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    Clinical Research Nursing: Scope and Standards of Practice
    Clinical Research Nursing: Scope and Standards of Practice
    Clinical Research Nursing: Scope and Standards of Practice
    Ebook190 pages2 hours

    Clinical Research Nursing: Scope and Standards of Practice

    By American Nurses Association and International Association of Clinical Research Nurses

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    About this ebook

    Clinical research nursing focuses on the care of research participants and the protocols of clinical research and trials. The clinical researcher nurse (CRN) balances the needs of the participant and the requirements of research across settings. The result: exceptional, ethical, and safe care that yields reliable, valid data and findings, high quality research outcomes, and, in time, better quality health care.
    The premier resource for today’s CRN, Clinical Research Nursing: Scope and Standards of Practice is informed by advances in this specialty’s unique body of knowledge: nursing care; research regulations; scientific process; and data collection, analysis, and interpretation. It addresses the CRN practice essentials, from education and certification and professional development to ethics and tenets to practice settings and roles.
    Among the other topics covered:
    -The five practice domains: Human subjects protection; care coordination and continuity; clinical practice; management of clinical and research activities; and contribution to science and nursing science/practice
    -Guiding principles of CRN practice: Safety and self-determination of participants, fidelity to research protocols, compliance with regulations, and research-specific informed consent
    -How each of the provisions of the Code of Ethics for Nurses with Interpretive Statements apply to CRN practice
    -Trends and issues, including big data, electronic health records, the evidence for practice, minority involvement in clinical research, and the safety of participants, the workplace, and the public.
    The seventeen competency-based standards both frame evaluation of practice outcomes and goals and delineate what is expected of all CRNs. Its scope of practice—which establishes the who, what, where, when, why, and how of their practice—is the context for applying these standards.
    Clinical Research Nursing: Scope and Standards of Practice is a must-have for practicing or aspiring clinical research nurses and a useful resource for allied interprofessional practitioners and stakeholders.
    LanguageEnglish
    PublisherNursesbooks
    Release dateOct 21, 2016
    ISBN9781558106772
    Clinical Research Nursing: Scope and Standards of Practice
    Author

    American Nurses Association

    The American Nurses Association (ANA) is the premier organization representing the interests of the nation's 4 million registered nurses. ANA is at the forefront of improving the quality of health care for all. Founded in 1896, and with members in all 50 states and U.S. territories, ANA is the strongest voice for the profession

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      Book preview

      Clinical Research Nursing - American Nurses Association

      Published by

      American Nurses Association

      8515 Georgia Avenue, Suite 400

      Silver Spring, MD 20910-3492

      1-800-274-4ANA

      http://www.Nursingworld.org

      The American Nurses Association (ANA) is the premier organization representing the interests of the nation’s 3.6 million registered nurses. ANA advances the nursing profession by fostering high standards of nursing practice, promoting a safe and ethical work environment, bolstering the health and wellness of nurses, and advocating on health care issues that affect nurses and the public. ANA is at the forefront of improving the quality of health care for all.

      The American Nurses Association (ANA) and the International Association of Clinical Research Nurses (IACRN) are national professional associations. This ANA–IACRN publication, Clinical Research Nursing: Scope and Standards of Practice, reflects the thinking of the nursing profession on various issues and should be reviewed in conjunction with state board of nursing policies and practices. State law, rules, and regulations govern the practice of nursing, while Clinical Research Nursing: Scope and Standards of Practice guides nurses in the application of their professional knowledge, skills, and responsibilities. For more about IACRN, see pg. viii.

      Notice

      No responsibility is assumed by the publishers for any injury and/or damage to persons or property as a matter of products liability, negligence, or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein. Because of rapid advances in the medical sciences, in particular, independent verification of diagnoses and drug dosages should be made.

      Copyright ©2016 American Nurses Association and International Association of Clinical Research Nurses. All rights reserved. Reproduction or transmission in any form is not permitted without written permission of the ANA in consultation with the IACRN. This publication may not be translated without written permission of ANA. For inquiries, or to report unauthorized use, email copyright@ana.org.

      ISBN-13: 978-1-55810-675-8SAN: 851-3481 10/2016

      First printing: October 2016

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      Contributors

      Scope of Clinical Research Nursing Practice

      Introduction to Clinical Research Nurses and Nursing

      Definitions of Clinical Research Nursing

      Differentiation of Clinical Research Nurse from Nurse Researcher

      Collateral Definitions

      History and Evolution of Clinical Research Nursing

      Prevalence of Clinical Research Nurses

      Populations Served by Clinical Research Nurses

      Pediatric Population

      Adult Population

      Older Adult Population

      Clinical Research Nursing Practice Environments

      Acute Care and Ambulatory Care

      Privately Owned Research Centers

      Community Settings

      Research Administration Settings

      Special Care Facilities

      Roles and Practice Domains of the Clinical Research Nurse

      Domains of Practice for the Clinical Research Nurse

      Human Subjects Protection

      Care Coordination and Continuity

      Contribution to Science in General and Nursing Science/Practice

      Clinical Practice

      Study Management

      Roles of the Clinical Research Nurse

      Clinician

      Manager

      Educator

      Advocate

      Regulatory Specialist

      Nurse Scientist

      Tenets of Clinical Research Nursing

      Principles that Guide Clinical Research Practice

      Safety and Self-Determination

      Research Informed Consent

      Fidelity to the Research Protocol

      Regulatory Compliance

      The Purpose of CRN Guiding Principles

      Professional Nursing Ethics in Clinical Research Nursing Practice

      Provision 1. Respect for the Individual

      Provision 2. Commitment to the Patient

      Provision 3. Advocacy for and Protection of the Patient

      Provision 4. Authority, Accountability, and Responsibility for Practice

      Provision 5. Duties to Self and Others

      Provision 6. Ethical Work Settings and Care Environments

      Provision 7. Nursing Profession Advancement

      Provision 8. Collaboration with the Public and Health Professionals

      Provision 9. Nursing Profession’s Integrity and Values and Social Justice

      Educational Preparation for Clinical Research Nurses

      Continuing Professional Development for Clinical Research Nurses

      Specialty Practice Certification for Clinical Research Nurses

      Importance of Certification

      Need for Certification

      Trends and Issues in Clinical Research Nursing

      Workplace, Participant, and Public Safety

      Electronic Health Records

      Privacy Issues

      Big Data

      Increasing Minority Involvement in Clinical Research

      Establishing the Evidence for Practice

      Summary of the Scope of Clinical Research Nursing

      Standards of Clinical Research Nursing Practice

      Significance of the Standards

      Standards of Practice for Clinical Research Nursing

      Standard 1. Assessment

      Standard 2. Diagnosis

      Standard 3. Outcomes Identification

      Standard 4. Planning

      Standard 5. Implementation

      Standard 5A. Coordination of Care

      Standard 5B. Health Teaching and Health Promotion

      Standard 6. Evaluation

      Standards of Professional Performance for Clinical Research Nursing

      Standard 7. Ethics

      Standard 8. Culturally Congruent Practice

      Standard 9. Communication

      Standard 10. Collaboration

      Standard 11. Leadership

      Standard 12. Education

      Standard 13. Evidence-Based Practice and Research

      Standard 14. Quality of Practice

      Standard 15. Professional Practice Evaluation

      Standard 16. Resource Utilization

      Standard 17. Environmental Health

      Glossary

      References and Bibliography

      Index

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      Clinical Research Nursing Scope and Standards Writing Group

      Shaunagh M. Browning, MSN, RN, FNP-BC

      Margaret A. McCabe, PhD, RN, PNP

      Tamara Kempken Mehring, MSN, RN, CCRC

      Mary Jane Williams, DNP, MPH, RN, NE-BC

      Scope and Standards of Practice Committee Member Contributors

      Susan Borgiasz, MSN, RN, FNP-BC

      Sheree C. Carter, PhD, RN

      Kathleen Johnson, MSN, RN, ANP-BC

      Carolynn Thomas Jones, DNP, MSPH, RN

      Vicki Turbini, BSN, MS, RN

      Acknowledgments

      Scope and Standards of Practice Committee Members 2010–2015

      National Institutes of Health Clinical Center Nursing Department

      Consultant

      Lorry Schoenly, PhD, RN, CCHP-RN

      American Nurses Association Staff

      Carol J. Bickford, PhD, RN-BC, CPHIMS, FAAN—Content editor

      Maureen Cones, JD—Legal counsel

      Yvonne Humes, MSA—Project coordinator

      Eric Wurzbacher—Project editor

      ANA Committee on Nursing Practice Standards

      Danette Culver, MSN, APRN, ACNS-BC, CCRN—Co-chair (02/2016–12/2017)

      Renee Gecsedi, MS, RN—Co-chair (03/2014–12/2015)

      Tom Blodget, PhD, MSN, RN-BC

      Deborah Finnell, DNS, PMHNP-BC, CARN-AP, FAAN

      Deedra Harrington, DNP, MSN, APRN, ACNP-BC

      Richard Henker, PhD, RN, CRNA, FAAN

      Maria Jurlano, MS, BSN, RN, NEA-BC, CCRN

      Carla A. B. Lee, PhD, APRN-BC, CNAA, FAAN, FIBA

      Tresha (Terry) L. Lucas, MSN, RN

      Verna Sitzer, PhD, RN, CNS

      About the International Association of Clinical Research Nurses (IACRN)

      The International Association of Clinical Research Nurses (IACRN) is a professional nursing organization founded in 2009. Its purpose is to define, validate, and advance clinical research nursing as a specialty practice and to support the professional development of registered nurses who directly or indirectly impact the care of clinical research participants across all clinical specialties. The IACRN vision: Enhancing clinical research quality and safety through specialized nursing practice. For more about IACRN, go to http://iacrn.memberlodge.org/.

      About the American Nurses Association

      The American Nurses Association (ANA) is the premier organization representing the interests of the nation’s 3.6 million registered nurses. ANA advances the nursing profession by fostering high standards of nursing practice, promoting a safe and ethical work environment, bolstering the health and wellness of nurses, and advocating on health care issues that affect nurses and the public. ANA is at the forefront of improving the quality of health care for all. For more about ANA, go to http://www.nursingworld.org/.

      About ANA’s Specialty Nursing Standards

      Since the late 1990s ANA has partnered with other nursing organizations to establish a formal process for recognition of specialty areas of nursing practice. This includes the criteria for approving the specialty itself and the scope statement, and an acknowledgment by ANA of the standards of practice for that specialty. Because of the significant changes in the evolving nursing and healthcare environments, ANA’s approval of specialty nursing scope statements and its acknowledgment of specialty standards of practice remain valid for five years, starting from the publication date of the documents.

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      Introduction to Clinical Research Nurses and Nursing

      Nurses are practicing as clinical research nurses (CRNs) worldwide. The global landscape for clinical research has changed dramatically in the past 10 years. Ninety-eight percent of all countries have participated in clinical trials and are represented on Clinicaltrials.gov, a database launched in 2000, up from 95% in 2014 (Richter, 2014). Although likely much higher today, it was estimated that more than 2.3 million volunteers completed participation in a U.S. clinical research study in 2013 (Center for Information and Study on Clinical Research Participation, n.d.). Currently, 37,476 clinical trials registered with Clinicaltrials.gov are open to recruitment worldwide, while 17,613 are recruiting in the United States (Clinicaltrials.gov, n.d.). In addition, participants are actively engaged in many more trials that are active but closed to recruitment.

      Both healthy people and those with health conditions have volunteered their time and their subjective and objective data to help advance health sciences. Often, these volunteer participants step outside the mainstream of clinical care, known as the standard of care, and are willing to give of themselves by participating in clinical research. Persons who volunteer to participate in clinical research deserve specialized nursing care that ensures exceptional, ethical, safe care yielding high-quality data. The care of the research participant must be consistent with the research plan, care protocol, and clinical need. The best interest of the participant, along with the integrity of the protocol, is the primary focus of the clinical research nursing specialty practice.

      Through specialty practice, the CRN makes important contributions to the clinical research process, facilitating positive outcomes affecting the quality of the research and the participant’s safety. The participant’s care and the research process are closely related, requiring the CRN to

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