Hey guys,

From Mrs. Plemmons Email, I think we went about the cases wrong. I think we should have shared the case we chose and then discussed it with each other rather than giving the full details already analyzed. So I am going to take down my posts, and send via email only my cases. (Dr. Plemmons cannot sign onto the group) That way we can discuss more in detail our thoughts.)

Hello ladies!

Was wondering if the owner of this circle could include Dena Plemmons to the group. Do you have her in your contacts?

Thanks!!

Use of Human Subjects
CASE 5.6 (Scientific Integrity)



Dr. James Murphy heads a new IRB-approved study to test a novel drug to control blood sugar levels in type II diabetics. To qualify, patient volunteers must meet several clinical criteria and must be taking sulfonylurea as their prescribed diabetes medication. Following a 4-week “washout” period in which the patients cease taking sulfonylurea, the subjects are randomized into two groups and are given a 20-week course of an experimental compound or a placebo. Patients will be paid $1,800 for completing the study. A partial payment, to be determined by Dr. Murphy, is stipulated for anyone who does not finish the study, regardless of whether they withdraw voluntarily or must be taken off the study for medical reasons. The informed consent document states that blood sugar level will be monitored by the research team on a weekly basis. Anyone whose blood sugar level exceeds 240 mg/dl (normal range is 80 to 120 mg/dl) will be taken off the drug or placebo and treated with standard therapy (e.g., sulfonylurea). The study accrues patients at a brisk rate. Several of the enrolled subjects are from a local “diabetes support group,” and they are zealous in their pursuit of knowledge and in their own health care. About 2 weeks into the washout period, Dr. Murphy receives an email from one of these subjects. She mentions that she uses an accurate device to check her blood sugar and has found her numbers steadily increasing since she went off the sulfonylurea. She says her day 14 reading was at 185 mg/dl and “on its way to 240 mg/dl.” She wants to be released from the study, put back on sulfonylurea, and appropriately compensated. Fearing other requests from support group members in the study, Dr. Murphy is worried that a collapse in enrollment will jeopardize the study. He asks Becky Baker, his research coordinator, to write to everyone enrolled in the study and assuage their anxiety about any rise in blood sugar levels. Ms. Baker composes a carefully worded, compelling letter to all current study participants. In the letter Ms. Baker restates the partial payment contingency. Are Dr. Murphy and Ms. Baker acting ethically?


Stakeholders:

Institution where the experiment is being held

Patients involved in the experiment

Dr. Murphy and the staff conducting the experiment.

Society and it’s involvement with experiments in the future.

Scientific Community as other research reflects upon them as a whole.



Interests and Principles:

Institution: The institution supporting the research for the experiment has special interests in the results. If this drug is to be a better method for blood sugar in diabetes patient, they would be highlighted. However, if it does come to pass that patient bring forth the "friendly" reminder Dr. Murphy sent, this same institution could be placed in another light of which its credibility and status may be questioned.



Patients: The patients involved in the study have direct interests in that they would like to improve their health. With the novel drug functioning as expected, they would be in better control of their blood sugar. Their interest in addition to getting outcomes from this drug, is as mentioned their health. If at any time they feel this trial is not the best fit for them they should be able to withdraw. While knowing the consequences of withdrawing upon signing the consent, they should feel at ease withdrawing without a soft threat.

Scientist and staff: The scientist and staff have an interest much like the institution of getting results. From these trials they are able to obtain information to be published. With a novel drug, promising results could lead to positive outlook in their research and acknowledgement among their peers.



Society: The interest of society is that they would want to explore research endeavors, but would be reluctant to do so. This is in part due to the cruel past of research in humans, but even more so now in the subtle creative ways it is now observed. Society is then in the middle of wanting to see advances in science, but being afraid to put them self in a position that may not be the best option for their health or only doing so for the interests of those conducting the experiment.

Research Community: The research community has an interest in that it would add to the many reasons why individuals fear partaking in the advancement of science. They would be placed in the position of questioning their real motives when research is performed, and continuous delay in research progress.

Principles

In understanding this case, I believe the principles at stake are nomaleficence, autonomy and justice. The concept of nomaleficence becomes pertinent as the research group became vulnerable to risks that were placed lower than the benefits of the research project. In any experiment, it is important that the risks of the patients are minimized despite the desire of results.



Furthermore, Justice focuses on not exploiting the patients and considering that all aspects are equally distributed. I believe that the email sent to the patients involved took away the justice initially introduced by the experiment. This injustice, placed patients in a position to be unsure of whether they should be removed from the trial based on their current health status and blood pressure. This took away their autonomy or ability to make an uncoerced decision.

Future

Reducing these dilemmas in the future begins with researchers and their staff understanding that the patient comes first. Allowing researchers to be more accepting that if an experiment is not going as planned; it is not of ethical grounds to "nicely" make a threat to keep patients in the trial. Additional, support should be given to researchers who face these challenges, in that they

Brevity
The issue of human subjects being used for experimentation has caused many controversial problems. Cases of unethical human experimentations have been the molding of what we now use to determine what is acceptable. Such cases include The Aversion Project in South Africa forcing white lesbian and gay members to sex changes and torture; Experimentations in North Korea, Germany or Japan during war; and the Tuskegee Syphilis study here in the US, which denied African Americans to treatment for the disease. Because of experiments such as these, laws such as Nuremberg Principles and Declaration of Helsinki were established to protect human and subjects in experiments. 


Overall, I do believe Dr. Murphy and his staff has worked well in organizing the research project. Having set forth immediately what is expected if a patient is to withdraw from the study and getting full consent. I do not however, believe that he truly contacted the patients to gather the possibility that maybe the drug was not the best fit for them and to reallocate the best treatment for the diabetes patients. Rather, he contacted them in hopes of sending a "friendly" reminder about the money involved if they complete the study. I think his first priority in the email should have been to request those with high blood sugar levels to report to him immediately and then they could discuss based on what is best for the patient what to do. Whether that is not completing the study or continuing to see if additional time will help. He however, would have placed individuals in a weak economic position to be forcefully kept in the trials, because of the fear of losing the stipend for the research. Even though this was already a set amount and the stipulations were clear it was not of ethical actions to re introduce that fear in candidates simply because Dr. Murphy did not want his research to lose too many patients. As researchers we must ensure we put the patients first.


Peer Review
Individual Writing Assignment #1

1. What are the advantages and disadvantages of having a reviewer blinded to the identity of manuscript authors, a grant applicant, or a candidate for academic advancement?

Having the identity of the manuscripts author, grant application or academic advance status has many advantages, which I believe outweigh the disadvantages. It first and foremost, creates unbiases from the reviewers to those that submit. If individuals are not easily identified, reviewers will less likely use biases to approve or reject submissions. This is vital in the scientific community for the integrity of all involved. Furthermore, if an individual were associated with a company or institution or group that is usually accepted or have promising research they would likely be accepted. This eliminates further biases. Having the submitters unidentified will also keep the reviewers from contacting them leaving them to only use the information submitted to make a decision. 

2. What are the advantages and disadvantages of having manuscript authors, a grant applicant, or a candidate for academic advancement blinded to the identity of a reviewer?

Having the identity of a reviewer unshielded could have several advantages. However, if the reviewer’s identity is revealed, he could be scolded or negatively thought about in the scientific community if they do not accept the papers individuals. This could later affect them when they too try to submit for publications, grants or advancements. Even if the direct persons whose manuscripts were rejected are not the reviewers, many scientists are associated with others on review boards that can be influenced. 

While this is an disadvantage, it could be an advantage as well, in that many reviewers are sometimes still identified by the way they comment or by quotations. It is also possible for reviewers to be identified wrongfully, and receive messages of disagreement or anger by submitters. Having their identity disclosed can eliminate this false accusation.

 Reviewers identified would also most likely force reviewers to be more tactful in their responses, which could otherwise be sarcastic or without consideration if they are anonymous. Some reviewers must also sign these reviews, which forces them to ensure that “bad” science is not published. This can be traced back to them showing the lack of commitment or time in reviewing the paper.

Conflict of Interest
Individual Writing Assignment #2

1. Define conflict of interest.

Conflict of interest legally can be defined as behaviors or actions that include personal gain or financial interest. Conflict of interest however changes within different jurisdictions such as state or federal laws, contracts or institutions. This conflict of interest is apparent when individuals exploit or are perceived to exploit a position for personal gain/profit. 

2. Why is a financial conflict of interest not necessarily considered to be misconduct? Discuss circumstances under which a financial conflict of interest might result in misconduct.

One of the main forms of conflicts of interest is financially based. However, financial conflicts of interest are not necessarily misconduct, though it does increase the possibility to have misconduct. Scientific misconduct has a grey area in which is said to be rare. It can include fabrication, falsification or plagiarism within the field, or it can be included on deviation from the accepted scientific practices.

While it is difficult to avoid all conflicts of interests, it is pertinent for the scientific community to understand and maintain integrity when conducting research. There are times however when individuals fail to keep the two segregated. Such instances include but are not limited to making purchases influenced to directly improve a family members business, accepting additional money or gifts to select a particular vendor, receiving multiple pay for one job. There are indeed additional means in which financial misconduct can be evaluated.

In a specific example, scientists may feel inclined to change results or remove negative data for a company they work with. If for example, a company has hired a scientist to prove positive outcomes, but the results have shown otherwise. It is okay for the scientist to perform these experiments knowing that it is in their best interest to acquiring promising outcomes. However, it is when a scientist realizes that the results are not as expected, and finds another way to report or removes data to maintain that communal role with the company that misconduct takes place.

Brittney Lewis Xavier University of Louisiana 
Mentoring: Case study #2 
May 5, 2013 

Dr. Morgan has had an active research program for 20 years and is well respected by his peers and his trainees. Because of his reputation and the caliber of his work, he has always attracted extremely talented graduate students to his laboratory. For a variety of reasons, Dr. Morgan's department has recently been accepting more students into the program, resulting in a greater range of ability. One of these new students, Ricky Trainee, showed some promise, but after 5 years in Dr. Morgan's laboratory, it is clear that Ricky is probably one of the worst students Dr. Morgan has ever trained. Ricky is certainly competent, but he does not stand out for his creativity, his ability to grasp new concepts easily, his willingness to work hard, or his ability to write. Nonetheless, Ricky's work will be sufficient to complete the program. Ricky has asked Dr. Morgan for a letter of support for his applications for postdoctoral positions in one of the two leading groups in his field of research.


Stakeholders  

• Dr. Morgan’s lab

• Trainees conducting Research

• Specific Trainee Ricky

• Postdoctoral Research community

• Investors in Dr. Morgan’s Program


Interests and Principles

 
Dr. Morgan’s Lab:  The outcome of this case if Ricky is accepted into the postdoctoral position could be a direct reflection on the quality of Dr. Morgan’s ability as a mentor.  Someone that has spent 5 years learning under one of the most praised mentors should show signs of improvement.  His program may no longer hold the reputation of molding the quality trainees that it was once known for producing.

Trainees conducting research:  Other trainees may become frustrated with picking up the slack from undertrained trainees like Ricky.  The work that Ricky is producing may reflect the work of the trainees as a whole instead of the work of an individual.  These results could effect future postdoctoral programs decisions that they are also applying to.  

Ricky:  This outcome could put Ricky in a position that would be harmful to his reputation as a professional researcher.  Potential postdoctoral programs that he is applying to would expect a certain quality of work from him that he will not be able to deliver.  If given a bad reputation at one postdoctoral program he may have issues with acceptance to other programs in the future.

Postdoctoral Research Community:  If Dr. Morgan’s program has had a reputation for producing well-qualified researchers.  A recommendation letter, and proof of enrollment in the program for an extended amount of time would say good things about that trainee.  If that trainee is all but what expected this postdoctoral research program might have lost a sufficient amount of money and time that could have been spent elsewhere.  This could also have a negative effect of their reputation as well.

 
Investors:  If not able to continue to successfully produce trainees ready for the next professional level then they could take away the funds provided to Dr. Morgan’s program.  If investors are not satisfied with the results produced, with the stipulations provided they may invest in another program. 


Principles

I believe in this case the principles that may have been overlooked or avoided are: constructive criticism, self-awareness, and an effective presence.  Constructive criticism is crucial in any mentoring relationship.  Communication in this way will correct things being done wrong and a great opportunity to introduce proper technique.  This could also be used as a tool to track progress of the trainee.  Self-awareness is key to self-improvement.  When the quality of work compared to the work of peers is not up to par, then that trainee should be aware of failure and seek help from a mentor.  At the same time an effective presence from a mentor is also a principle that could have prevented five years of improper technique.  If the mentor was never in the lab, or if he didn’t make himself available to train and mold the trainee then failure is inevitable for both parties involved.


Future


The department should have annual or biannual evaluations of the trainees and mentors. Dr. Morgan should closely evaluate the quality of potential trainees applying to the program.  If trainees are under qualified then clearly state the things expected and progress expected over time with consequences if those things are not achieved.  Mentor should be readily available through different venues like e-mail, office hours, phone calls etc.


Brevity


Mentoring someone and being a mentor takes effort and time from both people and or peoples.  The mentor should offer advice to the trainee, and at the same time the trainee should seek the help of the mentor.  When working with another person there may be things preventing a trainee to seek the help of a mentor.  

The case of Ricky and Dr. Morgan is unfortunately very common.  I believe that if the behavior could have been detected ahead of time that it could have been avoided.  If Ricky would have compared his work to the work of his peers he could have noticed a problem.  If Dr. Morgan had a greater presence in the workplace then he could have detected the problem over his five years as a trainee.  If Ricky was instructed that his technique in those areas were wrong and didn’t show effort to correct them then he should have been expelled or given a written warning.  All of these things could have been avoided with effort and communication between Dr. Morgan and Ricky.             
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