Research Ethics and the IRB: Protect the People in the Study
Signature Course No. 462 — A Signature AI Socratic Coaching Course.
No law degree and no prior board service needed — your coach starts where you are.
A New Kind of Learning
Socratic coaching, delivered by an agentic AI coach.
Not a course you watch. An AI coach you work with.
The Lighthouse Coach begins by discovering how you think about the subject, teaches what is missing, and gives you realistic practice before asking you to prove that you can use it. You may test out of concepts you already understand, while capstones turn the learning into a practical plan, decision, conversation, or other real-world result.
The curriculum is deliberately authored; the AI delivers it through coaching. It is not an AI randomly generating lessons.
A coach that teaches by asking — not by lecturing
The Lighthouse Coach is an AI Socratic coach built on Cognosco Learning's Research Ethics and the IRB: Protect the People in the Study course, in the Risk, Safety & Compliance category. It does not play videos at you. It holds a conversation: it asks you a question, listens to your answer, names the misconception it hears, affirms what you got right, and asks the next question — the way a great coach works in the room.
A protocol is a promise made to strangers. The review is where the promise is tested before a stranger is asked to trust it. Every study that involves people asks something of them — their time, their information, their bodies, their trust — and the person asking and the person being asked do not stand in equal positions. This course teaches the system that grew out of that history as a working discipline, in two seats at once: the seat of the investigator who submits a protocol, and the seat of the reviewer who must decide whether people may be asked to take part in it.
It starts with the three Belmont principles. Respect for persons, beneficence, and justice — not as slogans for a wall poster but as tests you apply to a protocol in front of you: deliberation possible, choice unpressured, protection added where deliberation is thin; risks inventoried by category and weighed, as residual risk, against benefits the design can actually deliver; and selection judged by why these people, why not those people, and who gains if it works.
It works in two movements. First, Module 1 — The Framework and the First Review — work through Concepts 1–9, finishing with The Submission That Earns Approval; then, Module 2 — Added Protections and the Life After Approval — work through Concepts 10–18, finishing with The Study That Changed Midstream.
Both capstones produce real artifacts — a review memorandum on a new submission at the fictional Estenbrook University: coverage and routing determined, the three principles applied as findings, every approval criterion at 46.111 tested on evidence, consent judged against the protocol, and stipulations drafted that a reply can actually satisfy; and an oversight memorandum on an approved study that has changed and stumbled — an amendment reaching a protected population, a stolen laptop holding a linkage key, and a consent deviation with a pattern — with the file assembled that proves every judgment.
The honesty standard is part of the course. When this course names a regulation, it names the provision in the Code of Federal Regulations — Title 45, Part 46, the Common Rule — checked against the regulation itself. Where a provision has subparts, conditions, or exceptions, the course says so rather than smoothing them away. And the limit is stated plainly: this course teaches judgment inside a framework; it is not legal advice, and it does not promise any regulatory outcome. Institutions apply the Common Rule through their own policies and their own review boards, and decisions about a specific protocol belong to the institution and its board, on its own facts.
The course is self-paced and always on — roughly 30 minutes per concept, about 9 hours in full, taken in as many sittings as you like. You can type your answers, or talk out loud: the Voice Coach speaks its questions and listens to your spoken replies. Learners who already know the material can test out concept by concept.
Research Ethics and the IRB: Protect the People in the Study is part of The Lighthouse Signature Series — the online counterpart to the one-day, in-person learning Cognosco Learning delivers.
Course Facts
One full concept, coached end to end — free: verify your email and we’ll send you a link to start.
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Diagnose → Learn & Practice → Prove → Capstone
Every learner moves through the same discipline a Cognosco instructor would insist on in the room.
Diagnose
The Coach starts where the course starts: with respect for persons. Think of a study that recruits through a relationship of dependence — a teacher studying her own students, a clinician studying his own patients — and say where exactly the pressure on the decision lives. A prospective participant reads slowly and asks no questions: what are three different explanations for that silence? Name a population whose autonomy you would call diminished, and the safeguard you would add first. Every concept opens with three questions that locate where you actually stand, and your answers shape how deeply the Coach works the concept with you. Everyone begins with Module 1 — no skipping the foundations you only think you have.
Learn & Practice
Work each concept in conversation with the Coach — spoken or written — then practice it against realistic situations until it holds up.
Prove
Every concept ends in proof: answer the check cold and demonstrate the skill. Know it already? Test out and take credit immediately.
Capstone
Finish with two capstones — The Submission That Earns Approval for Module 1 and The Study That Changed Midstream for Module 2 — that pull the whole course together, and earn the certificate.
What You'll Learn
The determination, not the impression. Review work is a chain of determinations — covered or not covered, exempt under which category, minimal risk or greater, approvable against each criterion or not yet — and each determination must be statable in a sentence that names its authority. A reviewer who cannot name the section has an impression, not a determination, and impressions do not survive an audit, an appeal, or a participant's complaint.
Module 1 builds the framework and the first review. The three Belmont principles as working tests; coverage from the definitions at 46.102; the board itself — membership, authority, and how a board may act; choosing the review path and reading the eight exemptions at 46.104(d) category by category; the approval test at 46.111; and consent as process under 46.116.
Module 2 adds the protections and follows the life after approval. Consent on paper — documentation, waivers, and alterations under 46.116(f) and 46.117; the added protections of Subparts B, C, and D for pregnant women, neonates, prisoners, and children; privacy and confidentiality; amendments, continuing review, and reportable events; noncompliance, suspension, and reporting; the investigator's side of the table; deception, secondary use, and broad consent; and one IRB across many sites — reliance, records, and the file that proves the review.
And it holds its boundary throughout. This course teaches the review side of human subjects research: it ends where study conduct begins, at approval, at oversight of the approved protocol, and at the ethics of the protocol itself. Running a study once approval is granted — conduct at a research site and the day-to-day operations of a study — belongs to a different course on this shelf.
What you will learn
- Apply the Belmont principles — respect for persons, beneficence, and justice — as working tests to a protocol
- Decide whether an activity is research involving human subjects under 45 CFR 46, and which parts of the rule apply to it
- Choose the correct review path — exemption, expedited review, or the convened board — and state the authority for the choice
- Test a protocol against the approval criteria at 45 CFR 46.111 and write determinations a record can support
- Judge informed consent as a process and as a document against 45 CFR 46.116 and 46.117, including waivers and alterations
- Apply the added protections for pregnant women, neonates, prisoners, and children under Subparts B, C, and D
- Judge privacy and confidentiality protections, amendments, continuing review, and reportable events after approval
- Recognize noncompliance, suspension, and reporting duties, and assemble the record that proves a review happened as claimed
Everything in the course
- All 18 concepts of Research Ethics and the IRB: Protect the People in the Study, in 2 modules
- A starting-point check first — the Coach finds where you actually stand before teaching
- Learn, Practice, Prove for every concept — no passive video watching
- A test-out on every concept: prove you know it and move on
- The Voice Coach: talk with the Coach out loud — it speaks, listens, and replies
- A personal Learner Record of your work across the course
- Two capstone exercises: The Submission That Earns Approval and The Study That Changed Midstream
- A printable session summary whenever you pause
- The Lighthouse Coach completion certificate (Signature Series)
- Your progress is saved as you go — stop anytime, resume where you left off
Built for the people who submit, review, and oversee protocols
Investigators and study staff who submit protocols — faculty, graduate researchers, and research coordinators who must build submissions that answer the board's questions before the board has to ask them; and review board members and administrators — new members, alternates, and human subjects office staff who must make determinations they can defend from the record.
Research administrators and compliance staff — who route submissions, track approvals and amendments, and recognize the moment a problem becomes reportable.
Graduate and professional students — whose first protocol will teach them either that the review is a hurdle to clear or that it is the discipline of protecting people; this course teaches the second. This course assumes no law degree and no prior board service. It assumes a willingness to read a regulation closely and to argue from its text rather than from habit.
Prefer to learn live and in person? The same material anchors Cognosco's one-day programs — browse the in-person catalog.
Start with Respect for Persons
$195 — introductory price. One payment. No subscription, no password to manage.
Here is exactly what happens when you enroll:
- Pay securely with Stripe — you are taken straight into the course
- Create your learner profile and begin the Module 1 starting-point check
- Save the access key you are given — it restores your enrollment on any device
- Learn at your pace; your progress is stored in your browser on your device
For the full voice experience, use Chrome and allow the microphone when asked. Typing your answers works everywhere, all the time. Questions before you enroll? Email hello@cognoscolearning.com.
Before you enroll
What is a Socratic coaching session?
A conversation, not a video. Your coach asks a question; you answer — out loud by voice, or by typing — and the coach responds to what you said: naming the misconception it hears, affirming what you got right, and asking the next question. You advance only when you have mastered each concept, so a finished course means the learning held.
How long does it take — and how long do I have?
About 30 minutes per concept. Learn in sittings of any length; your progress is saved as you go. You have a full year from purchase to finish, and you can revisit and retake within that year.
What does the certificate verify?
That you completed every concept and both capstones of this course. Anyone can confirm a Cognosco certificate online — enter its certificate ID on our verification page.
What if it isn't for me — what are the refunds?
If you have not started, cancel for a full refund within seven days of purchase. Once you have started, there is no cash refund — stop before finishing and we credit the full amount you paid toward any other course in the library (credit valid one year from your original purchase). Once you complete the course, no refund or credit applies.
More Signature Courses are coming
Research Ethics and the IRB: Protect the People in the Study is Signature Course No. 462. Leave your email and we'll send you news of future Signature Courses and Lighthouse updates as they are announced — nothing else.