How to Write an Informed Consent Form: A Step-by-Step Template
By Dr. Zubair Khalid, DVM, MS, PhD ·
Quick Answer
- Use a consent form template that covers all required elements: study purpose, procedures, risks, benefits, alternatives, confidentiality, and voluntary participation.
- Write consent language at a reading level your participants can understand, and test comprehension before finalizing the form.
- Institutional review board (IRB) requirements vary by institution, so always verify your form meets your specific ethics committee standards.
Understanding Informed Consent in Research
Informed consent is a foundational ethical requirement in human subjects research. It ensures that participants voluntarily agree to take part in a study after understanding what their involvement entails. The process involves more than obtaining a signature on a form. It requires a clear explanation of the research, an opportunity for questions, and confirmation that the participant comprehends the information provided.
The National Library of Medicine provides access to authoritative biomedical books and research-method references that describe the ethical foundations of informed consent. These resources emphasize that consent is an ongoing process, not a one-time event. Researchers should view consent as a conversation that begins before enrollment and continues throughout the study.
The consent form itself serves as documentation of this process. It records what information was shared with the participant and confirms their voluntary agreement to participate. A well-designed form protects both the participant and the researcher by establishing clear expectations about the study's procedures, risks, and benefits.
Core Principles of Informed Consent
Respect for Persons
Respect for persons is a core ethical principle in research. It requires that researchers acknowledge the autonomy of individuals and protect those with diminished autonomy. In practice, this means providing complete information about the study, ensuring comprehension, and allowing participants to make voluntary decisions without coercion or undue influence.
The consent form should be written in a way that respects the participant's capacity to understand. This includes avoiding technical jargon, using clear language, and providing information in a format that is accessible. When participants have questions, the researcher should answer them honestly and completely.
Beneficence and Non-Maleficence
Beneficence requires that researchers maximize potential benefits and minimize potential harms. This principle guides the risk assessment portion of the consent form. The form must accurately describe the risks and benefits of participation, including any discomfort, inconvenience, or potential adverse effects.
Non-maleficence, the obligation to avoid causing harm, requires that researchers carefully evaluate the risk-benefit ratio of their studies. The consent form should present this evaluation transparently, allowing participants to make an informed judgment about whether the potential benefits outweigh the risks.
Justice in Participant Selection
Justice requires that the benefits and burdens of research are distributed fairly. The consent form should explain who is being asked to participate and why. It should also clarify that the participant is not being selected because of convenience or vulnerability but because they meet the study's inclusion criteria.
The consent process should also address any potential conflicts of interest that might influence the researcher's judgment. Transparency about funding sources, institutional affiliations, and other potential conflicts helps participants understand the context of the research.
Required Elements of a Consent Form
Study Purpose and Description
The consent form must clearly state the purpose of the study. This includes explaining what the research aims to discover or measure and why the study is being conducted. The description should be specific enough that participants understand what they are being asked to do.
The form should also describe the study procedures in detail. This includes the number of visits, the duration of each visit, the types of tests or interventions involved, and any follow-up requirements. Participants should understand the time commitment and what will be expected of them throughout the study.
Risks and Discomforts
The consent form must describe the reasonably foreseeable risks and discomforts associated with participation. This includes physical risks, psychological risks, social risks, and economic risks. The description should be honest and complete, without minimizing potential harms.
For studies involving medical procedures or interventions, the risks should be described in terms that participants can understand. The form should also explain how the researchers will monitor for adverse events and what will happen if a participant experiences harm.
Benefits to Participants and Society
The consent form should describe any direct benefits that participants may receive from the study. If there are no direct benefits, the form should state this clearly. The form should also describe the potential benefits to society or to future patients that may result from the research.
Participants should understand that they may not receive any personal benefit from participating. The form should also explain any compensation or reimbursement for participation, including the amount and the schedule of payment.
Confidentiality and Data Protection
The consent form must explain how the participant's privacy will be protected. This includes describing who will have access to the data, how the data will be stored, and how long the data will be kept. The form should also explain any limits to confidentiality, such as mandatory reporting requirements.
The National Institutes of Health (NIH) provides guidance on data management and sharing expectations for research. The consent form should describe how the data will be managed and shared in accordance with these expectations. Participants should understand whether their data will be shared with other researchers and how their identity will be protected.
Voluntary Participation and Withdrawal
The consent form must state that participation is voluntary and that the participant may withdraw at any time without penalty or loss of benefits. The form should also explain the consequences of withdrawal, including what will happen to any data that has already been collected.
Participants should also be told who to contact if they have questions about the study or their rights as a participant. This includes the contact information for the researcher and the institutional review board.
Step-by-Step Template for Writing a Consent Form
Step 1: Study Title and Introduction
Begin the consent form with the study title and a brief introduction. The introduction should explain who is conducting the study and why the participant is being asked to take part. It should also state that the participant is being asked to participate in a research study and that their participation is voluntary.
The introduction should be written in plain language and should avoid technical jargon. It should also explain the purpose of the consent form and encourage the participant to ask questions before deciding whether to participate.
Step 2: Purpose of the Study
Describe the purpose of the study in clear, simple terms. Explain what the researchers hope to learn and why the study is being conducted. This section should also explain why the participant is being asked to participate, including any inclusion or exclusion criteria.
The purpose should be described in a way that is meaningful to the participant. For example, instead of saying "the purpose is to evaluate the efficacy of the intervention," the form might say "the purpose of this study is to learn whether a new educational program helps students improve their reading skills."
Step 3: Study Procedures
Describe the study procedures in detail. This should include the number of visits, the duration of each visit, and the types of procedures that will be performed. The form should also describe any tests, questionnaires, or interventions that will be used.
The procedures should be described in chronological order, so participants understand what will happen at each stage of the study. The form should also explain how long the participant will be involved in the study and what will happen after the study is completed.
Step 4: Risks and Discomforts
Describe the risks and discomforts that participants may experience. This should include physical risks, psychological risks, and social risks. The description should be honest and complete, without minimizing the risks.
The form should also explain how the researchers will manage the risks and what will happen if a participant experiences an adverse event. This includes explaining the availability of medical care and the process for reporting adverse events.
Step 5: Benefits
Describe the potential benefits of participation. This should include any direct benefits to the participant and any benefits to society. If there are no direct benefits, the form should state this clearly.
The form should also explain that the participant may not receive any benefit from the study. This is important because participants should not be led to believe that they will benefit from the study if the research is not designed to provide direct benefits.
Step 6: Confidentiality and Data Management
Explain how the participant's privacy will be protected. This should include a description of who will have access to the data, how the data will be stored, and how long the data will be kept. The form should also explain how the data will be shared with other researchers.
The NIH Data Management and Sharing Policy describes the expectations for data management and sharing in NIH-funded research. The consent form should describe how the data will be managed and shared in accordance with these expectations.
Step 7: Voluntary Participation and Withdrawal
Explain that participation is voluntary and that the participant may withdraw at any time without penalty. The form should also explain the consequences of withdrawing, including what will happen to the data that has already been collected.
The form should also explain that the participant's decision to participate or withdraw will not affect their relationship with the institution or their access to services.
Step 8: Contact Information
Provide contact information for the research team and the institutional review board. This should include the name and phone number of the principal investigator and the contact information for the IRB.
The form should also explain that the participant can contact the IRB if they have questions about their rights as a research participant or if they have concerns about the study.
At a Glance: Consent Form Sections
| Section | Purpose | Key Elements |
|---|---|---|
| Introduction | Explain the study and invite participation | Study title, researcher identity, voluntary participation |
| Purpose | Describe the research goals | What the study aims to learn, why the participant is invited |
| Procedures | Detail the study steps | Visits, tests, interventions, duration |
| Risks | Describe potential harms | Physical, psychological, social, economic risks |
| Benefits | Explain potential benefits | Direct benefits, societal benefits, compensation |
| Confidentiality | Describe data protection | Data storage, access, sharing, limits to confidentiality |
| Withdrawal | Explain voluntary participation | Right to withdraw, consequences of withdrawal |
| Contacts | Provide contact information | Researcher, IRB, emergency contacts |
Practical Implementation Steps
Step 1: Review the Study Protocol
Before writing the consent form, review the study protocol to understand the research procedures, risks, and benefits. This will help you write a consent form that accurately describes the study. The protocol should also identify the target population and any special considerations for the consent process.
Step 2: Draft the Consent Form
Use the template above to draft the consent form. Write in plain language and avoid jargon. Use short sentences and simple words. The form should be written at a reading level that is appropriate for the target population.
Step 3: Review the Consent Form
Review the consent form for accuracy and completeness. Check that all required elements are included and that the language is clear and understandable. The form should also be reviewed by someone who is not involved in the study to ensure that it is understandable to a layperson.
Step 4: Submit the Consent Form for IRB Approval
Submit the consent form to the institutional review board for approval. The IRB will review the form to ensure that it meets the ethical standards and regulatory requirements. The IRB may request changes to the consent form before approving the study.
Step 5: Implement the Consent Process
Once the consent form is approved, implement the consent process. This includes explaining the study to the participant, answering their questions, and obtaining their signature on the consent form. The consent process should be conducted in a private setting and should allow the participant to take the time to decide.
Step 6: Document the Consent Process
Document the consent process in the participant's research record. This should include the date of consent, the version of the consent form that was used, and any questions that the participant asked. The documentation should also include the name of the person who obtained consent.
Records and Measurements
Consent Form Version Control
Maintain version control of the consent form. Each version should be numbered and dated. The version control should also document the changes that were made and the reason for the changes. This is important for ensuring that the correct version of the consent form is used for each participant.
Consent Documentation
Document the consent process for each participant. This should include the date of consent, the version of the consent form that was used, and the name of the person who obtained consent. The documentation should also include any questions that the participant asked and the answers that were provided.
Participant Comprehension Assessment
Assess the participant's comprehension of the consent information. This can be done through a short quiz or by asking the participant to explain the study in their own words. The assessment should be documented in the participant's research record.
Common Failure Patterns
Failure to Use Plain Language
One common failure is using complex language that participants cannot understand. The consent form should be written in plain language and should avoid jargon. The form should also be written at a reading level that is appropriate for the target population.
Failure to Describe All Risks
Another common failure is failing to describe all the risks of the study. The consent form should describe all reasonably foreseeable risks, including physical, psychological, social, and economic risks. The form should also describe the risk of the study procedures and the risk of the study being discontinued.
Failure to Explain Voluntary Participation
The consent form should clearly explain that participation is voluntary and that the participant may withdraw at any time. The form should also explain the consequences of withdrawing, including what will happen to the data that has already been collected.
Failure to Provide Contact Information
The consent form should provide contact information for the research team and the institutional review board. This should include the name and phone number of the investigator and the contact information for the IRB.
Limitations and Professional Escalation
Limitations of the Consent Form
The consent form is a document that describes the study and the participant's rights. It is not a substitute for the consent process. The consent process involves a conversation between the researcher and the participant, and the consent form should be used to document that conversation.
The consent form is also not a substitute for the IRB review. The IRB reviews the consent form to ensure that it meets the ethical requirements and regulatory requirements. The IRB may require changes to the consent form before the study is approved.
Professional Escalation Criteria
If you have concerns about the consent process or the consent form, you should escalate the concern to the IRB or the research integrity office. This includes concerns about the accuracy of the consent form, the adequacy of the consent process, or the protection of participant privacy.
The Committee on Publication Ethics (COPE) provides core practices for research integrity, including guidance on the responsible conduct of research. If you have concerns about the ethical conduct of the research, you should consult the COPE guidelines and escalate the concern to the appropriate institutional authority.
Welfare and Safety Context
Participant Welfare
The consent process is designed to protect the welfare of the participants. The consent form should describe the risks and benefits of the study, and the participant should be given the opportunity to ask questions and to make a voluntary decision about participation.
The consent process should also be conducted in a way that respects the participant's autonomy. The participant should be given the time to read the consent form and to ask questions. The participant should not be pressured to sign the consent form.
Researcher Safety
The consent process also protects the safety of the researcher. The consent form documents the information that was provided to the participant and the participant's agreement to participate. This documentation can be used to protect the researcher in the event of a dispute.
The consent process should also be conducted in a safe environment. The researcher should be aware of the potential for the participant to become distressed or agitated, and the researcher should have a plan for managing these situations.
Frequently Asked Questions
What is the purpose of an informed consent form?
The purpose of an informed consent form is to document that the participant has been informed about the study and has voluntarily agreed to participate. The form describes the purpose of the study, the procedures, the risks, the benefits, and the participant's rights.
What are the required elements of an informed consent form?
The required elements of an informed consent form include the purpose of the study, the procedures, the risks, the benefits, the confidentiality of the data, the voluntary nature of participation, and the contact information for the research team and the institutional review board.
How long should an informed consent form be?
The length of the consent form should be appropriate for the complexity of the study. The form should be long enough to describe the study and the participant's rights, but it should not be so long that it is difficult to read. The form should be written in plain language and should be easy to understand.
Can a participant withdraw from a study after signing the consent form?
Yes, a participant can withdraw from a study at any time after signing the consent form. The participant should be informed of their right to withdraw and the consequences of withdrawing. The participant should also be informed of the process for withdrawing from the study.
What should the participant do if they have questions about the study?
The participant should contact the research team if they have questions about the study. The consent form should provide the contact information for the research team and the institutional review board. The participant should also be informed that they can ask questions at any time during the study.
What is the role of the institutional review board in the consent process?
The institutional review board reviews the consent form to ensure that it meets the ethical requirements and regulatory requirements. The IRB also reviews the consent process to ensure that the participants are being protected. The IRB may require changes to the consent form before the study is approved.
How should the consent form be written to be understandable to participants?
The consent form should be written in plain language and should avoid technical terms. The form should be written at a reading level that is appropriate for the target population. The form should also be reviewed by someone who is not involved in the study to ensure that it is understandable to a layperson.
What should be done if the participant does not understand the consent form?
If the participant does not understand the consent form, the researcher should explain the study in more detail and answer any questions the participant may have. The researcher should also consider whether the participant is capable of providing informed consent. If the participant is not capable of providing informed consent, the researcher should follow the institutional policy for obtaining consent from a legally authorized representative.
Using the Evidence
| Source | Best use in this topic | Important limitation |
|---|---|---|
| Research Methods Resources | official guidance | Check the linked page for current local requirements |
| EQUATOR Network | official guidance | Check the linked page for current local requirements |
| Core Practices | official guidance | Check the linked page for current local requirements |
Related Articles
- Informed Consent in Research: Principles and Common Pitfalls
- Ethical Considerations in Research: A Practical Guide for Scientists
- How to Write an Experiment Report: A Practical Template
- How to Write Expected Results in a Research Proposal: A Practical Guide
- Data Management Plan Template: A Practical Guide for Researchers
References and Further Reading
- Research Methods Resources. National Library of Medicine.
- EQUATOR Network. EQUATOR Network.
- Core Practices. Committee on Publication Ethics.
- NIH Grants and Funding. National Institutes of Health.
- ORCID for Researchers. ORCID.
- Data Management and Sharing Policy. National Institutes of Health.
- NCBI Literature Resources. National Center for Biotechnology Information.
- PubMed. National Library of Medicine.
This article is educational and does not replace institutional policy, professional advice, or applicable safety and regulatory requirements.