Research Proposal paper see attachment for further instructions
Final Retrospective Research Proposal
Must submit the Retrospective Records Review Research Proposal in (Word Doc) and create a data collection sheet (Excel) showing the variables you would be collecting. ( find excel sample online)
*Reminder* You are not collecting any data, you are not reviewing patient information. You are creating a proposal as if you were submitting it to an Institutional Review Board.
Find any data online to collect information to match the criteria from the sample attached to this assignment.
This is a nursing-related assignment
Must cite any sources
Must answer all questions.
Must follow the sample to answer all questions.
Plagiarism free, APA format. Please do not have it turniti
DATE
INSTRUCTIONS:
Use this RECORDS REVIEW PROTOCOL TEMPLATE to prepare a document with the information from following sections. This version is to be used for “records review” studies only.
Please remove all instructions in red so that they are not contained in the final version of your local protocol.
Study Title
Include the full protocol title as listed on the application form.
Objectives
Describe the study purpose, specific aims, or objectives.
Background
Describe the relevant prior experience and gaps in current knowledge.
Inclusion and Exclusion Criteria
Describe the criteria that define the type of records to be included or excluded in your final study sample.
Indicate specifically whether you will include or exclude each of the following special populations: (You may not include members of the below populations as subjects in your research unless you indicate this in your inclusion criteria.)
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Procedures Involved
Describe and explain the study design.
Describe how the records to be reviewed will be identified.
Describe the type of data to be collected; attach a copy of the Data Collection Sheet.
Provide the date range of the records review (if this is a retrospective chart review, the end date must come before the IRB submission date): mm/dd/yyyy to mm/dd/yyyy
Data Management
Describe the data analysis plan, including any statistical procedures.
Risks/Benefits
Describe the risks/benefits as a result of access to the records.
Tailor this section to your potential facility where your research could be conducted. Examples given below.
This study is a retrospective chart review; as such, patient information will be collected from the medical records (name of EMR). Although every measure will be taken in order to prevent any possible compromise of patient data (safe storage, password encryption, limited access, etc), the risks associated with possible disclosure of patient data are present. The risks include attainment of patient information by some third party – how they could use this information even if it were compromised, is not easily foreseen. Identifying variables (name, MRN, etc) will not be stored to minimize the risks, simply the variables that we are interested in. Although disclosure of patient information is conceptually possible, it is highly unlikely seeing as how we will take every possible precaution and not store any identifying information with the data.
The benefits include the possible identification of variables that affect patient outcome and the ways to correct them. We will gauge how our institution as a whole is performing in the treatment of [name disease/condition] and identify areas that we can improve. This information will eventually allow us to become more efficient overall with handling this patient population, allowing for shorter time to treatment and improving patient outcomes as a whole.
Setting
Describe the sites or locations where your research team (specifically indicating from where records will be accessed) will conduct the research; specifically, where records will be reviewed and stored.
Resources Available
Describe the qualifications (e.g., training, experience, oversight) of you and your staff as required to perform their role. Provide enough information to convince the IRB that you have qualified staff for the proposed research.
Local Number of Charts
Indicate the expected number of records to be reviewed locally.
Confidentiality
Describe to extent to which Confidentiality can be expected. Example given below.
Your description should match your area of practice.
Here is an example: Medical records will be reviewed in the medical records department and returned immediately to be filed. Data will be collected and stored in a computer using a number to identify each patient in place of their name. A database form will be completed in each patient using a number to identify each patient. The data will be stored on one computer in the principal investigator’s office. The address is
Consent Process
If the study involves the retrospective review of charts, there will likely be no prospective contact with potential subjects prior to data access. As a result, the study team will require a Waiver of Informed Consent as well as a Waiver of HIPAA Authorization.
HIPAA – Protected Health Information (PHI):
A) Participant Identifiers
To which of the following protected health identifiers about participants (or their relatives, household members or employers) might access be needed during the course of the proposed research?
Check all that apply:
___ Names
___ Geographic subdivisions smaller than state (e.g. street address, city, five digit zip code, county)
___ Months of specific dates (e.g. birth date, admission date, month of discharge, date of death)
___ References to age 90 or older or references to dates or years indicative of age 90 or older
___ Telephone numbers
___ Fax Numbers
___ E-mail addresses
___ Social security numbers
___ Medical record or prescription numbers
___ Health plan beneficiary numbers
___ Account numbers
___ Medical device identifiers or serial numbers
___ Biometric identifiers (e.g. finger or voice prints)
___ Full face photographic images or comparable images
___ Web Universal Resource Locators (URLs)
___ Internet Protocol (IP) address numbers
___ Certificate or license numbers (e.g. driver’s license numbers)
___ Vehicle identifiers or serial numbers (e.g. license plate numbers, VINs)
___ Linkage codes (to permit re-identification or longitudinal tracking) derived from or related to any of the above.
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