What should be included in an informed consent form for an investigator-initiated trial (IIT)? This guide outlines the essential components, structure, and compliance tips to help ensure your form is IRB-ready and participant-friendly.
Start with a Template
Your research institution will likely have an informed consent template that they prefer you to use, so we suggest checking with your university or college first. If your institution does not provide one, the World Health Organization offers comprehensive templates you can use to create your own informed consent forms. For example, see the WHO consent form templates. One of the key things to keep in mind is that you must write the form in language that can be understood by someone with a grade 5–6 reading level.
Requirement Checklist
To help you understand why each item is necessary, the following table outlines each required element from the ICH Good Clinical Practice Guidelines and the reason it must be included:
| Required Element | Why It’s Required |
|---|---|
| A statement indicating that the trial involves research | Ensures participants understand they are part of a research study and not receiving routine care. |
| The study’s purpose | Helps participants understand the goal of the research and why it is being conducted. |
| Description of the treatment groups and the probability of assignment | Makes participants aware of possible randomization and what treatment options they might receive. |
| Description of procedures, including invasive ones | Allows participants to give truly informed consent based on understanding the actions involved. |
| Subject responsibilities | Ensures participants understand what is expected of them during the study. |
| Experimental aspects of the trial | Clarifies which elements of the study are investigational to avoid therapeutic misconception. |
| Risks, inconveniences, and potential benefits | Enables participants to weigh possible harms and benefits before deciding to enroll. |
| Alternatives to participation, with associated risks/benefits | Informs participants of other options, reinforcing voluntary participation. |
| Compensation or treatment for trial-related injuries | Ensures transparency about what happens in the case of harm due to participation. |
| Payment, if any, for participation | Helps participants understand financial compensation and prevents undue influence. |
| Out-of-pocket expenses | Clarifies any financial burden associated with participation. |
| Statement on voluntary participation and right to withdraw | Reinforces that participation is optional and can be ended at any time. |
| Access to medical records by study monitors, IRB, and regulators | Informs participants about who can access their data and under what conditions. |
| Statement on subject confidentiality | Builds trust by assuring that personal data will be protected. |
| Timely updates about relevant new information | Ensures ongoing informed consent if new information arises that could impact decision to participate. |
| Contact information for questions or injury-related issues | Provides a way for participants to get help or more information. |
| Conditions for removal from the study | Helps participants understand scenarios where their participation may end. |
| Duration of the trial | Sets expectations about time commitment. |
| Total number of subjects in the trial | Provides transparency about the study’s scale and potential impact. |
Standard Structure
Most informed consent forms organize the above items into three sections:
1. Basic Information
Introduce yourself (including your institutional affiliation) and explain the purpose of the study. Emphasize that participation is voluntary and encourage participants to ask questions. Provide the study’s title, objectives, rationale, and a plain-language summary of risks and benefits.
2. Description of the Process
Detail how the study will be conducted. Describe participant responsibilities, the nature of any interventions, and logistical details like visit locations and timing. Clearly explain how participants were selected and reiterate that participation is voluntary.
3. Confidentiality and Reimbursements
Explain how participant identity and data will be kept confidential. Describe data security measures and any planned data sharing. Provide contact information for study-related inquiries. State whether remuneration will be provided. Include space for signatures and dates from both the participant and the researcher/witness. Ensure each party receives a copy.
Final Tips
Looking for more practical support? Grab a copy of the book Eye-dea to Impact: A Modern Blueprint for Investigator-Initiated Trials.
Preparing an informed consent form is straightforward once you start with a clear template. For additional guidance on research startup and clinical trial documentation, see our post on how to write a clinical trial protocol. Keep the language concise and accessible. Always ask someone else to review it for clarity and compliance.
📞 Need help finalizing your informed consent form? Book a free consultation for expert guidance or a template review.
