Informed Consent Form Writing for Trial Sponsors and Sites
Pubrica writes informed consent forms for clinical trial sponsors and investigator sites. Our regulatory medical writers prepare master and site-specific consent forms, assent forms and re-consent forms in language that participants can read and understand. We also confirm that the form covers every intended secondary use of data and samples before any participant signs, because a gap found after signature can only be closed through re-consent.
- Written to a target reading level — most committees expect grade 6 to 8, and draft forms are often written several grades above this level
- Risks presented prominently, described in the words a participant uses rather than in the clinical terms of the protocol
- Secondary use addressed before signature — registry deposit, data sharing, future research and biobanking must be covered now, or they cannot take place later
- Master, site-specific, assent and re-consent handled as one document family, so that a change to the master is carried through to every version
- Consistent with the protocol and the brochure, which is the comparison an ethics committee makes first
Master and site-specific consent formsIncluded
Assent and re-consent formsIncluded
Readability assessmentIncluded
Secondary-use and data-sharing languageIncluded
Ethics committee approvalTheir decision
Protocol → drafted → readability tested → reconciled → consent
- Written to a target reading level
- Risks in participant language
- Secondary use covered explicitly
- Reconciled with protocol and brochure
- Master and site versions kept in step
Deliverables
Four Core Elements of Every Informed Consent Form
Each consent form is written for one protocol and one participant population, and its content is determined by what the study asks of participants.
Example from a readability reviewYou may experience adverse sequelae including but not limited to hepatic dysfunction.Some people taking this drug have had liver problems. We will check your liver with a blood test at every visit. If the test changes, we will stop the study drug.
Example from a risk sectionA risk that a participant only encounters on page eleven has not been meaningfully disclosed. The placement of risk information is part of informed consent, not a formatting choice.
Example from a consent reviewThe most common problem we find is a protocol that commits to depositing data in a registry and a consent form that never mentions it. Found before ethics submission, it requires one additional paragraph. Found after enrolment, it leaves the study unable to meet its own commitment.
Example from a version setWhen site-specific versions drift from the master, two participants in the same trial can consent to different things. We manage the full form family under a single change control process.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Four Governing Standards and Guidelines for Informed Consent Forms
Where your ethics committee states its own requirement, that requirement takes precedence. Requirements differ between committees more than many sponsors expect.
Good Clinical Practice (E6(R3), not E6(R2))
Principles and Annex 1 took effect in the EU in July 2025; Annex 2, covering pragmatic and decentralised designs, follows in January 2027.
Declaration of Helsinki (adopted October 2024, not the 2013 version)
The ethical basis for consent: what a participant must understand, the voluntariness of participation, and the protections owed to people who cannot freely consent.
Plain language and readability (typically grade 6 to 8)
This is the level most committees expect. We test against it rather than assume it, because draft forms often sit several grades above it.
Quality management (cert. H3CR9TCU20251212INDQM10N)
How the document is drafted, reviewed, version-controlled and released.
Responsible Use of AI
Responsible Use of AI in Regulatory Writing
Regulatory reviewers trace each decision back to its evidence and to a responsible individual. For this reason, we treat source traceability as more important than drafting speed, and every statement in a regulatory document must be traceable to its source.
Why We Do Not Publish an AI Accuracy Figure
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote a self-generated accuracy figure, because it would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Methodology
How We Write Your Informed Consent Form
We address secondary use first, because after signature it can only be corrected through re-consent.
Protocol read and use mapping
We map what the study asks of a participant, what happens to their data and samples, and every intended downstream use, including registry deposit, data sharing, future research and linkage.
Drafting the master
We write the master form in participant language at the target reading level, place risks where they will be read and cover secondary uses explicitly.
Readability and reconciliation
We test the reading level and compare the risk language against the protocol and the investigator’s brochure so that the three documents agree.
Site versions, assent and re-consent
We prepare site-specific forms, assent forms for minors and re-consent forms for amendments, all derived from the master so that they remain consistent.
Our Experts
Our Regulatory Writing Team
A named team of regulatory specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Writes the document against the governing template and regulatory guidance, keeps every statement traceable to its source data, and maintains the version history and comment log through each review round.
Reviews the clinical and scientific content for accuracy and confirms that each conclusion is supported by the data. Each expert is matched to your therapeutic or device area.
Checks that statistical methods, tables and conclusions are consistent with the analysis plan, and reviews how the data are presented before the document reaches regulatory review.
Performs an independent check of the final document against source data, the template and the applicable regulatory checklist. Findings are logged and resolved before delivery.
Packages
Informed Consent Form Writing Packages
Pricing depends on trial complexity, the number of site-specific versions and whether assent and re-consent forms are in scope.
Consent form family
Sponsors and investigators preparing an ethics submission
Quoted per projectOn complexity and version count
Delivery By scope
- ✓Master informed consent form
- ✓Site-specific versions
- ✓Assent forms where minors are enrolled
- ✓Readability tested to your committee’s level
- ✓Secondary use and data sharing covered explicitly
- ✓Reconciled with protocol and brochure
We recommend commissioning the form before ethics submission so that secondary use can be addressed in advance.
Deliverables Request a quoteRewrite or re-consent
For forms returned by an ethics committee, or amendments that require re-consent
Quoted per projectOn what exists and what changed
Delivery By scope
- ✓Existing form read against the committee’s findings
- ✓Readability brought to the required level
- ✓Risk language reconciled with the current protocol
- ✓Re-consent forms for a substantial amendment
- ✓Change summary for the committee
Amendments trigger re-consent more often than sponsors plan for. On a typical substantial amendment, around two-thirds of participants are re-consented.
Deliverables Request a quoteSend us the protocol and the draft consent form, and we will tell you free of charge whether the consent covers everything the protocol commits you to doing with the data. In our experience, it often does not.
FAQs
Informed Consent Form FAQs
If your question is not answered here, ask an expert — no quote is required.
Most ethics committees expect grade 6 to 8. Draft forms written by scientific specialists are often several grades higher.
The aim is not simplicity for its own sake. Consent given without understanding is not informed consent, so we test the reading level rather than assume it, and we report the score to you.
Because it is the hardest part to correct later. If the form does not cover registry deposit, data sharing, future research or biobanking, those things cannot lawfully happen without re-consenting participants, which is slower and may not reach everyone.
The most common example is a protocol that commits to depositing data and a consent form that never mentions deposit. Found before submission, it requires one paragraph; found after enrolment, it is a commitment the study cannot meet.
Yes. Assent forms are separate documents, written for the relevant age range at an age-appropriate reading level, and used alongside the parental or guardian consent rather than instead of it.
Where a trial spans age bands, more than one assent version is usually needed. That is a scope question worth settling at the start.
If the amendment changes what participants are asked to do or what risks they face, they have to be re-consented — which means a re-consent form and a return visit for people already enrolled.
On a typical substantial amendment around two-thirds of participants are re-consented, and the process runs for months. Writing the master form with amendment in mind reduces how much has to change.
We prepare the documents and the responses to committee queries. The submission is made by the sponsor or the investigator, and the decision is the committee’s.
Responding to committee findings on the consent form is part of our service. Most findings concern readability or secondary use.
Related Services
Related Regulatory Writing Services
The consent form is read alongside the protocol and the investigator’s brochure, and it must agree with both.
1RELATED TRIAL DOCUMENTSreviewed together by ethics committees
Investigator's brochureFull nonclinical and clinical safety data. Clinical trial supportProtocol, SAP and registry records.2PATIENT-FACING CONTENTwritten for participants
Patient education contentWritten for people affected. Simplified abstractFindings in plain language.3DATA COLLECTION AND USEwhat consent has to cover
Medical data collectionCollection, de-identification and governance. Regulatory writingSubmissions and disclosure obligations.Request a Free Consent Coverage Review Against Your Protocol
We will review your consent form free of charge and tell you whether it covers everything the protocol commits you to doing with the data. Any gap is far easier to close before signature than through re-consent afterwards.