Running head: CRITIQUE

Ethical Conduct of Research in a Study Investigating Whether Perioperative Thrombin

Generation Is Predictive For the Risk of Blood Loss after Cardiac Surgery

Student’s Name

Institutional Affiliation

Date
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Ethical Conduct of Research

Ethical conduct of research can be defined as the performance of scientific research with

integrity and mainly involves the creation of awareness and applying developed professional

norms and principle ethics in conducting all the activities associated with scientific research.

Ethical and responsible conduct of research is critical for excellence together with public trust, in

science and engineering. Educating researchers and other scientific research stakeholders is

fundamental in enhancing the progressive adherence to the set research ethics in the world

(Barnett & Faye, 2016). Governments are concerned with the ethical conduct of research and

policies are being developed to establish and strengthen national organizations that are tasked

with ensuring compliance to the ethical conduct of research and also adherence to the set

professionalism norms in the performance of scientific research. The America COMPETES act

of 2007 is mainly focused on directing public attention on the benefits of the national

investigation community continued commitment and diverse efforts in providing responsible

conduct of research teaching as a important part of preparing and long term professional

establishment of current and future generations of scientists and engineers (Koller, Powell, &

Wolfe, 2014).

Ethical conduct of research is highly encouraged since many scientific research studies

involve human research subjects and animals. Vast debate has been ongoing about the ethical

conduct of research and it is highly accepted that all research studies involving or impacting

humans should largely conform with the highest standards of academic integrity and ethical

practice. Every country should have an ethical research body that ensures complete compliance

with the research ethics (Bennett, 2017). The study that I have chosen in this study is about a

critical issue in healthcare that is cardiac surgery and thus it requires complete adherence to the
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research ethics to ensure the safety of participants. This means that the study should ensure that

there are no gaps in the process of data collection and wellbeing of participants should be assured

that is on confidentiality, informed consent and controlling possible health risks (Taraban, 2016).

Title

This article is about a study on the perioperative thrombin generation is predictive for the

risk of blood loss after cardiac surgery. The title in this article is clear and precisely stated; it

includes the subject of the research topic, area of study and the group being studied. The authors

have given their credentials on the first page of this article which highly legitimizes this study,

actually all the authors and investigators who have been included in this study have been listed at

the top of the first page just above the abstract (Bosch et al., 2013).

Background

The investigators have started this study by discussing a credible background for

conducting this study. Blood loss and thrombotic incidences remain the most common and feared

complications that results from cardiac surgeries with cardiopulmonary bypass, despite of

preoperative evaluation of the homeostatic condition from the medical history and common

coagulation tests. In most cases the disrupted homeostasis can be associated with abnormal

thrombin generation, platelet dysfunctioning and excess fibrinolysis. Anticoagulation with

increased doses of heparin may lead to further haemostasis damaging. At this juncture, the tools

that can sufficiently offer predictions on haemostasis and thus control loss of blood are limited.

Previously it had been shown that the use of thromboelastography (TEG) may assist in reducing

blood product intake. Studies evaluating the association between the coagulating tests for

example TEG, homeostasis variable and bleeding are showing inconsistency in the
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demonstration of clear predictive value for the volume of blood loss after CPB. This

inconsistency may be as a result of the fact that the TEG only shows the formation of the clot

and not the whole amount of thrombin that plays a significant role in enhancing homeostasis.

The main aim of this study was to investigate the value of thrombin generation parameters as

calculated by the calibrated automated Thrombography (CAT) to predict blood loss following a

cardiac surgery.

Introduction

The introduction in this article is excellently developed and has discussed the purpose of

this study in details. Blood loss and thrombotic incidences are still major severe complications

that are highly feared in cardiac surgery with cardiopulmonary bypass in spite of conducting

preoperative evaluation of the homeostatic condition by assessing the medical history and

common coagulation tests. The significance of this study is to assess the value of thrombin

generation parameters measured by calibrated automated thrombography for prediction of blood

loss after cardiac surgery with cardiopulmonary bypass and this will assist in helping to predict

and prepare ways of managing blood loss in cardiac surgery. The significance of this study has

been discussed in details and perhaps it will achieve its objective of combating this problem

healthcare sector (Bosch et al., 2013).

Problem Statement

The problem statement in this research study has been discussed adequately with clear

supportive statements and available statistics in the healthcare industry and from reputable health

organizations such as the World Health Organization and the American Heart Foundation. The

investigators have identified all the variables that are to be examined in this research study. The
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researchers have also identified key research questions and the statement of hypothesis which are

very important in conducting this research and have laid out various strategies to enhance the

process of data collection and analysis which are important in promoting the validation of the

findings. The study has the potential of helping solve the problem of increased blood loss after

an incidence of cardiac surgery (Bosch et al., 2013).

Literature review

The literature review part in this study is excellently developed following a logical

sequence that probably includes a perfect review of both previous literature works which have

either supported or conflicted the use of preoperative thrombin generation for the risk of blood

loss after cardiac surgery. The researchers concentrated on picking articles that are not more than

five years during the time of study to ensure that all the information included in the study is up to

date thus reliable. The research study has provided a clear description of this study in

relationship to the findings of other research studies and they have helped in expounding the

statement of the problem providing wide scope of evaluating this problem and develop

applicable solutions to prevent and manage the issue of blood loss during cardiac surgery. The

literature review has covered various concepts underlying the use of preoperative thrombin

generation in the prediction of the risk of blood loss after cardiac surgery. Previous research

studies are showing the necessity of conducting this study and provide a solution to the risk of

blood loss during cardiac surgery (Bosch et al., 2013).

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Theoretical framework and hypothesis

A credible theoretical framework has been adopted in this research study. The statement

of hypothesis is present and has been adhered to in the entire processes of data collection,

analysis and discussion of the findings. The rationale of the used conceptual framework has been

discussed and the theoretical basis of this study has been adequately discussed by the investigator

for the basis of the hypothesis formulation. The statement of hypothesis is precise and is in good

form which allows it to be rested (Bosch et al., 2013).

Study Methods

The method of study entails the benefits and risks in this research have been keenly and

exhaustively addressed. Relevant variables and concepts have been clearly and operationally

defined in this study. This study involves a descriptive quantitative study. The selected research

design is appropriate considering the type of research questions and statement of hypothesis in

this study. The study exhibited minimal risks during and after the correction of data.

Before the study was conducted, Informed consent was sort from all participants

individually through writings to ensure that no right was infringed. The study was approved by

the local medical ethics committee and written informed consent was collected. The Miami

chapter for IRB reviewed and allowed the progress and conducting of the research. The research

portrays and distinguishes between the independent and dependent factors in this study.

The procedures of collecting data included the active participation of research subjects.

The researchers included various methods of data collection such as distributing questionnaires

to the research subjects; they were also conducting interviews at random on the research and also

engaging in various group discussions to collect information about the research topic. The use of
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these methods enabled the process of data collection to be conducted effectively and yield

excellent results. The methods of data collection had adequate convenience for both researchers

and research subjects since it involved only 30 days of data collection. The methods of data

collection were sufficiently described and potential threats to the internal and external validity

which were present in the study.

Sample

The sampling methods are described in this study. The sample include 30 male patients

who were undergoing elective first time coronary bypass grafting. The exclusion criteria

included the female gender, individuals below the age of 18 years, the use of preoperative

anticoagulation within the last five days, known coagulopathy, impaired renal function, liver

diseases leading in elevated liver function tests and redo surgery. This sample is sufficient

considering that not many patients undergoes cardiac surgery in a period of 35 days the timeline

for this study, therefore this sample of 30 male patients is sufficient considering the given

number of variables and design. During the entire process of data collection the selected research

subjects in the study were given assurance that their rights of the human subjects were fully

protected (Bosch et al., 2013).

Instruments

Appropriate instruments have been selected in this study to aid the process of data

collection and analysis. The reliability and validity of the measurement instruments have been

evaluated and is adequate to enhance accuracy.

Methods
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Populace of study

This study was given an approval by the local medical ethics committee and the informed

consent was also obtained. The study included various procedures of data collection such as the

anticoagulation and CPB, collection of blood samples, generation of thrombin, ACT and

laboratory tests and postoperative blood loss (Bosch et al., 2013).

Anticoagulation and CPB

Starting dose of about 300 IU/kg of body weight of heparin was given via an injection to

the central venous line before the start of CPB. The kaolin activated clotting time was calculated

and incase the value was below 400 s, CPB was started. By the end of CPB, heparin was

reversed using protamine chloride in a ration of 1:1 of the loading dose.

Blood samples

Samples of blood were obtained at T1 (pre-bypass ahead of administering heparin) and

T2 (approximately 5 minutes after giving protamine). The T1 measurement provided information

on the predictive ability of the parameters before their homeostatic intervention associated to

CPB that could give the differences in baseline homeostatic capacity of the blood between the

patients and T2 calculations may provide a forecast on blood loss after CPB and also the

influence of all the involve homeostatic damages associated with CPB (Bosch et al., 2013).

Generating Thrombin

The samples of blood from the arteries were collected to trisodium citrate and were also

analyzed with CAT. TG was also calculated in both the platelet rich plasma (PRP) plus in the

platelet poor plasma (PPP) to get the impact of platelets on TG. PRP was utilized after 60
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minutes of withdrawing blood. The recommended storage of PPP was -80 degree celcius until a

further analysis was conducted. The CAT assay was calculated in a previously warmed plate

fluorometer.

ACT and laboratory tests

Alongside the CAT calculations, ACT and laboratory parameters haematocrit,

hemoglobin, thrombocyte, fibrinogen and D-dimers plus PT and aPTT had their determination

performed at both timing levels for the assessment of patient’s haemostatic profile.

Postoperative loss of blood

The loss of blood was calculated at a predetermined time point postoperatively

determined by chest tube drainage after closure of the chest until 20 hours following the surgical

operation. The quantity of transfusing products was also kept in record pending 20 hours

following the surgery (Bosch et al., 2013).

Data analysis

The statistical tests used in this study have been identified and values have been reported.

The appropriate statistics have been used in accordance to the measurement, sample size,

sampling method and hypothesis. The SPSS statistical software was chosen for the process of

data analysis and was used properly to enhance the accuracy of the results. To avoid biasness

during the study two researchers were required to analyze the results independently and then

compare their analysis (Bosch et al., 2013).

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Analysis of Statistics

Data in this study was either defined as continuous or specific variables. Specific

variables were expressed as percents and continuous variable expressed as mean standard

deviation. Patients were classified into two teams that are those with high and those with low

loss of blood where the median value of blood loss volume at 20 hours postoperatively was

applied as cut off value. The two teams got their comparison with reference to the patient

features, medication used, mean time of bypass and infusion solution plus quantity of transfusion

products and mean values of CAT parameters. Chi square test was utilized in performing

comparisons on proportions and student’s t-test for independent samples to compare the mean

values. The potential of CAT and lab parameters for discrimination among the two groups which

was also under evaluation by the construction of a receiver operation curve (ROC). The

correspondence area under the curve AUC with 95% confidence interval was utilized in

quantifying the predictive value of the parameters. Multivariate linear regression analysis was

also performed for evaluation of the independent effects of parameters. Statistics analysis was

done using SPSS for windows 16.0 and P-values below <0.05 were considered for indication of

statistical significance (Bosch et al., 2013).

Results of study

The interpretations of the study results in this quantitative article are excellent and are in

line with previous studies that have been performed. These results have been validated meaning

that they are accurate and reflects the reality that is in hospital theatres. I have confidence in the

results that have been presented in this study because they have received approval from the

institutional review board. A number of weaknesses have been identified because some
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participants in the surgery theatre are not in a good position to offer the informed consent which

is mandatory in every research. One participant from the thirty was excluded from the study

since a long term adhesiolysis was recommended to achieve access to the heart leading in excess

loss of blood. Tables and figures have been used to provide an excellent analysis of the results

from the 29 patients involved in this study. The results are in light of the theoretical framework

and supporting literature that has been discussed in this study. The results have a coherence of

logic and this excellent for any presentation regarding this study (Bosch et al., 2013).

Conclusion

Conclusions have been made in this study based on the findings in relation to the

hypothesis. Study limitations have been discussed but the investigators were keen to ensure that

they don’t affect the validity of this study. Future implications of this study on the performance

of cardiac surgery have been discussed and this study has an impact on research, training of

physicians and clinical practice in the management of complications resulting from cardiac

surgery. Recommendations for further research have been given and investigators are being

encouraged to identify several of preventing and managing blood loss during cardiac surgeries or

even evaluate the significance of drugs and other medications present in health sector (Bosch et

al., 2013).

Research Utilization implications

This study is credibly developed on a rather rarely discussed topic but very critical on

enhancing the quality of life for patients undergoing surgical operations. Excess blood loss is life

threatening and should be addressed, this study has set a platform on other research studies to be

done on this topic. The article meets set standards to gain approval in the society and is of
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sufficient quality to meet criterion of scientific merit. The study also meets the criterion of

replicability and is important to advocate that it be used in future research concerning the

prevention of excess blood in cardiac surgery. The study contains various recommendations of

practice that are relevant to the nursing practice and I would recommend that surgeons apply the

findings of this study in their practice and in conducting further research on the topic (Bosch et

al., 2013).

Institutional board review

This is an independent ethic advisory committee which applies look into morals through

the audit and appraisal of the proposed strategies for research to guarantee that the examination

is moral. These sheets are fundamentally assigned in either endorsing or dismissing, checking

and inspecting the biomedical and conduct look into examines including people. They regularly

lead a kind of hazard advantage investigation with the point of deciding reasons of having the

examination finished (Ramers, 2017). The primary point of the IRB is guaranteeing that the

fitting advances are embraced and guarantee finish security of human rights and welfare of

human subjects who are associated with the procedures of information accumulation. Both the

creating and created nations have built up national, territorial and neighborhood institutional

survey sheets that are entrusted with defending moral lead of research about both the national

and universal practices and directions (Cook & Hoas, 2016).

The principle objective of IRBs is shielding human subjects from any physical or mental

mischief and they accomplish this by investigating the conventions and materials related with the

proposed inquire about examination. The survey as a rule evaluate the morals of the examination

together with its techniques and guarantees complete educated assent and willful interest by
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imminent subjects in a place of settling on related decisions and furthermore accentuates on

augmenting the security of research subjects. In the United States for instance, the Food and

Drug Administration (FDA) together with the division of wellbeing and humankind benefits that

is specifically the branch of human research insurances have controls that engaged IRBs to favor,

ask for alteration in the arranged research before endorsing or even object everything the same

(Koller, Powell, & Wolfe, 2014). For the most part, the IRBs are required to offer basic oversight

capacities for explore that is performed on human subjects which are logical, moral and

administrative. Another body that is entrusted with oversight in U.S governmentally should

inquire about utilizing creatures is the institutional creature care and utilize board of trustees

(IACUC). IRBs are for the most part utilized for ponders in the fields of wellbeing and

sociologies together with human sciences, humanism and brain research. These examinations

may incorporate clinical preliminaries on recently presented drugs; look into on how mind is

conveyed and how it may be enhanced (Taraban, 2016).

The IRB Approval Process

The IRB endorsement process is comparative in all the IRBs except if generally

expressed. The institutional audit board process expects one to present their examination for

survey and the audit procedure follows in how the investigations were displayed. Following the

accommodation of the examination it is typically affirmed as submitted with no IRB changes and

afterward a notice for endorsement is prepared (Cook & Hoas, 2016). The beginning of the

examination exercises can just begin following an email receipt of a Rutgers IRB endorsement

letter and this where the board of trustees begins looking into the investigation. The second

procedure includes the board of trustees experiencing the investigation and distinguishing any

minor issues that require minor change. The IRB board of trustees should then moment that they
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concurred with the approach in the examination and did not require re-accommodation by the

specialist but rather the he or she consented to execute the progressions expressed by the panel

(Barnett & Faye, 2016).

On the off chance that significant adjustments are required in the examination then

advisory group demands for illuminations from the specialist including the extra of data on how

the investigation will be directed and this may have an influence in turning around the IRB's

choice to upset the advance of the investigation with reference to the criteria of endorsing the

investigation, for example, the parts of secrecy and propriety of the educated assent together with

involved damages in the investigation (Koller, Powell, & Wolfe, 2014). In such a case the full

reactions and changes of the investigation must be introduced in full to the IRB board of trustees

for definite endorsement and assurance. On the off chance that the examination even in the wake

of being prescribed for significant adjustments does not satisfy the IRB advisory group then it

can be dropped and the agent is banished from directing the investigation. A few examinations

are ended for a specific period and others are affirmed with conditions that are observed by the

IRB (Ramers, 2017).

Conclusion

In conclusion, ethical conduct of research is a good aspect that promotes accountability and

professionalism in the performance of scientific research. Adhering to the set research ethics is

important in promoting the validity and reliability of results in a research study. The researchers

should ensure that they learn all the legal and ethical requirements in conducting scientific

research. The institutional board review is very essential in the performance of research, policies

should be formulated to enhance the efficacy of approving the studies that meets the set standard
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and request for the improvement of the studies that are not up to the set requirements and also

cancel studies that are completely violating key requirements of ethical research. Ethical conduct

of research is important especially for the research studies involving human subjects since this

ensures the safety of the research subjects and their wellbeing is also guaranteed prior to the start

of the study (Bennett, 2017).

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References

Barnett, J. E., & Faye, M. (2016). The Ethical Conduct of Research and Scholarship: A Basic

User’s GuideThe Ethical Conduct of Research and Scholarship: A Basic User’s

Guide. PsycCRITIQUES, 6161(2929). doi:10.1037/a0040279

Bennett, S. (2017). The ethical conduct of research in occupational therapy. Australian

Occupational Therapy Journal, 64(4), 281-282. doi:10.1111/1440-1630.12415

Bosch, Y., Al Dieri, R., Ten Cate, H., Nelemans, P., Bloemen, S., Hemker, C., … Mochtar, B.

(2013). Preoperative thrombin generation is predictive for the risk of blood loss after

cardiac surgery: a research article. Journal of Cardiothoracic Surgery, 8(1).

doi:10.1186/1749-8090-8-154

Cook, A. F., & Hoas, H. (2016). How to Participate in Institutional Review Board

Activities. The Associate Professor Guidebook, 269-277. doi:10.1007/978-3-319-28001-

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Koller, K. R., Powell, T. J., & Wolfe, A. W. (2014). Public health research: Institutional review

board review or no institutional review board review? The Journal of Pediatrics, 165(2),

420. doi:10.1016/j.jpeds.2014.04.040

Ramers, C. B. (2017). Ethical Conduct of Clinical Trials, Institutional Review Boards, Informed

Consent, and Financial Conflicts of Interest. Oxford Medicine Online.

doi:10.1093/med/9780190493097.003.0052

Taraban, B. (2016). Institutional review board review of clinical research. The Southwest

Respiratory and Critical Care Chronicles, 4(15), 89. doi:10.12746/swrccc.v4i15.284