Step 2: Document and Proposal Preparation

Before (or concurrently with) completing the IRB Proposal Form, researchers should develop supporting documents for their study. Some supporting documents may be previously developed as part of a funding proposal or a research methods class, and these may be attached later to the IRB Proposal Form. Examples of supporting documents include:

  • An Informed Consent Document (almost all IRB proposals will include this)
  • Surveys, either developed by the researcher or adapted/used from others
  • Interview/focus group protocols or lists of questions
  • Observation or fieldnote protocols, templates, or descriptions
  • Descriptions of other materials to which participants will be exposed (e.g., video or audio files or links; descriptions of exercises and exercise equipment participants will do/use)
  • Site letters

Note: Your study may or may not use some of these documents or elements.


STUDENTS & FACULTY SUPERVISORS: Click here for an IRB Proposal Form Worksheet! This worksheet can be used to prepare (and share) responses for the IRB Proposal Form prior to submission.

Writing an Informed Consent Document

An Informed Consent form is a document you produce or provide as a researcher that provides a potential research subject with information about your study. Using this form, the participant should be able to determine if they should participate in your study, based on the risks and benefits they may incur in doing so. An Informed Consent form will possess several elements:

1. Informed Consent forms identify the purpose of the study.

2. Informed Consent forms briefly explain that participants can consent to the study, and they can leave the study at any time for any reason.

3. Informed Consent forms outline whether their identities and data will be confidential or anonymous.

4. Informed Consent forms overview the procedures of the study (i.e., what participants will be asked to do). Your procedures will always identify procedures like audio/video recording, if used in your study.

5. Informed Consent forms identify the study's duration or time commitment.

6. Informed Consent forms identify the potential risks of participation, or the negative consequences that arise from participating in the study.

7. Informed Consent forms identify the potential benefits of participation for the participant and for others.

8. Informed Consent forms identify any compensation that is used to help recruit participants.

9. In most cases, Informed Consent forms will have a place for participants to sign to indicate their consent (or for parents to consent and children to assent).

Annotated Informed Consent Document Example

Hover your mouse over the document below to scroll up/down and left/right if the entire document does not appear in your browser. Alternatively, you can click "Sign In" to access this document directly in Google Docs.

Informed Consent Document Templates

To use these templates, you must be logged in to a Google account. Go to "File" and choose "Make a copy" to create your own form that you can edit.

Consent Template: Single Researcher

Consent Template: Student PI & Faculty Supervisor

Consent Template - Education Grad Students: Student PI & Faculty Supervisor

Opt-Out Template - Education Grad Students: Student PI & Faculty Supervisor

Note: Opt-Out Forms cannot be used in situations where explicit consent is required (e.g., analyzing student grades; audio/video recording research participants).

Developing Other Supporting Documents

Aside from an Informed Consent Document, supporting documents will vary from study to study. Your academic discipline and research methodology, among other considerations, will dictate the need, form, and/or content of these documents.

In reviewing these documents as part of a research, the IRB is examining the following:

  • Do the supporting documents help the researcher to address the research question(s) and/or objective(s) of the study?
  • Are the supporting documents consistent with the purpose and procedures of the study, as outlined in the Informed Consent document?
  • Do the supporting documents help the IRB to assess the potential benefits and risks of the study?

As you develop your documents and subsequently/concurrently your IRB Proposal Form, note that the best IRB proposals (i.e., the ones that are most efficiently reviewed and approved) typically do the following:

  • Separate data collection procedures into individual documents, when possible (e.g., a list of interview questions is attached to the IRB Proposal Form as a document, rather than embedded in the IRB Proposal Form)
  • Provide fully developed and "field ready" instruments for use by researchers and by/with research participants

 Example Supporting Documents

Focus Group Questions

Site Letters

The IRB can approve research conducted on campus, as well as certain forms of research conducted in public spaces, but it cannot approve research in any setting on its own. In situations where researchers want to do research off-campus or in non-public spaces, a letter of permission--or "site letter"--may be required. At SUU, the most common instance where site letters are required is K-12 school-based research.

Site letters will have the following elements to them:

  • The individual writing them will identify themselves and that they have the authority to grant permission for research to be conducted at the site
  • The name of the SUU researcher and the title of their study will ideally be referenced in the letter

Site letters can be submitted by the researcher themselves to the IRB, or directly to the IRB by the individual writing them.

Click here to access a site letter/letter of permission template that you can use.

Important Notes for Education Graduate Student Researchers

Site letters are almost always required for research in K-12 schools. However, each school district's process for approving research is different. Researchers who are working and researching in schools must inquire with their school and district as to the required policy.

Education graduate student researchers should note the following:

  • In some districts, approval will be granted by both the district and an administrator in the school where research is being conducted; in others, a building administrator like the principal may be the only individual whose permission is required
  • Some districts require the SUU IRB to approve the researcher's study first before the district/school will grant approval; when researchers discover this is the case for their district/school, they should communicate this to the SUU IRB