Researchers from DOE Laboratories
The following Frequently Asked Questions (FAQs) were prepared to assist those who are involved or with or have an interest in the DOE/NNSA Human Subjects Research. For additional information, please contact Libby White or John Ordaz.
Planning a Project Involving Human Subjects Research
Initiation of DOE IRB Review
After Initial Review and Approval
Projects Involving Human Terrain Mapping (HTM) Data
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 (www.nnsa.energy.gov). 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, both the DOE and NNSA program managers work together to ensure there is one seamless program.
Planning a Project Involving Human Subjects Research
There are two criteria for determining if a study falls under the Federal requirements (45 CFR 46) for human subjects research. First, the Principal Investigator (PI) must consult with the IRB Manager to determine if the study is indeed "research" and then whether the research protocol uses “human subjects.”
- Research is
- a systematic investigation, including research development, testing and evaluation.
- designed to develop or contribute to generalizable knowledge. To be generalizable, research must be shared beyond one location and one customer. The process of sharing may include presentations and publications. Proof-of-concept projects and pilot studies, even involving only one subject (such as the PI), are generalizable if the data is to be used in a proposal presented to a prospective sponsor.
- A human subject is a living individual about whom a PI obtains:
- Data through intervention with the individual; this includes:
- manipulations of the subject or the subject's environment. Such manipulations may be performed to either gain subject input in response to the manipulation or record by sensor a human activity or a biometric measurement;
- physical procedures following which data will be generated, for example, collection of bodily fluids or cells (use of either commercial or private cell lines, even from cells previously collected must also be reviewed).
- Data through interaction with the individual; this includes communication or interpersonal contact between the investigator and the subject. Examples include questionnaires and surveys.
- Identifiable private information about the individual; this includes information that an individual can reasonably expect will not be made public (for example, a record containing a social security number or medical information, or observations of behavior in a non-public setting). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. If private information is collected but is de-identified, the project still needs to be reviewed.
There are frequently gray areas related to applicability of these regulations to a project, especially for research projects involving the human/machine interface or Human Terrain Mapping (HTM). In these cases, there needs to be a dialogue among the PI(s), the appropriate DOE IRB, and DOE Headquarters to determine whether the PI(s) will need to submit an application.
If there are any questions regarding the applicability of human subjects research requirements, contact the Manager of the appropriate DOE IRB or one of the DOE Human Subjects Protection Program Managers (See Which DOE Sites have IRBs and whom do I contact with questions?).
If you and the IRB Manager determine that human subjects research regulations apply to your project, your first step will be to complete an application for initial review by the appropriate DOE IRB.
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.
There are two Central DOE IRBs and multiple DOE site IRBs.
The Central DOE IRB (CDOEIRB) was established in January 2010 by four DOE Headquarters organizations: the Office of Science (SC), the Office of Health, Safety and Security (HSS), the National Nuclear Security Administration (NNSA), and the Office of Intelligence and Counterintelligence. The CDOEIRB serves as DOE’s IRB of Record for purposes of satisfying the human subjects protection requirements of the DOE for study protocols that involve: 1) beryllium-related studies sponsored or conducted by DOE facilities or involving the DOE workforce; (2) the Former Worker Medical Screening Program; (3) multi-site research focused on the health and/or productivity of current workers at DOE sites; (4) human terrain mapping projects for DOE sites that do not manage or operate their own internal IRB; and (5) a portion of the energy efficiency studies sponsored by DOE. DOE has used a Central IRB since 2001, but the earlier IRB focused only on beryllium-related studies.
Contact: Becky Hawkins, Administrator (firstname.lastname@example.org or; 865-576-1725)
Contact: Ann-Marie Dake, (email@example.com or 925-422-0260)
IRB Managers/Points of Contact for DOE Site IRBs:
Argonne National Laboratory (ANL – uses the University of Chicago IRB)
Contact: Gail Van Gorp (firstname.lastname@example.org or 630-252-7608)
Idaho National Laboratory (INL): https://inlportal.inl.gov/portal/server.pt/community/home/255
Contact: Dena Tomchak, (email@example.com or 208-526-1590)
Lawrence Livermore National Laboratory
Contact: Ann-Marie Dake, (firstname.lastname@example.org or 925-422-0260)
Oak Ridge National Laboratory, Oak Ridge Institute for Science and Education, Y-12, or K-25: http://orise.orau.gov/orisehumansubjects/
Contact: Becky Hawkins, (email@example.com or 865-576-1725)
Initiation of DOE IRB Review
Contact the applicable IRB. The IRB will provide you with an application form and specific instructions.
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, you can proceed with the research.
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 for 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.
Information that is considered during IRB review:
- The nature and purpose of the research;
- 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;
- The subject population and whether selection of subjects is equitable;
- That 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.
- The process of informed consent and method of documentation.
- Data collection, processing and storage, including methods employed to ensure the safety, privacy and confidentiality of that data.
- If additional IRB review and/or oversight is required on more than an annual basis.
Human Subjects Research training is required for PIs and all project staff who will have access to personally identifiable information (PII) and is to be renewed every 2-3 years. DOE provides access to CITI Training (www.CITIprogram.org) at no cost to its sites. CITI training includes a variety of training modules that may be applied as appropriate. Contact your IRB Manager to discuss the modules required at your site. 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 are DOE’s requirements for researchers who will be working with Personally Identifiable Information (PII)?
Researchers must address the following items in all protocols:
- Methods for maintaining confidentiality of PII;
- Procedures for release of PII, where required;
- Documentation that the PII will be used for the program under review;
- Handling and marking documents containing PII as “containing PII or Protected Health Information (PHI);
- Establishing reasonable administrative, technical, and physical safeguards to prevent unauthorized use or disclosure of PII;
- Making no further use or disclosure of the PII 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;
- Protecting PII data stored on removable media (CD, DVD, USB Flash Drives, etc.), using encryption products that are Federal Information Processing Standards (FIPS) 140-2 certified;
- Using passwords to protect PII used in conjunction with FIPS 140-2 certified encryption that meet the current DOE password requirements cited in DOE Guide 205.3-1;
- Sending removable media containing PII, as required, by express overnight service with signature and tracking capability, and shipping hard copy documents double-wrapped;
- Encrypting data files containing PII that are being sent by e-mail with FIPS 140-2 (http://csrc.nist.gov/publications/PubsFIPS.html) certified encryption products;
- Sending passwords that are used to encrypt data files containing PII separately from the encrypted data file, i.e., separate e-mail, telephone call, separate letter;
- Using FIPS 140-2 certified encryption methods for websites established for the submission of information that includes PII;
- Using two-factor authentication for logon access control for remote access to systems and databases that contain PII. (Two-factor authentication is contained in the National Institute of Standards and Technology (NIST) Special Publication 800-63 Version 1.0.2 found at: http://csrc.nist.gov/publications/nistpubs/800-63/SP800-63V1_0_2.pdf); and
- Reporting the loss or suspected loss of PII 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-CIRC (1-866-941-2472, http://energy.gov/cio/office-chief-information-officer/services/incident-management). Refer to http://humansubjects.energy.gov/other-resources/pii.htm for additional information.
After Initial Review and 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 of approval. Prior to the expiration date of approval 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.
Most sites require some information from the researcher on an annual basis. Check with your site IRB manager.
Any changes to the protocol, including new amendments or revisions to the consent form or process, must be approved by the IRB before they may be initiated. Contact your IRB Manager for the proper forms.
If an adverse event or unanticipated problem associated with a 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.
An adverse event is: any unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.
Unanticipated problems must meet all of the following criteria. They must be:
- Unexpected (in terms of nature, severity, or frequency), given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
- Related or possibly related to participation in the research;
- Likely to place subjects or others at greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
PIs and project staff that have access to subjects and to PII complete refresher training every two to three years. Check with your IRB Manager. (Refer to the “How do I log on to the CITI training?” question for login instructions.)
Yes, you will be expected to report annually to the DOE Human Subjects Research Database (http://www.orau.gov/hsrdreport). Your IRB Manager will help facilitate this process.
Once your project is completed, you will need to notify the IRB and complete a final report form. The IRB will report to the DOE Human Subjects Research Database at the time of annual review.
Projects Involving Human Terrain Mapping (HTM)
Research and data gathering activities primarily conducted for military or intelligence purposes to understand the social, ethnographic, cultural, and political elements of the people among whom the U.S. Armed Forces are operating and/or in countries prone to political instability. While this work includes observations, questionnaires, and interviews of groups of individuals, the primary potential involvement of DOE researchers is in the modeling and analysis of collected data plus development of new tools for such activities.
DOE takes into consideration the intended use of the product their lab has been tasked with developing to determine if the research qualifies as HTM. Other names for Human Terrain Mapping (HTM) include human social culture behavior (HSCB) and human terrain systems (HTS) studies. It is DOE policy that HTM activities be managed as human subjects research and that only de-identified data be used by its researchers.
Provide a copy of the statement of work for the proposed project to the IRB contact at your site, or if you work at Argonne National Laboratory, both the site IRB contact and the Central DOE IRB. 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. Documentation of the preliminary review will be provided to the Work for Others Office to include with the proposal.
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.). Recent examples include: Afghanistan, Iraq, Libya, and Yemen.
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 (http://www.state.gov/j/ct/list/index.htm). 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.