What is informed consent in research?

Two key questions for most people-oriented research are what is informed consent in research, and how does it fit into research design?

Informed consent allows you to adhere to specific standards to protect your organization from liability. Seeking informed consent can also increase the validity of research by ensuring data comes from verified sources that are competent and experienced in the research subject.

Informed consent is one of the foundations of research ethics. This is especially true in scientific studies, but it applies more broadly to many kinds of research using living participants (i.e., non-archival data).

When a study requires informed consent, researchers must make sure the participants:

• Know fully what the research involves and how it will affect them

• Agree to the study voluntarily, free of undue influence or duress

• Provide their informed consent before the research begins

Why informed consent is important

In research, informed consent ensures your study meets or exceeds ethical and legal standards. That goes for both non-profit and for-profit purposes. In the latter case, future revenue could be at stake if you don't correctly follow the informed consent process.

Failure to gain full consent for all research subjects could expose your organization to legal issues—and many of them if there is a flaw in the entire consent process.

How researchers document informed consent

The informed consent form is usually the highest legal and scientific standard for proving research participants were competent and engaged voluntarily in the study. It involves keeping accurate records that prove a research study complies with relevant medical consent regulations and or contract law.

Above all, conduct your informed-consent-gathering mission to the strictest possible standards. Generally, if you can obtain informed-consent forms, do so. By anticipating challenges to your consent documentation, you're much less likely to be challenged.

First, obtain crystal clarity on whether your type of research requires informed consent. For this section, we'll assume that it does. In the next section, we'll discuss times when informed consent may not be necessary, or when unwritten consent may suffice.

The informed consent process

Documenting informed consent involves a specific and straightforward two-part process:

1. Giving prospective subjects information about the research, what it requires of them, and how the terms will or might affect them. You must then allow them to reflect on the offer without pressure or obligation.

2. Obtaining acceptance, where the researcher summarizes the research terms with distinct clauses or bullet points. The prospective subject can then explicitly agree or decline each point.

Again, you must acquire informed consent before research begins. Note also that while the two-step process may seem simple enough, you won't have control over how quickly each person accepts or rejects your terms.

Most research adheres to tight timelines, so plan enough time for participants to fully digest the informed-consent material you give them and ask you questions. This ensures you receive the most honest and accurate responses.

Care taken at the consent-gathering stage goes a long way to increasing participation and reducing the rate of drop-outs.

Tips for preparing a consent document

To streamline the informed consent process, make sure your documents:

• Are clear and understandable: Your consent form should use clear, non-scientific language so that participants can easily understand the content. Additionally, evaluate the form's readability to make sure it effectively communicates information to the target audience.

• Accurately explain the research and participant requirements: Your consent form needs to provide an accurate and comprehensive explanation of the research's purpose and what participants are expected to do. It should eliminate any ambiguity and ensure participants have a clear understanding of their responsibilities.

• Comply with data protection laws and regulations: Your consent form must comply with GDPR, HIPAA, and/or other relevant regulations. It must also clearly address data collection, handling, storage, and sharing in a manner that aligns with legal standards.

• Align with ethical review requirements: Confirm that your consent form follows the specified formatting and content guidelines set by the Institutional Review Board (IRB) or other ethical review bodies. Ensure that all necessary elements and information are included as per the IRB's requirements.

• Have a simple and consistent categorization system: Evaluate your consent form's categorization system for clarity and consistency in tracking participant responses. The system should be user-friendly and effectively support data management throughout the research process.

In some cases, informed consent doesn't require forms and signatures. Express consent may be valid if written consent isn't feasible—although in this day and age, it should be easy to at least obtain a digital record of informed consent.

If that's not possible, audio or video recordings of verbal consent could be adequate, depending on the context and format of the research study. Because the strongest proof of informed consent is signed written-consent forms, it's best to consider verbal consent as your Plan B and make every effort to obtain written informed consent.

Of course, that's not always feasible or possible. Scenarios where verbal consent is preferable or necessary include:

• When someone cannot physically sign a form, but is otherwise capable of communication

• Written language barriers, including illiteracy

• When signing a contract invokes cultural or geopolitical barriers

• If creating a paper record might somehow create risk for the participants and/or researchers

• Unavoidable time limitations that restrict the chance to obtain consent, although this isn't license to neglect proper planning

• When the nature of the research requires expediency (e.g., spontaneous or time-sensitive events, such as longitudinal studies or research into the immediate after-effects of sudden, life-threatening emergencies)

In such cases, you may still need timely documentation proving that you obtained consent. This includes a "researcher record of oral consent" or completing a written consent form on the participant's behalf. In the latter case, it's still best to have a recording unless doing so presents some risk.

What about research involving deception, surprise/shock, spontaneity, or other topics that depend on the participants' lack of knowledge? In these cases, you should still obtain as much consent as possible, even if certain topics must be kept a secret.

For example, explain that the research requires the participant to experience a state of genuine shock or fear, and you need their consent to engage them accordingly. Likely, you can still convey certain details, such as a window of time and/or a general description of the type of experience the subject will undergo, without compromising on prerequisite conditions.

In fact, it's more important to acquire consent for factors outside the researchers' control. This is the hallmark of conflict studies, where conditions can potentially get out of hand.

The threshold for implied consent

There are also scenarios when implied consent (neither written nor express) is sufficient. Compared to express consent, implied consent can involve a much narrower line of legal and ethical standards, or it can be easier to justify. It depends on the seriousness of the subject and what previous interaction researchers had with the participants.

Implied consent is most justifiable for straightforward research involving little-to-no risk, such as:

• Surveys that participants complete without direct contact with researchers

• When research data is anonymous and/or involves simple and basic tasks

• Previous engagement in the activity (e.g., blood draws for those who have given blood freely in similar contexts before)

At the other extreme, implied consent may be justifiable for those providing simple, low-risk treatments for someone who's been incapacitated—and all the more if it's a life-threatening emergency. For serious, but less time-independent issues, it may be a matter for the courts to decide.

The biggest difficulty arises when research involves sensitive or volatile topics. In these cases, implied consent isn't adequate, but confidentiality is also important because participation could damage people's reputations or welfare.

Sensitive topics that likely can't rely on implied consent include:

• Sexual behavior

• Activity that's either Illegal, politically volatile, or culturally stigmatized

• Subjects that most people consider embarrassing

• Violent and/or traumatic experiences

• Legally sensitive data (e.g, information on pending court cases)

• The research subjects' mental health

Sensitive topics underscore the need for clarity and tact during the informed consent process, even though it might be hard to get participants to agree. It also shows why research standards require strict limits on the sharing and use of research data.

It's usually necessary to provide supporting documentation alongside the informed consent form, such as:

• Statement of intent

• Project design, and how it will or could affect participants

• Recommended research plan (e.g., the treatments required in a medical study)

• Proposed schedule

• Legal release forms

• Industry-standard forms, especially for reviewing purposes

• Authorization by legal guardians

Sometimes, participants may need to reconsent (or reaffirm their previous consent), as in the following circumstances:

• A subject reaches legal adulthood throughout the study

• New laws or regulations that affect the terms of your research

• Certain changes in a participant's condition or availability

• Research spanning multiple stages, especially when spread over a long time

• New circumstances outside the original terms

Note that reconsent may not be possible if new circumstances or knowledge limit a participant's ability to safely or legally comply with the original consent terms.

Such matters may be outside your or the participant's control. A doctor could find health complications that make further participation risky, for example. You should constantly be on the watch for unforeseen issues that could affect consent, and if so, inform participants and acquire their reconsent.

Beauchamp (1997) has classified fully informed consent into seven essential elements:

• Competency, meaning the individual understands the offer and has the mental acuity to make a meaningful, conscious decision

• A voluntary decision, free of duress or coercion

• Disclosure of material information (i.e., what the research entails, what's being asked of participants, and how it might affect them)

• Recommendation of a plan for the procedure(s)

• Patient comprehension of the disclosure and plan

• The decision to accept the plan

• Authorization of the plan by the participant

At the heart of informed consent is an agreement, which invokes contract law.

In law, both consent and assent are forms of acceptance—but as a bedrock maxim of law puts it: "A thing different is not the same." Accordingly:

• Consent more overtly grants permission with the authority to do so

• Assent simply means someone approves of something, sometimes regardless of whether they have full legal authority

The subtle difference is that the one assenting may not have the authority to grant permission. Even if they do, assent may come with certain limiting factors (e.g., age, legal status, disqualifying medical conditions, preferences, etc.) that preclude the ability to properly consent.

It makes more sense to understand that an informed consent form is an offer, and the participant may do one of the following:

• Consent in full, and with full authority to do so

• Assent without any authority

• Assent, but with limited authority

In practice, most lawyers use "assent" when a participant is not of legal age or is under another legal authority, but adults with full legal authority can also assent. For example, if the consent form comes back with additional writing, it could be an acceptance of additional or different terms.

You then must choose whether to accommodate or disqualify the participant.

An IRB is a group that formally reviews research studies involving people, primarily for biomedical research. Their goal is to ensure a study complies with ethical, legal, and scientific standards.

Researchers must submit their plans to an IRB before seeking the consent of research participants. The IRB will then review the proposed study to determine what risks it might involve and how to minimize them. They may also conduct quality assurance reviews of the study once it begins.

IRBs also provide guidelines for maintaining ethical and scientific standards. An IRB can be comprised of any combination of:

• Lawyers

• Medical professionals

• Community members

• Other stakeholders impacted by human-subject research

For the fastest review, researchers' informed consent forms should match an IRB's application requirements. Be sure you know which IRB will approve or deny your research proposal, and draft your informed consent documentation appropriately.

At the strictest level, informed consent is necessary for any clinical trial involving people. Research that puts participants at significant risk also requires informed consent. If researchers can leverage their results for financial gain, they usually need to obtain informed consent first.

There are times when a rigorous informed-consent process is beneficial to the researchers, and not just about reducing liability. Informed consent can compel investors or regulators to take a favorable view of your research. This also rings true for the general public or other stakeholders.