Informed Consent Form for Clinical Trial

Overview and Regulatory Context

You are tasked with drafting a comprehensive Informed Consent Form for a clinical trial that complies with FDA regulations under 21 CFR Part 50, ICH-GCP guidelines, and applicable institutional review board (IRB) requirements. This document serves as both a legal protection mechanism and an ethical obligation to ensure research subjects fully understand the nature, risks, and implications of their participation in the clinical study. The informed consent form must be written in language understandable to the subject population, typically at an 8th-grade reading level, while maintaining legal precision and regulatory compliance.

Study Information Section

Purpose of the Research

Draft a clear and comprehensive explanation of why this clinical trial is being conducted. Begin by describing the medical condition or disease being studied in plain language that a layperson can understand. Explain what the research hopes to learn or prove, including the specific hypothesis being tested. Describe how this study fits into the broader landscape of medical research for this condition, including whether this is a Phase I, II, III, or IV trial. Include information about the sponsor of the study and the number of subjects expected to participate both at this site and overall. Conclude with a statement clarifying that this is research and not standard medical treatment, emphasizing that participation is entirely voluntary.

Description of the Procedures

Provide a detailed, chronological narrative of exactly what will happen to the subject if they agree to participate in this clinical trial. Begin with the screening process, including any tests or evaluations required to determine eligibility. Describe the randomization process if applicable, explaining in simple terms what randomization means and the probability of receiving each treatment arm, including placebo if relevant. Detail each study visit, including the frequency of visits, duration of each visit, total length of participation, and specific procedures that will occur at each visit such as blood draws, imaging studies, physical examinations, questionnaires, or administration of the investigational product. Specify any procedures that are being performed solely for research purposes versus those that would be part of standard medical care. Include information about any follow-up period after the active treatment phase concludes. If there are any procedures that may be uncomfortable, time-consuming, or require special preparation such as fasting, address these explicitly.

Foreseeable Risks or Discomforts

Articulate a complete and honest assessment of all reasonably foreseeable risks, discomforts, and inconveniences associated with participation in this clinical trial. Organize risks by severity and likelihood, beginning with the most common or most serious risks. For each significant risk category, describe the nature of the risk, the approximate frequency or probability of occurrence based on available data, and the potential severity of the outcome. Include risks associated with the investigational product itself, risks from study procedures such as blood draws or biopsies, risks from placebo treatment if subjects might forgo effective standard therapy, and psychosocial risks such as anxiety, loss of privacy, or time burden. Address any risks that may be specific to vulnerable populations such as pregnant women, children, or immunocompromised individuals. Include a statement acknowledging that unforeseen risks may exist, particularly for early-phase trials, and that subjects will be informed of any new information that might affect their willingness to continue participation. Describe the medical care and compensation available if research-related injury occurs, being specific about what is and is not covered.

Potential Benefits to the Subject or to Others

Present a balanced and realistic assessment of potential benefits, carefully avoiding therapeutic misconception. Begin with a clear statement about whether the subject may or may not receive direct medical benefit from participation, being honest if the primary purpose is to gather data rather than to treat the subject's condition. If direct benefits are possible, describe them specifically, including the probability of benefit based on available evidence, while emphasizing that benefits are not guaranteed. Distinguish between proven benefits and hoped-for benefits. Describe potential benefits to society and future patients, such as advancing medical knowledge, developing new treatments, or improving understanding of disease mechanisms. If subjects will receive any compensation for participation, free medical care, or free study medication, describe these clearly while noting they are not benefits in the medical sense. Conclude with a statement that participation is voluntary and that choosing not to participate will not affect the subject's access to standard medical care.

Subject Rights Section

Confidentiality of Records

Explain comprehensively how the subject's personal health information and research data will be collected, used, stored, and protected throughout the study and beyond. Describe the specific measures in place to maintain confidentiality, including data encryption, secure storage systems, coded identifiers, and limited access protocols. Identify all parties who may have access to the subject's identifiable research records, including the research team, the IRB, the FDA, the study sponsor, data safety monitoring boards, and any other regulatory authorities. Explain the circumstances under which confidentiality might need to be broken, such as mandatory reporting of child abuse, threats of harm, or court orders. Address how results may be published or presented, emphasizing that individual subjects will not be identifiable in publications unless specific additional consent is obtained. Describe the retention period for research records and what will happen to the data at the conclusion of the study. Include information about HIPAA authorization if applicable, explaining the subject's rights under the Privacy Rule and noting that authorization may be required for the research to proceed.

Voluntary Participation and Right to Withdraw

Articulate clearly and emphatically that participation in this clinical trial is completely voluntary and that the subject's decision whether or not to participate will not affect their current or future medical care, their relationship with their physician, or any benefits to which they are otherwise entitled. Explain that the subject may withdraw from the study at any time, for any reason or no reason, without penalty or loss of benefits. Describe the process for withdrawing, including whom to contact and whether any final procedures or visits are recommended for safety purposes. Address what will happen to data already collected if a subject withdraws, noting that data collected prior to withdrawal may still be used unless the subject specifically requests otherwise and such request is feasible. Explain circumstances under which the investigator, sponsor, or IRB might remove a subject from the study without their consent, such as if continuing poses safety risks, if the subject fails to comply with study requirements, or if the entire study is terminated. Include information about whether the subject will be informed of new findings developed during the course of the research that might affect their willingness to continue participation.

Contact Information for Questions

Provide complete and specific contact information for multiple resources available to the subject for different types of questions or concerns. First, identify the principal investigator and key study personnel by name, title, and telephone number, designating them as the primary contacts for questions about the research study itself, the study procedures, or research-related injuries. Second, provide contact information for the IRB or ethics committee, including name, address, and telephone number, identifying them as the resource for questions about the subject's rights as a research participant or concerns about the conduct of the study. Third, if applicable, provide contact information for a patient advocate or subject representative who is independent of the research team. Specify the hours of availability for each contact and provide after-hours emergency contact information if the study involves significant risk or requires urgent access to medical personnel. Encourage subjects to ask questions at any time before, during, or after their participation and to take as much time as they need to make their decision about participation.

Consent Section

Consent Statement

Draft a clear, affirmative consent statement that confirms the subject's understanding and voluntary agreement to participate. The statement should be written in first person and include the following elements in narrative form: acknowledgment that the subject has read the consent form or had it read to them, confirmation that the research study has been explained to them, acknowledgment that they have had the opportunity to ask questions and have received satisfactory answers, understanding that participation is voluntary and they may withdraw at any time, and agreement to participate in the research study as described. The statement should reference the specific study by title and protocol number. Include a separate statement if applicable regarding permission to use and disclose health information for research purposes. If the study involves any special circumstances such as collection of biospecimens for future research, genetic testing, or long-term follow-up, include separate optional consent statements for these elements. Ensure the language is clear, direct, and written at an appropriate reading level for the subject population.

Signature Block and Documentation

Design a signature section that provides complete documentation of the informed consent process and meets all regulatory requirements. Include signature lines for the research subject with printed name and date, ensuring adequate space for legible signatures. Include a signature line for the person obtaining consent, with printed name, role, and date, confirming that the information in the consent form was accurately explained to the subject and that the subject had the opportunity to ask questions. If applicable, include signature lines for a legally authorized representative if the subject cannot consent for themselves, with a line to indicate the representative's relationship to the subject and authority to provide consent. Include a signature line for an impartial witness if required by regulations or if the subject cannot read, with printed name and date. Provide a statement confirming that the subject will receive a signed and dated copy of the consent form for their records. If the study involves ongoing consent or re-consent at specified intervals, include language addressing this requirement and space for additional dated signatures. Ensure all signature blocks comply with 21 CFR 50.27 requirements for documentation of informed consent.

Output Requirements

The final Informed Consent Form must be a complete, legally compliant document formatted for presentation to potential research subjects. The document should be professionally formatted with clear headings, adequate white space, and a font size of at least 12 points. The reading level should be appropriate for the target population, generally not exceeding 8th grade. The total length should be comprehensive yet concise, typically ranging from 8 to 15 pages depending on study complexity. Include a header or footer on each page with the protocol title, version number, and date. Number all pages and include a statement on the signature page indicating the total number of pages. Ensure all required regulatory elements under 21 CFR 50.25 are present and clearly identifiable. The tone should be respectful, non-coercive, and focused on empowering the subject to make an informed decision. Avoid exculpatory language that waives or appears to waive any of the subject's legal rights or releases the investigator, sponsor, or institution from liability for negligence.