The IRB (Institutional Review Board) application process protects human subjects in research. For students, the typical timeline is 2-8 weeks depending on review level: Exempt (1-2 weeks), Expedited (3-4 weeks), or Full Board (1-2 months). Key requirements: complete CITI training beforehand, work closely with your faculty advisor, submit a complete protocol with informed consent documents, and respond promptly to revision requests. You cannot collect any data until you receive formal written approval.
What is an IRB and Why Do Students Need It?
An Institutional Review Board (IRB) is an administrative body charged with protecting the rights, safety, and welfare of human subjects in research. Federal regulations (45 CFR 46) require IRB review for any research involving human participants that is conducted by an institution receiving federal funding—which includes most universities.
For students, IRB approval is typically required for:
- Undergraduate honors theses
- Master’s theses and dissertations
- Doctoral dissertations
- Independent research projects intended for publication or presentation
- Course-based research projects that will be shared outside the classroom
Important: You cannot begin any data collection, recruitment, or analysis involving human subjects until you have received formal written IRB approval. This includes surveys, interviews, observations, and even accessing private records.
Note: If your project is purely for classroom learning and will not be shared beyond the course, it may qualify as “non-research” and not require IRB review. However, always confirm with your faculty advisor or institutional IRB office.
Before You Start: Essential Preparations
1. Complete Required Training
Most institutions require completion of the CITI Program’s Human Subjects Research (HSR) training before submitting an IRB application. Key points:
- Choose the correct track: Social & Behavioral Educational (SBE) for most humanities/social sciences; Biomedical for medical/health research
- Duration: The course takes approximately 4.5 hours to complete
- Passing score: Typically 80% or higher
- Validity: Training certificates are valid for 3-4 years
- Documentation: You’ll need to upload your completion certificate with the application
Pro tip: Some institutions require additional modules for vulnerable populations (children, prisoners, etc.). Check your university’s specific requirements.
2. Consult Your Faculty Advisor Early
Your faculty advisor or sponsor is your most valuable resource throughout the IRB process:
- They should review your research questions and methodology before you start the application
- They can help determine the likely review level (exempt, expedited, or full board)
- They will often need to co-sign the application or serve as the Principal Investigator (PI)
- They can help interpret IRB feedback and draft revision responses
3. Develop Your Research Protocol
An IRB protocol is a group of documents that conveys all necessary information about your research to reviewers. You’ll need:
- Clear research questions and hypotheses
- Detailed methodology (participants, recruitment, procedures, data collection)
- Risk assessment (physical, psychological, social, legal risks)
- Benefits analysis (direct benefits to participants or societal benefits)
- Confidentiality plan (data storage, anonymization, retention period)
- Informed consent process (script, form, or information letter)
Resource: For guidance on developing research questions, see our article on How to Write a Research Question: Examples by Discipline.
Understanding the Three Levels of IRB Review
The IRB categorizes studies into three review types. Your study’s risk level determines which category applies.
Exempt Review
What it means: Studies that qualify for exemption do not undergo continuing review after initial approval, and modifications don’t need submission as long as the research remains minimal risk.
Typical student projects:
- Anonymous surveys on non-sensitive topics
- Educational research in standard classroom settings
- Analysis of existing de-identified public data
- Observations of public behavior where subjects cannot be identified
Timeline: 1-2 weeks
Who reviews: IRB Chair or designated member
Expedited Review
What it means: Studies presenting no more than minimal risk that meet specific federal criteria. Review is conducted by the IRB chair or designated members.
Typical student projects:
- Interviews or focus groups with adults on non-sensitive topics
- Collection of biological specimens (e.g., saliva, blood) via non-invasive methods
- Research involving children with minimal risk
- Studies using voice, video, or digital recordings
Timeline: 3-4 weeks (depending on completeness and revision cycles)
Who reviews: IRB Chair or members
Full Board Review
What it means: Studies involving more than minimal risk, vulnerable populations, or sensitive topics require review by the fully convened IRB committee.
Typical student projects:
- Research involving prisoners, pregnant women, or individuals with impaired decision-making capacity
- Studies with sensitive personal information (health data, illegal behaviors, etc.)
- Research with deceptive practices that may cause distress
- Studies involving more than minimal risk of harm
Timeline: 1-2 months (meetings occur monthly or bimonthly)
Who reviews: Full IRB committee at a convened meeting
How to decide: The IRB makes the final determination, but you can estimate your level by considering: Is there any chance participants could experience physical, psychological, or social harm? Could participants be identified from the data? Are you studying vulnerable populations? If yes to any, expect Expedited or Full Board.
Step-by-Step IRB Application Process
Step 1: Prepare Your Research Protocol
Start by drafting a comprehensive protocol document. Use plain language—remember, reviewers are not necessarily experts in your field. Include:
Protocol Description:
- Research objectives and hypotheses
- Participant criteria (inclusion/exclusion)
- Recruitment methods (flyers, email, snowball sampling)
- Exact procedures (what participants will do, how long it takes)
- Data collection instruments (survey questions, interview guides)
- Data analysis plan
Risk Mitigation:
- How you’ll protect confidentiality (coded data, secure storage)
- What risks exist and how you’ll minimize them
- Debriefing procedures if deception is used
Example: Instead of writing “participants will complete a survey,” write: “Participants will be recruited via campus flyers and email listservs. They will complete a 15-minute online survey using Qualtrics, answering 25 multiple-choice and short-answer questions about their study habits. Data will be stored on the researcher’s password-protected computer. Participants will receive a $10 Amazon gift card upon completion.”
Step 2: Create Informed Consent Documents
Informed consent is the cornerstone of ethical human subjects research. Your consent document must include:
- Purpose of the study in layperson terms
- Procedures described clearly (what participants will do, time commitment)
- Risks (even if minimal, state them explicitly)
- Benefits (to participants or society)
- Confidentiality protections (who will have access, how long data retained)
- Voluntary participation statement and right to withdraw
- Contact information for the researcher and IRB
- Compensation (if any) and any costs to participants
Common formats:
- Consent form: Signed document (for in-person studies)
- Information letter: Used for online surveys where signed consent is impractical (includes statement “By completing this survey, you indicate your consent to participate”)
Template: Many universities provide consent templates. Check your IRB website for examples.
Step 3: Gather Supporting Materials
- CITI training certificates for all research team members (including advisor)
- Data collection instruments (survey questions, interview protocols, observation checklists)
- Recruitment materials (flyers, email scripts, social media posts)
- Data management plan (where and how data will be stored)
Step 4: Submit Through Your Institution’s Portal
Most universities use an electronic submission system (e.g., IRBNet, RAMP, eIRB). The process:
- Create an account and log in
- Select the appropriate application type (New Study, Revision, Renewal)
- Upload all documents (protocol, consent forms, instruments)
- Answer all questionnaire items completely
- Submit to your faculty advisor for review (they may need to approve before IRB submission)
- Submit to the IRB office
Critical: Incomplete applications are returned without review, causing significant delays. Use your institution’s pre-submission checklist if available.
Step 5: Respond to IRB Reviews and Revisions
After submission, you’ll receive one of the following:
Administrative Screening (within 5-7 business days):
- Checks for completeness
- If incomplete, you’ll receive a “Request for Revisions” with specific missing elements
- Fix and resubmit; this cycle can repeat until the application is complete
Scientific/ Ethical Review:
- Exempt/Expedited: Reviewer provides approval, approval with conditions, or revision requests
- Full Board: You’ll present at a meeting (sometimes by proxy); committee votes to approve, approve with conditions, defer, or disapprove
Responding to Revisions:
- Address every comment point-by-point
- Use a response letter that quotes each reviewer comment and explains how you addressed it (include page/line numbers)
- Highlight changes in the revised documents (use track changes or color)
- Submit through the same portal
Example response: “Comment 1: Please clarify inclusion criteria. Response: We revised the protocol (page 2, line 15) to state: ‘Participants must be undergraduate students aged 18 or older enrolled at XYZ University.'”
Step 6: Receive Approval and Begin Research
Once approved, you’ll receive an approval letter with:
- Approval period (usually 12 months)
- Any conditions or reporting requirements
- Required modifications if you change the protocol later
Keep this letter—you may need to show it to department chairs, journal editors, or conference organizers.
Important: Any changes to the approved protocol require an amendment submission to the IRB before implementation.
Common IRB Application Mistakes (And How to Avoid Them)
Based on guidance from multiple university IRB offices, these are the most frequent errors:
1. Incomplete or Inconsistent Information
Problem: Different documents say different things (e.g., survey length is 10 minutes in the protocol but 15 minutes in the consent form).
Fix: Cross-check every detail across all materials. Ensure participant time estimates match exactly.
2. Poorly Written Consent Forms
Problem: Using technical jargon, writing in the 3rd person about the IRB (“the IRB requires…”), or missing required elements.
Fix: Write to the participant, not the IRB. Use simple language at an 8th-grade reading level. Include all federal-required elements (purpose, procedures, risks, benefits, confidentiality, contacts, voluntary nature).
3. Insufficient Detail on Procedures
Problem: Vague descriptions like “participants will answer questions” without specifying what questions or how long.
Fix: Provide exhaustive detail: exact survey questions, interview script, observation protocol. Attach instruments as appendices.
4. Inadequate Risk Description
Problem: Claiming “no risks” when there are potential psychological, social, or legal risks (e.g., questions about illegal drug use, trauma experiences).
Fix: Honestly assess even minimal risks (embarrassment, discomfort, data breach). Describe how you’ll mitigate them (confidentiality, debriefing, referral resources).
5. Missing CITI Training Documentation
Problem: Forgetting to upload certificates for all team members.
Fix: Create a checklist; have all team members complete training before you start the application.
6. Not Starting Early Enough
Problem: Submitting a week before data collection must begin.
Fix: Allow at least 4-6 weeks for the entire process (longer for full board). Start at least 2 months before your planned data collection.
7. Faculty Advisor Not Involved
Problem: Student submits without advisor review; advisor later finds issues.
Fix: Establish a timeline with your advisor for draft reviews before submission. Some institutions require advisor electronic sign-off.
8. No Response to Revisions
Problem: Ignoring revision requests or taking months to respond.
Fix: Check your email and portal daily after submission. Respond within 1-2 weeks to keep the process moving.
Source: Common mistakes compiled from NYU, Edgewood College, Wright State, Brandeis, and Oregon State IRB offices.
How Long Does IRB Approval Take?
Timelines vary by institution, review type, and time of year. Here are typical estimates:
| Review Type |
Typical Timeline |
Best-Case |
Worst-Case |
| Exempt |
1-2 weeks |
5 business days |
3 weeks |
| Expedited |
3-4 weeks |
2 weeks |
6+ weeks |
| Full Board |
1-2 months |
6 weeks |
4+ months |
Factors that affect timeline:
- Completeness of initial submission: Incomplete apps are returned immediately
- Revision cycles: Each back-and-forth adds 1-3 weeks
- Submission volume: High at semester start/end; summer may be slower due to board member availability
- Quality of response to revisions: Clear, thorough responses speed up re-review
Realistic planning:
- Exempt: Submit 2-3 weeks before you need approval
- Expedited: Submit 6-8 weeks before
- Full Board: Submit 10-12 weeks before
Note: You cannot begin any research activities (recruitment, data collection, interviews) until you have the approval letter in hand. Plan accordingly.
What to Do If Your Application is Rejected or Needs Revisions
Rejection or “Revise and Resubmit” is common, especially for first-time applicants. Don’t panic—it’s part of the process.
Understanding the Outcomes
- Revise and Resubmit (Most Common): The IRB has identified issues (e.g., in recruitment, consent, risk management) that must be addressed before approval.
- Denied/Rejected: The proposal cannot be approved as written due to significant ethical concerns or high risk.
- Withdrawal/New Submission: If revisions are extensive or the student has failed multiple revisions, the IRB may withdraw the application and require a new submission, often with the faculty advisor taking a more active role.
Steps to Take
- Read the feedback letter carefully. The IRB coordinator or chair will list specific concerns.
- Consult your faculty advisor immediately. They can help interpret comments and plan revisions.
- Make specific changes to the protocol, consent forms, or procedures as requested.
- Draft a point-by-point response letter. Quote each comment and explain how and where you addressed it in the revised document (e.g., “See Protocol page 3, line 20”).
- Resubmit through the portal promptly. The same reviewer or sub-committee usually reviews revisions.
If You Disagree with the Decision
You have the right to:
- Appeal in writing to the IRB Chair, providing evidence and rationale
- Request a discussion with the IRB chair to clarify concerns
- Attend a convened meeting (in some institutions) to present your case, though you typically cannot be present during the final vote
Important: Institutional officials cannot overrule an IRB disapproval. The appeal must demonstrate that the IRB made an error in applying regulations or overlooked evidence.
Special Considerations: Undergraduate vs Graduate Research
While the basic process is the same, there are important differences based on academic level.
Undergraduate Research
- Scope: Usually limited to classroom projects, senior theses, or small-scale minimal-risk studies
- Review level: Often qualifies for Exempt or Expedited review
- Faculty role: Advisor often serves as PI or co-investigator with high oversight
- Timeline: Typically faster due to simpler designs
- Publication intent: Many undergraduate projects are not intended for publication; if they are, full review is required
Key tip: Even if your project is for a class, if there’s any chance it will be presented outside campus, submit for review now—retroactive approval is not possible.
Graduate Research (Master’s and Doctoral)
- Scope: Independent research for theses/dissertations, often more complex and higher risk
- Review level: Frequently requires Expedited or Full Board review
- Faculty role: Student often acts as PI with faculty as sponsor; student takes full compliance responsibility
- Documentation: More extensive (detailed protocols, data management plans, extensive consent)
- Generalizable knowledge: Graduate research is almost always considered aimed at contributing to generalizable knowledge, necessitating formal approval
Key tip: Graduate students should complete CITI training early (before coursework begins) and discuss research design with advisors and IRB offices during the proposal stage to avoid major redesigns later.
Resources and Templates
Many universities provide valuable resources:
- IRB websites with checklists, templates, and frequently asked questions
- CITI Program (https://about.citiprogram.org/) for training
- Sample protocols and consent forms (check your institution’s repository)
- Pre-submission consultations (some IRBs offer one-on-one meetings for student researchers)
Useful tools:
- IRB checklists from UCLA, Stanford, and other institutions to self-assess completeness
- Protocol writing guides from Columbia and Cornell
- Consent form templates adaptable to your study
Internal Resources at QualityCustomEssays.com
Frequently Asked Questions
Q: Can I start my research while waiting for IRB approval?
A: No. Any data collection, recruitment, or interaction with human subjects requires prior approval. Starting early is considered research misconduct.
Q: How long is IRB approval valid?
A: Typically 12 months from the approval date. Some studies require continuing review annually. If your study extends beyond the approval period, you must submit a renewal application before expiration.
Q: Do I need IRB approval for my class project?
A: If the project is solely for learning purposes and won’t be shared outside the classroom, it may not require review. However, if you plan to present at a conference, publish, or use data beyond the course, you need approval. When in doubt, ask your instructor or IRB office.
Q: What if my study involves multiple institutions?
A: You may need to obtain approval from each institution’s IRB, or rely on a single IRB if they have a reciprocity agreement. Discuss with your advisor early.
Q: Can I make changes after approval?
A: Yes, but you must submit an amendment for any changes that affect participant risk, consent, or procedures (e.g., adding questions, changing recruitment, extending study duration). Minor administrative changes may not require review—check your institution’s policy.
Q: What happens if I conduct research without IRB approval?
A: Consequences can be severe: your data may be discarded, you may fail the course or degree requirements, your research cannot be published, and institutional sanctions may affect your academic record. Plan ahead and get approval first.
Conclusion and Next Steps
The IRB application process may seem daunting, but with careful preparation, it’s entirely manageable. Here’s a checklist to guide you:
Before You Apply:
- ✅ Complete CITI training (and any additional modules)
- ✅ Develop your research question and methodology
- ✅ Discuss with your faculty advisor
- ✅ Draft your protocol and consent documents
- ✅ Gather all supporting materials (surveys, recruitment scripts)
During Application:
- ✅ Answer every question thoroughly
- ✅ Upload all required documents
- ✅ Have your advisor review before submission
- ✅ Submit well in advance of your desired start date
After Submission:
- ✅ Monitor email and portal daily
- ✅ Respond to revision requests within 1-2 weeks
- ✅ Keep your approval letter once received
- ✅ Submit amendments for any protocol changes
Remember: The IRB’s goal is not to obstruct research but to protect participants and researchers. By following ethical guidelines and submitting a complete, well-prepared application, you’ll navigate the process smoothly and be conducting your research in no time.
Need Help with Your IRB Application?
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- Protocol drafting and revision
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