An Institutional Review Board (IRB) Consent Form is integral to modern research. It is a formal document that outlines a researcher’s expected conduct throughout the research study and the rights and responsibilities of their research participants. Using an IRB consent form helps ensure that important humane and conscientious considerations are taken into account throughout the process and that all relevant information is communicated to research participants. With our professionally designed IRB Consent Form Template, you can easily create complete, legally and ethically compliant documents for your subjects.
These vital documents help provide a clear understanding of the researcher’s protocols and obligations to the participants in the research. It also protects both the researcher and the participants by ensuring that everyone understands the potential risks and benefits associated with participating in a study. Additionally, they aid in informing potential participants about their rights, the research objectives, procedures, and potential risks, benefits, and compensation.
What Is an IRB Consent Form?
An IRB consent form is a document used in research to outline a study’s risks, benefits, and procedures for potential participants. It is reviewed and approved by an Institutional Review Board (IRB) committee to protect participants’ rights and welfare. The form includes information about the purpose of the study, any potential risks or benefits associated with participation, how the data will be used and stored, who will have access to the data, and contact information for questions. Participants must sign the form to indicate their consent.
Who Can Make An IRB Consent Form
Groups of researchers draft some IRB consent forms from different disciplines and institutions who collaborate on a research project, or they can be created by one researcher working separately from colleagues. Medical ethics committees may also develop these documents.
Why is IRB Consent Form Important?
The IRB Consent Form is important both for its modern use and the history behind how it came about. The IRB consent form came into being following numerous unethical research experiments like the Tuskegee Syphilis Study in the 1970s. In order to better protect research participants, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed. They laid down guidelines and regulations for performing research involving humans, and the forms help make sure those rules are followed.
One of the primary tenets of the IRB regulations is the need for informed consent. Over time the IRB has continued to oversee consent forms, evaluate the ethics of human-based studies, and protect the participants in these studies. Today IRB consent forms exist to keep participants fully informed about studies, their part in them, the risks and benefits, and to evaluate and regulate those conducting research to hold them accountable for safe and ethical conduct.
For researchers, using an IRB-approved consent form helps build trust with study participants. It ensures they are performing their studies in accordance with the law and helps avoid ethics violations that could impact their efforts. Additionally, when properly composed and utilized, these crucial documents protect researchers against litigation.
Interesting Fact: Unlike some consent documents, IRB Consent Forms are not intended for single use but rather as part of an ongoing process. This type of consent involves maintaining open, transparent communication and keeping participants updated on changes and how they may be impacted.
Essential Elements of IRB Consent Form
The essential elements of an IRB consent form are comprehensive. These documents cover every aspect, from participant rights, how to withdraw, and the IRB’s role to what compensation is offered, if any. Below we’ve created a brief overview of how the form is composed so you know what to expect and what information to collect before filling out your template.
- Form Title- The title “IRB Consent Form” indicates what the document is used for.
- Study Name- The name of the individual study goes here and helps prevent confusion when multiple studies are being performed by the same researchers or at the same facility.
- Researchers- List all the researchers’ names for reference and credit.
- Objectives and Purpose- This should be a short description of what the study is for and its intended use.
- Introduction- The introduction has numerous aspects. Some are unique, such as explaining the IRB’s role, while others are redundant, like explaining the benefits and risks.
- Procedures- This section explains how people will participate, the duration, and other aspects of how the study will be carried out.
- Privacy and Confidentiality- Privacy and confidentiality explain aspects of the research, such as the limitations of privacy and how data will be used, shared, stored, and protected.
- Consent and Withdrawal- A section containing information about the voluntary nature of study participation, how to withdraw, and any potential risks associated with untimely withdrawal, like loss of compensation and other adverse effects.
- Risks and Benefits- The risks and benefits section should explain any expected side effects, possible adverse reactions, stressors, and other problems, along with the positive impact of participation for the subject, researchers, and anyone else who would likely benefit.
- Study Contact Information- This section explains who to contact if the participant has questions or concerns and provides contact information.
- Signature and Date Lines- Before allowing the participant to sign, you should ensure they have read and understood the form and consent of their own free will.
Pro Tip: The consent form should explain what will happen to the samples after the investigation has concluded for studies involving collecting and analyzing blood samples or other biological material from participants.
Here are some of the most frequently asked questions about IRB Consent forms.
The use of IRB consent forms in research studies is required by law in many countries. The U.S., for example, has the Common Rule, which mandates the use of informed consent forms for all research that involves human subjects. Similarly, the European Union has the General Data Protection Regulation (GDPR), which also requires informed consent forms for research studies involving human subjects. In addition, many countries have their own specific laws and regulations regarding informed consent for research studies. For example, in Canada, the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans requires informed consent forms for all research involving human subjects.
The process for obtaining approval from the IRB for a research study involves several steps.
ᐅ The researcher must submit an application to the IRB, including a detailed description of the research project, its purpose, methodology, and potential risks and benefits to participants.
ᐅ The IRB will review the application and may request additional information or clarification from the researcher.
ᐅ The IRB will then decide whether to approve the research study. If approved, the researcher will be provided with an approval letter outlining any conditions or restrictions that must be followed during the course of the study.
A participant can provide consent to participate in a study without signing a physical consent form. This can be done through an electronic consent process, such as e-signatures or online surveys. For example, an individual might be asked to check a box or click a button to indicate that they understand and agree to the terms of the study and are willing to participate. In addition, some research studies may not require a physical consent form. For instance, some studies may rely on implied consent. However, these studies do not meet the standards of the IRB.
An IRB consent form can be modified during the course of a study. The process for doing so depends on the type of modification being made and the policies of the institution’s IRB. Generally, changes to an IRB consent form should be submitted to the IRB for review and approval before implementation. For minor changes with little overall impact, the researcher may be allowed to adapt the wording without submitting a new consent form to the IRB. However, any changes that could significantly affect a participant’s understanding of the study should be reviewed and approved by the IRB prior to implementation. Changes to the IRB consent form should not be made without first consulting with the IRB and obtaining their approval.
For studies that involve remote or online participation, informed consent should be obtained as early as possible in the study process. This consent should be documented and stored securely. The informed consent process should include a clear explanation of the study, its purpose, and any risks or potential benefits associated with participation. It should also state that participation is voluntary and that the participant can withdraw anytime. Any data collected should be kept secure and confidential, with access limited to authorized personnel only.
The consent form should also clarify how the data from the study will be used, who will have access to the data, and if any other measures will be taken to ensure the confidentiality and security of the data. All information needs to be available in a language that participants understand. For example, when an online survey is conducted, consent forms should include a list of the translated text so that all participants can read them in their language. Suppose an Internet-based study is part of ongoing research using an existing cohort register or similar database. In that case, study participants who join the cohort during that period may not need additional informed consent (provided they know their rights).
Participants can change their minds and withdraw their consent to participate in a study after signing the IRB consent form. This is a common occurrence, and the researchers should have a plan for handling such requests. The researcher should inform the participant of the consequences of withdrawing their consent, such as not being able to receive any benefits from participating in the study. The researcher should also explain that the withdrawal of consent does not invalidate any data that has already been collected and whether the participant’s data will be removed from any analysis or reporting.
There are requirements for how IRB consent forms should be written or formatted. The specific requirements vary by institution, but generally, consent forms must include the following:
ᐅ A clear explanation of the research project, its purpose, and the procedures used.
ᐅ A description of any risks or discomforts associated with the research.
ᐅ A description of any potential benefits that may result from participation in the research.
ᐅ An explanation of whom to contact for answers to pertinent questions about the research and participants’ rights.
ᐅ A description of how the confidentiality of participants’ records will be protected.
ᐅ An explanation of how the participant or their guardian may stop the research at any time.
ᐅ If applicable, a description of how refusal to participate in the research or answer questions can affect a person’s eligibility to receive services and benefits.
ᐅ Identifying information collected as part of participation in the study, such as their name, age, and contact information.
ᐅ How long after a person withdraws consent before they can no longer be contacted for participation in other studies (usually three years).
ᐅ The names of the principal investigator and others who conduct the research and collect data.
Suppose researchers discover that they have not obtained adequate consent from a participant after the study has already begun. In that case, they should immediately stop data collection from the participant and ensure that the participant’s data is not used in any analysis or publication. They should then contact the participant and explain the situation, ensuring that the participant understands why their data cannot be used and informing them that their data will be destroyed, if appropriate. The researcher should then document the conversation with the participant, including any steps taken to rectify the situation.
Finally, the researcher should re-examine their consent procedures to obtain adequate consent from all participants in future research projects. Suppose the participant’s data has already been used in an analysis or publication. In that case, the researcher should make a public statement clarifying that the study was conducted without consent and offer to withdraw the paper or article from publication.
An IRB (Institutional Review Board) consent form is a document that outlines the rights of human research participants and seeks their voluntary agreement to participate in a research study. It is designed to ensure that participants understand their rights, the risks and benefits of the research, and their responsibilities as research participants. The form also allows researchers to obtain permission from participants to use their data in the study. This document is necessary to ensure that all research involving human participants is conducted ethically and in accordance with applicable laws and regulations. By choosing a high-quality, professionally created template for your IRB Consent Form, you can save time and effort while creating an outstanding, informative, legally binding document to recruit study participants.