Exempt Review Committee (ERC)
ANNOUNCEMENT: Revised Common Rule - Policy and Forms Changes
Exempt is a classification of human research review. While projects qualifying for exemption are not subject to federal human research regulations, they are subject to state and local laws, institutional policies, and ethical considerations. Thus, review must be performed to ensure that the rights and welfare of human subjects are protected. Review is is conducted by trained individuals, the Exempt Review Committee (ERC), rather than the IRB. The ERC makes the final determination about exemption eligibility.
ERC review must be sought, and approval achieved, prior to initiation of any research activities.
There are eight exemption categories available under the regulations. The first six are allowed by our ERC.
All materials must be sent electronically through our online submission system at www.irbnet.org. If your project is submitted to the wrong board, we will withdraw and forward it for you.
|Review Type||Submit To||
The following steps are also available in PDF format.
+Step 1: How to Prepare
- Read Marywood's IRB policies and procedures, which explain review types, requirements and definitions.
- Complete a human research training course online. All principal investigators, co-investigators, research advisors and research assistants must complete the course (Social/Behavioral or Biomedical group, based on discipline or activities) at the CITI website. Additional courses may be required for some research. Find registration instructions at the bottom of our Mandatory Training page.
- Register on IRBNet at www.irbnet.org. All principal investigators, co-investigators and research advisors must register. Registration is optional for research assistants. Click on the New User Registration link at the top right of IRBNet's home page and enter requested information. When asked for institutional affiliation, search for and select Marywood University. After clicking the register button, you will be emailed a confirmation message. Click the confirmation link in the email message to finalize registration.
- Decide the review type based on activities, population and risk. See our policies, or consult with your research advisor or our office. OHRP offers decision charts, but has not yet updated them to match the Revised Common Rule.
- Review our checklist of what to submit.
- Download forms and templates to create your documents. Find IRB forms and templates on the IRB's instructions and forms page (right menu), or Exempt forms at the ERC's forms website. DO NOT submit class, theses or dissertation proposals. DO NOT convert document types (e.g., if original is .DOC format, do not convert to .PDF).
- Proofread and run a spell check in your word processing software. Check for errors prior to submission. Editorial services should not be sought from the board and slow down review for everyone.
- Review the meeting schedule and submission deadlines. Follow deadlines and allow adequate review time. Student investigators must apply during the semester prior to the one in which they plan to graduate, unless taking a two semester research course (e.g., SSW 701/702, PSYCH 421/422) with a built-in deadline of February 1st.
+Step 2: How to Submit at IRBNet
- Carefully review our step-by-step IRBNet Instructions or view our tutorial videos. Contact email@example.com for the video site's password. Create your new project package and upload all necessary materials.
- Sign your package. E-signatures are required of the Principal Investigator (PI), the research advisor, or any co-investigators.
- Submit your package. The upload to IRBNet itself does not transmit it to a board. Click the submit button in IRBNet's left menu and follow the screens for it to be officially transmitted. You'll arrive at a confirmation page once submitted, and the package's status will change from Work in Progress to Pending Review.
+Step 3: How to Respond
- Monitor your e-mail account. IRBNet will email you when a decision letter has been uploaded to IRBNet (Reviews button on left>Board Documents table at the bottom). Office staff will also send instructions.
- Create a package of requested modifications.
- Track your changes. See How to Track Changes for assistance with enabling tracking to show insertions or deletions.
- Do not create a new project or ask for the initial package to be unlocked! The original package must remain locked to maintain a history. Create a follow-up package within your existing project (i.e., IRBNet# 12345-1, 12345-2, etc.). Print and review our written IRBNet Instructions for exact steps to follow.
- Upload your documents.
- Sign your package: The Principal Investigator must e-sign every package.
- Submit your package. The upload itself does not send it to a board. Click the submit button in IRBNet's left menu and follow prompts for it to be officially transmitted. You'll arrive at a confirmation page.
- Monitor your e-mail account. You'll receive an email, prompting you to log in at IRBNet to retrieve your approval letter and stamped materials. Stamped versions of materials must be used unless otherwise noted in your letter. An expiration date or check-in report due date and reporting requirements will be indicated in the letter.
+Step 4: What to Report After Approval
- Closure Report Form, Continuing Review Application or Check-In Form: A closure report form must be submitted when you complete your research or separate from MU, unless others from MU will still be engaged in activities. If activities will continue beyond one year, you must submit either a check-in report form annually (ERC and most Expedited IRB approved after 1/21/19) or apply for continuing review (annual renewal), budgeting ample time so that there is no lapse. All research activities must cease as of any expiration dates, until the board approves a renewal. Projects may not be closed until both data collection and analysis have been completed, unless all data are completely de-identified. See the appropriate forms on the right side of the IRB's instructions and forms page or the ERC's forms page.
- Deviations, Unanticipated Problems or Serious Adverse Events (All studies): Report these immediately. Please see our Mandatory Reporting policies and procedures, as well as the Deviation and Adverse Event/Unanticipated Problem forms on the IRB's instructions and forms page or the ERC's forms page.
- Revisions to Approved Research (All studies): Researcher initiated changes after approval, however minor, must be reviewed and approved prior to implementation. See our Revisions to IRB Approved Research Request form on the IRB's instructions and forms page or the ERC's forms page.