Human Participants

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: 

• Will you, a member of your research team or a collaborator observe, interact with or intervene with individuals to gather information that will be used for research? 
• Is the information being collected “about” the individuals? 
• Is the intent to generalize the data to draw conclusions about people or populations?

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: 

• Are the data or specimens about or from individuals who are, or who may be, still living? 
• Is the use or access to the data or specimens restricted? (For example, may the data or specimen only be used for research?)
• Were the data or specimens collected specifically for research through an interaction or intervention with living individuals? 
• Can the data or specimens be linked, directly or indirectly, to identifiable living individuals? 

For additional guidance, please refer to these documents:  

• IRB Review Requirements
• IRB Review Decision Trees
• Human Subjects Research Screening Form
• Worksheet on Engagement in Human Subjects Research

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. 

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 (New Version, September 2023) and creating recruitment materials (New Version, September 2023).

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 

• CITI Completion Certificates reports for the Principal Investigator (PI) and all key research personnel 

Additionally, if the PI is a student, the submission must also include a completed Faculty Advisor’s Statement. 

Please use these documents to create your submission: 

• Informed Consent 

  • Informed Consent Worksheet

  • Informed Consent Template for Adult Subjects

  • Informed Consent Template for Parents of Child Subjects
     

• New Research 

  • Human Subjects Research Protocol

  • Human Subjects Research Protocol if only using existing data
     

• Ongoing Research 

  • Continuation Request Form

  • Modification Request Form

  • Change of PI Form

  • Add or Delete Personnel Form

  • Closure Request Form
     

• Supplemental Forms 

  • Electronic or Online Data Collection

  • Use of Existing Data

  • Use of Experimental Equipment with Subjects

  • Use or Collection of Human Tissue or Biological Samples

  • Waiver or Alteration of Informed Consent

  • Use of Psychology 101 Participants

  • 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. 

Principal Investigators (PIs) must send a completed human subject protocols as Word documents to [email protected]. Hard copy submissions are not accepted. 

Submissions must come from the PI’s @albany.edu email address. Students serving as PIs must CC their Faculty Advisor for the study. 

For studies supported by external sponsors and administered by the Research Foundation for SUNY, please include copies of your proposal or award documents relevant to the funded research with human subjects. 

Applications are processed as they are received. Please submit documents in separate files, using these naming conventions: 

New Review Requests 

Please use the email subject line, “New Study Review Request," and the following document naming conventions:

• [Investigator name] – Protocol.docx 

• [Investigator name] – Informed Consent Information.docx 

• [Investigator name] – Recruitment Information.docx 

• [Investigator name] – Study Instruments.docx 

• [Investigator name] – Training Certificates.docx 

Modification Review Requests 

Please use the email subject line, “Modification Request for [Study Number],” and the following document naming conventions: 

• [Investigator name] – [Study Number] – Modification Request.docx 

• [Investigator name] – [Study Number] – Protocol.docx 

• [Investigator name] – [Study Number] – Informed Consent Information.docx 

• [Investigator name] – [Study Number] – Recruitment Information.docx 

• [Investigator name] – [Study Number] – Study Instruments.docx 

Continuing Review Requests 

Please use the email subject line, “Continuing Review for [Study Number]," and the following document naming conventions:

• [Investigator name] – [Study Number] – Continuing Review Request.docx 

• [Investigator name] – [Study Number] – Protocol.docx 

• [Investigator name] – [Study Number] – Informed Consent Information.docx 

• [Investigator name] – [Study Number] – Recruitment Information.docx 

• [Investigator name] – [Study Number] – Study Instruments.docx 

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.

The administrative assessment process aims to identify any incomplete or unclear information in a submission that would prevent or delay approval by the IRB. 

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. 

Types of IRB review are: 

• 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. 

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.