Submit or Manage Your IRB Protocol

Submission requirements for IRB protocol approval

UPDATED October 10, 2022

TRAINING UPDATE: Effective October 1, 2022, all Cornell study personnel involved in Exempt research protocols are now required to complete CITI training in human participant research ethics. This is the same training required of study personnel named on Expedited and Full Board IRB protocols. See details here. For more information about Cornell IRB training requirements, visit the IRB Training webpage.

COVID-19: Cornell IRB COVID-19 guidance and FAQs have been updated (Sept. 7, 2022). Face masks are still required for in-person, on-campus human participant research activities similar to clinical exams or procedures. Review the revised guidance in its entirety here.

IRB PROTOCOLS: As of February 1, 2022, we are using the RASS-IRB system for new protocol submissions, continuing reviews, amendments, and adverse event and protocol deviation reporting. See more details about the transition to RASS-IRB here. Find how-to documentation and recordings of Zoom training sessions on the RASS Guide Site. For help or feedback about the system, contact the RASS team at: rass@research.cornell.edu. For content-related questions about your IRB protocol or other human participant research topics, email irbhp@cornell.edu per usual. You can also schedule a Zoom meeting with members of the RASS or IRB teams via Microsoft Bookings.

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, or determined to be exempt from IRB review by IRB staff. Read on for more information about the IRB submission process, including links to important forms and templates.

Not Human Participant Research

Persistent Content

Not all interactions with humans or data collected from humans meets the definition of "human participant research" that is subject to the federal regulations.

Expandable Content

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

Persistent Content

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.

Expandable Content

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 support. (Note: in the new IRB system, RASS-IRB, upon the submission of your protocol, your advisor will receive an email prompting them to provide their attestation)
  • Not including a needed 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 relevant 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?

Persistent Content

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:

Expandable Content
  • 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?

Persistent Content

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.

 

Expandable Content

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 (rolling review)
  • If your project receives expedited review: 3-4 weeks for initial approval; 1-2 weeks for an amendment (rolling review)
  • If your project needs full board review: a minimum of 4-6 weeks (for initial, continuing, or amendment approval at a convened committee meeting). See the IRB Committee page for meeting dates and information about submission deadlines.

If your application is incomplete, please expect to add 5-7 days to the ranges listed above.

NOTE: During heavy protocol submission periods (e.g., mid-semester), reviews will take longer.

Prepare Your Protocol for Submission

Persistent Content

To ensure that your submission is reviewed in a timely manner, please submit a complete application and all supplemental documents via RASS-IRB. You can find help documentation for how to use the system on the RASS Guide Site.

Expandable Content
  1. 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.
  2. As of February 1, 2022, IRB protocol applications and revisions are submitted through RASS-IRB; all paper forms have been retired. You can do the following within RASS-IRB:
    • Create a new protocol for initial approval.
    • Request an amendment to make changes to your protocol. Note that if your protocol received an exemption determination prior to the implementation of RASS-IRB, you can continue to submit requests to amend that exempt protocol by sending an email to irbhp@cornell.edu, identifying the protocol (protocol number, title, PI), describing the proposed changes, and attaching any documents that need to be changed, such as consent forms. Otherwise, all other amendment requests must be submitted through RASS-IRB.
    • Request continuing review. Annual continuing review (sometimes called renewal) is generally required for protocols that received Full Board (Convened Committee) initial review. Rarely, a continuing review may also be required for protocols that received Expedited review (e.g., upon a sponsor's request). You can amend your protocol and submit a continuing review at the same time.
    • Prescreening (Program Development) Approval: If your study procedures or materials are not fully developed, but a sponsor is requesting proof of IRB approval for your project, the IRB office can grant an administrative Prescreening (sometimes called Program Development) approval for a very limited purpose (usually to enable the release of grant funds). This type of administrative approval does not permit any interaction with human participants, including recruiting. Once the project and study instruments are developed and finalized, you must amend the protocol in RASS-IRB to receive a complete IRB review and approval (or determination of exemption). Contact the IRB office to determine whether this type of review may be appropriate for your circumstances.
    • IRB Reliance (or Authorization) Agreement: If you are involved in collaborative or multi-site research and want (or need) to have one institution's IRB review the entire research study, Cornell will consider entering into an IRB Reliance Agreement (sometimes called an IRB Authorization Agreement). In this case, one IRB is considered the IRB of Record or single IRB (sIRB). These agreements are negotiated by the IRB staff from each participating institution on a case-by-case basis. Cornell will consider entering into a Reliance Agreement when doing so makes sense from an administrative and research perspective, or is required by a sponsor; however, Cornell will not enter into a Reliance Agreement when the research is exempt from IRB review. You can request the use of a Reliance Agreement in RASS-IRB.
    • Protocol Closure: To document completion of your research project and close the protocol, submit a closure request in RASS-IRB (one of the options at the top of the protocol record).
  3. Fill out all relevant sections of the application and ensure information is complete and accurate.
  4. Prepare your study materials in advance, including:
    • informed consent/assent documents (form or oral consent script). Note: Use our templates.
    • 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 or device use)
    • letter/email of support or permission (if applicable)
    • recruitment materials (oral script/flyer/social media content, etc.)
    • any other study-related documents
  5. Submit your application and all study materials through RASS-IRB.

What Happens Next?

Persistent Content

After the IRB office receives your submission...

Expandable Content
  1. Protocol submissions will be assigned to an IRB Administrator for initial review
  2. 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 obtain missing or inadequate materials
    • analyze the submission to determine the review type (exempt, expedited, full board, prescreening, or reliance agreement)
    • determine whether the study is a clinical trial
  3. Based on their administrative review, IRB staff will either issue an administrative determination (exempt, prescreening, reliance), or send the submission to a committee member for their review.
  4. If IRB staff or the designated committee member(s) determine that the protocol requires revision, IRB staff will contact the PI via RASS-IRB (and email) with specific feedback and requests.
  5. Once all outstanding concerns have been addressed, IRB staff will issue a formal approval or exemption notice to the PI by email.

Maintaining Compliance After Approval

Persistent Content

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:

Expandable Content
  • Any changes to procedures, documents, research personnel, etc., must be approved in advance through the amendment process in RASS-IRB.
  • For full board protocols only, annual renewal requests must be filed six weeks before the expiration date, to ensure that there is no interruption of IRB approval. Request continuing approval in RASS-IRB.
  • Ensure the safety and confidentiality of your research data, as described in your approved protocol.
  • Promptly report unexpected events (including complaints or breaches of confidentiality) and protocol deviations in RASS-IRB.
  • Ensure that all members of your research team renew their IRB training, when needed.

You can check the status and other key information about your protocols information about your protocols in RASS-IRB.