typed in the proposal.

However, since there was some uncertainty toward the effect of pomegranate juice on type 2 diabetics, I recruited in the study only the patients with the early stages of type 2 diabetes (FBS < 220 mg/dL), and in this case I will decrease the unexpected hyperglycemic effect of pomegranate juice to the minimum.

After discussing this case with my group, all felt that I have applied the bioethics in this study- I excluded any harm to the recruited patients.

 

7) Case Study:

By:Dr. Mahmoud Alomari

Study Purpose 1:  Examining the effect of smoking on CV risk factors.

Population: 7th-10th grade students

Study methods:

Questionnaires were used to collect information about smoking whereas body mass index was used to examine obesity and blood samples were drawn to examine glucose/lipid profile.

Problem: Parental inform consent was not found for 5 students after collected.

Solutions: 

Obtain another parental inform consent

Discard the data for the lost participants with lost consent.

Bases for these solutions: Integrity, Alternatives, Trust

Study Purpose 2:  Examining the effect of smoking on CV risk factors.

Population: 7th-10th grade students

Study methods:

Questionnaires were used to collect information about smoking whereas body mass index was used to examine obesity and blood samples were drawn to examine glucose/lipid profile.

Problem:

Teachers and principals tried to force the students, with parental informed consent, to participate in study, or part of it.

Solutions:  Asked the school officials to give the students freedom to participate

Bases for these solutions: Integrity, Alternatives, Trust

 

8) Case Study:

By:Dr. Nihaya Alsheyab

The study:

In 2013, I had conducted a research project about the Levels of per fluorinated Compounds in Human Breast Milk in Jordan and the Impact of Socio-demographic Characteristics. Informed consents were sought from women themselves who breastfed their child at the time of data collection.

The problem during recruitment: Some of the women thought that their breast milk is the right of their husbands and they had to seek consent from them before they could provide us with milk. Some of these women said that it’s “haram” (forbidden in Islam) not to seek husband’s consent.

Challenges:

Data collection period was limited and participation rate due to this issue was therefore limited. Although we had an ethical approval from the MOH and JUST to conduct the study, it’s very hard to recruit women unless you work there as these women are vulnerable and duration of hospitalization is short.

Solution:

All components of valid consent were there including adequate information, voluntary participation, and capacity to comprehend information. However, as a PI, I had to go back to these women and try to persuade them that this has nothing to do with your husbands and I therefore emphasized the importance of participation to public health. Most of these women were convinced with my perception and thus majority of them gave samples.

Ethical issues:

The challenges are related to whether by persuading women to participate one more time is considered ‘forced’ participation, which might have contradicted the ‘voluntary’ participation element in the valid consent form. Another challenge is related to having a nurse working in the hospital to collect data, which also may have caused alteration to the concept of voluntary participation.

Also, if the husband knew by chance about his mother providing milk after data collection there could have been a problem to the researcher.

Solution from group: in Islam, the husband is the cause of milk and therefore he has the right to choose who to give it to. And thus the woman should not have provided sample unless she consulted her husband.

How to approach this matter in an ethical manner?

  • Husband: Seek husband’s approval first because this is against women’s perception. Try to hire a researcher who doesn’t work in the same hospital.
  • Researcher/data collector: Train the nurse researcher to emphasize no penalty will be applied or the level of care will be diminished if the woman did not participate in this study.

إنّ لَبَن الفَحلِ يَحرِّم ” يُريد بالفَحْل الرجلَ تكون له امرأةٌ وَلَدت منه وَلَداً ولها لَبن ، فَكُلّ مَن أرْضَعَتْه مِن الأطفال بهذا اللَّبَن فهو مُحرَّم على الزَّوج وإخْوته وأولاده منها ومن غيرها ؛ لأنَّ اللبن للزوج ، حيث هو سَـبُبه . وهذا مذهب الجماعة .
ومنه حديث ابن عباس ، وسُئل عن رجل له امرأتان أرْضَعت إحداهما غلاماً والأخرى جارية : أيَحِلُّ للغلام أن يَتَزوّج بالجارية ؟ قال : لا اللِّقَاح واحد . اهـ .
فالمقصود به لبن المرأة ، إلاَّ أنه نُسِب إلى الرجل ؛ لأنه هو الْمُتَسَبِّب فيه .
ولذا فإنه يَحِقّ للزوج مَنْع زوجته من الإرضاع إلا بإذنه .

 

 9) Case Study:

By:Dr. Nehad Ayoub

A pharmaceutical company working on a new targeted therapy for breast cancer is interested in recruiting patients to a clinical trial to test therapeutic effectiveness of the new product compared to the best targeted therapy currently available in the market. In order to do this, representatives of this pharmaceutical company had approached oncologists in public hospitals and health clinics to encourage their patients to enroll in this study. Breast cancer patients enrolled will be randomized to receive an FDA-approved targeted treatment or the new therapy under investigations. The study will be double-blinded and will be conducted in a private hospital in which enrolled patients will be under the medical supervision of a panel of expert oncologists who will follow them while being enrolled in the trial. In addition, the pharmaceutical company is going to offer patients a full course of targeted therapy for free upon enrollment in the trial. According to study protocols, patients enrolled will not be followed by their clinicians and their progress information will be kept confidential till the end of study and data processing.

Dr. KF is an oncologist in a major public hospital in the city. He reviewed the study protocol and the IRB letter after which he accepted to recruit eligible patients to this study. Taking into consideration the free treatment offer provided by the pharmaceutical company, Dr. KF recruited eligible low-income patients believing that those patients are in greater need for this clinical study. Patients recruited by Dr. KF will be randomly selected to receive the approved targeted treatment or the new drug.

Ethical Considerations:

The above case is discussing enrollment of cancer patients in clinical trials which has been an issue of ethical debate. The clinical trial is to be sponsored by a pharmaceutical company which will conduct the study and currently enrolling patients. Multiple ethical considerations can be made according to this case:

Argument 1: Are clinicians recommended to enroll their patients in clinical trials?

Argument 2: Do patients receive better treatment in clinical trials?

Argument 3: Are eligibility criteria sufficient for patient enrollment in a clinical trial?

Argument 4: Is it ethical that a separate group of oncologists should conduct the study and supervise treatment administration while patients enrolled in the trial?

Argument 1: Are clinicians recommended to enroll their patients in clinical trials?

In the above case, Dr. KF decided to recruit his patients to the study if they are eligible. He made this decision based on his review to the study protocol and an IRB approval issued by the private hospital where the trial will be conducted. Approval for patient enrollment should not be based on a “personal” decision! It would be much appropriate if the study protocol was reviewed by the local IRB committee of the public hospital where Dr. KF works (independent review). IRB should approve the protocol and evaluate potential risks and benefits of this trial. This is particularly important taking into consideration the study is funded by a pharmaceutical company which is trying to test the therapeutic usefulness of its product (rather than a governmental organization). As a clinician responsible for his patients, Dr. KF should be aware of IRB members who serve on the committee of the private hospital assuring no conflict of interest regarding approval of study protocol would exist. In general, patients have good trust in their physicians. In part, this issue is very sensitive in which a patient approached by his/her physician for enrollment in a study might sound very appealing and welcome. Patients would think that their physicians are working for their good, in part, through recruiting them to a clinical trial. This is particularly important as introducing patients to clinical trials testing “new” drugs which could affect them adversely and thus question the need to enroll such patients to the trial.

Nevertheless, cancer patients might be encouraged to participate in clinical trials especially when they are in terminal stages of their disease or when enrollment is the only other option available for such patients. In case enrollment is an option, it’s the duty of the physicians and the IRB committee to assure the validity of the study and that it is ethically conducted.

Argument 2: Do patients receive better treatment in clinical trials?

The clinical trial in this case scenario is conducted to test the activity of a new targeted therapy to an approved treatment available commercially. Overall, it would be accepted to say that patients in clinical trials may receive improved treatment because of better drug administration, better medical supervision, and frequent monitoring. However, in this clinical trial, a “new” drug is being examined with minimal data about risks and adverse effects. If an approved and effective therapy for those breast cancer patients is already available in the market, would their enrollment in such a trial be justified??

If clinicians believe clinical trials are for the good of the patient, would it be possible to apply the same standards of patient care to regular treatment settings for the patients without the need to take the risk to expose them to the potential hazards of trying a new treatment? In other words, would those cancer patients be harmed by delaying administration of a known available therapy to treat their cancer disease by being randomized to the treatment arm of the new drug product?

Argument 3: Are eligibility criteria sufficient for patient enrollment in a clinical trial?

Inclusion and exclusion criteria are always set forward in clinical trials to define patient population eligible for enrollment. In this case scenario, Dr. KF had enrolled “eligible” patients, those who meet criteria for inclusion. But, was the enrollment approach appropriate? Taking into consideration that the pharmaceutical company is going to offer treatment for free for the patients to be enrolled, Dr. KF made somehow a “compassionate and biased” selection among his patients. Thus, being a breast cancer patient with good economic status excludes you from the study! This would violate justice and equity among patients. In part, Dr. KF might be under the impression that this would save money for this group of patients, however, in the same time; this would put those patients under greater risk for trying a new drug therapy. Financial considerations and cost of treatment should not be considered a priority to decide patient enrollment. Bringing such issues to patients might influence their ability to make decisions regarding participation, and it gets worse, if this was also influenced by a positive recommendation of their physicians (expert power). Alternatively, it would be appropriate to discuss patient enrollment to the trial based on its design, risks, and benefits putting little emphasis, if any, to the financial support.

Argument 4:

Is it ethical that a separate group of oncologists should conduct the study and supervise treatment administration while patients enrolled in the trial?

Physicians are different from investigators. Upon enrollment in a clinical trial, investigators are supposed to act in a non-biased way towards all participants accepting that some risks may happen, especially that a lot of factors regarding the new drug therapy is not known yet. In order to avoid a conflict of interest, it would be ethically acceptable not to supervise patients enrolled in the study if careful considerations to study protocol and implementation were made earlier by recruiting physicians and IRB committees.

 

Summary:

Clinical trials are essential to expand the current knowledge of therapeutic management of diseases. However, patient enrollment into clinical trials should be carefully considered and evaluated from both medical and ethical points of view. Eligibility for enrollment (defined by inclusion and/or exclusion criteria) is not the sole determinant for patient recruitment, especially if this kind of trials would be expected to hinder the patient access to a more well-established and available treatment for his/her condition. In special circumstances, such as cancer patients, treatment delay or exposure to treatment with incomplete efficacy and safety data profile may result in significant adverse consequences to such patients, especially if they are in advanced stages of their disease. Patient enrollment should not be affected by financial aspects which may influence appropriate decision making by patients. Physicians should thoroughly review and assess the potential benefits and hazards for getting their patients enrolled in clinical trials.

 

10) Case Study:

By:Dr. Nour Abdo

One of the requirements for promotion from assistant to associate and from associate to professor in JUST is to have 3 first author publications. In most fields, graduate students are accepted for a research project and the final dissertation is submitted for publication. It is a common norm for professors to put their names as first authors and the student name somewhere in the paper sometimes even after all professors.

Ethical Questions:

  • Is it right NOT to put the student name first?
  • Is it right to make it a condition in accepting the student prior to starting the project or is that coercion?
  • Isn’t the student a vulnerable victim?
  • How can we be sensitive to student’s right but fulfill our requirements for promotion?

A faculty in JUST started a collaborative project and included all collaborators in the proposal. At the end, some of the collaborators contributed to the research while others didn’t. The faculty published the final work and included only collaborators that contributed to the work. One of the collaborators who were not included made an official complaint to the deanship of research for not being included while he should have been. The dean of research asked them if they had other proposals together and decided that the collaborator should not include the faculty name in the next publication regardless of the faculty contribution in research. The collaborator was higher in administrative rank than the faculty and used his position to issue a discipline warning for the faculty for nonsense reasons.

Ethical Questions:

  • Was the faculty right not to include the non-contributing collaborator?
  • Was the dean of research right in his decision?
  • Do you agree with JUST’s regulation: as long as you are in the proposal you should be on the publication even if you haven’t contributed in the end toward the research, and if you weren’t on the proposal and you have actually contributed substantially to the research, this effort will not be credited toward promotion?
  • Do you agree that some of the promotion criteria in JUST should be modified substantially?

 

11) Case Study:

By:Dr. Mera Haddad

The case:

A 32 year old man visited a neurologist after feeling hand tremor and stiffness in the arm and legs. After running some tests, the patient was diagnosed with Parkinson Disease in a very early stage. The neurologist told the patient that he suffered from stress and that he should relax. The patient was prescribed a medication to treat the Parkinson Disease and was told by the neurologist that the medication is to relieve the stress. The patient was then referred to the physical therapy clinic for physical exercise which he was told to do as part of the treatment.

In the rehab clinic, a physical therapist was conducting a research on the effect of physical exercise in patients with Parkinson Disease and she agreed with the neurologist to refer patient affected with the disease to her clinic in order to participate in the study.

The patient went to the rehab clinic to complete the treatment for his condition. The physical therapist was reading the information sheet to him and was telling him about the nature of the study in order to sign the informed consent at the end. When the physical therapist mentioned Parkinson Disease many times, the patient posed and told her:” What are you talking about? What is this disease? “

And here was the problem:

  • The patient didn’t know about his disease.
  • The patient didn’t know that he was referred to the neurologist to participate in a study.

Ethical Concerns:

  • Is it ethical to hide information from a patient about his/her disease?
  • What was the physical therapist supposed to do? Should she tell the patient that he had Parkinson Disease and discuss the disease that the neurologist should have told him about?
  • Could she include this patient in the study? Knowing that the patient insisted to participate even though he knew it was for research purposes.

Taking into account that the study had potential benefits and very minimal risks.

Answers to Ethical Problems:

  • In my point of view, I think that it’s unethical to hide information from the patient about his/her disease. Doctors are taught to be honest with their patient and to maintain privacy and confidentiality.

However, this opinion disagrees with my colleagues who thought that hiding the disease from the patient would be for his benefit and it was the right decision especially that the patient was depressed and tired.  And what the neurologist did was for the sake of the patient’s psychological health.

  • I don’t think it was the therapist’s responsibility to tell the patient about the disease. She should have completed the study and referred the patient to the neurology clinic where he would know about the disease
  • Finally, I would definitely include this patient in the study especially that he wanted to participate.

 

12) Case Study:

By:Dr. Rami Mukbel

Case Description:

You are an editor for a journal and you have been sent a manuscript to be evaluated for publication. The researcher has evaluated two types of diagnostic tests commercially used in the labs. In his results, he found that one tests is better than the other and he recommended the use of this test more widely as it is more accurate. This manuscript was sent for reviewing and it was recommended later for publication. After the publication of the paper, the head of the second company that manufacture the diagnostic kit, which was found insensitive in the paper, sent you a letter. He inform you that the procedure used with their test done in a wrong way which made the results inaccurate for their product. This made the conclusion that there product is insensitive. At the same time, he mention that this error might be done intentionally as the researcher has been funded previously from the first company to do other research work.   As a reviewer, what can you do?

Ethical issues:

  • Is there any result falsification?
  • Is there any conflict of interest?

Discussion:

I think, as an editor, I should consider all of what have been sent to me from the second company as an accusation and it need to be investigated before giving my judgment. First of all, the researcher should be contacted to defend himself. The researcher has to explain the procedure that he used for the second test and I might have to send the response to the reviewers for further evaluation.

There might be four responses each with specific action:

  • The procedure and analysis were done in the right way and the researcher did not receive any fund from the first company. No action need to be done
  • The procedure and analysis were not done correctly by mistake and he did not have any fund form that company. The paper should be withdrawn, the researcher can correct the error and resend his work to be evaluated as new submission.
  • The procedure and analysis were done correctly but the researcher did get the fund from the first company without the declaration of the conflict of interest. This is a conflict of interest and the paper should be withdrawn.
  • The procedure and analysis were done incorrectly with the fund been received from the first company. This could be data falsification and conflict of interest, the paper should be withdrawn and a letter should be sent to the employer of the researcher for serious research misconduct and data falsification.

 

13) Case Study:

By: Farah Alhashimi

A master student has a 2 year scholarship .His thesis is Detecting novel biomarker in serum for certain diseases in Jordan using t 2 -D electrophoresis. The protein purification kits and IPG strips were bought from a company outside Jordan. When the student received the kits and strips after 5 months, they were expired. After contacting the company, he finds out that the shipment arrived to Jordan after 1 month .The Receiving Materials Unit at the University received the kits and strips without registering them in the receiving record. This is why they kept telling the student that his material has not arrived yet. Despite of that, he decided not to tell his mentor and run the experiment, supposing that the expired material may not affect the results that much. At the end of the experiment, he ran a conformation ELISA test on a large number of samples. The results of the test were negative. His mentor decided to omit the results of the conformation test from the thesis and repeat the test in the future.

The ethical issues regarding this case and the alternatives:

  • First this case is a clear example about conflict of interest. The student from one hand has a time limitation to graduate before his scholarship finishes. From the other hand, he knew that the expired material will in some way affect the accuracy of the result.
  • Second he made the decision depending on weak assumption that is not based on evidence and on that it was not his fault.
  • Third he did not respect his mentor’s trust so he became responsible for wasting time and effort.
  • Fourth his mentor’s act was unethical when he falsified the data.

 

The alternatives could be:

  • The student should extend his scholarship period by telling his mentor about the case and have the required report with reasons for the extension.
  • The mentor should find out the real reasons behind these contradictory results.
  • Having a well-organized communication system between all parties involved in the research is very important to have a successful research.
  • His mentor’s act was also unethical.

 

14) Case Study:

By:Dr. Hanan Khalil

Mr. Khalil is a 73 year old man who was diagnosed with Parkinson’s disease (PD) 6 years ago. In one of his clinical routine visits to the neurology clinic in the hospital, he was approached by his neurologist and invited to participate in a study that they are conducting in JUST for a new therapeutic exercise interventional approach for people with PD. The Subject showed his initial interest and accordingly he was provided with a copy of the study information sheet. The nurse at the clinic obtained his phone number and told him that they would speak to him later to arrange for a convenient time for his participation. The detailed information sheet included 7 pages along with one summary cover sheet.

One week later, the research assistant for the study called Mr. Khalil and scheduled an appointment for his first visit. On the day of his first visit, a consent form was initially going to be obtained before starting any other procedure. The subject was asked if he read and understood the provided information sheet in which he responded with “Yes”. When he was asked to give his written informed consent, the researcher found that Mr. Khalil was unable to, because he could not read or write ”He was illiterate”.

So the researcher took the one summary cover page only, and read it to the subject. This was followed by reading each sentence on the consent form in which the subject was asked to say if he agreed with it or not. The consent form was left without a signature from the subject. This was done solely between the researcher and the subject, nobody else was in place at the time of taking the oral consent.

Ethical Issues that were raised from this case:

  • Vulnerability of the subject (he is illiterate and lives alone).
  • Validity of the method in which information has been offered
  • Risk on patient: Researcher may not reveal all information.
  • Risk on researcher: Subject may deny being informed about certain information or being consented to the study.

Alternative Solutions:

  • A witness should be present during the consent process and sign on behalf of the subject.
  • A finger print of the subject on the consent form can be obtained but this should also be witnessed. Consent can be taped, but videotaping can be culturally unacceptable particularly for women participants.
  • Alternatively, consent process can be audiotaped and witnessed too.

This issue may also have implications of how information about research can be provided to certain populations in certain communities. For example, video information may act as a good alternative than written information.

 

15) Case Study:

By:Dr. Alaa Aljabali

Case Study: Food Vs Biofuel

I am applying for a governmental fund to develop new strain of genetically modified wheat for the purpose of the production of biofuel. The wheat will be specifically modified to grow in high salinity and low water areas (aired area-dessert). The research community will include; The Renewable Fuels Association, International Food Research Institute, International Food Research Institute, and JUST Bioethics Group.

The ethical dilemma

  • This new source of demand for agricultural commodities creates opportunities in using wasted land, but also risks for the food and agriculture sectors.
  • Increasing demand for biofuels may offer opportunities for farmers and rural communities in Jordan and this contributes to rural development.
  • At the same time, there is a risk that higher food prices could threaten the food security of the Jordan’s poorest people, many of whom spend more than half of their household income on food.

The ethical questions that I would like to answer are:

  • What impact does wheat demand for ethanol have on retail food prices?
  • Does Ethanol (fuel) production reduce the amount of food available for human consumption?
  • Can we produce ethanol from other non-traditional sources?
  • Advantages /Opportunities for the poor Vs Food security

 

16) Case Study:

By:Dr. Qais Alefan

Case:

R.E. who is an Alzheimer’s patient was asked to participate in a clinical trial. The clinical trial is testing a new drug that may help improve memory. On 07/26/2015, a signed informed consent was obtained from R.E. by the PI.

On 07/30/2015, the study started & investigators met with R.E. However, R.E. expressed that he had no idea about what the investigators were talking about!

Ethical issues:

  • The competence of R.E. to give a valid informed consent is in doubt.
  • There may be a first degree relative or a care giver who can give consent for his participation.
  • E. is considered a vulnerable research subject. However, R.E. belongs to the population that may benefit from the new intervention.
  • Finally, a careful balancing of risks and benefits should occur.

Abstract:

Research on Alzheimer’s disease is normally designed to bring interventions that may improve dementia. Such research projects tend to include patients with Alzheimer’s disease. Participants in these research projects should be protected and signed informed consent is essential. However, symptoms of Alzheimer’s disease may make it difficult for researchers to obtain a signed informed consent. In such cases, persons with Alzheimer’s disease must rely on surrogates. These maybe any trusted individuals.

In research, discussions on protecting participants should address all issues of risks that participants may encounter as a result f their participation in any research project. However, there is no consensus on what is “minimal risk” research.

 

17) Case Study:

By:Dr. Abeer Qandil

Case study:

A master student is conducting a research about sexual harassment prevalence, knowledge, and preventable measures among a population of Mothers. Dr. Qandil is a research committee member at the department that is  responsible for reviewing the proposal of the student. Dr. Qandil reviewed the proposal and wrote the following comments:

  • The setting of data collection is not suitable: Collecting data about a sensitive issue such as sexual harassment in a public place is:
    1. Risky (given the cultural beliefs and stigma, honor killing, etc.).
    2. Mothers might not disclose everything because they are not feeling safe talking in a public place.
    3. A face to face interview might limit the amount of data disclosed.
  • The recommendations were to change the setting and the process of data collection.

From Dr. Qandil’s point of view,her recommendations should be taken into consideration as she has justified these recommendations with the amount of risk in this type of research, also to be ready for the IRB(Institutional Review Board) application that is expected to be strict in reviewing such topics.

  • The proposal was returned to the student to think of a safer way to collect data.

Dr Qandil doesn’t have access to the proposal anymore to re-check if the proposal had been modified. The proposal then was sent to the IRB to be approved, and it was approved.

Dr Qandil attended the student’s defense and in the presentation she found that none of her recommendations had been taken into consideration, nothing had been changed. One of the numbers that caught Dr. Qandil’s attention was that 94% of the mothers took preventable measures and could recognize all signs and symptoms of sexual harassment, while the prevalence of sexual harassment during childhood among University students was above 50%. (Two different populations).

The following questions were raised:

  • Can we trust the IRB in their judgment concerning the research conduct? What are the consequences of having ineffective IRB?

The IRB is responsible of conducting an independent review of the research, anybody who is concerned about the ethics in research, for example the publishers, would assume that the research followed all the RCR when they see that the study is approved by the IRB in that institution.

  • What is the validity of such data, given the fact that the data collection process had some technical problems?

When a foreign reader criticizes the research looking at the potential risk, questionable results, they might come to a conclusion that research in Jordan is not trustworthy.

  •  What can Dr. Qandil do as a committee member now and in the future?

Dr.Qandil thinks that she does not have the authority to do anything; however there have been some suggestions from some colleagues to write to the IRB, either specifically concerning this case or in general, to be more strict when taking decisions concerning safety in sensitive issues such as sexual harassment, violence, etc.

  •  What if this data and other similar research projects were to be considered in planning for a program to prevent sexual harassment in Jordan?

Based on the data reported in this study and similar studies (concerning many Mother’s knowledge and their practices to protect their children from sexual harassment), this would be misleading to any program planner; the information reported would indicate that this area is not a priority since the mothers knew and took all the preventable measures, listed in the questionnaire, to prevent sexual harassment. While in fact it might be the opposite.

 

18) Case Study:

By:Dr. Belal Alhusein

 Case Study: Immunomodulatory Effect of Statins on Human Colorectal Cancer: Effect on T-regulatory Cells

 Summary:

It is well-established that more Treg infiltration into tumor tissue is associated with better prognosis of that cancer. I am studying the effect of Statins on infiltration of Tregs into colorectal cancer (CRC) tissue.

I am presuming that if Statins reduced infiltration of Tregs into a tumor, there will be better prognosis. My study will be based on the effect of Statin on lowering Tregs infiltration, but not if tumor prognosis has already been achieved.

Ethical Issues:

  • Maintenance of patient confidentiality is of high importance. We are accessing patient records to get patient drug history, this is going to be used for correction of possible concomitant use of immunosuppressive drugs and to stratify Statins dose into Simvastatin Equivalent doses to study the effect of doses of Statins on Treg Response.
  • We are also collecting information regarding the diagnosis and chemotherapy stage used to correct them. The correlation of patient responses (i.e. TRIAD of Statin Dose-Tregs infiltration-Tumor Prognosis) is not documented.
  • Should we link the triad of Statins-Tregs-Prognosis together?

If statins are only affecting Tregs, then there is no need to study the prognosis association part. Statins, however, have pleotropic effects and we should take into consideration that they can affect the tumor itself.

How should you handle ethical issues in this case?

  • Acquiring an IRB approval.
  • A medical Oncologist/Surgeon and Pathologist should have been involved in this research.
  • A verbal consent should have been acquired from the patients over the phone.

 

19) Case Study:

By:Dr. Mazhar Alzoudi

Research Ethics versus Moral Ethics in Clinical Trials:

  • Good response in drug-arm

At the end of phase II clinical trial of certain anti-cancer drugs, researchers noticed a significant response in the drug-patients arm.

  • Cancer Mortality and Severity

This kind of cancer has a high mortality rate and is very aggressive with a short life expectancy.

Opinions:

  • During the discussion of this trial there was a suggestion of stopping the study and starting treatment of the control group in the rest of phase II and getting approval for this new drug.
  • Another opinion is suggesting for more evidence after the completion of phase III.

Your suggestions:

  • We discussed this in our group discussion and we have the same opinions, still we need more opinions and suggestions.
  • We have more moral decision by treating all patients with intensive care and monitoring.

 

20) Case Study:

By: Mohamed Ahmed

Case Study:

A principal investigator (PI) at Jordan University of Science and Technology (JUST) is conducting an interventional research to evaluate the role of nicotine patches (NP) on smoking cessation among pregnant women. The aim of this trial is to establish the safety and effectiveness of nicotine patches plus behavioral counselling, compared with behavioral support alone.

Pregnant women who agree to participate will be asked to complete a questionnaire to establish that they meet the eligibility criteria, and then will be randomly assigned into three groups:

The first group will be exposed to smoking cessation behavioral support in addition to a few months of nicotine patches. The second group will follow the same behavioral counselling in addition to a similar course of placebo patches. The third group will receive a nicotine replacement therapy without any behavioral support.

The outcomes to be measured include:

  • Self-reported smoking abstinence
  • Cessation rates
  • Biochemical measurements
  • Neonatal birth weight and fetal abnormalities

Ethical dilemma in the case:

  • The possibility to conduct an interventional research on pregnant women.

I think we do not have another sample to conduct this research. Also we are trying to decrease the consequences of smoking among pregnant women. From this we can conclude that we may use pregnant women in this trial.

  • Do we need the husband’s agreement as a permission to let the women participate in the research?

Yes, It would be necessary to ask the husband’s agreements since they  are  also responsible for the lives of their babies.

  • It is not known whether the behavioral support or/and nicotine replacement therapy is preferable over behavioral support alone. But it is logically estimated to be less risky than augmentation therapy. Is this Beneficence?

I think it would not be beneficence. The last arm will not benefit from the behavioral support. We know that this is a psychological therapy and has no risk for mothers. Here we will be depriving mothers from such benefit.

 

21) Case Study:

By:Dr. Wael Hananeh

Case Study:

Instructors are given a period of time to evaluate submitted proposals before meeting with the Head of the Department to discuss these proposals. In addition, the instructors have to submit their evaluation online before their meeting with the Head of the Department.

After a very short period of time, one of the instructors submitted his evaluation. When the department head saw the evaluation for that instructor, as the proposal being excellent for all parameters of evaluation, he decided to download and read the proposal. When he downloaded the submitted file, he did not find any proposal but he found a CV instead.

The PI submitted mistakenly a CV instead of a proposal and one of the instructors evaluated the CV as an excellent proposal.

Ethical Questions:

  • What do you think about the PI?
  • He might have been in a rush to submit his proposal.
  • He was not focused, or was very busy at the time, so he uploaded the wrong file and was not aware at that time.
  • What about the Instructor who submitted the evaluation without reading the proposal?
  • He might have read his colleague’s proposal before the proposal was submitted.
  • He could not download the online proposal and he asked for a hardcopy from the PI.
  • He was thinking he was doing a favor to his colleague to hasten the evaluation process.
  • Would you let this instructor evaluate other proposals in the future?

My decision would be based on the facts and his intentions at the time.

  • Should any act be taken against the instructor?

I think it is better to talk to him and explain to him the situation he put himself in. That even if he had read the proposal before, he was supposed to access the submitted file to ensure that file was the same one he had read before.

 

22) Case Study:

By:Dr. Qosay Albalas

Case Study (Sickle Cell Anemia):

Sickle Cell Anemia (SCA) is a group of disorders affecting the RBCs, which hinders the transport of oxygen to the body. The abnormal shape of the cells blocks blood flow and increases the viscosity of blood.

A patient aged 26 years who was previously diagnosed with SCA was recruited as a volunteer for a clinical study on a medication named (PRC-156) which is designed to be an antithrombotic, anti-inflammatory, and a cytoprotective. The drug is expected to improve microvascular blood flow and reduction of Ischemia by reducing viscosity. The needed consent forms, FDA approvals, were taken as it is required according to Good Clinical Practice (GCP). The target population for this medication will be for patients aged 4-64 with SCA who suffer from episodes of VOC which requires hospitalization and analgesia with morphine.

The clinical study protocol requires the following steps to be done:

            1- Taking blood samples at baseline in normal day.

2- Taking blood samples during hospitalization, before and after giving

Morphine.

3- Taking a biopsy from the liver before and after giving the study

Medication, to study changes in the liver tissue.

4- The liver biopsy will be taken after giving the medication three times a month.

The patient was hospitalized and treated and all the tests were done as the study protocol indicated and was then released from the hospital. Due to another episode two months later, he was hospitalized again and he was given morphine according to the hospital protocol. The patient was scheduled to be given the medication (PRC-156) at 9:00 am, on his second day at the hospital.

But unfortunately at 4:00 am, the CPR unit was asked to rescue the patient from a heart attack, the trial failed and he passed away.

Ethical Dilemma for the patient:

The researcher requires a biopsy from the liver of this patient so he can finish the study and analyze the results.

Question:  Can he take the sample without the family’s consent and knowledge?

Solution: From an ethical point of view the researcher was advised not to get a sample from the (dead) patient. If the sample is taken without the knowledge of the family, this could cause many social problems for the researcher, as he did not consult the family, and he can be sued.

The researcher’s option is to consult the family, and ask to have a sample taken, although from a cultural point of view this is unacceptable, as the family is suffering from the trauma of the death of their son.

Suggestions:

  • It is agreed that this patient is to be considered a subject failure and a withdrawal from the study.
  • The researcher needs to modify the consent form of future patients, after getting approvals from IRB and FDA, to add a section concerning the allowance of the researcher to get a sample from the corpse, this will protect the researcher being sued in the future and the family will be informed previously about this action.

 

23) Case Study:

By:Dr. Ayman Mustafa

Case Study:

A group of researchers prospectively studied the efficacy of tirilazad mesylate, a novel aminosteroid, in humans with head injuries.

The researchers (based on the collected clinical and experimental data) believed that the therapeutic window was 8 hours.

A cohort of 1120 head-injured patients received at least one dose of study medication (tirilazad or placebo) within 8 hours of injury.

Eighty-five percent (957 ) of the patients had suffered a severe head injury (Glasgow Coma Scale [GCS] score 4-8) and 15% (163) had sustained a moderate head injury (GCS score 9-12).

After six months the outcome for the tirilazad- and placebo-treated groups showed no recovery and death and also showed no significant difference.

No significant differences in frequency or types of serious adverse events were shown between the treatment and placebo groups.

Conclusion: The trial failed to show that the treatment is effective.

The principal investigator reviewed the records of the clinical trial. He discovered that some patients were enrolled into the trial after more than 8 hours of the injury.

  • The principal investigator posted his analysis, in which he did time-based stratification of the participants.
  • He found that the drug was significantly effective within 3 hours.
  • He published his results but he received inflammatory hypercritical reviews by other scientists.

Ethical issues:

  • Giving patients a treatment that scientific evidence suggests they will not benefit from.
  • The secondary data analysis that was not declared in the methods and materials of the study.
  • Lessons from history, repeating the trial in a proper design, based on the new findings.
  • Help prove the efficacy of the drug, and make it available to patients.
  • Denying your control group a treatment that you believe is effective.