Written from the same pilot protocol as the IRB application, so the two can never disagree. It says in plain words that the device is investigational, that half of participants get a dummy, and that nobody should expect a benefit. Fill in the local details and the blanks fill themselves in — anything you leave empty stays a visible blank rather than invented text.
Randomised 1:1, double-blind, sham-controlled pilot study · 40 participants · 30 days of follow-up per participant
1. You are being invited to take part in research
This is a research study, not ordinary care. It is run by [principal investigator] at [study site] and paid for by [sponsor legal name]. It has been reviewed by [ethics committee name]. Taking part is your choice. If you say no, your treatment and your care will not change in any way. You can change your mind at any time, without giving a reason.
2. Why the study is being done
To estimate the effect size of pulsed radiofrequency energy on postoperative edema and pain, so that a pivotal trial can be sized. This pilot is not powered to prove efficacy. In plain words: we do not yet know whether this treatment helps swelling and pain after your operation. That is exactly what we are trying to find out. You should not expect it to help you.
3. The device has not been approved for this use
The device used in this study is investigational for this condition. That means no regulator has agreed it works for swelling and pain after surgery. It is being tested here to gather evidence.
4. Half of the people in this study receive a dummy device
You will be placed by chance into one of two groups, like a coin toss. One group uses a working device. The other uses a device that looks, feels and sounds the same but produces nothing at all. This is called a sham. You will not be told which group you are in, and neither will the staff who measure you. That is deliberate — it is the only way to know whether any change came from the treatment. The list is held by someone outside the study team and is opened at the end or sooner if your safety requires it.
5. What taking part involves
Randomised 1:1, double-blind, sham-controlled pilot study, with 40 people in total and 30 days of follow-up per participant for each person. You will use the device at home as instructed, and answer a few short questions about your pain, your painkillers and your sleep. We will measure both of your ankles with a tape measure and, where there is a wound, take a photograph of it. We will see or contact you at: 1 hour, 24 hours, Day 3, Day 7, Day 14, Day 30. Before every session the app asks you a short safety list. If you answer yes to any of it, the device will not switch on. That is built into the hardware, not just a warning on the screen.
6. When you cannot take part
You cannot take part if you have any active implanted electronic device — a pacemaker, a defibrillator, a nerve stimulator, an insulin pump, a cochlear implant or anything similar. Tell the study team if you are pregnant, or think you may be. Tell us about every implant you have, even one you think is unimportant.
7. What could go wrong
Known risks are mild: warmth, tingling, skin redness where the device sits, or short-lived discomfort. Skin irritation can happen where anything is held against the skin. Because the device is investigational, there may be risks we do not yet know about. If you are in the dummy group, you will get no benefit from the device itself. Your usual care and your usual painkillers continue either way — nothing is withheld. Stop the session and contact the study team if you get pain that is getting worse, spreading redness, heat or fever, a burn, or anything that frightens you.
8. What you might gain
You may get no direct benefit at all, and you should not join expecting one. What you give is information that may help people who have this operation in future.
9. What else you could do instead
You can simply have your normal care after surgery — painkillers, elevation, ice, compression and physiotherapy as your surgeon advises. Declining this study does not remove any of that.
10. Payment and costs
[payment, travel costs, or a plain statement that there is none]
11. Your information
In the study record you are a study code, not a name. Your measurements, answers and any wound photographs are stored securely and seen only by the study team and, where the law requires it, by regulators or the ethics committee. Records are kept as follows: [retention period and who holds the records]. Results may be published or used in a regulatory submission. Nothing published will identify you. Wound photographs will not be published without your separate written permission.
12. Stopping
You can stop at any time, without giving a reason, and without any effect on your care. Tell the study team and they will note the date. Information collected up to that point is usually kept, so the study results stay accurate; ask the team if you want that explained. The study team may also stop your participation — for example for a safety reason or if the whole study is halted.
13. If you are harmed
Contact [principal investigator] on [daytime phone and email] straight away. Out of hours, call [24-hour contact]. In an emergency, use your local emergency number or go to an emergency department first and tell the study team afterwards. If you have a concern about how the study is being run, you can contact [ethics committee name] independently on [ethics committee contact].
14. Questions
Take as long as you want to decide, and talk it over with family, your own doctor or anyone else. Ask anything, including anything in this form you did not follow. You should be given a copy of this form to keep.
The participant signs, the person taking consent signs, and a witness signs if the participant could not read the form. A study code is assigned only after signing — the study record never holds a name.
PARTICIPANT INFORMATION SHEET AND INFORMED CONSENT FORM Study title: Pulsed radiofrequency energy for postoperative pain and edema after elective foot and ankle surgery: a randomised, double-blind, sham-controlled pilot Protocol version: 1.0 Consent form version: 1.0 (matches the protocol) Sponsor: [sponsor legal name] Principal investigator: [principal investigator] Study site: [study site] Ethics committee: [ethics committee name] 1. YOU ARE BEING INVITED TO TAKE PART IN RESEARCH This is a research study, not ordinary care. It is run by [principal investigator] at [study site] and paid for by [sponsor legal name]. It has been reviewed by [ethics committee name]. Taking part is your choice. If you say no, your treatment and your care will not change in any way. You can change your mind at any time, without giving a reason. 2. WHY THE STUDY IS BEING DONE To estimate the effect size of pulsed radiofrequency energy on postoperative edema and pain, so that a pivotal trial can be sized. This pilot is not powered to prove efficacy. In plain words: we do not yet know whether this treatment helps swelling and pain after your operation. That is exactly what we are trying to find out. You should not expect it to help you. 3. THE DEVICE HAS NOT BEEN APPROVED FOR THIS USE The device used in this study is investigational for this condition. That means no regulator has agreed it works for swelling and pain after surgery. It is being tested here to gather evidence. 4. HALF OF THE PEOPLE IN THIS STUDY RECEIVE A DUMMY DEVICE You will be placed by chance into one of two groups, like a coin toss. One group uses a working device. The other uses a device that looks, feels and sounds the same but produces nothing at all. This is called a sham. You will not be told which group you are in, and neither will the staff who measure you. That is deliberate — it is the only way to know whether any change came from the treatment. The list is held by someone outside the study team and is opened at the end or sooner if your safety requires it. 5. WHAT TAKING PART INVOLVES Randomised 1:1, double-blind, sham-controlled pilot study, with 40 people in total and 30 days of follow-up per participant for each person. You will use the device at home as instructed, and answer a few short questions about your pain, your painkillers and your sleep. We will measure both of your ankles with a tape measure and, where there is a wound, take a photograph of it. We will see or contact you at: 1 hour, 24 hours, Day 3, Day 7, Day 14, Day 30. Before every session the app asks you a short safety list. If you answer yes to any of it, the device will not switch on. That is built into the hardware, not just a warning on the screen. 6. WHEN YOU CANNOT TAKE PART You cannot take part if you have any active implanted electronic device — a pacemaker, a defibrillator, a nerve stimulator, an insulin pump, a cochlear implant or anything similar. Tell the study team if you are pregnant, or think you may be. Tell us about every implant you have, even one you think is unimportant. 7. WHAT COULD GO WRONG Known risks are mild: warmth, tingling, skin redness where the device sits, or short-lived discomfort. Skin irritation can happen where anything is held against the skin. Because the device is investigational, there may be risks we do not yet know about. If you are in the dummy group, you will get no benefit from the device itself. Your usual care and your usual painkillers continue either way — nothing is withheld. Stop the session and contact the study team if you get pain that is getting worse, spreading redness, heat or fever, a burn, or anything that frightens you. 8. WHAT YOU MIGHT GAIN You may get no direct benefit at all, and you should not join expecting one. What you give is information that may help people who have this operation in future. 9. WHAT ELSE YOU COULD DO INSTEAD You can simply have your normal care after surgery — painkillers, elevation, ice, compression and physiotherapy as your surgeon advises. Declining this study does not remove any of that. 10. PAYMENT AND COSTS [payment, travel costs, or a plain statement that there is none] 11. YOUR INFORMATION In the study record you are a study code, not a name. Your measurements, answers and any wound photographs are stored securely and seen only by the study team and, where the law requires it, by regulators or the ethics committee. Records are kept as follows: [retention period and who holds the records]. Results may be published or used in a regulatory submission. Nothing published will identify you. Wound photographs will not be published without your separate written permission. 12. STOPPING You can stop at any time, without giving a reason, and without any effect on your care. Tell the study team and they will note the date. Information collected up to that point is usually kept, so the study results stay accurate; ask the team if you want that explained. The study team may also stop your participation — for example for a safety reason or if the whole study is halted. 13. IF YOU ARE HARMED Contact [principal investigator] on [daytime phone and email] straight away. Out of hours, call [24-hour contact]. In an emergency, use your local emergency number or go to an emergency department first and tell the study team afterwards. If you have a concern about how the study is being run, you can contact [ethics committee name] independently on [ethics committee contact]. 14. QUESTIONS Take as long as you want to decide, and talk it over with family, your own doctor or anyone else. Ask anything, including anything in this form you did not follow. You should be given a copy of this form to keep. STATEMENTS — please initial each line [ initials ____ ] I have read this form, or had it read to me, in a language I understand. [ initials ____ ] I have had time to ask questions and my questions were answered. [ initials ____ ] I understand this is research and that taking part is my choice. [ initials ____ ] I understand the device has not been approved for this use. [ initials ____ ] I understand half of the people in this study receive a dummy device, and that I will not be told which group I am in. [ initials ____ ] I understand I may get no benefit from taking part. [ initials ____ ] I understand I can stop at any time without giving a reason and without any effect on my care. [ initials ____ ] I have told the study team about every implanted electronic device I have. [ initials ____ ] I agree that my de-identified study information may be published or used in a regulatory submission. [ initials ____ ] I have been given a copy of this form to keep. SIGNATURES Participant name (printed): ______________________________________ Participant signature: ___________________________ Date: ____________ Time: ________ Person taking consent — name and role: ____________________________ Signature: _______________________________________ Date: ____________ Time: ________ If the participant could not read this form, an impartial witness signs: Witness name: ____________________________________ Signature: _______________________________________ Date: ____________ Time: ________ Study code assigned after consent: ____________ (The participant's name is never entered in the study record — only this code.) One signed copy is given to the participant, one is filed in the study record.
This goes to the ethics committee as Attachment B of the IRB application. No participant may be approached, screened or enrolled until that committee approves both documents in writing.