Tufts Medical Center and Tufts University view informed consent as a dynamic, ongoing, interactive and multifaceted process, not just “signing a form.” A subject’s consent must always be given freely, without coercion, and must be based on a clear comprehension of what participation involves.
The informed consent process begins during initial contact with a potential subject and continues for the entire duration of the subject’s participation. The informed consent form (ICF) provides a summary of the study (including its purpose, the duration, the procedures and schedule, potential risks and benefits, alternatives to participation, etc.), explains the subject’s rights as a participant, and documents the subject’s willingness to be in the study. Federal regulations outline the required elements of informed consent, specifically 21 CFR 50 and 45 CFR 46.
The ICF and all other materials given to subjects (including advertisements, contact letters, questionnaires, telephone scripts, and study summary sheets) should be written in “lay language” at an 8th grade reading level or lower, and should not contain technical and medical terminology or jargon. The institutions have developed template ICFs for adults and a template ICF for minors that investigators are strongly encouraged to use.
The consent discussion and ICF should be presented to a potential subject sufficiently in advance of the start of study-related procedures to ensure that a subject has adequate time to voluntarily decide whether or not to participate in a research study. The institutions strongly recommend that subjects be encouraged to discuss participation with their significant others (i.e. family, friends, etc.), and be encouraged to take as much time as needed to decide whether or not to participate.
Consent must be given by a subject before any study-related procedures, including screening procedures, may take place. Once the ICF has been signed, subjects are considered enrolled.
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.
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 each subject must sign and date the ICF him/her/themself. 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 his/her 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.
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:
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 would 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 obtaining a signed ICF, the complete informed consent process must take place, including giving subjects a written ICF containing all required consent elements, except that the subject will have the option to not sign the ICF.
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 based on this, investigators must completely inform potential subjects about the study, answer their questions and obtain their verbal agreement to participate in the study.
Refer to the following checklists for additional information:
HRP-410 - CHECKLIST - Waiver or Alteration of Consent Process
HRP-441 - CHECKLIST - HIPAA Waiver of Authorization
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:
The research involves no more than minimal risk to the subjects;
The waiver or alteration will not adversely affect the rights and welfare of the subjects;
The research could not practicably be carried out without the waiver or alteration; and
Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Requests for alterations in, or a waiver of, informed consent requirements should be made in the study protocol and justified by addressing each of the points above