Informed Consent in Research - Definition, Purpose, and Examples

Shalonda Skidmore, Devin Kowalczyk
  • Author
    Shalonda Skidmore

    Dr. Shalonda Skidmore is an educational professional with over 15 years of experience. She taught English I-IV for 5 years, served as a guidance counselor for 7 years, and has been working at the district level for 3 years. Dr. Skidmore has a BS degree from Grambling State University, a MA degree from Southern University in Baton Rouge, and a Ph.D. from Louisiana State University. Her expertise includes social and cultural studies, non-traditional counseling, and motivating students and adults to reach their academic and professional potential.

  • Instructor
    Devin Kowalczyk

    Devin has taught psychology and has a master's degree in clinical forensic psychology. He is working on his PhD.

Read about why informed consent is important in research. Learn the informed consent definition. Look at different methods of obtaining informed consent and see examples. Updated: 11/15/2021

Informed Consent in Research

Informed consent is the voluntary agreement regarding a role a person will play in a research study after they are fully informed. The purpose of informed consent is to increase the chances that the participant will become more involved in the study. Researchers are required by the ethics code of the American Psychological Association to disclose the intent, procedure, risks, and benefits of the study. The informed consent definition also includes the process of giving participants sufficient and continuous information so that they may be aware of what they will be asked to do for the duration of the study. Researchers have a responsibility to disclose the entire nature of the study, as well as the potential benefits so that the participants can make an informed decision regarding their participation. Therefore, all studies whose participants are human are required to have informed consent documentation either directly from the participant or from their parent or legal guardian if they are underage or lack the mental capacity to do so on their own. Studies that involve animals (primates cannot be used in studies) or written material such as archives do not require informed consent.

Components of Informed Consent

The following aspects of the study must be included in an informed consent document to participants:

  • Statement regarding that it is a research study
  • Explanation of the purpose of the research
  • How long the participant is expected to be engaged in the study
  • Description of the procedures to be followed and if any are experimental
  • Risks and discomforts
  • Benefits
  • Alternative procedures or treatments
  • Confidentiality
  • Compensation and medical treatment in case of injury
  • Emergency contacts
  • Voluntary participation
  • Clinical trial statement
  • Statement regarding who the results of the study will be made available to

There are requirements for all informed consent documents. The document should be kept available for the duration of the study and filed securely upon its completion.

Documents

Why is Informed Consent Important in Research?

In discussing what is informed consent in research, the informed consent document is important because failure to have it can turn into both a legal and ethical matter. An informed consent document defines and clarifies the nature of the study and will detail what happens to the notes, audio, and video of the participant to maintain confidentiality. Therefore, it is important that the researcher obtains consent prior to the start of the study. Consider this example: Dr. T is a researcher who is interviewing Mr. B for his research study. Dr. T does not provide Mr. B with an informed consent document and only speaks briefly about what the study will be about. Dr. T does not mention all aspects of confidentiality, but he does state to Mr. B that he hopes to share the results of the study with his colleagues at the university. Mr. B reluctantly agrees as Dr. T assures him that all will be well. During the study, Dr. T videotapes a research session. Mr. B asks him what will happen to the videotapes at the conclusion of the study. Dr. T tells him that they will be locked in a secured file, although he truly intends to destroy them. Mr. B becomes hesitant and reluctant and states that he would like to discontinue participation. Annoyed, Dr. T tells Mr. B that he cannot discontinue because he has already started the process.

There are several instances of unethical practices that have arisen during this study that could have been addressed and avoided if Dr. T had presented Mr. B with an informed consent document. Neglecting to provide everything that the study will entail was the first violation. Mr. B does not have a full understanding of what he is forcefully participating in. Another instance in not addressing confidentiality came back up during the videotaped session of the study. Dr. T should have included in an informed consent document that the videotapes would be destroyed, not secured after the end of the study. Then, Dr. T pressures Mr. B to begin and continue the study against his wishes. Due to all of the previously mentioned violations, Dr. T has opened himself up to not only legal liability due to deception but also professional repercussions from violating ethics.

Defining Informed Consent

Informed consent is so important that in the 9th revision of the American Psychological Association's Ethical Code it has its own section, 8.02. And, no, you won't be tested on that exact detail. However, it is worth mentioning because informed consent has its own dedicated section. It is that important. Informed consent provides participants with sufficiently detailed information on the study so that they can make an informed, voluntary and rational decision to participate. This includes:

  • The purpose of the study
  • Expected duration
  • Procedures of the study
  • Information on their right to decline or withdraw
  • Foreseeable consequences of withdrawing or declining
  • Potential risk, discomfort or adverse effects
  • Prospective research benefits
  • Incentives, such as payment or rewards
  • Whom to contact for questions

Lastly, as part of obtaining informed consent, a researcher must allow time for questions the participants might have. The answers should provide sufficient information without compromising the study. We will discuss how convoluted this gets with deceptive studies in a second.

Obtaining Informed Consent

It is customary for most researchers to obtain consent through written documentation for legal purposes. Just obtaining a signed document; however, is not enough. After the document has been made available to the potential participant, the researcher should also provide time for any questions that the participant may have to be answered. There are various legal and ethical considerations a researcher needs to make when writing the informed consent documentation and for presenting it to the potential participant. An informed consent ethics document should clearly include the elements of capacity, comprehension of information, and voluntariness. Capacity means that the client has the ability to make rational decisions. The comprehension of information means that the clients are given the information in a way that they can understand. Voluntariness means that the person who is giving consent is doing so freely without coercion.

It is customary, and best to obtain written informed consent from a participant of a study.

Agreement

Obtaining Informed Consent

All of the previously mentioned aspects must be provided to participants before they are entered into the study. Informed consent must be either documented by written consent or by oral consent in language that is reasonably understandable. Most researchers use a written form that the participants sign and date because there might be problems later on. One can never really predict the future and written proof is valuable in the courtroom setting.

Example

Let's develop an informed consent for a study involving the interaction with others in monkey suits. You're curious to see if the subjects will act differently if speaking to someone in a full monkey suit instead of regular clothes. Your informed consent must have:

  • The purpose is to study a person's interaction with others.
  • That it should last no longer than an hour.
  • The subject can chose to decline or withdraw.
  • That they will not be part of the study if they chose to decline or withdraw.
  • There may be some discomfort or confusion when talking to a person in a monkey suit.
  • How you hope to learn something about how people interact.
  • That each participant will receive a banana for their help.
  • And, your name and contact information if they have any questions afterwards.

Purpose of Informed Consent

A great deal of emphasis in psychology has been placed on respect for people's rights and dignity. It would not be difficult for a researcher to omit the section about how a participant can withdraw from a study. Or worse, the potential harm that may come from someone participating. Can you imagine the legal and financial fallout for failing to inform a subject in our monkey suit experiment about the use of monkey suits when the subject is allergic to monkey suits?

Special Considerations

There are times when the informed consent needs to be modified. We will discuss three unique situations in which informed consent would need to be modified. These are not the only times it would need to be, but these are the most common.

If you plan on using children, defined as anyone younger than 18, in your study, then you are legally required to obtain consent from their parent or guardian of the child. Obviously the consent form will need to be modified to indicate that you will be working with the children, but all of the same ideas still apply. This is the basic legal requirement. Most researchers will then go out and obtain assent, or the juvenile's consent to be part of the study. This makes things easier because the child's thoughts and feelings are considered and valued.

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Video Transcript

Defining Informed Consent

Informed consent is so important that in the 9th revision of the American Psychological Association's Ethical Code it has its own section, 8.02. And, no, you won't be tested on that exact detail. However, it is worth mentioning because informed consent has its own dedicated section. It is that important. Informed consent provides participants with sufficiently detailed information on the study so that they can make an informed, voluntary and rational decision to participate. This includes:

  • The purpose of the study
  • Expected duration
  • Procedures of the study
  • Information on their right to decline or withdraw
  • Foreseeable consequences of withdrawing or declining
  • Potential risk, discomfort or adverse effects
  • Prospective research benefits
  • Incentives, such as payment or rewards
  • Whom to contact for questions

Lastly, as part of obtaining informed consent, a researcher must allow time for questions the participants might have. The answers should provide sufficient information without compromising the study. We will discuss how convoluted this gets with deceptive studies in a second.

Obtaining Informed Consent

All of the previously mentioned aspects must be provided to participants before they are entered into the study. Informed consent must be either documented by written consent or by oral consent in language that is reasonably understandable. Most researchers use a written form that the participants sign and date because there might be problems later on. One can never really predict the future and written proof is valuable in the courtroom setting.

Example

Let's develop an informed consent for a study involving the interaction with others in monkey suits. You're curious to see if the subjects will act differently if speaking to someone in a full monkey suit instead of regular clothes. Your informed consent must have:

  • The purpose is to study a person's interaction with others.
  • That it should last no longer than an hour.
  • The subject can chose to decline or withdraw.
  • That they will not be part of the study if they chose to decline or withdraw.
  • There may be some discomfort or confusion when talking to a person in a monkey suit.
  • How you hope to learn something about how people interact.
  • That each participant will receive a banana for their help.
  • And, your name and contact information if they have any questions afterwards.

Purpose of Informed Consent

A great deal of emphasis in psychology has been placed on respect for people's rights and dignity. It would not be difficult for a researcher to omit the section about how a participant can withdraw from a study. Or worse, the potential harm that may come from someone participating. Can you imagine the legal and financial fallout for failing to inform a subject in our monkey suit experiment about the use of monkey suits when the subject is allergic to monkey suits?

Special Considerations

There are times when the informed consent needs to be modified. We will discuss three unique situations in which informed consent would need to be modified. These are not the only times it would need to be, but these are the most common.

If you plan on using children, defined as anyone younger than 18, in your study, then you are legally required to obtain consent from their parent or guardian of the child. Obviously the consent form will need to be modified to indicate that you will be working with the children, but all of the same ideas still apply. This is the basic legal requirement. Most researchers will then go out and obtain assent, or the juvenile's consent to be part of the study. This makes things easier because the child's thoughts and feelings are considered and valued.

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Frequently Asked Questions

When do you need informed consent for research?

Researchers are required by the ethics code of the American Psychological Association to disclose the intent, procedure, risks, and benefits of the study. Giving participants sufficient and continuous information so that they may be aware of what they will be asked to do for the duration of the study gives them the ability to make an informed decision to voluntarily participate.

Why is informed consent so important?

An informed consent document defines and clarifies the nature of the study. Informed consent is important because failure to have it can turn into both a legal and ethical matter.

What is an example of informed consent?

An informed consent ethics document should clearly include the elements of capacity, comprehension of information, and voluntariness. Some language you would see in an informed consent document is: "I have read and I understand the information provided to me and I have had the opportunity to ask questions. I understand that my participation is voluntary and that I am free to withdraw at any time."

What does informed consent mean?

Informed consent is the voluntary agreement regarding a role a person will play in a research study after they are fully informed. This agreement shows that they are willing to participate voluntarily after having a complete understanding of what the study entails, including the duration, risks, and benefits.

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