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Activities that meet the definition of Human Subjects Research:

• Surveys

• Observation

• Interviews

• Specimens Samples

• Intervention

• Data Records

• Interviews

It depends on whether the existing specimens are identifiable. If not, and if the investigator will make no effort to re-identify the specimens, the specimens do not meet the definition of human subject and IRB review would not be required. If the specimens are identifiable, or efforts will be made to re-identify the samples, IRB review is required. Research that only involves the use of existing identifiable samples may qualify for exemption if one of the following is true:

• the specimens are publicly available

• information is recorded in such a manner that the identity of the human subject cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subject, and the investigator will not re-identify subjects.

If the samples are to be used for a research purpose, and if at any point in time the investigator can link a sample (directly or through codes) to the individual from whom it came, IRB review is required. If information is recorded in such a way that individuals from whom the sample came cannot be identified the research may qualify for exempt status.

Conditional:

• KSU HRPP section 6.1, since 45 CFR 46.104(b)(2) makes exemptions unavailable for research involving prisoners, except for research aimed at a broader population that only incidentally includes prisoners. Under 45 CFR 46.304, the board must include a prisoner or prisoner representative, and a majority of the other members must have no association with the prisons involved. Full Board review is required.

• De-identify the data in accordance with applicable regulatory requirements so that the resulting dataset is no longer considered human subjects research. Under 45 CFR 46.102(e)(5), information is identifiable when "the identity of the subject is or may readily be ascertained by the investigator or associated with the information." That standard is met by matching to a public database as well as by a coding key. OHRP's 2018 Guidance, Coded Private Information or Biospecimens Used in Research, states that secondary research involving coded information does not involve human subjects when investigators cannot readily ascertain identity, including enforceable agreements, repository policies, or legal requirements prevent them from obtaining the key. This can be reviewed as Expedited.

Yes. Any change to a previously approved non-exempt study must be reviewed and approved by the IRB prior to implementation. This includes changes to any document related to the study (e.g. informed consent form, surveys, advertisements, recruitment letters, etc.) You will need to submit the form to request a modification to a previously approved study. The only exception to this is that a change can be implemented if it is needed to eliminate immediate harm to subjects or others. Such changes must be reported to the IRB within 5 business days. Investigators are encouraged to seek approval for any modification to an exempt study to ensure that the change does not invalidate the exempt status of the study.

Yes, however you may not need a full duplicate review if your institution agrees to cede oversight via an IRB Reliance Agreement (or Institutional Review Board Authorization Agreement), but you must still formally notify and coordinate with your own university's IRB office.

When saving and naming your CITI training certificate or research files, use a clear, consistent format like LastName_FirstInitial_CITI_CourseName_Date (e.g., Smith_J_CITI_HSR_2026-09-18.pdf).

Best Practices for Naming CITI and Research Files:

• Be Descriptive & Consistent: Ensure anyone on your research team or IRB office can immediately tell what the file contains from the name.

• Avoid Spaces and Special Characters: Use underscores (_) or hyphens (-) instead of spaces, and avoid symbols like !, @, or # which can break file systems.

• Use Standard Dates: Format dates as YYYY-MM-DD or YYYYMMDD so files sort chronologically in your folder.

• Keep It Concise: Make names meaningful but short enough to read easily in a file directory.

It should always be possible to quickly determine which version of the protocol was current when the application was signed. Investigators are encouraged to maintain a link between the consent document and current protocol. For example, if you submit a modification that affects the informed consent form, but not version 1.0 of the protocol, the informed consent version reference should be revised, by adding a number after the version reference, e.g., Version 1.1. This indicates that the informed consent form is still linked to version 1 of the protocol.

Revising the version number also helps investigators to differentiate between copies of the protocol that have been modified. For example, if a modification was made to procedures in the protocol but both versions were labeled as version 1 (as opposed to 1 and 2 or 1 and 1.1) it would be easier for the investigator to follow the incorrect version of the protocol.

Review of exempt and expedited applications occurs on an on-going basis. Screening of the application will generally occur within 7 to 10 business days of receipt. Any concerns will be communicated to the investigator through email. Once all concerns have been addressed the application will be forwarded for official review.

Studies requiring full board review must be submitted two weeks prior to the IRB Full Board meeting. This allows sufficient time for the committee to review the application prior to the meeting. Investigators should not expect an official letter until 7 to 10 business days after the meeting.

• Note that you may not begin your research until you have received final, unconditional approval from the IRB.

Expedited review does not mean a quicker review. It simply means that only the Chair or an IRB member designated by the Chair must review the project. All the same criteria for approval still apply and applications are reviewed with the same level of scrutiny as a full board review. Review may still take time, depending on the complexity of the protocol, the completeness of the submission, and the IRB鈥檚 current workload.

After you have submitted your application to the IRB for review, the IRB will assign an IRB number to your study. The first two digits represent the latter part of fiscal year that the study was submitted, and the next three digits represent the sequential order of receipt.

The IRB expects the investigator to respond to relevant items on the IRB application. Providing complete responses will make it less likely that the application will be returned for corrections. If you have a question as to how to respond you are encouraged to contact the Principal Investigator or the IRB office at irb@kysu.edu for guidance.

No, the application must be signed by the Principal Investigator.

Because every study is unique it is not possible to provide directions that will address every situation. The relevant IRB application checklist(s) should be used as guide in determining the submission requirements.

Yes, however the timing of when you report the non-compliance may differ. If the non-compliance was within the control of the research team (e.g. a follow-up appointment was scheduled by the research team outside of the study window) it should be reported within 5 business days of becoming aware of it. All reports should contain a description of the deviation, why and when it occurred, and corrective action implemented, if any, to prevent future occurrence. If the non-compliance was not within the control of the research team and it does not place a subject at risk (e.g. the subject canceled a scheduled appointment and had to be rescheduled outside of the study window) the event can be reported at the time of continuation. However, if the event was not within the control of the research team but had an impact on subject safety or data integrity it should still be reported within 5 business days of becoming aware of it. If possible, investigators should allow for 鈥渨indows鈥� within the protocol design to reduce the instances of non-compliance. For example, rather than stating that a second visit will occur in 2 weeks, state that second visits will occur within 10 to 18 days.

You must address HIPAA within your application if your study involves the use of protected health information. Protected health information means individually identifiable health information transmitted or maintained in any form (electronic means, on paper, or through oral communication) that relates to the past, present or future physical or mental health or conditions of an individual. In general,

• if you are obtaining informed consent, you will also need to obtain a HIPAA Authorization, or

• if you are seeing, but not recording any identifiable information you will submit a request for Waiver of HIPAA authorization and a Certification of Deidentification form, or

• if you need to keep some identifiable information, and you cannot obtain an Authorization, you will apply for a Waiver of HIPAA Authorization.

Yes. The IRB is the only office that can determine if a research project qualifies for exemption and must have sufficient information in order to make that determination; and training requirements pertain to them regardless of the type of review conducted.

Yes. The IRB must approve all translated documents that will be presented to subject, e.g. the informed consent form and surveys. Investigators may either use a professional translation service or the back translation process.

When the IRB grants you final approval the approval letter will include the date by which your request for continuation is due. The investigator retains the responsibility for seeking continuation of an approved study and the IRB encourages you to add reminder notices to your outlook calendar.

A lapse in IRB approval for the study will occur if continuing approval is not granted by the end of day on the expiration date of approval. For example, if the expiration date of a study is May 1st, research activity could occur on May 1st but could not occur on May 2nd unless continuing approval had been obtained. If a lapse in approval occurs, all research related activity must cease until approval for continuation is obtained. If a subject is on active treatment and will be exposed to harm if treatment is withheld during the lapse in approval, you must request in writing approval from the IRB Chair to continue to treat the subject. You must also confirm that you are seeking continuation and will meet the next submission deadline. Email your request to IRB@kysu.edu.

When continuing review is a requirement, regulations require that continuing review occur at least annually. However, the IRB has the authority to require that review occur more frequently. Example scenarios of when the IRB may exercise this option include studies that pose a high risk to subjects or studies for which the investigator does not have extensive experience in the field.

Federal guidance states that in order for continuing review to be meaningful and substantive the IRB must review the complete protocol.

Informed consent reflects an individual鈥檚 voluntary agreement to participate in a research study. To make this agreement the individual must have adequate knowledge and understanding of the relevant information (purpose of the study, risks and benefits of the study, methods to be used, etc.). The process of informing a subject about a study is documented using the informed consent form.

Individuals who have reached the age of majority and who are competent can provide informed consent to participate in a research study. If the subject is either a minor or lacks the capacity to provide informed consent, a surrogate person (i.e. a legally authorized representative) must provide consent and the subject will generally be asked to provide assent. The policy to provide surrogate consent for research studies follows the same standards as providing surrogate consent for clinical care.

The informed consent checklist outlines the regulatory requirements of the informed consent form, and these requirements are incorporated into the IRB sample consent form. If these documents are used as a guideline, you should address all required elements within your consent document. However, consent is more than a document. Consent must be a process in which the research subject has the right to read and discuss the form and to ask any questions regarding the study and have them answered in a satisfactory manner.

In the majority of non-exempt studies informed consent is required. However, there are situations in which the requirement to obtain informed consent may be waived or altered. A retrospective chart review study is an example of when the requirement to obtain consent may be waived. The form to request a waiver or alteration of informed consent must be completed and submitted to the IRB for review and approval. The form describes the criteria that must be satisfied for the IRB to grant approval to the request.

A research study should be closed by the Principal Investigator (PI) once all human research activities are completed regardless of whether a study is subject to the continuing review requirement.

If the study is an exempt study, the PI may allow the IRB approval to expire. When approval of an exempt study expires, the IRB will administratively close the study, but this does not invalidate the exemption. The research, as proposed to the IRB, may continue; it is not necessary to keep the exemption actively registered with the IRB.

Provide the IRB with a summary of the following information when closing a study:

• the findings of the study

• the final enrollment data

• whether the study met the recruitment goals, and

• whether any of the following events occurred since the last approval (initial or continuing review):

  • subject complaints.

  • unanticipated problems involving risk to subjects or others.

  • unexpected profile of adverse events in terms of frequency and/or severity.

  • non-compliance with or deviation from the approved protocol or procedures.

  • audits, inspections or monitoring visits by internal or external personnel.

  • any publications, presentations, trademarks, patents, etc. related to the study.

Things to Consider before Closing Research Studies

• Investigators should honor wishes of the sponsor or funding source to keep the study open or to close the study. Some funding entities require IRB approval for the duration of the funding, even if human research activities are complete, or they may not allow the study to close without the sponsor鈥檚 permission. It is the PI鈥檚 responsibility to be aware of, and comply with, those requirements.

• Sponsors, contract research organizations (CROs), or coordinating center personnel may need to verify or monitor individually identifiable study data at a specific site where human subjects activities have been completed. The study team should verify whether these organizations require the studies to be open when conducting their monitoring visits. IRB approval must be maintained while these activities are occurring.

When to Close a Study

• Is the enrollment closed?

• Are interactions and interventions with participants complete?

• Is data collection complete?

• Is analysis of identifiable information/biospecimens for the purposes of the current research complete?

If the answers to the above questions are yes 鈥� submit a study closure report.