Describing Study Strands in an IRB Application

For a mixed methods study, Institutional Review Board (IRB) applications (or ethics committee submissions) require clear, precise descriptions of each research strand to demonstrate ethical integrity, minimize risks, and ensure participant protections. The IRB needs to understand how qualitative and quantitative elements integrate without overlap or confusion. Focus on objectives, methods, participants, data collection, and analysis for each strand, while explaining their interplay.

I'll break this down step-by-step, assuming a typical mixed methods design (e.g., convergent parallel or sequential). Adapt this to your specific study—replace placeholders (e.g., [topic]) with your details. If your study is sequential (one strand informs the other), emphasize that linkage.

1. Overall Study Overview

Start with a high-level summary in the IRB application (often in Section 1: Study Description). This sets the context before diving into strands.

Example Text:
"This is a mixed methods study investigating [briefly state aim, e.g., 'the impact of remote work on employee mental health in tech firms']. The study employs a convergent parallel design, collecting qualitative and quantitative data simultaneously and integrating them during analysis to provide a comprehensive understanding. Both strands involve human participants and adhere to ethical standards for informed consent, confidentiality, and risk minimization. The quantitative strand assesses prevalence and correlations via surveys, while the qualitative strand explores experiences through interviews. Integration will occur at the interpretation stage to triangulate findings."

• Why this works: It signals the mixed methods nature early, justifies the approach (e.g., why mixed methods over single-method), and previews integration to show methodological rigor. Cite relevant guidelines like Creswell & Plano Clark's mixed methods framework if applicable.

2. Describing the Quantitative Strand

Dedicate a subsection (e.g., under "Research Design" or "Procedures") to this strand. Be explicit about sampling, instruments, and data handling to address validity and reliability concerns.

Key Elements to Include:

• Objectives: What specific questions does this strand address? (E.g., "To quantify the relationship between remote work hours and stress levels.")


• Participants: Number, recruitment method, inclusion/exclusion criteria (e.g., "200 full-time tech employees, recruited via company email lists; must be 18+ and employed ≥6 months").


• Methods/Data Collection: Tools (e.g., validated surveys like the Perceived Stress Scale), format (online via Qualtrics), duration (e.g., 15-20 minutes), frequency (one-time).


• Analysis: Statistical methods (e.g., regression analysis in SPSS).


• Ethical Considerations: How risks (e.g., survey fatigue) are mitigated; data security (e.g., anonymized storage on encrypted servers).

Example Text:
"The quantitative strand uses a cross-sectional survey to measure key variables. Participants (n=200) will complete an anonymous online questionnaire assessing [variables, e.g., 'work hours, stress levels, and productivity']. Recruitment will occur through purposive sampling from [source, e.g., three partnering tech companies], with informed consent obtained via an initial digital form. The survey includes validated scales: the 10-item Perceived Stress Scale (PSS-10) and a custom productivity index (Cronbach's α > 0.80 in pilot testing). Data will be collected over 4 weeks, with each session lasting 15-20 minutes. Analysis will involve descriptive statistics and multiple regression to identify predictors of mental health outcomes. To ensure confidentiality, responses will be de-identified immediately, stored on a password-protected university server compliant with HIPAA/GDPR, and accessible only to the research team. Minimal risks include temporary discomfort from self-reporting; participants can withdraw at any time without penalty."

• Tip: If your quant strand involves experiments or interventions, detail those here (e.g., pre/post measures). Quantify everything possible to build credibility.

3. Describing the Qualitative Strand

Mirror the structure from the quantitative section but emphasize depth over breadth. IRBs scrutinize qualitative work for emotional risks (e.g., sensitive topics) and bias in interpretation.

Key Elements to Include:

• Objectives: Exploratory aims (e.g., "To understand lived experiences of remote work challenges.").


• Participants: Subset or separate sample (e.g., "20-25 interviewees selected via stratified sampling from survey respondents; purposive for diversity in role/gender").


• Methods/Data Collection: Techniques (e.g., semi-structured interviews), mode (Zoom or in-person), duration (e.g., 45-60 minutes), probing questions.


• Analysis: Approach (e.g., thematic analysis using NVivo).


• Ethical Considerations: Rapport-building, debriefing, handling distress; transcription anonymity.

Example Text:
"The qualitative strand consists of in-depth semi-structured interviews to capture nuanced perspectives on [topic, e.g., 'remote work's emotional toll']. A subset of 20-25 participants will be purposively selected from the quantitative survey pool to ensure diversity (e.g., varying tenure and demographics). Interviews, lasting 45-60 minutes, will be conducted virtually via Zoom, with audio recorded only after verbal consent. An interview guide will cover topics like daily routines and coping strategies, allowing flexibility for emergent themes. Data will be transcribed verbatim and analyzed using Braun and Clarke's thematic analysis framework in NVivo software, with member checking for accuracy. Ethical safeguards include obtaining written consent outlining voluntary participation and right to skip questions; interviews will pause if distress arises, with referrals to counseling resources provided. All recordings/transcripts will be pseudonymized, stored securely for 5 years post-study, and destroyed thereafter. Risks are low but may include revisiting stressful experiences; benefits include contributing to workplace policy improvements."

• Tip: If sequential, note how quant informs qual (e.g., "Interviewees selected based on high-stress survey scores"). Highlight reflexivity (your role as researcher) to address bias.

4. Integration and Overall Procedures

End with how strands connect, as IRBs evaluate the whole study for coherence and efficiency (e.g., avoiding redundant participant burden).

Example Text:
"Data from both strands will be integrated during the interpretation phase using joint displays (e.g., side-by-side comparison of survey correlations and interview themes) to explain divergences or convergences, such as why quantitative data shows low stress prevalence but qualitative reveals hidden coping mechanisms. No new data collection occurs post-integration. Total participant burden is approximately 1 hour (survey + optional interview). The study timeline is 6 months, with full IRB oversight."

• Why this works: It demonstrates methodological justification, reducing approval delays.

Additional IRB Tips

• Attachments: Include protocols (survey/interview guides), consent forms, recruitment scripts, and data management plans. For mixed methods, a flow diagram visualizing strands can clarify.


• Risks/Benefits: Discuss cumulatively (e.g., "Combined strands offer holistic insights without increasing risks beyond individual components").


• Common Pitfalls to Avoid: Vague language (e.g., say "thematic analysis" not "analyze interviews"); assuming IRB knows mixed methods—define terms.


• Resources: Consult your institution's IRB template (e.g., via Cayuse or ERICA systems). Reference APA ethics guidelines or COREQ for reporting standards. If international, align with local regs (e.g., GDPR in EU).


• Next Steps: Pilot test descriptions for clarity. If you share more study details (e.g., your field or specific methods), I can refine this further.

This structure should help your application sail through review—IRBs appreciate transparency in complex designs. If you need help with other sections like consent forms, let me know!