Frequently Asked Questions
Do I need to submit my research?
- All research using human subjects must be submitted to the IRB. If your project has the purpose of contributing to generalizable knowledge, with some sort of dissemination (including, but not limited to, publications, presentations), then it is research. If there is any interaction with, or information about, individuals, then it is considered human subjects research. Regardless of whether you think it may be exempt review, you must submit to the IRB.
How long will the process take once I submit?
- The IRB reviews applications on a rolling basis, meaning we review them whenever they are submitted. For most exempt and expedited applications, our goal is to complete the review within three weeks. Applications that require additional feedback (as determined by the Board) from the principal investigator (PI), or those that require a full Board review may take longer.
If I want to include ESC students in my study, what student information is available?
- Disclosure of Directory Information- Student directory information which can be released by the college without prior consent of the student is limited to the following (as authorized by FERPA):
- phone number
- dates of attendance
- most recent previous educational institution attended
- major area of concentration
- degree and awards earned
- participation in officially recognized college activities
- date and place of birth
- email address
- enrollment status
If I want to include ESC students, faculty and/or staff members in my research, is institutional approval required in addition to IRB approval?
- Yes. If you plan to include ESC students, faculty and/or staff members in your population of subjects to be studied, the Provost and Vice President of Academic Affairs will need to grant consent for them to be included. Upon submission of your research application to IRB.Review@esc.edu, your application will be forwarded to the Provost/VPAA prior to the IRB conducting its review. The Provost/VPAA is only approving the participation of those individuals in the study, and not approving the study itself as that review is the responsibility of the IRB.
If my research involves other institutions, do I need to get their permission in advance?
- Yes, and it needs to be in writing. For each participating / collaborating institution (schools, prisons, clinics, etc.) you need to obtain permission by way of a signed letter from a senior administrator who has the authority to grant such permission. The letter should outline in detail the roles and responsibilities of each institution and the primary investigator(s), as well as who will be included as subjects of the study. For research within school districts, New York State law requires that the superintendent of schools (not a principal) grants permission in writing. Please include a copy of each letter with your IRB application.
Who are considered vulnerable subjects?
Special Consideration for Projects Involving Vulnerable Populations
pregnant women, human fetuses and neonates
cognitively impaired persons
students and employees
economically and/or educationally disadvantaged
terminally ill Subjects
Vulnerable Subjects and Exempt Research
Due to the vulnerable nature of the population the exemptions in 45 CFR 46.101(b) do not apply to certain types of research involving children and prisoners, Subparts C and D.
Specifically, the exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, Subpart D, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.
In addition, exemption from IRB review should be utilized conservatively when applied to research involving special classes of subjects who are not be defined by regulation as vulnerable.
Who do I contact if I have questions?
- Email your question(s) to IRB.Review@esc.edu.