Do you help run studies with real people? You must ask them if they want to join. This is called informed consent. Most times, they sign a paper to say yes. But sometimes, a signature is not needed. A waiver of the requirement for documentation of informed consent may be granted when the study is very safe or a signature could hurt their privacy. This rule comes from the government in a book called 45 CFR 46.117. It helps scientists, main leaders (called PIs), and review boards (called IRBs) keep things fair, kind, and easy. This long guide uses short words so anyone can read it.
What Is Informed Consent? Let’s Break It Down
Informed consent is like telling a friend all about a game before they play. You say:
- What the study is.
- What they will do.
- Any tiny risks.
- Good things that might happen.
- They can stop any time.
They say “yes” only after they understand everything.
Normally, they sign a form. It is proof they said yes.
But a waiver of the requirement for documentation of informed consent may be granted when the study fits special safe rules. You still tell them everything. They just say yes with words, by clicking a button, or by starting the task.
Why do we have this rule?
- It keeps people safe.
- It stops secrets from leaking.
- It makes studies faster when safe.
The big rule book is the Common Rule. It is from the Department of Health and Human Services (HHS). All schools and labs must follow it.
Who Needs This Guide?
This is for:
- Principal Investigators (PIs) – The main person who runs the study.
- IRB Members – The team that checks if the study is okay.
- Compliance Officers – People who make sure rules are followed.
- Students – Learning how to do research the right way1.
- Lab Helpers – Anyone who talks to people in studies.
If you make plans or check plans, this is for you. Learn more about how to follow federal rules.
Two Big Rules to Skip the Signature
An IRB (review board) looks at your plan. They say yes or no to the waiver. They use two simple rules from 45 CFR 46.117(c)2.
Rule 1: Signature Is the Only Link to the Study
A waiver of the requirement for documentation of informed consent may be granted when:
- The signed paper is the only thing that connects the person to the study.
- The main risk is someone seeing the paper and learning private info.
Example:
You ask people about their health habits. No names on the answers. But if they sign a consent form, their name is on it. If someone finds the form, they know who said what. That is a risk of confidentiality breach.
Fix:
Give them a page that says all the study info. Let them say “yes” out loud or keep going. No signature. No link.
Rule 2: Very Safe Study, No Normal Need for Signature
A waiver of the requirement for documentation of informed consent may be granted when:
- The study has no more than minimal risk. Minimal risk = The chance of harm is the same as a normal day. Like walking to school or eating lunch.
- The study does things you would not sign for in real life.
Example:
You call people and ask, “What is your favorite color?” No one signs a paper to answer that on the phone.
Bold words here: waiver of documentation of informed consent, IRB waiver of consent documentation, waiver of written informed consent, conditions for informed consent waiver, minimal risk research waiver, human subjects research consent waiver.
Table: Two Rules Side by Side
| Rule Number | What It Says | Easy Example |
| 1 | Signature is only link + privacy risk | Secret health survey |
| 2 | Super safe + no real-life signature | Phone poll on snacks |
Two Kinds of Waivers – Know the Difference
People mix these up. Let’s make it clear.
| Waiver Type | Do You Still Tell People? | Do They Sign? | When Do You Use It? |
| Skip Signature Only | Yes – full talk | No | Safe surveys, phone talks |
| Skip All Consent | No | No | Old public records, no new info |
This guide is about the first one – skipping the signature.
See the difference between waiver of informed consent and waiver of documentation.
Read more on ethical study plans.
Real Life Examples – See It in Action
A waiver of the requirement for documentation of informed consent may be granted when you see these cases.
Example 1: Online Surveys
You make a quiz on the computer. No names. Questions about school lunch.
- People read a short page of rules.
- They click “I agree.”
- No signature. This is waiver of documentation of informed consent in online survey research. Learn safe online survey tips.
Example 2: Phone Interviews
You call 100 people. Ask about TV shows.
- You read a 1-minute script: “This is a study. It takes 5 minutes. No risk. You can stop.”
- They say “okay” and answer.
- No paper. This uses oral or implied consent.
Example 3: Mail Forms with No Names
You send paper surveys. The return envelope has no name.
- Info sheet inside.
- They fill it and mail it back.
- Starting = saying yes.
Example 4: Watch People in Public
You sit in a park. Count how many kids play. No talking.
- No consent needed at all (if no names).
- But if you ask questions, use waiver.
Fun fact: Over 50% of safe studies use waivers for surveys (HHS numbers).
See examples of waiver of documentation of informed consent in minimal risk studies.
Step-by-Step: How to Ask for the Waiver
Follow these 7 easy steps. PIs love this list.
- Pick your study type. Is it a survey? Phone? Safe?
- Check the two rules. Does Rule 1 or Rule 2 fit?
- Write your big plan (protocol). Say: “We want a waiver because…”
- Make a short info script. 1 page. Easy words. Covers risks, quit rights.
- Fill the IRB form. Check the waiver box. Add documentation waiver justification.
- Send everything. Wait 2–6 weeks.
- Get the okay. Start your study!
Tip: Save old plans. Copy what worked.
See research protocol submission best practices.
What Can Go Wrong? Stay Safe!
Even with a waiver:
- Hide all names. Use codes like “Person 1.”
- Lock files. Passwords and safe computers.
- Tell the truth. No hiding risks.
- Let them quit. Say it many times.
Participant privacy protection is the top job.
Learn data privacy tips.
Tools to Help You
| Tool | What It Does | Why It Helps |
| Online survey sites | Auto “I agree” button | Easy oral or implied consent3 |
| Phone script sheet | Read the same words every time | Fair to all |
| Locked file folders | Keeps papers safe | Stops risk of confidentiality breach |
Words Experts Use – Simple Meanings
- IRB = Review board that says yes or no.
- Minimal risk = Same danger as a normal day.
- Confidentiality = Keeping secrets.
- Anonymity = No one knows who you are.
- Verbal consent = Saying yes out loud.
- Implied consent = Doing the task means yes.
Related: verbal consent vs written consent, informed consent documentation requirements, IRB approval criteria for consent waiver.
More Examples from Real Studies
- College student poll: “Do you like the new cafeteria?” Online. 500 answers. No signatures.
- Teacher feedback: Mail forms to 200 teachers. No names. Return = yes.
- Park behavior study: Watch kids play. No interaction. No consent needed.
- Old data check: Look at 10-year-old health records (no names). Full waiver.
See waiver of documentation of consent for anonymous questionnaire studies.
What If the Study Changes?
Tell the IRB!
- Add a new question?
- Ask for names now? You may need a real signature.
Training for Your Team
Teach everyone:
- Read the info script the same way.
- Never push people to join.
- Save “yes” proof (like click logs).
See research training.
FAQ – Fast Answers
When can an IRB waive the requirement for written informed consent?
When it is super safe or a signature hurts privacy.
What are the criteria for waiving documentation of informed consent?
Two rules – see the big list above.
Examples of waiver of documentation of informed consent in minimal risk studies?
Online polls, phone talks, no-name mail forms.
IRB guidelines for waiving signed consent forms?
Follow 45 CFR 46.117. Ask your school IRB.
How to apply for a waiver of consent documentation in behavioral research?
Write why it is safe. Send it to IRB.
Documentation waiver criteria under 45 CFR 46.117?
Same two rules. Check the government site.
How is verbal consent vs written consent different?
Verbal = words. Written = signature. Both work when allowed.
In Conclusion
A waiver of the requirement for documentation of informed consent may be granted when the study is very safe or a signature could share private info. Always tell people everything. Let them say yes with words or actions. This keeps studies kind, fast, and fair. PIs, IRB teams, and helpers can use this for surveys, calls, and more. Follow the two rules. Write a clear plan. Keep secrets safe.
What safe study are you working on? Did you get a waiver before? Share below!
References
- Studocu Waiver Answer – Short and clear. studocu.com ↩︎
- 45 CFR 46.117(c) – Full government rule. ecfr.gov ↩︎
- Quizlet Informed Consent Cards – Easy study cards. quizlet.com/454740183 ↩︎
