IRB Support and Research Ethics
An Institutional Review Board reviews research involving human participants to confirm it's ethical and that risks to participants are managed. Praxia Insights prepares and manages IRB submissions, writes protocols and consent materials, and advises on research ethics for studies that need review.
IRB submission is where a lot of research projects lose a month they hadn't planned for. The protocol comes back with questions, the consent language needs rewriting, and the timeline everybody agreed to no longer works
Most of that is avoidable. Reviewers ask the same categories of question, and a submission written by somebody who knows what they'll ask goes through faster and comes back with fewer revisions.
Our researchers hold current CITI certification in the responsible conduct of social and behavioral research, and we've taken studies through IRB approval before, including for a federally funded multi-site study.
Discuss your IRB submission
What We Prepare
The protocol
The full description of what the study does, who participates, how they're recruited, what data is collected, how it's stored, and what the risks are, and this is the document reviewers actually read closely.
Data management and security plan
How data is collected, stored, de-identified, shared, and eventually destroyed. Boards have been scrutinizing this section more closely in recent years.
Consent and assent materials
Consent forms written at a reading level participants can actually follow, plus assent materials for minors and permission forms for parents or guardians where the study involves children.
Responses to reviewer questions
Almost every submission comes back with questions, and answering them well is what determines whether you get approved on the second pass or the fourth.
Recruitment materials
The flyers, emails, scripts, and screener language participants will see, which reviewers examine for anything that could read as coercive or misleading.
Amendments and continuing review
When a study changes mid-stream or needs annual renewal, we'll handle the paperwork so it doesn't fall to somebody already running the study.
Working With Your IRB or Finding One
If your organization has its own IRB, and universities, hospitals, and larger nonprofits usually do, we'll work through it and follow their forms and process.
If you don't have one, and plenty of organizations doing legitimate research don't, an independent IRB can review your study for a fee. We'll advise on whether your study needs review at all, since some research is exempt or doesn't meet the federal definition, and on which route makes sense if it does.
Ethics Beyond the Paperwork
IRB approval is a floor and not a ceiling. A study can be fully approved and still handle people badly.
The questions worth asking go further than the form does. You want to know whether the incentive is fair for what you're asking of somebody, and whether a participant can genuinely say no without consequence, which matters enormously when you're recruiting your own students, employees, or clients. It's also worth asking whether the way you report findings could identify somebody in a small community, and whether the people being studied get anything at all out of taking part.
We think about those as part of designing a study, and we'll raise them with you when something in a design doesn't sit right.
Project Examples
A NIH-funded study examining neuropsychological predictors of adaptation after trauma.
A five-year randomized control trial (RCT), funded by the U.S. Department of Ed, to study individualized math instruction.
Led a national survey study in partnership with Berklee BEATL & Adobe to study AI use in the music industry.
How We Work
1. Initial consultation and plan
We meet to discuss your specific needs and confirm this is the right approach for the decision you're facing.
2. Project scoping and budget
You receive a custom scope of work with tasks, due dates, and budget before any work begins. Fixed scope, no hourly surprises.
3. Project execution
You receive updates on progress throughout, including recruitment status and fielding milestones.
4. A true partnership approach
We share insights with you as they come up throughout the project, so your team can start acting on what we learn long before the final report is finished.
5. Project completion
We deliver final insights in the format your team will actually use, whether that's a written report, an executive presentation, or a working session.
Frequently Asked Questions
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An Institutional Review Board is a committee that reviews research involving human participants to confirm the study is ethical, the risks are reasonable, and participants are giving genuine informed consent. Federally funded research involving human subjects generally requires it, and many institutions require it regardless of funding.
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It depends on whether it meets the federal definition of research with human subjects, and on your institution's own rules. Some studies are exempt, some qualify for expedited review, and quality improvement and internal program evaluation often fall outside the definition entirely. Tell us what you're planning and we'll tell you which category you're likely in.
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Exempt and expedited reviews often come back in two to four weeks. Full board review can take six to twelve weeks depending on the board's meeting schedule and how many rounds of questions come back. Build it into your timeline early, because it's a common reason projects slip.
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It depends on the complexity of the study and how much of the documentation you need written from scratch. Reviewing and strengthening a draft you've already prepared costs the least, and preparing a full submission for a multi-site study with vulnerable populations costs the most. We'll give you a fixed-scope quote after an initial consultation.
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An independent IRB can review your study for a fee, and that's a normal route for organizations without their own board. We'll advise on whether review is needed and which option fits your study and budget.
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Yes. Research with minors requires assent from the child alongside permission from a parent or guardian, and boards look at those materials carefully. Our team has run research in K-12 schools across all 50 states and managed a federally funded study with middle school students.
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Yes, and this is a common point to bring us in. Send us the submission and the board's questions, and we'll draft the responses and revise the documents. Most of these can be resolved in one round when the answers are specific.
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Yes. Our researchers hold current CITI certification in the responsible conduct of social and behavioral research and in conflict of interest, and we've taken studies through IRB approval before.
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Tell us early and we'll tell you honestly what's possible. Sometimes a study can be designed to qualify for exempt or expedited review, and those move much faster. What we won't do is help design around a review the study genuinely needs.
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Yes, and it's worth doing. Plenty of research falls outside IRB requirements and still involves real people who can be harmed by careless handling. Consent, incentives, confidentiality, and how findings get reported all deserve thought regardless of whether a board is checking.
Our Experience
More than 60 studies designed, including case study, quasi-experimental, RCT, and mixed-method designs
More than 100 focus groups and in-depth interviews conducted
More than $4 million in grant-funded research managed
Clients spanning Fortune 500 companies, startups, nonprofits, universities, and federally funded programs
Our researchers hold doctorates in educational neuroscience, psychology, and related fields
Need help getting through IRB?
Tell us about the study, your institution, and your timeline, and we'll advise on what review you need and what it would take.