Informed Consent Forms

Writing Readable Informed Consent Forms (ICF)
(or how to get your study approved more quickly)

45 CFR 46.116
Regulatory Requirements for Informed Consent

§46.116...The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

§46.116(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.

See the section on Regulatory Requirements.

Informed consent is a process and not simply a document. The ICF informs prospective participants of the purpose, procedures and risks and benefits of participation, it serves as a guide during discussions with the investigator and as a reference source during participation.

This section of the IRB's website provides guidance for investigators preparing consent documents. The IRB provides template consent documents but any format that is both readable and understandable is acceptable. For example, if the sponsor provides a template consent form, it can be used as the basis for the CHOP informed consent form (ICF). However, the IRB cannot approve a consent document that is not written in readable, understandable language or formatted in an approachable style.

What needs to be in the ICF?

The Federal research regulations (both FDA and the Common Rule) specify 8 required elements and 6 additional (optional) elements for consent. The Common Rule requirements 45 CFR 46.116(b) are listed above. The FDA's requirements are very similar and are available in 21 CFR 50.25. The IRB checks to see if the required and applicable optional elements are present in the submitted consent form.

When the consent document and HIPAA authorization are combined into a single form, then the ICF must also contain all of the requirements for HIPAA Written Authorization The IRB's Consent Form Templates contain all of the required elements and help guide the construction of a readable document. An example Consent Form is available on this site which shows where the common rule and HIPAA requirements are incorporated into our consent template.

In some circumstances that IRB can waive the requirements for documentation of consent. This is often confused with Waiver of Consent. When the IRB issues a waiver of documentation of consent, the IRB approves a consent form that contains all of the required elements of consent(above). The consent form is read to the subject either in person or over the telephone, and the investigator then must document that the consent conversation took place. See the IRB webpage on Waiver of Documentation for more information on verbal consent.

Why are few ICFs approved the first time?

HHS regulations at 45 CFR 16.116 and the FDA regulations 21 CFR 50.20 also require that the consent information be in language understandable to the subject or their legally authorized representative. This means the document must be written in plain language, using lay terms, and in a language the subject understands. Language the subject understands is interpreted to mean at a level compatible with their reading comprehension.

The following sections outline the most common problems that result in requested changes. Each request by the IRB delays approval and the start of the research.

Submitted Consent Forms are Too Long and Written in Technical Language

Tutorial and Resources for Writing in Plain Language

The Group Health Cooperative in Seattle has assembled training materials for writing in plain language. Their Plain Language Toolkit is an 81 page document with numerous before and after examples. They also provide PRISM Online Training, which is an hour-long, Web-based plain language tutorial created for research professionals, including scientists, research staff, Institutional Review Boards (IRBs), or communications staff. It covers health literacy and readability, plain language strategies and examples, and interactive editing examples and exercises. Access the course for free at http://prism.grouphealthresearch.org.

ICFs are generally much too long, use medical terminology rather than lay language and are written at much too high a grade level. To be approachable, investigators should aim for a 6th-8th grade reading level. Also, most readers cannot maintain their concentration or comprehension when an ICF exceeds 6 pages. It takes time and skill to write a simple, comprehensive ICF that is still brief.

Health Literacy of American Adults

Even when written at a 6th grade level 20 - 30% of prospective subjects will be unable to read the document. ICFs that are not written at an appropriate reading level, fail to achieve their intended purpose and are not approvable. Careful attention to development of a simple, readable document will expedite approval.

The two figures below are from the 2003 Health Literacy Statistics. While the

  • 12 - 16% of US adults cannot read;
  • about 22% have only basic reading skills;
  • 51 - 55% have intermediate reading skills
  • 11-12% have advanced skills.

Only those with advanced skills (~12%) are likely to be able to fully comprehend the current consent forms circulated for multi center clinical trials. It is pointless to provide documents that so few people can read. The FDA's 2014 Draft Guidance: Informed Consent Information Sheet discusses what language understandable to the subject means and points out the US adults are also severely challenged by low levels of numeracy.

“Understandable” means the information presented to potential subjects is in a language and at a level the subjects can comprehend (including an explanation of scientific and medical terms). In ensuring that information is understandable, it should be noted that more than one-third of U.S. adults, 77 million people, have basic or below basic health literacy. Limited health literacy affects adults in all racial and ethnic groups. In addition, more than one-half of U.S. adults have basic or below basic quantitative literacy and are challenged by numerical presentations of health, risk, and benefit data.

Overall US Health Literacy
Summary Health Literacy Statistics

Submitted informed consent forms (ICFs) are often poorly formatted and sloppily edited

The formatting, design and layout of the ICF has been shown to be one of the most important factors that affecting readability. (See for example Tait et al. Informing the uninformed: optimizing the consent message using a fractional factorial design.) Small type, wide margins, lack of white space and inconsistent typeface usage can all make the ICF less approachable and unreadable. A consistent approach to the layout and design of the ICF helps the reader understand the organization of the information and this contributes to understanding.

The ICF can projects either a favorable or unfavorable first impression. Sloppy, poorly formatted documents can detract from the prospective subject's view of the investigator and CHOP as an institution. A number of formatting techniques have been shown to enhance readability. All of these have been built in to the CHOP Consent Form Templates.

General Formatting Tips

Applying Styles in Microsoft Word Documents

Cutting and Pasting:
The IRB's informed consent form (ICF) and protocol templates contain customized styles to ensure consistent formatting. In the case of the protocol templates, they also ensure that the sections are numbered appropriately. To do this, the templates contain a collection of styles, each of which is pre-formatted for different parts of the document. Each part of the ICF and protocol template have a corresponding style which includes the font, the margins and the line spacing. For example, Heading 2 in the ICF template is Arial 12 point bold. Instead of formatting a section of text, (e.g., making text bold, or adjusting the line spacing), the correct style intended for that section of the document should be applied.

Cutting and pasting from another document will result in numerous paragraph styles, with a mixture of text sizes, and paragraph spacings. This happens because when text is pasted it brings with it the formatting from the original document intact. To prevent this problem, cut and paste using the Paste Special command and choose the Unformatted text option.

For additional information about using Style Sheets and links to Microsoft tutorials, see Preparation for Study Submission page.

See the Example Informed Consent Form for a practical application of the formatting techniques described below.

  • The question and answer style has been shown to result in shorter more readable ICFs;
  • Keep the column width to no more than 6-6.5 inches (1.5 inch margins). Columns that are too wide are hard to read;
  • Use a 12 point or larger serif typeface such as Times, Palatino, Garamond) for body text;
  • Use of a sans serif typeface such as Helvetica or Arial for headings;
  • Avoid the use of all UPPERCASE, it is hard to read;
  • Use bold, italic, or bold italic for emphasis; minimize the use of underlining;
  • Use bullet points with short phrases or sentences rather than long paragraphs for explanations;
  • Double space or add additional spacing (referred to as leading) between paragraphs;
  • Write in the second person, using 'you' throughout. Using the first person has been shown to be coercive.
  • When children are subjects of the research, and most will be capable of assenting to participation, use 'you' to refer to the child.
  • When most or all of the subjects will not be capable of providing assent (e.g. because they are under the age of 7, have cognitive deficits, will be sedated, etc.), you may use 'you' to refer to the parent or guardian and 'your child' to refer to the child.
  • Be sure to edit carefully to avoid unnecessary repetition and poorly formatted documents when cutting and pasting from a sponsor's ICF template into the CHOP template.

Example Consent Form

The Example Informed Consent Form below is a combined consent/HIPAA authorization. It is based on the current CHOP IRB Consent Form Templates. The example is annotated and explains how the form integrates the required basic and additional elements of consent. The example consent form also includes the requirements for a valid HIPAA Authorization.

Download a pdf version of the Example Consent Form for reference.

Example: Annotated Consent Form

Consent Documents for Non-English Speakers

To meet the regulatory requirements for approval, the IRB must find that the selection of subjects is equitable. The investigator must either (1) justify why they are excluding non-English speakers or (2) develop a plan to allow their enrollment. For more information on translated consent forms, see the IRB's webpage on Equitable Selection, Short Form Consent and IRB SOP 701: Required Elements of Consent and Documentation of Consent.

Resources

  • See the Summary of the NCI's guidance related to the Checklist to Develop Easy-to-Read Consent Documents

  • Download the Glossary of Lay Terms for lay language replacements for technical terms and jargon.

  • Readability tools are available for free at - http://www.storytoolz.com/readability. The best estimate of the reading difficulty of consent forms and other health-related content is the SMOG scale.

  • MS Word can calculate readability statistics using the Flesch Reading Ease Score.The Flesch-Kincaid Grade Level score rates text on a U.S. grade-school level. Unfortunately, this scale underestimates the reading level of health-related text by one to two grade levels. If the Flesch-Kincaid is used, it is safest to add 2 grade levels. The preferred tool to use for assessing the readability of health-related information is the SMOG (Simple Measure of Gobbledygook).

  • NIH Plain Language Initiative available at - http://execsec.od.nih.gov/plainlang/intro.html

  • Plain Language available at - http://www.plainlanguage.gov

CHOP - Related Policies

References

  1. Bjorn et al. Can the written information to research subjects be improved?--an empirical study.
  2. Coyne et al. Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group.
  3. Franck et al. Research participant information sheets are difficult to read
  4. Goldstein et al. Consent form readability in university-sponsored research
  5. Ogloff et al. Are research participants truly informed? Readability of informed consent forms used in research
  6. Philipson et al. Informed consent for research: a study to evaluate readability and processability to effect change
  7. Shalowitz et al. Informed consent for research and authorization under the Health Insurance Portability and Accountability Act Privacy Rule: an integrated approach
  8. Sharp. Consent documents for oncology trials: does anybody read these things?
  9. Tait et al. Improving the readability and processability of a pediatric informed consent document: effects on parents' understanding
  10. Tait et al. Informing the uninformed: optimizing the consent message using a fractional factorial design

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