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Tips for Writing Informed Consent Forms

Along with writing a clinical research protocol, an investigator is also responsible for writing the informed consent form. These are subject to IRB approval.

Informed consent is a process, not a document. It includes a conversation between the researcher or members of the research team and the potential participant. The goal is to ensure that the potential participant understands the risks and benefits of the research trial, as well as their rights as a participant.

The informed consent process and the elements that must be included in the informed consent document are governed by federal regulations under the oversight of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), as applicable.

Investigators may run into trouble when writing an informed consent form for a clinical trial because the form must clearly and accurately convey information about the potential risks, benefits, and alternatives of the trial, as well as the participant’s rights and the voluntary nature of their participation. This can be difficult to do in a way that is easily understood by potential participants, who may have varying levels of health literacy. Additionally, the form must comply with legal and ethical guidelines, which can be complex and subject to change.

Understand the regulatory requirements

Before writing an informed consent document, it is important to understand the laws and regulations that govern informed consent in the U.S., as well as any additional laws, guidelines or policies that are specific to your state and institution.

The regulations and guidance on informed consent from the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) continue to evolve.

For example, when the 2018 Common Rule went into effect in January of 2019, there were several major changes to the requirements for informed consent including the requirement to include a key information summary; requiring that participants be informed when their biospecimens may be used for future research, as well as recommendations for including, when applicable, additional elements such as information about possible commercial profit, returning results to participants, and notice when the research may involve whole genome sequencing.

In 2019, the FDA issued guidance on the use of electronic informed consent in clinical trials, which provides recommendations for using electronic informed consent processes that are consistent with the requirements of the FDA regulations.

In 2020, the FDA issued guidance on the use of telehealth technologies in clinical trials, which recognizes that the use of telehealth technologies can facilitate the informed consent process by providing participants with greater flexibility and convenience in accessing information about the trial and providing their informed consent.

Use plain language

The informed consent document should be written in plain language that is easy for potential participants to understand.

This means using language that is free of technical jargon or complex medical terminology. The goal is to ensure that potential participants can make an informed decision about whether to participate in the trial.

Plain language can include using simple sentence structures, avoiding acronyms or abbreviations without explaining them, and using lay terms to describe medical procedures and concepts. Using plain language is particularly important for individuals with lower health literacy.

Here are some examples of how plain language can be used in an informed consent form:

• Instead of saying “The study involves administration of an investigational drug,” say “The study drug is experimental which means that is being tested and is not approved by the United States Food and Drug Administration (FDA).”
• Instead of saying “The subject will undergo a diagnostic imaging procedure,” say “You will have a test that takes pictures of your body.”
• Instead of saying “The potential risks of the study include severe adverse reactions,” say ” Taking part in this may expose you to risks (side effects). Side effects may range from being mild to life-threatening and may go away with treatment or be permanent.”
• Using plain language also aligns with another change introduced in the new Common Rule, which put emphasis on the fact that the information provided in the informed consent document should be presented in a way that facilitates a participant’s understanding for why they may or may not want to participate in a research study.

A Special Note about Language Translations

Federal research regulations do require that the consent process be conducted in a language that the potential participant understands. This means that if a person does not speak or read English, or if English is not their primary language, the informed consent form must be translated into their primary language or be interpreted for them by a qualified interpreter. It’s also important to note that the translation must be accurate and not a summary of the form.

The regulations also require that when there are a significant number of individuals in a particular population who are not proficient in English, the informed consent documents should be translated into the language spoken by a significant portion of the population.

It’s worth noting that many institutions and organizations choose to provide translations of informed consent forms even if they are not legally required, as it can help to ensure that potential participants understand the information and can make an informed decision about whether to participate in the trial.

Organize the information clearly

The information in the informed consent document should be organized in a logical and easy-to-follow manner. The following are the basic elements to be included in an informed consent document for research studies:

A statement that the study involves research, and an explanation of the purpose of the research and the expected duration of the participant’s involvement.  A description of the procedures to be followed in the study, including any interventions, tests, or treatments that the participant will be asked to undergo.

• A description of any foreseeable risks or discomforts to the participant,
• A description of any benefits that are expected from the study.
• A description of any alternative treatments or procedures that may be available.
• An explanation of the extent to which confidentiality of the participant’s records will be maintained, and how any information that is obtained during the study will be used.
• A statement that participation is voluntary, that the participant may refuse to participate or may withdraw from the study at any time without penalty or loss of benefits to which the participant is otherwise entitled.
• A statement that the participant will be provided with a copy of the signed and dated informed consent form.
• Contact information for the study team, including the names and telephone numbers of the principal investigator, research coordinator, and any other important members of the study team.
• Information about compensation and treatment for research related injury.
• Information about who to contact in case of a research-related injury, or for questions about the research or about the participants rights as a participant in a research study.
• When research involves the collection of identifiable private information or biospecimens, the consent should include a statement about whether or not the information may be used in future studies.

Researchers must also consider when the additional elements of informed consent which can be found at 45 CFR 46.116(b) and 21 CFR 50.25 (b) should be included.

Emphasize the key information

Begin the informed consent form with a key information section that contains a concise explanation of the research study including facts such as:

• Participants are being asked to consent to participation in a research study and their participation is voluntary;
• The purpose of the research, including duration of participation and brief description of the research procedures;
• Foreseeable risks and discomforts;
• Any benefits to the participants or others;
• Alternative procedures or treatments, if any.

Additionally, there are several ways to highlight key information throughout the informed consent form:

• Use headings and subheadings: This can help to break up the information and make it easier for participants to find the information they are looking for.
• Use bullet points: This can make the information more visually appealing and make it easier for participants to scan the form quickly.
• Use bold or underlined text: This can help to draw attention to important information.
• Use tables or diagrams: This can help to present complex information in a clear and easy-to-understand format.
• Use highlighting colors or boxes: Use colors or boxes to highlight particularly important information, such as the alternative treatments or the contact information.

It’s important to keep in mind that the design of the form should be clear, easy to read and accessible, making sure that the key information is easy to find and understand.

Get feedback and review

Prior to submitting the form to the IRB, have other members of the research team review the document. Other types of review that an investigator can consider include:

• Feedback from potential participants: Feedback from potential participants, such as a cognitive debriefing, can be used to test the form’s readability and participants’ comprehension and overall understanding. This can help to ensure that the form is written in plain language and is easily understood by the target population.
• Feedback from experts: Feedback from experts in the field, such as ethicists or linguists, can also be used to identify any issues with the form and to provide suggestions for improvement.
• Legal review: While the informed consent document is not meant to be a legal document, organizations may require a legal review to ensure that the form is compliant with relevant laws and regulations, such as HIPAA (Health Insurance Portability and Accountability Act).

Avoiding Risks

If an investigator does not comply with the tips for writing an informed consent form, they may run several risks. Some of these risks include:

• Legal risks: If the form is not compliant with federal regulations and laws, the investigator may be subject to fines or penalties, and the study may be deemed invalid.
• Ethical risks: If the form does not accurately convey the risks, benefits, and alternatives of the study, or if it does not protect the participant’s rights, the investigator may be accused of ethical violations.
• Risk of participant withdrawal: If the form is not written in plain language or is difficult to understand, participants may be less likely to enroll in the study or more likely to withdraw from the study early.
• Risk of inaccurate data: If the form is not clear or easy to understand, participants may not fully understand the study or may misunderstand certain aspects of the study, which could lead to inaccurate data.
• Risk of negative publicity: If the form is not compliant with regulations or if there are other problems with the study, it could lead to negative publicity for the investigator and their institution and may damage the reputation of the institution.

Partnering with the IRB

The Institutional Review Board (IRB) is responsible for reviewing and approving the informed consent form. However, it’s also the investigator’s responsibility to ensure that the informed consent form is compliant with legal and ethical guidelines. The investigator is the one who will be conducting the study and interacting with the participants, so they are in the best position to understand the needs of the study and the population being studied. The investigator should work with the IRB to develop an informed consent form that meets the regulatory and ethical standards and is easily understandable to the population being studied. It’s a collaborative effort between the investigator and the IRB.

In summary, it’s important for investigators to take the time to write an informed consent form that is clear, accurate, and compliant with regulatory and ethical guidelines. Failure to do so can lead to serious regulatory, ethical, and reputational risks for the investigator and their institution.