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Capella University Protecting Human Research Participants Assessment

Capella University Protecting Human Research Participants Assessment

Capella University Protecting Human Research Participants Assessment

Assessment 1 Instructions: Protecting Human Research Participants

  • PRINT
  • Write a 3-5 page report on the historical development, ethical responsibilities, and legal considerations of research studies that involve human participants.You will use the training on protecting human research participants from the Collaborative Institutional Training Institute (CITI) as a basis for your assessment. This training will likely take you 3-6 hours to fully complete, so plan your time accordingly.

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    INTRODUCTION

    The profession of nursing is uniquely positioned to ensure the ethical planning, design, and implementation of research conducted in health care environments. The current approach to ethics in nursing research is based on the history of ethical and moral lapses associated with research, including nursing practice. For research to be ethical, it must first be determined to have scientific merit, meaning that the research is designed according to the scientific method to inform and enhance our thinking about a research topic. In addition to the requirement for scientific merit, the research must also be viewed from the perspective of protecting those who agree to participate in the research, so that risk is minimized and benefit is maximized.Ethical codes and regulations have been identified to provide a framework for how to determine whether research has scientific merit and if it is ethical. The Nuremberg Code and the Declaration of Helsinki were created after certain experimental projects were determined to be unethical. An outcome of these documents was the creation of the Belmont Report, which defined principles that could be used to integrate these codes into actual practice. In particular, the principles for the responsible and ethical conduct of research are respect for persons, beneficence, and justice.The master’s-prepared nurse is likely work at some point on a project with research elements. In today’s profession, there is a chance that any project will involve human participants in some way. This makes it critical that today’s nurses have an understanding of the ethical codes and regulations that are tied to any research involving human participants. By understanding the history and current state of this subject, the master’s-prepared nurse can be equipped to help ensure the safety of the patient and quality outcomes for patients and researchers.The U.S. Department of Health and Human Services (DHHS) and the U.S. Food and Drug Administration (FDA) passed several regulations that govern the ethical conduct of research, including the requirements for informed consent and external oversight. An institutional review board provides this oversight and consists of a committee that provides peer review of the research, including risks to the participants. More recent legislation addressing ethical issues associated with research includes the Health Insurance Portability and Accountability Act of 1996 (HIPAA).For this assessment you will examine the following elements of ethical research:

    • The important elements of human subject protection.
    • How to minimize risk for subjects while maximizing benefits.
    • What the requirements are for informed consent.

    PREPARATION

    As you prepare to complete this assessment, you may want to think about other related issues to deepen your understanding or broaden your viewpoint. You are encouraged to consider the questions below and discuss them with a fellow learner, a work associate, an interested friend, or a member of your professional community. Note that these questions are for your own development and exploration and do not need to be completed or submitted as part of your assessment.

    • Identify at least two current priorities for nursing research, as identified by the Collaborative Institutional Training Initiative (CITI).
      • Do you agree with the priorities or would you recommend additions to, or elimination of, some of the priorities?
      • What effect do the nursing research priorities have on nursing researchers?
      • Identify at least two current priorities for nursing research, as identified by CITI.
        • Do you agree with the priorities or would you recommend additions to, or elimination of, some of the priorities?
        • What effect do the nursing research priorities have on nursing researchers?

    REQUIRED RESOURCES

    HUMAN PROTECTIONS

    SCENARIO

    As someone who may be involved with consulting on and implementing research involving human participants, it is important that you understand and demonstrate ethical behavior when working with these participants. Use the Social-Behavioral-Educational (SBE) Basic tutorial from the Collaborative Institutional Training Initiative (CITI) as a basis for your assessment.You will apply what you learn from the CITI tutorial to the development of a concise review of the historical development, ethical responsibilities, and legal considerations of research studies that involve human participants.

    INSTRUCTIONS

    For this assessment, you will develop a concise but comprehensive report on what you learned from CITI’s SBE tutorial. While the CITI training should help to form the basis of your assessment, be sure that you are also citing other sources of professional and scholarly evidence in your report. The bullet points below correspond to the grading criteria in the scoring guide. Be sure that your submission addresses all of them. You may also want to read the Protecting Human Research Participants Scoring Guide to better understand how each grading criterion will be assessed.

    • Explain the history and importance of human subjects protection.
      • Support your statements using resources and at least three examples from your readings and the tutorial.
    • Describe the types of research activities that require the involvement of human subjects.
    • Describe strategies to minimize potential risks to research participants.
    • Analyze additional protections needed for federally identified vulnerable populations.
    • Explain ethical standards that are applied in research.
      • This includes regulatory privacy protections and issues related to informed consent.
    • Write clearly and logically, with correct use of spelling, grammar, punctuation, and mechanics and correctly format citations using current APA style.
    Additional Requirements
    • Length of submission: 3–5 typed, double-spaced pages, not including the title and reference pages. Your report should be thorough, but concise. No abstract is required for this assessment.
    • Number of references: Cite a minimum of three sources of scholarly or professional evidence. Resources should be no more than five years old.
    • APA formatting: Use APA Style Paper Tutorial [DOCX] to help you in writing and formatting your analysis.

    COMPETENCIES MEASURED

    By successfully completing this assessment, you will demonstrate your proficiency in the course competencies through the following assessment scoring guide criteria:

    • Competency 1: Analyze how research can be used to improve nursing practice.
      • Describe the types of research activities that require the involvement of human subjects.
      • Explain the ethical standards applied in research.
    • Competency 4: Explain how ethical protections can be implemented in research and evidence-based nursing practice.
      • Explain the history and importance of human subjects protection.
      • Describe strategies to minimize potential risks to research participants.
      • Analyze additional protections needed for federally identified vulnerable research population
    • Competency 5: Communicate effectively across disciplines, demonstrating respect for self and others.
      • Write clearly and logically, with correct use of spelling, grammar, punctuation, and mechanics and correctly format citations using current APA style