Getting Started

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Before you begin a submission to the IRB, whether it is for a new study, a modification/ amendment, or continuing review to a currently approved study, make sure you have done the following:

1.	Complete the Human Subjects Training. The IRB tracks completions. View the presentations on UWM's IRB Overview* and IRB Writing* for additional training. *Not required.
2.	Understand the IRB's Guidelines and Procedures.
3.	Studies being reviewed under Exempt and Expedited status may be submitted at any time and should expect approximately 2 weeks to complete the review. Studies being reviewed under Full Board status must follow the deadlines for submission based on when the IRB meeting dates occur.
4.	Plan ahead as there are multiple steps to the IRB process. The basic steps are outlined below:
		1.	Complete the IRB forms (e.g., New Study Submission Form, Protocol Summary Form, Face Page, etc.).
		2.	Attach all supporting documents (e.g., consents, questionnaires, advertisements, etc.).
		3.	Obtain appropriate signatures before submitting to the IRB (i.e., faculty advisor if you are a student, department/decentral reviewer for Exempt studies).
		4.	Submit the appropriate number of copies (collated) to the IRB. Submissions should include all materials, i.e., consents, questionnaires, scripts, recruitment materials, etc. Exempt: (1) Original copy + (2) Copies = 3 total Expedited: (1) Original copy + (2) Copies = 3 total Full Board: (1) Original copy + (15) Copies = 16 total
		5.	The IRB office will assign an IRB# and enter your study information into a database. The IRB office will also review your submission for completeness and will either, (1) request revisions, or (2) forward the submission to an IRB member(s) for review.
		6.	Submissions requiring Full Board review will be placed on the next scheduled meeting based on submission deadlines. Exempt and Expedited studies are not reviewed by the Full Board but by designated IRB reviewers.
		7.	You may be required to revise your submission once more based on the IRB member's review.
		8.	Submit your revisions to the IRB office. View the FAQ on submitting revisions for more instructions.
		9.	Receiving a letter of "Approved" or "Disapproved". Only after you have received a letter of approval can you begin your research study.
5.	If your study currently has IRB approval, keep track of the expiration date of IRB approval. Your study must be reviewed by the IRB before this date so allow adequate time for submission, review, and approval.
6.	The Office for Human Research Protections (OHRP) provides a decision chart guide for, investigators, helping them decide if a proposed study is considered "research involving human subjects" that must be reviewed by an IRB. The charts address decisions on the following: * whether an activity is research that must be reviewed by an IRB * whether the review may be performed by expedited procedures, and * whether informed consent or its documentation may be waived.