• ICF Template
  Combined consent and HIPAA research authorization template for a subject to consent to participate in research.
• Assent Form for Children 7-17 Years Old
• ICF Checklists
  Investigators and research team members can use these checklists when creating ICFs to make sure all of the necessary information is included:
  • Elements of Informed Consent Worksheet (Main Study ICF)
  • OHRP ICF Checklist

When new or additional procedures are added to a study, or if changes are made to the protocol or ICF that affect the subject, or if new safety information is learned, the subject must be made aware of the change and again give consent. Such changes or new information might affect subjects’ willingness to continue participation in the study.

An investigator may not perform a procedure, etc., on a subject without first obtaining new consent if the procedure was not part of the initial consent discussion and documented in the original ICF.

New safety information, a change in FDA approval status of a drug or device being studied, or a new or change in alternative to participation, etc., is to be conveyed to subjects in a timely manner so that they can make an informed decision about whether or not to continue study participation. Conveying such information should not be delayed.

For more information, please refer to the Tufts Health Sciences IRB Investigator Manual.

The following resources are provided to assist you in defining or replacing medical terms and jargon in your ICFs.

• Glossary of Terms
• PRISM Readability Toolkit
  • Plain language principles and strategies.
  • Quick reference guide and editing checklist.
  • Easy-to-read template language for consent forms and HIPAA authorizations.
  • Online Readability Training.
• KidsHealth: Kids’ Medical Dictionary
  • For help creating forms that are easy to understand for children
• NCI Dictionary of Cancer Terms
  • Cancer-specific glossary of terms

Other Useful Glossaries

• Harvard Medical School Medical Dictionary of Health Terms
• National Cancer Institute Tables of Possible Side Effects for Commonly-Used Oncology Drugs
• National Cancer Institute Tables of Possible Side Effects for Commonly-Used Oncology Regimens
• Medical Library Association Deciphering Medspeak
• Stanford University's Glossary of Lay Terms for Use in Preparing Consent Forms

Each IRB-approved ICF has an approval date in the footer.

The most recent IRB-approved version of the ICF must be used to enroll a subject and the subject or legally authorized representative (LAR) must sign and date the ICF themselves. Principal Investigators are reminded that outdated ICFs must not be used and the FDA explicitly requires ICFs to be signed and dated by the subject (21 CFR 50.27(a)).

The ICF with the subject’s original-ink signature should be retained in the Principal Investigator’s research files. One copy of the signed ICF must be given to the subject and one copy should be placed in the subject’s medical record, if relevant to their ongoing medical care.

In addition, the institutions advise investigators to consider including a note in a clinic chart or in the research file that the study was explained, when it was explained, who was present for the discussion, that any questions were answered, that the subject gave consent to participate, and that a copy of the signed ICF was given to the subject. This note should be signed and dated by the person who documented the subject’s consent.

For more information, please refer to the Tufts Health Sciences IRB Investigator Manual.

Under certain circumstances, the IRB may approve a consent process that does not include, or that alters, some or all of the elements of informed consent, or may waive the requirement to obtain informed consent, provided the IRB finds and documents that all of the following requirements apply:

1. The research involves no more than minimal risk to the subjects;
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
3. The research could not practicably be carried out without the waiver or alteration; and
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Requests for alterations of, or a waiver of, informed consent requirements should be made in the study protocol and justified by addressing each of the points above.

For more information, please refer to the following checklists available in the eIRB Library:

• HRP-410 - CHECKLIST - Waiver or Alteration of Consent Process
• HRP-441 - CHECKLIST - HIPAA Waiver of Authorization

The IRB may waive the requirement to document informed consent with a signed written ICF for some or all subjects, provided the study is not regulated by the FDA (unless it is emergency research), if the IRB finds either:

1. That the only record linking the subject and the research would be the ICF and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject should be asked whether s/he wants documentation linking him/her with the research, and his/her request will prevail. If the IRB approves a waiver of the requirement to obtain a signed ICF, the complete informed consent process must take place: investigators must completely inform potential subjects about the study, answer their questions and obtain their verbal agreement to participate in the study. The IRB may require subjects to be given a written ICF containing all required consent elements. The subject will have the option to not sign the ICF. 

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 out of the research context. If the IRB approves a waiver of the requirement to obtain a signed ICF, the complete informed consent process must take place: investigators must completely inform potential subjects about the study, answer their questions and obtain their verbal agreement to participate in the study. The IRB may require subjects to be given a written ICF containing all required consent elements.

OR

3. That the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and that there is an appropriate alternative mechanism for documenting that informed consent was obtained. If the IRB approves a waiver of the requirement to obtain a signed ICF based on this, the complete informed consent process must take place: investigators must completely inform potential subjects about the study, answer their questions and document their agreement to participate in the study. The IRB may require subjects to be given a written ICF containing all required consent elements.

For more information, please refer to the following checklists available in the eIRB Library:

• HRP-411 - CHECKLIST - Waiver of Written Documentation of the Consent Process

For more information, please refer to the following materials available on the IRB website or the eIRB library:

• Tufts Health Sciences IRB Investigator Manual
• SOP: Legally Authorized Representatives, Children, and Guardians (HRP-013)
• SOP: Informed Consent Process for Research (HRP-090)
• SOP: Written Documentation of Consent (HRP-091)
• SOP: Remote Consent Process (HRP-092)
• Enrollment of minors
• Enrollment of decisionally impaired persons
• Enrollment of non-English speakers
• OHRP Guidance Documents for Informed Consent
• FDA Guidance Documents for Informed Consent