Conducting ILE Research

In the Code of Federal Regulations (45 CFR 46.102(d)) pertaining to the protection of human subjects, research is defined as a systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge.¹

A broader definition of research is a systematic investigation of a subject aimed at uncovering new information (discovering data) and/or interpreting relations among the subject’s parts (theorizing).² Research can be understood as the collection and synthesis of data or information to develop new knowledge or understanding. However, the Integrated Learning Experience (ILE) project must be methodical, adhering to a series of pre-designed steps and protocols.

For example, to complete the ILE courses successfully, students must be able to:

• Develop an ILE proposal or concept paper.
• Complete an Institutional Review Board (IRB) application, if applicable.
• Implement the study protocol.
• Compare their findings with the existing scientific literature.
• Discuss the implications of their findings for public health practice, policy, and/or research.
• Draft a high-quality written product, defined by their concentration.
• Present their findings to the Department of Public Health faculty, students, and administrators.

For that reason, the research methods class for each concentration is an important foundational coursefor the ILE. These courses offer guidance on scientific writing and the logical framework necessary for crafting an ILE concept paper and/or proposal. Moreover, research methods courses’ learning activities describe how to select an appropriate research method based on the ILE’s research question(s)/aim(s). In sum, ILE students are strongly encouraged to review materials from their research methods class to develop a strong ILE concept paper, proposal, and final written product.

¹ Office of Research Integrity, Department of Health and Human Services. (n.d.). Module 1: Introduction: What is research? https://ori.hhs.gov/content/module-1-introduction-what-research

² Vogt, W.P. (1993). Dictionary of statistics and methodology. Sage Publication.

Completing an Institutional Review Board (IRB) Application

A human subject is defined as a living individual about whom a researcher—whether professional or student—conducting research either:

• Obtains information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens, or
• Obtains, uses, studies, analyzes, or generates identifiable private information or biospecimens. For more detailed information, refer to the federal website for the protection of human subjects.

While all students will propose a public health study, not all projects will involve human subjects as defined above. The student and their ILE Instructor must first determine whether the proposed research involves human subjects. If it does not, the student is not required to undergo the IRB process.

Students who propose to conduct human subjects research must submit their study to the University and Medical Center IRB (UMCIRB) for prospective review and approval. No research activities, including recruitment, consent, intervention, or interaction with participants, may begin until UMCIRB approval is granted. Students with questions about their proposed research should contact the UMCIRB office via email at UMCIRB@ecu.edu or by phone at 252-744-2914.

IRB submission must be completed in collaboration with the ILE Instructor. The following steps outline the process for submitting a human research study to the UMCIRB for review and approval:

1. Register with ePIRATE, the online IRB submission and review system, if not already registered.
2. Complete the mandatory online CITI training.
3. Create and submit the proposal in ePIRATE. The submission must include, but may not be limited to:
   1. A lay summary of the project
   2. Study team members, including the ILE Instructor (and Content Advisor, if applicable)
   3. Project funding and location information.
   4. Recruitment plans and informed consent documents, or a justification for a waiver of informed consent.
   5. The research proposal, including:
      • A literature review
      • Hypothesis/Research question
      • Goals/Objectives
      • Methodology, including recruitment and consent plan
      • Risks and benefits, with plans to minimize risks.
      • Data collection, management, and destruction plan.
      • Projected number of participants.
      • Discussion of risks and benefits.
4. Establish a plan for closing out the study in ePirate.

Revised 10/27/25