Human Participants
Institutional Review Board (IRB)
Institutional Review Board (IRB)
Researchers must obtain PACS access before starting to use the UAlbany PACS Portal. If you do not already have an account, please request a UAlbany PACS account.
Information about and training sessions on the the UAlbany PACS IRB module are available by request. Please email [email protected] for assistance. Learn more the UAlbany PACS IRB module.
Please use this page to complete the following tasks:
The UAlbany Institutional Review Board (IRB) for human research protections reviews all UAlbany activities that meet the regulatory definitions for research involving human subjects to:
For additional details, please refer to the IRB Procedures Manual (New Version: October 2024).
All submissions need to be submitted through the Research Foundation SUNY Pre-Award and Compliance System Login
At the University at Albany, research projects that meet the federal definition of research with human subjects (45 CFR 46.102) must be reviewed and approved, or receive an exempt determination, by the IRB prior to initiating the research.
The U.S. Department of Health & Human Services defines research as:
“A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.”
The U.S. Department of Health & Human Services defines human subject as:
“Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
i. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
ii. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”
IRB review is only required for projects meeting the definitions for research with human subjects. If you answer yes to the following questions, your research likely requires IRB approval:
Additionally, some research involving secondary or existing data, documents or biological samples require IRB approval. If you answer yes to the following questions, your research likely requires IRB approval:
For additional guidance, please refer to these documents:
Note: All survey and focus group activity involving UAlbany students, faculty, staff or alumni must also be coordinated with the Office of Institutional Research, Planning, and Effectiveness (IR) by filling out the UAlbany Survey Request Form.
We’re happy to meet virtually or in person to answer questions about the IRB review process, including what kind of review is required, if any, for a specific study.
Email [email protected] to set up an appointment. Or attend our open office hours, when no appointment is required.
Open offices hours are held from 12:30 to 1:30 p.m. Tuesdays and from 2:30 to 3:30 p.m. Wednesdays in Earth Sciences, Room 244, on UAlbany’s Uptown Campus.
Anyone conducting research with human subjects at UAlbany must complete the "IRB: Human Subject Research (Investigators, Advisors)" training before receiving IRB approval and starting their work. Training must be refreshed once every five years.
All researchers conducting externally sponsored clinical trials must also complete one of the offered "Good Clinical Practice" trainings.
These trainings are available online via the CITI Training Program.
Note: These rules apply to all PIs, key personnel and faculty advisors. Key Personnel means anyone who interacts with human subjects or accesses their research data.
PACS users who have taken CITI courses will have their CITI data pulled into PACS as long as their CITI ID has been added to their PACS record. Review instructions for changing UAlbany key personnel.
Most requests can be reviewed by IRB members outside of a convened meeting and are reviewed on an ongoing basis.
Studies that do require full IRB review — such as those where discussion regarding potential risks to participants is warranted or risks to subjects may be more than minimal — are handled at monthly meetings.
In those cases, please submit your application by the posted deadlines to ensure it is reviewed in a timely manner, especially when approvals are required to meet funding deadlines.
Month | IRB Review Meeting | Submission Deadline |
---|---|---|
November 2024 | November 15, 2024 | October 25, 2024 |
December 2024 | December 20, 2024 | November 29, 2024 |
January 2025 | January 17, 2025 | December 27, 2024 |
February 2025 | February 21, 2025 | January 24, 2025 |
March 2025 | March 21, 2025 | February 28, 2025 |
April 2025 | April 18, 2025 | March 28, 2025 |
May 2025 | May 16, 2025 | April 25, 2025 |
June 2025 | June 20, 2025 | May 23, 2025 |
July 2025 | July 18, 2025 | June 27, 2025 |
August 2025 | August 15, 2025 | July 25, 2025 |
Please use the following instructions for new submissions, continuation renewals, and requests to modify and/or amend approved protocols:
Submissions must be written in a style suitable for presentation to an undergraduate first-year class. Do not use jargon, terms of art or technical (discipline-specific) language. If the application does not use layperson’s terminology, the protocol will be returned to the investigator.
Review additional guidance on describing your research for the IRB and creating recruitment materials.
All submissions must include the following items to be considered complete and to be accepted for review:
Note: The following forms and templates were updated in October 2024. If you have previously downloaded documents to your device, we recommend checking to confirm you have saved the latest version before completing the form.
Protocol Form
Informed Consent
Recruitment
Supplemental Forms
International Research
International research with human subjects is held to the same rigorous standards as domestic research with human subjects. Additionally, the specific guidelines of the host country and partner institutions must be followed.
Please conduct research within the context of local socioeconomic, political and cultural norms. Visit the International Compilation of Human Research Standards for details.
For additional information, review guidance on conducting international research.
Ongoing Research
Note: Continuing review requests for studies that were previously approved by the IRB through exemption or expedited review and that are not sponsored by the U.S. Department of Justice or the National Institute of Justice do not require immediate review, so investigators may proceed with their studies. If additional information is needed, our office will reach out to the PI.
Research Key Personnel
If you have a non-UAlbany affiliate (external) investigator, please contact [email protected].
The investigator can send personnel update requests through the PACS system. Key personnel need access to the system to feed CITI reports into it. See Step 2 below for instructions on how to obtain IRB access to the PACS system.
Investigators need to submit complete human subject protocol documents and research information through the PACS system.
UAlbany Pre-Award and Compliance System (PACS) is a multi-year collaborative project to support principal investigators, students, and compliance and research administration staff.
UAlbany PACS integrates six aspects of grants management — IRB, IACUC, Conflict of Interest, Grants (proposal preparation), Agreements, and Safety — into a single system.
This platform follows the research administration process from beginning to end and allows us to achieve a new level of uniformity and efficiency, while producing valuable data analytics to guide future decisions.
The IRB module provides a streamlined way for researchers to create and submit protocols for studies involving human subjects. It provides support for initial submissions, modifications, reportable new information, and continuing reviews.
How to obtain access to PACS and log in.
Obtain PACS Access
Investigators must submit a PACS User Request Form to obtain access to the PACS system.
Note: Account creation is not instantaneous. It takes three to four business days to obtain access to the PACS system. Do not submit more than one account request.
If you need assistance, contact PACS support at [email protected].
Access the PACS System
Note: Investigators still need to submit a protocol document and supplemental forms (see Step 1 above). Do not create a PACS submission until all required documents are complete and ready for upload.
PACS User Training
Although UAlbany PACS IRB is intuitive and easy to use, we are offering end-user training. Participants will learn how to create a study protocol and submit it to the IRB for review. They will also receive an overview of the IRB workflow. Contact [email protected] to set up a session.
Additional Instructions
The administrative assessment process aims to identify any incomplete or unclear information in a submission that would prevent or delay approval by the IRB.
Pre-Review: When submissions are received at our office and the application is under administrative assessment, the work flow diagram on PACS should show “Pre-Review” as the current status.
The PI must respond to any identified issues and revise the submitted materials before the documents can be reviewed by the IRB.
Protocols that require extensive revision or are missing a significant amount of information will take longer to review.
The IRB staff member(s) completing the administrative assessment for your study will initially determine the type of review needed for the protocol. However, the IRB makes the ultimate decision on the type of review required for studies.
The IRB staff member(s) completing the administrative assessment for your study will initially determine the type of review needed for the protocol. However, the IRB makes the ultimate decision on the type of review required for studies.
Clarification Requested: When an administrator sends a clarification request, the workflow diagram on PACS should show “Clarification Requested” as the current status.
Types of IRB review:
IRB Review: Once you've completed the pre-review update and the administrator has sent your application to the IRB, the work flow diagram on PACS should show “IRB Review” as the current status.
Exempt Reviews & Expedited Reviews
The IRB or an individual IRB member will review your submission to determine if it meets the approval criteria.
The IRB may require changes before approval can be granted. If changes are requested, an IRB staff member will work with you to address the request.
Full Board Reviews
Your submission will be placed on the agenda for the next scheduled IRB meeting.
The PI will receive an email with the date of that meeting. They may be invited to address questions or concerns during the IRB’s discussion of their protocols.
If issues are identified during the full board review, the PI must respond to them and/or revise the submitted protocol before it can be approved.
Once the IRB has approved a study, Principal Investigators (PIs) are responsible for the following:
If there is an unanticipated problem involving risks to human subjects or others, related to study procedures, you must contact UAlbany’s Research Compliance Officer at [email protected] or 866-857-5459 right away.
Principal Investigators who fail to fulfill the above responsibilities may be deemed noncompliant and have their study suspended. Any noncompliance or study suspension is reported to the study sponsor.
IRB Reliance (single IRB review) is a formal legal arrangement that allows one institution to review a study occurring at multiple institutions (sites) or to review a single-site study that includes personnel from multiple institutions.
Even when UAlbany has ceded IRB review to another IRB, a submission request to the UAlbany IRB is required so that the UAlbany IRB can maintain its responsibilities under the Reliance Agreement.
Investigators engaged in non-exempt human subjects research are usually covered by their institution’s IRB. An IRB Reliance Agreement can allow one institution to delegate its IRB review to another IRB. An individual investigator agreement (IIA) covers independent investigators not covered by the Federalwide Assurance of an institution.
IRB Reliance Agreements are also sometimes called IRB Authorization Agreement, Cooperative Agreement or Memorandum of Understanding (MoU).
Reliance Agreements may cover single studies, categories of studies or all human subjects research conducted under an organization’s Federalwide Assurance (FWA).
Reliance Agreements document the respective authorities, responsibilities and communication between the organization/institution conducting the regulatory review of human subject research activities and the institution(s) relying on the reviewing IRB.
A single IRB review can be arranged under the following circumstances:
UAlbany’s IRB is asked to serve as the Reviewing IRB for a multi-center study
UAlbany personnel plan to participate in non-exempt research covered another institution’s IRB with a Federalwide Assurance for human subjects protections
UAlbany personnel plan to conduct research at non-UAlbany locations and personnel from those locations will be part of the study team
Personnel from another institution come to UAlbany to participate in our research
UAlbany does not enter into Reliance Agreements for exempt studies.
Additionally, UAlbany cannot rely on international IRBs or Ethics Review Committees that do not hold Federalwide Assurances. A global site may request reliance on UAlbany IRB if they have no available alternative but, if that site does have an IRB or Ethics Review Committee, its review is required to satisfy the need for knowledge of the local research context. Please consult with the UAlbany IRB for such requests.
Please submit the correct form(s) to [email protected].
Request for UAlbany to Extend Its Assurance to an External Institution
Request for UAlbany to Extend Its Assurance to an Independent Investigator
Note: A separate form must be completed for each institution or individual seeking reliance on the UAlbany IRB.
External investigators who want to conduct human subjects research on a UAlbany campus and/or conduct research involving UAlbany faculty, students and/or staff must obtain approval from:
To request UAlbany approval, please send the following documents to [email protected] and [email protected] in one email:
If you’re a research study subject and have questions regarding your rights, you have concerns about how the study is being conducted or you would like to lodge a complaint, please contact UAlbany’s Research Compliance Officer at [email protected] or 866-857-5459.
You can also use our Anonymous Reporting Form to report any concerns regarding research conducted at UAlbany.