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Consent Forms

EFFECTIVE DATE: MARCH 1, 2012

AUTOMATED IRB-APPROVAL PROCESS

For Informed Consent Documents & Revised UM Consent Document Templates

  • Informed consent documents will be automatically processed with approval date in CICERO at the time of IRB approval
  • Replaces current manual processing post IRB approval
  • Automated processing REQUIRES use of the revised UM CONSENT DOCUMENT TEMPLATES for ALL UM consent documents, including assent forms
  • The revised UM INFORMED CONSENT DOCUMENT TEMPLATES conform to all existing standard regulatory and institutional requirements. See Section 7 “WORKSHEET HRP-311: Criteria for Approval and Additional Considerations”

CONTENT REVISIONS INCLUDE:

  • Page 2, new section: WHAT ARE MY RESPONSIBILITIES IF I TAKE PART IN THIS RESEARCH?
  • Page 3, revised language: for clinical studies involving women of childbearing potential, pregnant women and/or embryos or fetuses
  • Page 4, additional language: for clinical studies, list risks and potential benefits of alternative procedures/treatments
  • Pages 5: additional language: pertaining to who can access research and clinical records; required language for FDA-regulated research
  • Pages 6: additional language: withdrawing from the research study
  • Page 6, new section: CAN I BE REMOVED FROM THE RESEARCH?
  • Pages 6-8, new language: the following statement must be included in the appropriate University Statement section: “This research has been reviewed and approved by the Institutional Review Board (IRB).”
  • Footer: page numbers. DO NOT add additional page numbers

IMPLEMENTATION:

  • ALL submissions to the IRB on or after March 1, 2012 must use the REVISED UM INFORMED CONSENT DOCUMENT TEMPLATES. These submissions include:
    • New protocols requiring informed consent documents
    • Modifications with revisions to currently approved informed consent documents
    • Continuing Review submissions with active informed consent documents at the time of renewal. These revised consents can be uploaded into the Continuing review application, you do not need to submit a separate protocol modification. However, only consent template changes will be accepted at the time of continuing review.

Submissions in process on March 1, 2012 will NOT require conversion to the revised templates. However, users may begin using the revised INFORMED CONSENT TEMPLATES immediately.

INSTRUCTIONS:

  • DO NOT use sponsor or other consent document templates
  • Download the UM INFORMED CONSENT DOCUMENT TEMPLATES
  • Complete ALL sections of the appropriate INFORMED CONSENT TEMPLATES, and include any additional required language
  • DO NOT change header and footer margins that conform to specific technical specifications for automation
  • DO NOT add anything to the header and footer sections
  • Upload the completed informed consent document in CICERO

The process for uploading into CICERO is unchanged.

Additional Instructions for preparing consent forms for approval by the University of Maryland, Baltimore IRB

According to UMB HRPP Policies and Procedures, readability of an informed consent document should be no greater than a 7th grade reading level. The IRB recommends the use of this website.

In order to measure readability using the Flesch-Kincaid reading level analysis function in Word, go to:

  • TOOLS, then OPTIONS, then SPELLING AND GRAMMAR
  • Select "Check grammar with spelling"
  • Select "Show readability statistics"
  • Click OK
  • Proceed through the spell check, and when finished, the readability level should be displayed.
  • Formatting and fonts should be simple. Use 12 point Times New Roman font, bullets, and keep underlining, bolding, and italicized words to a minimum.
  • MOST CONSENT DOCUMENTS ARE COMPRISED OF SECTION HEADINGS WHICH ADDRESS THE FOLLOWING: Purpose, Procedures, Potential Risks/Discomforts, Potential Benefits, Alternatives, Costs to Participants, Payment to Participants, Confidentiality, Right to Withdraw, & University Statement.

Consent & Assent Templates

The following basic elements of informed consent are required to be disclosed in all research consent forms pursuant to 45 CFR 46(a-b):

Basic elements of informed consent.

  1. 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;
  2. A description of any reasonably foreseeable risks or discomforts to the subject;
  3. A description of any benefits to the subject or to others which may reasonably be expected from the research;
  4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained, including the possibility that the Food and Drug Administration (FDA) may inspect the records if applicable;
  6. For research involving more than minimal risk, an explanation as to whether any compensation and 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;
  7. 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; and
  8. A statement that participation is 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.

Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:

  1. 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;
  2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
  3. Any additional costs to the subject that may result from participation in the research;
  4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
  5. 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; and
  6. The approximate number of subjects involved in the study.

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