What is the process of obtaining informed consent?

Informed consent is the process of telling potential research particpants about the key elements of a research study and what their participation will involve.  The informed consent process is one of the central components of the ethical conduct of research with human subjects.  The consent process typically includes providing a written consent document containing the required information (i.e., elements of informed consent) and the presentation of that information to prospective participants.  

In most cases, investigators are expected to obtain a signature from the participant on a written informed consent document (i.e., to document the consent to participate) unless the IRB has waived the consent requirement or documentation (signature) requirement.

• Projects which collect biospecimens for genetic analysis must obtain documented (signed) informed consent.
• It is an ethical best practice to include an informed consent process for most exempt research.  IRB-HSBS reviews, as applicable, the IRB application for exempt research, but not the informed consent document itself.  A suggested consent template for exempt research can be found below under the References and Resources section.  A companion protocol template for exempt research may be found in the feature box, Related Information (top right).

Informed consent documents

An informed consent document is typically used to provide subjects with the information they need to make a decision to volunteer for a research study.  Federal regulations (45 CFR 46.116) provide the framework for the type of information (i.e., the "elements") that must be included as part of the consent process.  New with the revised 2018 Common Rule is the requirement that the consent document begin with a "concise and focused" presentation of key information that will help potential participants understand why they might or might not want to be a part of a research study.  

Key Information Elements

The image below displays the five elements identified in the preamble to the revised Final Rule as suggested key information.  

Note: Element number 5 (alternative procedures) applies primarily to clinical research.

General Information & Tips for Preparing a Consent Document

Reading level

Informed consent documents should be written in plain language at a level appropriate to the subject population, generally at an 8th grade reading level.  A best practice is to have a colleague or friend read the informed consent document for comprehension before submission with the IRB application.  Always:

• Tailor the document to the subject population.
• Avoid technical jargon or overly complex terms.
• Use straightforward language that is understandable.

Writing tips

The informed consent document should succinctly describe the research as it has been presented in the IRB application.

• Use the second (you) or third person (he/she) to present the study details.  Avoid use of the first person (I).  
• Include a statement of agreement at the conclusion of the informed consent document. 
• The consent doucment must be consistent with what is described in the IRB application.

Document Formating for Uploading into eResearch

• Remove "track changes" or inserted comments from the consent documentation prior to uploading the document into the IRB application (Section 10-1) for review.
• Use a consistent, clearly identified file naming convention for multiple consent/assent documents.

Informed Consent Templates

IRB-HSBS strongly recommends that investigators use one of the informed consent templates developed to include the required consent elements (per 45 CFR 46.116), as well as other required regulatory and institutional language.  The templates listed below include the new consent elements outlined in the 2018 Common Rule.

While there are many important aspects of a clinical research trial, the trial itself wouldn’t happen without research participants. Running a successful trial depends on recruiting and retaining clinical research participants. In order for individuals to participate in a study, they must receive information about what their involvement would include and voluntarily agree to participate, known as the informed consent process. Aside from being a regulatory and ethical requirement, informed consent is a good way to ensure participant knowledge and start a relationship between researcher and participant based on communication and trust that continues throughout the trial.

Informed consent is defined as the process of providing participants important information pertaining to the clinical trial, including what procedures they will undergo and possible risks and benefits. The information is intended to help participants make an informed decision on whether or not they want to start or continue with a clinical trial.

When is Informed Consent Obtained?

The informed consent of the participant must be obtained before any research procedures start. This is documented by an informed consent form (ICF) signed by the participant. This document is kept on file for the duration of the clinical trial, as well as a specified time period afterwards for auditing purposes. Participants must know key aspects of the protocol and understand their involvement in the trial is voluntary. They can withdraw from the study at any given moment, without reason.

Informed consent is not a one-time process; it is the start of a relationship based on communication. Research staff should not only obtain informed consent before any trial-related procedures begin, but consistently throughout the trial. Oftentimes, new information arises and changes elements to the trial that may impact the participants’ decision to keep moving forward. While they might have agreed to the protocol the last time, it doesn’t guarantee they will agree to keep moving with the study if it is amended. It’s essential to maintain ongoing conversations with participants, and ensure they continue to understand the protocol, their responsibilities as well as have their questions answered and agree to continue.

Conversely, there are times when informed consent is not needed, although these cases are rare. Informed consent is typically waived during emergency situations when it’s unfeasible to obtain consent from the participant – such as a critically ill subject. It’s important during these situations for doctors to act in the subject’s best interest, even if it means ultimately deciding not to include them in the trial.

Why is Informed Consent Obtained?

There are many reasons why a participant decides to join a clinical trial – they might want to advance science, or they may see it as their best option for treatment. Regardless of their reasoning, participating is voluntary, and subjects can opt-out at any time without any given reason.

Since it’s voluntary, a research participant needs to go through the informed consent process on a consistent basis. Informed consent is obtained to assure the researcher that the participant knows every aspect of their participation in the trial – what the procedures or treatments are going to look like and the potential outcomes, including the benefits and the risks.

Obtaining informed consent also benefits the research staff. A good consent process means the participant understands what is being asked of them. An ongoing consent process means the participant stays up-to-date on what is happening next in the trial. If they are fully informed and truly understand what is being asked of them, they will be more likely to stick with the trial for its entirety. This improves data integrity, ensuring the trial meets its scientific objectives.

How is Informed Consent Documented?

There are two main ways consent is documented: on paper and in electronic format. Regardless of format, there are common elements to making sure the participant has the information needed and voluntary consent is obtained with their full understanding.

Paper consent is collected in person with a research professional and the participant, whereas electronic consent (eConsent) uses hyperlinks, videos, and assessment tools to assist with understanding the consent document. To ensure the consent is complete, information is reviewed by a physician or by other individuals (i.e., researchers) with appropriate scientific training and qualifications.

However, it’s important for the research team member facilitating the consent processer to break down the ICF in simple terms for their participants to understand. Oftentimes, participants do not have a scientific or medical background and have questions or need clarifications. Participants may also want to meet outside of the initial meeting so they can ask any questions they might have thought of after the fact or to address any concerns. They should be allowed to take the consent form home to think about their participation and talk to others, such as their primary care physician or family, about whether participating in the study is in their best interest.

Participants are a key stakeholder in clinical research. Ultimately, if the participant feels comfortable and educated during the trial, they will be more likely to stick through the trial. Knowing the basics of when, why, and how informed consent is obtained and documented provides a great foundation for ensuring participant satisfaction.

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