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 443.1C, please refer them to the DOE special requirements section of this website.

What are the expectations of me for classified human subjects research?

DOE Order 443.1C 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 and Strategic Intelligence Partnership Program work are different than those for unclassified HSR, so it is critical to read DOE Order 443.1C  carefully and speak with the DOE/NNSA HSPP managers if you have any questions.

What are the expectations for research involving employees as subjects?

All personnel (employees, contractors, and students) are vulnerable to pressures to appear cooperative with regard to projects conducted by their managers and/or coworkers.

The basic ethical principles that form the basis of U.S. Federal laws governing human subjects research are very clear on this topic: subject selection cannot be based solely on the subject’s ready availability or malleability.

Additionally, researchers are discouraged from conducting research on themselves, unless clearly justified and approved by the IRB and the researchers’ management. While researchers may be aware of the risks of self-experimentation, they may also be more willing to accept risks that are ill-advised. Application for review with the IRB allows a neutral third party to raise concerns and/or propose measures to promote the welfare of researchers.

Please review the lettersent by DOE Institutional Official on use of DOE and DOE contractor employees in HSR and HRP-423-Protecting Employees Who Participate as Research Subjects . 

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 443.1C (or current version), 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. Please see HRP-421-CHECKLIST-Modification of the Human Environment.

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 and for some DOE Headquarters-funded energy efficiency research. The Central DOE IRB-Classified must be used for all classified and unclassified projects funded through the Strategic Intelligence Partnership Program. 

Does DOE provide any software that might be useful for my IRB?

Yes.  DOE provides an electronic submission system for all IRB Managers/Administrators to use.  The IRB Electronic Submission System (hereafter, IRB system) is the Huron Click Commerce-based software used by DOE’s Central IRBs and a number of the DOE site IRBs for processing of IRB applications.  This cost of this software is covered by DOE. 

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.  These documents are included in the DOE Library in the IRB system.