Getting Started

Getting Started

1.	Complete the Human Subjects Training. The IRB tracks completions.
2.	Understand the IRB's Guidelines and Procedures.
3.	Studies being reviewed under Exempt and Expedited status may be submitted at any time. The turnaround time for: Exempt submissions are approximately 2-3 days; Expedited submissions are approximately 2 weeks; and Full Board must follow the deadlines for submission based on when the IRB meeting dates occur.
4.	All IRB submissions must be submitted through the IRBManager. User accounts, user guides, and registering for training sessions can be done here: http://www4.uwm.edu/usa/irb/researchers/irbmanager.cfm
5.	If your study involves other sites (e.g., recruiting from Milwaukee Public Schools, accessing medical records from Froedtert, using imaging equipment from Aurora, etc.), make sure you are aware of any additional IRB's or institutional policies beyond that of UWM's IRB.
6.	Plan ahead as there are multiple steps to the IRB process. The basic steps are outlined below:
		1.	Complete the required IRB form (e.g., IRBManager Protocol Form) and;
		2.	Attach all supporting documents (e.g., data collection instruments, consents, questionnaires, advertisements, etc.).
		3.	Only UWM faculty or staff may serve as the Principal Investigator (PI) on the study. If someone other than the PI submits through IRBManager, the PI listed on the study will receive a notice requiring them to log in and "submit" as the PI to the IRB.
		4.	The IRB office will review your submission for completeness and will either: (a) request revisions, or (b) forward the submission for IRB member(s) review.
		5.	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.
		6.	You may be required to revise your submission once more based on the IRB member's review.
		7.	You will Receive a letter of "Approved" or "Disapproved". Only after you have received a letter of approval can you begin your research study.
7.	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. The recommend submission due date is no later than three weeks before the date of expiration.
8.	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 UWM IRB office has also further clarified what is "research" and "human subjects."