Informed Consent
The Institutional Review Board is responsible for reviewing procedures and circumstances under which consent will be obtained to ensure that subject selection is equitable, and enrollment minimizes undue influence to participate. Likewise, all associated participant facing materials must be submitted to the IRB for review and approval.
Informed Consent Process
Informed consent for participation in research is a process that involves information exchange and on-going communication between the researcher and the potential participant.
The consent process starts with the initial presentation of the research to a prospective participant (including recruitment materials) and continues with a discussion between the researcher and the prospective participant. Consent is documented, usually utilizing a consent form.
Consent is ongoing through the research activity until the participant decides withdraw or until the research is complete.
Elements of the Consent Process
An effective informed consent process involves these elements:
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Conducting the process in a manner and location that ensures participant privacy
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Obtaining the prospective participant voluntary agreement to participate
This means the recruitment and consent processes minimize any undue influence (influencing one to act in a way other than their own free will or without adequate attention to the consequences) or coercion (persuading someone through force or threats). Consider whether vulnerable populations are targeted.
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Providing adequate opportunity for the potential participant to consider all options
Is there sufficient time for the participant to decide whether or not they want to participate? The consent process should not be rushed.
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Giving adequate information about the study
Does the information in the consent form provide all critical information so that the participant or the LAR can adequately understand the research and make informed choices?
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Information is provided in a language understandable to the participant
The researcher should ensure participant comprehension of the information provided. It is generally recommended that the consent form read at a 7th -8th grade reading level to be broadly understandable to individuals from various educational backgrounds. Please consider referring to the Health Literacy Guidance below. Also consider the inclusion of limited English proficiency participants, when applicable.
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Responding to the participant questions and/or concerns
Participants should be given the opportunity to ask questions during the consent process. If there are any complaints during the research, it is the responsibility of the study team to respond to these complaints.
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Continuing to provide information as the participant or research requires
Consent is an ongoing process, and ongoing consent becomes more critical as the duration of participation increases. If research procedures change, participants must be informed. New information may become available, such as new risks, benefits, or alternatives. Participants should be informed, as applicable.
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Documenting consent appropriately
Consent should be documented unless the IRB has approved a waiver of documentation. The preferred method is participant signature. Electronic consent may be appropriate as well.
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Providing copies of the consent documents to the participants
The original signed copy should be maintained by the research team. A copy of the consent should be provided to the participant.
Informed Consent Form
Informed Consent Form Completeness
The Common Rule states broad points about the consent process and documentation, along with basic required and additional elements of consent. Additionally, consent forms must contain required institutional language. Click for an in-depth guidance on this information and when HIPAA authorization should be included. Biomedical Consent Completion Guidance Social Behavioral Consent Completeness Guidance
Health Literacy Guidance
The Common Rule states that “the information that is given to the participant or LAR must be in language that is understandable to the participant or LAR.” About 30 million Americans have below-basic literacy, which can hamper the understanding of research. The Health Literacy Guidance outlines best practices for drafting consent forms to better facilitate participant comprehension. The NIA Glossary contains definitions of commonly used terms within clinical research.
Health Literacy Guidance
Clinical Research Glossary
Remote Consent & Procedures
The Penn IRB supports the use of remote consent and remote study procedures, when appropriate. However, the use of remote methods must be outlined for IRB review to ensure that risks to subjects continue to be minimized and the data integrity of the study can be maintained. This guidance is meant to serve as a resource to guide research teams considering the use of remote procedures for research. Penn Medicine and Penn Dental Remote Consent Guide Penn Medicine Guidance on the Use of Electronic Signatures in Research and 21 CFR Part 11 Compliance. Guidance for Other Schools
Inclusion of Participants Not Fluent in English
Non-English-speaking subjects should not be systematically excluded from research without a sound scientific or ethical rationale to ensure equitable subject selection. However, federal regulations at 45 CFR 46.116(a)(3) and 21 CFR 50.20 require that informed consent be obtained in language that is understandable to the subject (or the subject’s legally authorized representative). This guidance outlines procedures to ensure the equitable and safe enrollment of such participants.
Waivers of Consent
Click Learn More for guidance on the regulatory criteria for waivers of informed consent, alterations of informed consent, and waivers of documentation of informed consent.