C. Methods, Materials, and Analysis

The Research Plan is a narrative of the study and is a living document to be maintained over the life of the protocol. A Research Plan is required for every protocol submitted for IRB review.

  • When drafting the Research Plan, follow the format and use the section headings (i.e. A – I) provided below, refer to the bulleted items for section content.
  • For each section, this guidance includes a description of why the information is important for IRB review (in italics).

C. Methods, Materials and Analysis

The study design, methods and procedures must be adequately described in order for the IRB to understand all activities in which human subjects will participate. The IRB must also be able to differentiate those procedures that are performed for research purposes from those that are performed for routine care or evaluation.

The focus of this section is on methods and procedures. Risks must be discussed later in Section G.

  • Describe the study design and research methods used to meet the study aims and objectives stated above (e.g., on-line survey, open ended interview, randomized controlled trial, participant observation, field based research, lab/task based, etc.).

  • If there will be multiple groups of participants completing different sets of activities/tasks, clearly delineate the activities to occur for each group.

  • Describe in chronological order all research activities/procedures involving participants. This should walk the reader step-by-step through the research activities and include a description of the research procedures and instruments.

    • Include the title and descriptions of any measures, questionnaires, tasks, tests, and/or procedures. Titles need to be used consistently throughout the description(s).

    • The description must include whether these are standardized in the field or designed for this specific study.

    • Depending on the complexity or number of procedures, consider inserting a table or attaching an inventory list of measures or questionnaires as an appendix.

    • If the research involves any procedures typically used in a biomedical/clinical setting and/or administration of medications (e.g., blood draw, ultrasound, MRI, x-rays/radiographs, etc.) include the following:

      • The justification for the use of the procedures

      • The dosage

      • The qualifications of study personnel to conduct the procedures

    • If research will be conducted at the Lewis Center for Neuroimaging (LCNI), the investigator will need to work with the LCNI director to ensure research procedures are in line with their standard operating procedures. The Research Plan will need to reference the established LCNI SOP in the Research Plan.

    • If using deception, discuss the related activities, what that deception entails, and when and how the debriefing process will occur.

  • Include an estimate of the time each participant will spend completing the activities (in minutes or hours), the number of sessions the participant will engage in, and the total length of participation (in days, weeks, months, or years) from the beginning to the end of the study.

  • If follow-up with participants is planned, discuss the procedures and under what circumstances follow-up will occur.

  • Describe the methods of data collection and recording that will be utilized in the study (e.g., hand-written notes, survey platform, computer programs, videotapes, audiotapes, photographs, etc.).

  • Describe the specific locations where the activities will be conducted (i.e., in what labs, clinics, field sites, or online platforms will the procedures occur?). The investigator must determine if additional local, State and/or international policies and regulations are applicable to the research and include this information in the Research Plan.

  • Explain how the data will be analyzed/studied (i.e., quantitatively or qualitatively and what statistical tests are planned), how the interpretation will address the research questions, and how the research will be disseminated.

    • Describe how the data will be reported (e.g., aggregated, anonymously, pseudonyms for participants, etc.).