Ethics considerations and data integrity in nursing research


Assignment task:

Lecture Notes on Ethics Considerations and Data Integrity in Nursing Research 

The course "Applied Biostatistics and Epidemiology" requires students to apply what they have learned to evidence-based practice. The course covers the essential concepts and skills required for reading, communicating, interpreting, and applying statistical methods in healthcare. Various methods are reviewed with an emphasis on statistical application for the critical assessment of data. The use of statistics and the associated values of meaning and significance for appropriate and informed decision-making is a major underpinning of the course.

These lecture notes on ethical concerns and data integrity in nursing research are relevant to all inferential statistics and hypothesis testing discussed in the course and outlined in the textbook.  Knowledge gained from this reference will enable students to properly consider ethical implications in any data-driven initiative within an evidence-based practice (EBP) environment. Students are provided with several citations to access and review to maximize the benefit from these lecture notes. The course textbooks do not address the topic of ethics. Therefore, these faculty notes and other resources contained in week 7 are important for an advanced nurse practitioner to assimilate with respective statistical and research knowledge.

The undertaking of research, data analysis, and reporting is supposed to be objective and rigorous with the aim of contributing high-quality knowledge to the scientific field. However, the research process can be fraught with statistical and ethical issues due to outside influence and researcher misconduct. Research should be guided by an ethical commitment to protect the rights of human subjects, including respect for human dignity, informed and voluntary consent to participate and withdraw, beneficence or "doing good", non-maleficence or "doing no evil", justice, confidentiality, and anonymity.  After reviewing these lecture notes and other resources in week 7, students should be able to respond to the questions in the discussion board.

Ethics in Nursing Practice:

Patient advocacy is integral to nursing practice, where advocacy can be related to patients' clinical management or potential research participation through informed consent. As West's article advanced, the ethical issues most cited in conducting nursing research deal with issues related to informed consent, confidentiality, patient privacy, and beneficence.  These are very broad ethical issues that are really processes. See the provided reference.

For instance, the process of informed consent involves consideration of ethical principles such as autonomy (supporting the patient's right to independent decision making),fidelity (loyalty, fairness, truthfulness, advocacy, and dedication to patients served) and justice (equal chance to be included in a study through random sampling and fair distribution of resources), non-maleficence (avoiding harm), and beneficence (desire to do good to help others or ponder a cost versus benefit determination). See the American Nurses Association (n.d.) ethical definitions' reference for more information.   

American Statistical Association's Ethical Guidelines for Statistical Practice

The American Statistical Association (ASA) has written guidelines for statistical practice and practitioners (2018).  These guidelines aim to promote an ethical and consistent framework for conducting research and making statistical decision-making. The following principles were identified to emphasize the broad scope of accountability for the readers of this work and to serve as a model for the future. See the reference list.  

  • Professional Integrity and Accountability
  • Integrity of Data and Methods
  • Responsibilities to Stakeholders
  • Responsibilities to Research Subjects, Data Subjects, or Those Directly Affected by Statistical Practices
  • Responsibilities to Members of Multidisciplinary Teams
  • Responsibilities to Fellow Statistical Practitioners and the Profession
  • Responsibilities of Leaders, Supervisors, and Mentors in Statistical Practice
  • Responsibilities Regarding Potential Misconduct

Human Subjects Research Advanced Training

Researchers must undergo specific training in research conduct for a hospital to conduct human subjects research and obtain approval from the Institutional Review Board (IRB). Quality-driven initiatives may also require advanced research training for individuals seeking clinical and other organizational data for specific purposes. Certificates for research training are offered by various organizations, but one trusted standard for research, ethics, and compliance training is The CITI Collaborative Institutional Training Initiative (CITI Program).  The training track for human subjects research is the CITI Program "Social & Behavioral Research - Basic/Refresher" course, but other advanced courses are also offered. The CITI Program has partnerships with universities to offer research and ethics training courses for faculty and students.  Successful completion of the online course is approved for a three year period with requirement for renewal. Here is a link to CITI Program home page for overview of their course catalog. A list of the modules in the Social and Behavioral

Research certificate course follows for your consideration. Check out the website.

  • Belmont Report and its Principles
  • Students involved in Research
  • Historical and Ethical Principles
  • Definition of Research and Human Subjects
  • Federal Regulations
  • Evaluation of Research
  • Importance of Informed Consent
  • Ensuring Privacy and Confidentiality
  • Research Involving Prisoners
  • Research Involving Children
  • Research Conducted in Public Elementary and Secondary Schools
  • International Research
  • Internet-Based (Survey) Research
  • Research and HIPAA Privacy Protection
  • Vulnerable Subjects - Research Involving Workers and Employees

Another resource for human subjects research protection certificates of training is the Health and Human Services (HHS) Office of Human Research Protection.

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