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Ethics in Research01:56

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Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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Ethical Dilemmas II01:30

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Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
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Navigating the Institutional Review Board Process.

Paula Dutka1,2, Kim Schafer Astroth3,4

  • 1Director, Education and Research, Nephrology Network, NYU Langone Hospital - Long Island, Mineola, NY, a member of ANNA's Long Island Chapter.

Nephrology Nursing Journal : Journal of the American Nephrology Nurses' Association
|February 28, 2022
PubMed
Summary
This summary is machine-generated.

Principal investigators must obtain Institutional Review Board (IRB) approval before starting research with human participants. This guide offers essential IRB process information and submission steps for nephrology nurses.

Keywords:
Institutional Review Boardcomplianceresearch ethics

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Area of Science:

  • Medical research ethics
  • Clinical trial administration

Background:

  • Research involving human participants requires ethical oversight.
  • Institutional Review Boards (IRBs) are crucial for protecting participant rights and welfare.

Purpose of the Study:

  • To provide nephrology nurses with fundamental knowledge of the IRB process.
  • To outline practical steps for preparing and submitting research projects for IRB approval.

Main Methods:

  • Review of IRB guidelines and best practices.
  • Development of a step-by-step guide for research submission.

Main Results:

  • Understanding the necessity of IRB review for all human participant research.
  • Clear procedural steps for navigating the IRB submission process.

Conclusions:

  • Adherence to IRB protocols ensures ethical research conduct.
  • Preparedness in IRB submission facilitates efficient research initiation for nephrology nurses.