Biosafety Manual
Safety guidance, policies, and procedures for work with biological materials
Biological Project Registration
Summary
How to submit Committee on Microbiological Safety (COMS) protocols for research involving biological materials.
Who is this for?
Lab and research staff, including teaching labs.
Registering biological research
COMS is the Harvard Institutional Biosafety Committee.
You must receive COMS approval before:
- Buying, receiving, or storing any COMS-regulated materials (CRM).
- Initiating or modifying any research that involves CRM.
Additional CRM requirements:
- Animal research that involves CRM: Receive approval from the Institutional Animal Care and Use Committee.
- Using human embryonic stem cells: Register use with COMS and receive approval from the Embryonic Stem Cell Research Oversight Committee.
- Human studies: Contact your school Institutional Review Board.
Biological research protocols
- Only people listed as Principal Investigators (PI) or PI designees can edit COMS protocols.
- PIs can add PI designees to let others create new studies or amendments, edit their protocols, and submit annual renewals.
- Only people listed as study staff have approval to perform the work described in the protocol.
- COMS protocols are approved for five years, after which they must be resubmitted.
PIs or their designees can create a new COMS protocol to register their research in eCOMS (HarvardKey required).
Only the project PI can submit a new protocol or scientific amendment.
Before COMS approves the protocol, PIs must complete a COMS-required Harvard Training Portal (HTP) course and EHS must inspect the lab. Training and inspection frequencies follow COMS policies.
PIs must annually confirm that their COMS registration is still consistent with their research.
The first annual renewal date is one year after formal approval in eCOMS. PIs or their designees can submit annual renewals.
Unrenewed studies may be inactivated. Labs cannot continue working with CRM on inactive protocols.
PIs and designees should receive email reminders to submit their annual renewal before it is due.
PIs and designees can submit their review anytime within the renewal window. Submitting your annual renewal before the due date does not change the renewal date.
PIs can amend active and nonexpired COMS protocols to make changes or additions.
Amendment types:
- Administrative change amendments: Used for personnel changes. Amendments are immediately active after submission and do not generate a new approval letter due to automatic processing.
- Scientific change amendments: Used for all other changes, such as room additions or new biological agents. Amendments need further review before approval and generate new approval letters.
All amendments expire on the same date as the original study being amended.
You should withdraw protocols and amendments not yet approved by COMS and no longer necessary or desired. This applies to scenarios like if a PI decides not to complete a study or a Biosafety Officer (BSO) determines the application is not under COMS purview.
PI designees can submit withdrawal requests in eCOMS, but only the PI can give final consent to COMS to withdraw a protocol.
You should inactivate a study if either:
- A PI leaves Harvard.
- The work is no longer active and all materials were disposed of or transferred.
PI designees can submit inactivation requests in eCOMS, but only the PI can give final consent to COMS to inactivate a protocol.
Registering research with human participants
Projects that do not meet the regulatory definition of human subjects research as defined by Department of Health and Human Services' Office of Human Research Protections and Food and Drug Administration’s (FDA) regulations may still require COMS registration if the research involves human participants and collecting or administering CRM.
Research proposals that administer or collect CRM from participants require COMS approval unless:
- Administered materials are not CRM (COMS may require registering research that includes administering non-CRM animal materials to human research participants).
- Products or materials that would otherwise be CRM (for example, human cells, probiotic bacteria) are approved by the FDA and used strictly following the FDA-approved use during research.
The research only uses standard clinical procedures (usually designated by specific insurance codes) to administer CRM or collect patient material as part of a medical procedure.
You are only required to complete COMS registration for experimental procedures that involve CRM.
Protocol review schedule and submission deadlines
Submit your protocol in eCOMS by the deadline to allow enough time for biosafety review and to be added to the next COMS meeting agenda. At each meeting, COMS reviews protocols and determines approval status.
Including your protocol on the next meeting agenda depends on any edits needed and how quickly the PI or their designee responds to editing requests.
| eCOMS Protocol Submission Deadline | COMS Meeting Date |
|---|---|
August 29, 2025 | October 3, 2025 |
October 3, 2025 | November 7, 2025 |
November 7, 2025 | December 12, 2025 |
December 26, 2025 | January 30, 2026 |
January 23, 2026 | February 27, 2026 |
February 20, 2026 | March 27, 2026 |
March 27, 2026 | May 1, 2026 |
April 24, 2026 | May 29, 2026 |
May 22, 2026 | June 26, 2026 |
June 26, 2026 | July 31, 2026 |
July 31, 2026 | September 4, 2026 |
September 4, 2026 | October 9, 2026 |
October 2, 2026 | November 6, 2026 |
November 6, 2026 | December 11, 2026 |
Related resources
Find documents and online tools to register biological research projects.
eCOMs User Guide
Use eCOMS to register biological research projects
Mixed Microbial Isolates
Handle mixed microbial isolates
EHS support
Contact biosafety@harvard.edu or your BSO for more information about registering biological projects, including:
- Registering a new COMS protocol.
- Amending an existing registration.
- COMS approval schedules.