Institutional Review Board

• What should l do if I need to make changes to a project that has already received IRB approval?

  Answer:  Before implementing any changes to an IRB-approved project, you must submit an Amendment application for IRB review using the IRBManager portal. This applies even if you are only making changes to personnel (including the Principal Investigator (PI)/project lead). Please refer to the Amendments section of our IRB application information page for more information about submitting an amendment application.

• What happens if there is disagreement with the IRB’s decision or stipulations?

  Answer:  The IRB is here to help. If you have questions or concerns about our decision or stipulations, please contact us via email. There is no formal appeal process, but we can work with you to develop a successful application.

• What’s a DPH/DHS Liaison?

  Answer:  A DPH/DHS liaison is a person who is responsible for a research project when the PI/project lead or co-PI is not a permanent DPH or DHS employee. If the Principal Investigator/Project lead or co-PI for a research study is not a permanent DPH/DHS employee, a DPH/DHS staff member will need to be designated as DPH/DHS liaison on the IRB application.

• Does the IRB review the science and methodology of a project?

  Answer:  The IRB is required, under the federal regulations [45 CFR 46.111(a)(1)(i)], to consider the design and methods of a project in terms of demands on the subjects and whether the research questions can be answered by the proposed methods.

• What level of IRB review is right for my project? What if I pick the wrong level?

  Answer:  The level of IRB review is determined by the level of risk to participants and whether any vulnerable populations (such as minors, prisoners, etc.) are involved. The IRB application includes a list of the Expedited and Exempt categories as defined in the federal regulations, and several of the questions in the application are designed to help you self-determine the appropriate level of review. If the wrong level is selected on an IRB application, the IRB will return your application with a request to correct the level of review and additional information may be requested.

• Is informed consent required for all research projects?

  Answer:  Consent is generally required for all human subjects research except exempt projects. Signed consent can be waived for some situations. Elements of informed consent can be waived or altered if the IRB determines that the study meets criteria for “no more than minimal risk.” Inconvenience is not an appropriate justification for a waiver of informed consent. Please visit our forms and templates page for downloadable templates of informed consent, parental permission, and minor assent forms.

• What is informed consent?

  Answer:  “Informed consent” refers to the process of providing potential participants with detailed information about a research project, including its purpose, procedures, risks, benefits, and confidentiality measures, to ensure they fully understand what their participation entails before voluntarily agreeing to take part. The federal regulations specify certain elements that are required in a consent form. Consent is more than just the form – it is an ongoing process that starts with the first contact and ends when the participant’s role in the project ends. Please visit our forms and templates page for downloadable templates of informed consent, parental permission, and minor assent forms.

• Do I need approval from more than one IRB for a research project involving multiple locations?

  Answer:  If multiple institutions are engaged in a federally-funded research project, a single IRB must serve as the IRB of record via an agreement known as a reliance agreement. For projects that are not federally funded, review by DPH IRB may be required in addition to review by IRBs serving other sites involved in the project. Please contact the IRB via email before you complete an IRB application if you are involved in a multi-site project and have questions about IRB review.

• How long will it take to get IRB approval?

  Answer:  Before an application can undergo IRB review, it must first be screened to ensure that it is complete (including all necessary supporting documents). Once IRB staff deem an application complete, the application undergoes formal IRB review, which involves the application of ethical guidelines and federal and state regulations, as appropriate. IRB review tends to be an iterative process. The length of the process is impacted by the level of review, thoroughness of the application, and speed of responses from the applicant for information and edits requested by the IRB. Review of exempt projects takes on average 1-3 weeks. Review of expedited projects takes on average 2-4 weeks. Projects requiring Full Board review typically require at least 2 months to receive IRB review.

• Does the complexity of research determine how it is reviewed?

  Answer:  No, the level of IRB review is primarily determined by the level of risk and the population under study. Populations such as children, prisoners, pregnant women and neonates require added protections as specified in the federal regulations. Other vulnerable populations, such as persons with impaired decision-making or persons experiencing homelessness, may warrant further scrutiny as well.

• Are all IRB applications reviewed by a committee?

  Answer:  All IRB applications/submissions are reviewed initially by the IRB Vice Chair or an IRB analyst. The IRB Vice Chair or IRB analyst may issue exempt determinations. Expedited studies must be reviewed by both the IRB Vice Chair (or IRB analyst) and also by a member of the IRB committee. The minority of IRB submissions are reviewed by the “Full Board” at a monthly committee meeting.

• How do I apply for IRB review?

  Answer:  For all new projects seeking IRB review, please submit an application using our web-based application portal called IRBManager. Visit our IRB application page for a checklist of items needed for a complete IRB application. For projects that have already received IRB approval, if you need to make any changes to your project, including adding/removing personnel, please submit an amendment application using IRBManager.

• Does “Exempt” mean IRB review is not needed?

  Answer:  Researchers often interpret the word “exempt” to mean there is no IRB review needed. The level of review for a project is ultimately determined by the IRB. Projects that are designated as exempt must still undergo an initial IRB review, but they may not require further review (i.e. continuing review).

• Does an “Expedited” submission get a faster review?

  Answer:  No, expedited is a level of review named and defined by federal regulation. It does not indicate speediness. The speed of an IRB review depends on the thoroughness of the application and the speed of responses from the applicant to information and stipulations requested by the IRB.

• What about student, volunteer, or intern projects?

  Answer:  The IRB reviews student, volunteer, and intern projects. For such projects, an experienced researcher who is a full-time DPH staff member will need to be named as co-Principal Investigator on the IRB application.