Informed Consent Forms

Informed Consent Form Templates - Biomedical and Oncology
Georgetown University Biomedical Informed Consent Form 
Updated 17 May 2016
Joint MHRI-GU Informed Consent Form
Updated 17 May 2016

 

Informed Consent Form Template - GHUCCTS
GHUCCTS Informed Consent Form 

 

Informed Consent Form Templates - Social and Behavioral

You should use an informed consent form (ICF) when you plan to document informed consent, that is, to collect signed ICFs from all participants. If you plan to collect participant names or identifying information at any point during the research, you should use one of the below ICF templates.

You should also use a (parental) ICF if you plan to conduct research with minors. When you use a parental ICF, you should also use a minor assent form (AF). Templates for parental ICFs and minor AFs are also below.

If you are conducting research that involves both interview and survey research (or neither), you should still use the below ICF templates as a guide but modify them as necessary to be relevant to your research.

ICF – Interview (Not Anonymous)

ICF – Survey (Not Anonymous)

ICF – Other

Parent for Minor ICF – Interview (Anonymous)

Minor AF – Interview (Anonymous)

Parent for Minor ICF – Interview (Not Anonymous)

Minor AF – Interview (Not Anonymous)

Parent for Minor ICF – Survey (Anonymous)

Minor AF – Survey (Anonymous)

Parent for Minor ICF – Survey (Not Anonymous)

Minor AF – Survey (Not Anonymous)

Parent for Minor ICF – Greater than minimal risk

Minor AF – Greater than minimal risk

 

Informed Consent Script Templates

You should use an informed consent (IC) script when you do not plan to document informed consent. If you use an IC script, you need to request a waiver of IC documentation, that is, a waiver of the requirement to collect signed ICFs from all participants. If you do not plan to collect participant names or identifying information at any point during the research, you should (1) request a waiver of IC documentation in eRIC section 12.09 of the application and (2) use one of the below IC script templates.

The IRB may waive the requirement for documentation of informed consent (i.e. for the investigator to obtain a consent form) if either: (1) The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality; or (2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

More information about waivers of IC documentation can be found at 45 CFR 46.117(c).

If you are conducting research that involves both interview and survey research (or neither), you should still use the below IC script templates as a guide but modify them as necessary to be relevant to your research.

IC script – Interview (Anonymous)

IC script – Survey (Anonymous)

 

Other Templates

Addendum ICF for Video Recording the Study Procedure

Addendum Consent Form for Assent of Child < 12

 

Informed Consent Form Guidelines and Instructions

Required elements of a consent form

Code of Federal Regulations
Title 45 Public Welfare
Department of Health And Human Services
Part 46 Protection of Human Subjects
46.116 General requirements for informed consent
46.117 Documentation of informed consent

Guidelines for Completing an Informed Consent Form

 

Glossaries of Lay Terms
Glossary of Lay Terms
(medical terms in lay language, from Stanford)
Lay Language for Medical Terms
(University of Kentucky)
Lay Terminology
(North Shore Long Island Jewish Health System)
Simplification Guide to Medical Terms
(University of Michigan)