Informed Consent Development [HTML]
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 [HTML]
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 [HTML]

• 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 [HTML]

• Enrolling an unanticipated non-English speaking subject

Waiver or Alteration of Informed Consent [HTML]

• 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 [HTML]

• 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 [HTML]

• Subjects in a different location

Electronic Informed Consent (E-consent) [HTML]

• Obtaining electronic consent

Assent Process [HTML]

• Research involving children

• Obtaining assent of minors

• Obtaining parental permission

Impaired Consent Capacity Guidance (Survival Handbook) [HTML]

• Research involving individuals with impaired consent

• Completing Form T to outline assessment and accommodation plan

Students as Subjects Guidance (Survival Handbook) [HTML]

• Requirements applying to consenting K-12/University students

Research Involving Economically or Educationally Disadvantaged Persons Guidance [D139.0000] [PDF]

• Considerations when seeking informed consent 

Informed Consent for Survey Research [HTML]

• Consent options/requirements for survey studies

Exception from Informed Consent (EFIC) for Emergency Research [HTML]

• Regulatory criteria and community disclosure requirements