Institutional Review Board (IRB)

Revised IRB Manual July 2024

Application Submission Process

The Molloy University Institutional Review Board (IRB) reviews all research involving human subjects that is conducted by or under the direction of Molloy faculty and other employees, as well as by both undergraduate and graduate students. It also reviews all research that utilizes Molloy property, personnel, students, or facilities, or the institution’s non-public or website information to identify or contact human research subjects, even if it has received IRB approval from another institution. The IRB strives for thorough yet timely review of faculty and student IRB submissions. Please contact the Molloy University Institutional Review Board at irb@molloy.edu if you have questions.

The Molloy University IRB uses IRBNet.org, a secure, cloud-based platform, to manage all research involving human subjects conducted at Molloy University (as described above) from submission through completion of data analysis and project closure. Instructions on how to register for an IRBNet account and how to submit an IRB proposal and project materials to IRBNet are available on the Molloy University IRB webpage at https://www.molloy.edu/academics/research/irb

The Molloy University IRB webpage contains information on Human Subject Research and types of protocol determinations, such as exempt, expedited, and full board reviews, as well as the appropriate applications for the type and level of research such as Action Research and Quality Assurance/Quality Improvement evidence-based projects and undergraduate research and classroom research assignments.

The Application to Conduct Human Subject Research must be completed for all research projects from all disciplines that involve human subjects for review and determination of review category and research type by the Molloy University IRB. This includes Full Board, Expedited, Exempt, Action Research, and Quality Assurance/Quality Improvement Evidence-Based Projects.

Faculty Sponsored Undergraduate Research, Curriculum-embedded Undergraduate Research and Classroom Assignments complete the Classroom Research Assignment Determination Form.

Please consider the following information when preparing a submission for IRB review:

Download the Application to Conduct Human Subject Research from the Molloy University IRB website, then follow the Pre-Submission Instructions and complete the application.

As stipulated in the Pre-Submission Instructions, all research personnel including undergraduate students completing a classroom assignment research activity associated with the submitted protocol are required to complete and maintain current their CITI certifications in both the Responsible Conduct of Research (RCR) and either Social and Behavioral Research or Biomedical Research as applicable to their research discipline. Researchers are encouraged to link their CITI certifications to their IRBNet User Profiles.  Please see the IRB website for additional information concerning CITI Program training. Applications will not be approved if current CITI certifications for all research personnel are absent from project materials.

Faculty researchers submit the application and project materials to IRBNet.org after their Dean has reviewed and signed the application.

Doctoral and master's candidates submit the application and project materials to IRBNet after their faculty advisor has reviewed and signed the application.

Undergraduate students submit the completed application to their faculty advisors or course instructors for review and submission of their application and project materials to IRBNet.

Signatures of the PI and co-investigators are also required in the IRBNet project package section "Package Signatures."

Please allow at least three weeks from the date of submission for a response from the IRB with a decision regarding the submission.

Please respond to the IRB within one week if revisions or information are requested to the protocol.

Training Energizer 1 - Registering and Creating an Account in IRBNet

academics/research/irbnet_training_energizer-new_user_registration.pdf

Training Energizer 2 - Submitting an IRB Package in IRBNet

academics/research/irbnet_training_energizer-new-project-submission.researcher_1.pdf

Training Energizer 3 - Submitting Subsequent Packages (such as Amendments or Continuing Reviews)

academics/research/irbnet-training-energizer-researcher-2.pdf

Training Notes: Submitting a Revised Project Package

academics/research/irbnet-notes-subsequent-packages.pdf

academics/research/molloy-university-power-point-fall-2024-comprehensive-irb-review-process-12.12.2024-ms11.pdf

academics/research/molloy-university-power-point_spring-2025_submission-of-an-irb-proposal2.pdf

academics/research/molloy-university-power-point_spring-2025_submission-of-an-irb-proposal_9_18_2025.pptx

The Collaborative Institutional Training Initiative (CITI) is a subscription service providing Molloy's research community with comprehensive on-line training in human subjects research (HSR). If you are an investigator, research team member, or student doing human subjects research, you must take the “Responsible Conduct of Research Course” AND a "Human Subjects Research Course" in order to submit to the IRB or be listed as part of the research team.

CITI program content is organized into modules, which can be thought of as lessons. Modules of a course may be set as required; or they may be set as elective. Modules are composed of text, images, and video content which generally follows a standard format: It begins with an introduction of the topic(s) to be covered, then provides a set of learning objectives; after that comes the main material, broken up into sections, followed by a concluding summary sections. Each module may take 10-30 minutes to complete. You can leave and come back to the site using your CITI user name and password and quizzes can be retaken to achieve a higher score until a passing score is achieved.

Modules typically include a quiz made up of multiple-choice questions. Achieving a passing score on the set of quiz questions is required to "complete" the module. When you complete a quiz, feedback is usually provided for each question, which includes guidance on why the answer selected was correct or incorrect.  Module content can be revisited and quizzes can be retaken to achieve a higher score until a passing score is achieved.

For each set of modules that has been assembled into a course, a learner has an associated gradebook.  The gradebook shows your progress for each module of that course-not yet started, started but not completed, completed and passed, or not passed. Training is required every three years.

To Register:

1. Go to http://citiprogram.org.
2. Once there, simply click "Create an account".
3. You will be taken to the page "Personal Information".
4. Enter "Molloy University".
5. Enter your desired username and password where indicated.
6. Select a security question.
7. Enter your first and last name.
8. Enter your preferred email address.
9. Hit submit. You will be taken to Main Menu.

To Enroll in a Course:

1. Go to My learner tools for Molloy University. Click on Add a Course or Update Learner Groups.
2. The next page is Select Curriculum-Molloy University.
3. All investigators, IRB members, IRB chair, students, assistants on ANY IRB protocol MUST take the Responsible Conduct for Researchers course (required modules) and a Human Subjects’ Research course-either the Social & Behavioral course OR Biomedical course. Please see uploaded form “Required Citi Training at Molloy University” for required modules.

academics/research/rcr-hsr-citi-training-10_2023-12.pdf

academics/research/the-belmont-report-protection-of-human-subjects-of-research.pdf