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Discussion 1 – The Role and Importance of Ethical Research

 

Part One

1. Role and importance of ethical research

Findings from scientific research serve as the foundation of decision-making for government agencies and various organization which affect people of not just the region where the study is done, but also everyone one else around the world. Organization and individuals use research findings to make decisions because they believe that the researchers followed the stipulated guidelines in conducting the research so the data and information presented in the report is accurate. It is, therefore, important that researchers follow all the ethical guidelines for research because of the impact that the findings can have. In my field of education, for example, research is important in informing teaching methods. If researchers were to falsify data about the effectiveness of teaching methods, it can cause unimaginable damage to the literacy of not just the country, but also numerous countries around the world that would use the findings to guide policy and other decisions.

2. Common research methods

Research methods fall under two broad categories: experimental and non-experimental.

There are two common experimental methods: true experimental and quasi-experimental methods.

True experimental methods are used for research studies intended to test for true cause and effect relationships. Here, the researcher has a high control over the factors as they manipulate them to see the outcome which also means that the time frame is current. An example in my field would be to test the impact of learning technology on student grades.

The Quasi-experimental methods differ from true experimental method in that the researcher does not have full control over the factors. The time frame of interest here is both current and past. An example in my field here would be to study the impact of gender on language learning.

There are three common non-experimental methods: descriptive, historical, and correlational

Descriptive methods merely describe existing phenomenon. The researcher has low control over factors or no control at all. The time frame here is current. An example in my field is a survey of learning challenges among low income communities.

Historical methods investigate events from past to present. The time frame here is past and the researcher has minimal to no control over the factors. An example in my field would be to investigate how traditional teaching methods influenced the design of audio-visual learning technology used today.

Correlational methods investigate relationships between variables. The time frame is past, present and future. For past and present, the researcher investigates correlation whereas for the future they predict outcomes. The researcher has low to medium control over the factors. An example in my field would be a research study investigating the relationship between screen time and academic performance.

3. Importance of ethics within any research proposal

Research findings help make progress whether in terms of the products we use or in the way we do things. It is important that the research study will not be successful at the expense of the participants or other people that might be affected. Studies that do not follow the laid out ethical code may not benefit many people because reporting such findings might attract litigation against the researchers.

From another perspective, ethics in practices which involves the design, concept and application helps ensure that the findings are relevant to the subject matter of the study and that the findings are an accurate reflection of the matter being investigated. Furthermore, participants need to be protected from harm by oversight committees because they might not have enough knowledge about a study to refuse being involved. It is the role of oversight committees to ensure that potentially harmful studies are not given the go-ahead to be conducted.

 

  Part Two

On September 13, 2022, a federal judge imprisoned Jessica Palacio, 37, from Florida for her involvement in falsifying data to a U.S. Food and Drug Administration (FDA) investigator. Jessica was in charge of coordinating research at Unlimited Medical Research, a firm in Miami that conducts clinical trials. The allegations leveled against Jessica relate to a contract offered to the firm to determine the safety of an asthma drug meant for children. Jessica, in conspiracy with other officers, reported that she had attended to a child when she had not, which compromised the accuracy of the data used to evaluate the safety of the drug. The judge gave Jessica a 3-year sentence (The United States Department of Justice, 2023).

In another case, Miguel, 52, Bernardo, 58, and Ivette, 52, all of whom are from Miami were indicted on September 13, 2022 for fabrication and falsification of clinical drug trial data. The three were accused of fabricating clinical trial data at AMB Research Center Inc. for profit. They were accused of knowingly enrolling subjects to a clinical trial with the knowledge that the subjects did not meet the eligibility criteria. Further, the accused presented data showing that the subjects were taking the trial drug which was false (The United States Department of Justice, 2021b).

In a similar case, Dr. Martin Valdes, 64, of Coral Gables was charged with lying to an FDA inspector. He was charged alongside three other defendants for their role in falsifying clinical trial data. According to the unsealed indictment, the defendants knowing enrolled subjects who did not meet the enrolment criteria, falsified their medical records, and lied about the subjects taking the trial drug. Brian M. Boynton who was the acting assistant Attorney General at the time raised concerns that inaccurate clinical data can compromise the safety of patients because there is no guarantee that the approved drug is safe (The United States Department of Justice, 2021a).

The individuals charged in these three cases, some of whom have been sentenced, faced legal consequence because they failed to uphold their principal investigator obligations. According to Feehan and Garcia-Diaz (2020), clinical trials should only be conducted by trained individuals with the requisite experience to report findings accurately. It is the principal investigator, and not the contract research organization, that is responsible for the research and, therefore, bears the legal consequences if reporting is not done correctly (Feehan & Garcia-Diaz, 2020). The prosecutions are an indicator of the government’s commitment to ensuring safety of products that are allowed into the market.

 

  

 References

Feehan, A. K., & Garcia-Diaz, J. (2020). Investigator responsibilities in clinical research. Ochsner Journal, 20(1), 44-49.

The United States Department of Justice. (2022, October 13). Florida Medical Clinic owners and staff charged with falsifying clinical trial data. The United States Department of Justice. https://www.justice.gov/opa/pr/florida-medical-clinic-owners-and-staff-charged-falsifying-clinical-trial-dataLinks to an external site..

The United States Department of Justice. (2021a, March 8). Doctor, Clinic Owner and Staff Charged with Falsifying Clinical Trial Data. The United States Department of Justice. https://www.justice.gov/opa/pr/florida-woman-sentenced-prison-false-statement-investigator-related-pediatric-asthma-drugLinks to an external site..

The United States Department of Justice. (2021b, March 22). Medical doctor and study coordinator sentenced to prison in scheme to falsify clinical trial data. The United States Department of Justice. https://www.justice.gov/opa/pr/medical-doctor-and-study-coordinator-sentenced-prison-scheme-falsify-clinical-trial-dataLinks to an external site..

 

 

 

CLASSMATE 2

 

1. What is the role and importance of ethical research and how does it impact issues within your current job.

The role of ethical research is to help maintain scientific integrity, uphold research validity, and protect the rights of participants in research study. The principle ensures that participants take part in the study voluntarily and guarantees they are informed and safe for the research subject. Ethical dilemmas are gray areas where there is no legal mandate. These issues are best handled by having agency policies in place and through the creation of additional policies when new situations arise. During an initial meeting with a client, it is important to establish what information will be kept confidential between the social worker and the family and what will be shared with others in the agency and under what circumstances. Workers must be very clear that they are required to report child abuse or neglect, including domestic violence or use of illegal drugs by anyone in the home. It is also important to discuss the policy on keeping family health information confidential and only disclosing personally identifiable health information with written parental permission.

2. What types of common research methods are generally applied in scholarly research proposals and what criteria generally applies to the particular issue(s) under investigation for a study? 

The common types of research methods generally used are surveys, observations, and experiments. Surveys are used to gather information from people by asking a sequence of questions about their thoughts on a particular subject or matter. Observations are used to study a people’s behavior and reactions, and to gather information about their ability to perform under certain conditions. Observations also deliver the most detailed information about people, their responsibilities, and their needs. It is important to researchers and research that people know what they are doing and how to do it correctly. Experiments are done to check for changes, improvement, and sustainability. They allow for mistakes to be made and the improvement to correct those mistakes.

The criteria used for a particular study involve presenting, evaluating, proper planning and training, using suitable approaches or techniques, having clear and precise goals whether short or long term, introspective viewpoints, and complements of notable outcomes.

3. Explain the importance of ethics within any research proposal and explain the reasoning for methods and integrity in the concept, design and application of a proposed research study as well as protecting any participants. 

The importance of ethics, reasoning for methods, and integrity in research proposals are that it allows for fairness, trustworthiness, dedication, and commitment amongst researchers and people alike. It makes visible, one’s interactions and the ways in which they respond to each other and certain conditions in a variety of settings, and it brings about growth within a person and his peers who are doing the research. Methods and integrity used in research are for the understanding of what is being done to one’s work and assuring one’s research is accurate before presenting it to other researchers and people who trust and believe in them for the betterment of life situations and issues that may arise. If people trust you, they will trust your work. The design and application of a proposed research study bring about clarity and confidentiality. Research protects all participants, their rights, opinions, and information shared from surveys, observations, and experiments that are done on behalf of researchers for use for future purposes.

Part Two: 

Health Care Fraud

As stated by Sharma and Haken (2021), “Dr. Raymond Karnak, age 64, of Mt. Carmel, Pennsylvania, pleaded guilty on September 23, 2021, to 12 counts of unlawful distribution of a controlled substance. Karnak was indicted by a federal grand jury on December 20, 2017, in a 19-count indictment charging unlawful distribution and dispensing of controlled substances, causing the death of five patients by the unlawful distribution and dispensing of controlled substances, and maintaining two drug-involved premises, one in Mt. Carmel and the other Shamokin, Pennsylvania. Karnak stopped seeing patients and surrendered his license in December 2017 when he was arraigned in federal court on the indictment. Karnak operated two offices, one in Mt. Carmel and the other in Shamokin, Pennsylvania, both known as Keystone Family Medicine Associates, and prescribed approximately 9.5 million units of oxycodone, hydrocodone, oxycontin, and fentanyl to patients between January 2014 and July 31, 2017.

The prosecution evidence included testimony from DEA analysts that Karnak was the top prescriber of opioids in Pennsylvania in 2014, 2015, and 2016 and during those years prescribed more opioids than both the Veterans Medical Center in Pittsburgh and the Veterans Hospital in Philadelphia. The prosecution’s evidence at trial also included testimony by a medical expert that Karnak continued to prescribe high doses of opioids despite knowing that patients had previously been treated for drug overdoses, respiratory problems, and other medical conditions increasing the risks of overdose and death. The prosecution’s evidence also established that Karnak, in prescribing these opioids to multiple patients outside of the usual course of professional practice and without a legitimate medical purpose and did so without conducting a proper medical examination, inadequately verifying the patient’s medical complaint, and failing to assess the risk of abuse by individual patients. Karnak is awaiting sentencing” (p.1).

References

Sharma, R. and Haken, T. (2021, December 6). Health Care Fraud, p.1. Retrieved May 12, 2022, from, https://www.justice.gov/usao-mdpa/health-care-fraudLinks to an external site.