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Volume LVI, Number 2

Research Authorization and Protocol Review (RAPR): A Centralized Research Review Model for Advocate Health Midwest

Angela Navarrete-Opazo
Advocate Aurora Research Institute, Advocate Health
 960 N 12th Street, 4120
Milwaukee, WI 53233
414-534-7897
angela.navarreteopazo@aah.org

Cheryl Lefaiver
Advocate Lutheran General Hospital, Advocate Health  
1775 Dempster St
Park Ridge IL 60068
630-817-4704
Cheryl.Lefaiver@aah.org

Mercedes Robaina
Advocate Aurora Research Institute, Advocate Health
960 N 12th Street, 4120
Milwaukee, WI 53233
414-534-7897
Mercedes.Robaina@aah.org

Jessica Kram
Academic Affairs, Advocate Health 
Aurora Sinai Hospital
1020 N 12th Street
Milwaukee, WI 53233
920-285-2576
Jessica.Kram@aah.org

Vida Vizgirda
Center for Nursing Research Excellence, Advocate Health
2025 Windsor Dr
Oak Brook IL 60523
414-219-4592
Vida.Vizgirda@aah.org

Laura Wrona
Advocate Lutheran General Hospital, Advocate Health  
1775 Dempster St
Park Ridge IL 60068
630-785-2661
Laura.Wrona@aah.org

Abstract

Advocate Aurora Research Institute (AARI) has implemented a Research Authorization and Protocol Review (RAPR) process to streamline the review and authorization of research conducted within Advocate Health (AH) Midwest. RAPR aims to facilitate the submission and review of various types of research, coordinates scientific and administrative reviews, ensures proposals are compliant with AH policies and procedures, and, when applicable, authorizes research support services to studies that are meritorious as well as operationally and financially feasible. The process uses a Research Electronic Data Capture (REDCap) platform for submission, review, scoring, and tracking of clinical research requests. Unique REDCap workflows were customized for Academic Research, Graduate Medical Education Research, Nursing Research, and Sponsored Clinical Trials. Research studies are reviewed by scientific and clinical experts, as well as research administrators, and are evaluated based on standard scoring criteria, including organizational priority, patient impact, qualifications of the study team, funding, resource availability, research quality, contracting/legal support, and cybersecurity considerations. RAPR determinations are communicated to the study team and key personnel through REDCap notifications. RAPR authorization is a mandatory requirement at AH Midwest and a prerequisite for submitting a research study to the Institutional Review Board.

Keywords: Research Administration; Research Management, Clinical Research Operations; Scientific Review Committee; Institutional Research Activities 

Introduction

Effective research administration is crucial for facilitating research activities that advance healthcare and is an important goal of academic health centers. Research administration involves managing several aspects of research, including but not limited to compliance with institutional policies and applicable state and federal regulations, scientific merit and feasibility, contracting, cybersecurity risk assessment, grant administration, investigator training, resource allocation and utilization, dissemination of results, and ultimately, the potential impact on the organization and the medical field.
 
The Institutional Review Board (IRB) is responsible for overseeing the ethical and regulatory aspects of human subject research (HSR). However, their focus is on the protection of human subjects and the confidentiality of their data, which means that the responsibility for other aspects of research administration is often scattered among various departments. Furthermore, the IRB does not oversee research activities that are deemed non-HSR, though these projects require research administration oversight. This creates a need for a centralized review process to authorize research studies, that align with organizational priorities, support graduate medical education (GME) programs, have a scientifically valid study design, and are operationally and financially feasible before undergoing IRB review.

The Clinical and Translational Science Awards (CTSA) Consensus Working Group (National Center for Advancing Translational Sciences, n.d.) has proposed the establishment of Scientific Review Committees (SRCs) to evaluate the scientific quality and operational feasibility of research projects before they are reviewed by the IRB (Selker et al., 2015, 2020). The Working Group has recommended the implementation of a project management system that would support the SRCs' workflow, allowing for effective communication among key stakeholders, protocol submission, and review. Additionally, a data management system is recommended to support data entry, quality control, and collection of research-related metrics (Selker et al., 2015, 2020). 

Aligned with the recommendations of the CTSA Consensus Working Group, Advocate Aurora Research Institute (AARI) implemented a Research Authorization and Protocol Review (RAPR) process to ensure transparency and efficiency in research operations. RAPR is the mandatory, centralized process for reviewing and authorizing research at Advocate Health (AH) Midwest (Illinois and Wisconsin) prior to IRB submission. The purpose of this article is to provide an overview of the RAPR process across different research areas within the Midwest.

Technical Report

Objectives of RAPR

RAPR is the mandatory, centralized process for reviewing and authorizing proposed research for which AH Midwest will be engaged, regardless of project origin, funding, or resource need. RAPR is independent and required prior to protocol submission to the Advocate Health-Wake Forest University School of Medicine (WFUSM) IRB or external IRB. Specific goals of RAPR include, but are not limited to: 

• Ensure proposals are compliant with AH Midwest policies and procedures.
• Coordinate the administrative and scientific review of proposals in a timely manner.
• Serve as a liaison among AH Midwest departments, research support areas, and investigators.
• Facilitate the request and assignment of research support services to proposals that are meritorious, feasible, and have well-defined outcomes.  
• Develop, customize, and maintain a user-friendly electronic platform for research submission, review, and notification of RAPR determinations. 
• Develop unique electronic workflows for different research areas, including Academic Research, Graduate Medical Education Research (GMER), Sponsored Clinical Trials (CTs), and Nursing Research. 
• Develop and maintain standard scorecard criteria evaluation forms for different types of research and research areas.
• Notify investigators and key personnel of RAPR determinations and provide feedback to improve proposals as needed.
• Follow-up research projects after RAPR authorization to identify delays in study start-up. 
• Generate and report periodic operational metrics.
• Update and add RAPR workflows, as needed, based on users' feedback and institutional requirements. 

Research Electronic Data Capture (REDCap) Functionality

RAPR utilizes REDCap (Patridge & Bardyn, 2018; REDCap, n.d.) a web-based application to receive, review, and authorize research studies submitted to RAPR. REDCap is a well-established tool within the research community and has gained broad acceptance within AH as a toolset for providing secure, web-based data collection services. In May 2023, the REDCap interface for AH was upgraded to include the Alerts & Notifications, and Project Dashboards features (Patridge & Bardyn, 2018), which allowed RAPR to switch on November 1, 2023, from a less nimble application to the more advanced REDCap platform.

The Alerts & Notifications feature enables RAPR administrators to construct alerts and send customized email notifications to scientific and feasibility reviewers. Notifications can be sent to one or more reviewers and can be triggered when the administrative review form has been completed and saved. The notification customization requires defining alert triggers, when and how many times the notification should be sent, attaching multiple study documents, and specifying the recipient, sender, and message text. A personalized message is sent to reviewers including the message piped in field variable (e.g. referenced data entered in previous fields in the REDCap project) such as the review deadline, date of the PRC meeting, and study considerations. Additionally, each reviewer receives a unique evaluation form link embedded in the text, eliminating the need to log in to REDCap to complete their review.

The Online Designer feature was used to customize data collection instruments (i.e., forms), allowing the capture of feedback from different stakeholders, including investigator (Intake forms), reviewers' scorecard criteria evaluation (Evaluation forms), research support managers (Feasibility forms), and service line directors (Leader forms).  

RAPR uses branching logic to design the intake form. This feature allows RAPR to show different parts of the form based on specific answers given to certain questions. For instance, if a submitter answers “yes” to the question “Do you plan to use Advocate Aurora Research Institute resources?”, the field “Select the AARI resource(s) needed” will appear.

The file uploading feature is an integral part of the intake form, used to request various study documents such as protocol templates, data collection tools, delegation of authority logs, department support letters, budgets, and other relevant attachments. The rich text editor feature allows the hyperlinking of required document templates, enabling submitters to conveniently download the necessary templates directly from the intake form.

Project Dashboards are web pages that display dynamic content and can be customized to provide a high-level summary of the project. To build a dashboard, data can be imported directly from a form or a customized report. The rich text editor and the wizard tool were used to streamline the writing of smart variables and obtain aggregated data, pie charts, bar graphs, and tables for metric purposes. Once a dashboard is customized, it is automatically updated whenever forms are completed and saved. The dashboard is accessible only to RAPR administrators but can be shared via a public link. Additionally, dashboards can be exported as PDF or CSV files.

RAPR Workflows

Given the diverse administrative and scientific requirements for different types of research, separate RAPR areas were established for Academic Research, GMER, Nursing Research, and Sponsored CTs.

Figure 1. Schematic listing of the areas of Research Authorization and Protocol Review (RAPR) and the types of studies overseen by each area.

The diversity of research areas and study types precludes a one-size-fits-all RAPR process. Different workflows were developed, in collaboration with respective administrative leaders, for academic research, GMER, sponsored CTs, and nursing research, while still allowing for alignment and overlap when necessary. Scientific and clinical reviewers are expected to assess protocols for scientific merit and operational feasibility based on the definitions given for the evaluation criteria (Table 1). Criteria for evaluation include organizational priority, research strategy, patient impact, qualifications of the PI and study team, funding, resource availability, research quality, Diversity, Equity, and Inclusion (DEI) component, and contracting/legal considerations. Each criterion is scored on a scale of 1-5 where 5 = Exceptional, exceptionally strong with negligible to no weaknesses, 4 = Excellent, very strong with only some minor weaknesses, 3 = Good, strong but with numerous minor or one moderate weakness, 2 = Fair, some strengths also some moderate weaknesses or one major weakness and 1 = Weak, minimal or no strengths and a few major weaknesses.

Table 1. Research Authorization and Protocol Review (RAPR) scorecard criteria per research areas.

CLICK HERE TO DOWNLOAD/VIEW (PDF) SCORECARD CRITERA

RAPR - Academic Research

Academic Research (i.e., Investigator-Initiated Research) corresponds to research developed, initiated, and managed by AH-employed clinician investigators or research scientists or research developed in partnership with external academic or industry sponsors. Academic research studies include retrospective studies and prospective studies, industry data science projects, and biorepository and specimen projects. The Academic Research workflow is illustrated in Figure 2.  

Once the research proposal is received, the RAPR manager will check for completeness and conduct an administrative review before proceeding with the scientific review. Elements to consider for the administrative review include confirmation of research affiliation agreements, data management, health technology requiring Information Technology (IT) risk review, Epic services, Principal Investigator (PI) eligibility, and compliance with applicable AH policies and procedures. If additional information is required, the PI will be notified and given 30 business days to respond. Once the administrative concerns have been addressed, the proposal moves to scientific review.

The scientific evaluation can be conducted through either a fast-track review for observational studies or a PRC review for interventional clinical trials and biorepository and specimen research. Evaluation forms for retrospective or prospective studies (Table 1) are sent to clinical and scientific experts via REDCap. The fast-track review requires the completion of the evaluation forms by one or three reviewers for retrospective or prospective studies, respectively. The PRC review requires the completion of the evaluation form by three reviewers and a PRC meeting to make a RAPR determination. Regardless of the type of review, the study must have a minimum score of 70% out of 100% or an approved exception to receive RAPR authorization.

Concurrently with the scientific review, notifications via REDCap are sent to applicable research support areas including the Office of Research Analytics and Systems Computing (ORASC), academic research core, IT and the Office of Sponsored Programs (OSP) to complete the feasibility evaluation, assessment of research support services’ effort and budget. If the proposal requires PRC review, research support managers provide their review and feedback as ad hoc members to the PRC meeting. 

Once the scientific and feasibility review has been completed, the corresponding AARI leader confirms the RAPR decision to either authorize or decline a study. A decision notification is sent via REDCap to the PI and key personnel.

Figure 2. Flowchart depicting the academic research workflow from study submission to follow-up. 

Flowchart depicting the academic research workflow from study submission to follow-up. Following the administrative review, the proposal receives scientific review. The feasibility and scientific review are simultaneous. The corresponding Advocate Aurora Research Institute (AARI) leader must confirm study authorization before proceeding with the REDCap notification to the Principal Investigator (PI) and key personnel. The study submitter receives an automatic REDCap survey to inquire about Research Authorization and Protocol Review (RAPR) submission. Automatic REDCap follow-up surveys are deployed 60, 90 days, and one year after RAPR authorization to inquire about study status and dissemination of results.

RAPR - Graduate Medical Education Research (GMER)

GMER corresponds to research or quality improvement projects that either primarily or significantly involve residents and fellows participating in an AH-sponsored GME program (i.e., medical residencies, podiatry, dental, and chiropractic) or faculty research or quality improvement projects as designated by the respective program directors. The GMER workflow is illustrated in Figure 3.  

Research teams can receive guidance from the GMER support team during the project's planning phase. This team is composed of an administrative director, medical director, research coordinators, research associates, biostatisticians, and a research liaison. During the consultation, the GMER support team can provide project direction and evaluate the feasibility of providing GMER support throughout the study. GMER support is prioritized in the following order: 1) projects driven primarily by residents and fellows with faculty mentorship, 2) funded and unfunded projects of core faculty as designated by the program directors in which resident and fellow involvement is highly encouraged, and 3) other funded faculty project support based on the level and type of support requested. 

Once the study documents are finalized, the project can be submitted by completing a unique GMER REDCap intake form. The GMER liaison will review the submission to ensure it is complete and complies with all applicable policies and procedures. If any information is missing, the study team will be contacted before proceeding with the scientific review.

The scientific review can be either 1) a fast-track review for quality improvement studies requiring resources, 2) a fast-track review for most retrospective studies, or 3) an expanded review for prospective observational or interventional clinical trials. Scorecard evaluation forms for retrospective and prospective studies (Table 1) are sent to three or four clinical and non-clinical experts via REDCap. Two of the reviewers are GMER office leaders (unless otherwise designated). The study must have at least a score of 70% to receive RAPR authorization. The PRC review requires discussing the project at a PRC meeting, where scientific reviewers, GMER support team members, service line leaders, and research support managers may be invited to provide feedback and reach a consensus decision. Concurrently with the scientific review, the research liaison notifies research support managers via REDCap to complete the feasibility evaluation, including assessing available resources and the study budget if applicable. Once the scientific and feasibility reviews have been completed, the GMER office will authorize or decline a study. A notification is sent via REDCap to the PI and key personnel. Given the educational lens of GME, regardless of authorizing or declining a study, the GMER office will provide all feedback from reviewers to study teams for study improvements.

Figure 3. Flowchart depicting the Graduate Medical Education Research (GMER) workflow from study submission to follow-up. 

Flowchart depicting the Graduate Medical Education Research (GMER) workflow from study submission to follow-up. The study team may consult with the GMER team (research associate, research liaison, statisticians) to assess the effort required to support the study. After study submission, the research liaison conducts an administrative review and selects scientific reviewers. The scientific review is concurrent with the feasibility review. The corresponding GMER leader must confirm study authorization before proceeding with the REDCap notification to the Principal Investigator (PI) and key personnel. The study submitter receives an automatic REDCap survey to inquire about the Research Authorization and Protocol Review (RAPR) submission. Automatic REDCap follow-up surveys are deployed 60, 90 days, and one year after RAPR authorization to inquire about study status and dissemination of results.  

RAPR - Nursing Research

Nursing research corresponds to studies in which the PI is a nurse. The studies are conducted to fill a gap in nursing knowledge addressing national nursing issues, key strategic nursing priorities, and patient clinical outcomes. Protocols for nursing research include quantitative, qualitative, mixed methods studies, or psychometric testing of a research instrument. Nurse researchers submit their protocols through a unique REDCap link posted on the AH MW nursing intranet page (Nursing Hub SharePoint site). The nursing research workflow is illustrated in Figure 4. 

The Vice-President of Nursing Research (VP Nursing Research) or their designee conducts the administrative review of the research proposal to evaluate its completeness and feasibility, confirm PI eligibility, request IT risk review or contracting services (if applicable), and select scientific reviewers. 

Like the other RAPR workflows, the scientific evaluation utilizes a PRC review for all proposals submitted to the nursing RAPR. Three reviewers score the proposal using the standard evaluation criteria form (Table 1). Concurrently with the scientific review, the VP Nursing Research or designee notifies research support managers via REDCap to complete the feasibility evaluation, including assessing need for research support resources and study budget specifications. All completed reviews are discussed with final authorization or declination of the research study determined by a formal PRC meeting including the VP Nursing Research, scientific reviewers, and ad-hoc research support managers when needed. The PI is notified of the final study disposition decision by the VP Nursing Research. An approved study is authorized for submission to the IRB whereas declined studies can be revised according to the reviewers’ guidance and resubmitted for review by the nursing RAPR. The AH Midwest Nursing RAPR process meets one of the newest (2023) American Nurses Credentialing Center’s (ANCC) Magnet requirements that an infrastructure exists supporting nursing research within the organization seeking Magnet designation for nursing excellence (Center, 2021; Lal, 2021). 

Figure 4. Flowchart depicting the nursing research workflow from study submission to follow-up. 

Flowchart depicting the nursing research workflow from study submission to follow-up. Following the administrative review conducted by the nursing research leader, the proposal receives scientific review. The feasibility and scientific review are simultaneous. The corresponding vice-president of nursing research must confirm study authorization before proceeding with the REDCap notification to the Principal Investigator (PI) and key personnel. The study submitter receives an automatic REDCap survey to inquire about Research Authorization and Protocol Review (RAPR) submission. Automatic REDCap follow-up surveys are deployed 60, 90 days, and one year after RAPR authorization to inquire about study status and dissemination of results.  

RAPR - Sponsored Clinical Trials (CTs) 

CTs correspond to projects designed, directed, and funded by proprietary organizations. Research leaders aligned with oncology, neuroscience, cardiovascular, specialty areas, pediatrics or maternal health service lines perform RAPR for applicable CTs. The sponsored CT workflow is shown in Figure 5.  

The CT research leader will work with the PI and team members to conduct an initial feasibility assessment. This assessment will consider various factors, including, but not limited to, patient impact and potential for enrollment, availability of facility, staff, and services, financial impact, potential study start-up challenges, and alignment with AH Midwest's priorities.

If a CT is deemed feasible, the research leader or delegate will upload the study documents to a Microsoft® Teams folder and provide access to reviewers, including clinical experts and research support managers, as applicable. The CT is discussed at a PRC meeting and scored using standard criteria (Table 1). Once a determination has been made, relevant study information is submitted to REDCap by a clinical research coordinator (CRC). The REDCap Sponsored CT intake form captures information such as the AARI study number, sponsor protocol, National CT number, date of the PRC review, PRC scorecard evaluation form, and key personnel information. Once this form is completed and saved, REDCap triggers an automatic decision notification to authorize the CT, and an accompanying message is sent to the PI. 

For all the RAPR areas, the RAPR authorization notification is set up in REDCap and includes a customized message that includes: 1) Study number, 2) Study title, 3) Principal Investigator name and degree, 4) Confirmation of RAPR authorization and PI eligibility, 5) Contingencies, if applicable, 6) Reviewers’ recommendations, if applicable, and 7) Instructions to submit the project to the IRB office. The recipients of the RAPR notification include the PI, study submitter, corresponding AARI leader, research support managers, and additional personnel, as applicable.

If a study is not authorized, the leader of the corresponding research area will customize the decision notification detailing the reasons the proposal was not authorized. The leader may contact the PI personally and provide additional feedback.

Figure 5. Flowchart depicting the Sponsored Clinical Trials (CT) workflow from study submission to Research Authorization and Protocol Review (RAPR) notification. 

Flowchart depicting the Sponsored Clinical Trials (CT) workflow from study submission to Research Authorization and Protocol Review (RAPR) notification. Following the feasibility review conducted by the service line leader, the proposal receives a Protocol Review Committee (PRC) review. The study is discussed at a PRC meeting via Microsoft Teams with research leaders, clinical reviewers, and research support managers from Pharmacy, Business and Epic services as well as Information technology (IT). Once a RAPR determination has been made, the proposal is submitted to REDCap by a clinical research coordinator (CRC), and a REDCap notification is sent to the Principal Investigator (PI) and key personnel. After the PI has secured IRB authorization, the project is managed in OnCore as the Clinical Trials Management Software.

Following the feasibility review conducted by the service line leader, the proposal receives a Protocol Review Committee (PRC) review. The study is discussed at a PRC meeting via Microsoft Teams with research leaders, clinical reviewers, and research support managers from Pharmacy, Business and Epic services as well as Information technology (IT). Once a RAPR determination has been made, the proposal is submitted to REDCap by a clinical research coordinator (CRC), and a REDCap notification is sent to the Principal Investigator (PI) and key personnel. After the PI has secured IRB authorization, the project is managed in OnCore as the Clinical Trials Management Software. 

Discussion

The primary goal of AH is to advance care and to help our patients and the communities we serve to live well. Research embedded in our system serves as a catalyst to achieve this goal. RAPR was designed not only to create consistent processes across Illinois and Wisconsin, but also to ensure selection and authorization are transparent, awarded to sponsored and investigator-initiated studies of the highest quality and impact, and projects are feasible to support scholarly activity of institutionally sponsored GME programs. The nursing specific RAPR process is an important component of the AH Nursing Research infrastructure and strategy for advancing nursing research and dissemination thereby supporting Magnet recognition of nursing excellence (Lancaster et al., 2023). 

REDCap implementation creates a robust workflow for each research area, a standardized and transparent review process, and a continuous report of institutional research portfolio metrics. To the best of our knowledge, this is the first report of an academic or research institution using REDCap (Harris et al., 2019; Patridge & Bardyn, 2018; REDCap, n.d.) as the web-based management software for submitting, reviewing, and authorizing studies requiring institutional approval before IRB review. 

RAPR Implementation 

The National Institutes of Health (NIH) mission is to "seek fundamental knowledge about the nature and behavior of living systems and to apply that knowledge to enhance health, lengthen life, and reduce illness and disability" (National Institutes of Health, n.d.). To accelerate translational research, efficient research administration and continuous improvement efforts are crucial for adapting to the ever-evolving research landscape.   

Historically, AARI and other research areas had a semi-structured, but less robust, research review process prior to IRB submission. While this was beneficial for resource allocation and other ancillary reviews, a more robust and standardized process was needed. The AARI launched RAPR in February 2022 after two years of planning and piloting. Multidisciplinary teams, including scientists, clinicians, leaders, resource managers, and administrative personnel, developed the RAPR workflows and specific forms. As a result, the process was widely accepted from inception by all responsible areas.  

The implementation of RAPR was done simultaneously across research areas. Investigators and key personnel were notified in advance of the new submission and review process via group emails and various research communications. Additionally, relevant RAPR submission processes and links were posted on the corresponding research areas' SharePoint sites. RAPR is a mandatory prerequisite for IRB submission. If an investigator circumvents RAPR, the IRB will not begin their review until after the proposal is routed back through the RAPR process.

Critical facilitators for a successful RAPR implementation included: 1) clear mandate from institutional leaders that RAPR is a mandatory requirement for research studies, 2) available RAPR consultation for investigators to assess the operational and financial feasibility of sponsored and investigator-initiated research, 3) experienced and committed reviewers, including clinical and scientific experts, epidemiologists, statisticians, research associates, and research liaisons that can offer valuable insight and recommendations for protocol improvement, 4) improved quality of the research project after RAPR review, which facilitates subsequent IRB review and authorization, and 5) a RAPR Policy and Standard Operating Procedure (SOP) that outlines the submission, review, and authorization process across research areas. 

REDCap Features 

REDCap is a web-based application developed by Vanderbilt University to capture data for clinical research and create databases for projects (Harris et al., 2019; REDCap, n.d.). Although other web-based systems have been reported to be used by healthcare systems to streamline research administrative approvals (Bian et al., 2014; Murphy et al., 2012; Wood & Campion, 2022) and manage clinical trials (Campion et al., 2014; Mullen et al., 2023; Wood & Campion, 2022), these platforms are commercially available for a fee and require training before implementation. In contrast, REDCap offers a secure, customizable, intuitive, user-friendly, and compliant web-based interface without an institutional licensing fee. REDCap has key features that make it a suitable platform for RAPR: 

Reliable: REDCap offers a secure and reliable web connection, allowing the RAPR office to streamline the research review process without glitches since its implementation in November 2023.   

Accessible: The REDCap Intake Form is publicly accessible to researchers through survey links available on the AARI Investigator Hub SharePoint site and other corresponding research areas' SharePoint sites. Submitters can complete the intake and submit their proposal to the RAPR from anywhere at any time. No login is required. 

Intuitive: REDCap is a user-friendly tool for investigators, reviewers, and administrators. Intuitive data entry ensures that team members with little computer experience can quickly learn REDCap. No technical knowledge or prior experience is needed.

Autonomous utilization: The RAPR office has complete autonomy and control over customization and functionality without the need for a programmer. REDCap can quickly adapt to changes in policy, process, and requirements without disrupting existing system services.

Customizable: REDCap allows administrators to customize intake form questions and scorecard evaluation forms, track projects, and deploy feedback surveys by using advanced features such as file uploading, data validation, branching logic, calculated fields, smart variables, and piping. 

Informative: REDCap provides reports and statistics for any data collection instrument in the workflow, including study information, scientific review, resource utilization, RAPR determinations, and follow-up.  

Compliant: REDCap is compliant with the Health Insurance Portability and Accountability Act (HIPAA), federal regulations, and international standards. Most importantly, REDCap has institutional technological support to meet AH security policies and user needs. 

To evaluate the efficiency and utility of REDCap for RAPR, it is essential to analyze metrics for all workflow steps. Table 2 provides a summary of relevant metrics for studies authorized by RAPR using REDCap. Since its implementation on November 1, 2023, through January 30, 2025, a total of 251 studies have been authorized by RAPR, with an average approval timeline of 13.8 days. 

Table 2. Summary of studies submitted to REDCap since implementation (November 1, 2023 - January 30, 2025)

REDCap has proven to be user-friendly, placing a minimal burden on investigators. Once a study is approved, REDCap sends an automatic notification to the submitters along with a brief survey link. This survey asks about their satisfaction with REDCap's functionality. The available options are very unsatisfied, unsatisfied, somewhat satisfied, satisfied, and very satisfied. To date, 55% of investigators reported being very satisfied, while 45% indicated they were satisfied with REDCap's functionality.

From an enterprise perspective, REDCap has enhanced communication among key stakeholders while reducing administrative burdens by automating notifications to scientific reviewers, research support managers, leaders, and investigators. The customization of REDCap was accomplished by the RAPR project manager within 30 days, without the need for additional personnel for implementation. Finally, REDCap is available at no cost for REDCap Consortium partners worldwide. The cost savings of utilizing REDCap as the management software for RAPR is estimated at $36,000 per year, demonstrating that the use of REDCap is both efficient and cost-effective.

RAPR Strengths

Human Subject Research (HSR) must comply with ethical and regulatory requirements (United States Department of Health and Human Services, n.d.). An important ethical requirement is that HSR must have a scientifically sound design and statistical plan while being operationally feasible to provide a reasonable chance of generating new knowledge. RAPR ensures that HSR complies with accepted standards of scientific quality and operational feasibility prior to IRB submission. 

Scientific and clinical reviewers are expected to assess protocols based on the definitions given for the evaluation criteria (Table 1). RAPR aligns with the recommendations outlined in the CTSA Consortium Scientific Review Committee (SRC) Consensus Working Group Report on the scientific review (Selker et al., 2015, 2020), which recommends a framework for protocol assessment that precedes IRB review. However, RAPR has been adapted to comply with institutional priorities, internal policies, and GME scholarly activity requirements. 

One of the strengths of RAPR is the availability of ad honorem clinical and scientific reviewers. To serve as a reviewer, the following requirements must be met: 1) have the relevant scientific or clinical expertise to review the project, 2) not be members of the study team, 3) have no conflict of interest, and 4) be available and willing to review the study in a timely manner.

The goal of the RAPR is to ensure the clinical significance, scientific merit, feasibility, and well-defined outcomes of research conducted within the organization. Implementing a RAPR process or a similar approach could help manage a diverse range of research projects within academic or research institutions. It offers an opportunity to establish a centralized process to review various research projects, develop a standardized review across the organization, streamline the authorization of studies that are feasible and align with institutional priorities, create a comprehensive database of authorized studies and track periodic operational metrics across the institution.

RAPR Limitations

Although RAPR has been fully implemented across research areas, there are some limitations to the process including: 1) lack of responsiveness from PIs to the reviewers' recommendations, 2) limited resources available to unfunded proposals as support is prioritized to funded research, 3) RAPR has no control over the negotiation and execution of contracts that occurs after RAPR authorization which may lead to potential delays in study start-up, and 4) proposals including health technology such as wearables, software, websites, medical and mobile devices, and Electronic Data Capture (EDC) Systems require Information Technology (IT) risk review, which also may lead to potential delays in study start-up. 

Conclusion

This article outlines the successful implementation of RAPR by AH Midwest. RAPR provides a centralized process for the submission and review of research studies across several research areas; coordinates study reviews in a sequential or parallel manner; serves as a liaison among investigators, reviewers, and research administrators; selects studies that are feasible and meritorious; and provides metrics to enable continuous reassessment and quality improvement. Customization of REDCap has enabled RAPR to develop a robust workflow for tracking study authorization and guiding process improvement.

Acknowledgement

We would like to thank Carolina Leiterman for technical assistance with REDCap. We thank AH leaders, Nina Garlie, Denise Angst, and Lisa Sullivan Vedder for their vision and guidance throughout the developing and implementation phases of RAPR. We offer special thanks to former AH leader Dennis Baumgardner for their dedication to graduate medical education and guidance in early stages of RAPR. Finally, we are thankful to all the AH teammates from AARI, GMER, and Nursing Research for their unwavering support of RAPR operations.

Funding Source

No external funding was secured for RAPR implementation.

Conflict of Interest

All authors have no conflicts of interest to disclose. 

Corresponding Author

Correspondence concerning this article should be addressed to Angela Andrea Navarrete-Opazo, Advocate Aurora Research Institute, 960 N 12th Street, 4120, Milwaukee, WI 53233, 414-534-7897, angela.navarreteopazo@aah.org.

Angela Navarrete-Opazo
Advocate Aurora Research Institute, Advocate Health 

Cheryl Lefaiver
Advocate Aurora Research Institute, Advocate Health  

Mercedes Robaina
Advocate Aurora Research Institute, Advocate Health 

Jessica Kram
Academic Affairs, Advocate Health 

Vida Vizgirda
Center for Nursing Research Excellence, Advocate Health

Laura Wrona
Advocate Aurora Research Institute, Advocate Health  

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