Informed Consent

The Health Sciences Institutional Review Boards Office provides the following list of useful tips on writing consent forms

This page lists the federally required elements of consent.  All applicable elements should be included in consent documents.
  • A statement that the study involves research
  • An explanation of the purposes of the research
  • The expected duration of the subjects' participation
  • A description of the procedures to be followed
  • 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 which may be reasonably be expected from the research
  • A disclosure of an appropriate alternative procedures of courses of treatment, if any, that might be advantageous to the subject
  • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
  • For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are avaialble, 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 in voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled
  • The IRB may ask for the inclusion of additional elements of consent that are recommended by the Common Rule, including:
    • A statement that the particular treatment or procedures may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable
    • Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent
    • Any additional costs to the subject that may result from participation in the research
    • The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
    • 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
    • The approximate number of subject involved in the study

    Formatting and editorial suggestions for consent writing
    1. Write the consent form in the question and answer format.  For example, 'What are the Risks?'
    2. Write the consent form at a 6th-8th grade reading level.  Glossaries of lay terms for use in preparing consent forms can be found here, Reading Level .  Aside from word choice, shorter sentence length is one means of reducing the reading level of consent forms.
    3. Use a font that is no smaller than 12 point, and bold headings to enhance readability of the consent document.  If the subjects are likely to have low or impaired vision, larger fonts are recommended.
    4. The use of graphics is highly encouraged, especially to illustrate unusual or complicated study procedures.
    5. The use of tables to outline study procedures is encouraged.
    6. The use of bullet points is strongly encouraged, especially when listing study risks.
    7. In clinical research, use the term 'subject' rather than 'patient' when writing the consent form.  This wording is important because it reinforces the fact that research procedures are distinct from clinical procedures, even though the Principal Investigator may be the treating physician and the research subject may also be a patient.  For non-interventional studies, it may be acceptable to use 'volunteer' or 'participant' instead of 'subject' based on the nature of the study.
    8. Include the term 'Research' in the title or header of the consent form.  For example, 'Research Information and Consent Form' or 'Consent to Participate in a Research Study'.
    9. Obtain a translation of the consent form(s) if you will be enrolling subjects without proficiency in English.
    10. An assent form for minors may be necessary if you will be enrolling children in the study.
    11. Please leave sufficient space at the bottom right hand corner of the consent document for the IRB stamp of approval.
    12. Please include a version number and date on the bottom left corner of the consent document.

    A Note on Research Involving Storage of Tissue
    If you plan to save blood or tissue for future research, review the Guidelines for Genetic Research and the Use of Storable Tissues.  Issues that may need to be addressed in the consent form include:
    • Whether the tissue be used for future studies or a different research purpose in the future
    • Whether the tissue will remain identifiable
    • What the risks of breach of confidentiality are

    Consent and Assent Form Templates

    The Health Sciences IRBs developed several templates for the variety of research studies they review, including for FDA-regulated studies, studies not involving physical interventions, studies involving genetic testing, for humanitarian use devices, emergency and one-time use of investigational drugs or devices, and for re-consenting subjects. Please see the Consent Form Templates .

    See Also:

    Keywords:ICF, CF, elements of consent, wizard, template   Doc ID:18665
    Owner:Monica E.Group:Health Sciences IRBs
    Created:2011-05-26 19:00 CDTUpdated:2015-10-13 15:14 CDT
    Sites:Health Sciences IRBs
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