Eleanor Finch
Informed consent is widely considered the cornerstone of research ethics. It is the process by which researchers obtain and maintain permission from participants to take part in a research study. Informed consent is crucial as it ensures participants have an informed choice about whether to participate. This means that participants must be provided with all the information they need to make an informed decision about participating in the research. This includes details of the nature and purpose of the research, the expected duration of their participation, and a description of any potential risks. The participant should be given a reasonable amount of time to consider whether to consent and to ask questions. The consent should be obtained before the participant enters the research, and there must be no undue influence on participants to consent. While physical risks are minimal in social research, there are risks associated with participation, including the invasion of privacy and breach of confidentiality.
| Characteristics | Values |
|---|---|
| Voluntarily | Participants enter research willingly |
| Understanding | Participants understand what their participation entails |
| Information disclosure | Participants receive full disclosure of the research plan and its intent |
| Competence | Participants are competent to consent |
| Withdrawal | Participants understand they may withdraw from the study at any time |
| No undue influence | Participants are under no pressure to respond immediately |
| Understandability | The consent process must be understandable to the participants |
| Written information | Participants receive written information |
| Oral process | Researcher and participant have a conversation to give information and obtain consent |
| Written consent | Participants sign a written, dated informed consent form |
| No exculpatory language | Participants do not waive any legal rights |
| No liability release | Participants do not release the investigator or university from liability |
| Health information | Participants authorise the use or disclosure of health information |
| Data protection | Participants are informed about procedures for ensuring data protection, confidentiality and privacy |
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What You'll Learn
Participants must enter research voluntarily
Informed consent is a cornerstone of research ethics, and it is essential that participants enter research voluntarily, with a full understanding of what their participation entails. This means that participants should be given sufficient time to consider their decision and ask questions, and that there must be no undue influence or coercion.
The consent form that participants sign should cover several key points, including the purpose of the research, the identity of the researcher and their affiliations, and any risks involved. Participants should also be informed of their rights, including the right to withdraw from the research at any time.
The process of obtaining informed consent can vary depending on the context and design of the research, as well as the participants involved. It can be obtained orally or in writing, or a combination of both. Oral consent is often used when a written record is not feasible or could put the researcher or participant at risk. However, it is important to record oral consent using an audio recording device or a written record.
Informed consent should be obtained before the participant enters the research, and participants should be given the information they need to make an informed decision in a format that is understandable to them. This may involve tailoring the information to the interests and abilities of each individual and building rapport during face-to-face conversations.
In some cases, such as when working with vulnerable populations or minors, obtaining informed consent can be more complex. Researchers must ensure that participants have the capacity to make informed choices and protect their own interests. In these cases, alternative methods of obtaining consent, such as passive parental consent, may be considered.
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Participants must understand what their participation entails
Informed consent is a cornerstone of research ethics. It is a critical communication link between the researcher and the participant, ensuring that the participant enters the research voluntarily, with an understanding of what their participation entails. This understanding is facilitated through the exchange of information between the researcher and the participant. The participant must be provided with ample opportunity to ask questions, seek clarifications, and make informed decisions.
The informed consent process should ensure that all critical information about a study is completely disclosed, and the information must be presented in a language that is easily understandable to the participants. This includes providing an overview of the research, the researcher's identity and affiliations, the purpose of the research, the expected duration of participation, and the procedures to be followed. Participants must also be informed of any risks, discomforts, or benefits associated with their participation.
In certain cases, oral consent may be obtained instead of written consent. This is particularly relevant when there is a risk associated with the existence of a paper record or when time for consent is limited. However, it is important to record the oral consent process using audio recordings or written consent forms to ensure transparency and understanding.
To protect participants from coercion or undue influence, it is crucial to provide sufficient time for participants to consider the information and make an informed decision. This process should be free from pressure or external influence, allowing participants to reflect and ask questions. The researcher should also be mindful of the potential risks and benefits of the research, especially in studies involving "vulnerable populations," to ensure that participants' rights and interests are safeguarded.
In summary, participants must understand what their participation entails through comprehensive information disclosure, adequate time for consideration, and the opportunity to ask questions. This understanding is essential for ethical research, fostering trust and respect for participants' autonomy.
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Participants must be able to withdraw from the study at any time
Informed consent is a founding principle of research ethics. It requires that participants enter research voluntarily, with full information about what participation entails, and that they give consent before entering the research.
Participants must be able to withdraw from a study at any time without penalty or loss of benefits. This is a requirement of the U.S. Code of Federal Regulations (CFR) regarding voluntary withdrawal from research. The CFR also requires that the terms of withdrawal are communicated and that requests for withdrawal will be granted without repercussions.
The consent form signed by participants should include information on withdrawal from the research. This could include stipulations necessary for withdrawal, such as notifying a doctor or researcher. However, these stipulations could be perceived as persuasive tactics or undue influence to continue participating in the research. Therefore, it is important to clarify that participants are free to withdraw at any time.
When a participant withdraws from a study, the researcher must discontinue all research activities related to the participant, including interacting with the participant to obtain data, collecting additional identifiable private information, and observing or recording additional identifiable private information. However, the researcher may retain and use data collected prior to the participant's withdrawal, as long as it is consistent with the study's purpose and procedures.
In some cases, a participant may be willing to allow the researcher to continue certain research activities after their withdrawal, such as obtaining data through follow-up interviews or physical exams, or accessing identifiable private information from the participant's records. It is important to respect the participant's wishes and allow them to withdraw from the study to the extent that they are comfortable.
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Researchers must disclose all relevant information about the research
Informed consent is a cornerstone of research ethics. It is a critical communication link between the researcher and the participant, ensuring that the participant enters the research voluntarily, with full information about what their participation entails. The process of obtaining informed consent is an active exchange of information, where the researcher discloses all critical information about the study, and the participant is given ample opportunity to ask questions and seek clarifications.
The consent form that participants sign should cover the following key points:
- Participants should be informed about the researcher's identity, affiliations, and contact information, as well as whom to contact for further information or in case of problems with the research process.
- Participants must understand what the research is about, its purpose, and the procedures involved.
- Any risks or potential discomforts associated with the research must be clearly explained, and participants should be informed of their right to withdraw from the process at any time.
- Information about the benefits of the research, both to the participant and to others, should be disclosed.
- The extent to which confidentiality of records identifying the participant will be maintained should be explained, including any potential risks of breach of confidentiality and how these will be mitigated.
- If the research involves more than minimal risk, an explanation of whether any compensation or medical treatments are available in case of injury should be provided.
It is important to note that informed consent is not merely a signed form; it is a process that requires an understanding of the research and its risks by the participant. The language used in the consent form and during the consent process must be easily understandable, and the possibility of coercion or undue influence must be minimised. The participant should be given sufficient time to consider the information and make an informed decision.
In some cases, oral consent may be obtained instead of written consent, especially when a paper record could put the researcher or participant at risk, or when time for consent is limited. However, the oral consent process should still be recorded using an audio recorder or a researcher record of oral consent template.
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Researchers must respect participants' autonomy
Informed consent is a founding principle of research ethics. It requires that participants enter research voluntarily, with full information about what participation entails, and that they give consent before taking part. This consent must be free from coercion or undue influence. Participants must be given sufficient time to consider their participation and ask questions.
Respecting participants' autonomy is a fundamental ethical principle in research. Autonomy, or respect for persons, obligates researchers to allow participants the freedom to make their own choices after being informed of the potential costs and benefits of those choices. This principle is grounded in self-determination theory, which emphasises the importance of allowing individuals to make choices that affect their well-being.
Informed consent is a key aspect of respecting participants' autonomy. It is not merely a form that is signed, but a process in which the participant understands the research and its risks. This process may be oral or written, depending on the context, design, and participants in the research project. Oral consent is often used when a written record could put the researcher or participant at risk, or when time for consent is limited.
To respect participants' autonomy, researchers must ensure that information about the research is provided in a language that is easily understood by the participants. This includes information about the identity of the researcher, their affiliations, and whom to contact for more information. Participants must also be informed of any risks associated with participation, as well as their rights, including the right to withdraw from the research.
Respecting participants' autonomy can pose challenges in certain situations. For example, when working with "vulnerable populations", such as children or individuals with psychological impairments, researchers must balance the principle of autonomy with the need to protect participants from inherent or intended risks. In such cases, informed consent may be obtained from a legally authorised representative. Additionally, researchers must ensure that participants are not selected based on their compromised position or convenience to the investigator.
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Frequently asked questions
Informed consent is the process through which a researcher obtains and maintains permission from a person or their authorised representative to participate in a research study.
Informed consent requires that participants enter research voluntarily, with an understanding of what their participation entails. Participants should be given sufficient information about the research and its implications to make an informed decision about participating.
The information provided should include, but is not limited to: the nature and purpose of the research, the expected duration of participation, a description of any experimental procedures, a statement that participation is voluntary, the probable risks and benefits of participation, and details of how personal data will be protected.
Informed consent can be obtained through written or oral processes, depending on the context and design of the research, as well as the participants involved. Written consent is often used for literate participants and involves providing written information and obtaining a signed consent form. Oral consent is typically used when a written process is not feasible or when there are risks associated with creating a paper record.
