How to Apply to the IRB

Follow these steps to apply to the IRB:

Determine if the project meets the definition of human subject research.
Read through the Responsibilities of the PI section.
Complete the required training course on the protection of human participants in research. The IRB subscribes to the CITI Online Training Program to comply with this regulation. Additional information and the CITI website can be found here.
Determine the level of review.
Complete the IRB Application Form found on the Forms tab.
Complete any necessary consent forms and/or appendices to your application.
Submit your IRB Application Form and any other necessary appendices and documentation of CITI training to the IRB Office, 302 Old Main, or email it to irb@sru.edu.

You must receive approval from the IRB before conducting your research. DO NOT begin your study until approval has been granted. This is a violation of Federal regulations.

Call or email the IRB Office if you have any questions.

IRB Handbook for Investigators - designed to provide direction and assistance to faculty, staff and students or other personnel who are conducting human participants research at SRU.

Meeting Dates and Submission Deadlines

Exempt from Full Review: No deadline. Protocols are usually reviewed within 5-7 working days of receipt.

Expedited Review: No deadline. Protocols are usually reviewed within 15-20 working days of receipt.

Full Board Meetings: Unless otherwise noted, meetings start at 12:30p.m. in Old Main, Room 304. If the IRB does not receive the application packet by noon on the deadline date, it will be reviewed at the next month's meeting.

Full Board Review Submission Deadlines and Meeting Dates

Fall Semester 2023

Submit by Noon on:	Meeting Dates:
Thursday, September 14, 2023	Thursday, September 21, 2023
Thursday, October 19, 2023	Thursday, October 26, 2023
Thursday, November 23, 2023	Thursday, November 30, 2023
Thursday, December 7, 2023	Thursday, December 14, 2023

Spring Semester 2024

Submit by Noon on:	Meeting Dates:
Thursday, January 11, 2024	Thursday, January 18, 2024
Thursday, February 8, 2024	Thursday, February 15, 2024
Thursday, March 21, 2024	Thursday, March 28, 2024
Thursday, April 18, 2024	Thursday, April 25, 2024

Responsibilities of the Investigators

The Role of the Principal Investigator

The investigator who has the primary responsibility for the conduct of the research is the Principal Investigator (PI). All communications from the IRB Office will be with the project's PI. All forms must be signed by the PI. Students are NOT permitted to be PIs, but are required to have a SRU faculty or staff member supervise the research. Student researchers should be listed as co-investigators or research assistants.

It is the responsibility of the PI to complete and submit the application materials to the IRB Office in order to maintain his/her project timeline. PI's are required to inform the IRB Office of any changes to approved research and any adverse events or unanticipated problems.

PI's are responsible for the following:

Managing the development of the project in accordance with accepted scientific standards
Ensuring the project review of all human participant research by the IRB prior to the initiation of the study
Ensuring that participants in research be apprised of all risks and benefits so that their consent to participate is based on pertinent information
Assuring project adherence to approved research protocols and policies
Ensuring the integrity and safeguarding of all collected data
Remaining aware of, and comply with the policies of the IRB at SRU
Notifying the IRB of any changes made to the protocol and or participant consent process/document
Reporting any potential changes in the risk/benefit ratio that are manifested/discovered during the research process
Meeting the continuing review requirements established by the IRB
Reporting all serious and adverse effects encountered during the investigation to the IRB
Immediately notifying the IRB if a protocol is completed or withdrawn

IRB policies are subject to change. It is the responsibility of all researchers to be familiar with the current IRB policies.

The Role of Co-Investigators

Co-Investigators are key personnel who have responsibilities similar to that of a PI on research projects. While the PI has ultimate responsibility for the conduct of a research project, the co-investigator(s) is also obligated to ensure the project is conducted in compliance with applicable laws and regulations and institutional policy governing the conduct of sponsored research.

All co-investigators are required to be listed on the IRB Application Form and also to sign the form as the co-investigator(s).
Co-investigators are required to complete the CITI Online Training Program.

The Role of Research Assistants

Research Assistants are individuals who are involved on the project, but are not crucial to conducting the research. For example, they can assist in collection and input of data into a database or serve as an aide to the investigators.

Research Assistants cannot consent or enroll participants in the research project that are more than minimal risk.
Research Assistants are required to be listed on the IRB Application Form and also to sign the form as the research assistant(s).
Research Assistants are required to complete the CITI Online Training Program.

Application Process

The PI is required to submit a complete application packet to the IRB Office for review. Incomplete application packets will be returned.
Once a complete application packet is received, a protocol file will be created and a protocol-specific number will be assigned.
All communications with the IRB Office regarding specific protocols must include the protocol number.
Once a project expires, it will be closed, which means no participants may be enrolled and no data may be collected or analyzed. If the PI desires to continue the research once the protocol has been closed, a new protocol must be submitted to the IRB Office for approval.

Online Training

Federal regulations require all participating researchers complete a training course on the protection of human participants in research. The SRU IRB subscribes to the CITI Online Training Program to comply with this regulation. (see link to Online Training Program below)

CITI provides a certificate to the researchers upon completion of the appropriate training course. A copy of the CITI certificate must be included with the protocol submitted to the IRB Office for all participating researchers, including student researchers. Any and all questions should be directed to the IRB.

Instructions on choosing a course

Social & Behavioral Research Course - the majority of research at SRU falls under this module. The Social and Behavioral Research Module is for research such as surveys, observation of human behavior, etc. At the end of the required modules, you must complete three out of the eight elective modules.
Human Subjects Biomedical Courses - for researchers doing more invasive research such as those in the Exercise and Rehabilitative Sciences Department and The School of Physical Therapy, the Biomedical Course may be more appropriate. At the end of the required modules, you must complete three out of the six elective modules.
Students Conducting No More than Minimal Risk Research - students conducting Action Research projects should complete this course. At the end of the required modules, you must complete two out of the five elective modules
Responsible Conduct of Research (RCR) Courses - for researchers with NIH or NSF funding, it is mandatory that you complete the RCR Course.
Conflict of Interest (COI) Courses - for researchers with NIH Funding, it is mandatory that you complete the COI Course.

Instructions for CITI Online Training Program

Create a user account and password
Select Slippery Rock University from the participating institution drop-down menu
Provide user contact information
Select the course that most closely relates to the intended research
Complete all course modules
All quizzes must be passed before the completion certificate will be generated
Maintain a copy of the certificate and submit a copy to the IRB Office with the protocol.

CITI Training Information

CITI Online Training Program

Levels of Review

Before submitting a protocol for review, the PI should determine whether the proposed protocol meets the definition of human subjects' research as defined by the Federal regulations key definitions:

Research: a systemic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. (CFR 46.102(l))
Human Subject(s): Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (CFR 46.102(e)(1))

If you are unsure if your proposed protocol meets the definition of human subjects' research as defined by the Federal regulations, please click here to assist you in determining if your project is Quality Improvement or Human Subjects Research.

There are three levels of review:

Decision Trees:

Is Your Human Participant Research Eligible for Exemption?

Does Exemption 1 apply?

Does Exemption 2 apply?

Does Exemption 3 apply?

Does Exemption 4 apply?

Does Exemption 5 apply?

Does Exemption 6 apply?

The PI must decide and checkmark the review level on the IRB Application Form that best pertains to the intended research.

If the proposed protocol falls under the Exempt Categories 1-4, the corresponding exempt category appendix must be attached to the protocol application form. The appendices can be found under the forms tab.

Case Studies are comprised of one or more cases collected and presented to highlight an interesting condition, treatment, presentation or outcome. What type of review does this require by the IRB? If the "study" includes a hypothesis, methods/procedures, analysis and/or an outcome, it's probably research. In this case, IRB approval should be obtained prior to the beginning of any human subject participation.

A true case study is something that is only used to present interesting information to an audience. There is no systemic analysis done. If this describes the planned "study," the IRB should provide a simplified, "exempt" review focused on the protection of the identity of the person on whom the study is presented. The Principal Investigator of the case study is required to submit a Case Study Form, consent documents (if applicable) and CITI training certificates for all investigators to the IRB.

Forms

IRB Application Form - Original submission of a protocol (REVISED).
Action Research Application and Protocol Form - Original submission of an action research protocol (REVISED).
Case Study Form - Original submission of a case study.
Progress Report Form - Progress report for continuation.
Final Report Form - Closing a protocol (REVISED).
Change to Protocol Form - Request to make a change to an approved protocol (REVISED).
Reportable Events Form - Reporting of an unanticipated problem, adverse event or non-compliance to the IRB (NEW).
Exempt Category 1 Appendix - Determination of exemption under Category 1 (NEW).
Exempt Category 2 Appendix - Determination of exemption under Category 2 (NEW).
Exempt Category 3 Appendix - Determination of exemption under Category 3 (NEW).
Exempt Category 4 Appendix - Determination of exemption under Category 4 (NEW).
Limited IRB Review Appendix - Determination of Limited IRB Review (NEW).

Consent Form Templates

Informed Consent Form - consent used to enroll human participants over the age of 18.
Assent Form - sample assent form for enrolling children as human participants in research.
Informational Letter - sample letter to be used with protocols not requiring consent forms.
Parent/Guardian Consent Form - sample consent to be given to parents/guardians when enrolling minors
Informed Consent Checklist - must be submitted with protocol when any consent above is being used

Institutional Review Board