ICF—Clinical Trial Information Consent Form Explained

Clinical Trials ICF—Clinical Trial Information Consent Form Explained

Understanding ICF—The Clinical Trial Information Consent Form

The ICF is one of those clinical trial initialisms you should know if you want to participate in one

Regardless of whether you are joining a clinical trial for healthy volunteers or are trying to find a clinical trial that will help you with your medical condition, researchers from any clinical trial company will ask you to sign an ICF—Information Consent Form. 

This is a general rule applicable to any type of clinical study or clinical trial phase


What Are Clinical Trial ICFs?

National Institutes of Health (NIH) defines a clinical trial as a research process on human test subjects, with the purpose of finding new or improved methods to prevent, diagnose, or treat various diseases. 

Testing on humans is the main difference between laboratory work and pre-clinical studies and actual clinical trials. That kind of research requires consent.

The informed Consent Form (ICF) is a document that you have to sign before joining a clinical trial to confirm that:

  1. You take part in the trial willingly 
  2. You understand what will be done during the trial
  3. You agree to the conditions of the trial

You can withdraw your consent anytime and drop out of the trial.

Understanding the Structure of Clinical Trial ICFs

Since each clinical trial works differently, ICFs may not always look the same, but there is a basic outline that most of them follow. 

Here is a table with key sections of any ICF:

Section Includes or Explains

General Information

  • Summary of the study—title, who is doing it, why, and who can participate
  • Contact info of the research team
  • Explanation of the importance of the ICF

Purpose of the Trial

  • Explanation of the type of disease
  • The reason why the study is being performed

Detailed Description

  • Types of tests to be done
  • Whether it’s a randomized clinical trial or observational study
  • Treatment schedule
  • Timeline of the trial phases
  • Whether the trial includes a placebo
  • Is the trial double-blind, single-blind, or open-label

Risks and Benefits

  • Potential side effects with detailed explanations
  • Risk regarding privacy, confidentiality, and unknown risks
  • Potential benefits

Privacy and Data handling

  • Explanation of the safety measures
  • Whether there is a Certificate on Confidentiality
  • Clarification on how your data will be collected and stored
  • Explanation on how long will the clinic/institute keep your data
  • Whether the authorities can inspect the data
  • Whether the research results will be available on any database

Patients’ Rights

  • A statement that participation is voluntary
  • The explanation that you can refuse treatment
  • Clarification that you can withdraw from the trial at any time

Financial Aspect

  • Whether there is compensation
  • If you can expect additional costs

Consent Form

  • A statement that you have read all the info provided and that you agree with the conditions

Factors To Consider Before Signing Up for a Clinical Trial

Before signing up for any clinical trial, you should consider a few factors.

While the financial aspect is usually explained in the ICF, other unexpected matters may not be.

If the trial is not local, you may be required to travel. Take note of how that will affect your daily schedule and other obligations.

If you are a healthy volunteer, consider how big the compensation is and whether it is worth the possible risks and side-effects.

People suffering from the conditions that the study is focused on should know that by participating, they could get early access to some of the most advanced treatment options, but there are no guarantees that the method will have the desired effect on their condition.

You should also think about whether you are prepared to join a trial that includes a placebo since there is a 50% chance you will not get the treatment at all. 

The risks and long term effects are always stated in the ICF, but contemplate whether you are ready to take that chance.

Some of the benefits of joining a trial are:

  • An opportunity to make significant progress in your current treatment if the new drug proves to be more effective than the therapy you use
  • Enabling scientific progress and being an active part of finding better treatment options for thousands of patients
  • Having constant high-quality care by the medical professionals

How DoNotPay Helps You Sign Up For a Clinical Trial of Your Choice

DoNotPay is the only platform that can match you with the best psychological studies, medical surveys, or full-time clinical trials of your choice. 

You can completely customize the search of our extensive database regarding location, type of trial, placebo involvement, estimated compensation, safety, and other factors.

Follow these steps to find the clinical trial that works for you:

  1. Open DoNotPay in your web browser
  2. Pick the Clinical Trials feature
  3. Click on Get Started
  4. Set up your filters
  5. Find a study you want to join and click on it
  6. Tap Contact

DoNotPay will get in touch with the research team on your behalf to maximize your chances of acceptance.

The researchers will get back to you in a matter of days, but you can also check the status of that clinical study on our homepage.

Our app offers some extra perks:

  • Bookmark any study you want to keep tabs on
  • Turn on text notifications to be the first to know about new clinical trials in your area
  • Contact as many research teams as you want
  • Keep 100% of the compensation

Other Options To Sign Up for Clinical Trials

If you want to extend your search, make sure to consider only reputable clinical trial databases

Here are some of them:

  1. ClinicalTrials is one of the largest worldwide clinical research registries containing info about the purpose of each trial, participants’ requirements, location, duration, and contact phone number
  2. The National Institutes of Health (NIH) Database is an index of clinical trials with public funding. The downside is that it only lists trials carried out in Bethesda
  3. ResearchMatch is a national clinical trial database created to match volunteers with research teams across the nation

What Other Features Does DoNotPay Offer?

DoNotPay is a versatile virtual assistant app capable of helping you handle various tasks and support you on your clinical trial path.

Our app can help you sign up for clinical trials in North Carolina, Michigan, Utah, Philadelphia, or any other state. We can also work with you to find the best solution for dealing with your medical bills or paying hospital bills after insurance

Since DoNotPay is an expert in terminating unwanted services and can get rid of anything from Adobe Creative Cloud to Zamplebox, why not use it to put an end to dissatisfying health insurance options. 

Whether you signed up for United Healthcare, Cheers Health, IHC Health Solutions, or Oscar Health, we can get you out of any subscription. 

To check out what else we can do for you, open DoNotPay in your web browser and learn how we can assist you with: