Books Required Nursing Research: Studying A Study & Testing A Test, 6 th Edition, Reading Evidence – Based Health Research. Author: Richard K. Riegelman, MD, MPH, PhD; Michael L. Rinke, MD, PhD. ISBN: 978-0-7817-7426-0 Publisher: Wolters Kluwer / Lippincott Williams & Wilkins, (2013) Reading Assignment: Chapters 1- 4 in your Textbook Assignment: Explain the Institutional Review Boards (IRBs) and the roles they play. Write a 500-word paper using APA Format Purchase the answer to view it
Institutional Review Boards (IRBs) play a critical role in the oversight and regulation of research involving human subjects. They are responsible for ensuring the ethical and legal conduct of research and protecting the rights and welfare of participants. This paper will provide an overview of IRBs and explain their roles in the research process.
An IRB is an independent committee, typically affiliated with an academic institution or healthcare organization, that reviews and approves research protocols involving human subjects. Their primary purpose is to evaluate the ethical and scientific merit of proposed research and to ensure compliance with applicable regulations and guidelines. IRBs are guided by ethical principles such as respect for autonomy, beneficence, and justice, as well as federal regulations such as the Common Rule.
One of the key roles of IRBs is to assess the risks and benefits of proposed research. They carefully evaluate the potential harms and benefits of a study, considering factors such as the nature of the research, the population being studied, the study procedures, and the qualifications and experience of the investigators. IRBs aim to minimize risks to participants and maximize the potential benefits of the research. They may require modifications to the study design or procedures to reduce risks or enhance benefits.
Another important role of IRBs is to ensure informed consent of participants. Informed consent is a process through which individuals are fully informed about the nature, purpose, risks, and potential benefits of a research study before deciding whether to participate. IRBs review the consent documents to ensure that they are clear, comprehensible, and contain all the necessary information. They also assess whether the consent process adequately includes safeguards to protect vulnerable populations or individuals with impaired decision-making capacity.
Confidentiality and privacy protections are also of great concern to IRBs. They review the methods proposed by researchers to protect and secure participants’ data and ensure that appropriate measures are in place to maintain confidentiality. This includes assessing data storage and transfer procedures, as well as data anonymization or code encryption techniques.
Furthermore, IRBs play a vital role in the monitoring and oversight of ongoing research. They review and approve any modifications to the research protocol, ensuring that changes do not pose additional risks to participants or alter the scientific integrity of the study. IRBs also conduct periodic reviews or audits of approved studies to ensure ongoing compliance with ethical and regulatory requirements.
In addition to their primary responsibilities, IRBs also have an educational role. They provide guidance and support to researchers by interpreting applicable regulations, guidelines, and ethical principles. They may offer training sessions or workshops to familiarize researchers with the IRB review process and assist them in developing ethically sound research protocols.
It is important to note that IRBs are not only concerned with biomedical research but also review studies in various disciplines such as social sciences, education, and psychology. They must have members with diverse backgrounds and expertise to adequately represent the interests of participants and evaluate the scientific and ethical aspects of different research disciplines.
In conclusion, Institutional Review Boards (IRBs) play a crucial role in ensuring the ethical conduct of research involving human subjects. They evaluate the risks and benefits of proposed studies, ensure informed consent, protect participant confidentiality, monitor ongoing research, and provide guidance to researchers. IRBs are vital in safeguarding the rights and welfare of participants and promoting ethical research practices. Researchers and institutions must work in collaboration with IRBs to ensure compliance with ethical and regulatory requirements and maintain the integrity of research outcomes.