Spelling and grammar
Spelling and grammar must be correct before it is submitted for review.
Use lay language
The consent form is to be written in language understandable to the subjects or their representatives. For the typical subject population use of language at a 6th-8th grade level of schooling is recommended. Always keep in mind that informed consent is a process; the face-to-face discussion the most important part. The consent form is only a documentation of that process. If you write the consent form to be the same as the information you will give verbally, you will more likely use simple, direct language that anticipates and answers the prospective subject's needs for information.
Try to achieve a readability score at the grade 8 level
The Flesch-Kincaid tool in Microsoft Word can assist you by scanning your document and assigning a readability score (see instructions below on how to access this tool). If the score is greater than 8.9 (for adults), revise the consent document. Try using simpler words and shorter sentences, and writing in the active voice (For instance, say “You will be asked to do…” instead of “participation in the study will entail...”) If you do not have Microsoft Word, you can use the SMOG readability calculator instead. It can be found at: http://www.literacytrust.org.uk/about/faqs/710_how_can_i_assess_the_readability_of_my_document_or_write_more_clearly
Use three syllable or shorter words
Words longer than three syllables will increase the reading level of the consent. Avoid the temptation to use longer fancy words when short simple words will suffice. Examples: Visualize vs. sees; utilize vs. use; administer vs. give, discomfort vs. pain.
Avoid sentences longer than 20 words
Limit sentences to a single thought or idea. Avoid run-on sentences that contain too many commas, ands and ors. Use bulleted lists if needed.
Avoid paragraphs longer than ten sentences
Paragraphs that become too long increase the reading (grade) level of the consent and decrease the overall readability.
Use first or second person consistently
Throughout the form to refer to the subject ("I" or "you," but not both in the same consent form). Always refer to the investigators in the third person (i.e., "the investigators" or "the doctors," not "we"). If you are using "you" to refer to the subject rather than "I" as in the standard consent form, modify the wording of the required statements to consistently refer to the subject as "you."
Use factual statements
Use ("I have been informed...") rather than interpretive statements ("I understand...").
Use language and and set the tone in the consent form/information sheet that is understandable and does not intimidate or confuse participants.
Exculpatory language
Do not use exculpatory language through which the subject or 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.
Do not include excessive detail
While some detail is important, a balance between all inclusive information and minimal information must be attained. It is important not to minimize significant risks and procedures by having them “diluted” in a mass of insignificant material. Use concise language and descriptions and avoid repetition.
Use section headings as described in the sample format
Using bolded section headings that clearly identify new sections make it much easier for the reader to follow the consent and be clear about what they are reading. It also makes it easier to refer to specific sections for both the subject and investigative team.
Adequately describe the study
Make sure the project description adequately describes the study. Include 1-2 sentences of rationale for why the investigators think the study is a good idea.
Use white space effectively
White space can be used to break up large blocks of text. The white space makes it easier for the eyes to focus and find your place if distracted.
Use sufficiently large and readable fonts
Twelve point fonts such as Times New Roman, Century Schoolbook or any font that has the “little tails” on the ends of the character lines are easier to read in long documents than block type letters (e.g. Arial, Century Gothic, Helvetica). Use larger fonts (fourteen point or larger) if the potential subjects are elderly or likely to be sight impaired.
Use of Minors/Assent
Research involving minors requires documentation of child assent. Consent forms for research protocols involving subjects less than age 18 must contain documentation of children's assent. Review the Children's Assent procedures http://www.umbc.edu/research/ORPC/IRBspecialtopics.html#children) when developing assent documentation. A separate parental consent form is required for these participants providing parental permission to participate. Also, for minors under the age of 7 years, the assent form as well as the parental consent should be completed by the parent regarding the child.
Consent Forms Approved at Other Institutions
Many human research protocols conducted at UMBC involve collaboration with researchers from other institutions. At times, UMBC faculty members, masters and/or dissertation students are listed as a co-investigator on a collaborative project, with that institution’s IRB reviewing and approving the research protocol. External IRB institutional approval is accepted by the UMBC IRB; however, while the faculty member or student is listed on the consent documents as a co-investigator, no information is provided to potential participants of whom to contact at UMBC in the event of asking questions or addressing issues or problems. The purpose of this addition will provide complete and full information to participants about who is involved with the study and whom to contact with questions and concerns. Investigators are reminded to add a statement to the Whom to Contact section of the consent documents such as “In addition, this study has been reviewed and approved by the UMBC Institutional Review Board (IRB). A representative of that Board, from the Office for Research Protections and Compliance, is available to discuss the review process or my rights as a research participant. Contact information of the Office is (410) 455-2737 or compliance@umbc.edu”.
Resources:
PROTECTING HUMAN RESEARCH SUBJECTS: Institutional Review Board Guidebook," 1993, http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm
“Model Volunteer Consent Documents for the Indian Health Service” - 2nd Ed William L. Freeman, MD, MPH Chair, National IHS IRB, OCT 1, 2000
http://www.npaihb.org/images/epicenter_docs/irb/docs/consents2.pdf