Submission Process and Timeline
Steps in Choosing the Correct IRB Application Form
Prior to completing and submitting an IRB application, please:
Step 1:
Read and understand the updated Marymount IRB Policy & Procedures Manual
Step 2:
Complete the required CITI Training and obtain a completion certificate
Step 3:
Review the regulations and policies to determine if your research qualifies as human subject research. If you plan to disseminate the quality improvement (QI) project results externally (e.g., conference presentation, publication, thesis/dissertation, poster, or other public venues), you must obtain an IRB determination letter before beginning research activity. If you have questions, contact the IRB.
- If research, determine the category of review required: Exempt, Expedited, or Full Board. Please see the IRB Manual_2025.08.15, section 5.5, and OHRP for more detailed descriptions of each risk level.
Brief Overview of Categories of IRB Protocols
Exempt Protocols
Overview: Research that qualifies for an exempt review is considered to pose minimal risk to participants. This level is used for studies involving minimal risk and which fall into specific categories outlined by federal regulations.
Examples: Research involving educational tests, surveys, interviews, or observations where data is collected ; studies involving public behavior where individuals cannot be identified.
Process: Although labeled “exempt,” these studies still require IRB review to confirm their exemption status. You cannot self-declare a protocol as ‘exempt.’ Exempt protocols are typically reviewed by one members of the IRB committee. They do not require annual reviews.
Timeline: Exempt protocols can be submitted at any time. Investigators should anticipate up to 15 working days after submission to receive initial feedback. Recognize that your application may require modifications/clarifications before it can be approved. It may take up to 5 business days to respond to each re-submission.
Expedited Protocols
Overview: Expedited review is for research that poses no more than minimal risk to participants but involves procedures that are not exempt,falling into one of the expedited categories authorized by 46 CFR 46 and 21 CFR 56 (DHHS regulations). See the link to the regulation for details.
Examples: Studies involving non-invasive procedures, collection of blood samples from adults in small amounts, or research on behavior that does not involve sensitive topics.
Process: An IRB member or a small group of reviewers evaluates the research protocol. The process is quicker and less comprehensive than a full board review but still involves thorough evaluation. This level of review is used for studies the IRB can evaluate the risks and benefits without a full board review.
Timeline: Expedited protocols can be submitted at any time. Investigators should anticipate up to 15 working days after submission to receive initial feedback. Recognize that your application may require modifications/clarifications before it can be approved. It may take up to 15 business days to respond to each re-submission.
Full Board Review Protocols
Overview: Full board review is required for research that involves more than minimal risk to participants or does not fit into the other categories. This level is used for studies with potential for significant impact on participants’ rights and welfare.
Examples: Clinical trials involving high-risk procedures, research on sensitive topics such as mental health or substance abuse, or studies involving vulnerable populations like prisoners.
Process: The entire IRB committee reviews the protocol during a scheduled meeting. This review is detailed and includes a comprehensive assessment of risks, benefits, and ethical considerations.
Timeline: Protocols requiring full board review must be submitted two weeks before a scheduled IRB committee meeting as all IRB members must review the protocol and participate in discussion about approval. Given the complexity of full board reviews, it is not unusual for the initial review to result in requests for additional information before approval can be provided. Based on the extent of the modifications/clarifications required, the re-submission may be reviewed by a subset of the committee or may require full-board review which could require waiting until the next IRB committee meeting.
The IRB Committee Meetings for 2024-2025
Step 4:
For doctoral student-led research only, the student and faculty mentor must read, sign, and upload the Student PI and Faculty Mentor Agreement Form to the IRB application (more information below about the student-led research).
Step 5:
Complete the IRB application in Sitero Mentor by writing a clear and detailed description of the purpose of the research and research procedures. Providing the IRB reviewers with a clear understanding of your plan, data management, and data security plan will ensure participants’ safety, confidentiality, and privacy are protected, and those involved in the research understand the experience and expectations of the study. Be sure to include all related material, including instruments and consent forms, in the IRB application.
Applications with significant writing deficiencies (unclear purpose, poor alignment, significant grammatical errors, incomplete sections) will be returned to the Principal Investigator (PI) until these issues are addressed. Please ensure your submissions meet professional standards.
