ORCO Pilot Study Guidance
Purpose
This policy establishes the requirements for conducting pilot studies at Baruch College, particularly when pilot activities involve recruiting participants or collecting information for the purpose of refining research procedures, instruments, or protocols intended for future dissemination.
Scope
This policy governs all institutional activities at Baruch College that involve human subjects research and establishes requirements consistent with the U.S. Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR Part 46. These regulations, known collectively as the Common Rule, set forth the federal requirements for determining when research involving human subjects must undergo review and oversight by an Institutional Review Board (IRB).
Activities Covered Under This Policy
This policy applies to all Baruch College faculty, staff, and students who conduct, plan, or propose to conduct pilot testing, preliminary research, or other systematic investigations involving human subjects, including activities falling under the definitions and applicability criteria in 45 CFR § 46.101 and 45 CFR § 46.102.
Such activities are considered within the scope of this policy when they constitute:
- Research involving human subjects as defined in 45 CFR § 46.102, including activities that involve obtaining data through intervention or interaction with individuals or the collection of identifiable private information.
- Research subject to federal human subjects regulations under 45 CFR § 46.101, which outlines when the federal policy applies to research conducted, supported, or regulated by a federal department or agency.
This includes research conducted as part of coursework, independent study, pilot data collection for future studies, or any preliminary activities intended to contribute to generalizable knowledge.
Policy Requirements
1.IRB Review Requirements for Pilot Studies
Pilot activities that involve recruiting individuals and collecting information from them—regardless of whether the data will be published, analyzed, or retained—are considered human subjects research when conducted to develop or refine a study intended for future research dissemination.
In such cases, IRB approval or an official IRB determination is required prior to initiating any pilot activities.
2. Activities Requiring IRB Oversight
IRB review is required when pilot testing involves:
Recruiting participants through SONA or any other recruitment mechanism and having individuals complete the same or substantially similar procedures planned for the IRB reviewed study. Pilot sessions meeting these criteria may not be conducted without prior IRB approval.
3. Activities Potentially Outside IRB Oversight
Pilot activities may fall outside IRB oversight only when they are strictly limited to internal development or operational purposes, such as:
- Research assistant training,
- Testing equipment, software, or room setup,
- Activities that do not involve recruiting participants,
- Activities that do not involve collecting participant responses or data.
Once individuals are engaged as participants and asked to complete study tasks, IRB review is required, regardless of whether the data are retained, analyzed, or used in the final study.
4. Incorporating Pilot Testing Into an IRB Submission
Researchers may:
- Include pilot testing procedures within the initial IRB application, clearly labeled as pilot testing,
- or Submit a modification to add pilot testing to an already approved protocol.
5. Requesting an IRB Determination
If there is uncertainty about whether the planned pilot activities require IRB oversight, researchers may request an official IRB determination before initiating any pilot sessions. Please contact the Office of Research Compliance and Outreach if there are any questions.
Revised Version: 03.26.26