Human Research Protection Program

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Human Research Protection Program

LaGuardia Community College: Human Research Protection Program and IRB

CUNY Research Integrity & Compliance

CUNY Human Research Protection Program (HRPP)
The CUNY Human Research Protection Program (HRPP) is responsible for the protection of the rights and welfare of human subjects in research conducted at CUNY or by CUNY faculty, staff and students and RF CUNY staff. CUNY applies the ethical principles and federal regulations to all human subjects research conducted at CUNY or by CUNY employees (faculty and staff) and students, regardless of funding or funding source. The program provides oversight, administrative support and educational training to ensure that CUNY research complies with Federal and State regulations, University policy, and the highest ethical standards. The CUNY HRPP comprises of University Integrated Institutional Review Boards (IRBs) and on-site HRPP offices. LaGuardia HRPP Office is one of them.

The CUNY UI (University Integrated) IRB
The Institutional Review Board (IRB) for the Protection of Human Research Participants is an independent compliance committee mandated by the U.S. Department of Health and Human Services (DHHS). The role of the IRB is to protect the rights and welfare of persons recruited to participate in research activities conducted under the auspices of the University. The IRB reviews proposed research protocols to ensure that the proposed research follows federal guidelines and accepted ethical principles. The IRB has the authority to approve, require modifications, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy. Research that has been reviewed and approved by the IRB may be subject to review and disapproval by officials of the institution. However, those officials may not approve research if it has been disapproved by the IRB.

Contact HRPP Coordinators

HRPP Coordinators are working remotely via email or phone and in-person meetings are available by appointment. Please contact Dr. Xiwu Feng by email if you have questions regarding IRB application or need assistance in IRB submission via IRB Manager. Consultations and trainings will be available remotely or in person as needed.

Xiwu Feng, CUNY IRB Member,
Professor Education and Language Acquisition
LaGuardia Community College, B234N
Phone: (718)-482-5623
Email: xfeng@lagcc.cuny.edu
Rejitha Nair, Ph.D.
Executive Associate, Academic Affairs
LaGuardia Community College, Room M-403B
Phone: 718-482-5149
Email: rnair@lagcc.cuny.edu

IRB Manager FAQs

What is the link for IRB Manager?

https://cuny.my.irbmanager.com/

What credentials will be used to access IRB Manager?

From the IRB Manager home page, select “To login using CUNY Login”. You will use your CUNYFirst credentials, where your username is entered as firstname.lastname##@login.cuny.edu followed by the password associated with that username.

If you are a CUNY researcher/research personnel who DOES NOT have CUNYFirst credentials, request an IRB Manager account by emailing (HRPP@cuny.edu) and include the following information in your email:

- First and Last Name
- EMPLID
- DOB
- PIN (4 digits – you can make something up)
- CUNY email address
(You will be notified within 1-2 business days with your credentials to log into IRB Manager.)

Will I have to upload my current CITI Certifications?

No. If you have completed CITI training as a CUNY researcher, information related to your CITI training will be linked automatically to your IRB Manager profile, and will be available to HRPP and IRB reviewers; however, you MUST log into CITI (link provided below) and confirm that your preferred email address in CITI is your CUNY email address. Your secondary email address should be a personal email address. Your preferred email address is to ensure your CITI Certification is linked to your profile in IRB Manager.

The process for confirming and/or changing your preferred email address in CITI is as follows (this process applies to ALL research personnel on a protocol (if applicable):

Log in to CITI at https://www.citiprogram.org
In the upper right corner under your name and ID, click the down arrow.
Select “Profiles”.
Under “Member Profiles”, click “Edit Profile”.
Scroll down to Your preferred email address.
Confirm that this is your current CUNY email address, or revise if needed.

If you have not completed this process above then you MUST upload our current CITI Certification to your profile in IRB Manager. As a reminder, your CITI Certification is required for HRPP/IRB review of your IRB application.

Will Faculty Advisors be able to review a student PI’s IRB application before the student PI submits the application for HRPP/IRB processing and review?

Yes. Faculty Advisors will review and sign off on their student PIs IRB applications. Faculty Advisors will also receive email notifications on their student PIs IRB applications.

What is meant by ONLY shells will be migrated into IRB Manager?

Only the information below will be migrated from IDEATE into IRB Manager:

Protocol Number
Protocol Title
Approval Period
Approval Category
Research Personnel
Link to the IDEATE protocol

If ONLY the shell will be migrated, how do I get my active approved protocol into IRB Manager?

The current process is for researchers and/or their staff to create an amendment to populate their active approved protocol in IRB Manager with the details and documents retrieved from their active approvedIDEATE protocol. Researchers may also obtain assistance from staff at CUNY Central. Please coordinate this process with your campus HRPP Coordinator Office.

Will research personnel be able to create IRB applications on behalf of the PI?

Yes; however, the PI will be required to review and sign off on the IRB application before it is submitted forHRPP/IRB processing and review. This is the same process from IDEATE.

What can I do to prepare for the move from IDEATE to IRB Manager?

Attend IRB Manager training and have your students and research personnel attend training as well. Look for your protocols in IDEATE and ensure that any pending tasks are addressed. Get in touch with your HRPP Coordinator with any specific questions about your protocols.

Download your IDEATE applications, documents, and approval letters.

The process is as follows:

To download an application and attachments:

The current approved attachments can be downloaded from the LiveList application Attachments tab or via each Submission.

To create a PDF of the application:

From the LiveList, go to the Lifecycle Event Manager tab, Submissions, and click “View”
Under Details for the Initial Application (or the most recent approved Amendment, which would then reflect the current approved application), a pop-up window will generate; click “Print” in the upper right corner to generate a PDF of that submission.

You can do this for each submission to keep a record in your files. You can also download the attachments included with each submission via this process.

Approval letters can be downloaded from the LiveList – go to the Communications tab.

What will happen to my protocols in IDEATE that are closed or expired?

Researchers need to comply with the CUNY’s retention policy for human subjects research. It is highly suggested that researchers log into IDEATE and save their closed and expired protocols.

Q. Will I have access to my IDEATE protocols indefinitely?

No. For active approved protocols that are migrated from IDEATE to IRB Manager, you will be able to access the IDEATE protocol via a link for a period of time, but there will be a deadline for transferring data from IDEATE to IRB Manager.

Please contact the Office of Research – Research Integrity & Compliance at hrpp@cuny.edu if you have any questions about the transition and/or the registration for training.

CUNY Policies & Procedures

Please click HERE for CUNY Policies & Procedures:

Submitting to the IRB
Review Types and Processes
IRB Requirements
Informed Consent
Types of Research
Education and Training, etc.

Submitting to the IRB

All Applications (Exempt, Expedited or Full) should be submitted via online to the PI's primary affiliationor home campus. Primary affiliation or home campus is where a PI has his/her full-time appointment.
CUNY Students should submit their applications to their faculty advisor’s primary affiliation.
IRB Manager is being used for all submissions, including new protocols, continuing reviews, amendmentsresearch determination forms, final reports, etc.
Instructions and directions for submitting all protocols can be found from IRB Manager homepage.
If you are unsure about which forms to submit, please contact LaGuardia Community College HRPPOffice.
Faculty Advisors will review and sign off on their student PIs IRB applications before the student PIsubmits the application for HRPP/IRB processing and review. Faculty Advisors will also receive emailnotifications on their student PIs IRB applications.

To assess IRB Manager, please click HERE

Logging-in

Investigators are to use their CUNYFirst credentials to log-in to IRB Manager.

From the IRB Manager home page, select “To login using CUNY Login”. You will use your CUNYFirst credentials, (firstname.lastname##@login.cuny.edu + the password) to create an account in IRB Manager.

First and Last Name
EMPLID
DOB (Does not need to be your actual DOB)
PIN (4 digits – you can make something up)
CUNY email address

You will be notified within 1-2 business days with your credentials to log into IRB Manager.

IRB/HRPP Submission Checklist :

Verify that all application questions (tabs) have been relevantly and accurately answered.
Add all Co-PIs, Faculty Advisors and Research Personnel to the Personnel tab.
Are all recruitment materials, consent documents, and data collection materials (i.e., survey and/or interview questions) attached within the application?
Did you describe your study’s consent process within your application?
Has the screening process been clearly outlined in your application if your study needs careening process?
Have all Research Personnel’s valid training certificates - CUNY’s CITI Human Subjects Research (Social & Behavioral) been properly linked with your application?
For Student Researchers: Has your Faculty Advisor reviewed and approved the application? Has the Advisor’s CUNY HSR CITI certificate been properly linked?
For Multi-Site/Collaborative Research: Have collaborating sites been added as External Sites (in the Research Sites tab)? Have relevant determination letters and/or letters of support been attached?
For Funded Research: Has the information in the Funding tab been answered completely?
For International Research: Has you reviewed the CUNY International Research policy and included the requested information in the IRB application?

Education and Training Certificates

A. Training Requirements

All research personnel involved in human subjects research must complete the CUNY- required modules of the Collaborative Institutional Training Initiative's (CITI) online training in the protection of human subjects (basic course) prior to IRB approval of a new, continuing, and amendment review application. The following certificates must be attached with the submission for HRPP/IRB review of your IRB application:

Human Subjects Protection Basic Course (CITI) for Social & Behavioral Faculty, Graduate Students & Postdoctoral Scholars,
Responsible Conduct of Research (RCR).

Instructions for completing this training are available from CUNY Policies and Procedures

For the Collaborative Institutional Training Initiative, please click CITI Program to Register.

Organization – “City University of New York.”

Online training certificates will be valid for three years. Key personnel are required to take the CITI training in the protection of human subjects (Refresh Course) every 3 years following completion of the basic course.

Definition

Key Personnel are defined as the Principal Investigator, co-investigators and research personnel who interact directly with human subjects or who have access to private information related to human subjects during the course of a research project. Key personnel also include faculty sponsors /advisors who provide direct oversight of research with human subjects or research using private information about human subjects.

B. CITI Training Automatic Linking to Your IRB Manager Profile

If you have completed CITI training as a CUNY researcher, information related to your CITI training will be linked automatically to your IRB Manager profile, and will be available to HRPP and IRB reviewers; however, you MUST log into CITI (link provided below) and confirm that your preferred email address in CITI is your CUNY email address. Your secondary email address should be a personal email address. Your preferred email address is to ensure your CITI Certification is linked to your profile in IRB Manager. The process for confirming and/or changing your preferred email address in CITI is as follows (this process applies to ALL research personnel on a protocol (if applicable): :

Log in to CITI at https://www.citiprogram.org
In the upper right corner under your name and ID, click the down arrow
Select "Profiles"
Under “Member Profiles”, click “Edit Profile”
Scroll down to Your preferred email address
Confirm that this is your current CUNY email address, or revise if needed

NOTE: If you have not completed this process above, then you MUST upload our current CITI Certification to your profile in IRB Manager.

Researcher's Guide to IRB Manager

IRB Manager Manual and Videos are available on the CUNY HRPP Website -IRB Manager and on the right side of the IRB Manager website (to view these resources on IRB Manager you must click on the view dashboard link).

For IRB Manager Manual for PI, Click HERE

Training Videos

Review of Protocols

Does Your Project Warrant IRB Review?

The study requires advance IRB approval if it meets the following:it is designed to develop or contribute to generalizable knowledge;it involves a systematic investigation to obtain information from or about living individuals;it is conducted by CUNY faculty, staff, and students.

Such projects need IRB review: funded and non-funded questionnaire, interview, qualitative, secondary, experimental research, and pilot projects. However,In-class exercises done wholly for pedagogical purposes and institutional research (assessments) that are not disseminated externally do not require IRB approval.

Reviewing Processes

Human Subjects Research Determinations: Submissions that require a determination of whether the Research is considered “human subjects research” and falls within the purview of IRB review, will be conducted by the campus HRPP Coordinator.

The HRPP Coordinator confirms the researcher’s CITI training status, determines if the study involves vulnerable populations, and assesses any implications of external funding or other institutions’ involvement. The HRPP Coordinator will conduct an administrative review for all applications (also known as packages) submitted via IDEATE with the exception of continuing fullboard applications. The HRPP Coordinator will review exempt packages to determine if it meets the definition of research as defined by the federal regulations per 45 CFR 46.102 (d) (f). Once all requested information has been submitted by the PI, the Coordinator will forward the package to the Expedited Reviewer for review. If particular expertise is needed, the LaGuardia HRPP Office in consultation with the CUNY Office of Research will select a CUNY UI IRB Member with the required expertise.

Review of Exempt or Expedited protocols takes five business days. The review process for protocols submitted for Full Review can take up to a month or longer to complete.

HRPP FAQs

This Q&A page addresses some of the most commonly raised issues pertaining to HRPP/IRB Review:

Does My Project Warrant UI IRB Review?

If a study is designed to develop or contribute to generalizable knowledge, and if it involves obtaining information from or about living individuals, the project requires advance UI IRB approval. Such projects include funded and non-funded questionnaire, interview, qualitative, secondary, and experimental research. Pilot projects need review.

In-class exercises done wholly for pedagogical purposes need not be submitted for prior UI IRB review, and institutional research that is not disseminated externally does not require approval. Research conducted by faculty, staff and students needs IRB approval.

What does the IRB look for in an application?

The IRB seeks:

Research design that's sound, given the proposed use of human subjects in the project
Equitable selection of subjects
Balanced risks and benefits
A thoughtful and comprehensive informed consent process

What steps do I need to take if I want to submit something for the IRB to review?

First, contact your campus HRPP Coordinator xfeng@lagcc.cuny.edu for any necessary consultation on new and/or existing protocols. Second, review CUNY Policies & Procedures for step by step instructions on submitting a project for review.

What documents and information do I need to include for a new protocol? A continuation request? An amendment?

Please refer to the “Submitting to the IRB” section within the “Policies, Procedures & Guidelines” section of the CUNY HRPP website for submission checklists on the required items for specific submissions. Click HERE.

Where do I submit my application?

You can ONLY submit your application electronically by Logging in to IRB Manager at the link - https://cuny.my.irbmanager.com/

How do I log-in to IRB?

Investigators are to use at their CUNYFirst credentials, “To login using CUNY Login” to IRB Manager.

Who do I contact for a status/update on my study I submitted?

Log in to IDEATE and click on the protocol for which you need a status update.If you still have questions, please contact HRPP Coordinator xfeng@lagcc.cuny.edu for information regarding your study.

I am a CUNY faculty member with multiple CUNY campus affiliations. How do I affiliate with CUNY campus in my user profile in IRB Manager?

CUNY Faculty must affiliate themselves with their primary campus and submit all human research proposals to the primary campus.

I am a faculty member and would like to conduct research at a CUNY campus other than my own or the one I am primarily affiliated with. Where do I submit the submission package for review?

Researchers must submit their submission packages to the CUNY HRPP office of their primary campus, e.g. “LaGuardia Community College HRPP Office.”

What if I am an adjunct professor?

CUNY adjunct faculty who wish to conduct human subject research as part of their institutional responsibility at CUNY should obtain an approval from their Provost prior to submitting an IRB application. Please complete the form and attach it with your IDEATE submission and Current CV. See CUNY Adjunct Faculty as PI of IRB Application Form.

I would like to conduct research at an outside (non-CUNY) institution, is there anything I should know?

Please contact your campus HRPP Coordinator for guidance on conducting research at non-CUNY institutions. If you are planning research at an international setting or multiple non-CUNY institutions, please refer to the policy on Collaborative Research.

How long does review take?

An Exempt Review takes no more than five business days and an Expedited Review takes about 10 business days. The review process for protocols submitted for Full Review can take up to a month to complete. You should include sufficient time in your research plan as allowance for any IRB-required changes to the research protocol.

I want to administer my study in a language other than English. What do I do?

All consent documents and instruments must be translated. The IRB must certify that the translated documents translate equivalently in English.

I'm working with other researchers on this project. What should I do?

The protocol package in IRB Manager should specify these researchers and their CITI certificates must be attached to the package being submitted for review.

How do I know when my protocol has been approved?

You can check the progress of your submission on your IRB Manager homepage. Once an approval letter has been issued, an email will be sent to you notifying you of this.

My research is finished. Now what?

You must complete a Continuing Review before its expiration date and a Final Report form upon completion to inform the committee about your research. These forms can be completed in the IRB Manager website. This form can be completed in the Ideate website.

Online Surveys

Security of the data is extremely important when online surveys are used. The IRB therefore recommends that researchers use the encrypted version of commercial software (e.g. Survey Monkey). This version, sometimes referred to as a professional version, protects the confidentiality of the transaction. There is usually a fee for the encrypted version.
If you are using Survey Monkey (or other commercial software), please add the following language to the consent form:

“We are making every effort to ensure that no one knows what your responses were on the survey. Survey Monkey (or other commercial software) is a well known company that collects data for online survey research. The researchers have purchased an encrypted version of their product to reduce the risk to subjects that their responses will be viewed by unauthorized persons. However, the study is not being run from a secure http server such as those used to handle credit card transactions, so there is a small possibility that responses could be viewed by unauthorized third parties, such as computer hackers.”
Please include the online version of the survey with your application. The IRB requests the online version to ensure the following:

A. The survey includes the necessary language. Most commercial software vendors (e.g. Survey Monkey) will allow you to create surveys for free.
B. Participants should have the option to skip questions. The IRB must ensure that the survey is designed so that participants are not forced to answer one question before going to the next.

Informed Consent Forms

Please follow the instructions and then fill in Informed Consent Document Template. Click HERE