Critique of Ethics in Medical Research

Critique of Ethics in Medical Research

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Abstract

Ethical consideration in biomedical studies is a mandatory requirement before carrying out and publishing research. Sampling methods of a meta-analysis must also take into account works which are in tandem with moral aspects in medical field. However, research cannot be free from ethical mishaps. This paper sought to analyze and critique whether the topiramate study sampled sources that reflect the ethical standards such as informed consent, the use of placebo, confidentiality, use of children as participants, and the conditions of the involved parties. The work was aimed to investigate the efficacy of the topiramate drug in the treatment of migraine in comparison to placebos. The analysis reveals that the meta-analysis used the best selection criteria and extraction of data which minimized bias. The sampled studies significantly showed the consideration of ethics in medical research. However, the tested sources partially failed to take into account some moral aspects required in biomedical investigation. Nevertheless, the researchers could not find comprehensive studies and resort to the four which worked well. The major concerns for the studies sampled in the meta-analysis were the adverse side effects of the topiramate drug on the patients.

Key words: biomedical research, topiramate, ethics, placebo, migraine treatment

Table of Contents

Critique of Ethics in Medical Research

Introduction

Ethics is the knowledge of the conflicts that may arise due to the moral imperatives during research and how the authors can address them. Moral consideration is majorly focused on the choices the investigators render and their actions concerning the decisions. In order to understand ethics in medical research, it is crucial to comprehend what the scientific inquiry entails. According to Khan, Tareen, and Sultan (2016), (worng citation) research is referred to as any activity that is aimed at testing a particular hypothesis for the conclusions to be generated to develop new knowledge or treatment.

Furthermore, according to Barber (2018), it is the activity intended to develop or add to existing knowledge that can be generalized. Such generalized knowledge may include principles, theories, relationships, or claims based on specific information. The researcher should be able to prove that putative scientific observation and inference methods can verify the knowledge. For this essay, a study involves both behavioral and medical research relating to human wellbeing; hence, it is sometimes amended by the term “biomedical” to show the association to the health.

Biomedical research promises possibilities of abundant blessings of science to human wellbeing, but it requires a great amount of care to ensure that it does not violate the dignity of the very people it is supposed to help. Therefore, the investigators are bound to ethically respect the autonomy and life of humans in all stages of their inquiries. Morality in research is intended to achieve essential objectives of how people should act in whichever scenario and ensure there are strong justifications for their actions. Ethical consideration plays a fundamental role in ensuring any study is done after following general ethical procedures. However, there is no standard method of organizing morality in biomedical research or public wellness. The bottom line is that the design of the research must be scientifically sound, possess enough power to test a specific hypothesis, and respect human dignity.

The Topiramate Study

The study is a meta-analysis of topiramate for the prevention of migraine in young patients of 18 years and below. The researchers aimed at finding out the effectiveness of using the medicine in averting the condition in the minors (Le, Yu, Wang, Ali, & Guo, 2017). Their investigation was based on the proof of the success of topiramate in adults for similar scenarios. They also based their study on the fact that many medications are usually used in preventing pediatric migraines. Topiramate is an approved drug for migraine prevention in kids aged 12. The study hence focused on looking at the efficacy of the same drug on adolescents. In their investigation, the researchers used various data sources such as PubMed, Cochrane Library, and Embase databases to select eligible studies for review.

The authors used four randomized controlled trials (RCT) which matched the criteria for inclusion with an aggregate of 465 sick adolescents (Le et al., 2017). These patients were divided into two segments: topiramate group with 329 and placebo group with 136 (Le et al., 2017). The results showed that the first option failed to reduce the headache frequency compared to the second alternative according to the various scores recorded from the data sources. The researchers concluded that topiramate is not effective compared to placebo in preventing migraines in young patients aged 18 and below (Le et al., 2017). duplicate citation for the same paragragh usa APA format… Furthermore, the medication proved the possibilities of having side effects in the included patients.

Meta-analysis research involves statistical integration of data originating from different yet similar studies. Just as the topiramate study, such an approach systematically gathers various published reports relating to the topic, excerpts the effect sizes, combines them to find an estimate the average, and examines samples and the research features which are likely to affect the outcome. However, the ethical considerations of the meta-analysis research are different from primary studies since they do not have to face issues concerning the treatment of animals or humans who engage in the study (Le et al., 2017). Typically, there is no institutional review board (IRB) to convince that the benefits of applying such a method significantly outweigh the risks. Meta-analysis uses public documents as their objects of research as witnessed in the topiramate study where data sources were documents from various databases. Therefore, ethical issues such as confidentiality and informed consent are not a concern in this instance since such public documents can neither be mistreated nor deceived. However, conducting a meta-analysis still requires certain ethical responsibilities. (IRB intext citation??)

Sampling Size and Features

One of the biggest concerns when planning research is the decision of how to use a large sample and the selection method to estimate the sample to achieve an objective and ethically sound study. Sampling is a fundamental tool in scientific inquiries, especially the healthcare field. It is essential that sample size for medical research such as randomized control trials are determined from the design and objectives of a particular study. The topiramate investigation sampled studies using random sampling with no further explanation of how the choices were drawn. It would seem as if random means the generic to the popularly known methods of collecting samples. It is essential for the researcher to explain the selected frame and the way samples were drawn. A sample frame is referred to as a comprehensive enumeration of the units being sampled for the study population. (intext citation)

The studies selected by the researchers used participants aged less than 18 years with a total population of 465 randomized patients (Le et al., 2017). There is a need for exercising caution when dealing with a large sample size as the case with the studies reviewed. Preferably, meta-analysis should sample studies which have small sample sizes as long as they fit the definition of what is required or the inclusion criteria. Using such works would make it significantly easier to conduct a meta-analysis. The researchers for the topiramate study sampled four studies which had about 465 participants, and each source had sample sizes ranging from 42 to 163 (Le et al., 2017). Therefore, it suited the analysis. The choice of four publications from the different databases is an indication that the researchers narrowed down to the most qualified studies as per the inclusion criteria. The investigators were also successful in eliminating unsuitable sources from 541 articles only to remain with the four best ones (Le et al., 2017). same citation usa APA format

Furthermore, the researchers picked studies where placebo was used for the control group. The selection is crucial since the investigation aimed at comparing the effectiveness of topiramate and placebo in the treatment of migraine in minors (Powers et al., 2017)). Therefore, any study with any other control, for example, sodium valproate, or propranolol. However, the sample of the participants referred to in the four studies selected had a unique feature. The respondents were aged between the age of seven and 18. Topiramate is a drug used in the treatment of epilepsy with a positive effect on adults and older children (Le et al., 2017).

However, it has not been proved to be a proper mechanism of treating migraine since no adequate research has been conducted in that regard. Topiramate was approved in the United States for treatment of migraine in children aged 12 and above (Kacperski & Bazarsky, 2017). this studyy was relevant any safety conclussion?? However, previous research indicates that over six million minors in the US did not respond positively to the drug as compared to placebo; hence, the relevant authorities in America ordered a further investigation on topiramate effectiveness (Le et al., 2017). The investigators, however, risked children of up to seven years.

Sampling Methods

The researchers engaged two independent investigators to evaluate the studies which were retrieved from their data sources (Le et al., 2017). For the investigators to include the study samples into the meta-analysis, the reviews had to meet specific criteria. The elements were divided into either inclusion or exclusion. The study did well to observe evidence using the correct criteria. Just as the other types of researches the meta-analysis followed the required guidelines of formulating the problem, collecting and analyzing data, and then reporting the results.

The researchers also defined the eligibility criteria for inclusion or exclusion of the studies found from their data sources, hence following the guidelines for sampling in a meta-analysis, especially in biomedical research (Le et al., 2017). Such guidelines always narrate the value of the studies sampled and the ability to combine outcomes. The application of criteria in sampling for meta-analysis is fundamental since features of the value and methodology of a research sample can affect the outcomes. The separation of the reporting elements of inclusion and exclusion of studies raises no ethical concern.

Preferably, one ought to consider the inclusion of only controlled trials followed by appropriate randomization of patients. These individuals should be the ones that account on all originally involved clients as per the purpose to the treat principle with a target if possible blinded results analysis. The researchers in the topiramate study had seven quality elements which included blinding of the outcome assessment.

Assessment of quality study to include in the research is normally a subjective process since the information that is reported can sometimes be insufficient for the intention of the investigation. Therefore, successful meta-analysis should preferably define only the basic criteria for inclusion before performing a comprehensive sensitivity analysis. Furthermore, the strategy for the identification criteria of the relevant studies should be delineated clearly.

According to the researchers, they would only include a study if it was a trial that compares topiramate with placebo in migraine treatment (Le et al., 2017). The study must have had similar diagnostic standards for the condition and the participants less than 18 years (Le et al., 2017). In addition, it had to be a clinical RCT that provided the intent to treat patients in the placebo and topiramate groups. Finally, their inclusion standards required that the participants show 50% or more reduction in the frequency of headache with proper follow-up data presented. same intext citation in paragarah APA

The research, therefore, had a clear definition of the relevant studies required. In particular, the sampling should indicate whether the studies to be included are published or unpublished. Establishing the latter is crucial because the outcomes may be systematically different for the two categories. For example, a meta-analysis that is strictly using published evidence is likely to generate outcomes that are distorted due to bias. Therefore, despite the usefulness of electronic databases and published studies, when they are used alone, they could lack a significant proportion of relevant works which may have impacted the results. (referecens in metaanalysis)

Even though the researchers failed to indicate the type of publications they used, reading through the data sources shows that they relied on electronic databases to obtain eligible studies. Some of the electronic databases included Embase, PubMed/Medline, and the Cochrane Library which were used to recover the RCTs of the use of topiramate in the prevention of migraine (Le et al., 2017). The latter offers one of the best alternatives for extensive manual examination of biomedical articles and journals which are available in English and other languages. Therefore, the researchers sampled their studies for the review from one of the finest single electronic trial sources. Nevertheless, it is crucial to scrutinize the bibliographies and citation indices of all the studies to ensure the selected articles are credible.

The engagement of two independent observers in data collection and sampling was useful in avoiding or reducing errors. The former had proved valuable in the process as they could take away the bias that the researchers may have had. The investigators were also successful in their attempts to minimize the risk of inclination of individual studies. They applied seven elements which included blinding of personnel and participants, concealing allocation, randomizing sequence generation, and blinding results assessment. Furthermore, the investigators engaged two independent researchers to select the studies and extract data. Having different researchers for data collection and extraction comes with its risks such as discrepancies. However, they have used consensus through discussion with a third party to agree. IN text citations??

Ethical Principles in Medical Research

A study is considered ethical in its methodology if the projected value of conducting it outweighs the probable risks to the respondents. In most scenarios, inconveniences, dangers, and distresses that affect the participants exceed the merits that can be directly attributed to the outcomes of the study. This scenario has made many small studies unethical, especially in biomedical research. Without the investigators projecting the net burden, any sample size then becomes immoral because the damages and profits of a study will not be known.IN text citations??

Nevertheless, even by having the net burden, biomedical research only becomes ethically correct if the probable scientific or medical value is more than the potential burden on the participants. The risks involved in the respondents’ side should be reasonable and minimized. The participants should be able to make an informed decision before taking part in the study for them to accept any potential burdens, even if they do not have a direct personal benefit.IN text citations??

In the topiramate study, the researchers did not calculate the projected burdens and value of the studies they used. However, it is always difficult to do so because both the two variables are hard to quantify. Regardless of the difficulty in calculating value and burden, the researchers could have devised other means such as standard approximations to reliably deduce the impact of sample size on the ethical balance without having to calculate. Standard approximation could have focused on similar sample sizes in the categories to be matched – in this case, placebo and topiramate group.IN text citations??

The major ethical concerns when sampling for clinical trials include: informed consent, the use of placebos, approval by IRB, confidentiality, issues relating to children, and conditions of the participants.

Informed Consent

Consent is one of the biggest ethical considerations any investigator should take into account before conducting biomedical research whether it is meta-analysis or the other studies. Informed agreement is referred to as the participant’s willingness to be used in the researcher knowingly, intelligently, and voluntarily. Through such consent, patients have the right to autonomy. The latter is the ability to self-determine an action according to an individual plan. The topiramate study was a meta-analysis; hence, the researchers ought to have sampled studies which respected their participants’ autonomy. Informed consent is an important ethical concern because it seeks to avoid assaults on the participant’s integrity, veracity, and protection of personal liberty. Furthermore, people can only make voluntary decision to participate in research if they are provided with the information on the possible burden and value of the study. They need to understand the risks involved and the benefits of the results that shall be obtained.IN text citations??

Informed consent requires that the participants are introduced to the study and the purpose is well explained. It is the responsibility of the researcher to make the respondents wary of any physical harm or privacy invasion before they render their decision. In case of any harm, there should be a compensation plan for the subjects. The samples used by the researchers for the topiramate study seemed to have bypassed some of these ethical requirements. The trials proved to have side effects for the participants such as weight loss, paresthesia, allergy, somnolence, and stressful liver injury (Slomski, 2016). All the participants from the placebo and topiramate groups were impacted by these adverse events, hence showing the high magnitude of the risks compared to the benefits of the studies under review. While documenting these repercussions would be necessary for the research, there was no clear indication of a compensation plan for the affected patients.

If participants are to be given freedom of making an informed choice, the researchers should use an appropriate procedure for consent. For example, some participants may feel free to ask a question in an open discussion of a local community as opposed to discussing their question about the study in a one on one setup. The researcher should understand that different respondents have varying cultural and social backgrounds which need to be considered to ensure they have informed consent. In some cases, individuals may feel uncomfortable refusing to participate in research that family members or elders of the community have agreed to. These dynamics should be considered by the researcher to come up with an objective and ethical research.IN text citations??

Moreover, the patients were aged between seven and eighteen years; thus, there should have been a different dynamic when seeking their informed consent. Preferably, minors are incapable of giving voluntary agreement, especially in medical research. Therefore, if children are enrolled for research, their parents or guardians must be the ones providing informed consent on their behalf. Studies intending to involve minors require the careful intervention of the Institutional Review Board (IRB).IN text citations about IRB ??

Medical research normally encounters disagreements on the risks the participants face which have hidden the related concern of the information that researchers should disclose to participants concerning the study. Identifying what data one should disclose to the respondents is complicated when the studies compare various approaches to the standard of care. Informed consent in clinical research must address the ethical standards it raises. The studies used in the meta-analysis involved participants who were informed that the outcomes would be used to help others through determining the efficacy of the topiramate drug over placebo. However, it is not enough to enable individuals to have informed consent. The researchers should have provided details on the side effects of using the drug during the study period. Therefore, the topiramate meta-analysis involved some studies which were not ethically sound in the research.IN text citations??

The studies picked by the researchers for sampling should have shown evidence of the participants’ capability to give informed consent as subjects of the studies. There is no evidence of even contacting their family members or guardians before enrolment in the investigation. Human subjects in medical research must be given adequate information such as the respective methods, aims, funding, possible risks, institutional affiliations, and the benefits. For the topiramate study, the investigators should have informed the patients that topiramate may cause side effects such as weight loss, fatigue, fever, and many more.IN text citations ??

The Use of Placebo

There is controversy over the use of placebo groups to control clinical trials when operative treatments exist. The debate is centered on various issues. There is the methodological superiority of trials that are controlled by placebos in discerning the effects of treatment. Also, it is not clear whether the latter includes total outcomes of therapy including that of the placebo or they are confined to particular results of the process that excludes placebo. Another issue of controversy is the fact that participants in the placebo group can be unprotected from dangers and develop hostile side effects. The fourth point of argument over the use of placebo is whether the available treatment standards are based on local or international standards. While the researchers continue to find consensus, investigators employing such methods need to observe certain ethical standards.IN text citations??

The concept of equipoise is what underlies the controversy of placebos. Rooshenas et al. (2016) define equipoise as for the actual state of indecision regarding the discussion about which between the two groups of clinical trial offers the best effectiveness. In case there is a treatment that is effective, the state of equipoise ceases to exist. Therefore, clinical trials using placebo group should give an efficient active treatment; otherwise, it would be considered unethical. The topiramate study used placebo controlled-group while investigating the efficacy of topiramate in treating topiramate among minors. Researchers using a placebo to control experiment are usually condemned harshly, since they are criticized for focusing on societal interest at the expense of the patients.

The topiramate study equally sought to help the society by finding out if the topiramate drug was more effective than placebo in the treatment of migraine in children below 18 years. The research would be necessary since the mechanism of using the medication in dealing with the condition in minors was unknown. Therefore, the investigators would help society by bringing in new knowledge that would even influence policy change. However, the ethical considerations of taking care of the risks faced by the participants in the studies selected for review did not come out apparently.IN text citations??

Understanding the controversy of the use of placebo groups requires a distinction between the two types of control groups in a randomized controlled trial. A control group is meant to distinguish the effects of treatment from any other effects that may be caused by other factors. The use of placebos is appropriate due to the methodological strength and the necessity for developing drugs (Cree et al., 2016). Therefore, the choice of studies with placebo as the controlled group was appropriate in establishing the effectiveness of topiramate in treating migraine in adolescents. Such an approach is generally superior, hence being appropriate for measuring the efficacy of another drug in a randomized controlled trial. Furthermore, it is available at lower costs and has fewer adverse effects for the patients.

Approval by IRB

Every study that involves human subjects should be registered in a database that is publicly accessible even before recruiting the first participant. There are ethical obligations for every researcher or author regarding their publications and dissemination of the outcomes. Apart from ensuring the study results are available publicly, the investigators must determine if their studies are approved by an Institutional Review Board (IRB). Before a study begins, the IRB must review the project whenever it involves human subjects. For example, the works selected for the topiramate research involved human subjects in the name of patients aged 18 years and below. IRB clearance is generally required for medical studies. For a project to be approved by the Board, it must be a systematic investigation aiming at contributing to the generalizable knowledge. The topiramate research used works that fall under the definition of research as per the IRB. Therefore, the studies must be approved by the aforementioned body to qualify to be used in a meta-analysis. The inclusion criteria for the searched publications should have included an IRB approval. However, the researchers focused more on the topic rather than the overall qualification of medical studies. Probably, the IRB approval should have been the first factor of eliminating the studies even before the removal of duplicates. Another element looked at by the IRB is whether the study involves human subjects. The latter are referred to as any living individual from whom the researcher seeks to obtain data through his/her intervention or possess identifiable private data. The researchers for the topiramate investigation sampled the studies which involved human subjects, hence requiring an IRB review. Despite involving human subjects, there was no evidence of them undergoing the examination, yet the researchers in the topiramate study chose them.IN text citations about IRB and human protection ??

Confidentiality

There have been concerns from patients, patient advocacy groups, and other healthcare providers over the privacy of the medical data stored in numerous clinical computerized databases. The accumulation of increasingly large stockpiles of sensitive information related to patients has led to valid ethical concerns regarding the possible inappropriate use and access to data in biomedical studies. Some medical condition often comes with stigma; hence, the researcher must ensure confidentiality of the data used in biomedical studies. However, some investigators have inappropriately disclosed and publicized clinical details. Every researcher in the medical field must safeguard the principle of confidentiality is adhered to. The studies sampled for the topiramate investigation have no signs of breaching the confidentiality principle in medical research. There are scenarios which would have indicated a breach of confidentiality.IN text citations??

First, accessing population-based information is vital in ensuring the protection of welfares and the rights of the participants involved. An investigator conducting any study should always provide limited access to data from the patients being used in the research. For example, the information received from the participants in the topiramate investigation should only be used for that particular case and not shared for any other purposes. One of the best ways of ensuring that data are not disclosed is through removing any identifying content related to the patients from the database. Information worth concealing, in this case, may include names and location of the individuals. However, crucial data such as age remains relevant to the study and hence cannot be hidden because it is not identifying information.IN text citations??

The studies sampled in the survey disclosed the data of the young patients to a level which cannot identify them. There were no mentioned names or where they individually come from. The focus remained on the elements of the study such as the side effects of the ones using topiramate treatment and their age group. To that extent, the works, therefore, met the ethical threshold for inclusion in the meta-analysis.

Secondly, once the potential use of the study is established during the data collection process, the individuals in charge of gathering information must be obligated to advise the participants concerning the possible use of the study once it is completed. However, despite instructing the patients on the use of the study, the researchers must allow them to have their consent to provide their clinical details. Because obtaining approval for every study purpose is impracticable, the investigators can seek a single consent for the different use of the final study. For example, the research may be aiming at adding knowledge in the medical field through testing the effectiveness of a particular drug and at the same time be an academic paper for a specific institution. Some respondents may provide their informed consent for the former and deny for the later. To eliminate such conflict, the researcher may ask them to agree or refuse from all the uses and proceed with those accepting to participate in the research for the two purposes. The topiramate study picked cases which did not have such conflicts, hence making them fit for the meta-analysis.IN text citations??

In some cases, patients may be vulnerable to provide information because the research promises greater benefits for them and others. Despite such vulnerabilities, the guidelines focusing on the deficits could exacerbate the stigmatization which may be associated with a particular study population (Avasthi, Ghosh, Sarkar, & Grover, 2013). Furthermore, it is unjust to omit certain groups of patients by overregulating research concerning their conditions, yet they could also benefit from the results despite the risks involved. Therefore, there should be an ethically balanced framework with rigorous protection for patients as well as recognition for huge individual and social benefits. Striking this balance is essential for ethics in medical research, especially when vulnerable human subjects are involved.

The studies for the topiramate research sought to strike a balance between the benefits of the outcomes for the minors versus their protection. However, once the outcomes showed that the alternative was not effective for migraine patients, it was clear that the individual clients affected by the adverse effects of the drug did not individually benefit. The results of the studies were positive for the general societal good of understanding that placebos are still the best options for treating migraine yet the patients in the topiramate group were not favored.IN text citations??

Even though there are various ethical regulations which have been formulated for biomedical research, malpractice still exists (Avasthi et al., 2013). The studies sampled for the meta-analysis are indicators of existing misconduct when it comes to studies involving vulnerable human subjects – in this case, the children aged below 18 years. For proper application of these guidelines, they should be made law as it is in certain countries such as, for instance, the United States.

Conducting Research Involving Children

Scientific studies involving children are approached differently as compared to adults. For research to be ethical, when it comes to recruiting minors, it must follow certain guidelines. First, involving children in a study is essential for their benefit and of other children; hence, it should be encouraged and done ethically. The topiramate studies would be necessary for the youngsters because it would determine the effectiveness of the drug on kids suffering from migraine. The outcome of the meta-analysis determined that topiramate drug was not effective; hence, the rest of the patients would continue using placebo treatment. Secondly, children require an additional and unique consideration because they are vulnerable compared to adults (Powell, Graham, & Truscott, 2016). Therefore, they have unique interests when participating in research. For example, their informed consent must come from the parents or guardians except for special cases. The four studies used for the meta-analysis used children as participants since they aimed at investigating the efficacy of topiramate against placebos.

Ethical standards for conducting scientific studies require that children should only be used in a study if comparable research on adults is not relevant for the case. The works sampled for meta-analysis sought to find the efficiency of the drug on individuals aged 18 and below. In this instance, using adults as respondents would not have made sense according to the purpose of the studies. Therefore, the researchers in the meta-analysis made the right choice to exclude sources that did not investigate children in that age category. Also, studies involving kids as participants or respondents should undergo the review of an ethics committee. There was no indication of the four studies adhering to the above requirement. However, ethical standards require that the researchers submit the proposals to the ethics committee to elucidate several issues.IN text citations??

Children are unique because they are young and have potential many years ahead of them to experience either benefits or adverse effects of research. To safeguard both the health care and long-term advantages of the investigation, pediatrics in charge of the patients must be informed about the study. The authors can also involve follow up interventions on the clients used in research. The respondents for the four studies in the topiramate group showed adverse effects concerning their response to the drug. The meta-analysis revealed that both placebo and topiramate groups suffered considerable side effects. However, the adverse repercussions of the latter were higher than the former. For example, the children suffered from paresthesia, fatigue, weight loss, and nausea among others. The pediatrics in charge of the patients should have been informed about the study in order to outline the possible interventions for the side effects after research. It would be important because ethical considerations for children participants demand the protection of their interests.IN text citations??

Conditions of the Participants

Ethical concerns in biomedical research essentially involve the protection of the welfare, safety, and rights of the participants. The fundamental issue that is usually discussed when it comes to medical studies is whether to and when to allow the individuals involved in the research to be exposed to threats for the general benefit of others. Ethics committees which are mandated to approve medical research proposals have a role in carrying out a risk-benefit analysis. In doing so, they should consider the principles of beneficence and non-maleficence. The studies sampled for the meta-analysis involved exposure to high risks and pain with the topiramate drug causing even more adverse side effects to the children.IN text citations??

Preferably, procedures that are applied in medical research should involve just minor discomfort such as temporary dizziness. However, in this case, the drug being tested led to adverse side effects on the part of the patients. Therefore, to this extent, the sampling of the studies did not reflect the ethical principles of medical research. Moral standards in biomedical investigation require that a study should not entail any substantial risks that go beyond the ones presented by the available intervention. The reviews had different types of threats to the patients with some within the ethical principles and some being significantly inappropriate for ethical research. For example, nausea, dizziness, fever, dry mouth, and fatigue could be tolerable. However, adverse effects such as cognitive disorder, viral infection, asthma, allergy, traumatic liver injury, suicide ideations, and lack of concentration in school were too much for the participants. It can be argued that the condition of the participants was not fit for the trial of such a powerful drug. However, the researchers sought to test the effectiveness of the topiramate in migraine treatment or reduction; hence, they could not have used other children apart from those who are already suffering from the condition. Therefore, the investigators should have gone ahead to confirm the available medical interventions to protect the patients from high risks and allow only low permissible perils according to the ethical requirements in biomedical research.IN text citations??

Conclusion

The meta-analysis aimed at investigating the effectiveness of the topiramate drug on the reduction of migraine in children aged 18 years and below. The choice of studies sampled was vigorous with the researchers employing good strategies to ensure the best trials are selected from the numerous available publications in the databases. The most significant element that made the chosen works to somehow fall short of the ethical standards especially regarding the participants involved who were children aged 18 and below. Issues about the high risks involved in exposing the patients to the topiramate drug raise moral concerns. However, it is debatable whether it was right to do so for the benefit of knowing the effectiveness of the topiramate drug over placebos. Furthermore, there was no evidence of informed consent of the participants, but a study of such magnitude must ensure that respondents agree to be involved in the research after they are provided with information regarding the risks and benefits of the study. The meta-analysis met some of the important ethical principles in its sampling methods. The inclusion and selection criteria were suitable for the research. Involvement of two investigators in data extraction and the reduction of publication bias significantly improved the ethical standards of the investigation. Despite coming up with the best four studies for review, the sampling methods partially failed to meet the ethical principles used in biomedical studies. ( conclusions are too short) …..

References

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