Consent Forms
A Consent Form is a document that informs participants about a study's purpose, procedures, risks, benefits, and their rights. It ensures that participation is voluntary, explaining how confidentiality will be maintained, and provides contact information for questions. Participants are required to read and sign this form to give their informed consent before participating in the research, indicating they understand and agree to the study's terms.
Examples and Guidelines
We have compiled some examples and guidelines to use when preparing your consent forms:
Biomedical Research Consent Forms
If your research falls under this classification, you will need to use these consent templates:
- Biomedical Consent Document (HRP-592): This document serves as the foundation for informed consent. It is designed to ensure that participants are fully aware of the nature of the research, its purpose, procedures involved, potential risks and benefits, and their rights as participants.
- Emergency Use Consent Document (HRP-506): An Emergency Use Consent Document is used in clinical settings to obtain consent for the use of experimental treatments or procedures during emergencies, when traditional approval processes cannot be followed due to the immediate need for intervention. This document is crucial for informing patients or their legal representatives about the potential risks and benefits of the unapproved treatment.
- Short Form Consent Document (HRP-507): A Short Form Consent Document is used in research when participants may not understand the standard consent form, often due to language barriers. It outlines the essential information about the study and participants' rights, and an oral explanation is provided in the participant's language.
- Verbal Consent (HRP-1710): It is a tool designed for research contexts where written consent is not feasible. It outlines key information and questions to ensure participants understand the study, its risks, benefits, and their rights, facilitating informed verbal agreement to participate. This approach is especially useful in studies involving phone interviews or where literacy is a concern.
Social Behavioral Research Consent Forms
If your research falls under Social Behavioral research, use these consent templates:
- Social Behavioral Consent Document (HRP-582): This is a Consent Template designed for use in studies focusing on social, behavioral, or educational research. It outlines the study's purpose, procedures, risks, benefits, and participants' rights, ensuring informed consent is obtained ethically and effectively from participants.
-
Social Behavioral Consent Document with HIPAA Authorization (HRP-1721):
This is a form used in social, behavioral, or educational studies that not only seeks consent for participation
in the study but also includes authorization under the Health Insurance Portability and Accountability Act (HIPAA)
for access to or use of participants' protected health information.
This document ensures compliance with privacy regulations while informing participants about the study's nature, procedures, risks, and benefits. -
Social Behavioral Supplemental Consent Language (HRP-1722):
This is a document designed to add specific details relevant to social and behavioral research studies to the
standard consent forms. It includes additional information on privacy, confidentiality, and the handling of data
specific to social and behavioral sciences.
This supplemental language ensures that participants are fully informed about the nature of the research, any potential risks, and how their information will be used, helping to protect their rights and maintain trust in the research process.