What is informed consent?
Understanding informed consent in research studies: Definition, key topics, and guidance how to create an informed consent form
For more best practices see our method overview
Definition of informed consent
Informed consent is a foundational ethical principle in the field of research studies, ensuring that participants have a clear understanding of the study's purpose, procedures, risks, and benefits before voluntarily agreeing to participate. It is an essential aspect of ethical research practices, aimed at respecting the autonomy and rights of individuals involved in scientific investigations.
How to create an informed consent form
Creating an informed consent form involves careful consideration of the study's specifics and the ethical guidelines governing research. You can use the following steps for developing a clear and effective informed consent form:
Understand ethical guidelines
Before drafting an informed consent form, you must familiarize yourself with relevant ethical guidelines, such as the guidelines from institutional review boards (IRBs) at your institution. These guidelines provide a framework for ethical research conduct and can inform the content and structure of the consent form.Tailor information to participants
Consider the characteristics and backgrounds of the target participant population. You should consider the language and comprehension level of your target participant population when preparing informed consent materials. Using plain language and avoiding technical jargon ensures that information is accessible to a diverse audience, promoting true understanding.Provide a clear introduction
The informed consent form should begin with a clear and concise introduction that outlines the purpose of the study, the role of the participant, and the voluntary nature of participation. This sets the tone for the document and establishes the framework for understanding.Include key elements
Ensure that the informed consent form includes all the key elements discussed in the next section of this page. These include the purpose of the study, procedures involved, potential risks.What Topics Should Informed Consent Cover (with examples)
Informed consent should cover a broad range of topics to ensure that participants are well-informed and can make decisions in their best interest. Addressing the following key areas is crucial in creating a comprehensive informed consent process. The example boxes given here are from an actual study we conducted in 2019 in a mixed-methods research project we did on using qualitative data analysis in the field of software engineering.
The study is led by Andreas Kaufmann and supervised by Prof. Dr. Dirk Riehle at the Open Source Research Group of the Friedrich Alexander University Erlangen Nürnberg (FAU). It is funded, in part, by Deutsche Forschungsgesellschaft (DFG) grant RI 2147/7-1.
This Informed Consent Form has two parts:
The study we are inviting you to participate in aims to evaluate the method compared to an existing method.
Each week you will receive a set of one to two interview transcripts from expert interviews we already conducted. Your task will be to apply the respective method to analyze the unstructured data with the purpose of creating a conceptual model using the assigned method. The analysis will take place without our direct supervision on your own time. You will be asked to document the time spent on specific parts of the analysis. During the full duration of the experiment you are not permitted to share any information about the data or your analysis artifacts with anyone except us. After each week we will have a one on one meeting and we will ask you to answer a few questions regarding the method and your experience.
Other than these potential benefits, you have the benefit of a guaranteed compensation in the agreed-upon lump sum payment.
Andreas Kaufmann: andreas.kaufmann@fau.de
Prof. Dr. Dirk Riehle: dirk.riehle@fau.de
The ombudsperson of FAU for good scientific practice is:
Dr. Dietmar Fey: dietmar.fey@informatik.uni-erlangen.de
I have read the foregoing information, or it has been read to me. I have had the opportunity to ask questions about it and any questions I have been asked have been answered to my satisfaction. I consent voluntarily to be a participant in this study.
Your Name:
Your Signature:_______
Date (DD.MM.YYYY):_______
In addition to agreeing to participate, I also consent to having the interviews tape-recorded.
Your Signature:_______
Date (DD.MM.YYYY):_______
Preamble
The first section of the consent form should state the name of the study, and the institution carrying out the research. It should also identify the researchers responsible for the research design, and lay out the structure of the document.Example of a preamble for an informed consent form
This informed consent form is for the Open Source Research Group and who we are inviting to participate in our research titled "Domain Modeling using Qualitative Data Analysis"The study is led by Andreas Kaufmann and supervised by Prof. Dr. Dirk Riehle at the Open Source Research Group of the Friedrich Alexander University Erlangen Nürnberg (FAU). It is funded, in part, by Deutsche Forschungsgesellschaft (DFG) grant RI 2147/7-1.
This Informed Consent Form has two parts:
- Information Sheet (to share information about the study with you)
- Certificate of Consent (for signatures if you choose to participate)
Introduction
The introduction section introduces the research topic briefly and states the purpose of the document. Readers should be encouraged to incquire about anything about the document or the study that remains unclear to them.Example of an introduction section for an informed consent form
We developed a novel method for conceptual domain modeling, called QDAcity-RE, and invite you to participate in a field experiment for the evaluation of this method compared to an existing method for conceptual domain modeling. We will describe our research, and what your participation would entail, in this document. If there is anything that you do not understand, or if you have any kind of question regarding our research and the planned study, please ask us. You are also free to consult any third party on any of the information given here.Nature and purpose of the study
Participants should be informed about the overarching goal of the research and its relevance to the scientific community. Providing a clear understanding of why the study is being conducted helps participants contextualize their role in the research process.Example of a purpose section for an informed consent form
Defining the right requirements for a software project is an important factor for its success. To identify adequate requirements, a deep understanding of the target domain has to be developed. To facilitate such an understanding, and providing the means to share it among stakeholders, domain modeling can be employed. Unfortunately the process of domain modeling frequently relies a lot on intuition and experience of the analyst. Our method attempts to formalize the process to ensure rigor in its execution and also create traceability from developments artifacts beyond the defined requirements to stakeholder material the specifications were built upon (so-called Pre-RS-Traceability).The study we are inviting you to participate in aims to evaluate the method compared to an existing method.
Procedures and intervention
Detailing the specific procedures involved in the study and estimating the time commitment required from participants is essential. This includes any interventions, data collection methods, or experimental tasks that participants will be asked to perform.Example of a procedures section for an informed consent form
The evaluation takes place in a field experiment. We will divide participants into two groups. One using QDAcity-RE and one using a method based on strategic reading. We will inform you in which group you can participate after signup to the study concluded. You will be instructed on the respective method by us and are encouraged to seek guidance w.r.t. the method.Each week you will receive a set of one to two interview transcripts from expert interviews we already conducted. Your task will be to apply the respective method to analyze the unstructured data with the purpose of creating a conceptual model using the assigned method. The analysis will take place without our direct supervision on your own time. You will be asked to document the time spent on specific parts of the analysis. During the full duration of the experiment you are not permitted to share any information about the data or your analysis artifacts with anyone except us. After each week we will have a one on one meeting and we will ask you to answer a few questions regarding the method and your experience.
Voluntary participation
Emphasizing the voluntary nature of participation is a key aspect of informed consent. If there exists a power dynamic such as when recruiting students, special care should be taken that participation or refusal to participate does not have any consequences outside of the study.Example of a voluntary participation section for an informed consent form
Your participation in this research is entirely voluntary. It is your choice whether to participate or not. If you choose not to participate this will not affect your status, rights and obligations as a student at FAU in any way. In particular your participation, or refusal of participation has no bearing on your participation or evaluation in any of the courses offered by the Open Source Research Group.Duration
The consent form should specify the expected duration of the participation.Example of a duration section for an informed consent form
The study takes place over a period of five weeks. A potential extension may be warranted due to unforeseen circumstances such as illness. We expect the average effort for you to be around 8-10 hours per week. The study will take place in June / July of 2019.Potential risks
Transparent communication about potential risks associated with participation is critical. This encompasses physical, psychological, social, and even economic risks that participants might face during or after the study. Understanding these risks allows individuals to weigh the potential harm against the benefits.Example of a risk section for an informed consent form
We do not anticipate any immediate risks to you participating in this study other than those encountered in day-to-day life.Anticipated benefits
Clearly outlining the potential benefits of the research is equally important. These benefits may be direct, such as improvements in health or well-being, or indirect, contributing to scientific knowledge or societal advancements.Example of a benefits section for an informed consent form
Potential benefits are learning about HR development through the analysis of expert interviews, learning, and applying a new method for conceptual modeling, and if you are interested in a research career, it might be a benefit to experience such an experiment as a participant. We are happy to share information about questions you might have about the research process with you.Other than these potential benefits, you have the benefit of a guaranteed compensation in the agreed-upon lump sum payment.
Compensation or reimbursement
If applicable, researchers should clearly communicate any compensation or reimbursement arrangements for participants. This includes details about the amount, as well as the condition for payment. Clarity in this area helps manage participant expectations and avoids misunderstandings. You need to ensure that the compensation is high enough to recruit enough participants but it needs to be low enough so potential participants will not take undue risk because of it. Inappropriately high compensation can also lead to selection bias.Example of a benefits section for an informed consent form
For your completed participation in the study you will receive a compensation for your time of 500EUR.Confidentiality
Participants should be assured that their personal information will be handled with utmost confidentiality. Researchers must explain how data will be collected, stored, and shared, emphasizing measures taken to protect participant privacy.Example of a confidentiality section for an informed consent form
The information that we collect from this research project will be kept private to the Open Source Research Group. We intent, however to publish aggregated statistics in scientific publications. We also may publish quotes from the interviews. Any information about you in textual form will have a number identifier on it instead of your name. The only people with access to an encrypted key file linking your identifier to your name will be Andreas Kaufmann and Prof. Dr. Dirk Riehle. The audio recordings of the interviews will be stored as-is private to the Open Source Research Group.Right to refuse or withdraw
Emphasizing the voluntary nature of participation is a key aspect of informed consent. Participants should be aware that they have the right to withdraw from the study at any time without facing negative consequences. This reinforces the principle of autonomy and ensures participants feel free to make decisions that align with their best interests.Example of a section on the right to withdraw for an informed consent form
You do not have to take part in this research if you do not wish to do so, and choosing to participate will not affect your student status in any way. You may stop participating in the study at any time that you wish without impact on your relationship with the university or the Open Source Research Group. By doing so, you forfeit your claim to compensation.Contact information
Providing contact information for the research team, including a principal investigator or a designated representative, allows participants to seek additional information or clarification at any stage of the study. If an ombudsperson for good scientific conduct exists at your institution, they should be named here as well. Open communication channels foster trust and transparency.Example of a contact section for an informed consent form
If you wish to ask questions about the study or this form, you may contact any of the following persons responsible for planning and execution of this study:Andreas Kaufmann: andreas.kaufmann@fau.de
Prof. Dr. Dirk Riehle: dirk.riehle@fau.de
The ombudsperson of FAU for good scientific practice is:
Dr. Dietmar Fey: dietmar.fey@informatik.uni-erlangen.de
Certificate of consent
The certificate of consent states that the participant has read and understood the conditions and consents to the participation in the study. The form should carry an original signature of the participant.Example of a certificate of consent for an informed consent form
I have been invited to participate in research about conceptual domain modeling.I have read the foregoing information, or it has been read to me. I have had the opportunity to ask questions about it and any questions I have been asked have been answered to my satisfaction. I consent voluntarily to be a participant in this study.
Your Name:
Your Signature:_______
Date (DD.MM.YYYY):_______
In addition to agreeing to participate, I also consent to having the interviews tape-recorded.
Your Signature:_______
Date (DD.MM.YYYY):_______
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