Tips for Creating a Consent Document

Last updated on August 29, 2016 5 min read Working with Human Subjects - Tips for Creating a Consent Document

Getting Started

The consent form or study information sheet is a document used to guide your consenting process. The consent form should include several sections, which are called “elements.”

To help investigators create a consent document that includes all of the necessary elements, and is more readable, the IRB has created consent/assent form templates. We recommend that investigators use the templates OR use them as a guide in creating a consent document.

To get a sense of how the IRB reviews consent forms, please review the Consent Form Review Checklist. This document is used by the IRB reviewers when reviewing submissions and can be used as a guide when preparing your consent document.

If you are submitting an Exempt application, be sure your consent script/form, assent script/form or information sheet includes the following:

  • That the activities involve research;
  • The procedures to be performed;
  • Participation is voluntary;
  • The time involved for study participation;
  • How confidentiality of data is maintained;
  • Risks of participating in the study;
  • Benefits of participating in the study (if any);
  • Name and contact information for the investigator;
  • Name and contact information for the BU IRB, if applicable; and
  • Student researchers: 1) indicate in the consent script/form that he/she is a student and 2) list the Faculty Advisor as a contact in the document

Important Note: To further protect the confidentiality and privacy of subjects, a signature line on the consent form is not required for Exempt studies. If there is a specific reason why an investigator wishes to retain a signature line, please state so in the IRB application.

If you are submitting an expedited or full board study, there are several required elements for the consent document.

Required* elements

  • A concise and focused presentation (summary) of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research study;
  • A statement that the study involves research;
  • An explanation of the purposes of the research;
  • The expected duration of the subject’s 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 reasonably be expected from the research;
  • One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens: 1) A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility OR 2) A statement that the subject’s information or biospecimens collected as part of research, even if identifiers are removed, will not be used or distributed for future research studies;
  • A disclosure of appropriate alternative procedures or 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 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, 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

  • 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;
  • 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 subjects involved in the study

*Please note, in very specific situations, the IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to document informed consent.

  • Use words familiar to the non-academic/non-scientific reader
  • Avoid abbreviations and acronyms if possible (if using, spell out when first used)
  • Avoid contractions
  • Avoid long words with many syllables
  • Avoid unnecessary adjectives
  • Avoid legal jargon
  • Use active verbs
  • Use the second person (you) not third person (the participant) to increase personal identification
  • Use a conversational tone
  • Use headings and subheading to group text together
  • Standardize the layout throughout the document (for example, use the same typeface, size, etc.)
  • Write short, simple, and direct sentences
  • Avoid using e.g. or etc., use instead, “for example,” “so forth”
  • Divide sentences into two when necessary
  • Keep paragraphs short and limited to one idea
  • Use page numbers, if appropriate
  • Use at least 12-point font and consider a larger font based on your audience
  • Check the text to see if each idea is clear and logically sequential
  • Avoid repetition
  • Avoid large blocks of printed text and embrace “white space”
  • Use photos or pictures if they will help clarify procedures
  • Be consistent with use of all terminology, such as procedures or treatment names and abbreviations

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