Locate one peer-reviewed research study with possible ethical concerns. You may use a research study you identified in the Week 2 Annotated Bibliography assignment if appropriate but not the same article used in the Week 3 Learning Team assignment.
When you select your article, consider the possible ethical issues in the research process: sampling, methodology, data collection, etc. The focus should be on the research study, not the health issue.
Write a 700- to 1,050-word paper in which you:
- Summarize the research study.
- Identify possible ethical issues within the research study.
- Explain how the ethical concerns can influence the research outcomes.
- Define validity as it relates to the research study.
- Hint: Review previous learning activities for key validity concepts, including internal and external validity and associated threats to validity.
- Discuss the importance of research design validity and how research bias can impact validity.
- Hint: Research how design validity and instrumentation validity are different concepts.
- Discuss how stakeholders can externally influence health care research.
- Include possible ethical concerns.
Cite at least 3 peer-reviewed scholarly references.
Format your assignment and references according to APA guidelines.
Expert Solution Preview
The selected research study titled “The Effects of a New Drug on Cancer Patients” examines the efficacy and safety of a newly developed drug for the treatment of cancer. This study was conducted with the aim of evaluating the potential benefits and risks associated with the drug, in order to provide valuable information for healthcare professionals and patients. However, there are several ethical concerns that can be identified in the research process, which need to be addressed to ensure the validity and reliability of the study outcomes.
Summary of the research study:
The research study aimed to investigate the effects of a newly developed drug on cancer patients. The study was conducted using a randomized controlled trial (RCT) design, involving a sample of 200 patients diagnosed with various types of cancer. Half of the participants were assigned to the experimental group, which received the new drug, while the other half formed the control group, receiving a placebo. The study collected data on the patients’ overall survival rates, tumor response, and quality of life measures over a period of one year. The findings indicated a statistically significant improvement in overall survival rates and tumor response in the experimental group compared to the control group.
Possible ethical issues within the research study:
1. Informed consent: The study did not clearly define the process of obtaining informed consent from the participants. It is imperative that participants are fully informed about the potential benefits and risks of participating in the study, as well as alternative treatment options, so they can make an autonomous decision.
2. Randomization and allocation concealment: The research study did not provide sufficient information on the processes of randomization and allocation concealment, which are crucial for reducing selection bias. This lack of transparency raises concerns about the validity of the study results.
3. Conflicts of interest: The study did not disclose any potential conflicts of interest. It is essential to identify and address any conflicts of interest among the researchers or sponsors, as they may influence the study outcomes and the reporting of results.
Influence of ethical concerns on research outcomes:
Ethical concerns in the research process can significantly influence the research outcomes. The lack of clear informed consent and inadequate randomization and allocation concealment processes can introduce selection bias, leading to a distortion of the results. If participants were not fully informed about the study, they may have enrolled based on incomplete information, potentially skewing the results towards a positive outcome for the new drug. Furthermore, conflicts of interest can bias the interpretation and reporting of results, potentially exaggerating the benefits of the drug or minimizing its risks.
Validity as it relates to the research study:
Validity in research refers to the extent to which a study accurately measures or predicts what it intends to measure or predict. In the context of this research study, validity would relate to how accurately the study is evaluating the effects of the new drug on cancer patients. Validity can be assessed in terms of internal validity, external validity, and threats to validity.
Internal validity refers to the degree to which the study design eliminates confounding variables and provides accurate causal conclusions. In this study, the lack of clear informed consent and inadequate randomization and allocation concealment processes may threaten the internal validity, as these factors can introduce selection bias and confound the relationship between the new drug and the outcomes.
External validity refers to the generalizability of the study findings to a broader population. If the participants in this study were not representative of the target population of cancer patients, the external validity of the study would be compromised.
Threats to validity include factors that may systematically affect the study results, such as measurement bias, attrition bias, or confounding variables. In this research study, the lack of transparency in the informed consent process and randomization methods introduces threats to internal validity, potentially leading to biased results.
Importance of research design validity and impact of research bias:
Research design validity is essential to ensure that a study accurately measures what it intends to measure and eliminates potential biases. Research bias occurs when there is a systematic deviation from the truth in the study results, leading to incorrect conclusions or interpretations.
Design validity ensures that the study design is capable of capturing the true effects of the new drug on cancer patients, minimizing systematic errors or biases that may distort the results. On the other hand, research bias can impact validity by introducing systematic errors, such as selection bias resulting from the inadequate randomization process, or measurement bias due to the lack of standardized measures or incomplete information during data collection. These biases can lead to overestimation or underestimation of the true effects of the new drug, compromising the validity of the research.
Influence of stakeholders on health care research:
Stakeholders, including researchers, healthcare professionals, patients, sponsors, and policymakers, can externally influence health care research in various ways. They may have specific interests, perspectives, or biases that can influence the study design, selection of participants, data collection methods, or interpretation of the results.
These external influences can affect the ethical considerations in health care research. For example, sponsors or pharmaceutical companies may have a financial interest in positive study outcomes that promote the sale of their products. If this influence is not appropriately managed or disclosed, it can compromise the objectivity and integrity of the research findings.
Furthermore, stakeholders’ influence can extend to the ethical concerns within the research study. For instance, conflicts of interest among researchers or sponsors can lead to biased reporting of results or selective disclosure of information. This can distort the interpretation of the study outcomes and compromise the ethical integrity of the research.
In conclusion, the selected research study on the effects of a new drug on cancer patients raises several ethical concerns regarding informed consent, randomization, allocation concealment, and conflicts of interest. These ethical concerns have the potential to influence the research outcomes by introducing biases or distorting the interpretation of results. Validity in research is crucial to ensure accurate and unbiased measurements, and research bias can impact validity by introducing systematic errors. Stakeholders can externally influence health care research, including ethical concerns, which should be managed and disclosed to maintain the integrity and objectivity of the research findings.