Helpful hints on navigating the IRB review process:
Click below for guidance before, during, and after IRB review.
- Use the Investigator Manual and templates to ensure that you provide the IRB with the necessary information for review. Each section of the protocol template will have instructions and ideas on what information to include for IRB review. Clearly reference any supporting materials or appendices in your protocol.
- Do not assume the IRB reviewer(s) can "fill in the blanks". Write your research protocol for someone who knows nothing about your study or discipline. Don't use legalese and technical terms that would make it difficult for anyone but the researchers to understand. Please convey your research plan with clarity and detail. Your research plan should read like a recipe that anyone can follow. Pay particular attention to those activities within your study that involve participants and/or identifiable data. Remember, the IRB members are tasked with protecting the rights and welfare of participants. If the reviewer does not clearly understand your research process or procedures, he/she will have to request revisions or clarifications, delaying the process.
- Review the IRB checklists and worksheets in the For Reviewers. These documents list the questions reviewers ask themselves when evaluating a submission.
- Include CITI Training certificates of completion for your research team - or - ensure that the HSPP staff can confirm that this requirement has been completed for ALL investigators involved with human subjects. In IRBNet, the Principal Investigator can attached a CITI training report to his/her profile. For MSU Denver researchers, the HSPP staff can confirm completion of CITI training online as part of their triage process. However, we cannot access training from individuals who are not affiliated with MSU Denver. If you are not sure specifically who on your research team needs to complete the CITI Program training, please contact the HSPP. Be advised that submission materials are not considered complete and are not assigned for IRB review until all study investigators have completed this required training.
- Focus on your consent process and form. The IRB reviewer(s) has to consider everything that participants will see and hear in a research study - in recruitment, consent, research procedures, and debriefing or follow-up. Researchers need to clearly demonstrate to the IRB that participants are informed about the study and provide voluntary permission to participate. The consent form that you use in your study should clearly explain to individuals the details of the research, so they can decided whether or not they want to participate. The IRB can only approve consent forms that contain the elements required by federal regulations, or the researchers must provide appropriate justification for alteration of consent or conducting research without consent. While you may use any appropriate format for your consent form, please review our consent templates (please refer to HRP 502 - 507) for guidance and correct language for contacting the HSPP/IRB.
- Keep your submission materials consistent. Before submitting all your documents to the HSPP through IRBNet, please review the materials for clarity and consistency. One of the most common IRB requests for revisions is to reconcile discrepancies between the protocol and the consent form. In the IRB review, your protocol is considered the source document for all the supporting materials. The IRB reviewer cannot approve any recruitment materials, consent forms, and/or study instruments that are inconsistent with the information in your protocol.
- If you don’t know, ask! The HSPP staff members are available for consultations on submissions for IRB review and can provide recommendations on what to to include in your application, offer guidance on what the IRB review entails, and troubleshoot any potential issues before and during the review process. Contact the HSPP firstname.lastname@example.org
- The HSPP will keep you informed of any requests or determinations from the IRB reviewer(s) through IRBNet. If you receive a request for more information, clarification, and/or revisions and you are not sure how to respond, please contact the HSPP for assistance. The IRB review process is not a test; rather it is an oversight process to ensure that participants are duly protected in the research. If the IRB reviewer cannot grant approval for your study, he/she will inform you in their determination letter as to what is needed to gain approval. Please collaborate with the HSPP staff and IRB members, so that you (the researchers) and the institution meet the standards and requirements for the ethical conduct of human subjects research.
- Be responsive and communicate with the HSPP to facilitate the review process. IRB requests for clarifications and modifications should be responded to within 25 days to remain under IRB consideration. If you need more time to revise your research materials and/or gather the requested information or materials, please inform the HSPP staff and request an extension as needed. It is the researchers responsibility to meet the requirements of the IRB. Pending studies that go more than 25 days without a response or communication from the PI will be administratively withdrawn from IRB consideration. Once withdrawn, proposed research would need to be submitted as a new study submission.
- Highlight revisions or changes to materials under review. When you respond to an IRB request for revisions or clarifications, create a point-by-point response to reviewer's concerns. Also, consider using track-changes or otherwise highlight any changes that you make to your submission materials. This will help facilitate the next round of review, drawing the IRB member's attention to specifically the documents and language added or changed in your submission packet - rather than requiring the IRB member to re-review the entire submission and compare the documents to the original submission. In addition, you should carefully maintain version control over all of your submission materials. If you make changes to your protocol and/or supporting documents, you will want to ensure that you are modifying the last version submitted to the IRB. When asked for revisions or clarifications, you only need to re-submit revised or additional materials to the HSPP, not the entire submission each time. If you are unsure what to send the IRB in response to a request letter or how to respond in IRBNet, consult with the HSPP staff for guidance.
- Review your IRB approval letter and stamped consent form(s). No research activities involving participants, including recruitment, may commence until you have an IRB approval letter in-hand. This letter will indicate all approved study documents and for expedited or full Board approvals the letter will indicate an expiration date of IRB approval. If a consent form is being used in your study, a pdf version of the approved consent will accompany the approval letter. The approved consent form will have an IRB date stamped footer. If any corrections need to be made to the letter or consent, contact the HSPP before you initiate the research.
- Pay attention to your study expiration date. Your letter will clearly indicate an expiration date for the IRB approval for all studies that undergo expedited or full Board review. In most cases, IRB approval is granted for one year at a time. Prior to that date, you must submit for continuing review (if you intend to continue the research beyond the expiration date) or final review to have the study formally closed with the IRB (if all research activities involving participants and identifiable data is completed) using the same form. Conducting research beyond the expiration date of IRB approval may constitute noncompliance and may be reportable to the institution, federal oversight entities, and funding agencies. If you are not sure how to continue or close research after IRB approval, please contact the HSPP for assistance. Studies that are determined exempt have no expiration date and continuing review and closure are not required.
Notifications of pending expiration and expired IRB approval are provided via email to the PI as a courtesy. It is the responsibility of the PI to submit for continuing or final review prior to the expiration date to avoid any lapse in IRB approval. As a best practice, continuing review should be submitted at least 30 days prior to expiration to allow for the IRB review process. PIs who neglect to submit for continuing or final review and allow their study approval to lapse will not be allowed to submit new studies until this is resolved.
- Use the IRB date-stamped consent form(s). Once your research is approved, you will be issued an IRB stamped version of any approved consent form(s). The stamped version of the consent form is the version that should be presented to participants in your study. For consent statements provided to participants electronically (e.g. in the body of an email, SurveyMonkey, Qualtrics, etc.), please ensure that the language used is consistent with the approved version.
- Submit any proposed changes or amendments for IRB review and approval. In the course of your research study, if you decide to add to or modify your protocol or any approved supporting materials, you must gain IRB approval to do so prior to implementing any changes. Use the Modification form to submit for review. Attach a detailed summary of the proposed changes and reference all relevant revised documents.
- Report any unanticipated problems or new information that poses harm or increased risk to participants. If an incident, event, protocol deviation, or omission occurs in the course of your study that may adversely affect participants or others, you are required to report this information to the IRB. There is a Reportable New Information form (HRP 214: Reportable New Information) to report these issues to the IRB. If you have questions, the HSPP can assist you in determining what information needs to be reported to the IRB.
- Maintain research records according to your protocol. The IRB is required to maintain records related to a study for 3 years following the end or closure of that study and researcher are requested to do the same. The IRB/HSPP conducts post-approval monitoring of human subjects research for-cause and at random. Researchers should ensure that they are following the latest approved protocol in the conduct of their research and that study records (including consent forms) and data are being collected, stored, and disposed of according to their approved protocol.