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Frequently Asked Questions

What is the purpose of the Institutional Review Board (IRB)?

The role of the HRPP/IRB is to protect the rights and welfare of persons recruited to participate in research activities conducted under the auspices of Hunter College. The CUNY UI-IRBs have the authority to approve, require modifications to, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy.

 

What is human subjects research?

Human subjects research is a systematic investigation designed to develop or contribute to generalized knowledge, or investigation designed to test a hypothesis.

 

Who must apply for review by the Human Research Protections Program (HRPP)/IRB?

Anyone who wishes to conduct research with human subjects. HRPP/IRB review is conducted regardless of funding. Conducting human subjects research without prospective HRPP/IRB review and approval is considered nonā€compliance.

 

What are the different levels of HRPP/IRB review?

  • Not Human Subjects Research (NHSR)
  • Exempt ("Exempt" does not mean the protocol is exempt from IRB review)
  • Expedited (review category)
  • Full/Convened Board (greater than minimal risk, non-compliance and adverse events)

 

How often does the Full/Convened Review meet?

The UI-IRBs meet twice a month to conduct full-board reviews. Expedited and exempt reviews occur on a rolling basis.

 

Do I have to attend the IRB meeting when my IRB application is reviewed?

No. If the Full/Convened Board has questions, or believes the investigator(s) could lend valuable insight for review, the IRB Administrator and/or HRPP Coordinator may contact the researcher during the meeting. You will be notified in advance if you need to attend a scheduled IRB meeting.

 

How long does HRPP/IRB review?

HRPP/IRB review is about two to three weeks; however, it depends on the completeness of the IRB application. The review process for protocols submitted for Full Review can take up to a month. You should include sufficient time in your research plan as allowance for any HRPP/IRB review required changes to the research protocol.

 

How do I submit an IRB application for review?

All IRB applications for new, continuing review, amendments, and final reports are submitted electronically. The HRPP/IRB does not accept any paper applications. Please log into IRBManager with your CUNYFirst credentials. The information under Notices in IRBManager should be reviewed. The PI manual is also located under Notices. For more information on submitting an application, please see the HRPP/IRB section of this website.


How do I know the IRB will understand my proposed research?

The study application should be written in language understandable to a non-scientists/non-specialist.

 

What does the IRB look for in an application?

The IRB seeks applications that are:

  1. Consistent - throughout the application and the supporting documents.
  2. Clear - what you have written on the application should be clear to anyone who does not do research or is not familiar with the type of research you will be conducting. This includes the supporting documents.
  3. Concise - brief but comprehensive.


Can Adjunct Professors conduct human subjects research?

Adjunct Faculty who wish to serve as PI for non-exempt human subjects research must obtain prior written approval from the Vice Chancellor for Research. To request an approval, the adjunct faculty must submit CUNY Adjunct Faculty as PI of IRB Application. Please send the completed form along with the Hunter College Provost's approval and a copy of your CV to hrpp@hunter.cuny.edu. More information on this policy can be found in the Principal Investigator Qualifications and Responsibilities.

 

Is training required for human subjects research?

All research personnel must complete training in Human Subjects Research (HSR). See CITI training for all training requirements. Your campus email address should be used as your primary email at registration. Certificates are issued at the completion of the training.

 

How do I know when my IRB application has been approved?

You can check the progress of your submission on your IRBManager Dashboard. Once approved, you will receive an automatic email notification from IRBManager with your approval letter.

 

When should a continuing review, amendment, or final report be submitted?

Based on a change to federal regulations in 2019, CUNY no longer requires continuing review of minimal risk research studies. However, please check to make sure your protocol does not have an expiration date.

Any changes to an active protocol, including changes to research personnel, require submission of an amendment application for review and approval.

A final report should be submitted at the conclusion of the research study. All human subjects research activities should be completed, including analysis of all identifiable data and/or specimens.

 

What is the difference between identifiable and de-identified data?

Identifiable: Means the identity of the subject is known or may be readily ascertained by the investigator or anybody associated with the information.

Identifiable data can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems, or when characteristics of the information obtained are such that by their nature a reasonably knowledgeable person could ascertain the identities of individuals.

De-identified data: If the dataset has been stripped of all identifying information and there is no way that it could be linked back to the subjects from whom it was originally collected (through a key to a coding system or by any other means). Its subsequent use by the PI or another investigator would not constitute human subjects research, since it is no longer identifiable.


However, even though a dataset may have been stripped of direct identifiers (names, addresses, student ID numbers, etc.), it may still be possible to identify an individual through a combination of other characteristics (e.g., age, gender, ethnicity, and place of employment).

 

What is an adverse event and how do I report it?

Breaches in protocol, adverse events, and unanticipated problems include, but are not limited to, breakdowns in the consent process, violations of confidentiality of the data, complaints by participants, and adverse physical events. Serious problems and adverse events must be reported to the HRPP/IRB within 48 hours.

 

What if I am collaborating with researchers affiliated to other institutions?

The research team should consider getting in to an IRB Authorization/Reliance Agreement (IAA). An IAA is the process by which one institution's IRB assumes IRB responsibilities for another institution. These types of agreements are put into place after HRPP/IRB approval for research studies approved under an expedited category or the full/convened board.

 

How do I add non-CUNY/independent investigators to my research study?

An Independent Researcher Agreement (IRA) is the mechanism by which an individual who is not affiliated with CUNY or another institution can be involved in research activities being conducted by CUNY. The IRA requires the completion of an Independent Researcher Agreement Application. The application can be found on CUNY's Research Agreements webpage. This can be linked to our website.

 

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

All consent documents and instruments must be translated after HRPP/IRB review and approval via an amendment application. Please see instruction in section 5 of the Informed Consent Process and Documentation policy.

 

Who is considered a vulnerable subject?

Subjects that are minors, prisoners, fetuses, pregnant women, or individuals that have a diminished mental capacity are considered vulnerable subjects.

 

FERPA Compliance-Use of Educational Records for Research

Please see the information found in this guidance document for information on methods of using educational records for research and maintaining FERPA compliance.

 

What are my responsibilities after protocol approval?

You are responsible for:

  • Familiarizing yourself with ethical guidelines and regulations regarding the protection of human participants from research risks
  • Conducting the research according to the approved protocol
  • Obtaining written informed consent using the approved consent form for each and every study participant if required by the IRB
  • Immediately reporting any unanticipated effects on participants which become apparent during the course of the study and the actions taken as a result, to the IRB through the HRPP Office and your immediate administrator
  • Obtaining prior review from the IRB if you wish to amend or alter the scope of the project or implement changes in the approved consent form
  • Maintaining documentation of consent forms and progress reports for three years in a safe place
  • Once the research is completed, submit the final report

 

I still have questions. Who can help?

HRPP Office at (212) 650-3053 or hrpp@hunter.cuny.edu

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