Module Components

• Overview
• Assignments

Topics

• Non-Human Subject Research (NHSR)
• NHSR Application Example
• NHSR Application Process
• NHSR Determination

NDNP 811 - DNP Project Development

Module 2:HRPO Submission Process

NON-HUMAN SUBJECT RESEARCH APPLICATION PROCESS

All student DNP projects must be submitted to the University of Maryland Baltimore (UMB) Human Research Protections Office (HRPO) through their online submission portal (CICERO) for a Non-Human Subject Research (NHSR) determination. To prepare for this process, all students should create a CICERO account and forward the account verification email to faculty by the deadline indicated in the Class Schedule in the course syllabus. Project Faculty Advisors will be designated as the Responsible Party (Primary Investigator) on the application and are responsible for initiating and adding the student to the application in CICERO. Students will be listed as Secondary and will be responsible for inputting the required information into CICERO. The information will then be reviewed and formally submitted by the project faculty advisors as the Responsible Party (Primary Investigator).

The only documents that should be uploaded in the CICERO submission are data collection tools/forms (e.g., instruments, demographic forms, training documents, data management spreadsheet). Do NOT upload documents that reflect the specific practice changes such as protocols, checklists, algorithms, pathways, policy, references, teaching plans, or any documents other than data collection tools/forms.

CICERO NON-HUMAN SUBJECTS RESEARCH PROCESS

The process for UMB HRPO submission is the same for all DNP students regardless of the type of project or project site. The following information is required for a CICERO NHSR application. It is prudent to re-visit the videos and slides provided in the Overview to prepare for this submission. Comments in red are directions on how to complete this portion of the application.

INTRODUCTION PAGE

1. Abbreviated Title (include “NDNP 811:” at the beginning of the title)
2. Full Title (include “NDNP 811:” at the beginning of the title)
3. Select type of submission (check “Unsure if this proposal requires IRB review”)
4. Original version # (leave this blank)

CONTACT INFORMATION - NHSR

1. Responsible Party: the name of the faculty member goes here
2. Secondary: DNP Student name goes here
3. Other persons: Can list other people but each person listed must have current CITI, GCP, and HIPAA training documentation

PROJECT SUMMARY

Place the project summary (previously graded by project faculty and vetted by the UMSON Quality Research Manager) here. The summary should be BRIEF – limited to one page.
• See the previous topic tab for details regarding a properly constructed summary
• Cut and paste the summary into the text box provided in the application

HUMAN RESEARCH UNDER DHHS REGULATIONS

1. Is the activity an investigation
   • A searching inquiry for facts; detailed or careful examination.
     
     Yes/No - answer Yes
     
     
2. Is the investigation systematic?
   • Systematic: Having or involving a system, method, or plan.
     
     Yes/No - answer Yes
     
     
3. Is the activity designed to develop or contribute to knowledge?
   • Designed: evaluate whether the activities will develop or contribute to knowledge.
   • Develop: to form the basis for a future contribution.
   • Contribute: to result in.
   • Knowledge: truths, facts, information.
     
     Yes/No - answer Yes
     
     
4. Is the knowledge the activity is designed to develop or contribute generalizable?
• Generalizable: Universally or widely applicable.
  
  Yes/No - answer No
  
  If you say yes to this question, you project may be considered as research requiring the submission of a full application. If you answer yes, the following set of questions will be asked to determine if the project includes human subjects

Human Research Under FDA Regulations

No student should be conducting a project that falls under FDA regulations and therefore these answers should all be “No”. If you think your project requires you to answer “Yes” to any of these questions please contact your faculty advisor.

1. Is the activity conducted in the United States and involves the use of a drug in one or more persons that is NOT the use of an approved drug in the course of medical practice?
   
   Yes/No
   
   
2. Is the activity conducted in the United States and evaluates the safety or effectiveness of a device in one or more persons?
   
   Yes/No
   
   
3. Is data regarding subjects or control subjects going to be submitted to or held for inspection by FDA as part of an application for a research or marketing permit?
   
   Yes/No
   
   
4. Is data regarding the use of a device on human specimens going to be submitted to or held for inspection by FDA as part of an application for a research or marketing permit?
   
   Yes/No

Human Research Determination Summary - no response required here

Based on the answers you provided to the previous questions, this activity does not appear to be Human Research. However, other Federal, State, and local laws and/or regulations may apply to the activity. The HRPO staff will review your answers to verify whether or not your activity involves human research. Please do not proceed with your proposed activity until you have received confirmation, in CICERO, from the HRPO that your activity does not qualify as Human Research according to DHHS or FDA regulatory definitions.

NHSR - Additional Documents

• Provide data collection tools as attached files.
• File names must exactly match the naming used in the summary, ie, file name: Appendix A: Beck’s Inventory
• DO NOT include any other nomenclature on the attached file name such as your name, course, project title