How should an Informed Consent document be written?

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The regulations state that the consent shall be in language understandable to the subject. This goes beyond having the consent document just in the language understandable to subject (English, Spanish, etc.). To enhance understandability and readability, the consent should be written in active voice, and avoid grammatical and typographical errors. It is primarily recommended, in order to maintain consent language simple (layman terms), the consent should not be written beyond a 9th grade reading level (Flesch-Kincaid Grade level). However, the investigator should consider the subject population (target audience) when writing the consent. For example, an investigator interviewing doctors might include in the consent technical (medical) terminology instead of using the equivalent simplified version.

Nonetheless, it is important for the consent document to be clear and have a concise explanation of the various elements of the research study. In addition, the language should not contain any element of coercion nor appear to waive subject’s legal rights, or release the investigator, sponsor or institution from liability for negligence (no exculpatory language).

The structure of the consent document entails the following:

(1) Heading and Title of the Study: Office of Research Compliance (OReC) recommends the heading of the document to be “INFORMED CONSENT TO PARTICIPATE IN A RESEARCH PROJECT”

(2) Identification of Investigators: Starting with the PI, the names and titles of all the investigators should be included. In addition, name the institution affiliated with each investigator(s).

(3) Introduction: Give a brief description why the subject is being asked to participate in this research study.

(4) Study Purpose: State in layman terms the overall purpose, objective or goal of the study. The subject must understand how this procedure, intervention or observation differs from medical/health care, and research.

(5) Study Procedures: Give a step-by-step description of the procedures to occur in the study place. The subject should be able to understand what is expected of them, when and how often the visits will take place, and the duration of each visit and study. Be thorough- describe what will occur when and for how long with each visit, etc.

(6) Risks and Discomforts of the Study: There are two types of risks associated with research studies i) informational and ii) physical risk. Informational risk involves the possibility of a breach of confidentiality. This is not limited to only personal identifiers but also responses to sensitive questions. Physical risk also called “procedural risk” is more common in biomedical research studies or clinical trials.

(7) Contacts: Indicate the contact information of the principal investigator (research coordinator, if applicable) and the Chairman of the Institutional Review Board (for UNTHSC, 817-735-0409).

(8) Benefits: Explain whether the study will have a direct or indirect benefit to the subject. If no direct benefit to a subject say so but also mention the value of doing this research. NOTE: Receiving compensation is NOT considered a benefit for the subject.

(9) Alternative Treatment (if any): If applicable, explain if there is any alternative to a subject’s research procedure or intervention.

(10) Confidentiality: Provide a description of the measures that will be taken to secure the privacy of subject data and identifiers. Since there is always a potential risk of loss of confidentiality, refrain from any language guaranteeing/assuring complete privacy.

(11) Compensation for Injury (if applicable): Explain the availability of compensation and/or medical treatment in case of a research-related injury.

(12) Costs and Compensation of the Study:If applicable, detail any costs subject may accrue during this study or anypaymentthe subject may receive for time and effort.

(13) Withdrawing from the Study: This statement must clearly indicate that participation is voluntary and the subject may withdraw/leave at any moment without penalty or loss of benefits that the subject was otherwise entitled. If investigators will be recruiting from UNTHSC, the following statement must be included.

“If you are a student of the University of North Texas Health Science Center, your participation (or non-participation) will in no way affect your academic standing or employment status.”

(14) Consent Statement: This statement should indicate that the subject will receive a copy of the signed informed consent and the subject voluntarily agrees to participate in the study. This is the only statement that should be written in first person (e.g. “I” instead of “you”).

(15) Signatures: Have signature lines for the subject or legal representative and the investigator/research staff who administered consent. Label signature lines as well as indicate the date of signing.

For more guidance on writing an informed consent document, please follow the link shown below for various informed consent templates or examples.

Social/Behavioral Informed Consent Samples/Templates:

Public Health Consent

Survey Sample Consent

Cover Letter (in lieu of informed consent)

Biomedical Informed Consent Samples/Templates:

Integrative Physiology Consent

Biomedical Consent

Clinical Trial (non-sponsor driven) Informed Consent

Parental Consent (permission) and Child Assent

Cover Letter (in lieu of informed consent)

OReC would like to extend our grateful appreciation to , Dr. Cardarelli, Dr. Larrañaga , Dr. Anthony, Dr. Dawson and Dr. Mathew, all principal investigators at UNTHSC, for permission to use their informed consent for educational purposes.