Writing for an IRB Review

Writing for an IRB Review

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When writing protocols, consent forms, assent forms, etc., researchers often mistakenly use the same writing style in materials for both the IRB and participants. However, it is important to distinguish between writing for a general audience, versus an academic or scientific audience. Discipline-specific language or jargon might not be appropriate for use with your participants. For instance, when conducting research with children, you will want to ensure that the assent form includes age-appropriate language.

Additionally, when working in international settings, you want to strive for cultural competence and sensitivity, especially with individuals of culturally and linguistically diverse backgrounds. 

What is Cultural Competence?

Cultural competence describes a concerted effort to incorporate special knowledge about individuals and groups of people into standards, policies, procedures, and practices. An individual with cultural competence expresses appreciation of individuals, families, communities, and their unique backgrounds, and aims to increase the quality and effectiveness of communication, interactions, and engagement with others in order to produce better outcomes. Becoming culturally competent takes time, effort, and a commitment to understanding the moods, values, and motivations of individuals with culturally and linguistically diverse backgrounds. While cultural competence is a learned experience, researchers can consider the following goals along this path: 

  • Strive to learn and understand the moods, values, and motivations of others.
  • Incorporate cultural knowledge into daily practices.
  • Establish values, procedures, systems, and principles that recognize diversity.
  • Include accessibility in research practices, and provide accessibility options for individuals.
  • Demonstrate behaviors, attitudes, policies, and structures to value diversity, and enable others to work effectively in cross-cultural contexts.
  • Conduct regular self-assessments in order to ensure sensitivity to cultural and linguistic characteristics.
  • Recognize limitations, and acknowledge misunderstandings if they arise.
  • Aim to improve upon missteps, miscommunications, or digressions.
  • Adapt to diversity and the cultural contexts of communities.

To learn more about initiatives concerning community, diversity, civility, equity, and anti-discrimination, visit TC's Office for Diversity and Community Affairs.

IRB Submissions vs. Participant Materials

For an IRB protocol submission, you will want to include specific details about the study location and context that explain risks, benefits, measures, and justifications for the use and selection of human subjects. When writing your IRB protocol, you can use the TC Reviewer Questions as a guide for what IRB reviewers will look for in your protocol. The following is a table to help prepare you for the different kinds of writings you may need to submit with an IRB protocol.

IRB Protocol SubmissionParticipant Materials
Justification for selection of subjects Age-appropriate language
Detail probability of risk Contextually appropriate language
Create adequate provisions to handle adverse events Culturally appropriate language
Do not overstate the protection of confidentiality Avoid biased writing
Clarify data storage Clear and understandable writing
Explain eventual disposal of audio/video recordings Avoid scientific jargon
Address potential for coercion due to PI's position of authority Do not overstate benefits
  Detail length and intensity of involvement

Readability and Language of Participant Materials

Identify how “readable” your document is for your target population. There are two common tests that score readability and determine how difficult it is to understand your writing.

Microsoft Word can calculate your readability scores. After you have typed your text in Word for Windows devices, click the following: File menu > Options > Proofing tab. 

Under the “When correcting spelling and grammar in Word” heading, check the box labeled “Show readability statistics.” Then, exit the options menu and return to your document text. Next, run a standard spelling and grammar check and review your readability scores. The first score is the Flesch Reading Ease test, and the second is the Flesch-Kincaid Grade Level score. 

For Apple products, on open Microsoft Word and select "Preferences" in the menu. Find the folllowing: under "Authoring and Proofing Tools" > click "Spelling and Grammar" > under "Grammar" > click "Check grammar with spelling check box"> then select "Show readability statistics" checkbox" and close the box. On the "Tools" menu, click "Spelling & Grammar". Word will finish checking and will display the reading level of the document.

For further assistance, please visit this website.

If your document scores at least 60, it should be relatively easy to read, although you can aim for higher scores to improve readability. The grade-level score is equivalent to the reading level of students. An 8, for example, would mean that the material is appropriate for an 8th-grade reader. A score of 8 is typical for adults competent to consent.

You should translate all relevant participant materials into the preferred language of your participants. For examples of translated participant forms, please download the following documents:

No matter your population of interest, always make sure your writing is clear and concise. To learn more about the writing process, you can visit TC's Graduate Writing Center or review a Guide to Writing for the IRB.

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