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Social, Behavioral, and Educational Institutional Review Board (IRB)

 

Social, Behavioral, and Educational IRB News and Developments!

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. As we continue to integrate RowanSOM into the Rowan University Colleges and Schools, we are also creating a single IRB webpage that will allow all faculty, researchers, staff and students to use when researching and obtaining information related to the IRB here at Rowan University. Please click on Rowan University Institutional Review Board to go to our single IRB webpage.

eIRB! The Social, Behavioral and Educational Institutional Review Board is currently in the beginning stages of implementing the eIRB system for the 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.

Electronic Application Submissions! The Social, Behavioral and Educational Institutional Review Board is now accepting electronic IRB applications. Researchers are no longer required to submit hardcopies. Please follow the directions located in the IRB applications below.

New Disclosure Form required when submitting IRB Applications! The Social, Behavioral and Educational Institutional Review Board has updated the IRB application to include an Interest Disclosure Form. This form is required to be completed and signed by investigators, including students,and advisors, and subsequently submitted with the IRB application to the IRB office. Faculty Advisors and investigators must download the new IRB application form so that the Interest Disclosure Form is present. If an IRB application is received that does not have the Interest Disclosure Form attached, then the IRB office will inform the investigator of the required documentation, which may delay the review process. All faculty advisors, applicants, and faculty conducting research classes are encouraged to contact the IRB office for any questions and guidance related to IRB processes and submissions.

 

Institutional Review Board Mission

Rowan University's Institutional Review Board's mission is to assure the safe and ethical treatment of human participants in research. Federal and university regulations require that all research involving human participants conducted by Rowan faculty, staff, and students be reviewed and approved by the IRB before initiation!

RowanSOM IRB

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 RowanSOM IRB webpage.

Some of the following documents below are provided in PDF format. You will need the free Acrobat Reader software at the Adobe Website.

Survey Information

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.

General Information for Social, Behavioral and Educational IRB

Meeting Information
Submission Schedule for Full Board Reviews Only
Committee Members

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.

Policies
IRB Policy (Click for Word version)
Oral History Policy (Click for Word version)

Frequently Asked Questions (FAQ)
IRB Application Form (Click for Word version)
IRB Revision Request (Click for Word version)
IRB Continuing Review/Final Report Form (Click for Word version)
Consent Procedures and Samples

Full Board Review Consent Form Example

 

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


Sample Debriefing Form (Click for Word version) In the attached sample debriefing form, yellow highlighted text indicates information that needs to be included, revised, expanded upon, or removed prior to creating your final draft.

 

Application Status

Application Status - July 2014 - June 2015
Application Status - July 2013 - June 2014
Application Status - July 2012 - June 2013
Application Status - July 2011 - June 2012

Application Status - July 2010 - June 2011
Application Status - July 2009 - June 2010

Application Status - July 2008 - June 2009
Application Status - July 2007 - June 2008

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.

 

Instructions:

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

Internet Research Ethics

Office for Human Research Protections (OHRP)
Guidance on Reporting Incidents to OHRP

Training

Collaborative Institutional Training Initiative (CITI) Human Subjects training is necessary for all investigators at Rowan University. Investigators who have an existing National Institutes of Health (NIH) training certificate that is current (they expire after 3 years) may use this certificate, but all new and existing investigatorss must complete the CITI Human Subjects Research training after the NIH training has expired. Before submitting an IRB application, click the "Required IRB Training for Faculty/Staff/Students" link under and complete the “Human Subjects Research” module in your area of expertise. In addition, all other key personnel and faculty advisors may be instructed to complete Human Subjects Research training.

CITI Training Homepage

IRB Human Subjects Training Guide

New to CITI? Never created a CITI User Account? Please follow the directions below:

  • Use the link above to access the CITI program
  • Click on the link "New Users: Register Here"
  • Complete registration information as requested and relevant
    • Select Rowan University as the Participating Institution
    • Include your Banner ID in the box requesting employee ID
    • Use your Rowan University email address in the box requesting an email
  • After creating your profile, you should go to a screen to select the appropriate training
  • For any and all training that is not Human Subjects Training (Question #1), please mark the box saying "Not at this Time" or "Not Applicable" or if that option is not available, leave blank and do not select any training

    NOTE: When you need to complete the Basic Human Subjects Training (Question #1), please mark the Refresher Course for Human Subjects training as "Not at this time"

  • When selecting Human Subjects Research (Question #1) training, choose the most appropriate course related to the research project/purpose
    • The Refresher (Question #3) human subjects research course is ONLY applicable if you have already completed the initial/basic training. If so, please provide a copy of the past certificate in your IRB Application.

Already have a CITI account? Transfered from another University or recent hire that already has an exiting CITI account? Please follow the directions below:

For individuals that need to sign up for a refresher course, please go to Question #3 in CITI's Add a Course or Update Learner Groups and select the appropriate course based on your research.

Existing CITI users:

  • Use the link above to access the CITI program
  • Go into your profile
  • Select Add a Course or Update Learner Groups
  • Select the appropriate Human Subjects Training course

Transfers and recent hires that already have an existing CITI account:

  • Use the link above to access the CITI program
  • Select "Click here to affiliate with another institution"
  • Select Rowan University
  • Complete and fill-in information that is requested and relevant
    • Include Rowan ID as the employee ID number
    • Use your Rowan University email address in the box requesting an email
  • Go into your Rowan University newly created profile and verify that the affiliation change went through
    • You may have to select Remove affiliation and identify your former institution
  • Select Add a Course or Update Learner Groups
  • Select the appropriate Human Subjects Training course
    • Select the previous training completed at your prior institution - For example, if you completed the Basic Course at your other institution, select the Basic Course (Question #1)
    • You may have to take one or two additional modules in Human Subjects Training depending upon what training at your former institution is required and how it compares to Rowan University's Human Subjects training
  • Submit copy of past Initial/Basic Human Subjects Training certificate with your IRB application if you are going to complete the Refresher course in CITI