# IRB Application & Human Subjects Protocol > Draft IRB applications and human subjects research protocols for institutional review board submission. Covers protocol narrative, informed consent, risk/benefit analysis, privacy protections, and participant selection for surveys, interviews, experiments, and clinical research under 45 CFR 46 and 21 CFR 50/56. Tags: IRB, Human Subjects, Research Ethics, Informed Consent, Common Rule, Academic Research ## Example Prompts - Write an IRB protocol for a survey study on workplace stress - Draft informed consent documents for a clinical intervention study - Prepare an expedited review application for an interview-based qualitative study - Create a human subjects protocol for a secondary data analysis of medical records URL: https://rakenne.app/skills/irb-human-subjects/index.md Try this skill: https://rakenne.app/a/?skill=irb-human-subjects ## Overview An IRB protocol is required before any research involving human subjects can begin — and getting it wrong means rejection, which typically delays a study by 2-6 months. Every institution has its own forms, but the underlying regulatory requirements are the same: 45 CFR 46 (Common Rule, as revised in 2018), and 21 CFR 50/56 for FDA-regulated research. The tricky parts aren't the forms themselves — they're determining the correct review category (exempt vs. expedited vs. full board), writing a risk/benefit analysis that satisfies reviewers, correctly addressing privacy and confidentiality for your specific data types, and producing an informed consent form with all required elements under the 2018 revised Common Rule. This skill handles all study types — surveys, interviews, experiments, secondary data, clinical interventions — and adapts the protocol to your review category, vulnerable populations, and institution. ## What It Covers - **Review category determination** — Exempt (8 categories under 45 CFR 46.104(d)), expedited (9 categories under 45 CFR 46.110), or full board review, with regulatory criteria for each - **Protocol narrative** — Background, research questions, study design, methods, data analysis plan, participant selection with sample size justification - **Risk/benefit analysis** — Enumerated risks by type (physical, psychological, social, economic, informational), minimization strategies, and honest benefit assessment - **Privacy & confidentiality** — Identifiers collected, de-identification procedures, data security, HIPAA considerations, Certificate of Confidentiality, limits of confidentiality - **Informed consent** — All 9 basic elements per 45 CFR 46.116(b) (including 2018 revisions), key information requirement, waiver options, consent for minors/LAR - **Vulnerable populations** — Additional protections for children (Subpart D), prisoners (Subpart C), pregnant women (Subpart B), cognitively impaired, students, employees - **Supporting documents** — Informed consent form, assent form, recruitment materials, data collection instruments, CITI training documentation ## Example Conversation > **You:** I'm an assistant professor in psychology. I want to study how remote work affects burnout and job satisfaction. I'm planning an online survey of 500 full-time employees who have been working remotely for at least a year. The survey uses the Maslach Burnout Inventory and the Minnesota Satisfaction Questionnaire, plus some demographic questions. I need to submit an IRB protocol to my university. > **Agent:** This sounds like a strong candidate for **exempt review** under 45 CFR 46.104(d)(2) — survey research with adults where the information is recorded without identifiers (or where disclosure wouldn't place subjects at risk). Let me confirm a few things: > > 1. Will you collect any **identifiable information** — names, email addresses, IP addresses? If the survey is anonymous (no identifiers linked to responses), exemption is straightforward. > 2. Will you ask about **sensitive topics** — substance use, illegal activity, sexual behavior, immigration status? These could change the risk profile. > 3. Are any of your participants **vulnerable populations** — students you teach, employees you supervise, minors? > 4. What platform will you use — Qualtrics, REDCap, Google Forms? This matters for the data security section. > > Important note: **exempt does not mean no IRB submission.** You still need to submit the protocol for the IRB to make the exemption determination — researchers cannot self-exempt. > **You:** Fully anonymous — no names, no emails, no IP logging. I'll use Qualtrics with the anonymous link setting. No sensitive topics — just burnout and job satisfaction scales plus demographics (age range, gender, industry, tenure). Participants are recruited through LinkedIn and Reddit — not my students or employees. No minors — inclusion criterion is 18+. > **Agent:** Perfect — this is a clean exempt case. Anonymous survey, non-sensitive topics, adults only, no power dynamics, and Qualtrics with anonymous link setting (which disables IP logging). I'll draft the protocol for **exempt review under Category 2(i)** — survey research where information is recorded so subjects cannot be identified. > > I'm creating `output/irb-protocol.md`. Let me start with the background section. What's the specific gap in the literature you're addressing? There's a lot of remote work research post-COVID — what's your unique angle? > **You:** Most studies looked at the transition period (2020-2021). I'm focusing on long-term remote workers (3+ years) and whether burnout patterns differ from the initial transition. My hypothesis is that chronic remote work burnout has a different factor structure than acute transition burnout — more depersonalization, less emotional exhaustion. > **Agent:** Interesting — that's a clear gap with a testable hypothesis. I've drafted the background section citing the Maslach Burnout Inventory's three-factor structure and noted the gap in longitudinal remote work research. Now let me work through the risk/benefit analysis: > > **Risks:** > - Psychological: minimal — the MBI asks about feelings of burnout but does not probe trauma or mental illness. Risk is no greater than daily self-reflection. > - Informational: minimal — survey is anonymous, no identifiers collected. Even if data were breached, responses cannot be linked to individuals. > > **Benefits:** > - No direct benefits to participants. I'll state this clearly — payment/compensation is not a "benefit" in IRB terminology. > - Societal benefit: contributes to understanding long-term remote work effects on employee wellbeing, informing organizational policy. > > **Risk/benefit assessment:** Risks are minimal — no greater than those ordinarily encountered in daily life. This is consistent with the minimal risk standard at 45 CFR 46.102(j). > > For compensation — are you offering anything? Gift card, raffle entry? > **You:** $5 Amazon gift card for completing the survey, distributed via a separate form link so the gift card email isn't linked to survey responses. > **Agent:** Good approach — using a separate form link for compensation preserves anonymity. I've documented that the compensation link is accessed from the survey completion page but the two data sources cannot be linked. $5 for an estimated 15-minute survey is proportionate and does not constitute undue inducement. > > I've completed the protocol and informed consent. Since this is an online anonymous survey, I'm using a **waiver of documentation of consent** per 45 CFR 46.117(c)(1)(ii) — minimal risk, no procedures requiring written consent outside the research context. Instead of a signed consent form, participants will see an information sheet on the first survey page with all required elements and will indicate consent by clicking "I agree" to proceed. The information sheet includes the **key information** section required under the 2018 revised Common Rule (46.116(b)(1)). ## Output Excerpt After the agent completes all sections, the output includes the complete protocol narrative and informed consent form. Here is a representative excerpt showing the risk/benefit analysis, privacy section, and the consent information sheet: ```markdown # Human Subjects Research Protocol **Protocol Title:** Long-Term Remote Work and Burnout: Factor Structure Differences in Chronic vs. Transition-Period Remote Workers **Principal Investigator:** Dr. Sarah Chen, PhD **Department/Institution:** Department of Psychology, [University] **Date:** March 2026 **Version:** 1.0 **Funding Source:** Unfunded **IRB Review Category Requested:** ☒ Exempt --- ## 6. Risks and Benefits ### 6.1 Potential Risks | Risk | Type | Likelihood | Severity | Minimization Strategy | |------|------|-----------|----------|----------------------| | Mild discomfort reflecting on burnout experiences | Psychological | Low | Minimal | Participants may skip any question; survey includes a message: "If any questions cause discomfort, you may skip them or discontinue at any time without penalty" | | Breach of confidentiality | Informational | Very Low | Minimal | Survey is fully anonymous: no names, emails, or IP addresses collected. Qualtrics anonymous link setting enabled (IP logging disabled). Compensation collected via separate, unlinked form. | ### 6.2 Benefits **Direct benefits to participants:** There are no direct benefits to participants from this study. The $5 Amazon gift card is compensation for time and effort, not a benefit of participation. **Benefits to others/society:** This study will contribute to the understanding of long-term remote work effects on employee burnout, potentially informing organizational policies around remote work support, hybrid work design, and employee wellbeing programs. ### 6.3 Risk/Benefit Assessment The risks of this study are no greater than those ordinarily encountered in daily life or during routine psychological self- assessment. The minimal risks are reasonable relative to the anticipated societal benefits of understanding chronic remote work burnout patterns, consistent with the minimal risk standard at 45 CFR 46.102(j). --- ## 7. Privacy and Confidentiality ### 7.1 Identifiers Collected This study collects **no identifiable information**. Specifically: | Potential Identifier | Collected? | Explanation | |---------------------|-----------|-------------| | Name | No | Not requested | | Email address | No | Compensation collected via separate, unlinked Qualtrics form | | IP address | No | Qualtrics anonymous link setting enabled; IP logging disabled | | Location data | No | Not requested; no geolocation features enabled | | Audio/video recordings | No | Online survey only | Demographic data collected (age range, gender, industry, tenure) are categorical and cannot be combined to identify individual respondents given the target sample of 500 participants recruited from large- population platforms (LinkedIn, Reddit). ### 7.3 Data Security | Data Type | Storage Location | Security Measures | |----------|-----------------|-------------------| | Survey responses | Qualtrics cloud (SOC 2 Type II, GDPR compliant) | AES-256 encryption at rest; TLS 1.2+ in transit; access limited to PI | | Exported data (for analysis) | [University] OneDrive (institutional) | Password-protected, encrypted; access limited to PI | ### 7.7 Limits of Confidentiality Because this survey is fully anonymous, there are no limits of confidentiality to disclose — responses cannot be linked to any individual. Mandatory reporting obligations (child abuse, imminent harm) do not apply as the survey does not ask about these topics and no identifying information is available to act upon. --- # CONSENT INFORMATION SHEET # (Waiver of Documentation of Consent — 45 CFR 46.117(c)(1)(ii)) ## Key Information - **What:** You are invited to participate in a research study about remote work and burnout. The study involves completing an online survey. - **Time:** The survey takes approximately 15 minutes. - **Risks:** Minimal — you may experience mild discomfort reflecting on your work experiences. You may skip any question. - **Benefits:** There are no direct benefits to you. Your responses will contribute to research on remote work and employee wellbeing. - **Voluntary:** Participation is completely voluntary. You may stop at any time by closing your browser. Your decision will not affect you in any way. ## Detailed Information **Purpose:** This study examines how long-term remote work (3+ years) affects burnout patterns compared to the initial transition to remote work. **Procedures:** You will complete an anonymous online survey including the Maslach Burnout Inventory, the Minnesota Satisfaction Questionnaire (short form), and demographic questions. **Confidentiality:** This survey is fully anonymous. No names, email addresses, or IP addresses are collected. Your responses cannot be linked to you in any way. **Compensation:** $5 Amazon gift card for completing the survey. The gift card is collected through a separate link that is not connected to your survey responses. **Contact:** For questions about this study, contact Dr. Sarah Chen at [email]. For questions about your rights as a research participant, contact the [University] IRB at [phone/email]. **By clicking "I agree to participate" below, you confirm that you are 18 years or older, have been working remotely full-time for at least one year, and voluntarily consent to participate in this study.** ``` The protocol includes all elements required for an exempt determination under 45 CFR 46.104(d)(2)(i), with complete privacy and confidentiality documentation, a risk/benefit analysis using the 45 CFR 46.102(j) minimal risk standard, and a consent information sheet with the key information section required under the 2018 revised Common Rule. ## Getting Started Add your research questions, study design, and any validated instruments to the project workspace, then activate the *IRB Application & Human Subjects Protocol* skill. The agent will determine your review category, collect your study details, and produce a complete protocol narrative with informed consent documents — ready for your institution's IRB submission. --- Back to [Skill Library](https://rakenne.app/skills/index.md)