Chapter 7 – IRB Application Preparation and Submission

7.A. Contact with the IRB
7.B. Preparation for IRB Review
7.C. Time Allowance for IRB Approval
7.D. Application Preparation Requirements
7.E. Template for IRB Research Proposals
7.F. Application for Full Review
7.G. Application for Expedited Review
7.H. Application for Exempt  Research Study Review
7.I. Method for Application Submission

Applications for IRB review and approval should be submitted using the IRB Application and Research Proposal template. Researchers need to follow the guidelines for preparing the template.

  1. Application preparation. Applications need to be clearly written, meet all IRB requirements (see "Application Preparation Requirements"), and contain all information necessary for the IRB to make a determination. Documents that will be given to participants are to be error-free. Applications that do not meet IRB requirements may not be accepted by the IRB.
  2. IRB decisions. Official IRB decisions are communicated in writing by letter; only communications from the IRB Committee Chair, the IRB Director, or the Director’s designee are considered official.
  3. Students' studies. All academic approval processes for a student's degree program (e.g., certification, successful dissertation proposal defense, final document/ thesis proposal approval) should be completed before the student submits an IRB application.
  4. Faculty sabbatical research. An approved sabbatical leave proposal needs to be attached to faculty IRB applications submitted for review of research involving human subjects conducted during sabbaticals.
  5. Employee research. Supervisors' approvals are needed for employees planning human subjects research projects.
  6. Internal assessment studies. The Associate Provost for Institutional Effectiveness may, in some cases, be required to approve internal assessment research studies before they are submitted to the IRB.

 

7.A. Contact with the IRB

  1. Contact the IRB Director. Researchers who have questions about their applications should contact the Director. They should not contact any voting IRB member other than the Director. Such contact might later cause the member to be recused from voting on approval of the application.
  2. Send email to the IRB Director. The preferred method for communication with the IRB Director is by email using irb@myunion.edu. Email allows the Director to document all research study-related communications.

7.B. Preparation for IRB Review

The researcher, in consultation with the IRB Director, will determine which type of review is needed—exempt, expedited, or full—based on potential risks to study participants.

Decision trees, available on the Links page, may help researchers determine which type of IRB review is indicated for their studies. Researchers may also consult with the IRB Director.

  1. Research training prerequisite. Successful completion of the basic modules of the CITI Course is a prerequisite for all researchers who submit applications to the IRB. A completion report is automatically generated and sent to the IRB Director via e-mail and must be on file with the Director before an application will be accepted for IRB review.
  2. Internet research. Researchers who plan to conduct studies involving the Internet are required to complete the Internet Research module.
  3. International research. Researchers who plan to conduct studies in a country other than the United States are required to complete the International Research module.
  4. Research involving children. Researchers who plan to conduct studies involving children are required to complete elective modules directly related to research involving children.

 

7.C. Time Allowance for IRB Approval

  1. Early submission is important. Submitting an application at least two months before the desired start date for the study is strongly recommended. The IRB meets once a month to conduct full reviews. A possible delay in the expected project start date is not considered sufficient reason to expedite IRB consideration of an application outside the normal meeting agenda.
  2. Official IRB approval is required before the study, including recruitment, may begin. Waiting until receiving IRB approval before making final arrangements to begin the study is recommended. IRB approval may be needed before researchers can make arrangements and/or obtain approval from individuals responsible for the physical location of their studies such as a school, a homeless shelter, or a treatment center.
  3. All location/ site permissions/ approvals are needed before the IRB will approve a research study. Ensuring that appropriate location officials, such as owners, administrators, and/or supervisors, have been contacted and have granted permission to conduct research in a specific location/ room/ building is an essential element of ethical research. Submit approval letters on letterhead from the appropriate officials or supervisors with the IRB application or submitted as soon as received.
  4. Studies must begin within six months after IRB approval. Studies are expected to begin within six months of the date that IRB approval is granted. Under special circumstances, the IRB will consider applications for which the start date is more than six months in the future. However, if a researcher makes any substantive changes to an approved study in the interval between IRB approval and the start date, the researcher must submit a Modifications Request form for approval of those changes before they are implemented. (See “Modifications to Previously Approved Research.”)

7.D. Application Preparation Requirements

Applications must meet all the following requirements to be accepted for consideration by the IRB:

  1. Successful completion of the CITI Course in the Protection of Human Research Subjects. Completing the basic modules of this course is a prerequisite for submitting an IRB application.
  2. Preparation of the IRB application and research proposal and study documents. The application and research proposal and study documents should be prepared according to the IRB Application and Research Proposal template and guidelines for preparation. All study documents/ attachments – consent forms, data collection instruments, etc. – should be attached.
  3. Academic approval. The research proposal must have received academic program approval through appropriate procedures; e.g., faculty advisor's written approval, successful dissertation proposal defense, final document/ thesis proposal approval.
  4. Faculty advisor or other approval. Written approval from a faculty advisor, dean, dissertation chair, or supervisor should be submitted with the IRB application and research proposal.
  5. Principal faculty investigators (PIs) for undergraduate and PsyD students. Faculty advisors serve as faculty PIs for undergraduate and PsyD students conducting research projects involving human subject interactions. Undergraduate and PsyD students serve as student PIs on these studies. All faculty advisors serve as research supervisors and resources for assistance for their students during human subjects research projects.
  6. Professionally prepared and error-free. The application should be written at a level appropriate for college or professional work – free of typographic or grammatic errors and submitted via e-mail attachment. Handwritten applications or other study documents will not be accepted.
  7. Concise proposal description. The descriptive section of the research proposal should be no more than 15 pages, double spaced, exclusive of attachments.
  8. Consistent wording throughout. Time estimates for participant involvement, descriptions of potential or possible risks and benefits, and other study details should be stated consistently throughout the proposal and in all study documents.
  9. Validity and reliability statistics. Researchers should provide validity and reliability results from prior use of an instrument developed by someone other than the researcher, including purchased instruments.
  10. Attachments. All applicable supporting documents, such as informed consent forms, interview questions, survey instruments, recruitment materials and media, scripts for e-mail and telephone recruitment contacts, etc., should be attached to the application and research proposal.
  11. Approval signatures. Approvals for conducting your research study at a specific location, such as a school, nonprofit agency, etc., should be submitted to the IRB on facility letterhead before the study may begin.
  12. Page headers/ footers. The researcher's name and study title should appear on every page. Page numbering should show the total number of pages (i.e., Page 3 of 15, Page 3 of 5, etc.).

7.E. Template for IRB Research Proposals

All applications submitted for IRB consideration must include a description of the proposed research following the IRB Application and Research Proposal template to ensure standard formatting. Follow the bold and italicized items on the template and incorporate information described in the guidelines for preparation. If any item is not applicable, it should not be ignored—enter N/A. Research proposals should be no longer than 15 pages, double-spaced, not including attachments.

7.F. Application for Full Review

An application for full review is a comprehensive description of a proposed research project. (See “Full Review.”) Research studies involving more than minimal risk to participants are reviewed by the full IRB committee. Researchers need to provide the following information for full reviews:

  1. A clear description of participants and any characteristics that would make them members of a vulnerable population and for whom the research activities present more than minimal risk.
  2. A detailed explanation of the data collection and analysis methods used for the study.
  3. A detailed description of procedures to minimize and/or mitigate the risk level for participants; e.g., use of pseudonyms or number codes for identity protection. If used, pseudonyms and number codes should be written onto the audio/ video tapes, used in transcribed interview notes, written onto completed surveys, and so on.
  4. A clear description of how the data and results will be used or publishedcourse report, dissertation, thesis, other final document, and beyond the course or degree program research requirements such as in professional journal articles or presentations.

7.G. Application for Expedited Review

  1. Complete the Expedited Review Checklist to verify that your study is eligible for expedited review and submit the completed checklist with the IRB application and research proposal containing the details of your research study.
  2. Focus on establishing eligibility for expedited review and documenting that the proposed study poses no more than minimal risk to the human subjects in your study. (See “Expedited Review” and “Criteria for Approval.”)

 

7.H. Application for Exempt Research Study Review

  1. Prepare and submit the Exempt Research Study Checklist  Application, making sure to check all appropriate descriptions of data and identity protection. Attach a summary of the proposed research that includes a description of participants (if any), data source(s), and the data collection and analysis method(s).
  2. Prepare and submit the IRB Notification of Theoretical/ Creative Research Projects form and a summary of the research that includes the data collection and analysis methods. (See “Exempt Review.”)

 

7.I. Method for Application Submission

Applications may be submitted only to the IRB Director. Email attachments are preferred.

  1. Undergraduate faculty advisors submit applications for and serve as principal investigators (PIs) for human subjects research projects conducted by their undergraduate students. PsyD faculty also serve as PIs for their students. All faculty advisors serve as research supervisors and resources for assistance during students' research projects.
  2. Graduate students and employees may submit applications directly to the IRB Director, after obtaining written approval from their faculty advisor, dean, dissertation chair, or supervisor.
  3. Electronically-submitted applications should be formatted in MSWord.
  4. Attachments available only on paper, such as externally developed and purchased questionnaires, may be scanned to PDF, or included in an e-mail to the IRB Director. Facility approval letters, such as letters from school principals on school or district letterhead, may be faxed to the IRB Director.

Electronically-submitted applications should be sent to: irb@myunion.edu. Hard-copy attachments may be mailed and should be clearly marked, “Attention: Institutional Review Board,” to ensure prompt delivery. IRB applications should NOT be sent to academic program offices.