Institutional Review Board (IRB)
Office of Regulatory Research Compliance LCSB 28
(Phone) 442-9050 (Fax) 442-9997 (E-mail)
Version 09.01.11
IRB SCREENING FORM
Please complete form electronically; handwritten forms will not be accepted
All faculty, staff and students at the University at Albany conducting research involving human subjects must submit their research protocol to the IRB for review and approval prior to commencing the project.
While many scholarly and artistic activities undertaken by faculty, staff, and students at the University at Albany involve human participants, not all are defined as research involving human subjects that require IRB review.
An activity requires review by an Institutional Review Board when it meets the federal definition of
Research involving + Human subjects. The activity must meet both tests. This screening form is designed to assist faculty, staff, and students to determine whether their activities are 'human subjects research' that require submitting an IRB protocol. For those who are aware that their projects will definitely require IRB review, the screening form need not be completed and you should complete and submit an IRB protocol application.
Principal Investigator (PI) Contact Information
Principal Investigator (PI):The PI is the individual who has absolute responsibility for the overall conduct of all activities involving human subjects, including all technical, compliance and administrative aspects. The PI is responsible for controlling the technical direction and academic quality of the project, and for ensuring the project is carried out in compliance with the terms, conditions, and policies of the sponsor, the IRB, and the University at Albany.
Name: / Department
Affiliation: / University at Albany College of Nanoscale Science and Engineering
The Neural Stem Cell Institute Other (specify):
Campus address: / E-mail Address **(must be a UAlbany domain email address, e.g, , etc.)
Phone: / Fax:
Position: / Faculty Staff UAlbany Undergraduate Student* UAlbany Graduate student* Other specify : ()
*UAlbany requires a faculty advisor to serve as co-investigator. **Email is the primary contact used by our office.
Co-investigator:
(Is also the individual designated to oversee research activity in the PI’s absence.)
Name / Department
Affiliation: / University at Albany College of Nanoscale Science and Engineering
The Neural Stem Cell Institute Other (specify):
Institution Name (if not affiliated with UAlbany):
Address: / E-mail Address
Phone: / Fax
Position: / Faculty Staff UAlbany Undergraduate Student* UAlbany Graduate student* Other specify : ()
Project Title:
Answer all of the following questions:
1. Will research be supported by sponsored by funding (UAlbany or Extramural)?
No Yes
If “YES” provide Source of Funding and Name of Sponsor
2. Is your project “research”? Research is a systematic (having or involving a system, method, or plan) investigation (a searching inquiry for facts; detailed or careful examination) designed to develop knowledge that can be generalized (universally or widely applicable). If information from a project will be published in a scientific journal or presented at a scientific meeting, the project is considered research by the federal definition and requires IRB review and approval. If the project is conducted solely in satisfaction of classroom study or coursework and will not be published nor used for thesis/dissertation is it typically not “research.”
No Yes
Explain:
3. In order to determine if project involves “human subjects” please answer the following:
a) Are the proposed participants, individuals living? No Yes
If “NO” – Stop – your project does not require IRB review.
b) Will the information obtained be identifiable private information? For information to be considered “identifiable private information,” first, the information must be private, meaning it is either about behavior that occurs in a context where the individual reasonably expects no observation is taking place or the individual has provided the information for a specific purpose and reasonably expects the information will not be made public. Second, the information must be individually identifiable, meaning the identity of the person is or may be readily ascertained by the investigator or the identity of the person is or may readily be associated with the information. No Yes
c) Will you be obtaining this data through intervention or interaction with the individual(s)? No Yes
d) Will you be obtaining or accessing the existing data or records about the individual(s)? No Yes
If “YES” --
i. Please provide description and source of these data and, if applicable, provide link to website.
ii. Are the existing data or records publicly available? Publicly available, for this purpose, means that the data are available to the general public, without restriction. Medical or educational records are examples of records that are NOT publicly available.
No Yes
4. Provide a brief synopsis of the project. In particular, please include:
i. The characteristics of the subject population (e.g., anticipated number, age, sex, ethnic background, and state of health, etc.);
ii. The procedures for recruitment of subjects and the consent procedures to be followed;
iii. The project’s methodology in summary (i.e., survey, questionnaire, or interview, etc.);
iv. Type of information/data to be collected/studied (e.g., personal experiences with anxiety disorders, review of school records, etc.)
5. Additional Information for consideration:
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CERTIFICATION OF INVESTIGATOR RESPONSIBILITIES
By submitting this form to the IRB I agree/certify that:
1. I am cognizant of, and will comply with, current federal regulations and IRB requirements governing human subject research.
2. I will not begin conducting the above referenced activity until the status of this application has been determined by the IRB and I have been informed in writing.
3. I will respond promptly to all requests for information or materials solicited by the IRB.
PRINCIPAL INVESTIGATOR ASSURANCE: By signing this form you are acknowledging that the
information that you reported on this form is true and accurate.
Do not complete this section. ORRC Use Only.
The activities as described DO NOT constitute Human Subjects Research. Submission of an IRB protocol is not required.
45CFR46.102(d) - (not research) 45CFR46.102(f) (not human subjects research)
The activities as described DO constitute Human Subjects Research. Submission of an IRB protocol IS REQUIRED. IRB Approval must be obtained before the research can begin.
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ORRC/IRB Signature Date
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