Research consent form template
What is a research consent form?
A research consent form is a legal document that informs potential participants about a research study and obtains their voluntary agreement to participate. The form explains the study's purpose, procedures, risks, benefits, and participants' rights, ensuring they can make an informed decision about whether to take part.
Think of it as the ethical foundation of your research, it protects both participants and researchers by documenting that everyone understands what the study involves and that participation is completely voluntary. A well-crafted consent form meets regulatory requirements (like IRB approval) while being clear and accessible enough for participants to genuinely understand what they're agreeing to.
What you'll get in this template
- Five research consent form templates covering different study types including standard informed consent forms for typical research studies with minimal risk, minimal risk consent forms with streamlined language for low-risk studies like surveys or interviews, assent forms specifically designed for minor participants (under 18) with age-appropriate language, waiver of documentation templates for studies where signed consent isn't required but verbal agreement is documented, and parental permission forms for research involving children where legal guardians provide consent on behalf of minors
- Complete consent form sections with guidance featuring study information blocks explaining purpose, procedures, and duration in plain language, risk and benefit descriptions with frameworks for accurately communicating potential harms and advantages, confidentiality and data protection clauses covering storage, access, anonymization, and retention policies, voluntary participation statements clearly explaining participants can withdraw anytime without penalty, contact information sections for researchers, IRB offices, and participant rights advocates, and signature blocks with proper legal language and witness requirements where needed
- Compliance and legal frameworks including IRB submission checklists ensuring your forms meet institutional review board requirements, GDPR compliance guidance for research with EU participants, HIPAA considerations for health-related research in the US, Belmont Report principles ensuring respect for persons, beneficence, and justice, capacity assessment guidance for determining if participants can provide informed consent, vulnerable population protections with special considerations for children, prisoners, pregnant women, and cognitively impaired individuals, and multi-site research templates when studies span multiple institutions or countries
Why use a research consent form template?
Meet ethical and legal requirements
Institutional Review Boards (IRBs), ethics committees, and regulatory bodies require properly structured consent forms before research can begin. A template ensures you include all mandatory elements, reducing the risk of IRB rejection or compliance violations.
Protect research participants
Clear, comprehensive consent forms ensure participants genuinely understand what they're agreeing to, the procedures they'll undergo, potential risks, how their data will be used, and their right to withdraw. This protects their autonomy and wellbeing.
Protect researchers and institutions
Properly documented informed consent protects you and your institution from legal liability. If participants later claim they weren't adequately informed, a thorough consent form provides evidence that proper procedures were followed.
Communicate clearly with non-experts
Good consent forms translate complex research procedures into plain language that non-scientists can understand. Templates provide proven language structures that balance legal precision with readability.
Save time on IRB submissions
Rather than starting from scratch and risking multiple rounds of IRB revisions, templates give you a head start with language and structures that typically meet approval requirements.
Ensure consistency across studies
If you run multiple research projects, standardized templates ensure consistent ethical standards and make it easier to train research staff on proper consent procedures.
How to use this template
1. Select the appropriate consent form type (10 minutes)
Choose the template that matches your study: standard informed consent for typical research, minimal risk consent for low-risk studies, assent form if working with minors, or waiver templates for specific situations.
2. Customize study-specific information (30 minutes)
Fill in details about your specific study: title, purpose, procedures, duration, number of participants, principal investigator information, and institution. Replace all bracketed placeholders with your actual information.
3. Describe procedures in plain language (45 minutes)
Explain what participants will actually do in the study. Avoid jargon. Use active voice and short sentences. If procedures are complex, break them into numbered steps. Include timing (e.g., "This will take about 30 minutes").
4. Accurately describe risks and benefits (30 minutes)
Be honest about potential risks, physical, psychological, social, or economic. Include even minor risks like discomfort or time commitment. For benefits, distinguish between benefits to participants (if any) and benefits to society or science.
5. Add institutional and regulatory information (15 minutes)
Include your IRB approval number (once obtained), IRB contact information, participant rights statements, and any institution-specific required language. Check your IRB's website for mandatory sections.
6. Ensure compliance with applicable regulations (30 minutes)
Review GDPR requirements if working with EU participants, HIPAA rules for health information, or FERPA for education records. Add necessary clauses for data protection, international transfers, or specific populations.
7. Review for readability and comprehension (20 minutes)
Read your consent form aloud. Is it understandable without specialized knowledge? Could a non-expert genuinely understand what they're agreeing to? Consider having someone outside your field review it. Target 8th-grade reading level or lower.
8. Submit for IRB review (ongoing)
Submit your consent form as part of your IRB application. Be prepared to make revisions based on IRB feedback. Keep a version control system to track changes and maintain approved versions.
What makes this template different?
Written in plain language, not legalese
Unlike many institutional templates that prioritize legal protection over comprehension, these forms balance legal requirements with genuine readability. Participants can actually understand what they're agreeing to.
Covers diverse research scenarios
Most templates assume traditional academic research. This collection includes formats for UX research, market research, online studies, minimal-risk surveys, and vulnerable populations, reflecting how research actually happens today.
Includes guidance, not just blank forms
Each template includes inline comments explaining why sections are included, what information to provide, what pitfalls to avoid, and how to customize for your specific study. You're not just copying text, you're learning to create compliant forms.
Addresses modern data concerns
Traditional consent forms were written before digital data, cloud storage, and international data transfers. These templates include appropriate language for data security, anonymization, long-term storage, and compliance with modern privacy regulations.
Covers international research considerations
If your research involves participants from multiple countries, you need to navigate different regulatory frameworks. Templates include guidance for GDPR (EU), HIPAA (US), and general principles for cross-border research.
Provides vulnerable population protections
Special templates and guidance for research with children, prisoners, pregnant women, cognitively impaired individuals, and other populations requiring additional protections beyond standard consent.
Frequently asked questions
Do I need a consent form for all research?
Most research involving human participants requires informed consent. Exceptions include some minimal-risk research, research using existing de-identified data, or certain observational studies in public settings. Check with your IRB, they make the final determination.
What's the difference between consent and assent?
Consent is provided by adults who can legally make their own decisions. Assent is provided by minors (under 18) who agree to participate, but legal consent must come from their parent or guardian. Both documents are typically required for research with children.
How detailed do risk descriptions need to be?
You must disclose all reasonably foreseeable risks, even if they're minor or unlikely. This includes physical risks, psychological discomfort, time commitment, potential embarrassment, and risks to privacy or confidentiality. When in doubt, disclose.
Can I use electronic signatures?
Many IRBs now accept electronic signatures for online studies, especially post-COVID. However, you must ensure the electronic system documents who signed, when, and that they had access to the full consent form. Check your IRB's specific requirements.
What if participants can't read or speak English?
You must provide consent forms in languages participants understand. This means professional translation, not just machine translation. The translated version must be IRB-approved. For participants who can't read, you may use verbal consent with a witness.
How long do I need to keep signed consent forms?
Typically 3-7 years after study completion, but requirements vary by institution, funding source, and regulations. Federal regulations require 3 years minimum. Some clinical trials require longer. Check with your IRB and funder.
What if participants want to withdraw after consenting?
Participants can withdraw anytime without penalty. However, you may not be able to remove their data if it's been de-identified or already analyzed/published. Your consent form should explain this and describe what happens to their data if they withdraw.
Do online surveys need the same consent as in-person studies?
Online studies still require informed consent, but the format may differ. For minimal-risk surveys, IRBs often allow an information sheet instead of a signed form, where clicking "I agree" constitutes consent. Check your IRB's policies for online research.
Ready to create ethical research consent forms?
Download the template and ensure your research meets ethical and legal standards.
