Human Research Protections Office (HRPO)
Consent Forms
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: http://healthcare.partners.org/phsirb/consfrm.htm
In order to measure readability using the Flesch-Kincaid reading level analysis function in Word, go to:
• TOOLS, then OPTIONS, then SPELLING AND GRAMMER
• 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
Which Consent Form Template should you use?
- Sponsor’s Template - If your study already has a sponsored consent template, you can use your sponsor’s template and incorporate UMB standard language including the applicable University Statement.
- Consent Form Template – This template should be used as a guide for all research studies including parental consent forms and LAR consent forms. Click Here to download a blank Consent Form Template
- Assent Form Template – This template should be used to assent participants ages 13-17 and if applicable to your study - cognitively impaired participants. Click Here to download a blank Assent Form Template
- VA Consent Form Template – This template should be used if your study is being conducted at the Baltimore VA. Click Here to download a blank VA Consent Form Template
The following basic elements of informed consent are required to be disclosed in all research consent forms pursuant to 45 CFR 46(a-b):
(a) 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.
(b) 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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