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Establishing the doctor of nursing practice project ethical review process to improve standardization, efficiency, and timeliness

      Highlights

      • Development of DNP Project ethical review process expedited QI determination.
      • Ethical review process provides scholarly and ethical determination that aligns with the IRB.
      • Review process protects participants, supports students, and empowers faculty.
      • Ethical review combines project management, understanding QI VS. HSR, and expert consensus.
      • Rationale and process for creating and implementing an ethical review committee.

      Abstract

      Background

      DNP Scholarly projects require review for scientific merit and human subject protection. Rapid growth of DNP programs and projects has increased Institutional Review Board (IRB) burden and increased the length of project approval time when most DNP scholarly projects are quality improvement (QI) projects and not deemed Human Subjects Research (HSR).

      Purpose

      Develop a process and describe the rationale for creating and implementing a Project Ethical Review Committee (PERC) in the School of Nursing and to evaluate the experience of the first cohort of submissions.

      Process

      Committee was formed using expert consensus approach, in collaboration with IRB. Standards of Procedures and training materials created.

      Outcome measure

      100 projects submitted to committee; 95 deemed QI (95%) and 5 projects considered HSR (5%). First 94 projects were reviewed, and approval letters sent within 8 weeks.

      Discussion

      This paper discusses how PERC ensures rigorous and ethical review process for standardization, timeliness, and efficiency.

      Keywords

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      References

      1. American Association of Colleges of Nursing (2020). Fact sheet: the doctor of nursing practice (DNP). Retrieved from https://aacnnursing.org/DNP/Fact-Sheet

      2. Johns Hopkins Medicine Office of Human Subjects Research Institutional Review Board, 2019 Data risk tier calculator (version (2019).0611a) riskmatrixcalculator.pdf (insidehopkinsmedicine.org)

      3. Johns Hopkins Medicine Office of Human Subjects Research Institutional Review Board, 102.2a Organization policy on quality improvement/quality assurance activity, (2020)., https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/organization_policies/102_2a.html

        • Institute of Medicine [IOM]
        Committee on Quality of Health Care in America.
        in: Kohn LT Corrigan JM Donaldson MS To Err Is Human: Building a Safer Health System. National Academies Press, Washington, DC, USA2000
      4. International Committee of Medical Journal Editors [ICMJE]. (2022). Retrieved from www.ICMJE.org

        • Mundinger M.
        • Carter M.
        Potential crisis in nurse practitioner preparation in the United States.
        Policy, Politics and Nursing Practice. 2019; 20: 57-63
      5. National Bioethics Advisory Commission (NBAC).2000 Ethical and policy issues in the oversight of human research. federal register, citation: 65 FR 79368, 79368-79369.

      6. US Department of Health and Human Services. 2020 Human subject regulations decision charts: 2018 requirements. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts-2018/index.html#c1.