Case Studies for the Participants in the Jordan RCR Program Year 2(2016-2017)

1) Case Study: Authorship

By: Aceil Al-Khatib

Scenario

Dr. H. is a pathologist who wanted to investigate the use of immunohistochemistry in squamous cell carcinoma. She submitted a proposal to the chairman of the department research committee, who found the idea very interesting to the extent that he replaced her name by his name before her eyes.

The chairman obtained the approval of the IRB. Dr. H found out that his brother was the head of the IRB so she decided not to file a complaint.

Ethical challenges

  • Coercive authorship
  • Theft of ideas
  • Plagiarism/copyright infringement
  • Conflict of interest
  • No institutional policy on reporting misconduct
  • Does a witness have the obligation to report misconduct?

Solution/s

  • H could write the chairman a letter in an attempt to solve the issue
  • She should notify the dean of research or university president
  • The witness could blow the whistle
  • Other alternative dispute resolution/court

 

2) Case Study #1: Research grant fellow

By: Adnan Al-Hindi

A researcher has been granted a research fellowship for three months, he travelled to the host institution to do his research, he was able to achieve all the research requested in five weeks, he must  leave due to his VISA ending  in the host country.

The problem:

  • What are the Ethical issues emerged?
  • What should he do?
  • What should he tell the granted body?

The suggested solution:

  1. He was un-able to commit to the original fellowship period (three months). He should report the results in the specified period in which the research was done.
  2. He must tell the funding body about the conditions, with emphasis on honest clarification, explanation why this was happening.
  1. Then he will wait for their suitable decision.

Case Study #2: Valid Consent

An Ophthalmologist has organized a meeting for a number of patients regarding a photo for fundus. Immediately after the nurse delivered the dye through the vein, the physician started to take the photo?

The problem:

  • What are the Ethical issues emerged?
  • What should he tell the patients?

The suggested solution:

  1. The physician should obtain a valid consent from each patient separately.
  2. The physician should inform each patient on the side effects of the dye because the dye could cause dizziness, headache or comma.

The benefits: This will enhance and strengthen the respect between the physician and the patient.

 

3) Case Study: Authorship and Publication

By : Ahmed Al-Azayzih

A.M is a 3rd year graduate student at one of the Jordanian Universities. She got upset when she found out that her name had been left off the final draft of a journal article which she had worked hard at for the last 2 years. She helped design the experimental approach and even collected some of the data. “I was promised the second author slot,” complained A. M. “I don’t know what happened. Maybe Dr. X forgot, or something, but I barely made it on as fourth author after I complained.” A.M knew of other grad students that were collaborating with Dr. X on the project, but two of the co-authors listed on the final draft were added at the last minute. One was a graduate student just finishing up his degree, he was given second authorship. He was also expected to go on a postdoc job in the coming year. The other was a professor from the same department who A.M suspects did nothing except provide material for the experiment.

Discussion Questions

  1. Is A. M justified in being upset about her place in the list of authors?
  2. If A.M suspicions about the graduate student and the professor added to the paper are true, is this an appropriate use of authorship?
  3. Whose responsibility is it to determine authorship on this paper?
  4. Did A. M do the right thing in complaining to Dr. X? How would you have handled it if you were in the same position as A.M?
  5. Imagine that A. M is herself about to graduate and plans to go on the postdoc position in the next year. Does this change your evaluation of the fairness of this situation?

 The ICMJE recommends that authorship be based on the following 4 criteria:

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

 

4) Case Study:Authorship and Plagiarism

By: Ahmed Al-Delaimy

An Associate Professor named “H” works at the Faculty of Medicine at (X) University. She submits three publications to the research committee to be considered for a promotion to a full professor position. One of her publications was rejected for unqualified reasons; she had to submit an alternative publication. She contacts one of her colleagues (Professor “N”) who works in the same department telling her the whole story and asking for her help.

Professor “N” tells her about an excellent dissertation that was submitted by one of her students that had just graduated with a Master’s degree (MSc) from the same department. She gave her the whole thesis; professor “H” submitted the thesis as is to the research committee. The paper was published and accepted by the committee. The 1st author was professor “H”, the 2nd author was professor “N”and the last author was the graduate student (without taking his consent or signature). Professor “H” was promoted to a professor and shortly after became head of the department.

Unethical issues:  

  • Academic dishonesty.
  • Publication authorship.
  • No consent or signature from the graduate student

Suggested solutions: 

  1. Withdraw professor “H’s” position (both professor position and head of department).
  2. Withdraw the article.
  3. In the future the Committee should inspect, investigate, and follow-up with guidelines.
  4. Ethics in research should be taught to all persons involved in research.

 

5) Case Study: Conflict of Interest

By: Ahmed Alhusban

X.D. is an investigator working on recovery after spinal cord injuries (SCIs) applied for the IRB approval to conduct a study assessing the potential of a highly promising novel rehabilitation program to improve SCI patient’s recovery.

Study participants will be recruited from SCI patients referring to the rehabilitation unit in the hospital and the intervention will be provided by a physical therapist. Baseline assessment and outcome evaluation will also be made by a blinded physical therapist.

The IRB gave a conditional approval for the study and asked the investigator to add a neurosurgeon to the research team. The investigator appealed the decision and argued that there will be no need for a neurosurgeon in the study especially that there will be no therapeutic or surgical intervention included. Additionally, the whole study is made by physical therapists. The chair of the IRB is the head of the neurosurgery department and a powerful figure in the department as well as in the hospital.

Other investigators advised the applying investigator to abide with the committee’s recommendations. Their advice is based on previous incidences where this surgeon undermined many research projects for investigators who did not include him in the study. Additionally, including any of the other neurosurgeons will indirectly place the project under his control as other surgeons are reporting to him. Additionally, including him or any other neurosurgeon will necessitate including them in any publication as authors where in fact they did not have any contribution.

Ethical considerations:

  1. Trust.
  2. Conflict of interest.
  3. Undue influence?
  4. Authorship?

Possible solutions:

  1. Since the investigator applied for an appeal of the committee’s decision, the head of the committee should step down of heading the IRB committee during appeal’s revision.
  2. There should be a formal and well-structured body to study similar cases.

 

6) Case Study:Authorship and Plagiarism

By: Amal Sallam

A postgraduate student (A master student) was asked by his main supervisor to carry out an assay as a part of the practical section of his thesis. The supervisor checked the final results and agreed for them then asked the master student to write the thesis according to these findings. Moreover, the results were promising that encouraged the supervisor to apply for a grant that can help in extending a future work in this point with other researchers. Fortunately, the proposal for the grant was accepted.

A precise revision of the detailed methodology and data by the other supervisor who has just returned from a postdoctoral fellowship revealed mistakes that affected the validity of the data consequently changed the final findings.

The due date for the master thesis defense was 3 days, a time that is not enough to repeat the practical part again to correct the results.

What should the main supervisor do in this case?

  • Delay the master thesis defense till repeating the assay again and correct the results although this can affect the trust in his laboratory, this may consequently affect the grant he gained.
  • Accept the results without any change.

Recommendations:

  • The supervising committee must be at least 2 or 3 supervisors. One of them is in direct contact with the student for training, revising the detailed methodology and the detailed results before writing the final findings.
  • Meetings between the supervising committee and the student should be held monthly or even weekly for intensive discussion with the student, checking the results of the previous step and plan for the next step.
  • The date for the thesis defense should be decided after revising the detailed methodology and data and intensive discussions between the student and the supervising committee.

 

7) Case Study: Authorship: Publication from the Thesis of a Master Student.

By: Basima Almomani

Ali was the main supervisor for master student and he was in the process of submission the paper from the thesis to the journal. During this time, the co-advisor (Sara) wanted to use some collected data urgently in other publication (as she had no enough time for her promotion). Basically, Ali agreed on this idea but refused to release any data at that time till the paper from student thesis is published in case if the Journal asked about any addition information or analysis. The situation was aggravated by a personality clash between Ali and research assistant of Sara. Moreover, Sara sent an email to Ali blaming and asking him to remove her name from the paper if she did not receive the required data. Meanwhile, Ali had been feeling rather frustrated about his failure to communicate with Sara.

Ali thought it was very important to publish the work of the thesis.  He would like to keep Sara name as she contributed to the research provided that she showed more cooperation regarding finalization of the publication process. Ali asked the dean of Graduate Studies in JUST about his advice in this situation. After 1 week of negotiations, the issue was sorted out in agreeable way and Sara sent an email to Ali informing him about her willing to resume her role as a co-adviser of the work towards paper publication.

 

8) Case Study: Fear in Women who are Deaf

By: Eman Al-Zboon

A qualitative research design was adopted, in order to gain an in-depth understanding of the quality and content of fears in young women who are deaf. 18 women were selected using purposive sampling. The interviews were individually conducted in the meeting rooms in their schools with male or female interviewers based on women’ choice.

To protect the participants’ anonymity, actual names were not used in this study, with pseudonyms being allocated to report the results. The interviewers were trained in how to conduct interviews using suitable labels through lectures and individual instruction.

Official approval for the study was obtained from the Ministry of Education. Participants were informed about the aims of the research on initial contact, and their consent was obtained. Informed consent entails not only ensuring that potential research participants are fully informed about the research but that they understand its implications; their freedom to choose to participate in the research or not; and  their freedom to withdraw from participation in the research at any time.

Interviews were scheduled to take place at their school at times convenient to them with existence of sign-language interpreters who are familiar to research participants. Assurances of anonymity and confidentiality were given. This study has been conducted in consistent with the ethics issued by Institutional Review Board (IRB) at the Hashemite University.

 

9) Case Study

By: Enas Mokhemer

Reem is a clinical researcher who works in a neuropsychiatric practice center in Irbid. She is responsible of the recruitment of subjects to participate in a study that aims at testing a group of newly developed medical agents, with potential beneficial therapeutic effects. Dr. Derek, who is the head of the center, noticed that of all other researchers Reem has the highest enrollment rate – nearly twice as many as the others. After a close observation during an interview with one of the patients, Reem clearly implicated that the tested agents are indeed more beneficial than the medications the patient is currently taking. The patient asked whether it would be really wise to go off her medication and to risk receiving an unproven treatment. Reem replied, “Oh yes, there is no reason to believe that current treatments are any more effective than our experimental treatments, the Institutional Review Boards that approve our studies made  sure of that, therefore I highly encourage you to participate in the study”. Dr. Derek was shocked and confronted Reem about her strategy of participant’s enrollment; she replied that everything she’s telling the patients is true. “The IRBs wouldn’t agree to conduct the study unless the fundamental ethical principle “Beneficence” is fulfilled. In addition to the “clinical equipoise” which indicates that there is no reason to believe that current therapies are superior to their experimental treatments”.

Prof. Derek realized that having the approval of the IRB can be a strong argument in support of Reem’s speech toward the patients; however, he is confident that there is an ethical breach in giving false promise in such an affirmative way.

How should he respond to her?
* The principle of beneficence indicates that the clinical research is designed to maximize the benefit and to minimize the risks. It doesn’t mean in any way that it will benefit the participants. Research subjects should understand that participation in the trial is to advance scientific knowledge and it may not be for their medical interest.

*The term “equipoise” indicates that “the investigators must not know that one arm of a clinical trial provides greater efficacy over another, or there must be genuine uncertainty among professionals about whether one treatment is superior to another”. However, it should not be used to encourage the patient to enter the study as the researcher did. Instead, an honest clarification about the benefits and risks for being enrolled in each arm of the study should be explained.

Note: There is a strong debate about the fragility of applying the concept of “equipoise” in conducting clinical research. In many cases evidence favoring one arm of a trial could exist. For example, a study compared hypericum, sertraline, and placebo. Prior to the trial there was substantial evidence that sertraline is superior to placebo in treating major depression (some evidence that sertraline is superior to hypericum in treating major depression). Participating in the trial was therefore not in the medical best interests of some of the research subjects. Nevertheless, the trial has been justified. (1)

The concept of “clinical equipoise” proposed by Benjamin Freedman 1987. Under this principle having beliefs about the superiority of one treatment over another in an RCT can be ethical. As he puts it : “Instead of emphasizing the lack of evidence favoring one arm over another that is required by [individual] equipoise, clinical equipoise places the emphasis in informing the patient on the honest disagreement among expert clinicians. The fact that the investigator has a “treatment preference,” if he or she does, could be disclosed; indeed, if the preference is a decided one, and based on something more than a hunch, it could be ethically mandatory to disclose it. At the same time, it would be emphasized that this preference is not shared by others”(2)

References:

  • Hypericum Depression Trial Study Group, “Effect of Hypericum Petforatum (St. John’s Wort) in Major Depressive Disorder: A Randomized Controlled Trial,” Journal of the American Medical Association 287 (2002): 1807-1814.
  • Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987;317(3):141-145.

 

 10) Case Study: Authorship

By: Hana Abu-Hassan

  • Dr L and Dr R are assistant professors and colleagues at the same faculty. Dr L asked Dr R to help out on editing the language and grammar on a paragraph on Day 1.
  • Dr R happily agreed, and thought this could be her random act of kindness for the day or whatever… but it’s certainly a good idea to help out her colleague. Keeping in mind this was going to be hard work and time consuming, with her busy schedule.
  • Dr R worked on that paragraph and sent it back to Dr L
  • Dr L was very happy with the finalised work. (Dr R gained Dr L’s approval. Lucky? Think again…)
  • Several days later Dr L sends Dr R a message asking her to check her email… Another paragraph arrived. Dr R thought to herself… Whatever I will help out.
  • Several of these random paragraphs arrived on Dr R’s email, and Dr R politely and extremely unaware of the bigger picture rewrote paragraphs.
  • It was hard work
  • 6 or so months later… Dr R hears from some random person that Dr L and her colleagues had a publication (the exact work she helped out on)

 Discussion:

  •  Dr R was quite unhappy with the unfair conduct and lack of transparency from her colleagues
  • Dr R thought to herself… she will be with these colleagues for a while.
  • Dr R chooses her battles…this was something to avoid a confrontation on. Is it?
  • If Dr R would like to take matters further, who would be the person or party she should be approaching first?
  • Is Dr R partially held responsible for this authorship problem?
  • Dr R needs to know her rights and protect herself from a similar problem recurring in the future.

 

11) Case Study: Recruiting Minorities in Nontherapeutic Drug Research

By: Hanin Makhlouf

A big pharmaceutical company is conducting a clinical trails designed to test the safety and the pharmacological effect of a new drug recruiting participants who reside in a refugee camp

This drug has just passed phase zero and is now ready for phase one

Ethical Issues:

  • What ethical problems are raised by this case?
  • In what ways might the case be considered exploitative?
  • Are there /should there be any laws specifically regulating research conducted on this community?

Discussion:

Almost all ethical challenges in this case can be attributed into two of the four fundamental principles in bioethics which are justice and autonomy.

Justice

  • This is a case of exploitation
  • It’s an injustice to conduct a clinical trial on a specific population over another
  • Especially with this type of drug research it should only involve healthy individuals
  • The drug may not benefit the tested community
  • The risk is far greater than benefits for the tested group
  • It involves taking advantage of a vulnerable unprivileged group

Respect of Autonomy

  • Lack of autonomy (competence)
  • Subjects consents are compromised
  • Power imbalance
  • Studied group are the minority
  • They may feel threatened or coerced to take part
  • They are in a physical and psychological condition that leave them liable to harm

 

12) Case Study: Social Desirable Response in Mental Health Research

By: Heyam Dalky

I conducted a study for my PhD, “Translation and Cultural Adaptation of Stigma Devaluation Scale for use among family caregivers of relatives with mental illness in Northern Jordan”.

IRB was obtained from Both, University of Texas Health Science Center at Houston and JUST.

Informed consents were obtained from family caregivers.

Ethical Concerns:

  • Definition of Family caregivers: Agreed on “Adult person who lives with a relative with mental illness at home, could be; spouse, husband, father, mother, son, brother, sister.

I met many cases where “caregivers” were neither one of the previously mentioned, should I involve them in the study, or not …?

  • The questionnaire items were about “how you as ‘caregiver’ perceive caring for a relative with mental illness’; thus I found some caregivers when they ask for clarification during data collection, are concerned how to prove if they are “good” caregivers themselves.
  • So, how does a researcher make sure “that the responses are reflecting the actual feelings, attitudes, knowledge, etc.…..”
  • This concern led to what we know as “testing for social desirability”.
  • There is a scale developed for this purpose.
  • For my PhD study, I paid attention to this issue in my discussion of the findings, and recommendation.
  • This issue could be a matter of concern in research studies with human subjects; especially those tackle sensitive or critical issues.

 

13) Case Study: Authorship

By: Jihad Alzyoud

Dr. X is a researcher who supervised a master student (Y), Dr. X published a paper (after the student finished the master degree) in one of the high impacted journals, where some parts were derived from the student’s work; Dr. X didn’t include the name of the student neither in the authorship list nor the acknowledgment.

A colleague in the same department discovered this; what should he/she do?

  1. Talk with Dr. X first
  2. Tell the student Y
  3. Tell the department
  4. Inform the journal
  5. Report it anonymously

 

14) Case Study: Ethics of Research

By: Laila Akhu-Zaheya

A study was conducted relating to violence against women. Women were assured their participation was voluntary. They were also guaranteed of their privacy, as well as the confidentiality of their information; a condition insisted upon by the women of the study.

During the course of the study, the researcher learned one of the participants suffered both physical and verbal abuse from her husband. The researcher attempted to convince the participant to report the issue. She refused. As a result, the researcher became rife with guilt.

Is it ethical for the researcher to report the woman’s abuse? If not, what would be the solution to the issue?

Problem: The researcher is in conflict with his/her conscience. He/she now struggles with his/her ethical obligation to the patient. Due to cultural and familial norms, the participant refused to report the incident. Should the researcher report the incident, he/she would be breaching the patient/researcher confidentiality agreement as well as the patient’s privacy. As a result, such a dilemma requires considerable ethical consideration.

Action:

  1. Respect the participant’s decision to not report
  • Good Result: The participant’s rights are safeguarded; no violation of confidentiality/privacy agreement
  • Bad Result: It is not in the participant’s best interest
  • Nullification of Rules: none, in regards to ethical consideration of research
  • Expected Outcome:
    • Best: The participant will be protected from divorce, a violation of cultural and familial norms; the maintaining of the trusting relationship between participant and researcher
    • Worst: She will be most likely continue to be abused
  • Potential Benefit > Harm
    • The participant’s rights regarding confidential and private information are protected
    • A relationship of trust between participant and research continues to exist
    • The continuity of physical and verbal abuse
  1. Report the case to family protection
  • Good Result: Protect the woman, preserve her dignity, and provide her with the opportunity to have a good life
  • Bad Result: The woman could become a divorcee, and consequently, unacceptable to her family
  • Nullification of Rules: The principles of confidentiality and privacy are violated
  • Expected Outcome:
    • Best: The participant is awarded a respectful life, without the threat of harm
    • Worst: She will be considered unacceptable, due to cultural and familial views
  • Potential Benefit > Harm
    • The participant’s issue is addressed
    • The participant’s dignity is preserved
    • There is mistrust between the participant and the researcher

 

15) Case Study:Familial Genetic Study for Autism

By: Loai Alzghoul

A family has an 11 years old son that has been diagnosed with autism. He has 5 older siblings that are normal with ages between 19 and 34 years old. The parents want to participate their child with research study about the etiology of autism which has a  genetic part ( family based study) and an environmental part ( metal toxicity analysis) as well as (immunological analysis) were the latter two are considered as incentives for families to participate as they offer free laboratory tests.

When the research team ask for blood samples from the healthy sibling as that strengthens the genetic study, the other siblings not only refuse to participate , but start to pursue their parent to drop off  the study. They even called the researcher to stop him from working on these their parent’s and brother’s samples.

The Problem:

  • Do the siblings have the right to do this and ask for their parents to drop out of the study?
  • What should the researcher recommend to the parents?
  • If the parents decide to drop out of the genetic study, is it ethical for the researcher to drop them from all the other studies?

 

16) Case Study

By: Maysa Almomani

Dr. A. is the principal investigator (PI) of a study on metabolic control of patients with type 2 diabetes. After obtaining the approval from the IRB of Jordan University of Science and Technology (Where she works), she applied for IRB under the included settings:

  • One of the institutions (National Center for Diabetes, Endocrinology & Genetics) required the PI to attend their IRB meeting.
  • The PI has been informed by the committee members that he can’t obtain the approval unless signing an agreement that has three conditions for approval:
  1. the institution will assign one of their members to be a co-author in the study,
  2. Researchers have to share the data (soft copy of raw data)
  3. They also have to share hard copies of the questionnaires.
  • The research is funded by JUST

Ethical Issues on Whether to Share the Data or not:

  • respect for credit
  • reuse of the data
  • Authorship (Co-authorship)
  • Interest issues
  • Future publication plans
  •  Funding  & funders
  • Obtaining prior informed consent from participants with clarifying what is being proposed
  • Ownership & intellectual property interests (questionnaires translated & modified by the researcher)
  • Confidentiality: even if the data set was ‘anonymized’.
  • It is inappropriate to give the data without specifying (in writing) in advance what are the uses or analyses that are to be conducted.
  • To enhance the quality of any further analysis, the original investigators should be involved in the work, this is not accomplished by forcing investigators to share data.
  • Reanalysis (joint re-analysis) &co-authors of any resulting publications
  • Is there any “Official Information Act”?

In the end the decision was to be left up to the researcher who had originally collected the data.

 

17) Case Study

By: Mera Ababneh

A 23 year old male scheduled for ureteroscopy. The patient was a candidate for clinical trial conducted by the medical team members. The trial aim is to investigate the role of stent insertion in uncomplicated ureteroscopy.  The patient was offered to participate in the study and informed consent was obtained. Just before the procedure the patient father approached the urologist shouting in a loud voice: “I don’t approve my son participation in this clinical trial……. You can’t do experiments on my son”. The father and his son had an argument about who has the right to decide to participate in the study.  When the medical team saw what is happening between them they decided to withdraw the patient from the study to solve the problem.

What are the ethical issues?

 

18) Case Study

By: Mohammad Malkawy

 Case scenario:

Dr X is an assistant Professor in the university Y. Dr X has conducted a research aimed to investigate the effect of specific anti-rotavirus antibody as a treatment for gastroenteritis caused by rota virus in children less than five years old in developing countries.

His results showed promising prophylactic and therapeutic effects of the antibodies against rotavirus which will help to reduce the morbidity and mortality rates among susceptible children.

During his study he also, found that the therapeutic antibody has other effects on the intestinal normal flora of the subjects.

He prepared two manuscripts using the same data but different interpretations relative to the aforementioned two different ideas. The first manuscript described the effect of the antibodies on rotavirus while the second manuscript described the effect of the antibodies on the intestinal microbiota.

 Ethical controversy:

  • Is it ethical to publish two or more articles derived from a single study?
  • Is it ethical to split data collected from a single study into several segments just large enough to gain reasonable results and conclusions, also known as “minimal publishable unit”?.
  • Is citation of the first article would be enough to segment the data and get a new publication?

 Potential solutions:

  • The authors must declare which of the outcomes are already published and give the full source and consent of the original author/s.
  • The author must describe the similarity percentage of the two manuscripts in the second manuscript.
  • There are some situations when salami publication is allowed. Manuscripts based on the same or similar subject samples can be published in more than one journal for a different population of readers, for example different specialty point of view
  • Follow up study can be published using parts of already published results when the new manuscript largely contributes added scientific value.

 Alternatives:

Include all the data in one publication (if applicable).

 

19) Case Study: After Death Consent

By: Mohammed Al-Azzani

 Prof. R was conducting a clinical study on the safety and efficacy of two HIV vaccines alone and in combination in healthy subjects. IRB has approved the research project and subjects gave their informed consent to participate in the study. The study project involved collection of blood samples from participants. After completion of the study some blood sample left over from each subject. The researcher told each subject that he wants to keep and use the left over sample for other future research that may not be related to the current main study. Among several participants, AZ said that my remaining blood sample may not be used in the future research unless the researcher contacts me to tell me about the study and ask me my permission. One year later, researcher conducted the second research, and AZ died 6 months before the time of research. The current research will involve genetic tests for left over samples about susceptibility of subjects to liver cirrhosis. The researcher wants to analyze also the sample of AZ.

What are the ethical challenges in this case?

AZ is a dead subject who previously did not give his consent for the future use of his remaining sample. Actually I think it is not ethical to use the sample of AZ because he did not give permission to using his sample in the future study. We should respect his right even when he became dead. In addition, the current study is dealing with genic test that also make it unethical to make such analysis since genetic test is sensitive issue that will not be restricted to the dead subject alone but it includes his family.

What are the suggested solutions to this case?

Since it is not ethical to use AZ blood sample due to the absence of after death consent, I think dropping out AZ sample from the study is the best option; one subject will have a minimum, if any, effect on the study findings if this sample was not involved in the study. Also the researcher may contact the close relatives for asking their permission for using AZ blood sample although, from my point of view, I prefer not using sample at all.

 

20) Case Study

By: Noor Al-Mortadi

 Three authors agreed to conduct a research on the association between the smoking and lung cancer on a certain population. They decided to choose one brand of cigarette for this research to make the research very specific.

Then the data was collected and analyzed, the result showed there is no significant difference between smoking and lung cancer. The authors submitted the manuscript to the journal editor. The result was positive and very interesting to the editor because it conflicts with the previous studies on the same area. A paper was published in a reputable scientific journal and shown on most of the resources.

After a couple of years, it has revealed there is an agreement between the principal investigator and the cigarette brand prior to conducting the research. The second and third authors of the team was unhappy because there is a conflict of interest between the PI and the cigarette brand as well as the PI hadn’t revealed about it to them or even to the editor of the paper.

 

21) Case Study: Responsible Conduct of Scientific Research

By: Osama Alshogran

AB is a professor of Pharmacy and interested in studying drug transporters in the kidney. A post-doc (Ali) of him is close to complete his work in the lab. He has done a series of experiments designed to investigate the modulation of transporters function by the drug JUST50. The results of the study are interesting and may eventually lead to NOVEL treatments for hypertension. Ali has submitted a manuscript describing the experiments to a prestigious journal of pharmacology, with himself as the first author and his mentor as the second.

While the paper is under review, AB receives a manuscript for review that suggests that the primary finding of Ali’s work is incorrect.

How would you deal with this?

Without specifically mentioning the manuscript he is reviewing, AB questions Ali about his experiments.

Ali insists that his results are correct. However, when AB reviewed the data books from the experiments, he found that the documentation is incomplete and messy, and he was unable to determine the cause for the discrepancy in the findings.

 What would you suggest to your student to do?

The professor suggests that Ali performs some new experiments that would confirm his original findings, but responds that he doesn’t have time to do any more experiments since he is moving to another institution.

Shortly after that the paper got accepted for publication.

What would you do at this point?

  • AB insists that Ali withdraw the paper because he is unsure of the results, but Ali refuses.
  • Thus, Dr. AB insists that his name be removed from the author’s list and reference to his grant be removed from the acknowledgments. Ali agrees, and the paper is published with him as the sole author.
  • AB asks his new post-doc to repeat the experiments, and the new results clearly support that the findings in question are incorrect.
  • AB and the new post-doc prepare a manuscript reporting this and ultimately publish their results in the same journal.

Things to Think About:

  • Who is responsible about the data (Authorship)?
  • How do you mentor your students (Mentorship)?
  • Do you believe in your students (Trust Relationship)?
  • Data documentation (Student duties).
  • Case follow-up by the professor (Honesty).
  • The discrepancy in research findings.

 

22) Case Study

By: Shoroq Altawalbeh

AJ is a second-year fellow-in-training in psychology clinics under the supervision of a faculty member who is a well-known psychologist.

The supervisor is currently a principal investigator for a clinical research for which he is looking for patients with depression diagnosis.

Due to the slow recruitment rate, the supervisor starts to be anxious about finding patients for this study.

The fellow is asked by the supervisor to keep a sharp look out for candidate patients and so he was doing the initial assessment for all potential patients visiting the clinic.

The supervisor identifies two patients in clinic and talks to them about joining the study. The fellow is in doubt whether these patients are really having depression based on his initial assessment to them (he thought they are not).

Ethical Dilemma:

  • Is it ethical to recruit from your own patient population, when you are making the diagnosis that is required for study participation?
  • In this case:
    • Clear motivation to recruit patients by the PI.

BUT

  • The PI is a senior clinician with many more years’ experience than the fellow.
  • As a fellow, it is important to establish relationships with well-known famous supervisor.
  • What should the fellow do?
  • How to avoid this situation?

Thoughts:

  • As the fellow, negotiate with the supervisor to determine why he thought the patient had depression; have a discussion about the signs, symptoms, and diagnosis.
  • If after this discussion, you still had concerns about the diagnosis, you might discuss with another senior faculty member.
  • If the second senior faculty agreed with you, there is an obligation to speak out and say that you feel that these patients do not meet criteria for depression and should not be included in the study.

How to avoid this situation:

  • Try to avoid recruiting from your patients when you make the diagnosis needed.

Or

  • Before recruitment: Having a questionnaire that includes the most common symptoms of depression and is agreed by the expert clinicians will help in doing a standardized approach of diagnosis that will ascertain equal chances for patient’s recruitment.

 

23) Case Study: Who Should Give the Consent

By: Wejdan Khater

A researcher was conducting a study to examine uses of palliative sedation (PS) on dying patients receiving palliative care services at different Jordanian hospitals. One of the participants on the study was a male patient who is dying and he was unconscious. The consent form for this patient was given by his wife.

After starting the study one of patient`s brothers knew about the study and he approached the researcher telling her that she cannot continue studying his brother since they did not get their consent. Researcher had told the brother that consent was taken by his wife. However, the brother insisted that his wife cannot give the consent without their permission, specially, when there is no advance directive and she is not the surrogate decision maker of her husband.

Ethical Concerns:

  • What should the researcher do?
  • In the first place can this patient be a participant in this study?
  • Who should give the consent for this case?
  • Will a guardian with authority to makes health caring decisions can give consent for a research purposes?
  • Was the situation ethical?

 

24) Case Study: Tests on Students by University Teacher

By: Wesam Ahmed

Prof. FU, a pathology teacher of X University, is planning to do a clinical research that involves undergraduate students in his department. In one of his course lectures he requests from students who would like to participate in the research to come to his lab. In the lab, volunteered students are informed regarding the experiment and its risks and how the data will be handled and then were asked to sign an informed consent. Also the participants were rationally compensated for their time and transportation costs. Does this agree with the ethical practice of research?

Discussion:

The volunteer students were provided with an informed consent to sign, but was this consent valid?

Three criteria for a valid consent:

  1. Adequate information
  2. Capacity
  3. Voluntariness

a) Adequate information

Some information were provided to the participants, but were they adequate?

Answer: Explicit consent would be required if students might experience physical or psychological distress during the study, or if published information could be traced to individual students (privacy issue).

b) Capacity

Assuming that the volunteers are undergraduate students, their age is expected to be between 18-25 year-old; so we assume they have capacity.

c) Voluntariness

This could be a source of ethical misconduct if:

– There are any incentives that the researcher gives for testing and might seem coercive to the students.

– Students even after being informed regarding the risks, they may still feel pressured to participate. This is because they may feel embarrassed or even threatened to back off from the study.

Suggestions:

Inviting students to participate could be achieved through other means (e.g. student emails, in-campus ads or fliers) by which there is no link to be established between the research and the researcher, so students do not feel pushed to participate.

 

25) Case Study

By: Wesam Ismail

An investigator is trying to conduct a research (survey) about the lifestyle and living conditions inside a foundling foundation and the future plans of the foundation’s residents. The targeted population is the teenagers of the facility (12 – 14 years old). The researcher met the manager of the facility – who is the legal guardian of the children- and the teenagers to explain the general idea and objectives of the research. The teenagers understood well the study and looked motivated to participate and tell their opinions. The legal guardian refused to involve his facility residents in the study.

The investigator had the required IRB and other formal papers approved.

Since the teenagers are willing to participate, could the investigator depend on their assent to waive the legal guardian consent?!

Discussion

Before we can answer the question, we need to make sure that the research objectives were understood very well by the teenagers, was told in a neutral manner, will be in the benefit of them, and will not cause any kind of harm to them.

The objectives of the research are intended to be in the benefit of the facility residents; since the research will address their current living issues which could be improved and the results might help them to plan well for their future. Also, they are old enough (12-14 years) to understand and be able to decide and the research needs the direct participation of the residents since it will study directly an area that could only be assessed by them.

I think in this case that the teenagers assent can waive the legal guardian’s consent.

On the other hand, if the legal guardian approved to involve the teenagers in the study, the investigator still needs the assent of the children.

An important point to be considered regarding the future plans; it should be clear that the results of the study will not cause any harm to participants or stigmatize them in any way since they are considered a vulnerable group in our society, otherwise they should not be involved in the study even the legal guardian and themselves are willing to participate.

26) Case Study

By: Yazan Akkam

I was working on a project to identify proteins that help bacteria to survive harsh conditions. Luckily, Jordan has the Dead Sea which retains challenging environments for living organisms (high atmospheric pressure, high temperature, in addition to high salt and presence of heavy metals). So I had two choices either to reach out to a researcher who has isolated the bacteria from the Dead Sea or isolate the bacteria by myself. I’m not a microbiologist, so it might take me a while to successfully isolate the bacteria. Fortunately, there are multiple researcher have isolated different types of bacteria from Dead Sea in both sides (Jordan and Palestine). Therefore, I have contacted a researcher A (who has published that he successfully isolated the bacteria from Dead Sea) asking if he could provide me with bacteria. He was into the idea, but the problem was he requested an authorship on any scientific article that might be published from that research. I think his request is unethical.

Comments:

1-The research was not about bacterial isolation, it was a proteomics project that would take at least two years of work utilizing complex techniques, and researcher A would have no contribution in the research process except providing the bacteria.

2- Researcher A’s work on the bacterial isolation was already published, so he took the credit for that work. Asking for more credit on the same work is unethical.

3- Researcher A’s name on the paper should be on the acknowledgment section.

4- I totally refused it, I considered it “blackmail”, and I took a decision not to conduct the research.

 

27) Case Study: Clinical Pharmacist Role in Asthma Management

By: Zeinab Al-Subeh

Z.A is a master student in clinical pharmacy department that is trying to investigate the role of clinical pharmacist interventions and counseling in controlling asthma symptoms.

To do so she contacted the respiratory specialist in King Abdullah University Hospital, and asked him to collect her sample from his clinic. He welcomed this collaboration as his name will be added to the authors list.

The study design consists of two groups:

1) Intervention group in which patients will receive counseling and interventions from clinical pharmacist in addition to the usual physician care.

2) Control group where the patients will receive the usual physician care only.

During the study, the specialist encouraged his asthma patients with severe symptoms to participate in the study as they will benefit from the counseling and interventions provided by the clinical pharmacist, so they will have better health outcomes, while patients with mild to moderate symptoms will be considered as control group in the study.

The ethical issues in this case:

1) The “free rider”: Involving the specialist’s name within the authors list without having any contribution in conducting the study. In other words, recruiting patients from the specialist’s clinic isn’t enough to consider him one of the authors.

However, the specialist’s name can be added to authors list if he will participate in assessing patients’ symptoms at baseline and assessing their improvement after follow up.

2) Trying to affect patient’s decision: the relationship between physicians and patients depends mainly on “trust”, and patients tend usually to take the physician advice seriously. In this case, the specialist tries to encourage his patients to participate in the study, as this can help them to control their symptoms and to achieve better health outcome, and this can highly affect their decision to accept or reject the participation in the study.

3) Subjects are not randomly assigned in study groups, as the specialist tries to involve patients with severe symptoms in intervention group, while those with mild symptoms will be in the control group!

From one side, the specialist may try to help patients who really need the help of clinical pharmacist!, but having only those with severe symptoms in intervention group may exaggerate the role of clinical pharmacist in this settings, as patients with severe symptoms will show more improvement in symptoms than those with mild to moderate asthma, therefore, the study will end up with a significant results for sure.