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Social, Behavioral, and Educational Institutional Review Board (IRB)
Social, Behavioral, and Educational IRB News and Developments!
RowanSOM Researchers should not use Consent Forms on this webpage! Please click here to view consent forms for RowanSOM.
Single IRB webpage coming soon! Recently, the integration of the School of Osteopathic Medicine has propelled Rowan University into a new chapter in its history. The RowanSOM and Glassboro/CMSRU IRB Boards are creating a single IRB webpage that will allow all faculty, researchers, staff and students of all campuses access to templates, guidance, policy and procedures. Please click on Rowan University Institutional Review Board to go to our single IRB webpage, which is currently in the ending stages of development.
eIRB! The Social, Behavioral and Educational Institutional Review Board is currently in the end stages of implementing the eIRB system for Glassboro and CMSRU IRB submissions. This system will allow electronic submission and management of IRB applications submitted to the Social, Behavioral, and Educational IRB. Please contact Eric Gregory for any inquiry or questions.
Institutional Review Board Mission
The mission of Human Subject Protection Program (HSPP) at the Institution is to:
- Safeguard and promote the health and welfare of human research subjects by ensuring that their rights, safety and well-being are protected;
- Provide timely and high quality education, review and monitoring of human research projects;
- Assist investigators in designing a research study that embraces ethical and responsible conduct of human subject research;
- Facilitate excellence in human subjects research;
- Establish a formal process to monitor, evaluate and continually improve the protection of human research participants;
- Provide sufficient resources for the program;
- Implement oversight of research protection;
- When appropriate, intervene in research and respond directly to concerns of research participants;
- Implement the research protocol strictly adhering to the policies described in this guidelines document and;
- Engage human research volunteer participants through proper informed consent process.
If you are faculty, staff or students conducting or proposing to conduct human subject research using RowanSOM data, employees, students or on the premises of RowanSOM, you should direct your inquiry to Patricia Gessner and you can also consult the Rowan University IRB webpage.
Some of the following documents below are provided in PDF format. You
will need the free Acrobat Reader software at the Adobe
Is your human subject research going to involve the use of online surveys or survey software? If yes, then please review the Rowan University Survey Policy. If you have any more questions about the survey policy, please review the Office of Institutional Effectiveness, Research, and Planning (IERP) webpage.
eIRB IRB APPLICATION INFORMATION
When proposing any human subjects research to the IRB using the eIRB submission and review system, all faculty and staff must use the information located here. The link will take you to our main IRB website. On that website, you will find information regarding protocol submission, continuing review, modifications, protocol template, consent forms, conflict of interest forms, meeting dates, policies and procedures, training, additional guidance and information; and an IRB FAQ. Rowan University Institutional Review Boards.
PDF (Paper) IRB APPLICATION INFORMATION
PDF (Paper) applications will only be accepted up to October 15th, 2014. After October 15th, all new, initial IRB applications must be submitted via eIRB.
Protocols approved prior to Ocotober 15th, 2014, will need to submit PDF (Paper) applications for Continuing Reviews, Modifications and Closures/Final Report.
The information below is only to be used when submitting a PDF or Word IRB application to our office. If you are submitting your IRB application through the eIRB system, then please follow the information and guidance, as well as templates and consent forms, that can be found on the Rowan University IRB webpage.
Submission Schedule for Full Board Reviews Only
Expedited and Exempt Reviews are handled on a rolling basis. As those types of projects are submitted to the office, they are reviewed and forwarded for IRB Member review. Expedited and Exempt reviews do not follow the Submission Schedule listed above.
IRB Policy (Click for Word version)
IRB Guidance Book
Click CITI TRAINING to review training requirements and procedures
IRB Continuing Review/Final Report Form - Expedited and full board review procedures
IRB Applications and protocols approved using the expedited and full board review procedures are approved for the study to be conducted in the 12-month period from the date on the formal approval letter. If your research is to continue, then you need to complete and submit an IRB Continuing Review/Final Report Form to the IRB - Office of Research. If your study will end at the 12-month period, then you must submit an IRB Continuing Review/Final Report Form indicating the study is completed to the IRB - Office of Research
Cooper Medical School at Rowan University IRB Policies
Cooper Health System, Cooper Medical School at Rowan University, and Rowan University IRB Policy
Template and Protocol Application with Investigator-Initiated Protocol Template (Click for word version)
Guidelines, Additional Information and Sources of Information
Clinical Trials Registration Guidelines
National Institutes of Health (NIH) requires certain clinical trials sponsored by NIH to register in the ClinicalTrials.Gov website. For more information about registering, please review NOT-OD-08-014. Principal Investigators are responsible for managing and updating the study in clinicaltrials.gov. More information and instructions for registering a study are located below.
Point of Contact for studies originating from the Glassboro (Social, Behavioral and Educational IRB) campus: Eric Gregory or (856) 256-4058.
Point of Contact for studies originating from the Stratford (RowanSOM IRB) campus: Christine Besswick or (856) 566-6003.
1) Make sure you have your clinical trial information available
2) Principal Investigators should contact the above Points of Contact depending on where you are located and depending on what IRB (Either Glassboro or RowanSOM) you submitted your study to for review
3) Upon notification, the Point of Contact will create a user account in the ClinicalTrials.gov system
4) Upon completion of the user account, the Principal Investigator will receive an email from ClinicalTrials.gov to complete the registration
5) When registering the study, in the Responsible Party Field select Principal Investigator.
6) Principal Investigators are responsible for releasing the trial in clinicaltrials.gov and performing periodic updates of trial information as needed
Human Subjects Research Classroom Exercises - Professors and instructors that want to conduct classroom exercises in human subjects research should use the following guide to assist them in the preparation and performance of classroom exercises. This guidance is intended for faculty and instructors to use. This guidance should not be used when developing human subject research protocols, and students should always consult with their instructor or faculty advisor when developing human subjects research protocols. This guide is not to be used for class projects that meet the definition of human subjects research. Classroom Exercise Guide
Internet Research Guidelines
Office for Human Research Protections (OHRP)
Guidance on Reporting Incidents to OHRP
Please go to the Rowan University IRB Webpage to review instructions and other information related to CITI training.
CITI Rowan University CITI Instructions
CITI Training Homepage