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AMU IRB Research Paper

AMU IRB Research Paper

Attache is the instruction for an IRB Application as well as a blank IRB application that needs to be filled out. This is congruent to my research paper that I will be doing later. The picot question is ” Does mentorship influence positive mental health in new Nurse Practitioners graduating entering the workforce in the first year of practice.” This has to be for Nurse practitioners only. In the application we have to put in what type fo research we will be doing as well as who will be the people researched. I was thinking of doing a survey type research for Nurse practicioners that have just finished there first year of practice. This would compare NPs that did not have mentorship vs mentorship and the outcomes. I was also thinking of maybe relating this two hospitals and clinics that don’t have mentorship. If we can find something about high retention rate and how hospitals/clinics can save money if they included a mentorship. These are just thoughts you can build off of. This has to pertaining to the picot question and nurse practitioners only.
IRB Application
Purpose
The purpose of this activity is to provide the student with an opportunity to complete all of
the components of an Institutional Review Board (IRB) Application or its equivalent in order
to adhere to the rules and procedures established for research to protect human subjects.
Directions
1. Obtain the IRB Application Form to conduct your proposed study from your
instructor.
2. Complete the application, giving particular attention to the categories that exempt or
expedite the study from full review. Read the rules for exemption and determine if your
study fits or should be sent forward for a full review. What you provide as information
about your study will govern whether you need full, expedited or exemption from review.
1. Describe your data collection plan in the IRB Application and attach to the
application. If you are adapting items from other instruments to create your data
collection form, please be sure you give credit to those authors who developed the
original instrument and include this information in the IRB Application.
2. On the IRB Form, note the potential risks of the study and what provisions you will
provide, noting that the attached data collection plan will further refine your protocol
statements. A consent form and data collection form for the planned study should
also be attached to the IRB application.
3. Provide, on the Application Form, the ways that you are prepared to secure data and
how the data will be ultimately destroyed. Note that in the final hybrid session that
you will be presenting the actual PLAN for data analysis, including the one page data
collection form, coding scheme, and data entry that protect anonymity and
confidentiality and address other ethical concerns.
6. Prepare your consent form, noting the rules regarding subject competency.
Development of a consent form checklist to perform an ‘internal
audit’ of your materials before they are presented for review to the IRB committee is
suggested.
Grading
This activity is worth 7.5 points, which are distributed as follows:
1. Time Plan is clear, reasonable and realistic for proposed study
2 points
2. The project timeline is complete and addresses all components of the research process,
including possible backup Plan B for obstacles
1.5 points
3. The project timeline is consistent with the research protocol and the IRB application
2 points
4. The paper is written in a scholarly manner using APA guidelines and includes a title page,
abstract and references.
2 points
IRB RESEARCH PROTOCOL
DESCRIPTION OF STUDY
All researchers/investigators (faculty and students) must obtain prior approval to
conduct research with human subjects. This application is to be submitted to and
approved in writing by IRB/Committee prior to the initiation of any investigation
involving human subjects, data, or material
Date Received:
Date Returned for
Revisions__________
Date Reviewed:
Approval Date: ________
Signature of Approval:
___________________________________________
Free Training (without contact hours)

Ethics and Human Subject Protection: A Comprehensive Introduction

A. PRINCIPLE INVESTIGATOR
Name: _______________________________________
Title: ________________________
Department/ Program: ______________
Anticipated level of review: ________________________
(exempt, expedited or full)
Rationale for level of review:
Other Investigators (name and title):
B. TITLE OF THE STUDY
Beginning Date: _______________
Ending Date: _______________
Is extramural funding being sought?
_________________
PROBLEM STATEMENT
.
1
PURPOSE OF STUDY
RESEARCH QUESTION
DATE OF STUDY
LOCATION OF STUDY (general description)
SUBJECTS
POTENTIAL BENEFITS OF THE STUDY
METHODS AND PROCEDURES
PARTICIPANTS PAYMENT OR COSTS
METHODS FOR PROVIDING SUBJECT CONFIDENTIALITY
POTENTIAL RISK TO SUBJECTS
2
RISK/BENEFIT RATIO (IF REQUIRED FOR FUNDED PROJECT)
HOW IS INFORMED CONSENT PROVIDED?
ARE CONSENT FORMS AND DOCUMENTS FOR SUBJECTS PROVIDED IN
APPROPRIATE/ ACCESSIBLE LANGUAGE?
Study Participant
Consent to Participate in a Research Study
Purpose and Background
Research Question/Hypothesis
Procedures to be Used During the Research
3
Methods for Providing Confidentiality
Date_________
Participant’s Signature___________________________________________
Date_________
Researcher’s Signature___________________________________________
4

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