RETROSPECTIVE CHART/RECORD REVIEW
PROTOCOL TEMPLATE
(HRP-503c)
INSTRUCTIONS:
This protocol template may be used for research that involves solely the retrospective review of records or charts.
A research protocol should provide the information needed for reviewers to determine that the regulatory and Human Subjects Protection Program (HSPP) policy requirements have been met.
This protocol should be completed in Microsoft Word and attached as a required supplemental document to your eIRB application.
Sections in red may not be applicable to your research: you may replace the instructional text with “N/A”.
As you are writing the protocol, remove all instructions in blue italics so that they are not contained in the final version of your protocol.
Note: All data must be in existence at the time of IRB submission.
STUDY INFORMATION
a. Title of Project:
b. Principal Investigator:
i. Name:
ii. Department:
iii. Division
iv. Telephone Number:
v. Email Address:
PROTOCOL VERSION NUMBER:
Table of ContentsSkip To Section: Hold CTRL + Click (Below) To Follow Link in Blue
1.0 / Research Introduction
1.1 / Purpose/Specific Aims
2.0 / Research Significance
2.1 / Research Design and Methods
2.2 / Date Range For Record Review
2.3 / Record Selection
3.0 / Study Variables
3.1 / Independent Variables
3.2 / Dependent Variables
4.0 / Project Management
4.1 / Research Staff and Qualifications
4.2 / Research Sites
4.3 / Non-Rutgers Research Sites
5.0 / Research Data Source/s
5.1 / Secondary Data – Chart Review Process
5.2 / Data Abstraction
5.3 / Data Source
5.4 / Multi-Database Links
5.5 / Data Management Services
5.6 / Data Collection Form
6.0 / Waiver of Alteration of Consent Process
6.1 / Risks to Subjects
7.0 / Special Considerations
7.1 / Health Insurance Portability and Accountability Act (HIPAA)
7.2 / Family Educational Rights and Privacy Act (FERPA)
8.0 / Research Data Protection and Reporting
8.1 / Data Management
8.2 / Data Security
8.3 / Reporting Results
9.0 / Other Approvals/Authorizations
10.0 / Bibliography
1.0 Research Introduction
1.1 Purpose/Specific Aims
Clearly state the overall purpose of the study. [Note: IRB reviewers come from a diversity of backgrounds. Therefore, avoid the use of acronyms and highly technical language.]
A. Objectives
Create objectives—statements outlining specifically what will be achieved by the study—that derive directly from the overall purpose.
B. Hypotheses / Research Question(s)
Describe underlying reasons/motivations for this project and/or the research question (s) specific to the topic and/or populations being studied.
OR
Express any scientific hypotheses—statements about expected relationships between variables—that are testable and that include measurable outcomes/endpoints as described in the Research Design and Methods section of the protocol. Hypotheses correspond directly to the objective(s).
2.0 Research Significance (Briefly describe the following in 500 words or less):
Provide the scholarly or scientific background for, rationale for, and significance of the research based on the existing literature and how will it add to existing knowledge. Describe the relevant current context of the study and gaps in current knowledge.
*** Do NOT include your full Dissertation/Grant/Thesis section here.
2.1 Research Design and Methods
Describe the design of the study. (A retrospective record review means that the data are already in existence when the project is submitted for IRB review (already collected for non-research purposes).
2.2 Date Range For Record Review (End Date Must Precede IRB Submission Date)
Provide the data range for record review. Dates must be the same on the eIRB application. For example: Record review from 1/1/2009 through 12/30/2014. Determine how long it will take to complete the study including data analysis. For example: the study will take 2 years to complete.
2.3 Sample Size
Estimate the number of records you plan to review, should be the same as eIRB application.
2.4 Record Selection
Provide details on how records will be identified and by whom (For example: are you querying a data base or is someone providing a list and if so whom. You may use titles rather than specific names in the protocol to minimize protocol modifications due to personnel changes. (e.g., the Surgical Information Systems Manager for the RWJUH Operating Room Trauma Registry).
A. Inclusion Criteria
Describe characteristics for the selection of records. Provide all relevant demographic (e.g., age, ethnicity), biomedical (e.g., disease status, laboratory values, pregnancy) and behavioral characteristics (e.g., cognitive abilities, mood) relevant for inclusion and exclusion.
B. Exclusion Criteria
Describe what relevant demographic, biomedical or behavioral characteristics exclude records from the research.
3.0 Study Variables (Variables listed here should include those listed on your data collection tools).
3.1 Independent Variables or Interventions
Indicate what variables you will be using to compare groups (e.g., past treatments) or what variables you will use to predict outcomes (e.g., demographics).
3.2 Dependent Variables or Outcome Measures
Clearly define the outcomes/variables you will be extracting from the record with justification for the information collected as it relates to your objectives.
4.0 Project Management
4.1 Research Staff and Qualifications
(Preliminary information about research staff will be provided in your eIRB Application)
Describe the qualifications (e.g., training, experience, oversight) of the study team to perform their role. When applicable describe their knowledge of the local study sites, culture, and society. Provide enough information to assure the IRB that you have qualified staff for the proposed research.
4.2 Research Sites
List the sites where research activities will be conducted.
4.3 Non-Rutgers Site Research
For research conducted outside of the organization and its affiliates describe: Site-specific regulations or customs affecting the research for research outside the organization and Local scientific and ethical review structure outside the organization.
5.0 Research Data Source/s
5.1 Secondary Data - Chart Review Process
5.2 Data Abstraction
Provide a complete list of all electronic data bases and/or paper records to be reviewed and who will perform the review. Suggest listing study role instead of actual name to minimize amendments due to personnel change.
5.3 Data Source
Indicate the source or location of the data bases and records.
5.4 Multi-Database Links
If more than one database is being used, list the variables used to link the databases and who on the study team will manage the data.
5.5 Data Management Services
List any data management services you may use (e.g., RedCap)
[Must match the same as listed on the eIRB application.]
***Note that patient lists and/or protected health information ‘preparatory to research’ is to determine the feasibility of a particular research idea; such information may not be used to conduct research.
***Note that data containing Protected Health Information cannot be stored on personal or mobile devices such as laptops and memory sticks.
5.6 Data Collection Form (De-Identified Variables To Be Analyzed):
Include a data abstraction sheet or excel file with the unique record code you have assigned and all data elements or variables you will collect from each record (this data form should have no identifiers). In the case that you are obtaining information with identifiers (names, dates, etc.) from a database and then removing identifiers please provide both tools/sheets (with and without identifiers) so it is clear that you are removing all identifiers.
6.0 Waiver or Alteration of Consent Process
(If this section does not apply to your research, replace the instructions below with “N/A”)
Confirm if you wish to request waiver or alteration of Consent Process. If yes, describe the process for situation when consent will not be obtained or certain required elements of consent are being altered. Summarize the key elements of the justification for a request for the waiver. (Review HRP-410 to ensure you have provided sufficient information for the IRB to make their determinations.)
6.1 Risks to Subjects
A. Description of Subject Risks
Address the steps to be taken to minimize this risks (e.g. Breach of Confidentiality) including timely destruction of the link between identifiers and health data.
§ Certificate of Confidentiality
If any data collection includes sensitive data (e.g., alcohol, drug use, sexual attitudes and behaviors, etc.), indicate whether or not a Certificate of Confidentiality will be obtained. See https://orra.rutgers.edu/coc for more information.
§ Potential for Benefit
Explain if and how society and/or the investigator may benefit from the knowledge gained since the individuals whose records you are reviewing are not likely to receive any benefit from the research.
§ Provisions to Protect the Privacy Interests of Subjects
Describe the steps that will be taken to protect subjects’ privacy interests. “Privacy interest” refers to a person’s desire to place limits on whom they interact or whom they provide personal information.
7.0 Special Considerations
7.1 Health Insurance Portability and Accountability Act (HIPAA)
(If this section does not apply to your research, replace the instructions below with “N/A”)
Indicate if you will be obtaining, creating, using, and/or disclosing individually identifiable health information associated with a HIPAA-covered component or entity in the course of the research.
A. Waiver or Alteration of HIPAA Authorization
(Requires Use or disclosure to involve no more than minimal risk to the privacy of individuals)
Explain how your study meets the criteria for Waiver or Alteration of HIPAA (45 CFR 164.512(i)(2)(ii))
7.2 Family Educational Rights and Privacy Act (FERPA)
(If this section does not apply to your research, replace the instructions below with “N/A”)
(Complete this section if student records will be accessed). If data (beyond directory information) will be obtained from educational records for the purposes of research, review your protocol along with WORKSHEET: FERPA Compliance (HRP-331). Ensure that your protocol is clear regarding what records are request to be accessed and include required information in the consent form or justification of or waiver of consent.
8.0 Research Data Protection and Reporting
8.1 Data Management
Describe the data analysis plan, including any statistical procedures. Describe any procedures that will be used for quality control of collected data.
8.2 Data Security
Describe the steps that will be taken secure the data (e.g., training, authorization of access, password protection, encryption, physical controls, certificates of confidentiality, and separation of identifiers and data) during storage, use, and transmission.
***Note: It may be appropriate to discuss your plans for collecting, storing, and securing data with your IT Support Team. The IRB may ask that you consult with Rutgers Office of Information Technology to make a security and privacy impact assessment. This plan should also be adequately represented in your Subject Confidentiality plan.
A. Destruction of Identifiers
If a waiver of consent is granted, identifiers should be destroyed with no possibility of linking the data with these identifiers as soon as possible. Please explain your procedures for this task.
***Note: Although you will destroy the Personal Identifier Link, Rutgers University requires that the actual data set on which you perform analysis and developed manuscripts, must be kept for a minimum of 6 years.
8.3 Reporting Results
A. Sharing of Results with Subjects
Describe whether results (study results or individual subject results, such as results of investigational diagnostic tests, genetic tests, or incidental findings) will be shared with subjects or others (e.g., the subject’s primary care physicians) and if so, describe how the results will be shared. If providing individual results, provide evidence of appropriate lab certifications (e.g., CLIA) and the qualification(s) of the study staff who will return such results.
B. Individual Results
Describe your plan for notifying subjects of study or individual test results that have clinical importance (e.g., abnormal lab values on screening). If providing individual results, provide evidence of appropriate lab certifications (e.g., CLIA) and the qualification(s) of the study staff who will return such results.
C. Aggregate Results
Describe your plan for notifying subjects of aggregate research results, as applicable.
***Note: Studies show that a primary reason persons enroll in research is to make a meaningful contribution to future health of others. Returning aggregate results to subjects respects and recognizes their contributions to research.
D. Professional Reporting
Describe your plan to share the results of your research with the scientific community.
9.0 Other Approvals/Authorizations
Describe any approvals that will be obtained prior to commencing the research. (E.g., school site authorization, data use agreements, external site authorization, funding agency, Bio-Safety, Radiation -Safety etc.)
10.0 Bibliography
Include all references cited in the text.
Protocol Number: (If Available)PI Name:
Protocol Title: / 6 / RESERVED FOR IRB STAMP
DO NOT MODIFY THIS SPACE
IRB Form Version v120116