FAQ’s

Federal regulations define a human subject as,  

... a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (45 CFR 46.102(e)(1)) 

Applying the federal definition of human subjects, all research activities involving the collection of information about individuals through interaction and/or intervention are considered to be using human subjects and subsequently are required to obtain PSU IRB approval before beginning. 

Often students at all levels are required to conduct “research” as part of class responsibilities or activities. Most of this research does not qualify for IRB review. These are the essential questions to be answered:  

• Will this research be published in any way? Will the research be presented outside of the institution or otherwise through a peer reviewed process?  

 If you answered yes to either of these your research is required to be reviewed by the PSU IRB prior to beginning your study.  

• What will be done with the data / information?  

If the information is identifiable to an individual or may be used or published in the future, the research may require PSU IRB review prior to being implemented. If you have any questions about this area, please check with the IRB at PSU-IRB@plymouth.edu before conducting or planning “class project” research. 

The short answer is that it depends on the nature of the proposed study. Studies involving more than minimal risk to participants and/or protected populations generally take longer than other proposals. Applications that require full board review may take as long as two months, depending on when the application is received and the board member availability.  

Exempt or expedited reviews will generally take about 7 to 14 days if all required information and documents are provided and there are no revisions or additional information requested.

Currently Plymouth State University requires human subjects training CITI Program to be eligible to submit a proposal for research. Some federal agencies also require this training and applicants should check with any funding agency for their requirements. We do strongly recommend, where appropriate, University courses include human subjects in research training within their curriculum. Documentation certifying the completion of this training is required to submit a proposal for IRB review. Training must have taken place within the last 3 years. 

Approval to conduct proposed research is given only on the application and protocol as presented or amended at the time of approval. If there are any changes to the research protocol after initial approval has been granted these proposed changes must also be reviewed by the IRB before being implemented. This includes, but is not limited to, any changes in the selection of participants, additional questions or additional survey items, changes in the approved protocol or any deletions or additions in the approved consent forms. This applies to research approved by full board review, expedited review, or exempt approval.  

For studies submitted in Cayuse IRB/Human Ethics, modifications should be submitted to the IRB for review via Cayuse IRB/Human Ethics. To request changes to an existing (legacy) study (a study that was approved by the PSU IRB prior to the implementation of the Cayuse system, researchers need to submit a new application in Cayuse IRB/Human Ethics to replace the existing study (as approved and without any changes). Once the IRB has approved the study, the IRB will close the existing (legacy) IRB study and researchers can then submit modifications via Cayuse IRB/Human Ethics. 

If you have any additional questions about this, please contact the IRB at PSU-IRB@plymouth.edu prior to any changes in your research.

Yes. Please do not hesitate to contact the IRB at PSU-IRB@plymouth.edu if you have questions about any aspects of the application requirements, required forms, or eligibility criteria.

The PSU IRB does not have a cut-off date for application submission and accepts applications on a rolling basis for review.

The answer is yes, if: 
• You will be using the data in your dissertation or thesis. 
• The data will be published (including at Lamson library). 
• The data will be used to create a presentation that will be given at a peer-reviewed or professional conference. 
• Your research poses more than minimal risk to participants. 
• You wish to have your research reviewed by IRB for grant review. 

 
The answer is no, if: 
• You will be collecting the data only to better your teaching skills. 
• The data will be shared only on a casual basis with other teachers close to you. 
• You will share the data only within the school. 
• You will present the data only to the principal. 
• You will be presenting the data only to your teacher, class members, and other Plymouth State University students and faculty (not for a thesis or dissertation). 
• Your research does not involve vulnerable populations (children, prisoners, pregnant women, or handicapped or mentally disabled persons). 
• Your research poses minimal risk to the participants, meaning the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. 
• Your research is the analysis of de-identified, publicly available data. 

Research can only begin once an approval letter is received from the IRB. Therefore, subjects should not be contacted or recruited before the approval letter is obtained. 

Studies that involve secondary analysis of data are generally not considered human subjects research.

Pilot studies and feasibility studies, including those involving only one human subject, require the same scrutiny as full-scale research projects. Pilot studies should be identified as such in applications to the IRB. Ordinarily, the data collected from subjects in a pilot/feasibility study are not used for study findings. It must be explained to subjects during the consent process that the study is a pilot. When the pilot study becomes a full study, the PI will need to apply for IRB approval again. 

• If the investigator or members of the investigator’s family have significant financial interest in the study, sponsor of the study or the subjects, technology, site, etc. being investigated 
• If you have an immediate family member including a spouse, domestic partner, dependents, and all members of the employee’s household listed as an investigator 
• If you have any conflict that might be perceived to inhibit a fair and unbiased review of the research 
• If you have any interests that may adversely affect the rights and welfare of the subjects 

Documents researchers should have on file with the IRB, and maintain for their own records, include but are not limited to the following: 

• IRB Application 
• Consent and/or assent form(s) 
• IRB’s response or request for additional information or revisions 
• Responses to the IRB’s requests for additional information or revisions 
• Notice of final approval 
• Correspondence between the investigator and the IRB 
• Continuing review forms and attachments (if applicable) 
• Renewal of Approval, (if applicable) 
• Amendment forms and attachments (if applicable) 
• Amendment approval (if applicable) 
• Original letters of collaboration from other institutions 
• All approved research study materials, including IRB validated copies, if applicable (e.g., consent forms, recruitment materials, data collection instruments or forms, etc.)