DNP 960 Population Management IRB Submission Process

DPI and quality improvement projects require approval from various research approval regulators such as IRB, especially when the projects involve human subjects (Lynch, 2018). These regulators demine if a project is appropriate for study, depending on the level of risk for the human subjects involved (  Choudhury et al., 2018).

DNP 960 Population Management IRB Submission Process

The Goodlife medical center is where the quality improvement project will be conducted. The institution requires the researcher to have IRB approval before commencing any research project that involves the patients. This paper presents the steps required for the DPI project approval process for IRB and quality improvement projects.

Process

The process begins with submissions to the Institutional Review Board (IRB) and the Grants Contract Office. The Grants Contract office is responsible for approving grant-related research and research funded by grants or aiming to attract grant funding. Resnik (2019) notes that the IRB office is responsible for confirming whether the research protocol on the proposed research has been developed in accordance with human ethics (protection of human rights) as recommended by the state or federal research regulations.

IRB approval process follows five steps which are confirmation of the human research project, completion of the human subject education, selection of the IRB review approval based on the project risk level, completion of the IRB approval forms/external approvals, and submission (Including supporting documentation from the institution). According to Sabati (2019), DPI projects that had IRB approval also require post-approval.

The post-approval requires submission of study modification, if any modification was made, a status/continuing report, reportable event, consent posting requirements for clinical trials not approved by FDA, final/closing the study report, and responsibilities after the study report. The authorization signatures required for the approval include the quality improvement officer of the institution and the nursing research committee. The quality improvement offices approve if the project meets the QI criteria. The additional supporting documents required are;

Informed Consent form

The informed consent form indicates all the elements of informed consent that the study participants should understand prior to participating in the research. The form includes the research purpose, duration, participation terms, and whether participation is voluntary. According to Biros (2018), research participants should be given information about the research purpose, duration, and term, after which they are allowed to participate voluntarily.

Site Authorization Letter

The site authorization form is a form that includes information about the site whereby the research will take place. In this case, the authorities at Goodlife medical center will sign the form.

Recruitment Script

The form includes information on the criteria for inclusion and exclusion requirements for the research subject.

Confidentiality Statement

The statement includes information about the anonymity that is supposed to be maintained while dealing with the research subjects. It also states whether the research findings will be used for the stated purpose.

Conflict of Interest Form

The conflict-of-interest form outlines any conflict of interest shown towards the project.

HIPAA Authorization Form

The HIPAA authorization form will include a statement on patient information safety, privacy considerations, and security safeguards. It also includes how the researcher will ensure that no identifiable patient information is used and how patient information will be protected.

DNP 960 Population Management IRB Submission Process References

  • Biros, M. (2018). Capacity, vulnerability, and informed consent for research. The Journal of Law, Medicine & Ethics, 46(1), 72-78. https://doi.org/10.1177/1073110518766021
  • Choudhury, O., Sarker, H., Rudolph, N., Foreman, M., Fay, N., Dhuliawala, M., … & Das, A. K. (2018). Enforcing human subject regulations using blockchain and smart contracts. Blockchain in Healthcare Today. https://doi.org/10.30953/bhty.v1.10
  • Lynch, H. F. (2018). Opening closed doors: Promoting IRB transparency. Journal of Law, Medicine & Ethics, 46(1), 145-158. https://doi.org/10.1177/1073110518766028
  • Resnik, D. B. (2019). Citizen scientists as human subjects: Ethical issues. Citizen Science: Theory and Practice, 4(1). http://doi.org/10.5334/cstp.150
  • Sabati, S. (2019). Upholding “colonial unknowing” through the IRB: Reframing institutional research ethics. Qualitative Inquiry, 25(9-10), 1056-1064. https://doi.org/10.1177/1077800418787214

DNP 960 Population Management IRB Submission Process Guidelines

This purpose of this assignment is to increase familiarity with the IRB submission process.

In this assignment, you will create a mock GCU Quality Improvement (QI) IRB submission. You will be required to submit your actual DPI-Committee-Approved DPI Project Proposal to iRIS in the DNP-960 course, and so to prepare, you will begin reviewing the submission process and all requisite IRB documents in this assignment. However, you will not be submitting an IRB proposal for your DPI Project at this point in time. This assignment is a practice opportunity to ensure you are aware of the QI-IRB submission process at your clinical/practicum site and that you are familiar with the types of documents required.

Construct a 250-500-word Clinical/Practicum Site QI-IRB Report that outlines the steps in the DPI Project approval process for IRB and quality improvement projects

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