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Step 1: Is It Human Subjects Research?

Qualifications as Human Subjects Research

All projects meeting the definition of research and the definition of human subjects outlined below are required to submit an HSRB application.

Definition of Research:

A “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” ().

Definition of Human Subjects

A person or persons being studied, investigated, or analyzed; either directly (via surveys, observations, or interviews) or indirectly (via data, information, or specimens) associated with that individual.

Examples of Projects and Activities REQUIRING an HSRB Application

• Federal, State, Local, and Institutional grants involving Human Subjects research
• Student research projects, theses, and dissertations (undergraduate and graduate)
• Survey, interview, and observational research studies
• Archival research involving identifiable data with human participants
• Classroom projects extending and/or disseminating findings beyond the classroom context
• Program evaluations involving the dissemination of data
• Community engagement projects involving the dissemination of data
• Scholarship of teaching and learning projects (SOTL) intended for conference presentations or publications

pilipili���� Employees and Students

pilipili���� employees and students conducting projects meeting the definition of research with human subjects must apply to the pilipili���� Human Subjects Review Board (HSRB) prior to beginning the activity.

Following the guidance of the federal Office of Human Research Protections (OHRP), researchers may not self-determine if a project is exempt from review.  All projects meeting the definition of research with human subjects outlined above are required to submit an HSRB application.

Please refer to Sample Applications for additional information and examples of HSRB project submissions.

Frequently Asked Questions (FAQs)

Q:  I am not sure if my projects meets the definition of research—do I apply?

A:  You are encouraged to contact the HSRB Director at hsrb@rwu.edu for a consultation regarding your project.

Q: My project involves human participants, but I believe it is Exempt from HSRB review.  What do I do?

A:  Researchers are not permitted to self-determine the status of the project.  You should submit an HSRB application.  If your project is Exempt, you will be notified.

Q: What if I have completed a project that may have required HSRB approval?

A: Projects cannot be awarded HSRB approval retroactively.  For questions regarding HSRB compliance regarding completed projects, please contact the HSRB Administrator (hsrb@rwu.edu).

Q:  I have concerns that someone is conducting research without HSRB approval.  What should I do?

A:  Failure to submit an HSRB application for a project which qualifies as Human Subjects Research constitutes noncompliance with HSRB protocols, with potential consequences for continuance of the research and for the researcher’s eligibility on future projects.  Please refer the pilipili���� HSRB Noncompliance protocols and Incident Report Form.

What's Next?

If you are not sure if you need to submit or have other questions or concerns, contact us for a 1:1 discussion of your project at hsrb@rwu.edu.

If you know you need to submit, please continue with Step 2.

Step 2: Before You Submit

Required Training

All employees, students, and co-investigators conducting research with human subjects (affiliated and non-affiliated with pilipili����) must complete education and training via the Collaborative Institutional Training Initiative (CITI). 

Completion of the training is required for all Exempt, Expedited, and Full-board proposals.

All trainings are free, and certification remains valid for three (3) years.

Begin the CITI certification process

Preparing the HSRB Application

The HSRB application is an online survey via the pilipili���� Etrieve Application.  The application is a a single form and you can continue to modify until you submit the form.  If you leave the application, your information will be saved and you can return to complete it later.

However, we strongly recommend that researchers review and prepare all required information for the HSRB application in advance of the submission.  To help you with this process, the HSRB has outlined the Etrieve application as a word document:  HSRB Application Prep.  This document provides step-by-step guidelines for the submission of the HSRB application.

Additional Documentation

Please take note of the guidelines outlined in the documents and links above regarding additional documentation.

The HSRB application requires details and documentation regarding recruitment protocols, copies of informed consents and research materials, descriptions of risks and potential benefits, co-investigator information and training credentials, and other materials particular to each research study.

Completing a Practice Application

To help you to become familiar with the HSRB process, you may choose to complete a practice HSRB application. You may submit as many practice applications as you like.  Practice applications are not reviewed by the HSRB.  Begin your practice application here:

Examples of HSRB Applications

The HSRB recognizes that research with human participants encompasses a broad range of projects and project types.  As noted in the HSRB preparation document, you will be asked to classify your research project type as part of the HSRB application.

Researchers are encouraged to view Sample Applications for examples of HSRB applications.

Frequently Asked Questions (FAQs)

Q:  Do students (undergrad and grad) require CITI training certifications?

A:  Yes.  Anyone identified as a co-researcher on the study must be certified.  This includes all individuals involved in data collection, coding, and analysis.

Q:  Could someone from the HSRB provide a training/workshop on research with human participants (HSRB) to a class or cohort of students?

A:  Yes.  The HSRB welcomes opportunities to visit classes and work with undergraduate and graduate student cohorts in anticipation of their HSRB application for a project or thesis.

Q:  Do I need a CITI certification for co-researchers of my study who are not affiliated with pilipili����?

A:  Yes.  All researchers affiliated with a study must provide documentation of CITI certification.

Q:  Do I need CITI certification for individuals affiliated with an external community organization/community partnership?

A:  It depends.  If the program evaluation is part of standard practices for the organization, CITI certification may not be required.  Please contact us at hsrb@rwu.edu to discuss the specifics of your situation.

Q:  What if I’m not sure if my CITI certification has expired?

A:  We may be able to access that information, and can review your certification as part of your application.  You may need to renew your certification prior to beginning your research study. 

Q:  What does the HSRB application look like?

A:  Here is the link to the . You will log into your Etrieve account and find the application under the Research tab.

What's Next?

If you have questions or concerns regarding preparing your application and/or your agreement/collaborations with other organizations and institutions, contact us for a 1:1 consultation regarding your project at hsrb@rwu.edu.

Prepared to submit?  Please continue with Step 3.

Step 3: How To Submit

Commitment to HSRB Policies and Procedures

Researchers should review and be familiar with pilipili���� HSRB policies prior to submission of an application.   

You can access current HSRB policies on the Important Dates and Forms tab.  

Researchers must commit to compliance with pilipili���� HSRB protocols as part of the verification of the application and as a condition of the approval process.

Submitting the Application

Ready to Apply? Click the below to begin the pilipili���� HSRB application in Etrieve.

Frequently Asked Questions (FAQs)

Q:  Who do I contact for questions regarding my HSRB application and/or the timeline of my review status?

A:  Email hsrb@rwu.edu.

Q:  I am a co-researcher on a study which has been previously approved at another institution.  Do I need to resubmit the study to the pilipili���� HSRB?

A:  You will need to complete an Institutional Agreement Form, and provide copies of the original IRB and documentation of its approval from all cooperating institutions.  You can find this form under the "Important Dates and Forms" tab.

Q:  I submitted an HSRB application, but we have made changes to our study.  What do I do?

A:  If the changes are substantive, you will need to submit a new HSRB application.  Please feel free to contact us at hsrb@rwu.edu for clarification.  (Note that you will need to provide copies of all new materials.)

Q:  My research involves collaborations with colleagues outside of pilipili����.  Is there anything special I/we need to do as part of my HSRB application process?

A:  All researchers affiliated with the study should be identified as co-investigators.  They are required to complete the required CITI certification and submit that to the HSRB.  It is also important to clarify if the study's participants will be recruited from more than one location.  If so, an Institutional Agreement Form may be required.  Please feel free to contact us at (hsrb@rwu.edu).

Q:  In my application, I propose collecting data from an off-campus organization/institution not affiliated with pilipili����.  I have the verbal permission of the manger to allow me to do so.  Will that work?

A:  If you are collecting data from another organization or institution not affiliated with pilipili����, you will need a written statement of consent/permission from a designated manager or authority within the institution, confirming their cooperation and collaboration.  Depending on the nature of the collaboration, this may be an email, letter, statement, or formalized correspondence.  Written documentation is required.

Step 4: After You Submit

Types of Review and Timelines

Once an application is submitted, the HSRB classifies the proposal as Exempt, Expedited, or Full Board review status.

As per the Office of Human Research Protections (OHRP), researchers may not self-determine if their proposal qualifies for Exempt or Expedited review.  The HSRB classifies each application based upon federal guidelines for research with human participants.  The pilipili���� guidelines for the different types of proposal review are as follows:

Exempt

The OHRP outlines several criteria which may qualify an application to be Exempt from HSRB review.  If the HSRB classifies the study as Exempt, the HSRB will provide a formal letter acknowledging the exemption as a record for the researcher, the HSRB, and any relevant community or institutional partners (as needed).  Exempt applications typically will be notified of approval or the need for revisions/additional documentation within 10-14 business days. 

Expedited

Expedited applications require additional review due to potential questions or concerns regarding the study’s consent procedures, research protocols, protections regarding participant’s confidentiality, and/or risks to study participants.  Expedited applications typically will be notified of approval or the need for revisions/additional documentation within 10-14 business days. 

Full

Proposals involving considerable risks or involving potentially vulnerable populations require Full HSRB review.  Applications which qualify for Full review status receive a more comprehensive review by the HSRB.  The HSRB meets, at minimum, once per semester to review Full review board proposals.  Additional meetings may be scheduled, as needed, to accommodate researchers’ timelines for data collection or other deadlines (i.e., for grant proposals, etc.).  Upcoming HSRB meetings are posted in the IMPORTANT DATES AND FORMS tab.  Researchers may also contact the director at hsrb@rwu.edu to request a specific review date.

HSRB Feedback and Recommendations

The HSRB commonly requests addendums, clarifications, and modifications to applications.  The HSRB Director will notify Primary Investigators (PIs) of such requests via Etrieve.  Responses to these requests should be entered directly into the Etrieve system. Questions related to any feedback can be discussed with the HSRB director at hsrb@rwu.edu.

Final HSRB Approval Requirements

Once the HSRB approves the study, the HSRB Director sends a formal notification letter to the Primary Investigator via Etrieve requiring an electronic signature.  For student submissions, the PI Faculty will be required to sign this letter in addition to the student researcher.

The HSRB approval letter must be signed by the PI prior to initiating data collection.  Once the letter has been signed, it is automatically returned to the HSRB office, and the researchers may begin the research process.  PIs will also receive a confirmation email sent via Etrieve to your pilipili���� email.

NOTE:  The Etrieve system will house a copy of the entire application and will contain the signed approval letter.  This letter can be downloaded in the event the PI, or their co-investigators, must provide documentation regarding their HSRB approval.

Frequently Asked Questions (FAQs)

Q:  By the standards of the Office of Human Research Protections (OHRP), my study qualifies as Exempt.  Do I need to apply?

A:  Yes.  According to the OHRP, researchers may not self-identify their research as Exempt.  You should submit an application to the HSRB.

Q:  I am not sure if my project requires Full Board Review.  What do I do?  

A:  The HSRB will determine the status of your review.  If it requires a full board review, you will be notified within 10-14 days after you submit your application.

Q:  I am continuing a research study previously approved by the HSRB, with a new group of students.  Do I need to reapply?

A:  No. You may update your the names of you co-researchers and their CITI certifications using the Protocol Change Application (see Important Dates and Forms).

Q:  Do I need to sign and return a hard copy of my HSRB approval letter?

A:   No.  An electronic copy of your approval letter will be automatically returned to the HSRB.

Step 5: After Approval

Following approval by the pilipili���� Human Subjects Review Board (HSRB), researchers must continue to adhere to federal and institutional policies and procedures relating to research with human subjects.  

The Primary Investigator (PI) for an HSRB-approved study retains responsibility for the following:

• Adherence to the specific recruitment strategies and methodology set forward in the HSRB application
• Ongoing compliance with HSRB policies
• Monitoring and reporting protocol changes
• Reporting issues of researcher noncompliance (unintentional and intentional) and/or concerns regarding risks to human participants
• Requests for extensions and final reporting regarding the study's completion

Protocol changes

Researchers must adhere to the methodology and procedures specified in the original HSRB document throughout the course of the research study.  Changes to the protocols of approved, ongoing studies must be report and vetted by the board.

Examples of protocol modifications include (but are not limited to):

• Newly identified risks to be disclosed in the informed consent
• Changes to the research questionnaire (adding or modifying measures)
• Adding co-investigators or researchers
• Using incentives not previous disclosed
• Expanded participant recruitment strategies
• Modifications in data coding and/or storage protocol
• Adjustments in observational procedures, locations, times, etc.

Protocol changes should be submitted using the following form:

The HSRB will review the changes to determine if the study continues to meet approval status or requires additional review/revisions.

Potential incidents of risk and/or noncompliance

Al primary investigators and researchers affiliated with an HSRB-approved study maintain responsibility for upholding the ethics of research with human participants as outlined by the pilipili���� HSRB Policies, the Office of Human Research Compliance (OHRP), and all other organizational and institutional policies particular to a specific research study.

Any individuals with concerns about a study's risk to participants or noncompliance with protocols relating to human subjects research should document and report the incident as soon as possible using the 

Additional information regarding pilipili���� policies for reporting potential issues of risk or noncompliance may be accessed in the Policies and Membership tab.

HSRB status updates

Approval status continues for one (1) year following the pilipili���� approval letter for the study.  Within that timeframe, primary investigators (PIs) should confirm the completion of their study OR their intent to continue their research via the .

This form allows PIs seeking to continue their research beyond the one (1) year approval period to apply for a continuance of their study.

Reactivation of a study

If a study has expired (failed to apply for continuance and has not submitted a status conclusion, researchers may apply for review of a study reactivation.  These applications will be reviewed on a case-by-case basis.

Researchers should contact the HSRB (hsrb@rwu.edu).  Please include the protocol number, the name of the primary investigator, and the title of the original study in the email.
 

Note that eligibility as a continuation study requires documentation of the continued relevance of the research portals and procedures in relation to current research/best methodological practices, and may require a new application.

Final reporting

Researchers should use the  to document the conclusion of data collection/recruitment protocols outlined in the HSRB.  For the final reporting purposes, the form requests documentation of characteristics of the final sample (i.e., number of participants, demographic characteristics) and of the data collection protocols (i.e., risk to participants, incidents of concern), as per the original HSRB proposal and policies.

Please contact hsrb@rwu.edu for any further questions regarding past and future research proposals.

Frequently Asked Questions (FAQs)

Q:  Why do I need to submit a status update on my research?

A:  The OHRP requires IRBs to report on their research annually, as part of the federal approval process.  

Q:  Where do I find my HSRB protocol number?

A:  The unique HSRB protocol number associated with your study is included in your HSRB approval letter.

Q:  I have a question about a study previously submitted to the HSRB.  Where can I access that information?  

A:   The HSRB maintains electronic records of all applications.  Please contact us at hsrb@rwu.edu.