Exempt Review Committee
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 six exemption categories allowable under the regulations.
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||
+Step 1: How to Prepare
- Read Marywood's IRB policies and procedures, which provide definitions and explain review types and requirements.
- Complete online training courses. All principal investigators, co-investigators, advisors and research assistants must complete two courses, one in human research and one in responsible conduct of research, at the CITI website. Registration instructions are shown at the bottom of our Mandatory Training page.
- Register on IRBNet at www.irbnet.org. All principal investigators, co-investigators and 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 sent a confirmation email message. Click the confirmation link in the email message to finalize registration.
- Decide the review type based on activities, population and risk. See decision charts, policies, or consult with your advisor or our office.
- Review our checklist of what to submit.
- Download and create supporting documents. IRB forms and templates are available on the IRB's instructions page (right menu). Exempt forms are found at the ERC's website (left menu - Forms button). Application forms must be completed in their entirety. DO NOT submit thesis or dissertation documents. DO NOT convert document types (e.g., if original is .doc format, do not convert to .pdf).
- Proofread and run a spellcheck in your word processing software. Check for errors prior to submission. Editorial services should not be sought from the board and slow down review.
- 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 advisor, or any co-investigators.
- Submit your package. The upload itself does not transmit 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.
+Step 3: How to Respond
- Monitor your e-mail account. The board will send notification when a decision letter has been uploaded to IRBNet (Project Overview button on left>Review Details link in middle of page>Board Documents table at the bottom).
- Create a package of requested modifications.
- Do not create a new project or ask for the initial package to be unlocked! The original package must remain locked to maintain a submission trail. Create a follow-up package within your existing project (i.e., IRBNet# 12345-1, 12345-2, etc.). Print and reivew our written IRBNet Instructions for exact steps to follow.
- Track your changes. See How to Track Changes for assistance with enabling tracking to show modifications or deletions.
- 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 approval 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. The expiration date and reporting requirements will be contained in the letter.
+Step 4: What to Report After Approval
- Six-month Status Report (IRB reviewed studies only): This is due six months after approval unless you close your study in less than six months. On the IRB forms page, find form at right.
- Closure Report (All studies): A closure report is due prior to the 1-year expiration date. Find the form to the right (for IRB) or the ERC's website (forms button). If activities will continue beyond the 1-year approval period, you must apply for renewal (continuing review), allowing ample time for review so there is no lapse. All research activities must cease as of the expiration date, unless the board approves a renewal. Projects may not be closed until both data collection and analysis have been completed. If analysis is ongoing, renewal is required. See our Continuing Review (Renewal) form on the right side of this page (IRB) or the ERC's website.
- Deviations, Violations, Unanticipated Problems or Serious Adverse Events (All studies): Any of these must be reported in a timely fashion. Please see our Mandatory Reporting policies and procedures, as well as the Deviation/Violation and Adverse Event/Unanticipated Problem forms on the right side of this page (for IRB). ERC forms may be found on the ERC's website.
- 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 right side of this page (for IRB) or the ERC's website.