Institutional Review Board (IRB)
Questions or comments about the committees, about submitting protocols, or about the information contained in these pages can be directed to Lois Levy at lois.levy@lehman.cuny.edu or by phone at 718-960-8717.
Institutional Review Board for the Protection of Human Subjects
The Institutional Review Board for the Protection of Human Subjects (IRB) is dedicated to the protection of human research subjects by fostering the ethical conduct of research at Lehman College and ensuring compliance with federal and state regulations pertaining to research with human beings. The IRB also provides education to researchers, and those acting in a supervisory or administrative capacity to researchers, to ensure that all research is conducted in an ethical manner, and to ensure that all research gets submitted to and approved by the IRB prior to the recruitment of any subjects. Finally the IRB provides aid to researchers so that valuable human-subjects research can precede in a safe and humane way that does not put subjects or research institutions at risk. This page contains information to help faculty, students and staff learn about ethical principles of research with human participants and how to submit a protocol to IRB.
Frequently Asked Questions
What is the IRB?
- An IRB (Institutional Review Board for human participants) is a group of at least five individuals with varying backgrounds to promote complete and adequate review of research studies. An IRB conducts the initial and annual reviews of a research study.
What is a human participant?
- A human participant is a living individual about whom a researcher obtains data through intervention or interaction (interviews) with the individual, or through identifiable private information (data with identifiers)
What is research?
- Research is defined as a systematic investigation, including pilot research, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research that needs to receive IRB approval before the research can begin.
How do I know if I should submit a research application to the IRB?
- If an investigator’s (faculty and students) research project involves any human participants (including observation, interviews, surveys and data collection), an IRB application must be submitted. (IRB approval cannot be given retroactively.)
What are the review categories of an IRB application?
- There are three review categories depending on the potential risk to the participants. Full Review (high risk) needs full IRB review; Expedited Review (minimal risk) needs two IRB members to review; and Exempt Review (low risk) and is reviewed by the Chair of the IRB.
What is exempt research?
- Exempt does not mean exempt from IRB review. The IRB rather than the researcher determines when research is exempt. Researchers proposing exempt research should submit an IRB application requesting exempt review. Examples of exempt research include educational tests, surveys, or interviews without individual identification or the use of existing data, documents, or other records without individual identifiers.
What is the difference between anonymity and confidentiality with research subjects?
- Anonymity means the researcher has no record of the identity of the participants. For example, having participants mail back questionnaires or hand them back in a group, without names or other unique identifiers. Or working with data where all the identifiers have been removed.
Confidentiality means the researcher knows the identity of the participants but will keep the participants’ identity and all identifying characteristics confidential.
Timetable
If you are submitting an exempt or expedited (see definitions below) research study submit 1 paper copy to Shuster Hall, room 330 and email a copy to the IRB at lois.levy@lehman.cuny.edu. There is no deadline for submitting under these categories. A response will take about three weeks. Keep in mind that the final determination whether a research study is exempt, expedited or full will be made by the IRB.
If you are submitting a research study for a convened meeting, submit 11 paper copies to Shuster room 330 and email a copy to lois.levy@lehman.cuny.edu by the dates listed:
IRB Meeting Schedule
Protocol Submission Deadline Meeting Date
Protocol Submission Deadline |
Meeting Date |
August 29, 2007 |
September 12, 2007 |
| September 26, 2007 | October 10, 2007 |
| October 31, 2007 | November 14, 2007 |
| November 28, 2007 | December 12, 2007 |
| January 30, 2008 | February 13, 2008 |
| February 27, 2008 | March 12, 2008 |
| March 26, 2008 | April 9, 2008 |
| April 30, 2008 | May 14, 2008 |
Instructions & Guidelines
- CUNY Office of Research Conduct [PDF]
- CUNY Policy for Student Research with Human Subjects [PDF]
- Describing Your Research to the IRB and Sample[PDF]
- Exempt Review Categories [PDF]
- Expedited Review Categories [PDF]
- Training Requirements for Researchers
- Special Protections for Children as Research Subjects
- Waiver of Informed Consent; Waiver of Documentation of Consent
Checklists
Forms
- Application for Approval to Use Human Subjects in Research (Word File)
- Continuing Review/Final Report [Word]
- Sample Consent Forms [Word]
- Request for Amendments/Modifications [Word]
- Lehman/CUNY Research Determination Form [Word]
- HIPAA Forms: for information go to CUNY Office of Research Conduct
General Information, Policies & Links
- The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (NIH)
- Office of Human Research Protections
- Code of Federal Regulations (45 CFR 46)
- The Milgram Study
- The Nuremberg Code
- The Tuskegee Study