Informed Consent

Informed consent is one of the primary ethical considerations underlying research with human subjects. It is too often forgotten that informed consent is an ongoing educational process that takes place between the investigator and prospective subject.

The table below was designed to meet all of your informed consent needs, with "how to" information organized by category.

Categories
Informed Consent Development Templates & Tools	Improve readability Key information defined Future research use after study is done Checking draft consent to ensure it contains required and additional elements Non-English-speaking subjects
Informed Consent Process Discussion to Documentation	Notifying or re-consenting existing participants Conducting the consent discussion Documentation of the process in the research or medical record Policy on posting a copy of the informed consent on a federal website
Repository/Bank/Registry	Designing a consent document/process for a repository, registry, or bank for future research Consent contents for genetic research or genomic data sharing
Short Form Process	Enrolling an unanticipated non-English speaking subject
Waiver or Alteration of Informed Consent	Requesting waiver if research cannot be done if required to obtain informed consent (e.g., large record review) Requesting to alter informed consent for Deception Research (i.e., initially withhold purpose with debrief and request to use data)
Waiver of Signatures	Requesting IRB approval for waiver of the requirement for signature in informed consent (e.g., minimal risk for which signature not normally required or participant cannot sign due to their cultural beliefs, confidentiality concerns, legal risks, etc.)
Remote Informed Consent	Subjects in a different location
Electronic Informed Consent (E-consent)	Obtaining electronic consent
Assent Process	Research involving children Obtaining assent of minors Obtaining parental permission
Impaired Consent Capacity Guidance (Survival Handbook)	Research involving individuals with impaired consent Completing Form T to outline assessment and accommodation plan
Students as Subjects Guidance (Survival Handbook)	Requirements applying to consenting K-12/University students
Research Involving Economically or Educationally Disadvantaged Persons Guidance [D139.0000]	Considerations when seeking informed consent
Informed Consent for Survey Research	Consent options/requirements for survey studies
Exception from Informed Consent (EFIC) for Emergency Research	Regulatory criteria and community disclosure requirements