Some kinds of human subjects research (HSR) conducted by Berkeley Lab qualify as eligible for "Common Rule Exempt (CRE)" review. While these kinds of HSR are exempt from most of the requirements of The Common Rule (45 CFR 46), they still have institutional requirements and Department of Energy requirements that apply. To ensure all Berkeley Lab CRE HSR meets these requirements, a protocol submission and HSC review is still required. To qualify for this type of review, studies must:

  1. Only include research activities involving human subjects that fall into one or more of the Exempt categories listed at 45 CFR 46.104;
  2. Not be an FDA-regulated activity subject to regulations at 21 CFR 50 or 56;
  3. Not target participation of prisoners, and/or meet restrictions when targeting participation of children.


EXEMPT PROTOCOLS - Google Doc Workflow

As of May 2026, HSR meeting all requirements for eligibility as Common Rule Exempt may be submitted to the HSC using the new Google Doc protocol submission process described below.

What Do You Need?

Google Doc Workflow Process

Link to Get Started

CREATE A NEW PROTOCOL

  1. Submit the intake form to provide basic eligibility and reporting information HARC needs to create a new protocol template.
  2. A new Google Doc template will be shared for collaborative completion among your study team.
  3. Work through the submission and review process with HARC and the HSC by using Google extensions that create version-controlled files within a secure Google Drive folder managed by HARC.

Link to Start New Protocol!

 

CHANGE MY APPROVED PROTOCOL

After initial approval, submit changes in the following situations:

  • When you have new personnel join the team
  • When the participant-facing materials change
  • When the methods for outreach, interaction, or data storage change
  • When you decide to collect more data from a new source/interaction
  • When the reporting information changes (See🚧in protocol)

Link to Start New Amendment!

SUBMIT MY ANNUAL CHECK IN

Each fiscal year you are required to submit an annual check in to meet reporting requirements of DOE Order 443.1C.chg1. A notification should be sent to study contacts approximately 1 month before the anniversary of your initial protocol approval. 

Annual Check in submissions are required to be received before August 30th of each Fiscal Year or continued approval for the study can be revoked.

Link to New Annual Check In!

CLOSE MY APPROVED PROTOCOL

When you have completed your study and are ready to close the protocol, begin a new submission of the annual check in form and select the option on the first page that the study is ready for closure.

Final closeout information must be submitted and accepted by the HARC Office in order to close the DOE HSRD record for the study.

Use Annual Check In Link Above!


  • No labels