When to Amend a Study vs. Start a New Study
Overview
Investigators often need to modify an approved research protocol as a study progresses. Determining whether a change requires an amendment to an existing protocol or submission of a new study is essential to ensure compliance with institutional policies and federal regulations. This guidance outlines factors to consider when deciding whether to submit an amendment or a new study application.
When a New Study is Typically Required
A new study submission is required when the proposed changes are so substantial that they create a different research project from the one originally approved. A new study requires a separate IRB review and approval process.
A new application is generally warranted when changes involve one or more of the following:
Section: Lay Summary
- The study aims to answer different scientific or research questions.
- New objectives are added that are not related to the original objectives.
Section: Funding
- If new funding points to new directions for the research and the aims and research design need to change, a new application can cleanly delineate this new focus and ensure an approved protocol is accurate and relevant to the planned research.
Section: Data Collection
- Existing data will be used to answer new research questions that were not previously approved.
- A new collaboration or legal agreement is established to perform analyses beyond the scope of the original study.
Section: Research Procedures
- New research procedures are introduced that were not part of the original protocol.
- The methodology differs substantially from the approved research plan.
- The study design changes in a way that creates a different participant experience or risks.
- Adding a new intervention, treatment, or experimental procedure.
- Adding blood draws, biopsies, imaging procedures, or other physical procedures not previously approved.
- Increasing the number, duration, or invasiveness of participant interactions.
- Collecting new categories of sensitive information.
- Adding collection of identifiable information when the study was previously anonymous.
- Expanding eligibility criteria to include vulnerable populations.
- Changing the study design in a way that affects risk, scientific validity, or participant protections.
- Introducing new data-sharing activities or increasing confidentiality risks.
Section: Subject Enrollment
- The study targets a substantially different population.
- New vulnerable populations are added.
- Recruitment expands beyond the originally approved population in a way that changes the study’s focus.
Section: Risks and Benefits
- The risk-benefit assessment changes significantly change, typically when risks increase.
When to Amend an Active Study
An amendment (also called a modification) is a change to an already approved research study that does not fundamentally alter the study's original objectives, design, or overall scope.
A minor modification is a change to previously approved research that does not materially affect the study's risk level, research objectives, study design, participant population, informed consent process, privacy and confidentiality protections, or the rights and welfare of research subjects.
Submitting a modification to an existing study does not necessarily result in a faster or less extensive review. The IRB evaluates all proposed changes using the same regulatory and ethical standards applied to new submissions to ensure the continued protection of human participants.
If the protocol is intended as a longitudinal study or is operating within the planned study timeline and if changes are otherwise closely related to the previously approved study, then submitting an amendment is likely appropriate.
Please review the relevant sections of the application that you plan to change.
Section: Study Information
- Adding or removing research team members.
- Updating investigator roles or responsibilities.
- Changing faculty advisors or principal investigators (when permitted by institutional policy).
Section: Lay Summary
- The core research question, purpose, and aims remain unchanged.
- Changes are intended to refine or expand the existing project without changing its fundamental purpose.
Section: Funding
- New funding supports the existing approved research.
- The analyses remain consistent with the objectives described in the approved protocol.
Section: Data Collection
- Minor modifications (e.g., replacing a questionnaire with a similar instrument)
- When substituting one questionnaire for another that are similar.
- Changing in-person collection to online or vice versa.
- Adding survey questions that are not sensitive and do not increase risk
Section: Research Procedures
- Study is ongoing, within its planned timeline, and changes are closely related.
- Clarifying instructions provided to research subjects.
- Reordering the sequence of study activities without changing the activities themselves.
- Shortening a survey or removing questions.
- Adding a small number of non-sensitive survey or interview questions.
- Changing the location of a study visit to a comparable setting.
- Adjusting scheduling windows (e.g., conducting a follow-up visit within 10–14 days instead of exactly 14 days).
- Allowing an already approved procedure to be completed remotely rather than in person when risk remains unchanged.
- Reducing the frequency or duration of study activities.
- Correcting errors or inconsistencies in study documents.
- Collecting a small amount of additional information that is not sensitive and does not increase privacy risks.
Section: Subject Enrollment
- Adding non-vulnerable populations without changing risk level or protections.
- Adding recruitment methods that target the same participant population.
Section: Consent Documentation/Waivers
- Minor modifications to informed consent documents.
Final Determination: Amendment vs. New Study Application
The IRB and the HRPP at BYU will make the final determination regarding the study. If you are unsure whether to submit an amendment or create a new application in OneAegis(OA), please contact IRB@byu.edu for guidance.
Resources
Amend Protocol
Submitting a New Application
Request for Protocol Amendment
University of Illinois- Urbana Champaign."Should I submit an Amendment or a New Study?.”
University of Oregon. “Amending a Protocol vs. Submitting a New Protocol”
The University of Virginia. “Amending a Protocol vs. Submitting a New Protocol.”
Cornell University. “Amending an Existing Protocol vs. Submitting a New Protocol.”