Boston University Medical Center
Institutional Review Board
Policies and Procedures
Table of Contents

 

VIII. Informed Consents

Federal Regulations Regarding Informed Consent
Elements of Informed Consent
Review of Informed Consent
Informed Consent Categories

VIII. Informed Consent

Federal Regulations regarding Informed Consent
Federal regulations require that no investigator may involve a human being as a subject in a research project without obtaining legally effective informed consent of the person or the person's legally authorized representative (LAR). The investigator must provide the prospective subject or the LAR sufficient opportunity to consider whether or not to participate and must minimize the possibility to coercion or undue influence. The information that is given to the subject or LAR shall be in language understandable to the subject or LAR.
21 CFR 50.25(a) and 45 CFR 45.116 require that the elements of informed consent criteria be met. The information that should be provided to each subject has been incorporated in the BUMC Informed Consent Template (www.bumc.bu.edu/irb). The template is provided to the investigator and is located on the BUMC IRB website, along with a checklist of elements. Informed consent forms must be submitted in the proscribed templated format for review by the IRB. The IRB may waive the requirement for use of the BUMC format as appropriate.

Elements of Informed Consent
The following are required elements in an informed consent form (ICF):

  • A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
  • A description of any reasonably foreseeable risks or discomforts to the subject.
  • A description of any benefits to the subject or to others that may reasonably be expected from the research.
  • A disclosure of appropriate alternative procedures or courses of treatment, if any, which might be advantageous to the subject.
  • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the IRB, the Food and Drug Administration, the Department of Health and Human Services, the National Institutes of Health, the sponsor (and others, as appropriate) may inspect the records.
  • For research involving more than minimal risk, an explanation as to whether any compensation and/or an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
  • An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
  • A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
  • When appropriate, a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
  • When appropriate, anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
  • When appropriate, any additional costs to the subject that may result from participation in the research.
  • " When appropriate, the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.
  • When appropriate, a statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.
  • When appropriate, the approximate number of subjects involved in the study.

    • The IRB review focuses on the informed consent form and assures inclusion of required elements.. All consent forms must be in the format that the IRB dictates.

    Review of Informed Consent
    The IRB reviewers and the IRB coordinators review the informed consent form using the Informed Consent checklist of required and optional elements (45 CFR 46.116 and 21 CFR). Changes are marked on the informed consent form and returned to the Principal Investigator for revision. Once the informed consent form is modified and approved, the PI is sent a validated copy, stamped with the date of the IRB approval ("valid from") and the date though which the form is valid ("valid thru"). All signed informed consent forms must be retained after the end of the study for a period of three years by the Principal Investigator.


    Informed Consent Categories

    Written Consent
    Informed consent must be documented on a stamped BUMC IRB approved consent form unless these requirements are specifically waived or modified by the IRB. The consent form (ICF) must be signed and dated by the subject or his/her legally authorized representative. The expiration date on the ICF is the last day of the current IRB approval. The date of the subject's signature on the ICF must be prior to the expiration date stamped on the ICF.


    Waiver of Documentation of Consent
    Federal regulations permit an IRB to waive the requirement for the PI to obtain a signed consent form for some or all subjects if the IRB finds and documents in the minutes either

  • That 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 in confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subjects' wishes will govern;
    or
  • 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

    • Waiver of documentation of consent is granted by the BUMC IRB on a case-by-case basis. It is not permitted except in those rare instances in which the above criteria apply and in which the research could not practicably be carried out without the waiver. In cases in which the documentation requirement is waived, the IRB may require that the PI provides subjects with a written statement regarding the research. The rationale for requesting the waiver of documentation of consent must be justified in the IRB submission.


    Waiver of Consent in Non-Emergency Research
    The BUMC IRB can approve a request for waiver of the informed consent procedure either by the expedited or convened full board process. In order to qualify for waiver of informed consent the research study must fulfill all of the following (four) criteria

  • The research must present no more than minimal risk of harm to subjects (see Appendix C for definition of minimal risk);

  • The waiver will not adversely affect the rights and welfare of the subjects

  • The research could not practicably be carried out without the waiver

  • Whenever appropriate, the subjects will be provided with any additional pertinent information after participation.

    • Waiver of consent is allowed by the IRB on a case-by-case basis. IRB review (whether expedited or full board) must ensure that each protocol satisfies each of the above criteria. In instances where consent is waived, it is still essential that appropriate procedures for maintenance of confidentiality be described in the protocol.


    Informed Consent for Non-English Speakers
    Special issues arise in situations when the research subjects do no speak or read English. Federal regulations require that informed consent be presented "in language understandable to the subject" and be documented in writing. Whenever possible, the documentation must be in the form of an informed consent written in a language understandable to the subject that embodies all of the elements of informed consent.

    The Principal Investigator must translate the consent form if subjects expected to be enrolled are not fluent in written English. A completely translated copy of the informed consent and a complete back- translation done by two qualified translators must be submitted to the IRB before the translated ICF is approved. Expedited review of these versions is done if the protocol and the full English language ICF have already been approved. The PI must provide in writing to the IRB the qualifications of the persons who completed the translation and the back-translation of the documents.

    Short Form Consent
    In accordance with 45 CFR 46.117 (b)(2) and 21 CFR 50.27(b)(2), the BUMC IRB allows the use of a short form written consent document.
    Short form consents, for use with non-English speaking subjects or illiterate (non-English reading) subjects may only be used with specific IRB approval. Use of the written short form consent must include documentation stating that the required elements of informed consent have been presented orally to the subject or his/her legally authorized representative (LAR) in their language. Expedited review of the short form is allowed if the protocol, the full English language version of the ICF, and the English version of the short form document have already been approved by the IRB. The IRB must approve a written summary of what will be said to the subject or the LAR. The short form is signed by the subject or LAR and the person who provided the oral translation. A copy of the summary along with a copy of the short form must be given to the subject or LAR.