Frequently Asked Questions for Researchers

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Planning a Project Involving Human Subjects Research

How do I know if my project qualifies as human subjects research?

For all DOE-funded, or DOE/Laboratory conducted research, consult with the applicable DOE IRB Manager/Administrator, who will use the following approach: 1) determine whether the study is indeed "research*"; and if so, 2) whether it is “research involving human subjects*.”

Research:  A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Generalizable:  Information/research findings that are intended to be applied to populations or situations beyond that studied/will have meaning and impact outside of the single immediate activity itself.

Human Subject: A living individual about whom an investigator (whether professional or student) conducting research:
(1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record).
Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

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.

When, and by whom, does human subjects research training need to be completed?

Human subjects research training is required for Principal Investigators (PIs) and all project staff who will have access to personally identifiable information (PII) and also to those who will have interaction or intervention with human subjects, and is to be renewed at least every 3 years. The specific training requirements  for studies that fall under the Central DOE IRBsare outlined in HRP-422.  DOE provides access to CITI Training at no cost to researchers at DOE sites and/or funded by DOE (as well as to IRB members who serve on DOE IRBs, DOE and DOE site Institutional Officials, and others involved in the DOE HSSP). CITI training includes a variety of training modules that may be applied as appropriate. Contact your IRB Manager/Administrator to discuss the modules required. In special situations, alternative training may be considered. All training must be completed and documented to the IRB prior to final approval of the application.

What will I need to do if human subjects research requirements are applicable to my project?

If the IRB Manager/Administrator determines that Federal and DOE-specific human subjects research requirements apply to your project, your first step will be to complete an application for initial review by the applicable DOE IRB. (Note that there are certain cases, particularly in DOE-funded research at universities, in which another institution’s IRB may be used in lieu of a DOE IRB, but this can only be done if that institution has a Federalwide Assurance, DOE-specific requirements are met, and an IRB Authorization Agreement is established between the applicable DOEIRB and the IRB of record.) 

What if I am a researcher from a DOE site and I become involved with a human subjects project initiated at another institution?

You cannot begin work on your portion of the study project until you receive approval from the applicable (site or Central) DOE IRB to proceed. In some cases the DOE IRB may defer IRB review to the other institution. To make that determination, however, the DOE IRB may need information from you, including an application, copies of consent forms and the other institution’s IRB letter of approval, and any consent forms.

Which DOE Sites have IRBs?

There are two Central DOE IRBs and multiple DOE site IRBs.
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Initiation of DOE IRB Review

How do I submit my project to the IRB for review?

Contact the applicable IRB. The IRB will provide you with an application form and specific instructions.

After I have submitted my application to the IRB, can I start my project?

You cannot start your project until the IRB has completed its review and issued formal approval. The IRB may require clarification on information provided in the application and request that you address these questions before making their determination. You will receive a letter from the IRB Chair indicating approval status when the review is completed. Once you receive this notification, and all other non-IRB related institutional requirements have been met you can proceed with the research (assuming the research is not classified (see DOE Order 443.1C for specific classified research requirements). Classified human subects research must be approved by the DOE Institutional Official prior to initiation.

How long does it take to complete the IRB review process?

The IRB approval process is designed to turn around research proposals requiring review in as timely a manner as possible while at the same time ensuring full protection of the rights and welfare of the human subjects under the regulation. Depending on the level of risk to the subjects, reviews can typically be completed in 1-2 weeks for minimal-risk projects unless there are questions from the IRB. Thus it is to the PI's advantage to completely fill out the application carefully answering all relevant questions and putting N/A for those which are not relevant. Your IRB will notify you upon completion of the review.

What does the IRB consider when reviewing the application?

Information that is considered during IRB review:

  1. The nature and purpose of the research;
  2. Risks and benefits to the subjects, including physical, psychological, sociological, economic, and legal risks and whether the risks are minimized and reasonable in relation to anticipated benefits, if any;
  3. The subject population and whether selection of subjects is equitable;
  4. Whether additional safeguards have been included when subjects are considered vulnerable, such as children, prisoners, pregnant women, mentally or physically disabled or economically or educationally disadvantaged persons, or DOE employees.
  5. The process of informed consent and method of documentation.
  6. Data collection, processing and storage, including methods employed to ensure the safety, privacy and confidentiality of that data.
  7. Whether additional IRB review and/or oversight is required on more than an annual basis.

What are DOE’s requirements for researchers who will be working with Personally Identifiable Information (PII) or Protected Health Information (PHI)?

Researchers must address the following items in all protocols:

  1. Methods for maintaining confidentiality of PII/PHI;
  2. Procedures for release of PII/PHI, where required;
  3. Documentation that the PII/PHI will be used for the program under review;
  4. Handling and marking documents containing PII as “containing PII/PHI;
  5. Establishing reasonable administrative, technical, and physical safeguards to prevent unauthorized use or disclosure of PII/PHI;
  6. Making no further use or disclosure of the PII/PHI except when approved by the responsible IRB(s) and DOE, where applicable, and then only under the following circumstances: (a) in an emergency affecting the health or safety of any individual; (b) for use in another research project under these same conditions and with DOE written authorization; (c) for disclosure to a person authorized by the DOE program office for the purpose of an audit related to the project; (d) when required by law; or (e) with the consent of the participant;
  7. Protecting PII/PHI data stored on removable media (CD, DVD, USB Flash Drives, etc.), using encryption products that are Federal Information Processing Standards (FIPS) 140-2 certified;
  8. Using passwords to protect PII/PHI used in conjunction with FIPS 140-3 certified encryption that meet the current DOE password requirements cited in DOE Order 205.1C, DOE Cyber Security Program, and DOE Order 206.1, DOE Privacy Program (or current versions of these documents); ;
  9. Sending removable media containing PII/PHI, as required, by express overnight service with signature and tracking capability, and shipping hard copy documents double-wrapped;
  10. Encrypting data files containing PII/PHI that are being sent by e-mail with FIPS 140-3 certified encryption products;
  11. Sending passwords that are used to encrypt data files containing PII/PHI separately from the encrypted data file, i.e., separate e-mail, telephone call, separate letter;
  12. Using FIPS 140-3 certified encryption methods for websites established for the submission of information that includes PII;
  13. Using two-factor authentication for logon access control for remote access to systems and databases that contain PII/PHI. (Two-factor authentication is contained in the National Institute of Standards and Technology (NIST) Special Publication 800-63 Version 1.0.2 (PDF)); and
  14. Reporting the loss or suspected loss of PII/PHI immediately upon discovery to: 1) the DOE funding office Program Manager; and 2) the applicable IRBs (as designated by the DOE Program Manager). If the DOE Program Manager is unreachable, immediately notify the DOE Integrated Joint Cybersecurity Coordination Center (iJC3) (1-866-941-2472). Refer to the Protection of PII section for additional information.

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After Initial Review and Approval

The IRB has approved my project for 12 months. What will I need to do to extend the approval?

The IRB can only approve a project for 12 months or less, depending on the level of risk associated with the project. Other factors may also be considered. The IRB will notify you of the expiration date. Prior to the expiration date, the IRB will notify you that an application for continuing review is required. The continuing review application provides the IRB with current project information and requires that informed consent be re-approved at each renewal. The continuing review application must be approved before the expiration date or the research will be put on hold until approval is renewed.

Do exempt projects require continuing approval?

Some information from the researcher is required on an annual basis. Check with your site or Central DOE IRB Manager/Administrator.

What if I want to change the study protocol?

Any changes to the protocol, consent form or recruitment forms, must be approved by the IRB before they may be initiated. Contact your IRB Manager/Administrator regarding the process for submitting a modification.

What if an adverse event occurs that seems minor to me and is already listed on the informed consent form?

Please notify to the IRB, so that the IRB can work with you to determine what follow-up and, if applicable, other actions, are needed .

What if a significant adverse event, non-compliance, or unanticipated problem associated with my project occurs?

The PI should stop work and immediately notify the IRB. The IRB will work with you and DOE HQ to investigate and document the problem and will determine if any corrective actions are necessary to resolve the issue. The IRB will notify the PI when the issue has been resolved to its satisfaction and work may recommence. 

Are there any requirements for refresher training?

PIs and project staff that have access to subjects and to PII complete refresher training every  three years. Check with your IRB Manager/Administrator.

Is there anyone else I need to report to on an annual basis once my project has been initiated?

Yes, you will be expected to provide information annually as part of your continuing review that will be included in an internet accessible database of all DOE research projects, known as the DOE Human Subjects Research Database, involving human participants since 2006. The database contains information for HSR that is funded by the DOE, conducted in DOE facilities, performed by DOE or contractor employees, or includes current or former DOE or contractor personnel.  Your IRB Manager/Administrator will help facilitate this process.
Your IRB Administrator may determine that some projects that are minimal risk that have been initiated after January 2019 will not need annual continuing review. You will still be asked to provide updates for the DOE Human Subjects Research Database, however.   

I have completed my project. Do I need to do any follow-up with the IRB?

Once your project is completed, you will need to notify the IRB and complete a final report form.
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Projects Involving Human Terrain Mapping (HTM) Data

How does DOE determine whether a project involves Human Terrain Mapping (HTM) research?

DOE takes into consideration the intended use of the product the DOE lab has been tasked with developing to determine if the research qualifies as HTM. It is DOE policy that HTM activities be managed as human subjects research and that only de-identified data be used by its researchers.

How do I obtain review of a project that might involve HTM?

Provide a copy of the statement of work for the proposed project to the IRB contact at your site. The statement of work will be used to initiate a preliminary review and a determination by DOE and the IRB as to whether the work qualifies as HTM and requires additional review.

What does the following mean: “among whom the U.S. Armed Forces are operating and/or in countries prone to political instability?"

In simple terms, it means that the U.S. has active military operational activities (war, police action, military advisors, U.N. and/or NATO peace action, etc.).
Countries prone to political instability are those countries with which the U.S. does not have diplomatic ties and/or those countries that are listed by the Department of State as terrorist states. Those countries for which the State Department has issued travel warnings, because of “long-term, protracted conditions make a country dangerous or unstable,” should also be considered as prone to political instability unless a justification is approved by the appropriate DOE/NNSA Human Subjects Protection program manager, after discussing it with the DOE Institutional Official.
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Projects Involving Modification of the Human Environment

What types of studies involve modification of the human environment?

  • Generalizable studies in human environments (e.g., occupied homes and offices, classrooms, and transit centers like subway systems and airports) that use tracer chemicals, particles, and/or other materials, such as perfluorocarbons, to characterize airflow.
  • Generalizable studies in occupied homes and/or offices that:
    • manipulate the environment to achieve research aims (e.g., increasing humidity and/or reducing influx of outside air through new energy-saving ventilation systems).
    • test new materials (e.g., sequentially changing the filter materials in the HVAC system while monitoring the effects on air quality and energy use).
    • collect information on occupants’ views of appliances, materials, or devices installed in their homes or their energy saving behaviors through surveys and focus groups. Some surveys may be online surveys administered through providers such as Amazon Mechanical Turk and Survey Monkey.

What is DOE’s philosophy regarding such studies?

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 researchers conduct the research and do not participate in HSR, but when they do, the potential risks to the researchers must also be considered by the IRB.

Exactly what does “managed as HSR” mean?

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 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. Adherence to each specific requirement of 45 CFR Part 46 is not required in such a case, but DOE does require that:

  1. An application and supporting materials be submitted to the IRB;
  2. The Chair decide the level of review;
  3. During the review, the IRB assess risks associated with the research and whether the individuals to be included in such research will be properly informed and protected. Subject Matter Experts (SMEs) should be used, as needed, in assessing risks and in determining whether risks have been mitigated to the extent practicable (to minimal risk).
  4. After the review, the Chair sends a letter to the PI indicating that the project has been reviewed in accordance with DOE expectations and will be monitored and tracked by the IRB, which means that the PI will:
    1. Implement any IRB recommendations before the project begins;
    2. Notify the IRB of any proposed changes to the protocol in the future and ensure IRB review and authorization to proceed before implementing these changes;
    3. Provide an annual update to the IRB; and
    4. Follow the notification and reporting requirements in DOE O 443.1C for reporting adverse events, annual update of the DOE HSRD, etc.

Examples of Relevant Questions for the IRB to Consider During Initial Review of Projects Involving Modification of the Human Environment:

  • Is there is a compelling and credible case for anyone not on the research team to be present during the experiment? Are there other ways to achieve the research aims?
  • Have all the risks and discomforts been identified and considered, e.g., have: a) chemicals/materials to be used been evaluated for potential human health and safety effects; b) all devices had appropriate safety testing; c) other potential risks been identified in the population group(s) to be exposed?
  • Have appropriate mitigations been taken to minimize the risks, and are risks considered minimal for all involved?
  • How will anyone who is involved in the study but not part of the research staff be informed of the research? Will consent forms be used? Are the key elements of informed consent included or the requirements for waiver of consent met?
  • Is there a way for people to “opt out” if they wish without any repercussions?
  • How will the PI monitor the research and measure outcomes?
  • How and from what sources will data be collected? Will characteristics of the subject population be determined and/or required for the research?

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Projects that are Classified, in Whole or In Part

What are the requirements for Classified HSR?

Carefully review DOE Order 443.1C and discuss specific requirements with your IRB Manager/Administrator.
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