IRB Review: Forms, Sample Documents, Timeline for Review

In accordance with federal regulations, human subjects research conducted by employees, students, or other agents of Kenyon College must receive IRB approval or determination of exemption prior to initiation of any research involving human participants. Research will remain under IRB oversight until all human participant research activities are complete.

Principal investigators should expect that the application will be returned with feedback from IRB.  In many cases this will require some modification of the application, so PIs should be aware that the application process is an iterative one.

Principal Investigator Responsibilities and the Application 

Principal investigators (PIs and co-PIs) must ensure that the research proposed follows the ethical principles and guidelines outlined in the U.S. Department of Health and Human Services requirements and Belmont Report and all information on the IRB application form is accurate. They are also responsible for carrying out the research in the manner described that is IRB approved.  

PIs and co-PIs are responsible for ensuring that the questions are fully and seriously answered the first time the application arrives for IRB approval. Additionally, principal investigators must make sure the material submitted is accessible to the IRB, e.g. all participant materials have been submitted, links to electronic surveys are functional, electronic surveys do not require members of IRB to answer questions prior to moving to the next page of the survey, etc. Applications with such issues can not be properly reviewed and will be returned to the applicant.  

At Kenyon, student PIs must have a faculty co-PI that guides and oversees the human participant research. The faculty co-PI serves as the student PIs mentor and is considered the final responsible party when considering the participant’s rights during the actual research study. Consequently, the faculty co-PI must discuss the IRB application questions with the student PI prior to submission to the IRB. Since students are learning the research process, faculty co-PIs also carry the additional responsibility of ensuring the student’s ethical development in working with human participants. 

Student or non-Kenyon Principle Investigators

  • Student PIs will need a faculty co-PI that has current CITI human participant certification and is able to provide oversight of the project with respect to the human participant research process.

  • Similarly, researchers that are not associated with Kenyon will need a Kenyon faculty co-PI that has current CITI human participant certification and is able to provide oversight of the project with respect to the human participant research process.

  • Kenyon faculty co-PIs must understand that they are ultimately responsible for the proper conduct of the research with respect to the human participant research process.

Note: All PIs and co-PIs must have completed the appropriate CITI training course(s) prior to approval. 

Helpful Information

To find the appropriate application form, please read the descriptions of form usage below. Samples of documents that may be associated with the application (ex. Informed consent, debrief) follow the application forms

Timeline for Review 

Applications submitted to the Kenyon College IRB will be reviewed as promptly as possible. Typically there is at least one round of revisions and/or clarifications required between the submission and final approval. The timeline to receive this feedback will often depend on whether the application needs to be reviewed by the full IRB or a subset of its members (for exempt or expedited reviews). The levels of review are described on the IRB application form.

For research that qualifies for the exempt or expedited level of review, the applicant will typically receive the IRB’s request for revision and/or clarification within two weeks after the application has been received. For research that requires a full board review, the applicant will typically receive the IRB’s request for revision and/or clarification within two after the full board has met to discuss the application; expect at least a month between application and the receipt of revision/clarification document. Study approval is only granted after the IRB is satisfied that there is adequate evidence that the research process will follow procedures that adhere to the HHS requirements and Belmont Report and for the protection of human research subjects.  

All decisions of the IRB are final.  If your study is not approved, the IRB will offer reasoning for the denial. If requested, the reviewing IRB chair (or designate) may be able to offer suggestions on alterations that may provide a path towards approval.

Application Forms

If you have questions about which form to use or how to answer a particular question, please contact irb@kenyon.edu.

General Research IRB Application Form

This is the form most principal investigators will use. 

  • If the research project emanates from course-based research that is largely educational, involves an instructor-defined set of parameters, and minimal risk, the “Course-Based Research application form” may be more appropriate.
  • If the research is being conducted by a Kenyon office (ex. Institutional Research) in aid of the institution, the “Institutional Research application form” may be more appropriate. 

Course-Based Research IRB Application Form

Instructors of courses use this form if there is a component of the course that will require the class to do projects that introduce students to research in a focused manner. That is, the instructor has a defined set of parameters for the possible research projects (ex. minimal risk, does not involve sensitive topics or deception/misleading, no audio/video recording or photographic records) and the informed consent statement, etc., will be similar or the same for all projects in the course. Additional details are found in the application form.

Institutional Research IRB Application Form

This form is used by offices such as Institutional Research for research in aid of the institution.

Protocol and Personal Change Forms

  • IRB Personnel Change application form: Used to make changes in the PIs and research assistants associated with a previously approved and active protocol. If there is a PI change, the new PI must have CITI training and the replacement must be approved by the IRB.
  • IRB Protocol Change application form: Used to request approval for changes to the protocol in previously approved and active protocols.
  • IRB Project Closure form: Used to request approval for changes to the protocol in previously approved and active protocols.

Adverse Events

Sample Documents

These samples include frameworks and example language for commonly needed documents. The samples should give PIs an understanding of the information needed so that each unique project can be documented appropriately.

General Informed Consent Statement: Every request must include an informed consent statement. Informed consent is an interactive educational process that takes place between an investigator and a prospective participant and ensures that the participant is aware of their rights.  It is not a form to be signed without participant thought. The consent process should:

  • provide full disclosure of the nature of the research and the participant's role in this research
  • ensure potential participants will have adequate comprehension of the research project and the potential risks and benefits to the participant. 
  • allow the participant to make a voluntary choice to participate.
  • be written and communicated in language that is understandable to the participant.

The informed consent statement example provides a framework in which these major requirements are met.

Informed Consent for Audio and/or Video Recording or Photography: Every request that involves audio and/or video recording or photography must include a specific informed consent for recording/photography along with the general informed consent statement. The informed consent for recording/photography should be presented after the participant agrees to take part in the project and signs the general informed consent. 

If an application requests such recording/photography, there is a significant burden placed on the PI and co-PI to ensure the security and proper use of this data. This security must be explained in detail on the application form.

Debrief Statement: Required for all requests involving sensitive topics, requests for interventions like interviews, focus groups, etc. This statement may also be required by certain disciplines. (For other projects it is generally a good way to remind the participant of their rights as a participant and give additional education about the project.) The purpose of this document is to reiterate the purpose of the research, provide potential sources of support for the participant after completing the research procedure, reiterate contact information for the researcher (in case of general questions) and IRB (in case of questions about the research ethics).