Human Participants

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: 

• All related documents and materials for participants 
• A clear and complete explanation for all research procedures 
• Any materials related to the funding award, if the research is externally sponsored 

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

• Human Subjects Research Protocol
• Human Subjects Research Protocol if only using existing data
• Additionally, if the PI is a student, the submission must also include a completed Faculty Advisor’s Statement. 
   

Informed Consent 

• Informed Consent Worksheet
• Informed Consent Template for Adult Subjects
• Informed Consent Template for Parents of Child Subjects
• Informed Consent Template for Exempt Study
   

Recruitment

• Recruitment Guidelines
   

Supplemental Forms 

• Use of Experimental Equipment with Subjects
• Use or Collection of Human Tissue or Biological Samples
• Waiver or Alteration of Informed Consent
• Research at or with International Sites
   

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 

• Continuation Request Form
• Modification Request Form
• Closure Request Form

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

• Change of PI Form

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
 

UAlbany PACS Portal

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

• How to make an Initial Review Request
• How to make a Modification / Continuation Request if your protocol is in the PACS system
• How to make a Modification / Continuation Request if your protocol is not in the PACS system (For protocols approved before October 2024 only)
• How to add UAlbany Key Personnel
• How to delete UAlbany Key Personnel
• PACS workspace flowchart and review flow quick index

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: 

• Exempt Reviews are used for studies that are no more than minimal risk to study participants and only involve activities eligible for exemption. Only a limited set of review criteria need to be met for the IRB to approve the study. The IRB Manual has details on the types of research eligible for exemption.
• Expedited Reviews are used for studies that meet regulatory requirements for review by a single IRB member. The standard review criteria apply whether the study gets an expedited or full board review. The IRB Manual has details on the types of research that may be reviewed by a single member. 
• Full Board Reviews are used for protocols reviewed at a convened IRB meeting. The IRB must find the study plan meets all criteria for approval. The IRB may require changes to the study in order to secure approval. The IRB may determine the study cannot be conducted because one or more approval criteria cannot be met. 

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: 

• Requesting IRB review and approval of any changes in the study plan before changes are implemented 
• Ensuring anyone involved in research with human subjects adhere to the study protocol
• Notify the IRB of staff changes and providing copies of new study staff’s training Completion Certificates
• Including the IRB-issued Study Number, as listed in the approval letter, on any materials participants will see 
• Requesting IRB review of any research activities that will continue beyond the approval’s expiration date 
• Ensuring current IRB approval is maintained for the life of a sponsored project that includes research with human subjects 

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.

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 Rely on Another IRB

• 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.