Institutional Review Board (Human Subjects Review Board)

The IRB (HSRB) at RWU protects individuals who participate in research conducted at the university or as sponsored by a member of the RWU community. 

We also offer resources and consultation to students, staff, and faculty conducting research with human participants.

New Process

We are excited to announce the new process for submitting IRB (HSRB) Initial Applications! 

The new Etrieve system is now live and the Qualtrics application is no longer available.


  • IRB (HSRB) Initial Application, Protocol Change and Continuing Review Forms will contain the same information; however, the application will be submitted via Etrieve rather than Qualtrics. 
  • You can find details about this change, and the process of application, in the Basic Steps section of this website
  • There are additional details, including a video showing the process of Initial Application, in the Resources section of this website
  • Still have questions about this change or anything IRB (HSRB) related? We welcome questions and consultation!  Please fill out the Consultation Request Form or contact us at hsrb@ejly.net

Overview

The IRB (HSRB) adheres to federal assurances through the Office of Human Research Protections (OHRP). 

Additional information and resources regarding federal assurances 

The IRB (HSRB) evaluates an applicant's level of request for review (Exempt, Expedited, or Full) based upon the definition of research and level of risk to participant outlined by the OHRP and RWU IRB (HSRB) protocols.  Board members are available to provide consultation and support throughout  the IRB (HSRB) process. Please feel free to email us at hsrb@ejly.net.

The role of the IRB (HSRB) is to evaluate your protocol to ensure that individuals' rights are respected, according to the OHRP guidelines and recommendations for research, including the following activities involving human participants:

  • quantitative or qualitative research studies
  • community engagement activities
  • program evaluations
  • interviews
  • surveys
  • observations
  • other activities and interventions with human participants

How to Apply

The IRB (HSRB) offers guidance regarding the definition of research, determining the appropriate review status for your proposal, and the application process.  Please begin with the BASIC STEPS tab to begin the IRB (HSRB) application process. 

Please note that IRB (HSRB) will respond to your application within 12-14 business days.  However, oftentimes, applications reviewed require additional clarification and/or modification.  As such, IRB (HSRB) recommends that your study timeline include 3-4 weeks for the IRB (HSRB) application process from submission to final approval.  Please let us know if you have any questions.  

Important Dates and Forms

The IRB (HSRB) reviews applications on a rolling basis. Exempt and Expedited reviews are typically completed within ten working days of notification, unless considerable revisions are required. If your application requires Full Board review, you should plan to submit your application and documentation at least one week prior to the scheduled board meeting. Please note that the full board meets a minimum of 1 time per semester.  Should you need full board review after the posted meeting date, please contact hsrb@ejly.net and submit your application. 

The next IRB (HSRB) Full Board meeting is scheduled for: TBD, Spring 2025

If you have a study that needs full board review, please submit the study for review and the board will schedule an additional review meeting as needed. 

The IRB (HSRB) Application

The document links below contain information you will need in order to complete the online application. Please review the Guidelines for Preparing an application prior to beginning the application.  The guidelines contain information to ensure you have all necessary documentation accessible prior to completing the IRB (HSRB) Application. We have a new submission system (Etrieve) for all Initial Applications.  Please see the Basic Steps and Resources sections of this website for additional details. 

Guidelines for Preparing an RWU HSRB Application

Guidelines for Submitting an Initial RWU HSRB Application via Etrieve

Informed Consent Documents

Researchers should follow the university's templates for Informed Consent documents.  Researchers should download the template and adapt it accordingly for your research study.  The template below includes recommended text by the HSRB.  

Informed Consent Template

The following form is available as a template to assist you in your research study with children (this template is a study taking place at a child's school).

Parental Permission Template

Updating Research Protocols

Researchers are required to notify the IRB (HSRB) of changes in the study and to submit copies of updated materials for our records.  If you have made changes to your original IRB (HSRB) application and/or have updated your research study, please complete the Protocol Change Application found in Etrieve. 

IRB (HSRB) approvals remain active for one (1) year from the date of the signed and filed acceptance letter.  Researchers are required to notify the HSRB upon completion of the study.  If you have completed your study or are seeking to extend the activity period for your research, please complete the HSRB Status Report Form found in Etrieve.

Incidents of Concern or Violations of IRB (HSRB) Policies

According to protocols outlined by the Office of Human Research Protections (OHRP), the IRB (HSRB) serves as the regulatory body for documenting and investigating concerns and potential ethical violations of the university's policies and of regulations at the federal, state, and local level(s).

The IRB (HSRB) vets concerns regarding research protocols with human participants by individuals within and outside of the RWU community using the IRB (HSRB) Incident Report Form.  The IRB (HSRB) welcomes consultations regarding any of the above protocols and the submission of anonymous questions at hsrb@ejly.net. 

HSRB Incident Report Form

Co-operating IRB Institutional Agreement

Individuals seeking approval for research affiliated with or previously approved by another organization or institution's IRB should submit documentation using the IRB Authorization Agreement Form.  

OHRP Federal wide Assurance (FWA):  FWA00018407  (exp. 09/12/2029)

IRB Registration:  IORG0007182  (exp. 01/05/2024)

IRB Authorization Agreement

Policies and Membership

Policies

The Roger Williams University IRB (HSRB) policies are informed by the guidelines of federal regulatory agencies.  The RWU IRB (HSRB) is ultimately the agency responsible for creating and overseeing policies regarding research with human participants specific to our institution. The Board adheres to policies consistent with the most recent revisions to the Common Rule (Revisions to the Common Rule), and updates outlined by the federal Office of Human Research Protections (OHRP).

Current IRB (HSRB) policies:.

HSRBPolicy2019.pdf

2021 HSRB Protocol Compliance Update

Membership

According to federal guidelines (45 CFR, part 46), IRB (HSRB) membership must include at least five members with various backgrounds to promote complete and adequate review of research. At a minimum, one member must be an individual whose primary research is scientific, one member must be an individual whose research is non-scientific, and at least one member must have no affiliation with Roger Williams. Additional members should represent more than a single area or profession.

The Roger Williams University Institutional Review Board (HSRB) includes individuals from the RWU faculty and administration and one member from outside of the University.  Membership beyond the minimum requirement at RWU is a function of our diverse research community and supports the diverse scope of research at RWU.  

Becky Spritz
Associate Provost for Academic Affairs
Professor of Psychology and Public Health
401-254-2664
bspritz@ejly.net 

Administrative Assistant:  Beth Cook
Administrative Assistant
School of Humanities, Arts and Education and School of Social and Natural Sciences
401-254-5455
bcook@ejly.net

Committee Members

Selby Conrad (7/1/2021 - 6/30/2025)
Faculty Director
Associate Professor, Psychology
401-254-5501
sconrad@ejly.net

Robert Dermody (7/1/2024 - 6/30/2027)
Professor, Architecture 
401-254-3094
rdermody@ejly.net

Rebecca Distefano (7/1/2023-6/30/2025)
Assistant Professor, Psychology
401-254-5738
rdistefano@ejly.net

Pamela Judge (1/4/2021 - 12/31/2024)
Assistant Professor, Engineering
401-254-3870
pjudge@ejly.net

Rachel McCormack (1/4/2024 - 12/31/2027)
Professor, Elementary Education
401-254-3019
rmccormack@ejly.net

Katrina Norvell (7/1/2023-6/30/2025)
Associate Professor, Public Administration and Leadership
401-254-4845
knorvell@ejly.net

Jason Patch (7/1/2023-6/30/2025)
Professor, Anthropology/Sociology
401-254-5723
jpatch@ejly.net

Melissa Russano (7/1/2023-6/30/2025)
Professor, Justice Studies
401-254-3878
mrussano@ejly.net

Required Training (CITI)

Instructions for CITI Certification for Ethical Research with Human Subjects

All faculty, staff and students engaged in research with human participants MUST complete a series of online training courses through the Collaborative IRB Training Initiative (CITI).  Additional information about the program and its affiliation with the Office of Human Research Protections (OHRP) is available on the OHRP website.

CITI modules standardize ethics training for research, and certify persons conducting research on human participants within the United States. The oversight of institutional and regional boards assures compliance with these standards at the national, regional, and local level.

Who should complete CITI training?

For research involving human participants, all university personnel affiliated with the study as primary investigators or research assistants must complete the course.  This includes faculty, staff, and students (undergraduate and graduate).  The course must be completed PRIOR to submission of the Human Subjects Research Board application.

For CiTI trainings completed as part of a course requirement (e.g., Research Methods), it is recommended that faculty complete the course prior to assigning it. 

What to do?
  • Go the Citi Program website.
  • Register as a new user (make sure to affiliate with Roger Williams University).
  • Select the following modules:
    • Social & Behavioral Research, Basic Course
  • Complete the exam. The Course is separated into modules to allow you to log in and out at your own pace. Completion of the course will require 4-6 hours.
  • Students may print a copy of their certificate of completion and provide this to their professors.
  • Each certificate is valid for three years.

Please be reminded that The Responsible Conduct of Research (RCR) course will not meet the requirement. If the RCR course is the only course you have completed, you will be asked by the HSRB to complete the required course. 

Please contact Selby Conrad (sconrad@ejly.net) for questions regarding CITI training as it pertains to RWU HSRB applications.  

How to Add or Remove Courses

CITI Training Steps

  1. Log onto the CITI Program site
    1. In the upper righthand corner of the website you will see options to Login or Register. 
    2.  If you have a log in from RWU, or another university, please use that one and Login 
    3. If you are a new user, please click register.
  2. For new users,  
    1. you will be asked to select your organization.  Please select Roger Williams University.
    2. The next step, asks you to enter your name and contact information.
    3. Then you will be asked to create a username and password, in addition to some security questions
    4.  Step 4 asks you about where you are located and if you’d like to receive any additional information (the answer to this question is up to you)
    5. Step 5 asks about CEUs.  Unless you are a professional who needs CEUs (or collect CEUs for another reason), the answer to this question is usually no (you can always change your preference).  If you answer no, you will still receive the CITI certificate (once the course is complete)
    6. In step 6, you are asked several important questions.  First you are asked to provide your institutional email.  Please use RWU email for this: Next you will be asked your department and role.  If you are a student, please enter the department of your faculty research mentor. You will also be asked which course you plan to take.  Assuming that this is the 1st time you are taking the course (or your previous coursework has expired), you will select: Basic Human Subjects- Social and Behavioral Focus. 
    7. The next section allows you to enroll in a course.
      1. Question 1: asks about if you plan to conduct human subject’s research 
      2. Question 2: asks about if you have taken the CITI training before 
      3. Question 3: Is related to public health research.  This is not required for HSRB but may be required for a public health course.  Your instructor will let you know if you need to check yes to this question.  
      4. Question 4: Is related to IACUC.  This is lab sciences research that uses animals.  
      5. Question 5: You will skip unless you do research with animals and need this training 
      6. Question 6: Is related to the Responsible Conduct of Research.  If you would like additional information about the research process, this is a good course to take.
      7. Question 7: Is related to conducting research during COVID-19 and you are welcome to take this, if you’d like the information, but it is not required.  
    8. The next step asks you to finalize your registration.
    9. This will take you to the page where you can see your affiliations and you can click on your coursework.  If you change institutions, you can add and remove affiliations on this page as well. 
    10. Once you click on view courses you should see the Basic Course. You are able to complete modules and save them to come back and finish later.  When you return, you will come back to this page and be able to resume the training.  On this page you will also be able see completed courses and print certificates.  
  3. For returning users, once you log into the site, you will be taken to the affiliations home page:  
    1. On this page, you can add and remove affiliations as needed. 
    2. For Roger Williams University related trainings, please click view courses.
    3. When you look at your courses, if you do not see the course that you would like to add, please select the “add a course” tab at the bottom of this page.
    4. This will take you to the course enrollment questionnaire.
    5.  You will need to scroll down to see the questionnaire.  Your answers to these questions will help determine which courses you are assigned.  Please see 2g above for details.
    6.  Please pay close attention to Question 2.  If, you have completed the CITI course be sure indicate this in Question 2.
    7. The course(s) will then be added to you course list.  

Approved Projects

The HSRB welcomes and supports ongoing research endeavors with RWU faculty and students, and with individuals affiliated with the RWU community.  

Annual updates for reporting must be adhered to by the Primary Investigator of an approved RWU HSRB project, as per the Office of Human Resource Protections (OHRP).

For Ongoing Studies

HSRB approval remains in effect for one (1) calendar year, as outlined by the Office of Human Research Projections (OHRP) and the HSRB policies of Roger Williams University (RWU),

HSRBPolicy2019.pd

Proposals involving organizations not affiliated with RWU may require additional review. Please contact the Director at hsrb@ejly.net for questions regarding grant reviews and/or institutional agreements regarding participant involvement affiliated with RWU.

For Concluded Studies

Please report final data regarding studies which have been concluded please complete the termination report found in Etrieve. Please direct questions or concerns to hsrb@ejly.net.