For Researchers

This section contains resources to help researchers comply with DOE requirements regarding human subjects research.

It is critical that all researchers who plan to engage in human subjects research that is funded by DOE, conducted at DOE facilities/national laboratories, or conducted by or with DOE or DOE laboratory employees, first:

  1. Carefully read these Frequently Asked Questions;
  2. Ensure that the PI, and all members of the research team who will interact with human subjects or their identifiable data, complete required training;
  3. Ensure you understand Federal and DOE-specific requirements;
  4. Be aware of the following additional responsibilities.
    • Do not start human subjects research activities until you have the final IRB approval letter. NOTE: It is up to the IRB to determine the identifiability of data to be used for research projects. Even if you think you will only be working with de-identified or anonymized data, you will need to first consult the appropriate IRB prior to proceeding with your study. It is the IRB that will make the HSR/not HSR determination. DOE Order 443.1C also requires that any research using social media data be submitted to the IRB for review/HSR determination prior to initiation.
    • Do not start human subjects research activities until you have obtained all other required institutional approvals, including approvals of departments or divisions that require approval prior to commencing research that involves their resources.
    • Ensure that there are adequate resources to carry out the research safely. This includes, but is not limited to, sufficient investigator time, appropriately qualified research team members, equipment, and space.
    • Ensure that Research Staff are qualified (e.g., including, but not limited to, appropriate training, education, expertise, credentials, protocol requirements and, when relevant, privileges) to perform procedures and duties assigned to them during the study.
    • Update the IRB office with any changes to the list of study personnel.
    • Personally conduct or supervise the research:
      • Conduct the research in accordance with the relevant current protocol as approved by the IRB.
      • When required by the IRB, ensure that consent or permission is obtained in accordance with the relevant current protocol as approved by the IRB.
      • Do not modify the research without prior IRB review and approval unless necessary to eliminate apparent immediate hazards to subjects.
      • Protect the rights, safety, and welfare of subjects involved in the research.
    • Submit to the IRB:
      • Proposed modifications.
      • A continuing review application as requested in the approval letter.
      • A final report when the research is closed.
    • Report any complaint, adverse event, unanticipated problem, non-compliance  or other new development of any significance to the project to the IRB right away. In the case of loss of personally identifiable information, reporting to the IRB and other authorities is required immediately.
    • Submit an updated disclosure of financial interests within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new financial interest related to the research.
    • Do not accept or provide payments to professionals in exchange for referrals of potential subjects (“finder’s fees”).
    • Do not accept payments designed to accelerate recruitment that are tied to the rate or timing of enrollment (“bonus payments”).
    • Ensure that you comply with the requirements of sponsoring organizations/agencies, which may be in addition to those that are required by the Federal Regulations and DOE. You must comply with the most stringent requirements. Consult with the IRB if you need clarification.
  5. Don’t be afraid to ask questions of the IRB when preparing an application.  Alternatively, you can reach out to the DOE and NNSA Human Subjects Protection Program Managers at DOE HQ if you have general questions about the DOE program. We are here to help!