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Understanding Artificial Intelligence Through the IRB Lens

  • QT Press
  • Jan 1
  • 7 min read

Updated: Jan 7

You're using ChatGPT to help draft your IRB protocol. Or maybe Whisper for AI transcription of research interviews. Then it hits you: Do I need IRB approval for this?


The short answer: probably yes.

The good news: it's not as scary as it sounds.


This guide covers everything researchers need to know about using AI tools for research ethically, getting IRB approval fast, and avoiding common pitfalls. Whether you're conducting qualitative research with AI transcription or using machine learning for data analysis, understanding IRB requirements saves time and protects your participants.


Blog cover for "Understanding Artificial Intelligence Through the IRB Lens" featuring a neural network, magnifying glass examining code about ethics and consent, and floating words like privacy and compliance against a dark tech-inspired background.


Why AI Tools Trigger IRB Review (And Why That's Actually Good)


Artificial intelligence is moving faster than most IRBs know how to handle. While AI tools offer huge advantages for academic research, faster transcription, better data analysis, broader participant reach, they also create new ethical challenges around privacy, consent, and data security.


Here's the thing: IRBs aren't anti-AI. They're anti-risk.


When you use AI in human subjects research, you're introducing new variables:

  • Where does participant data go?

  • Who (or what) has access to it?

  • Can it be deleted permanently?

  • Might the AI introduce bias into your findings?


These aren't hypothetical concerns. They're real risks that require thoughtful answers.



The Rise of AI in Academic Research: What's Changed


As internet mediated research expands, many investigators have turned to AI tools to support their work. Artificial intelligence refers to computer systems designed to mimic human intelligence to perform tasks such as robotics, decision making, game strategies, and machine learning.


Internet-mediated research has exploded over the past few years. Researchers now conduct studies entirely online; recruiting participants through social media, collecting data via digital surveys, and analyzing results using AI-powered tools. AI as a digital resource is not new, but public use increased significantly when generative AI tools like ChatGPT and Midjourney became widely accessible.


This shift brings massive benefits:

  • Faster participant recruitment

  • Access to diverse, global populations

  • Real-time data collection

  • Automated analysis of large datasets


Researchers may use AI tools to help with generating ideas, analyzing text, organizing information, summarizing large volumes of data, or supporting certain administrative tasks. While these benefits are significant, they also create new ethical questions that must be reviewed by the IRB.


But it also creates vulnerabilities that traditional in-person research never faced:


  • Data breaches from unsecured cloud storage

  • Bot interference in online surveys

  • Algorithmic bias in AI analysis

  • Participant re-identification from supposedly anonymous data


The Bot Problem Nobody Talks About

One of the most common challenges in internet mediated research is the presence of bots. Bots are AI driven programs created to complete tasks quickly, often for financial compensation from online surveys or incentives. They can seriously mess up your research data by:


  • Providing nonsensical responses

  • Inflating sample sizes with fake participants

  • Introducing patterns that look human but aren't

  • Compromising data integrity


Basic attention checks help, but sophisticated AI bots are getting harder to detect. This is why IRBs increasingly ask about verification methods for internet-mediated research.


When Does “I’m just using ChatGPT/Whisper/Claude/etc.” Trigger IRB Scrutiny?


Almost always. Here's the reality check:


Most researchers think AI tools are "just software", like using Microsoft Word or Excel. But when AI tools process human subjects' data, they become part of your research methodology. And that triggers IRB review.

How You’re Using AI

Why the IRB Classifies It as More Than “Just a Tool”

Using AI transcription (Whisper, Otter.ai, etc.)

  • Creates verifiable records from private, identifiable data

  • Transcription accuracy affects data integrity and participant privacy

  • Most free AI transcription services use your data for model training

Analyzing interviews with ChatGPT or Claude

  • The model is performing analysis on identifiable human subjects data

  • Third-party APIs mean data leaves your institution's control

  • Most LLM providers aren't HIPAA-compliant by default

Generating synthetic data or mock participants

  • Risk of AI "hallucinating" realistic but false confidential information

  • Could create ethical issues if synthetic data is mistaken for real

Using AI to screen or recruit participants

  • The AI is making decisions about living individuals

  • Potential for algorithmic bias in participant selection

Using AI image/audio tools on participant photos or voice recordings

  • Creates risks of deepfakes or misuse

  • Participants may not have consented to AI processing

Using AI to "anonymize" or "clean" data

  • LLMs frequently fail at true de-identification

  • IRBs consider this a research procedure requiring human verification


The 4 Questions Every IRB Will Ask About Your AI Tools


When you submit a research protocol using AI, expect these questions:


1. Human Subjects Protections

The IRB must determine whether AI tools will directly interact with participants or indirectly analyze personal data. Even AI that operates only on recordings or transcripts may still count as human subjects research if the data contain identifiable information.


What you need to explain:

  • Exactly what data the AI sees

  • Whether participant identifiers are present

  • How AI outputs will be verified by humans


2. Data Privacy and Security

What the IRB wants to know:

  • Where is participant data stored?

  • Who has access to it (including AI vendor employees)?

  • Does the AI vendor store, copy, or reuse your data?

  • Is data encrypted in transit and at rest?

  • Does your AI tool comply with HIPAA, FERPA, GDPR, or CCPA?


What you need to explain:

  • Your data handling workflow step-by-step

  • Vendor agreements (especially Business Associate Agreements for HIPAA)

  • Data retention and deletion policies


This is why many academic researchers and research teams choose professional research transcription services like Qualtranscribe over free AI tools. IRB approval happens faster when data security is already handled.


3. Algorithmic Transparency

What the IRB wants to know:

  • What does the AI actually do with the data?

  • What are its limitations?

  • How are errors detected and corrected?

  • Are AI decisions reviewed by humans?


What you need to explain:

  • The AI's purpose in your research methodology

  • Known accuracy rates or error margins

  • Your human oversight process


This is particularly important in qualitative research where nuance, emotion, and context matter.


4. Risks of Bias

What the IRB wants to know:

  • How was the AI model trained?

  • Could it produce biased results for certain demographic groups?

  • How will you verify the AI isn't introducing or amplifying bias?


What you need to explain:

  • The AI's training data (if known)

  • Your bias mitigation strategies

  • Plans for human review of AI outputs


AI models can inherit biases from training data. For example, speech recognition AI trained primarily on American English might perform poorly on participants with accents, potentially excluding certain voices from your research.


Real IRB Cases: What Worked and What Didn't


Case 1: Nursing Study Using GPT-4


The Setup: Researchers wanted to use GPT-4 to code open-ended patient feedback from focus group transcription.


IRB Decision: Initially returned for revision


Why: No Business Associate Agreement (BAA) with OpenAI, and consent forms didn't mention AI analysis.


The Fix: Researchers switched to an on-premises AI model that didn't send data to external servers. Approved in one revision cycle.


Lesson: Always check if your AI vendor offers HIPAA-compliant options with BAAs.


Case 2: Education Dissertation with Claude


The Setup: PhD researcher using Claude for AI transcription and summarization of student focus groups.


IRB Decision: Approved with minor modifications


Why it worked: Researcher added clear consent language about AI use and used Anthropic's VPC enterprise instance that keeps all data private.


Lesson: Transparency in consent forms + secure AI deployment = smooth IRB approval.


Case 3: Sociology Study with Whisper


The Setup: Qualitative researcher using OpenAI's Whisper for interview transcription.


IRB Decision: Initially rejected, then approved


Why rejected: The free Whisper API sends audio to OpenAI servers where data might be retained.


The Fix: Researcher switched to self-hosted Whisper large-v3 model on university's high-performance computing cluster.


Alternative fix: Many researchers simply use human-verified transcription services like Qualtranscribe instead. Getting IRB-compliant transcripts without technical setup headaches.



Free AI tools often come with hidden data privacy costs.


The Most Common IRB Questions About AI


Prepare for these questions in your protocol:


Q: "Does your AI provider use uploaded data to train its algorithms?"

  • Check the vendor's terms of service carefully

  • Many free AI tools do use your data for training

  • Enterprise/paid tiers often exclude your data from training


Q: "Can participant data be permanently deleted?"

  • Document the vendor's data retention and deletion policies

  • Get written confirmation if needed

  • Consider using self-hosted AI models for sensitive research


Q: "How will you anonymize data before AI processing?"

  • Explain your de-identification process

  • Note: Simply removing names often isn't enough

  • Consider using professional academic transcription services with built-in anonymization


Q: "Will humans verify all AI-generated outputs?"

  • Always answer yes

  • Explain your verification process

  • Document who performs verification and their qualifications


Q: "Can participants opt out of AI analysis?"

  • Include this option in your consent form

  • Explain alternative data processing methods

  • Be prepared to handle opt-outs manually


Q: "How will you handle incidental findings?"

  • Example: AI detecting potential mental health indicators in interview transcription

  • Have a protocol ready for unexpected discoveries

  • Know when you're required to report findings


💡 Pro tip: IRB-compliant research transcription services handle most of these concerns automatically. Get a quote for your dissertation transcription


IRBs Support Innovation, When It's Done Responsibly


Here's something many researchers don't realize: IRBs want your research to succeed.

They're not trying to block your use of AI transcription, machine learning analysis, or automated data collection. They're ensuring that:


  • Human subjects remain protected

  • Data is handled ethically and securely

  • Participants give truly informed consent

  • Research integrity is maintained

  • Privacy risks are minimized


When you present AI tools clearly, address security proactively, and show strong human oversight, most IRB-compliant research protocols get approved quickly.


The researchers who face delays usually:

  • Assume AI tools don't need disclosure

  • Underestimate data privacy concerns

  • Fail to verify AI vendor security practices

  • Don't explain their human verification process


Why Human Oversight Still Matters (Even With Advanced AI)

AI is powerful, but it's not infallible. Human researchers are still essential for:


Accuracy verification:

  • Catching AI transcription errors

  • Identifying misunderstood context

  • Correcting cultural or linguistic mistakes


Ethical judgment:

  • Recognizing when AI introduces bias

  • Handling sensitive participant disclosures appropriately

  • Making nuanced decisions AI can't make


Contextual understanding:

  • Interpreting emotion and tone

  • Understanding cultural references

  • Recognizing sarcasm, humor, or ambiguity


Regulatory compliance:

  • Ensuring IRB requirements are actually met

  • Documenting processes properly

  • Maintaining audit trails


Your IRB Approval Checklist for AI Tools

Use this checklist when preparing your protocol:




The Bottom Line: AI Can Accelerate Research When Used Ethically


Understanding AI through the IRB lens isn't just about compliance, it's about conducting better, more ethical research. AI tools can accelerate research, but they also introduce privacy, bias, and transparency risks that IRBs must evaluate carefully. The researchers who succeed with AI in human subjects research don't try to hide their AI use, they showcase it as a thoughtful, well-planned methodological choice that enhances research quality while protecting participants.



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