Mock IRB Application Instructions: Type Your Information In

Mock Irb Applicationinstructionstype Your Information In Theshaded Bo

MOCK IRB Application Instructions: Type your information in the shaded boxes and insert an “X” in the applicable checkboxes. Incomplete forms will delay the IRB review process and may be returned.

SECTION A: Investigators & Research Team

A1. Principal Investigator (P.I.): Name:_____ Degree(s):_____ Title/Position:_____ Program:_____ Contact Numbers:_____ Physical Address:_____ MyCampus Email:_____

SECTION B: Research Information

B1: Title

B2: Introduction

Please provide a brief (word) summary of your research project, including background and rationale for your study. Be sure to include what kinds of data you are planning to collect such as surveys, interviews, observations, etc.

SECTION C: Review Type

C1. Does the study involve greater than minimal risk? (Minimal risk means the probability and magnitude of harm or discomfort are not greater than those encountered in daily life or routine exams. More than minimal risk will require Full Committee Review.) Place an “X” next to the appropriate response.

[__] Low/Minimal Risk

[__] Greater Than Minimal Risk

C2. Which level of review do you believe best matches your research? (Exempt, Expedited, or Full). For more info, view categories on the APUS IRB Website.

[__] a. Exempt

[__] b. Expedited

[__] c. Full Board Review

SECTION D: Project Purpose/ Research Question/ Objectives

In non-technical language, address:

  • The topic and scope of the study.
  • The research questions or hypothesis.
  • How this study will contribute to knowledge in the field.

SECTION E: Participant Population and Recruitment

E1. In non-technical language, address:

  • Who will the participants be? How many? What ages?
  • Inclusion/exclusion criteria for participants.
  • Where and how participants will be recruited.

E2. This study will involve participants with the following characteristics (place “X” in all that apply):

  • [__] Not Applicable (e.g., de-identified datasets)
  • [__] Individuals who cannot read/speak English
  • [__] Individuals living outside of the United States
  • [__] Students of PI or Research Team Members
  • [__] Students in educational settings
  • [__] Staff, Faculty, or Students
  • [__] Minors/Children
  • [__] Prisoners
  • [__] Individuals with diagnosable psychological disorders
  • [__] Individuals who are institutionalized
  • [__] Individuals who are poor/uninsured
  • [__] Pregnant women
  • [__] Fetuses
  • [__] Nursing home residents
  • [__] Individuals who are cognitively or psychiatrically impaired
  • [__] Limited or non-readers
  • [__] Wards of the state
  • [__] Individuals who are terminally ill
  • [__] Others vulnerable to coercion (Specify below):
  • [__] Other (Specify below):

SECTION F: Research Design

In non-technical language, address:

  1. The chronological study activities, including research team and participant activities (e.g., screening, surveys, tests, interviews, tasks, recordings, debriefing). If videotaping, photographs, or audio, explain how and why.
  2. How data will be analyzed or studied, indicating any quantitative or qualitative methods.
  3. How data will be reported to protect participant confidentiality or anonymity (e.g., aggregated data, anonymized, using professional roles, names with consent).

SECTION G: Data Collection

Indicate all applicable types with an “X”:

  • [__] Email Questionnaires
  • [__] In-person Interviews
  • [__] Phone Interviews
  • [__] Video Interviews (e.g., Skype, FaceTime)
  • [__] Paper Surveys
  • [__] Online Surveys
  • [__] Audio-recording
  • [__] Video-recording
  • [__] Photography
  • [__] Existing datasets
  • [__] Focus Groups
  • [__] Internet research
  • [__] Observations
  • [__] Questions involving criminal activity
  • [__] Questions about child or elder abuse
  • [__] Review of academic or medical records
  • [__] Exposure to psychological stress
  • [__] Use of physiological sensors
  • [__] Physical exercise
  • [__] Collection of biological specimens
  • [__] Genetic Material
  • [__] Diagnostic imaging (MRI, X-rays, etc.)

Paper For Above instruction

The purpose of this research study is to explore the impact of mindfulness-based stress reduction (MBSR) programs on reducing anxiety and improving overall well-being among college students. This study aims to fill a gap in existing literature by providing empirical data on the efficacy of MBSR interventions within a university setting, particularly focusing on psychological health outcomes. The study hypothesizes that students participating in an 8-week MBSR program will demonstrate significant reductions in anxiety levels and enhancements in subjective well-being compared to control participants not engaging in the intervention.

This research employs a quantitative approach, utilizing pre- and post-intervention surveys to assess changes in anxiety and well-being. The study is designed as a randomized controlled trial involving approximately 100 students aged 18-24 from diverse backgrounds, recruited via campus flyers and email lists. Inclusion criteria entail current enrollment at the university and consent to participate; exclusion criteria include students with ongoing psychiatric treatment or prior experience with mindfulness practices. The participants will be randomly assigned to either the intervention or control group, with assessments occurring at baseline, immediately post-intervention, and at a 4-week follow-up.

Activities include initial screening, informed consent, questionnaire administration, participation in the MBSR program or waitlist control condition, followed by post-intervention surveys. The data will be analyzed using paired t-tests and ANOVA to evaluate changes within and between groups. Confidentiality will be maintained by assigning unique codes to participants and aggregating data prior to reporting, thereby ensuring anonymity and minimizing risk of identification.

The study involves collecting survey data through online questionnaires at three time points, with additional demographic data gathered during initial screening. No sensitive personal data such as medical records or biological specimens will be collected, and risks associated with participation are minimal, primarily related to the time commitment required. The overall goal is to generate evidence supporting mindfulness interventions for mental health promotion in college populations, ultimately contributing knowledge to mental health practices in educational settings.

References

  • Cohen, S., Kamarck, T., & Mermelstein, R. (1983). A global measure of perceived stress. Journal of Health and Social Behavior, 24(4), 385-396.
  • Goyal, M., Singh, S., Sibinga, E. M. S., et al. (2014). Meditation programs for psychological stress and well-being: A systematic review and meta-analysis. JAMA Internal Medicine, 174(3), 357-368.
  • Kabat-Zinn, J. (1994). Wherever you go, there you are: Mindfulness meditation in everyday life. Hyperion.
  • Baer, R. A., Smith, G. T., Hopkins, J., Krietemeyer, J., & Toney, L. (2006). Using self-report assessment methods to explore facets of mindfulness. Assessment, 13(1), 27-45.
  • Shapiro, S. L., Astin, J. A., Bishop, S. R., & Cordova, M. (2005). Mindfulness-Based Stress Reduction for Health Care Professionals: Results from a randomized trial. International Journal of Stress Management, 12(2), 164-176.
  • Chiesa, A., & Serretti, A. (2009). Mindfulness-based stress reduction for stress management in healthy people: A review and meta-analysis. Journal of Alternative and Complementary Medicine, 15(5), 593-600.
  • Segal, Z. V., Williams, J. M. G., & Teasdale, J. D. (2018). Mindfulness-based cognitive therapy for depression. Guilford Publications.
  • Khoury, B., Lecomte, T., Fortin, G., et al. (2013). Mindfulness-based therapy: A comprehensive meta-analysis. Clinical Psychology Review, 33(6), 763-771.
  • Doorley, J. D., & Li, E. (2017). The efficacy of mindfulness interventions in reducing anxiety among college students: A systematic review. Journal of College Student Psychotherapy, 31(4), 273-291.
  • Smalley, S. L., & Winston, D. (2010). Fully Present: The science, art, and practice of mindfulness. New Harbinger Publications.

Note:

This research strictly adheres to ethical standards, emphasizing minimal risk, confidentiality, and voluntary participation, aligning with IRB requirements and guidelines.

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