Assignment 1

Purpose

The purpose of this assignment is to provide you with an opportunity to complete the professional activity of obtaining Institutional Review Board (IRB) prescreening determination for your DNP practice change project. The intent of this prescreening determination is to ensure the protection of human subjects and confidential health information.

Completion of the DNP IRB Prescreening Supplement Form has several required components and frequently requires revision of the form before final submission and eventual prescreening determination by the IRB. IRB prescreening determination of the DNP project means the project does not constitute human subjects research as defined by the Department of Health and Human Services (DHHS) Regulations, Title 45 of the Code of Federal Regulations part 46, also known as the “Common Rule.” The project must have IRB determination from Chamberlain University and the practicum site (if required) to progress in the course and to begin implementation.

This is an important step because timely completion of the IRB documents will allow course faculty sufficient time to review the documents thoroughly and determine if revisions are needed. If revisions are needed to the project, please be sure to provide a timely response with those revisions so your project can be submitted to the Chamberlain University IRB for prescreening determination. The timely completion of this process depends upon you!

Instructions

Use full sentences when completing all of the forms for this assignment, including the informed consent and the IRB Prescreening Supplement Form. Follow these guidelines when completing each component of the assignment. Contact your course faculty if you have questions.

Submit the following items:

1. The DNP IRB Prescreening Supplement Form
   1. The form is entirely complete.
   2. Write in full sentences throughout the form.
   3. All revisions based on course faculty feedback are complete.
2. Practicum Site IRB requirements
   1. Students who are implementing at a practicum site must do the following:
      1. Submit the practicum site Letter of Support
      2. Submit email or letter stating the practicum site does not have an IRB or Submit the practicum site IRB approval letter.
      3. The Letter of Support and the practicum site IRB requirement can be in one or two emails from the decision maker at the practicum site, or the letter of support and the practicum site IRB requirement can also be on practicum site letterhead with the signature of the decision maker.
3. Collaborative Institutional Training Initiative (CITI) Certificate
   1. Submit your CITI Training Certificate.
   2. Certificate must not expire until after you complete your last course in our DNP Program.
4. Data Collection Tools and Data Collection Plan
   1. The data collection plan is described in detail.
   2. If using a questionnaire, survey, or similar data collection tool for project evaluation, submit the tool to this assignment.
      1. If using a questionnaire, survey, or similar data collection tool, discuss the validity and reliability of the tool in the IRB Prescreening Supplement Form.
      2. Submit the approvals for using or adapting pre-established questionnaires or surveys from the tool's author/owner. If the tool is available in the public domain, state that in the IRB Prescreening Supplement Form.
5. Informed Consent Form (if required)
   1. Submit the Informed Consent Form (if required).
   2. Write in full sentences throughout the form.
   3. Write from the participant’s point of view.
   4. Do not include medical jargon or abbreviations.
   5. Write the consent information on the fifth-grade level of reading.
6. Recruitment materials (if required)
7. Johns Hopkins Individual Evidence Summary tool
8. IRB Prescreening Determination (if obtained)

Required forms must be completed accurately and responses must address requested information. Make sure to incorporate any revision requests made by course faculty into the final submission.

Once each document has been audited and you can be confident that they are ready for submission, submit your documents.

Writing Requirements (APA format)

• Standard English usage and mechanics
• No spelling or typographical errors
• Organized presentation of ideas

Program Competencies

1. Integrates scientific underpinnings into everyday clinical practice. (POs 3, 5)
2. Applies organizational and system leadership skills to affect systemic changes in corporate culture and to promote continuous improvement in clinical outcomes. (PO 6)
3. Uses analytic methods to translate critically appraised research and other evidence into clinical scholarship for innovative practice improvements. (POs 3, 5)
4. Appraises current information systems and technologies to improve health care. (POs 6, 7)
5. Analyzes health care policies to advocate for equitable health care and social justice to all populations and those at risk due to social determinants of health. (POs 2, 9)
6. Creates a supportive organizational culture for flourishing collaborative teams to facilitate clinical disease prevention and promote population health at all system levels. (PO 8)
7. Translates a synthesis of research and population data to support preventative care and improve the nation’s health. (PO 1)
8. Leads others in professional identity, advanced clinical judgment, systems thinking, resilience, and accountability in selecting, implementing, and evaluating clinical care. (POs 1, 4)

Course Outcomes

This assignment enables the student to meet the following course outcomes:

1. Exhibit adherence to ethical principles in the delivery of healthcare, program planning, and financial management. (PCs 7, 8; POs 1, 4)

2. Demonstrate effective project management strategies. (PCs 1, 2, 3, 4, 5, 6; POs 2, 3, 6, 7, 8)

5. Demonstrate knowledge and skills in support for and dissemination of scholarship. (PCs 1, 3, 5; POs 2, 3)

Due Date