Avoid delays by understanding the IRB process from protocol submission to review, revision, and approval.
All research involving human participants conducted by Cornell faculty, staff, and students must be reviewed in advance by the Cornell IRB. Read on for more information about the IRB submission process, including links to important forms and templates.
Not Human Participant Research
Not all interactions with humans or data collected from humans meets the definition of "human participant research" that is subject to the federal regulations.
If your project is considered research under IRB rules, you must submit an application and receive either confirmation of exemption, or a letter of approval from the IRB before research can begin. Unsure about whether your project is regulated human participant research? Use our decision tree, contact a member of the IRB staff, or review our guidance document, Determining Whether a Research Activity Needs IRB Review.
Get your Submission Right the First Time
The single most significant cause of delays in protocol approval is submitting an incomplete application to the IRB. We urge you to take the time to send in a complete application the very first time, use the consent templates, check out the FAQs and guidance documents, and complete required training before you submit your application.
Common omissions that cause delay include:
- Including research personnel who have not completed or renewed required IRB training
- For students, sending in an application without a faculty advisor's review and approval
- Not including a consent document or script, or failing to submit survey instruments or interview guides when these procedures will be used in the research
In addition to missing items or information, these common mistakes can delay the IRB approval:
- Leaving questions blank on the application form
- An insufficient consent document – Consent scripts/documents that are missing fundamental elements of consent will result in the need to revise and resubmit
- Using unclear, academic or “jargon”-laden language in the application or consent document, overstating potential benefits to participants (it is fine if there is no benefit to participants!), insufficient attention to issues of confidentiality and data protection, and missing or out of date contact information for the IRB.
What Happens After I Submit My Protocol?
The process your application takes from here depends upon the completeness and quality of your submission (see above) and the level of review that the IRB needs to apply, as governed by the regulations and Cornell IRB policy:
- Exempt means that your protocol is regulated research, but that it poses no real risks to participants and fits into certain categories of research that can be reviewed and approved by a member of the IRB office staff. The term "exempt", which comes from the federal regulations, is confusing because does NOT mean that your study is ‘exempt’ from any review by the IRB office. Rather, an exemption review is a more minimal one, and can done by staff as opposed to a voting member of the IRB committee.
- Expedited means that your protocol poses no more than minimal risk to participants, but must be reviewed and approved by a voting member of the IRB committee according to the federal regulations. "Expedited" does NOT mean that you should expect the IRB to process your application on an accelerated schedule.
- Full Board means that your protocol poses more than minimal risk to participants and must therefore be reviewed by the full IRB committee at one of its monthly meetings.
How Long Will it Take to Receive IRB Approval?
It depends. How long you will need to wait for approval depends on a number of factors outside your control-- including what the federal regulations require given the type of research you want to do, and the volume of other IRB submissions making their way through the IRB process at the same time -- and many that are within your control -- how complete and clear your application is, and how thoughtfully and quickly you respond to any feedback or requests for edits that you receive from the IRB.
If you submit a complete application to the IRB, you can generally expect the following turnaround times:
- If your project is exempt: 2-3 weeks
- If your project receives expedited review: 3-4 weeks for initial approval; 1-2 weeks for an amendment
- If your project needs full board review: a minimum of 4-6 weeks (for initial, continuing, or amendment approval)
If your application is incomplete, please expect to add 5-7 days to the ranges listed above.
NOTE: During heavy protocol submission periods, reviews will take longer.
Prepare Your Protocol for Submission
To ensure that your submission is reviewed in a timely manner, please send your application and all supplemental documents as email attachments to email@example.com.
In drafting your consent, use our templates. The IRB has developed consent, assent, and debriefing templates to help guide preparation of your informed consent materials. These should be customized for your particular research project.
- First, complete the online IRB training and ensure all research personnel on your project have done so as well. The IRB will not be able to approve an expedited or full board protocol until all persons named on the IRB protocol are current in their IRB training.
- Download the relevant application form, based on the action you are seeking from the IRB:
- New Protocol Application: Use this form for all new research projects involving human participants, regardless of the anticipated level of IRB review (i.e., exempt, expedited, or full board). There are separate versions for PC and Mac computer users. This Word-based form has instructions on page 1 that all PIs should read.
- Amendment Application: Use this form to request changes to an existing approved IRB protocol. Note that if your protocol received an exemption, the form is not required-- you can request an amendment to an exempt protocol by sending an email to firstname.lastname@example.org, identifying the protocol (give protocol number and title, at a minimum), describing the proposed changes, and attaching any documents that need to be changed, such as consent forms.
- Renewal Application: Use this form to request continuing approval of an existing approved protocol. Note that annual/triennial renewal is no longer required for expedited studies following recent changes to IRB regulations. Renewals are still required for all full board protocols. Rarely, a continuing review may also be required by certain sponsors of expedited studies or, in the case of collaborative research, by one of our partner institutions. This form is a dynamic, interactive PDF document. When using it you should save a copy for your records before submitting it to the IRB. You may need to update to the latest version of Adobe Acrobat.
- Program Development Approval: Use this form when your study procedures or materials are not fully developed, but a sponsor is requesting an IRB protocol number for the project. This is an administrative approval granted by IRB staff for a very limited purpose-- usually to enable the release of funds. This type of administrative approval does not permit any interaction with human subjects, including recruiting. Once the project and study instruments are developed and finalized, you will need to submit a new application for IRB review and approval. Contact the IRB staff to determine whether a Program Development approval may be appropriate.
- Institutional Authorization Agreement: This is the form to use when you are involved in collaborative or multi-site research and wish to have one institution's IRB review the involvement of 2 or more institution's researchers in the project, in order to avoid duplicate review. Institutional Authorization Agreements (also called AAs or reliance agreements) are negotiated by the IRB staff from each participating institution on a case-by-case basis. Cornell will consider entering into an AA when doing so makes sense from an administrative and research perspective, however we will not enter into an AA when a proposed study is exempt.
- Project Closure: Use this form to document completion of a research project and close the protocol in the IRB system.
- Fill out all relevant sections of the application and ensure information is complete and accurate.
- Prepare your study materials, including:
- informed consent/assent documents (form or oral consent script)
- debriefing documents (for studies involving incomplete consent disclosure or deception)
- data collection instruments (surveys, interviews, focus groups and/or interview guides)
- study procedures (narrative description of the steps involved in an experiment)
- standard operating procedures (related to biospecimen collection)
- letter/email of support or permission (if applicable)
- recruitment materials (oral script/flyer/social media content, etc.)
- faculty supervisor attestation
- any other study-related documents
- Submit your application and all study materials as attachments by email to: email@example.com
What Happens Next?
After the IRB office receives your submission...
- Protocol data must be manually entered into our system. This could take a day or more, depending on the volume of IRB submissions. Expect to receive an automated email notification the day after the protocol is entered into the system. This will include a protocol ID number. Please reference this protocol ID number when communicating with the IRB office.
- IRB staff will ensure that the submission is complete and conduct an initial review to:
- verify that the research activity constitutes human participant research
- verify that training is complete (for expedited and full board studies)
- verify completeness of study materials and/or coordinate with the PI to achieve completion
- analyze the submission to determine the review type (exempt, expedited, or full board)
- determine whether the study is a clinical trial
- Based on their administrative review, IRB staff will either approve the study as "exempt" or send the submission to a committee member for their review.
- If IRB staff or the designated committee member(s) determine that the protocol requires revision, IRB staff will email the PI with specific feedback and requests.
- Once all outstanding concerns have been addressed, IRB staff will issue a formal approval or exemption to the PI by email.
Maintaining Compliance After Approval
Once a protocol has been approved, the PI is charged with conducting the research consistent with the approved protocol, and otherwise maintaining compliance. This requires that:
- Any changes to procedures, documents, research personnel, etc., must be approved in advance through the amendment process. Download an amendment request form.
- For full board protocols only, annual renewal requests must be filed more than a month before the expiration date, to ensure that there is no interruption of IRB approval. Download a renewal request form.
- Ensure the safety and confidentiality of your research data, as described in your approved protocol.
- Promptly report unexpected events to the IRB (including complaints, breaches of confidentiality, loss of data). Download an Unexpected Event Report Form.
- Ensure that all members of your research team renew their IRB training, when needed.