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 - Definition, Purpose, and Examples
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
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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.
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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.
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Accessible Language
Informed consent documents are usually lengthy and complex because they must be so comprehensive. Because of this, it is of extreme importance that the language contained in an informed consent document is accessible and easy to understand. This ensures that technical or scientific jargon does not confuse the potential participants in a way that they do not fully understand what they are consenting to. In addition, the document must be free from any exculpatory language as well. Exculpatory language is writing in which the participant waives their rights or frees the researcher, institution, or any other entity involved in the study from the responsibility of negligence. If the document is not written in a way that can be easily read and understood by a potential participant, it may actually dissuade them from participating in the study.
Accuracy
Informed consent forms are should always present the components of the study in accurate, comprehensive detail. The client should read the document and feel empowered to make an informed decision. The document is the first step in fostering a collaborative partnership with the researcher. Making sure the prospective participant is educated regarding the contents of the document is a way to engage them and reduce misunderstandings regarding the nature of the study. Intentionally obscuring or omitting the truth is unethical and can cause the researcher to lose his or her license, funding, or be terminated from their place of employment. Providing misleading, inaccurate, or withholding information relevant to the study is considered deception; however, there are some instances where keeping participants in the dark regarding certain aspects is necessary and is allowed. An example would be a double-blind study. The result of the treatment is less likely to be influenced by whether or not a participant knows if they were actually receiving treatment and the researcher is less likely to give hints or clues as to what group the participant is in. Regardless, using deception should not cause undue harm or stress to the participant.
Special Considerations
There are special considerations regarding informed consent especially in terms of age and mental capacity. In regard to age, if a researcher is planning to use someone under the adult age, they are required to obtain consent from that child's parent or legal guardian. Decreased mental capacity in someone can happen due to age (for example, an elderly person who suffers from Alzheimer's) or due to a diagnosed disability. When a researcher isn't sure if someone is suffering from decreased mental capacity, they may have to ask clarifying questions to make sure the participant understands what is expected of them. If a person's decreased capacity shows that they are incapable of making an informed decision, the researcher can find a substitute decision-maker or remove them from the study altogether. The decision-maker could be a parent, a family member who is the primary caretaker, or a court-appointed administrator. In both cases, the process of obtaining consent from the guardian or caretaker of someone other than the person who will appear in the study is called assent.
Lesson Summary
Informed consent is an agreement from a person who agrees to participate in a study. 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. The three principles of informed consent include capacity, comprehension of information, and voluntariness. This means that participants of all research projects have the right to know precisely what is being studied, what benefits can be expected, and what risks are involved. After being so informed, consumers then have the right to refuse or terminate participation. When individuals, for some reason, can't give their consent, a parent, legal guardian, or family member, can be allowed to give assent. In research, consent should best be obtained in writing to protect both the researcher and the participant. The informed consent document should be written in accessible language and be accurate, detailing all aspects of the study.
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.
Deception means intentionally misleading, providing incorrect information or omitting relevant information. Informed consent is tricky without this and must follow rigorous guidelines when a researcher is seeking approval by the Institutional Review Board. A researcher who uses deception must still ensure that no harm comes to the subject and the act of misleading or omitting must not cause undue suffering. An example of misleading is placing experimenters among the subjects and not informing the subjects that there are confederates among them.
Incorrect information typically deals with what the focus of the study is actually about. For example, having subjects perform tasks, but really recording how they react emotionally. Omitting information is when details like those discussed before are left out. What exactly is acceptable deception is left up to Institutional Review Boards, since there is never a 'this is always ok.' Furthermore, following the experiment, the researcher must fully inform the participant of what occurred, known as a debriefing.
When creating an informed consent form, the researcher cannot omit or mislead the participant about things that might affect their willingness to join. For instance, if you are injecting a person with something, it is highly unlikely that you will receive approval to run your study if the person is not informed of what it is. But, if you are performing an experiment where you want to see if one person will shock another person to death, like the Milgram Experiment, then that cannot be spelled out in the consent form.
Recording a participant requires an additional section on the informed consent form that details the purpose of recording, how recordings will be handled during the interview or experiment and how the recording will be handled following the experiment. Obviously, this works for both auditory and visual recordings of a subject. Recording is often done with interviews so that the interview can be reviewed later and transcribed into a written form.
Lesson Summary
Informed consent provides participants with sufficiently detailed information on the study so they can make an informed, voluntary and rational decision to participate. Several specifics are to be divulged to the participants prior to the experiment even starting. Furthermore, additional sections or different consent forms must be used when working with children, with the parent or guardian giving consent and the child giving an assent, or the juvenile's consent to participant.
If you are using deception, then only certain sections can be omitted that are relevant to the study and wouldn't alter their willingness to participate. This always requires full disclosure following the experiment in the form of a debriefing. Lastly, an additional section must be added if the researcher is recording an individual, with additional information about the purpose of recording, how recording will be handled during the interview or experiment and how the recording will be handled following the experiment.
Learning Outcomes
Learners should be able to do the following after completing this lesson:
- Define informed consent in research
- Describe the many requirements of informed consent
- Explain why deception can only be used in certain cases
- Remember what takes place after an experiment that has included deception
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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.
Deception means intentionally misleading, providing incorrect information or omitting relevant information. Informed consent is tricky without this and must follow rigorous guidelines when a researcher is seeking approval by the Institutional Review Board. A researcher who uses deception must still ensure that no harm comes to the subject and the act of misleading or omitting must not cause undue suffering. An example of misleading is placing experimenters among the subjects and not informing the subjects that there are confederates among them.
Incorrect information typically deals with what the focus of the study is actually about. For example, having subjects perform tasks, but really recording how they react emotionally. Omitting information is when details like those discussed before are left out. What exactly is acceptable deception is left up to Institutional Review Boards, since there is never a 'this is always ok.' Furthermore, following the experiment, the researcher must fully inform the participant of what occurred, known as a debriefing.
When creating an informed consent form, the researcher cannot omit or mislead the participant about things that might affect their willingness to join. For instance, if you are injecting a person with something, it is highly unlikely that you will receive approval to run your study if the person is not informed of what it is. But, if you are performing an experiment where you want to see if one person will shock another person to death, like the Milgram Experiment, then that cannot be spelled out in the consent form.
Recording a participant requires an additional section on the informed consent form that details the purpose of recording, how recordings will be handled during the interview or experiment and how the recording will be handled following the experiment. Obviously, this works for both auditory and visual recordings of a subject. Recording is often done with interviews so that the interview can be reviewed later and transcribed into a written form.
Lesson Summary
Informed consent provides participants with sufficiently detailed information on the study so they can make an informed, voluntary and rational decision to participate. Several specifics are to be divulged to the participants prior to the experiment even starting. Furthermore, additional sections or different consent forms must be used when working with children, with the parent or guardian giving consent and the child giving an assent, or the juvenile's consent to participant.
If you are using deception, then only certain sections can be omitted that are relevant to the study and wouldn't alter their willingness to participate. This always requires full disclosure following the experiment in the form of a debriefing. Lastly, an additional section must be added if the researcher is recording an individual, with additional information about the purpose of recording, how recording will be handled during the interview or experiment and how the recording will be handled following the experiment.
Learning Outcomes
Learners should be able to do the following after completing this lesson:
- Define informed consent in research
- Describe the many requirements of informed consent
- Explain why deception can only be used in certain cases
- Remember what takes place after an experiment that has included deception
To unlock this lesson you must be a Study.com Member.
Create your account
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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