What is the major rationale for providing the information that comprises informed consent?

An oral consent process is where researcher and participant have a conversation to give information and obtain consent.  There is no paper form to sign. It is normally used:

• where literacy is a problem
• where there are cultural or political concerns with signing contract-like documents
• where either the researcher and/or the participant could be put at risk by existence of a paper record
• where time for consent is limited, eg a chance interaction between researcher and participant (although you should not use an oral process merely to correct poor planning of research)
• for research conducted via remote video conferencing software

It may also be more appropriate when interviewing elite participants as part of the research.

For all other research, how you arrange the oral process depends on how you will encounter your participants (for example email, phone, an on-the-street-meeting by chance). Between the information-giving and consent stage the participant should be given a reasonable amount of time to consider whether to consent, though this depends on the project design, the type of participants and the context of the research.

When obtaining oral consent, please ensure you are recording the consent process either using a recording device (for example audio recorder if you are conducting an interview that needs to be recorded) or, if participants do not agree to audio recording or if using or keeping audio records is unsafe, by using a researcher record of oral consent template or completing a written consent form on their behalf.

The oral consent templates below can be adapted to suit your study, but careful consideration is required to ensure that these are appropriate for the research and the participants.

Informed consent ensures that patients, clients, and research participants are aware of the important facts of research, including duration, purpose, and potential benefits and risks.

For informed consent to be considered valid, the participant must be physically or mentally able to make the decision to participate in research. A person's consent must be given voluntarily, without coercion.

History of Informed Consent

Several court cases involving medical procedures that were performed without a patient's permission set the groundwork for establishing informed consent as a concept for both medical treatment and research.

However, the term informed consent wasn't officially used in court documents until 1957 in the case Salgo v. Leland Stanford Jr. University Board of Trustees.

Martin Salgo underwent a procedure at a Stanford University medical center. The surgeon injected a contrast agent into Salgo's aorta, causing paralysis of his lower limbs. Salgo sued the medical center and the chief surgeon for not informing him before the surgery of the potential risks. The court ruled in Salgo's favor.

Salgo's was the first legal ruling that determined doctors must provide patients with information about the benefits and risks of procedures.

A trial in 1947 investigating Nazi war crimes further cemented the idea of informed consent. Nazis conducted experiments on people held in concentration camps without their consent. The people who underwent the tests were exposed to freezing cold temperatures or even wounded intentionally so that experimental treatments could be tested on them. Many died as a result.

After the trial, American judges created the Nuremberg Code, which contains 10 basic rules for conducting human experiments. The rules stated that a person needs "sufficient knowledge and comprehension" of what they are agreeing to as part of the research.

Sufficient knowledge includes, among other elements, how long the research will last, what its purpose is, the research methods, all hazards of research, and what the possible outcomes are. Today, researchers and health professionals are still held to the standards established by the Nuremberg Code.

Informed Consent for Psychology Research

According to the American Psychological Association (APA), researchers must follow several steps to obtain informed consent from participants in psychology research:

• Inform the participants about the purpose of the research, the anticipated duration of the study, and the procedures that will be used.
• Tell participants that they have the right to decline to participate in the study. They also must know that they can withdraw from the experiment at any time.
• Inform participants of any possible consequences of declining or withdrawing from the study.
• Inform participants of any potential consequences of participating in the study. This includes any potential risks, adverse effects, or discomfort that may occur.
• Tell participants about the potential benefits of the research.
• Disclose any limitations on confidentiality.
• Clearly identify any incentives for participation.
• Tell participants who they can contact if they have questions about the research or the rights of participants in the study.
  

How Researchers Obtain Informed Consent

In most instances, researchers use a prewritten form that outlines all of the required information on the study. Participants sign and date the form to confirm that they have read and understood the information.

Informed consent is not as simple as getting a participant to sign a piece of paper, however. Informed consent means giving a potential subject time to ask questions and consider whether or not they want to participate in a study. Someone knowledgeable about the research should be available to answer questions and conduct a consent interview.

The consent process may even continue after the research is underway. The participants should always be given opportunities to ask questions and withdraw from a study if they wish.

Is Informed Consent Always Necessary?

There are a few instances when psychologists may do without informed consent. Such cases include when there is a reasonable assumption that the research would not cause any distress or harm to participants. Another instance is when a study examines normal classroom curricula or educational practices, in which interfering with observation would negatively affect the study.

Studies that involve anonymous questionnaires or archival data do not usually require informed consent as long as the research presents no risk to the participants' financial standing, employability, or reputation.

Researchers must make sure participants' confidentiality is protected at all times.

Even in cases where informed consent is not needed, participants can still withdraw at any time.

Deception in Research

What about cases where deception may be an integral part of the study? In some instances, informing participants about the nature of the experiment might influence their behavior and therefore the results. 

Deception should only take place if the use of such techniques is justified given what might be gained from performing the study. It is often the duty of an institutional review board (IRB) to determine if the use of deception is acceptable and to grant permission for such studies to take place.

If researchers do use deception as part of an experiment, ethical guidelines suggest that participants should be informed of the deception and the true nature of the experiment as soon as possible.

Once such deception has been revealed, participants should also be given the opportunity to withdraw their data if they so desire.

Indirect deception may be considered more ethical than direct deception. In studies that use indirect deception, participants know before the study takes place that they won't be given all of the facts until the end. They can choose to participate or not based on the information that they will be deceived in some way.

Direct deception is when researchers lie or deceive participants intentionally without telling them. By deceiving participants, a researcher is infringing on a participant's autonomy, meaning a participant won't have the honest facts they need to decide whether or not they want to participate in the research. Direct deception is linked with negative emotional states and the low self-esteem of participants.

Example of Research That Used Deception

In 1968, psychologists John Darley and Bibb Latané conducted an experiment on individuals to test what became known as the bystander effect. They put people in separate rooms and had them listen to an audio recording of an actor pretending to have a seizure. Participants were directly deceived because they believed this was a person having a seizure in real time.

Darley and Latané were testing whether or not and under what conditions someone would intervene and try to get help for another person who they believed was experiencing a life-threatening situation.

This study has been considered unethical by some in the psychology community because participants in the study were put at risk of psychological harm by listening to what they believed, falsely, was a person having a seizure.

However, others argue that in order to attain the most accurate results possible, some level of deception in the researcher-participant relationship is required.

Potential Drawbacks

While some argue that there are benefits for the results of a study if participants aren't aware of all of the facts, research shows that withholding information can be damaging to a study as well.

Participants who are deceived may know they are being lied to and withhold this knowledge from researchers.

Participants' distrust or suspicion of the researchers can lead to skewed study results as well as a negative reputation of the researchers.

More Resources

There are plenty of organizations you can turn to for support as you learn more about obtaining informed consent. Check out the below resources for more information:

• American Psychological Association's Study Participants and Informed Consent: This article goes into further detail about the ethical obligations of researchers to obtain informed consent.
• Food and Drug Administration's Information Sheet on Informed Consent: This includes a digital download of how to draft an informed consent sheet of your own.

A Word From Verywell

Understanding more about this process is essential, whether you are planning to conduct or participate in psychology research. Informed consent is an essential part of ethical research, which means it must be obtained voluntarily and fully inform the participant of anything they need to know before they decide to move forward as part of the research. 

If you are concerned about this process when you take part in a study or experiment, understand that it helps protect your rights and well-being by ensuring that you are aware of any risks or benefits associated with taking part in the study.

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