IRB Consent

What do I need to know about the informed consent process?

The informed consent process requires ongoing information exchange beyond just obtaining signatures. See detailed guidance below for essential information on consent documentation, signatures procedures, and special population considerations.

Comprehensive Informed Consent Guidance Document

What should be included in the consent document? 

The link below outlines the necessary requirements of a Carilion Clinic informed consent document, as defined by the Federal Regulations as well as additional guidance on the following: 

• Requirements for waivers of informed consent and waivers of documentation of informed consent
• Virginia consent law
• Parental permission for assent for children
• Tissue banking consent
• Obtaining consent using the telephone
• Witness signatures

Components of Informed Consent

What is electronic informed consent (eConsent), and is it available for research studies? 

eConsent refers to the use of electronic systems and processes to convey information related to a research study and to obtain and document informed consent. The guidance link below outlines the process for obtaining informed consent for a study. 

Electronic Informed Consent

What are considerations for consent for non-English speaking participants? 

The document linked below outlines the process researchers and IRB-approved study team members should use to obtain and document informed consent from subjects who are non-English speakers and require an interpreter and translated consent materials.

Obtaining Consent from Non-English Speaking Subjects

When do we need to ask a legally authorized representative to provide consent? 

Federal regulations that govern research involving human subjects define a legally authorized representative as an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. 45 CFR 46.102(i) and 21 CFR 50.3(l). The guidance linked below outlines considerations for the use of a legally authorized representative. 

Informed Consent Process: Use of Legally Authorized Representatives

How do we assess a participant's capacity to provide informed consent? 

Investigators should use the guidance linked below for projects in which the design of the study is expected to recruit from populations with disorders known to be associated with impairment of decision-making capacity.

Decision-Making Capacity Assessment for Adults

Do children have a role in the consent process? 

In all instances in which children are capable of providing assent, the investigator shall develop a separate assent form written at a developmental level appropriate to the child's age, maturity and experience. The guidance linked below outlines the considerations for determining the need for assent from children. 

Determining the Need for Assent: Children

Are there specific assent and consent requirements for children who are wards of the state or emancipated minors? 

Very specific federal, state and local requirements address the inclusion of wards of the state and emancipated minors in a research study. The guidance linked below provides specific requirements for including these individuals in a research study. 

Wards of State and Emancipated Minors