Frequently Asked Questions for IRB Managers/Administrators

What DOE-specific requirements should the IRB and researchers be made aware of?

In addition to DOE Order 443.1B Chg 1 and DOE Notice 443.1, please refer them to the DOE special requirements section of this website.

What is DOE Notice 443.1, and what are the expectations of me?

DOE Notice 443.1 includes requirements that must be met when DOE/DOE site researchers engage in HSR that is classified, in part or in whole. The requirements for review and approval of classified HSR are different than those for unclassified HSR, so it is critical to read DOE Notice 443.1 carefully and speak with the DOE/NNSA HSPP managers if you have any questions.

What is the status of the proposed changes to the federal regulations for the protection of human subjects in research?

The Department of Health and Human Services is reviewing comments received and determining the best approach for resolving comments and revising the documents. HHS and the Office of Management and Budget hope to have a final rule in place in September 2016.

What are the expectations for research involving modification of the human environment?

In all research, potential risks must be evaluated and mitigated to the extent practicable. When:

(a) people are included in research or experiments, and/or

(b) people have their environment intentionally changed or manipulated for the purposes of the research, with or without their knowledge, and/or

(c) research can only be validly conducted with people present (other than those conducting the research), regardless of whether personally identifiable information is collected about them, the potential risks to those individuals must be considered by the appropriate IRB.

Note: Typically, such projects are minimal risk HSR, but even if the IRB does not view a project as meeting the definition of human subjects research as defined in DOE Order 443.1B Chg 1, DOE requires initial review by the IRB of the application and supporting materials to determine whether the individuals included in the research will be properly informed and protected.

Why do we have two HQ human subject protection program managers – one DOE and one NNSA?

In 2000, Congress established NNSA as a semi-autonomous agency within the U.S. Department of Energy. One of NNSA’s key functions is to maintain and enhance the safety, security, reliability and performance of the U.S. nuclear weapons stockpile without nuclear testing; and work to reduce global danger from weapons of mass destruction (NNSA Website). The NNSA Act directs that only NNSA personnel, in addition to DOE’s Secretary and Deputy Secretary, give direction to its employees and contractors. Hence, actions involving NNSA projects require involvement of NNSA personnel in the approval, concurrence, consultation, etc. However, the DOE and NNSA program managers work together to ensure there is one seamless program.

When should DOE’s Central IRBs be used?

The Central DOE IRB should be used anytime multiple DOE sites are engaged in the same project. Additionally, the Central DOE IRB is the IRB of record for the DOE HQ-funded Former Worker Medical Screening Program, and for other DOE-funded/conducted research on the health impacts of exposure to beryllium. The Central DOE IRB also serves as the IRB of record for several DOE sites that do not have internal IRBs.

Does DOE have any sample templates for protocols and consent forms, as well as any other resources that might be useful for my IRB?

Yes, see the sections on Central DOE IRB (CDOEIRB) and Central DOE IRB-Classified (CDOEIRB-C).