What Is Informed Consent in Research Studies? Everything You Need to Know

Informed consent is a foundational principle in ethical research involving human participants. It is more than just a signature on a form—it’s an ongoing process that ensures participants are fully informed about a study’s purpose, procedures, potential risks, and their rights. 

Whether you’re considering joining a clinical trial, a behavioral study, or a psychology survey, understanding informed consent empowers you to make decisions in your best interest.

In this article, we’ll explain everything you need to know about informed consent in research studies, including what it entails, how the process works, the differences across study types, and what to do if you don’t understand something.

Key Takeaways

• Informed consent is a legal and ethical requirement for most human research studies, ensuring participants know what to expect before agreeing to take part.
• The process includes disclosure of the study’s purpose, risks, procedures, and your right to withdraw at any time.
• Consent must be given voluntarily, without coercion, and participants must understand what they are consenting to.
• The consent process varies between clinical trials and social science research but always involves protection of personal rights.
• Special rules apply to minors, non-English speakers, and vulnerable populations to ensure true informed participation.

Understanding Informed Consent in Research

Informed consent protects the dignity, autonomy, and safety of research participants. It ensures that people are not unknowingly subjected to experiments, and it empowers individuals to make voluntary, educated choices about participation.

There is much recent research that underscores the effectiveness of informed consent processes. In fact, a 2024 meta-analysis revealed that most clinical trial participants comprehended key aspects of informed consent, such as the study’s purpose, their rights to withdraw, and confidentiality measures, which are essential for obtaining informed consent.

From a research ethics standpoint, informed consent:

• Builds trust between researchers and participants
• Prevents exploitation of vulnerable individuals
• Promotes transparency and accountability
• Supports compliance with legal regulations and international standards

Historically, unethical research practices—such as the Tuskegee Syphilis Study—exposed the dangers of conducting research without proper consent. These events led to stricter global standards and regulations for protecting participants.

Legal and Ethical Foundations of Informed Consent

The requirement for informed consent is supported by several ethical codes and legal frameworks, including:

• The Nuremberg Code (1947) – After WWII, this set of principles emphasized voluntary consent.
• The Declaration of Helsinki (1964, updated 2013) – Issued by the World Medical Association, it outlines ethical principles for medical research involving humans.
• The Belmont Report (1979) – A U.S. framework defining key principles: respect for persons, beneficence, and justice.
• U.S. Common Rule (45 CFR 46) – Federal policy for protecting human subjects in research.
• FDA Regulations (21 CFR 50) – Specific to clinical trials involving drugs and medical devices.

These documents stress the need for clear communication, participant autonomy, and ethical oversight by Institutional Review Boards (IRBs).

What Information Is Included in an Informed Consent Form?

An informed consent form is a comprehensive document designed to clearly communicate what a study involves. It helps participants understand their role, their rights, and what to expect throughout the research process.

In fact, a global review of informed consent documents found that over 50% of participants met the consent requirement for the study. These forms across multiple countries included essential elements such as the study title, objectives, procedures, potential risks, and confidentiality protections. This reflects growing international consistency in ensuring the protection of human subjects and ethical, transparent research practices.

Here’s what you can expect it to include:

Study Purpose and Procedures

This section outlines the research’s objectives and the specific activities participants will undertake. It provides clarity on the study’s goals and the participant’s role.

Risks, Benefits, and Compensation

Participants are informed about potential risks (physical, psychological, or social), anticipated benefits, and any compensation or reimbursement they may receive.

Voluntary Participation and Right to Withdraw

This emphasizes that participation is entirely voluntary, and individuals can withdraw at any point without penalty or loss of benefits.

Confidentiality Measures

Details on how participant data will be protected, stored, and used, ensuring privacy and confidentiality.

Contact Information

Provides details for participants to reach out with questions or concerns about the study or their rights.

Read more: How to Apply for Paid Research Studies

How the Informed Consent Process Works

The informed consent process is at the heart of ethical research involving human participants. While it often begins with a document, true informed consent is a step-by-step process—not a one-time transaction. It’s designed to give participants everything they need to make a thoughtful, voluntary decision about whether or not to take part in a study.

Whether in a hospital, university, or virtual setting, the process must prioritize clarity, transparency, and autonomy.

Step 1: Information Disclosure

The process begins with the presentation of essential information about the study. Researchers must explain:

• The purpose of the research
• What the study hopes to learn or accomplish
• What participation will involve—tests, interviews, medication, surveys, or other procedures
• The duration of participation

• Any known risks or discomforts, and how they will be managed
• Any benefits, whether personal (e.g., free check-ups) or societal (e.g., contributing to public health knowledge)
• Whether the study is one of many types of paid research studies and what compensation, if any, is offered
• Confidentiality—how data will be stored, protected, and used
• The voluntary nature of participation and the right to withdraw at any time

All of this must be communicated in language that is easy to understand, avoiding medical or academic jargon. Encouragingly, a 2024 meta-analysis published in PLOS ONE found that approximately 75% of clinical trial participants understood the fundamental components of informed consent, such as the nature of the study, compensation, voluntariness, and the freedom to withdraw at any time. 

A researcher may provide both a written document and an in-person explanation, highlighting key points and checking in frequently to confirm the participant’s understanding.

Step 2: Time for Review and Reflection

Ethical standards require that participants be given adequate time to consider whether they want to take part. For complex studies or those involving medical procedures, this reflection period is critical.

Participants should be encouraged to:

• Read the form on their own
• Consult with family members, legal advisors, or doctors
• Write down any questions or concerns for discussion
  

For minimal-risk studies (e.g., short surveys), review time may be brief. But for clinical trials or behavioral studies involving sensitive topics, researchers must allow for thoughtful deliberation—sometimes across multiple visits.

Step 3: Questions and Clarification

This is a core part of the consent process: the opportunity to ask questions.

Researchers must create a safe, open environment where participants feel comfortable voicing uncertainty. Common questions might include:

• “What happens if I stop participating midway?”
• “Will this affect my current medical treatment?”
• “Who will have access to my personal data?”
• “What happens if I have a bad reaction or side effect?”

Researchers must respond honestly and ensure that participants truly understand the answers. In some cases, comprehension may be assessed with a quiz or summary to confirm understanding.

Step 4: Voluntary Decision

After reviewing all materials and getting answers to their questions, the individual makes their decision.

Participation must be:

• Voluntary—without pressure, fear, or obligation
• Uninfluenced by financial incentives that may cloud judgment
• Based on the belief that they can say “no” without consequences
  

No one should feel rushed or guilted into signing. This is particularly important in contexts where power dynamics exist—such as between patients and healthcare providers or students and university researchers.

Step 5: Documentation of Consent

Once a participant agrees, they will sign the informed consent form. In most studies, this takes the form of:

• Written consent (paper or electronic)
• Digital signatures for online or remote studies
• Verbal consent, recorded with documentation (for some low-risk studies)
• Implied consent, when completing an anonymous survey with no identifying data

The participant should always receive a copy of the signed form. This serves as a personal record and reinforces their ongoing rights throughout the study.

Role of the Researcher or Study Coordinator

The individual responsible for leading the informed consent process—whether a principal investigator, study coordinator, research nurse, or trained assistant—plays a central role in ensuring the ethical integrity of the study. Their job is not simply administrative. It is fundamentally about advocacy, communication, and protection of participant autonomy.

Ethical and Regulatory Responsibility

From both a legal and moral standpoint, researchers are obligated to ensure that participants:

• Fully understand the study they are joining
• Are participating voluntarily, without coercion
• Have the opportunity to ask questions and receive clear answers
• Feel empowered to withdraw at any time

These responsibilities are enforced by Institutional Review Boards (IRBs), research ethics committees, and, in the case of clinical trials, regulatory agencies like the FDA or EMA.

Key Duties in the Consent Process

In practice, the researcher or coordinator’s role includes:

Presenting Information Clearly and Without Bias

They must avoid exaggerating benefits or downplaying risks. The language should be neutral, accurate, and tailored to the participant’s comprehension level. For example, instead of saying, “This drug could cure your condition,” they might say, “This drug is being studied to determine whether it helps people with your condition.”

Answering all Questions Honestly and Transparently

Researchers must be willing to address concerns, admit when something is unknown, and avoid misleading statements—even unintentionally. Their responsibility is to inform, not persuade.

Checking for Comprehension

This is especially critical when working with vulnerable populations (e.g., individuals with cognitive disabilities, those with limited literacy, or non-native speakers). In some cases, comprehension assessments or “teach-back” methods are used, where participants are asked to explain the study back in their own words.

According to a study published in Trials, among staff who do check for understanding, 88% ask participants directly whether they feel they’ve understood the information. This emphasizes how simple, participant-led approaches are commonly used to reinforce clarity and ensure informed decisions.

Documenting the Process Thoroughly

It’s not enough to collect a signature. Researchers must note the time, date, method of consent (e.g., written, verbal, digital), and any conversations that took place. This documentation serves as proof of ethical compliance.

Maintaining Communication Throughout the Study

Informed consent is not a one-time event. If the study changes significantly—such as new risks being identified or the study extending beyond its original timeline—participants must be re-informed and possibly re-consented. The researcher ensures these updates are communicated promptly and effectively.

Specialized Training and Oversight

In large-scale or high-risk studies, research staff are often required to complete specialized training in:

• Informed consent communication strategies
• Cultural competency
• Working with minors and legally authorized representatives
• HIPAA or GDPR compliance for privacy
• Responding to emotional distress or adverse events

Institutions may use standardized scripts, consent checklists, or video explanations to promote consistency and reduce variability in how consent is presented across different sites or staff members.

While regulations are critical, so is empathy. A respectful, patient-centered approach is often what separates a perfunctory consent process from a meaningful one. Participants may be anxious, uncertain, or intimidated by the idea of research. The coordinator’s ability to build rapport, listen attentively, and show compassion can significantly influence whether a participant feels safe and confident moving forward.

Ultimately, the researcher’s role in the consent process is a balancing act between rigorous compliance and human-centered care. When done well, it reinforces trust—not only in the specific study but in the broader institution and the scientific process itself.

Informed Consent in Clinical Trials vs. Other Studies

Aspect	Clinical Trials	Social, Behavioral, or Educational Studies
Primary Role	Protects against physical harm; ensures legal compliance	Protects privacy, emotional comfort, and voluntary choice
Risks Addressed	Medical risks, side effects, experimental treatments	Emotional discomfort, sensitive topics, confidentiality
Regulatory Oversight	Strict oversight by FDA, EMA, and IRBs	Reviewed by IRBs or ethics committees; less regulatory load
Form Complexity	Lengthy (10–20 pages), formal, legal language	Short (1–3 pages), plain language
Consent Format	Signed written consent required	Written, verbal, or implied (if IRB-approved)
Ongoing Consent	Often requires re-consent for protocol updates	Rarely needed unless major changes occur
Ethical Focus	Safety, risk transparency, legal protection	Autonomy, privacy, data protection

What Happens If You Don’t Understand Something?

Informed consent only works if you truly understand what you’re agreeing to. If something in the consent form or explanation doesn’t make sense, it’s important to pause and seek clarification—asking questions is not just allowed, it’s expected.

Researchers have an ethical responsibility to make sure you fully grasp the purpose of the study, what your participation involves, what the risks are, and what your rights include. If at any point you’re confused or unsure, you have every right to speak up and ask for clarification on the consent to participate.

What to Do if Something Is Unclear

If you don’t understand a term, procedure, or section of the consent form, here’s what you can do:

Ask the researcher or coordinator to explain it in simpler terms. You can say things like:

• “I need more information to make an informed decision.”
• “Can you walk me through that again in plain language?”
  • “What does this term mean?”
  • “What would this part of the study look like in practice?”
• Request additional time to review the form. You don’t need to sign it on the spot. Many studies encourage participants to take the document home, think it over, and return with questions.
• Bring someone with you. If allowed, you can review the consent form with a family member, friend, or healthcare provider who can help interpret and guide your decision.
• Ask for the form in a different language or format. Ethical guidelines require that consent be accessible. If English isn’t your first language—or if you have low vision or a learning disability—you can request translated, audio, or large-print versions.

Questions You Should Always Feel Comfortable Asking

Here are examples of questions every participant has a right to ask before giving informed consent:

• What exactly will I be doing if I join this research project?
• How long will the study take?
• What are the risks or side effects I should know about?
• Will my information be kept private?
• Can I leave the study at any time after giving my signed consent?
• What happens if I have a bad reaction or change my mind during the research project?

If the person obtaining consent cannot answer your questions clearly—or seems dismissive—that’s a red flag. Ethical researchers want you to feel fully informed before making a decision.

Your Rights as a Participant

You are never obligated to sign a consent form if you don’t fully understand it.

According to U.S. federal guidelines (45 CFR 46), researchers must present information in a way that allows the participant to “understand the reasons why one might or might not want to participate.” That means informed consent isn’t valid if it’s confusing, overly technical, or rushed.

You have the right to:

• Take your time before deciding
• Decline to participate without penalty
• Withdraw after signing, at any point
• Receive clear answers to any questions you raise

If you don’t understand something, ask. The entire purpose of informed consent is to empower you to make the right decision for yourself—freely and knowledgeably. No reputable study wants you to agree to something you don’t fully understand.

Special Considerations: Minors, Cognitively Impaired, and Non-English Speakers

Informed consent must be adapted to suit the needs of all potential participants, including those who may not be able to give full legal or informed consent on their own. These include minors, individuals with cognitive impairments, and people who do not speak or read the language in which the study is conducted.

Ethical research demands not only that consent is obtained—but that it is meaningful, comprehensible, and respectful of the participant’s situation.

Consent vs. Assent: When Children Are Involved

Minors (usually under the age of 18) are generally not legally able to provide full informed consent in research. Instead, researchers must obtain:

• Parental or guardian consent: A parent or legally authorized representative must review the study and agree to the child’s participation.
• Child assent: If the child is capable of understanding in simple terms, they must also agree to participate. This is called assent, and it’s required in most IRB-approved studies involving children.

For example, in a study on reading comprehension for 10-year-olds, the researcher might provide a simple, illustrated explanation of the study for the child, while also giving a full-length consent form to the parent.

Researchers must ensure the child’s comfort and willingness to participate throughout the study—not just at the start. If a child shows distress or wants to stop, their decision should be respected even if the parent has consented.

Cognitively Impaired Participants: Ensuring Ethical Inclusion

Some adults may not have the capacity to understand a standard consent form due to:

• Developmental disabilities
• Neurological conditions (e.g., Alzheimer’s disease)
• Mental health disorders
• Temporary impairments (e.g., sedation, trauma)

In these cases, researchers must involve a signed consent form of a legally authorized representative (LAR) to provide consent on behalf of the participant. However, whenever possible, the individual should still be involved in the discussion and encouraged to provide assent.

Additional safeguards often include:

• Simplified explanations or visual aids
• Consent discussions over multiple sessions
• Ongoing monitoring to ensure continued willingness to participate

Ethical guidelines require that researchers only include cognitively impaired individuals if the research cannot be carried out with capable adults alone, and if the research addresses issues relevant to that population.

Non-English Speakers: Language Accessibility in Consent

If a potential participant does not speak or read the language in which the consent form is written, the study team must provide:

• A translated version of the consent form
• A qualified interpreter to assist in the consent process
• Documentation that the translation was accurate and approved by the IRB

Participants should never be expected to sign a form they don’t fully understand.

For example, a Spanish-speaking participant in a diabetes research study should receive a Spanish-language version of the form and have access to a bilingual staff member or interpreter who can walk them through it and answer questions.

Many IRBs now require researchers to plan for language access in their study design in advance and may not approve studies unless reasonable accommodations are in place for diverse populations.

Respecting Autonomy and Inclusion

These special considerations are not just procedural—they reflect a deeper commitment to equity in research. People from all backgrounds and with varying abilities deserve the opportunity to contribute to research that affects their communities—but only when it’s done safely, respectfully, and ethically.

Researchers must balance the need to protect vulnerable individuals with the need to include their voices in scientific inquiry. Informed consent, when properly adapted, is how that balance is achieved.

Challenges and Controversies in Informed Consent

Although informed consent is a cornerstone of ethical research, implementing it effectively can be complex. Researchers often encounter real-world challenges that affect how well participants understand, engage with, and act on the information presented in the context of the informed consent requirement. These issues don’t undermine the importance of consent—they highlight where improvements are still needed.

1. Therapeutic Misconception

In clinical trials, participants may confuse research with personal treatment—believing that the experimental intervention is meant to directly benefit them. This misunderstanding can persist even when the study is clearly described as investigational.

Why it matters: It undermines voluntary participation if individuals join a study under false assumptions about its purpose or benefits. Researchers must clearly differentiate between research goals and clinical care.

2. Complex and Technical Language

Many consent forms are written at a 12th-grade reading level or higher, and include legal or medical terminology that the average participant may not fully understand.

Why it matters: If participants don’t understand the written informed consent form, their consent isn’t truly informed. This is especially concerning for populations with low health literacy, cognitive challenges, or limited English proficiency. Simplified language and visual aids can help bridge the gap.

3. Perceived Pressure or Influence

Participants sometimes feel subtle pressure to enroll—especially in hierarchical settings like hospitals, universities, or workplaces. For instance, a patient may feel obligated to join their doctor’s study, or a student may think research participation is required for a better grade.

Why it matters: True informed consent must be given freely. Even the perception of coercion compromises the ethical foundation of the process. Researchers should reassure participants that declining will not affect their care, grades, or job status.

4. Digital Consent (eConsent)

Online consent platforms are increasingly common, especially in remote studies. While convenient, they come with new risks: participants may skim through content, skip over risks, or sign without fully understanding the informed consent requirement of the study.

Why it matters: Without in-person explanation, it’s harder to ensure comprehension. eConsent tools must be thoughtfully designed—with interactive content, summaries, and comprehension checks—to make consent as meaningful as it is convenient.

5. Cultural and Community Contexts

Informed consent is based on the Western idea of individual autonomy. However, in many cultures, decisions are made communally—with input from elders, family members, or spiritual leaders.

Why it matters: If researchers fail to adapt the consent process to local norms, participation may feel intrusive or disrespectful. Ethical research in global or cross-cultural settings should incorporate community engagement and culturally appropriate consent models.

6. Consent Fatigue in Long-Term Studies

In studies involving multiple phases or ongoing participation, participants may be asked to re-consent several times. Over time, this can lead to disengagement—where participants sign without carefully reading or processing updated information.

Why it matters: Consent must remain informed throughout the study. Researchers should streamline re-consent procedures and clearly explain what has changed and why re-consent is needed.

7. Broad Consent for Future Use of Data

Participants are often asked to provide broad consent for their biospecimens or data to be used in future, unrelated studies. While this supports long-term research, it can raise ethical concerns.

Why it matters: Participants can’t predict all the future uses of their data or how those studies might make them feel. Clear opt-out options, tiered consent models, and transparent data governance policies are crucial to respecting autonomy.

Moving Toward Better Practice

These challenges don’t mean informed consent is ineffective—they highlight where consent must evolve. Research teams should:

• Test consent materials with real users
• Use plain language and layered explanations
• Provide space for questions and follow-up
• Consider cultural, technological, and emotional contexts
• Treat consent as an ongoing dialogue—not a one-time transaction

Informed consent remains one of the most powerful tools for protecting participant rights. But it must be approached with care, creativity, and constant reflection.

The Rise of Digital and eConsent

As research moves beyond labs and clinics into virtual spaces, the way informed consent is obtained has evolved too. The rise of digital platforms has transformed the consent procedure in human subjects research. Digital consent—commonly referred to as eConsent—has transformed how participants review study information, ask questions, and provide their agreement to participate.

eConsent refers to the use of electronic systems and technologies that are increasingly used in the consent procedure for human subjects research to deliver study information and obtain consent. It can include web-based forms, interactive videos, animations, comprehension checks, and digital signatures. While widely adopted in clinical research and decentralized trials, eConsent is also growing in behavioral studies, public health surveys, and mobile app-based research.

eConsent platforms guide participants through the consent process using a computer, tablet, or smartphone. Instead of a printed packet of documents, participants view:

• Slide-by-slide study explanations
• Visual diagrams or illustrations of procedures
• Short videos on study purpose, risks, and rights
• Multiple-choice questions to check understanding
• Fields for electronic signatures

Some platforms also include real-time chat or video calls with a study coordinator to support participant comprehension—bridging the gap between convenience and personal interaction.

Benefits of eConsent

The adoption of digital consent systems offers numerous advantages. They are:

• Improved Accessibility: Participants can review information remotely and at their own pace, without the need to travel to a research site.
• Greater Comprehension: Interactive elements, such as videos and knowledge checks, help clarify complex concepts more effectively than text alone.
• Auditability and Compliance: Digital systems automatically track when and how consent was given, which helps ensure compliance with regulations like FDA 21 CFR Part 11 and GDPR.
• Scalability: eConsent is ideal for large, multi-site, or decentralized studies where consistent delivery of information is critical.
• Customization: Platforms can adapt to different languages, reading levels, and learning styles, improving inclusivity.

But, despite its advantages, eConsent also raises important concerns:

• Digital Literacy and Access: Not all participants have equal access to technology, reliable internet, or the digital skills needed to navigate an eConsent platform.
• Reduced Human Interaction: Without face-to-face contact, it may be harder for researchers to gauge whether a participant truly understands the study—or to answer questions in real time.
• Consent Fatigue: Digital platforms may lead to “click-through” behavior, where participants agree quickly without fully reviewing the content—especially if the interface feels like a software license agreement.
• Security and Privacy: Storing consent records and sensitive participant data online raises concerns about data breaches, cyber threats, and compliance with privacy regulations.

To ensure eConsent is as ethical and effective as traditional methods, researchers should:

• Use plain language and culturally appropriate materials
• Include options for real-time support (e.g., phone, chat, or video)
• Offer paper-based alternatives for those who prefer them
• Test the interface with target users before deployment
• Log consent comprehension with built-in assessments or summaries

As research becomes increasingly digital and global, the future of informed consent will likely involve hybrid models—combining the scalability of eConsent with the personal support of in-person conversations. The key is to maintain clarity, transparency, and participant empowerment, no matter the format.

Informed consent is evolving—but its purpose remains the same: to ensure people understand what they’re agreeing to, and that they agree freely.

Conclusion

Informed consent is not just a form—it’s a process built on respect, transparency, and participant protection. Whether you’re enrolling in a groundbreaking medical trial or a simple behavioral survey, understanding your rights and responsibilities is essential. Always take the time to read, ask questions, and make informed choices.

If you’re ever unsure, don’t hesitate to consult with your doctor, an ethics board, or a legal advisor before signing a consent form.

Ready to participate in research that values clarity and ethics? Join Focus Group Panel today and take part in studies that prioritize your voice, your comfort, and your informed consent every step of the way.

FAQs

Can I change my mind after signing the form?

Yes. Participation is voluntary, and you can withdraw at any time without losing access to care or facing penalties.

Is informed consent legally binding?

It is a legal document that proves you were informed, but it does not lock you into participation. You retain the right to withdraw at any point.

What if I feel pressured to join a study?

Speak up. No one should pressure you into participating. Report any coercion to the ethics committee or IRB overseeing the study.

Are there different types of consent (written, verbal)?

Yes. While written consent is most common, verbal or electronic consent may be acceptable for low-risk studies with IRB approval.

Do I get a copy of the consent form?

Yes. You should always receive a signed copy, either on paper or electronically, for your records.

Is consent always required in anonymous surveys?

Not always. For low-risk, anonymous surveys, implied consent (e.g., choosing to complete the survey) may be sufficient, but this must still be approved by an ethics board.

What is the informed consent process in research?

The informed consent process is a fundamental ethical requirement in research involving human participants. It ensures that potential research participants are fully aware of the nature of the study, including its purpose, procedures, risks, benefits, and their rights.

How do researchers obtain informed consent?

Researchers can obtain informed consent by following a systematic approach that includes providing comprehensive information about the study through an informed consent document. This document should be written in clear, understandable language, ensuring that participants know what to expect. 

What are the key elements of informed consent in research?

Key elements of informed consent in research include:

1) Disclosure of information, where researchers provide detailed information about the study

2) Comprehension, ensuring participants understand the information presented

3) Voluntariness, confirming that participation is entirely voluntary without coercion

4) Competence, where participants are capable of making an informed decision

5) Consent, where participants formally agree to participate by signing a consent form.

What is the difference between written informed consent and oral consent?

Written informed consent involves participants signing a consent form that documents their agreement to participate in the study. This form serves as a legal record of consent. In contrast, oral consent may be appropriate in certain situations, especially when the research involves minimal risk.