79C3C34C52B45572883A05D425EB0F82
DOE Order 443.1B
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.000006: (IN)). A list of study-specific waiver requests and the actions taken will be provided monthly to the DOE IO.
p.000006:
p.000006: b. Solicitations. Any solicitation issued by a DOE element for HSR must require compliance with the
p.000006: requirements of this Order, 10 CFR Part 745, and 45 CFR Part 46.
p.000006:
p.000006: c. Contracts, Financial Assistance Agreements, and Other Agreements. Any DOE contract, financial assistance
p.000006: agreement, or other agreement involving HSR must require compliance with the requirements set forth in this Order
p.000006: and/or the CRD associated with this Order (Attachment 1), as well as with 10 CFR Part 745 and 45 CFR Part 46.
p.000006:
p.000006:
p.000006:
p.000006: 2 The Presidential Memorandum, Strengthened Protections for Human Subjects of Classified Research, dated March 27,
p.000006: 1997, requires such an appeal process.
p.000006:
p.000006: DOE O 443.1C
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p.000007: 11-26-2019
p.000007:
p.000007: d. Notification. The Human Subjects Protection (HSP) Program Manager (and when an NNSA element is involved, the
p.000007: NNSA HSP Program Manager) must be notified in writing:
p.000007:
p.000007: (1) Prior to initiation of the HSR portion of a new project, even if it meets the regulatory definition of exempt
p.000007: HSR as outlined in 10 CFR Part 745.104, that involves:
p.000007:
p.000007: (a) an institution without an established IRB;
p.000007:
p.000007: (b) a foreign country;
p.000007:
p.000007: (c) a potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight
p.000007: groups);
p.000007:
p.000007: (d) research subjects in a protected class (prisoners, children, individuals with impaired decision making, or
p.000007: DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to coercion and undue
p.000007: influence to participate) that is outside of the reviewing IRB’s typical range/scope; or
p.000007:
p.000007: (e) the generation or use of classified information.
p.000007:
p.000007: (2) Immediately upon a finding of a suspected or confirmed data breach involving Personally Identifiable
p.000007: Information (PII) in printed or electronic form, and the incident must be reported to the DOE-Cyber Incident Response
p.000007: Capability in accordance with the requirements of DOE O
p.000007: 206.1. The appropriate HSP Program Manager must also be notified of any corrective actions taken and consulted
p.000007: regarding the plan for any remaining corrective actions.
p.000007:
p.000007: (3) Immediately upon learning of a serious adverse event. The appropriate HSP Program Manager must also be
p.000007: informed of any corrective actions taken and consulted regarding the plan for any remaining corrective actions.
p.000007:
p.000007: (4) Within 48 hours, with a description of corrective actions taken. The appropriate HSP Program Manager must
p.000007: also be consulted regarding the plan for any remaining corrective actions, following other incidents not covered in (2)
p.000007: and (3) above:
p.000007:
p.000007: (a) unanticipated problems, significant adverse events, and complaints about the research, as well as suspension
p.000007: or termination of IRB approval of research; and
p.000007:
...
p.000008: DOE O 443.1C
p.000008: 11-26-2019
p.000008:
p.000008: (5) Immediately upon the appointment of a new DOE or NNSA Site IRB Chair, Co-Chair or IO.
p.000008:
p.000008: e. Human Subjects Research Database (HSRD) Reporting. HSR projects (excluding classified and/or
p.000008: intelligence-related HSR) must be reported annually to the HSR Projects Database (HSRD) in accordance with directions
p.000008: and schedules provided by the appropriate HSP Program Manager. Such reporting is also required when HSR is minimal
p.000008: risk (exempt) and the IRB has determined a continuing review is not required.
p.000008:
p.000008: f. Records. Project- and meeting-specific record keeping for all DOE/NNSA site and central IRBs must be done
p.000008: via the DOE Headquarters-provided electronic IRB protocol system. Additionally, all records related to IRB
p.000008: review/approval of classified HSR and key research records must be maintained permanently, subject to NARA
p.000008: requirements, but not less than 100 years. During and following the completion of the research, copies of all signed
p.000008: classified consent forms must be stored in a separate but secure central location (e.g., security policy officer or IRB
p.000008: office), other than the researchers’ office, and participants of such research must be notified during the consenting
p.000008: process regarding how to access a copy of their individual signed classified consent forms should they want to in the
p.000008: future.
p.000008:
p.000008: g. Protected Classes. Research involving prisoners, children, and individuals with impaired decision making
p.000008: must be conducted in accordance with the appropriate Subpart(s) of 45 CFR Part 46. Care should also be taken to ensure
p.000008: the proper protections are in place for DOE/NNSA federal and/or contractor employees who become human subjects of
p.000008: research and may be subject to coercion or undue influence.
p.000008:
p.000008: h. IRB Registration. Each IRB that is designated by an institution under an assurance of compliance approved
p.000008: for Federalwide use by the Office for Human Research Protections (OHRP) under 45 CFR Part §46.103(a) and that reviews
p.000008: research involving human subjects conducted or supported by the Department of Health and Human Services (HHS) must be
p.000008: registered with HHS in accordance with 45 CFR Part 46 Subpart E.
p.000008:
p.000008: 5. RESPONSIBILITIES.
p.000008:
p.000008: All DOE employees, contractors, financial assistance recipients, and parties to other DOE agreements share the
p.000008: responsibility to protect the rights and welfare of human research subjects.
p.000008:
p.000008: a. The Secretary of Energy.
p.000008:
p.000008: (1) Responsible for oversight of the conduct of DOE-related human subject research. Delegates this responsibility
p.000008: to a Senior DOE Institutional Official (IO) for HSR. For the DOE, the IO is the Associate Director of Science for the
...
p.000020:
p.000020: (2) that cannot be validly conducted without people present (other than those conducting the research),
p.000020: regardless of whether identifiable private information is collected about them. Before such research begins, the
p.000020: potential risks to those individuals must be considered by the appropriate DOE IRB.
p.000020:
p.000020: x. NNSA Human Subjects Protection Designee (NNSA HSP Program Manager). The program manager responsible for
p.000020: overseeing the Human Subjects Protection Program for NNSA elements.
p.000020:
p.000020: y. Personally Identifiable Information. Any information collected or maintained about an individual, including
p.000020: but not limited to, education, financial transactions, medical history and criminal or employment history, and
p.000020: information that can be used to distinguish or trace an individual’s identity, such as his/her name, Social Security
p.000020: number, date and place of birth, mother’s maiden name, biometric data, and any other personal information that is
p.000020: linked or linkable to a specific individual.
p.000020:
p.000020: z. Protected Class of Human Subjects. Populations who may be more vulnerable to coercion or undue influence
p.000020: when participating as research subjects,
p.000020:
p.000020: DOE O 443.1C
p.000021: 21
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p.000021:
p.000021: including children, prisoners, decisionally impaired individuals, economically or educationally disadvantaged persons,
p.000021: and other vulnerable populations, who are thus afforded additional protections by the Federal regulations (see
p.000021: additional subparts of 45 CFR Part 46) and/or the IRB. DOE and DOE site employees are considered vulnerable subjects
p.000021: when participating in research and additional care must be taken to ensure their participation is truly voluntary
p.000021: (e.g., by ensuring they do not report to members of the research team) and that data collected about them is kept
p.000021: confidential.
p.000021:
p.000021: aa. Research. A systematic investigation, including research development, testing and evaluation, designed to
p.000021: contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this
p.000021: policy, whether or not they are conducted or supported under a program which is considered research for other purposes.
p.000021: For example, some demonstration and service programs may include research activities. For purposes of this part, the
p.000021: following activities are deemed not to be research:
p.000021:
p.000021: (1) Scholarly or journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal
p.000021: research, and historical scholarship), including the collection and use of information, that focus directly on the
p.000021: specific individuals about whom the information is collected.
p.000021:
p.000021: (2) Public health surveillance activities, including the collection and testing of information or biospecimens,
...
p.000023: DOE O 443.1C
p.000023: Attachment 1
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p.000023: Page 1
p.000023:
p.000023: CONTRACTOR REQUIREMENTS DOCUMENT
p.000023:
p.000023: DOE O 443.1C, PROTECTION OF HUMAN RESEARCH SUBJECTS
p.000023:
p.000023: Regardless of the performer of the work, the contractor is responsible for compliance with the requirements of this
p.000023: Contractor Requirements Document (CRD).
p.000023:
p.000023: The contractor is responsible for flowing down the requirements of this CRD to subcontracts at any tier to the extent
p.000023: necessary to ensure the contractor's compliance with the requirements.
p.000023:
p.000023: Note: Throughout this CRD, the term "Human Subjects Protection Program Manager (HSP Program Manager)" refers either to
p.000023: the DOE HSP Program Manager or to the NNSA HSP Program Manager except where otherwise noted.
p.000023:
p.000023: As directed by the contracting officer, the contractor must—
p.000023:
p.000023: 1. Notify the DOE HSP Program Manager (and, when an NNSA element is involved, the NNSA HSP Program Manager):
p.000023:
p.000023: a. Prior to initiation of any new HSR project, even if it meets the regulatory definition of exempt HSR as
p.000023: outlined in 10 CFR Part 745.104, involving:
p.000023:
p.000023: (1) an institution without an established Institutional Review Board (IRB);
p.000023:
p.000023: (2) a foreign country;
p.000023:
p.000023: (3) the potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight
p.000023: groups);
p.000023:
p.000023: (4) research subjects in a protected class (prisoners, children, individuals with impaired decision making
p.000023: capability, or DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to
p.000023: coercion and undue influence to participate) that is outside of the reviewing IRB’s typical range/scope; or
p.000023:
p.000023: (5) the generation or use of classified information.
p.000023:
p.000023: b. Within 48 hours of the following, and provide a description of corrective actions taken immediately
p.000023: following the incident and consult with the HSP Program Manager(s) regarding additional corrective actions to be taken
p.000023: in the case of:
p.000023:
p.000023: (1) any significant adverse events, unanticipated problems, and complaints about the research;
p.000023:
p.000023: (2) any suspension or termination of IRB approval of research; and/or
p.000023:
p.000023: (3) any significant non-compliance with HSP Program procedures or other requirements.
p.000023:
p.000023: Attachment 1
p.000023: DOE O 443.1C
p.000023: Page 2
p.000023: 11-26-2019
p.000023:
p.000023: c. Immediately, upon finding of a suspected or confirmed data breach involving PII in printed or electronic
p.000023: form, and additionally immediately notify the DOE-Cyber Incident Response Capability, in accordance with the
p.000023: requirements of the CRD associated with DOE O 206.1. The HSP Program Manager(s) shall also be notified of any
p.000023: corrective actions taken and consulted regarding the plan for any remaining corrective actions.
p.000023:
...
Political / criminal
Searching for indicator criminal:
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p.000020: Protections (OHRP) and designated on an FWA.
p.000020:
p.000020: v. Minimal Risk. The probability and magnitude of harm or discomfort anticipated in the research are not
p.000020: greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine
p.000020: physical or psychological examinations or tests.
p.000020:
p.000020: w. Modification of the Human Environment. Research:
p.000020:
p.000020: (1) in which people have their environment intentionally changed or manipulated for the purposes of the research,
p.000020: with or without their knowledge; and/or
p.000020:
p.000020: (2) that cannot be validly conducted without people present (other than those conducting the research),
p.000020: regardless of whether identifiable private information is collected about them. Before such research begins, the
p.000020: potential risks to those individuals must be considered by the appropriate DOE IRB.
p.000020:
p.000020: x. NNSA Human Subjects Protection Designee (NNSA HSP Program Manager). The program manager responsible for
p.000020: overseeing the Human Subjects Protection Program for NNSA elements.
p.000020:
p.000020: y. Personally Identifiable Information. Any information collected or maintained about an individual, including
p.000020: but not limited to, education, financial transactions, medical history and criminal or employment history, and
p.000020: information that can be used to distinguish or trace an individual’s identity, such as his/her name, Social Security
p.000020: number, date and place of birth, mother’s maiden name, biometric data, and any other personal information that is
p.000020: linked or linkable to a specific individual.
p.000020:
p.000020: z. Protected Class of Human Subjects. Populations who may be more vulnerable to coercion or undue influence
p.000020: when participating as research subjects,
p.000020:
p.000020: DOE O 443.1C
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p.000021: 11-26-2019
p.000021:
p.000021: including children, prisoners, decisionally impaired individuals, economically or educationally disadvantaged persons,
p.000021: and other vulnerable populations, who are thus afforded additional protections by the Federal regulations (see
p.000021: additional subparts of 45 CFR Part 46) and/or the IRB. DOE and DOE site employees are considered vulnerable subjects
p.000021: when participating in research and additional care must be taken to ensure their participation is truly voluntary
p.000021: (e.g., by ensuring they do not report to members of the research team) and that data collected about them is kept
p.000021: confidential.
p.000021:
p.000021: aa. Research. A systematic investigation, including research development, testing and evaluation, designed to
p.000021: contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this
p.000021: policy, whether or not they are conducted or supported under a program which is considered research for other purposes.
p.000021: For example, some demonstration and service programs may include research activities. For purposes of this part, the
p.000021: following activities are deemed not to be research:
p.000021:
p.000021: (1) Scholarly or journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal
p.000021: research, and historical scholarship), including the collection and use of information, that focus directly on the
p.000021: specific individuals about whom the information is collected.
p.000021:
p.000021: (2) Public health surveillance activities, including the collection and testing of information or biospecimens,
p.000021: conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are
p.000021: limited to those necessary to allow a public health authority to identify, monitory, assess, or investigate potential
p.000021: public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends,
p.000021: signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities
p.000021: include those associated with providing timely situational awareness and priority setting during the course of an event
p.000021: or crisis that threatens public health (including natural or man-made disasters).
p.000021:
p.000021: (3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for
p.000021: activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
p.000021:
p.000021: (4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland
p.000021: security, defense, or other national security missions.
p.000021:
p.000021: bb. Strategic Intelligence Partnership Program (SIPP). SIPP, formerly the Intelligence Work for Others (IWFO)
p.000021: program, is the mechanism by which DOE provides highly-specialized scientific and technical services and products to
p.000021: non-DOE Intelligence Community (IC) and other agencies for intelligence and intelligence-related activities carried out
p.000021: under unique IC authorities held
p.000021:
p.000022: 22
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p.000022:
p.000022: by DOE’s Office of Intelligence and Counterintelligence and sponsoring IC agencies.
p.000022:
p.000022: cc. Strategic Partnership Projects (SPPs). SPP, formerly the Work for Others (WFO) program, is the mechanism by
p.000022: which non-DOE entities fund DOE/NNSA and/or their contractors or use DOE/NNSA facilities for work that is not directly
p.000022: funded by DOE/NNSA appropriations.
p.000022:
p.000022: dd. Unaffiliated IRB Member. For review of unclassified protocols, must not have a direct affiliation (employee,
p.000022: contractor, student in a fellowship, volunteer at the institution, or business related to the IRB, and must not have an
p.000022: immediate family member who is affiliated with the institution). For review of classified protocols, must be a
p.000022: nongovernmental member (not currently a Federal employee or a DOE site contractor employee) with the appropriate
p.000022: security clearance.
p.000022:
...
Political / political affiliation
Searching for indicator party:
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p.000002: NNSA employees, contractors, and elements comply with their respective responsibilities under this directive. Nothing
p.000002: in this Order should be construed to interfere with the NNSA Administrator's authority under Section 3212(d) of Public
p.000002: Law (P.L.) 106-65 to establish Administration-specific policies, unless disapproved by the Secretary.
p.000002:
p.000002: (2) In accordance with the responsibilities and authorities assigned by Executive Order 12344, codified at 50 CFR
p.000002: Parts 2406 and 2511, and to ensure consistency throughout the joint Navy/DOE Naval Nuclear Propulsion Program, the
p.000002: Deputy Administrator for Naval Reactors (Director) will implement and oversee requirements and practices pertaining to
p.000002: this Directive for activities under the Director’s cognizance, as deemed appropriate.
p.000002:
p.000002:
p.000002:
p.000002: AVAILABLE ONLINE AT:
p.000002: INITIATED BY:
p.000002: www.directives.doe.gov
p.000002: Office of Science
p.000002:
p.000002: 2
p.000002: DOE O 443.1C
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p.000002:
p.000002: b. DOE Contractors. Except for the exemption in paragraph 3.c., the Contractor Requirements Document (CRD),
p.000002: Attachment 1, sets forth the requirements of this Order that apply to contracts that include the CRD. The CRD must be
p.000002: included in contracts (i.e., those contracts that include the clause at 48 CFR Part (DEAR) 970.5204-2, Laws,
p.000002: Regulations, and DOE Directives) for the management or operation of a DOE-owned or –leased facility that involves human
p.000002: subjects research (HSR) as defined in paragraph 8.m., and comprehensively explained in paragraph 4.a., irrespective of
p.000002: the party conducting the HSR under the contract. For all other contracts that involve HSR, the applicable requirements
p.000002: set forth in this CRD must be included in the contract terms and conditions as appropriate.
p.000002:
p.000002: c. Exemptions for DOE O 443.1C.
p.000002:
p.000002: Any requests for partial or full exemptions by Departmental Elements from the requirements of this Order must be
p.000002: submitted in writing to the DOE Human Subjects Protection (HSP) Program Manager (and when an NNSA element is involved,
p.000002: the NNSA HSP Program Manager). An exemption may be recommended to the Secretary by the DOE HSP Program Manager (or by
p.000002: the NNSA HSP Program Manager when an NNSA element is involved) after concurrence by the DOE Institutional Official (IO,
p.000002: see paragraph 8.k.). The basis for granting or denying exemption requests must be set forth in writing.
p.000002:
p.000002: Exemption. Bonneville Power Administration is exempt from the requirements of DOE O 443.1C.
p.000002:
p.000002: 4. REQUIREMENTS. Research using human subjects provides important medical and scientific benefits to
p.000002: individuals and to society. The need for this research does not, however, outweigh the need to protect individual
p.000002: rights and interests. DOE requirements are established in the Federal Policy for the Protection of Human Subjects, (45
p.000002: CFR Part 46), Protection of Human Subjects, in 10 CFR Part 745 (DOE’s implementation of Subpart A of 45 CFR Part 46),
p.000002: and in this Order.
p.000002:
p.000002: a. Requirement Criteria.
p.000002:
...
Searching for indicator political:
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p.000019:
p.000019: (2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
p.000019:
p.000019: Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations
p.000019: of the subject or the subject’s environment that are performed for research purposes.
p.000019:
p.000019: Interaction includes communication or interpersonal contact between investigator and subject.
p.000019:
p.000019: Private information includes information about behavior that occurs in a context in which an individual can reasonably
p.000019: expect that no observation or recording is taking place, and information that has been provided for specific purposes
p.000019: by an individual and that the individual can reasonably expect will not be made public (for example, a medical record).
p.000019:
p.000019: Identifiable private information is private information for which the identity of the subject is or may readily be
p.000019: ascertained by the investigator or associated with the information.
p.000019:
p.000019: An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by
p.000019: the investigator or associated with the biospecimen.
p.000019:
p.000019: q. Human Subjects Research (HSR). Any activity meeting the definitions of both: 1) research, and 2) human
p.000019: subject, as defined in this section.
p.000019:
p.000019: r. Human Terrain Mapping. Research and data gathering activities primarily conducted for military or
p.000019: intelligence purposes to understand the “human terrain,”—the social, ethnographic, cultural, and political elements of
p.000019: the people among whom the U.S. Armed Forces are operating and/or in countries prone to political instability. This
p.000019: work includes observations, questionnaires, and interviews of groups of individuals, as well as modeling and analysis
p.000019: of collected
p.000019:
p.000020: 20
p.000020: DOE O 443.1C
p.000020: 11-26-2019
p.000020:
p.000020: data, and may become the basis for U.S. military actions in such locations. In addition to Human Terrain Mapping
p.000020: (HTM), such activities are often referred to as human social culture behavior (HSCB) studies. It is DOE policy that
p.000020: HTM activities will be managed as HSR.
p.000020:
p.000020: s. HTM Data. Data collected or used as part of HTM efforts, as described above, as well as any auxiliary data
p.000020: on the same group(s) of individuals.
p.000020:
p.000020: t. Institution. Any public or private entity or agency (including Federal, State, and other agencies). This
p.000020: term refers to laboratories and other facilities managed by DOE, DOE contractors, or DOE financial assistance
p.000020: recipients.
p.000020:
p.000020: u. Institutional Review Board (IRB). A committee or board established by an institution that performs initial
p.000020: and continuing reviews of research involving human subjects, and is registered with the Office for Human Research
p.000020: Protections (OHRP) and designated on an FWA.
p.000020:
p.000020: v. Minimal Risk. The probability and magnitude of harm or discomfort anticipated in the research are not
p.000020: greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine
p.000020: physical or psychological examinations or tests.
p.000020:
p.000020: w. Modification of the Human Environment. Research:
p.000020:
...
Political / vulnerable
Searching for indicator vulnerable:
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p.000006: agreement, or other agreement involving HSR must require compliance with the requirements set forth in this Order
p.000006: and/or the CRD associated with this Order (Attachment 1), as well as with 10 CFR Part 745 and 45 CFR Part 46.
p.000006:
p.000006:
p.000006:
p.000006: 2 The Presidential Memorandum, Strengthened Protections for Human Subjects of Classified Research, dated March 27,
p.000006: 1997, requires such an appeal process.
p.000006:
p.000006: DOE O 443.1C
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p.000007: 11-26-2019
p.000007:
p.000007: d. Notification. The Human Subjects Protection (HSP) Program Manager (and when an NNSA element is involved, the
p.000007: NNSA HSP Program Manager) must be notified in writing:
p.000007:
p.000007: (1) Prior to initiation of the HSR portion of a new project, even if it meets the regulatory definition of exempt
p.000007: HSR as outlined in 10 CFR Part 745.104, that involves:
p.000007:
p.000007: (a) an institution without an established IRB;
p.000007:
p.000007: (b) a foreign country;
p.000007:
p.000007: (c) a potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight
p.000007: groups);
p.000007:
p.000007: (d) research subjects in a protected class (prisoners, children, individuals with impaired decision making, or
p.000007: DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to coercion and undue
p.000007: influence to participate) that is outside of the reviewing IRB’s typical range/scope; or
p.000007:
p.000007: (e) the generation or use of classified information.
p.000007:
p.000007: (2) Immediately upon a finding of a suspected or confirmed data breach involving Personally Identifiable
p.000007: Information (PII) in printed or electronic form, and the incident must be reported to the DOE-Cyber Incident Response
p.000007: Capability in accordance with the requirements of DOE O
p.000007: 206.1. The appropriate HSP Program Manager must also be notified of any corrective actions taken and consulted
p.000007: regarding the plan for any remaining corrective actions.
p.000007:
p.000007: (3) Immediately upon learning of a serious adverse event. The appropriate HSP Program Manager must also be
p.000007: informed of any corrective actions taken and consulted regarding the plan for any remaining corrective actions.
p.000007:
p.000007: (4) Within 48 hours, with a description of corrective actions taken. The appropriate HSP Program Manager must
p.000007: also be consulted regarding the plan for any remaining corrective actions, following other incidents not covered in (2)
p.000007: and (3) above:
p.000007:
p.000007: (a) unanticipated problems, significant adverse events, and complaints about the research, as well as suspension
p.000007: or termination of IRB approval of research; and
p.000007:
p.000007: (b) known or potential incidents of noncompliance with requirements of this Order, 10 CFR Part 745, or 45 CFR
p.000007: Part 46.
p.000007:
p.000008: 8
p.000008: DOE O 443.1C
p.000008: 11-26-2019
p.000008:
p.000008: (5) Immediately upon the appointment of a new DOE or NNSA Site IRB Chair, Co-Chair or IO.
p.000008:
...
p.000020: physical or psychological examinations or tests.
p.000020:
p.000020: w. Modification of the Human Environment. Research:
p.000020:
p.000020: (1) in which people have their environment intentionally changed or manipulated for the purposes of the research,
p.000020: with or without their knowledge; and/or
p.000020:
p.000020: (2) that cannot be validly conducted without people present (other than those conducting the research),
p.000020: regardless of whether identifiable private information is collected about them. Before such research begins, the
p.000020: potential risks to those individuals must be considered by the appropriate DOE IRB.
p.000020:
p.000020: x. NNSA Human Subjects Protection Designee (NNSA HSP Program Manager). The program manager responsible for
p.000020: overseeing the Human Subjects Protection Program for NNSA elements.
p.000020:
p.000020: y. Personally Identifiable Information. Any information collected or maintained about an individual, including
p.000020: but not limited to, education, financial transactions, medical history and criminal or employment history, and
p.000020: information that can be used to distinguish or trace an individual’s identity, such as his/her name, Social Security
p.000020: number, date and place of birth, mother’s maiden name, biometric data, and any other personal information that is
p.000020: linked or linkable to a specific individual.
p.000020:
p.000020: z. Protected Class of Human Subjects. Populations who may be more vulnerable to coercion or undue influence
p.000020: when participating as research subjects,
p.000020:
p.000020: DOE O 443.1C
p.000021: 21
p.000021: 11-26-2019
p.000021:
p.000021: including children, prisoners, decisionally impaired individuals, economically or educationally disadvantaged persons,
p.000021: and other vulnerable populations, who are thus afforded additional protections by the Federal regulations (see
p.000021: additional subparts of 45 CFR Part 46) and/or the IRB. DOE and DOE site employees are considered vulnerable subjects
p.000021: when participating in research and additional care must be taken to ensure their participation is truly voluntary
p.000021: (e.g., by ensuring they do not report to members of the research team) and that data collected about them is kept
p.000021: confidential.
p.000021:
p.000021: aa. Research. A systematic investigation, including research development, testing and evaluation, designed to
p.000021: contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this
p.000021: policy, whether or not they are conducted or supported under a program which is considered research for other purposes.
p.000021: For example, some demonstration and service programs may include research activities. For purposes of this part, the
p.000021: following activities are deemed not to be research:
p.000021:
p.000021: (1) Scholarly or journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal
p.000021: research, and historical scholarship), including the collection and use of information, that focus directly on the
p.000021: specific individuals about whom the information is collected.
p.000021:
p.000021: (2) Public health surveillance activities, including the collection and testing of information or biospecimens,
p.000021: conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are
p.000021: limited to those necessary to allow a public health authority to identify, monitory, assess, or investigate potential
p.000021: public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends,
...
p.000023: Contractor Requirements Document (CRD).
p.000023:
p.000023: The contractor is responsible for flowing down the requirements of this CRD to subcontracts at any tier to the extent
p.000023: necessary to ensure the contractor's compliance with the requirements.
p.000023:
p.000023: Note: Throughout this CRD, the term "Human Subjects Protection Program Manager (HSP Program Manager)" refers either to
p.000023: the DOE HSP Program Manager or to the NNSA HSP Program Manager except where otherwise noted.
p.000023:
p.000023: As directed by the contracting officer, the contractor must—
p.000023:
p.000023: 1. Notify the DOE HSP Program Manager (and, when an NNSA element is involved, the NNSA HSP Program Manager):
p.000023:
p.000023: a. Prior to initiation of any new HSR project, even if it meets the regulatory definition of exempt HSR as
p.000023: outlined in 10 CFR Part 745.104, involving:
p.000023:
p.000023: (1) an institution without an established Institutional Review Board (IRB);
p.000023:
p.000023: (2) a foreign country;
p.000023:
p.000023: (3) the potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight
p.000023: groups);
p.000023:
p.000023: (4) research subjects in a protected class (prisoners, children, individuals with impaired decision making
p.000023: capability, or DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to
p.000023: coercion and undue influence to participate) that is outside of the reviewing IRB’s typical range/scope; or
p.000023:
p.000023: (5) the generation or use of classified information.
p.000023:
p.000023: b. Within 48 hours of the following, and provide a description of corrective actions taken immediately
p.000023: following the incident and consult with the HSP Program Manager(s) regarding additional corrective actions to be taken
p.000023: in the case of:
p.000023:
p.000023: (1) any significant adverse events, unanticipated problems, and complaints about the research;
p.000023:
p.000023: (2) any suspension or termination of IRB approval of research; and/or
p.000023:
p.000023: (3) any significant non-compliance with HSP Program procedures or other requirements.
p.000023:
p.000023: Attachment 1
p.000023: DOE O 443.1C
p.000023: Page 2
p.000023: 11-26-2019
p.000023:
p.000023: c. Immediately, upon finding of a suspected or confirmed data breach involving PII in printed or electronic
p.000023: form, and additionally immediately notify the DOE-Cyber Incident Response Capability, in accordance with the
p.000023: requirements of the CRD associated with DOE O 206.1. The HSP Program Manager(s) shall also be notified of any
p.000023: corrective actions taken and consulted regarding the plan for any remaining corrective actions.
p.000023:
p.000023: d. Immediately upon learning of a serious adverse event. The HSP Program Manager(s) shall also be informed of
p.000023: any corrective actions taken and consulted regarding the plan for any remaining corrective actions.
p.000023:
p.000023: e. Upon appointment of a new DOE or NNSA Site IRB Chair, Co-Chair, or Institutional Official (IO).
p.000023:
...
Health / Cognitive Impairment
Searching for indicator impaired:
(return to top)
p.000006: b. Solicitations. Any solicitation issued by a DOE element for HSR must require compliance with the
p.000006: requirements of this Order, 10 CFR Part 745, and 45 CFR Part 46.
p.000006:
p.000006: c. Contracts, Financial Assistance Agreements, and Other Agreements. Any DOE contract, financial assistance
p.000006: agreement, or other agreement involving HSR must require compliance with the requirements set forth in this Order
p.000006: and/or the CRD associated with this Order (Attachment 1), as well as with 10 CFR Part 745 and 45 CFR Part 46.
p.000006:
p.000006:
p.000006:
p.000006: 2 The Presidential Memorandum, Strengthened Protections for Human Subjects of Classified Research, dated March 27,
p.000006: 1997, requires such an appeal process.
p.000006:
p.000006: DOE O 443.1C
p.000007: 7
p.000007: 11-26-2019
p.000007:
p.000007: d. Notification. The Human Subjects Protection (HSP) Program Manager (and when an NNSA element is involved, the
p.000007: NNSA HSP Program Manager) must be notified in writing:
p.000007:
p.000007: (1) Prior to initiation of the HSR portion of a new project, even if it meets the regulatory definition of exempt
p.000007: HSR as outlined in 10 CFR Part 745.104, that involves:
p.000007:
p.000007: (a) an institution without an established IRB;
p.000007:
p.000007: (b) a foreign country;
p.000007:
p.000007: (c) a potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight
p.000007: groups);
p.000007:
p.000007: (d) research subjects in a protected class (prisoners, children, individuals with impaired decision making, or
p.000007: DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to coercion and undue
p.000007: influence to participate) that is outside of the reviewing IRB’s typical range/scope; or
p.000007:
p.000007: (e) the generation or use of classified information.
p.000007:
p.000007: (2) Immediately upon a finding of a suspected or confirmed data breach involving Personally Identifiable
p.000007: Information (PII) in printed or electronic form, and the incident must be reported to the DOE-Cyber Incident Response
p.000007: Capability in accordance with the requirements of DOE O
p.000007: 206.1. The appropriate HSP Program Manager must also be notified of any corrective actions taken and consulted
p.000007: regarding the plan for any remaining corrective actions.
p.000007:
p.000007: (3) Immediately upon learning of a serious adverse event. The appropriate HSP Program Manager must also be
p.000007: informed of any corrective actions taken and consulted regarding the plan for any remaining corrective actions.
p.000007:
p.000007: (4) Within 48 hours, with a description of corrective actions taken. The appropriate HSP Program Manager must
p.000007: also be consulted regarding the plan for any remaining corrective actions, following other incidents not covered in (2)
p.000007: and (3) above:
p.000007:
p.000007: (a) unanticipated problems, significant adverse events, and complaints about the research, as well as suspension
p.000007: or termination of IRB approval of research; and
p.000007:
p.000007: (b) known or potential incidents of noncompliance with requirements of this Order, 10 CFR Part 745, or 45 CFR
p.000007: Part 46.
p.000007:
p.000008: 8
...
p.000008:
p.000008: e. Human Subjects Research Database (HSRD) Reporting. HSR projects (excluding classified and/or
p.000008: intelligence-related HSR) must be reported annually to the HSR Projects Database (HSRD) in accordance with directions
p.000008: and schedules provided by the appropriate HSP Program Manager. Such reporting is also required when HSR is minimal
p.000008: risk (exempt) and the IRB has determined a continuing review is not required.
p.000008:
p.000008: f. Records. Project- and meeting-specific record keeping for all DOE/NNSA site and central IRBs must be done
p.000008: via the DOE Headquarters-provided electronic IRB protocol system. Additionally, all records related to IRB
p.000008: review/approval of classified HSR and key research records must be maintained permanently, subject to NARA
p.000008: requirements, but not less than 100 years. During and following the completion of the research, copies of all signed
p.000008: classified consent forms must be stored in a separate but secure central location (e.g., security policy officer or IRB
p.000008: office), other than the researchers’ office, and participants of such research must be notified during the consenting
p.000008: process regarding how to access a copy of their individual signed classified consent forms should they want to in the
p.000008: future.
p.000008:
p.000008: g. Protected Classes. Research involving prisoners, children, and individuals with impaired decision making
p.000008: must be conducted in accordance with the appropriate Subpart(s) of 45 CFR Part 46. Care should also be taken to ensure
p.000008: the proper protections are in place for DOE/NNSA federal and/or contractor employees who become human subjects of
p.000008: research and may be subject to coercion or undue influence.
p.000008:
p.000008: h. IRB Registration. Each IRB that is designated by an institution under an assurance of compliance approved
p.000008: for Federalwide use by the Office for Human Research Protections (OHRP) under 45 CFR Part §46.103(a) and that reviews
p.000008: research involving human subjects conducted or supported by the Department of Health and Human Services (HHS) must be
p.000008: registered with HHS in accordance with 45 CFR Part 46 Subpart E.
p.000008:
p.000008: 5. RESPONSIBILITIES.
p.000008:
p.000008: All DOE employees, contractors, financial assistance recipients, and parties to other DOE agreements share the
p.000008: responsibility to protect the rights and welfare of human research subjects.
p.000008:
p.000008: a. The Secretary of Energy.
p.000008:
p.000008: (1) Responsible for oversight of the conduct of DOE-related human subject research. Delegates this responsibility
p.000008: to a Senior DOE Institutional Official (IO) for HSR. For the DOE, the IO is the Associate Director of Science for the
p.000008: Office of Biological and Environmental Research.
p.000008:
p.000008: DOE O 443.1C
p.000009: 9
p.000009: 11-26-2019
p.000009:
...
p.000023: DOE O 443.1C, PROTECTION OF HUMAN RESEARCH SUBJECTS
p.000023:
p.000023: Regardless of the performer of the work, the contractor is responsible for compliance with the requirements of this
p.000023: Contractor Requirements Document (CRD).
p.000023:
p.000023: The contractor is responsible for flowing down the requirements of this CRD to subcontracts at any tier to the extent
p.000023: necessary to ensure the contractor's compliance with the requirements.
p.000023:
p.000023: Note: Throughout this CRD, the term "Human Subjects Protection Program Manager (HSP Program Manager)" refers either to
p.000023: the DOE HSP Program Manager or to the NNSA HSP Program Manager except where otherwise noted.
p.000023:
p.000023: As directed by the contracting officer, the contractor must—
p.000023:
p.000023: 1. Notify the DOE HSP Program Manager (and, when an NNSA element is involved, the NNSA HSP Program Manager):
p.000023:
p.000023: a. Prior to initiation of any new HSR project, even if it meets the regulatory definition of exempt HSR as
p.000023: outlined in 10 CFR Part 745.104, involving:
p.000023:
p.000023: (1) an institution without an established Institutional Review Board (IRB);
p.000023:
p.000023: (2) a foreign country;
p.000023:
p.000023: (3) the potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight
p.000023: groups);
p.000023:
p.000023: (4) research subjects in a protected class (prisoners, children, individuals with impaired decision making
p.000023: capability, or DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to
p.000023: coercion and undue influence to participate) that is outside of the reviewing IRB’s typical range/scope; or
p.000023:
p.000023: (5) the generation or use of classified information.
p.000023:
p.000023: b. Within 48 hours of the following, and provide a description of corrective actions taken immediately
p.000023: following the incident and consult with the HSP Program Manager(s) regarding additional corrective actions to be taken
p.000023: in the case of:
p.000023:
p.000023: (1) any significant adverse events, unanticipated problems, and complaints about the research;
p.000023:
p.000023: (2) any suspension or termination of IRB approval of research; and/or
p.000023:
p.000023: (3) any significant non-compliance with HSP Program procedures or other requirements.
p.000023:
p.000023: Attachment 1
p.000023: DOE O 443.1C
p.000023: Page 2
p.000023: 11-26-2019
p.000023:
p.000023: c. Immediately, upon finding of a suspected or confirmed data breach involving PII in printed or electronic
p.000023: form, and additionally immediately notify the DOE-Cyber Incident Response Capability, in accordance with the
p.000023: requirements of the CRD associated with DOE O 206.1. The HSP Program Manager(s) shall also be notified of any
p.000023: corrective actions taken and consulted regarding the plan for any remaining corrective actions.
p.000023:
p.000023: d. Immediately upon learning of a serious adverse event. The HSP Program Manager(s) shall also be informed of
...
Health / Drug Usage
Searching for indicator substance:
(return to top)
p.000023:
p.000023: (2) any suspension or termination of IRB approval of research; and/or
p.000023:
p.000023: (3) any significant non-compliance with HSP Program procedures or other requirements.
p.000023:
p.000023: Attachment 1
p.000023: DOE O 443.1C
p.000023: Page 2
p.000023: 11-26-2019
p.000023:
p.000023: c. Immediately, upon finding of a suspected or confirmed data breach involving PII in printed or electronic
p.000023: form, and additionally immediately notify the DOE-Cyber Incident Response Capability, in accordance with the
p.000023: requirements of the CRD associated with DOE O 206.1. The HSP Program Manager(s) shall also be notified of any
p.000023: corrective actions taken and consulted regarding the plan for any remaining corrective actions.
p.000023:
p.000023: d. Immediately upon learning of a serious adverse event. The HSP Program Manager(s) shall also be informed of
p.000023: any corrective actions taken and consulted regarding the plan for any remaining corrective actions.
p.000023:
p.000023: e. Upon appointment of a new DOE or NNSA Site IRB Chair, Co-Chair, or Institutional Official (IO).
p.000023:
p.000023: 2. Ensure that research involving human subjects, regardless of source of funding, is conducted in accordance
p.000023: with applicable Federal, DOE-specific, sponsor-specific, and other applicable requirements, including relevant
p.000023: international requirements. (See also 10 CFR Part 745 and 45 CFR Part 46.)1
p.000023: 3. Ensure that contractor-issued solicitations or proposals for research, studies, tests, surveys,
p.000023: surveillance, or other data collection are reviewed to identify research involving human subjects and that any
p.000023: resulting agreements include the substance of the requirements in this CRD.
p.000023:
p.000023: 4. Ensure that no research involving human subjects, regardless of funding source, is initiated without prior
p.000023: IRB approval under the terms of an approved assurance covering the research.
p.000023:
p.000023: 5. Ensure that all exempt HSR determinations are made by the appropriate IRB and/or IRB office.
p.000023:
p.000023: 6. Ensure that informed consent is documented or waived in accordance with 10 CFR Part 745.117.
p.000023:
p.000023: 7. Ensure that HSR involving multiple DOE sites (e.g., members of the research team from more than one DOE site
p.000023: and/or data or human subjects from more than one DOE site) is reviewed and approved by one of the Central DOE IRBs
p.000023: prior to initiation, or if authorized by the DOE and/or NNSA HSP Program Manager, other appropriate IRB of record. In
p.000023: all cases, an IRB Authorization Agreement (IAA) or Memorandum of Understanding (MOU) must be in place between the
p.000023: organization(s) conducting the HSR and the organization responsible for IRB review.
p.000023:
p.000023: 8. Ensure that HSR that involves DOE Federal and/or contractor employees is first reviewed and approved by the
p.000023: appropriate DOE IRB (the DOE site IRB or one of the Central DOE IRBs), or if deemed more fitting by the Federally
p.000023: assured DOE site or Headquarters,
p.000023:
p.000023: 1 Ensure that research is reviewed at intervals appropriate to the degree of risk, but not less than once per year, to
...
Health / Mentally Disabled
Searching for indicator disability:
(return to top)
p.000017: program within DOE and NNSA to identify certain unclassified controlled information as Official Use Only (OUO) (e.g.,
p.000017: PII and proprietary information) and to identify, mark, and protect documents containing such information to ensure it
p.000017: is protected according to legal and Departmental requirements.
p.000017:
p.000017: s. DOE M 471.3-1, Manual for Identifying and Protecting Official Use Only Information, current version, which
p.000017: provides detailed requirements to supplement DOE O 471.3.
p.000017:
p.000017: 8. DEFINITIONS.
p.000017:
p.000017: a. Adverse Event. Any unfavorable medical occurrence in a human subject, including any abnormal sign (for
p.000017: example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s
p.000017: participation in the research, whether or not considered related to the subject’s participation in the research
p.000017: (Unanticipated Problems Involving Risk and Adverse Events Guidance, OHRP, 2007). A significant adverse event is an
p.000017: adverse event that is unexpected and substantively impacts the human subjects. A serious adverse event (Unanticipated
p.000017: Problems Involving Risk Adverse Events Guidance, OHRP, 2007) is any adverse event temporally associated with the
p.000017: subject’s participation in research that meets any of the following criteria: a) results in death; b) is
p.000017: life-threatening; c) requires inpatient hospitalization or prolongation of existing hospitalization; d) results in a
p.000017: persistent or significant disability/incapacity; e) results in a congenital anomaly/birth defect, or f) based upon
p.000017: appropriate medical judgment, may jeopardize the subject’s health and may require medical or surgical intervention to
p.000017: prevent one of the other outcomes listed in this definition.
p.000017:
p.000017: b. Appropriate HSP Program Manager. The DOE HSP Program Manager (and when an NNSA element is involved, the NNSA
p.000017: HSP Program Manager).
p.000017:
p.000017: c. Assurance. The written documentation, satisfactory to the Secretary of Energy, required from the prospective
p.000017: performing institution, that ensures institutional compliance with and implementation of DOE and Department of Health
p.000017: and Human Services (DHHS) regulations for the protection of human research subjects. The only documentation currently
p.000017: meeting this requirement is a Federalwide Assurance (FWA). See: http://ohrp.cit.nih.gov/efile/FwaStart.aspx. Also see
p.000017: definition of Federalwide Assurance in this section.
p.000017:
p.000017: d. Certificate of Confidentiality. Authorizes persons engaged in Federally-funded research to protect the
p.000017: privacy of human subjects of sensitive research against
p.000017:
p.000018: 18
p.000018: DOE O 443.1C
p.000018: 11-26-2019
p.000018:
p.000018: compulsory disclosure in any Federal, State, or local judicial, administrative, or legislative proceeding.
p.000018:
p.000018: e. Classified Human Subjects Research. Research involving human subjects that is classified, in whole or in
p.000018: part, in accordance with the Federal sponsor and/or DOE criteria.
p.000018:
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000021: activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
p.000021:
p.000021: (4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland
p.000021: security, defense, or other national security missions.
p.000021:
p.000021: bb. Strategic Intelligence Partnership Program (SIPP). SIPP, formerly the Intelligence Work for Others (IWFO)
p.000021: program, is the mechanism by which DOE provides highly-specialized scientific and technical services and products to
p.000021: non-DOE Intelligence Community (IC) and other agencies for intelligence and intelligence-related activities carried out
p.000021: under unique IC authorities held
p.000021:
p.000022: 22
p.000022: DOE O 443.1C
p.000022: 11-26-2019
p.000022:
p.000022: by DOE’s Office of Intelligence and Counterintelligence and sponsoring IC agencies.
p.000022:
p.000022: cc. Strategic Partnership Projects (SPPs). SPP, formerly the Work for Others (WFO) program, is the mechanism by
p.000022: which non-DOE entities fund DOE/NNSA and/or their contractors or use DOE/NNSA facilities for work that is not directly
p.000022: funded by DOE/NNSA appropriations.
p.000022:
p.000022: dd. Unaffiliated IRB Member. For review of unclassified protocols, must not have a direct affiliation (employee,
p.000022: contractor, student in a fellowship, volunteer at the institution, or business related to the IRB, and must not have an
p.000022: immediate family member who is affiliated with the institution). For review of classified protocols, must be a
p.000022: nongovernmental member (not currently a Federal employee or a DOE site contractor employee) with the appropriate
p.000022: security clearance.
p.000022:
p.000022: ee. Unanticipated Problem. In general, to be classified as an unanticipated problem, any incident, experience, or
p.000022: outcome should meet all three of the following criteria:
p.000022:
p.000022: (1) Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described
p.000022: in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b)
p.000022: the characteristics of the subject population being studied
p.000022:
p.000022: (2) Related or possibly related to participation in the research (possibly related means there is a reasonable
p.000022: possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research)
p.000022:
p.000022: (3) Likely to place subjects or others at greater risk of harm (including physical, psychological, economic, or
p.000022: social harm) than was previously known or recognized.
p.000022:
p.000022: ff. Waiver from the Additional Requirements for Classified HSR. In certain cases, when classified projects can
p.000022: be fully reviewed in an unclassified form (e.g., because the protocol and consent form are unclassified), the IRB may
p.000022: submit, for consideration by the appropriate HSP Program Manager (and for intelligence-related HSR, also in
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000005: followed by DOE IO approval. The DOE IO, in consultation with the HSP Program Managers, will determine whether he/she
p.000005: will approve/disapprove the project or brief the Secretary about the project prior to his/her approval/disapproval.
p.000005:
p.000005: (c) Informed consent may only be waived for classified HSR if the work meets one of the categories of the
p.000005: minimal risk HSR addressed at 10 CFR Part 745.104.
p.000005:
p.000005: (d) The use of the expedited review process is prohibited. The fact that research meets a particular expedited
p.000005: category may be noted, but a full IRB review will be required.
p.000005:
p.000005: (e) HSR exemptions (as per 10 CFR Part 745.104) will not be used. The fact that research meets a particular
p.000005: exemption category may be noted, but a full IRB review will be required.
p.000005:
p.000005: (f) The identity of the sponsoring Federal agency must be disclosed to subjects, unless the sponsor requests it
p.000005: not be done. The only acceptable reason for non-disclosure is that disclosure could compromise intelligence sources or
p.000005: methods. Additionally, the research must be no more than minimal risk, and the IRB must determine that not disclosing
p.000005: the identity will not adversely affect the subjects.
p.000005:
p.000005: (g) The informed consent document will state that the project is classified, what that means for the purposes of
p.000005: that project, and what part of the research that applies to. The IRB must determine whether the potential human
p.000005: subjects need access to classified information in order to make a valid informed consent decision.
p.000005:
p.000005: (h) When reviewing classified HSR, the unaffiliated member of a DOE or DOE site IRB must be a nongovernmental
p.000005: member (not currently a Federal employee or a DOE site contractor employee) with the appropriate security clearance.
p.000005:
p.000006: 6
p.000006: DOE O 443.1C
p.000006: 11-26-2019
p.000006:
p.000006: (i) Any IRB member can appeal an IRB decision to approve a project to the DOE IO, and if not resolved to the IRB
p.000006: member’s satisfaction, to the Secretary of Energy. If still dissatisfied, the IRB member can appeal that approval
p.000006: decision to the Director of the Office of Science and Technology Policy (OSTP) or that Director’s designee, or the
p.000006: Director of National Intelligence (ODNI), or that Director’s designee.2 The Director of OSTP, or that Director’s
p.000006: designee, or the Director of National Intelligence, or that Director’s designee will review and approve or disapprove
p.000006: the research, or will convene or designate an IRB that is, to the extent possible, made up of unaffiliated members with
p.000006: the appropriate qualifications and clearance to approve or disapprove the research.
p.000006:
p.000006: (j) Information on each HSR project that is classified must be submitted annually, or in accordance with the
p.000006: directions and schedules provided by the appropriate HSP program manager. The HSP program managers will compile this
p.000006: information and prepare a summary document, for signature by the DOE IO and delivery to OSTP and/or ODNI, in accordance
p.000006: with Executive Orders (see Reference 7g.) and other Federal requirements.
p.000006:
...
p.000007: or termination of IRB approval of research; and
p.000007:
p.000007: (b) known or potential incidents of noncompliance with requirements of this Order, 10 CFR Part 745, or 45 CFR
p.000007: Part 46.
p.000007:
p.000008: 8
p.000008: DOE O 443.1C
p.000008: 11-26-2019
p.000008:
p.000008: (5) Immediately upon the appointment of a new DOE or NNSA Site IRB Chair, Co-Chair or IO.
p.000008:
p.000008: e. Human Subjects Research Database (HSRD) Reporting. HSR projects (excluding classified and/or
p.000008: intelligence-related HSR) must be reported annually to the HSR Projects Database (HSRD) in accordance with directions
p.000008: and schedules provided by the appropriate HSP Program Manager. Such reporting is also required when HSR is minimal
p.000008: risk (exempt) and the IRB has determined a continuing review is not required.
p.000008:
p.000008: f. Records. Project- and meeting-specific record keeping for all DOE/NNSA site and central IRBs must be done
p.000008: via the DOE Headquarters-provided electronic IRB protocol system. Additionally, all records related to IRB
p.000008: review/approval of classified HSR and key research records must be maintained permanently, subject to NARA
p.000008: requirements, but not less than 100 years. During and following the completion of the research, copies of all signed
p.000008: classified consent forms must be stored in a separate but secure central location (e.g., security policy officer or IRB
p.000008: office), other than the researchers’ office, and participants of such research must be notified during the consenting
p.000008: process regarding how to access a copy of their individual signed classified consent forms should they want to in the
p.000008: future.
p.000008:
p.000008: g. Protected Classes. Research involving prisoners, children, and individuals with impaired decision making
p.000008: must be conducted in accordance with the appropriate Subpart(s) of 45 CFR Part 46. Care should also be taken to ensure
p.000008: the proper protections are in place for DOE/NNSA federal and/or contractor employees who become human subjects of
p.000008: research and may be subject to coercion or undue influence.
p.000008:
p.000008: h. IRB Registration. Each IRB that is designated by an institution under an assurance of compliance approved
p.000008: for Federalwide use by the Office for Human Research Protections (OHRP) under 45 CFR Part §46.103(a) and that reviews
p.000008: research involving human subjects conducted or supported by the Department of Health and Human Services (HHS) must be
p.000008: registered with HHS in accordance with 45 CFR Part 46 Subpart E.
p.000008:
p.000008: 5. RESPONSIBILITIES.
p.000008:
p.000008: All DOE employees, contractors, financial assistance recipients, and parties to other DOE agreements share the
p.000008: responsibility to protect the rights and welfare of human research subjects.
p.000008:
p.000008: a. The Secretary of Energy.
p.000008:
...
p.000023: followed by DOE IO approval. The DOE IO, in consultation with the HSP Program Managers, will determine whether he/she
p.000023: will approve/disapprove the project or brief the Secretary about the project prior to his/her approval/disapproval.
p.000023:
p.000023: c. Informed consent may only be waived for classified HSR if the work meets one of the categories of minimal
p.000023: risk HSR addressed at 10 CFR Part 745.104.
p.000023:
p.000023: d. The use of the expedited review process is prohibited. The fact that research meets a particular expedited
p.000023: category may be noted, but a full IRB review will be required.
p.000023:
p.000023: e. HSR exemptions (as per 10 CFR Part 745.104) will not be used. The fact that research meets a particular
p.000023: exemption category may be noted, but a full IRB review will be required.
p.000023:
p.000023: f. The identity of the sponsoring Federal agency must be disclosed to subjects, unless the sponsor requests it
p.000023: not be done. The only acceptable reason for non- disclosure is that disclosure could compromise intelligence sources
p.000023: or methods. Additionally, the research must be no more than minimal risk, and the IRB must determine that not
p.000023: disclosing the identity will not adversely affect the subjects.
p.000023:
p.000023: g. The informed consent document will state that the project is classified, what that means for the purposes of
p.000023: that project, and what part of the research that applies to. The IRB must determine whether the potential human
p.000023: subjects need access to classified information in order to make a valid informed consent decision.
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: 2 It should be noted that: 1) only limited communications, if needed, may take place between the organization de-
p.000023: identifying and/or re-identifying the sponsor’s data and the organization performing work on the sponsor’s task;
p.000023: 2) the identified dataset shall not be shared with the individual who will perform work on the sponsor’s task; and
p.000023: 3) the de-identified dataset shall be sent directly by the sponsor to the individual performing work on the sponsor’s
p.000023: task and not by the organization at the DOE site that de-identified it.
p.000023:
p.000023: DOE O 443.1C
p.000023: Attachment 1
p.000023: 11-26-2019
p.000023: Page 5
p.000023:
p.000023: h. When reviewing classified HSR, the unaffiliated member of a DOE or DOE site IRB must be a nongovernmental
p.000023: member (not currently a Federal employee or a DOE site contractor employee) with the appropriate security clearance.
p.000023:
p.000023: i. Any IRB member can appeal an IRB decision to approve a project to the DOE IO, and if not resolved to the
p.000023: IRB member’s satisfaction, to the Secretary of Energy. If still dissatisfied, the IRB member can appeal that approval
p.000023: decision to the Director of the Office of Science and Technology Policy (OSTP) or that Director’s designee, or the
p.000023: Director of National Intelligence (ODNI), or that Director’s designee.3 The Director of OSTP, or that Director’s
p.000023: designee, or the Director of National Intelligence, or that Director’s designee will review and approve or disapprove
p.000023: the research, or will convene or designate an IRB that is, to the extent possible, made up of unaffiliated members with
...
p.000023: consulting with the site office as appropriate. Participate in triennial (or biennial for sites that perform
p.000023: classified HSR) QA consultation led by the appropriate DOE HSP program manager, which will be designed to provide each
p.000023: site with useful information and understanding of HSP program requirements, including any changes in those requirements
p.000023: and recommendations for continuous improvement.
p.000023:
p.000023: 19. Provide data for the HSR Projects Database (HSRD), and separately transmit data on unclassified intelligence
p.000023: projects and, in accordance with directions and schedules provided by the appropriate HSP Program Manager. Such
p.000023: reporting is also required when HSR is minimal risk (including exempt) and the IRB has determined a continuing review
p.000023: is not required.
p.000023:
p.000023: 20. DOE/NNSA site and central IRBs must keep key project- specific and meeting-specific records in the DOE
p.000023: Headquarters-provided electronic IRB protocol system. Additionally, all records related to IRB review/approval of
p.000023: classified HSR as well as key researcher records must be maintained permanently, subject to NARA requirements, but not
p.000023: less than 100 years. During and following the completion of classified research, copies of all signed classified
p.000023: consent forms must be stored in a separate but secure central location (e.g., security policy officer or IRB office),
p.000023: other than the researchers’ office, and participants of such research must be notified during the consenting process
p.000023: regarding how to access a copy of their individual signed classified consent forms should they want to in the future.
p.000023:
p.000023: 21. Submit requests for exemptions from the requirements of this Order in writing through the contracting officer
...
Searching for indicator freedomXofXinformation:
(return to top)
p.000015: policies and procedures applicable to the award and administration of financial assistance agreements and cooperative
p.000015: agreements for health-related research, education/training, conferences, communication, and related activities.
p.000015:
p.000015: b. 10 CFR Part 605, Office of Science (formerly Office of Energy Research) Financial Assistance Program, as
p.000015: explained at https://science.energy.gov/grants/policy-and-guidance/605/, which provides policies and procedures for the
p.000015: administration and management of basic and applied research financial award agreements awarded by the Office of
p.000015: Science.
p.000015:
p.000015: c. 10 CFR Part 745, Protection of Human Subjects, which set Federal requirements for DOE for the protection of
p.000015: human subjects involved in research activities.
p.000015:
p.000015: d. 10 CFR Part 1008, Records Maintained on Individuals (Privacy Act), which establishes the procedures to
p.000015: implement the Privacy Act of 1974 (PL. 93-579, 5
p.000015: U.S.C. 552a) within DOE of Energy.
p.000015:
p.000015: e. 45 CFR Part 46, Protection of Human Subjects, Subparts B, C, and D, which sets out DOE prescribed DHHS
p.000015: requirements for protected classes of human research subjects and Subpart E for IRB registration.
p.000015:
p.000015: f. Presidential Memorandum, Strengthened Protections for Human Subjects of Classified Research, dated March
p.000015: 27, 1997 and published in the Federal Register on May 13, 1997 (62 Fed. Reg. 26369).
p.000015:
p.000015: g. The Freedom of Information Act, 5 USC Section 552, as amended, which establishes the right of citizens to
p.000015: request information from Federal agencies and establishes a framework of procedures to implement this right.
p.000015:
p.000015: h. The National Nuclear Security Administration Act, Title 32 of the National Defense Authorization Act for
p.000015: Fiscal Year 2000, Public Law No. 106-65; 50 USC 2401 et seq.
p.000015:
p.000015: i. European Union (EU) General Data Protection Regulation (GDPR), dated 04-14- 2016. The GDPR not only applies
p.000015: to organizations located within the EU but also may apply to organizations located outside of the EU if they offer
p.000015: goods or services to, or monitor the behavior of, EU data subjects. It may apply to U.S. organizations processing and
p.000015: holding the personal data of data subjects residing in the European Union, regardless of the company’s location.
p.000015:
p.000016: 16
p.000016: DOE O 443.1C
p.000016: 11-26-2019
p.000016:
p.000016: j. 21st Century Cures Act, dated December 13, 2016, expands researchers’ ability to obtain a Certificate of
p.000016: Confidentiality by making the issuance of a Certificate of Confidentiality mandatory for investigators engaged in
p.000016: federally funded research involving certain sensitive, identifiable information about research subjects.
p.000016:
p.000016: k. DOE Policy Memorandum on Research Involving Intentional Modification of the Human Environment, dated
p.000016: 4-25-13.
p.000016:
p.000016: l. DOE O 206.1, Department of Energy Privacy Program, current version, which ensures compliance with privacy
...
Social / Child
Searching for indicator children:
(return to top)
p.000006:
p.000006: b. Solicitations. Any solicitation issued by a DOE element for HSR must require compliance with the
p.000006: requirements of this Order, 10 CFR Part 745, and 45 CFR Part 46.
p.000006:
p.000006: c. Contracts, Financial Assistance Agreements, and Other Agreements. Any DOE contract, financial assistance
p.000006: agreement, or other agreement involving HSR must require compliance with the requirements set forth in this Order
p.000006: and/or the CRD associated with this Order (Attachment 1), as well as with 10 CFR Part 745 and 45 CFR Part 46.
p.000006:
p.000006:
p.000006:
p.000006: 2 The Presidential Memorandum, Strengthened Protections for Human Subjects of Classified Research, dated March 27,
p.000006: 1997, requires such an appeal process.
p.000006:
p.000006: DOE O 443.1C
p.000007: 7
p.000007: 11-26-2019
p.000007:
p.000007: d. Notification. The Human Subjects Protection (HSP) Program Manager (and when an NNSA element is involved, the
p.000007: NNSA HSP Program Manager) must be notified in writing:
p.000007:
p.000007: (1) Prior to initiation of the HSR portion of a new project, even if it meets the regulatory definition of exempt
p.000007: HSR as outlined in 10 CFR Part 745.104, that involves:
p.000007:
p.000007: (a) an institution without an established IRB;
p.000007:
p.000007: (b) a foreign country;
p.000007:
p.000007: (c) a potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight
p.000007: groups);
p.000007:
p.000007: (d) research subjects in a protected class (prisoners, children, individuals with impaired decision making, or
p.000007: DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to coercion and undue
p.000007: influence to participate) that is outside of the reviewing IRB’s typical range/scope; or
p.000007:
p.000007: (e) the generation or use of classified information.
p.000007:
p.000007: (2) Immediately upon a finding of a suspected or confirmed data breach involving Personally Identifiable
p.000007: Information (PII) in printed or electronic form, and the incident must be reported to the DOE-Cyber Incident Response
p.000007: Capability in accordance with the requirements of DOE O
p.000007: 206.1. The appropriate HSP Program Manager must also be notified of any corrective actions taken and consulted
p.000007: regarding the plan for any remaining corrective actions.
p.000007:
p.000007: (3) Immediately upon learning of a serious adverse event. The appropriate HSP Program Manager must also be
p.000007: informed of any corrective actions taken and consulted regarding the plan for any remaining corrective actions.
p.000007:
p.000007: (4) Within 48 hours, with a description of corrective actions taken. The appropriate HSP Program Manager must
p.000007: also be consulted regarding the plan for any remaining corrective actions, following other incidents not covered in (2)
p.000007: and (3) above:
p.000007:
p.000007: (a) unanticipated problems, significant adverse events, and complaints about the research, as well as suspension
p.000007: or termination of IRB approval of research; and
p.000007:
...
p.000008:
p.000008: e. Human Subjects Research Database (HSRD) Reporting. HSR projects (excluding classified and/or
p.000008: intelligence-related HSR) must be reported annually to the HSR Projects Database (HSRD) in accordance with directions
p.000008: and schedules provided by the appropriate HSP Program Manager. Such reporting is also required when HSR is minimal
p.000008: risk (exempt) and the IRB has determined a continuing review is not required.
p.000008:
p.000008: f. Records. Project- and meeting-specific record keeping for all DOE/NNSA site and central IRBs must be done
p.000008: via the DOE Headquarters-provided electronic IRB protocol system. Additionally, all records related to IRB
p.000008: review/approval of classified HSR and key research records must be maintained permanently, subject to NARA
p.000008: requirements, but not less than 100 years. During and following the completion of the research, copies of all signed
p.000008: classified consent forms must be stored in a separate but secure central location (e.g., security policy officer or IRB
p.000008: office), other than the researchers’ office, and participants of such research must be notified during the consenting
p.000008: process regarding how to access a copy of their individual signed classified consent forms should they want to in the
p.000008: future.
p.000008:
p.000008: g. Protected Classes. Research involving prisoners, children, and individuals with impaired decision making
p.000008: must be conducted in accordance with the appropriate Subpart(s) of 45 CFR Part 46. Care should also be taken to ensure
p.000008: the proper protections are in place for DOE/NNSA federal and/or contractor employees who become human subjects of
p.000008: research and may be subject to coercion or undue influence.
p.000008:
p.000008: h. IRB Registration. Each IRB that is designated by an institution under an assurance of compliance approved
p.000008: for Federalwide use by the Office for Human Research Protections (OHRP) under 45 CFR Part §46.103(a) and that reviews
p.000008: research involving human subjects conducted or supported by the Department of Health and Human Services (HHS) must be
p.000008: registered with HHS in accordance with 45 CFR Part 46 Subpart E.
p.000008:
p.000008: 5. RESPONSIBILITIES.
p.000008:
p.000008: All DOE employees, contractors, financial assistance recipients, and parties to other DOE agreements share the
p.000008: responsibility to protect the rights and welfare of human research subjects.
p.000008:
p.000008: a. The Secretary of Energy.
p.000008:
p.000008: (1) Responsible for oversight of the conduct of DOE-related human subject research. Delegates this responsibility
p.000008: to a Senior DOE Institutional Official (IO) for HSR. For the DOE, the IO is the Associate Director of Science for the
p.000008: Office of Biological and Environmental Research.
p.000008:
p.000008: DOE O 443.1C
p.000009: 9
...
p.000020: with or without their knowledge; and/or
p.000020:
p.000020: (2) that cannot be validly conducted without people present (other than those conducting the research),
p.000020: regardless of whether identifiable private information is collected about them. Before such research begins, the
p.000020: potential risks to those individuals must be considered by the appropriate DOE IRB.
p.000020:
p.000020: x. NNSA Human Subjects Protection Designee (NNSA HSP Program Manager). The program manager responsible for
p.000020: overseeing the Human Subjects Protection Program for NNSA elements.
p.000020:
p.000020: y. Personally Identifiable Information. Any information collected or maintained about an individual, including
p.000020: but not limited to, education, financial transactions, medical history and criminal or employment history, and
p.000020: information that can be used to distinguish or trace an individual’s identity, such as his/her name, Social Security
p.000020: number, date and place of birth, mother’s maiden name, biometric data, and any other personal information that is
p.000020: linked or linkable to a specific individual.
p.000020:
p.000020: z. Protected Class of Human Subjects. Populations who may be more vulnerable to coercion or undue influence
p.000020: when participating as research subjects,
p.000020:
p.000020: DOE O 443.1C
p.000021: 21
p.000021: 11-26-2019
p.000021:
p.000021: including children, prisoners, decisionally impaired individuals, economically or educationally disadvantaged persons,
p.000021: and other vulnerable populations, who are thus afforded additional protections by the Federal regulations (see
p.000021: additional subparts of 45 CFR Part 46) and/or the IRB. DOE and DOE site employees are considered vulnerable subjects
p.000021: when participating in research and additional care must be taken to ensure their participation is truly voluntary
p.000021: (e.g., by ensuring they do not report to members of the research team) and that data collected about them is kept
p.000021: confidential.
p.000021:
p.000021: aa. Research. A systematic investigation, including research development, testing and evaluation, designed to
p.000021: contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this
p.000021: policy, whether or not they are conducted or supported under a program which is considered research for other purposes.
p.000021: For example, some demonstration and service programs may include research activities. For purposes of this part, the
p.000021: following activities are deemed not to be research:
p.000021:
p.000021: (1) Scholarly or journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal
p.000021: research, and historical scholarship), including the collection and use of information, that focus directly on the
p.000021: specific individuals about whom the information is collected.
p.000021:
...
p.000023: Page 1
p.000023:
p.000023: CONTRACTOR REQUIREMENTS DOCUMENT
p.000023:
p.000023: DOE O 443.1C, PROTECTION OF HUMAN RESEARCH SUBJECTS
p.000023:
p.000023: Regardless of the performer of the work, the contractor is responsible for compliance with the requirements of this
p.000023: Contractor Requirements Document (CRD).
p.000023:
p.000023: The contractor is responsible for flowing down the requirements of this CRD to subcontracts at any tier to the extent
p.000023: necessary to ensure the contractor's compliance with the requirements.
p.000023:
p.000023: Note: Throughout this CRD, the term "Human Subjects Protection Program Manager (HSP Program Manager)" refers either to
p.000023: the DOE HSP Program Manager or to the NNSA HSP Program Manager except where otherwise noted.
p.000023:
p.000023: As directed by the contracting officer, the contractor must—
p.000023:
p.000023: 1. Notify the DOE HSP Program Manager (and, when an NNSA element is involved, the NNSA HSP Program Manager):
p.000023:
p.000023: a. Prior to initiation of any new HSR project, even if it meets the regulatory definition of exempt HSR as
p.000023: outlined in 10 CFR Part 745.104, involving:
p.000023:
p.000023: (1) an institution without an established Institutional Review Board (IRB);
p.000023:
p.000023: (2) a foreign country;
p.000023:
p.000023: (3) the potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight
p.000023: groups);
p.000023:
p.000023: (4) research subjects in a protected class (prisoners, children, individuals with impaired decision making
p.000023: capability, or DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to
p.000023: coercion and undue influence to participate) that is outside of the reviewing IRB’s typical range/scope; or
p.000023:
p.000023: (5) the generation or use of classified information.
p.000023:
p.000023: b. Within 48 hours of the following, and provide a description of corrective actions taken immediately
p.000023: following the incident and consult with the HSP Program Manager(s) regarding additional corrective actions to be taken
p.000023: in the case of:
p.000023:
p.000023: (1) any significant adverse events, unanticipated problems, and complaints about the research;
p.000023:
p.000023: (2) any suspension or termination of IRB approval of research; and/or
p.000023:
p.000023: (3) any significant non-compliance with HSP Program procedures or other requirements.
p.000023:
p.000023: Attachment 1
p.000023: DOE O 443.1C
p.000023: Page 2
p.000023: 11-26-2019
p.000023:
p.000023: c. Immediately, upon finding of a suspected or confirmed data breach involving PII in printed or electronic
p.000023: form, and additionally immediately notify the DOE-Cyber Incident Response Capability, in accordance with the
p.000023: requirements of the CRD associated with DOE O 206.1. The HSP Program Manager(s) shall also be notified of any
p.000023: corrective actions taken and consulted regarding the plan for any remaining corrective actions.
p.000023:
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.000016: with Other Federal Agencies, Independent Organizations, and the Private Sector, current version, which sets the context
p.000016: in which DOE and its laboratories, plants, and sites should pursue Strategic Partnership Projects (SPPs) with other
p.000016: Federal government agencies, state and local institutions, universities, foreign entities and/or private companies. The
p.000016: Policy is applicable to the DOE laboratories, plants, and sites, and to the DOE programs that own them and facilitate
p.000016: their work.
p.000016:
p.000016: n. DOE O 481.1E, Strategic Partnership Projects [Formerly Known as Work for Others (Non-Department of Energy
p.000016: Funded Work)], current version, which establishes the policy, requirements, responsibilities, and procedures for
p.000016: authorizing, administering, and performing work for non-DOE entities by DOE/National Nuclear Security Administration
p.000016: (NNSA) and/or their respective contractor personnel or the use of DOE/NNSA facilities that is not directly funded by
p.000016: DOE appropriations.
p.000016:
p.000016: o. DOE O 483.1B, DOE Cooperative Research and Development Agreements, current version, which establishes
p.000016: requirements for the performance of technology transfer through the use of Cooperative Research and Development
p.000016: Agreements (CRADAs).
p.000016:
p.000016: p. DOE O 484.1, Reimbursable Work for the Department of Homeland Security, current version, establishes DOE
p.000016: policies and procedures for the acceptance, performance, and administration of reimbursable work directly funded by the
p.000016: Department of Homeland Security.
p.000016:
p.000016: q. DOE O 475.2B, Identifying Classified Information, current version, establishes the program to identify
p.000016: information classified under the Atomic Energy Act [Restricted Data (RD), Formerly Restricted Data (FRD), and
p.000016: Transclassified Foreign Nuclear Information (TFNI)] or Executive Order (E.O.) 13526 [National
p.000016:
p.000016: DOE O 443.1C
p.000017: 17
p.000017: 11-26-2019
p.000017:
p.000017: Security Information (NSI)], so that it can be protected against unauthorized dissemination in accordance with legal
p.000017: and Departmental requirements.
p.000017:
p.000017: r. DOE O 471.3, Identifying and Protecting Official Use Only Information, current version, which establishes a
p.000017: program within DOE and NNSA to identify certain unclassified controlled information as Official Use Only (OUO) (e.g.,
p.000017: PII and proprietary information) and to identify, mark, and protect documents containing such information to ensure it
p.000017: is protected according to legal and Departmental requirements.
p.000017:
p.000017: s. DOE M 471.3-1, Manual for Identifying and Protecting Official Use Only Information, current version, which
p.000017: provides detailed requirements to supplement DOE O 471.3.
p.000017:
p.000017: 8. DEFINITIONS.
p.000017:
p.000017: a. Adverse Event. Any unfavorable medical occurrence in a human subject, including any abnormal sign (for
p.000017: example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s
p.000017: participation in the research, whether or not considered related to the subject’s participation in the research
p.000017: (Unanticipated Problems Involving Risk and Adverse Events Guidance, OHRP, 2007). A significant adverse event is an
p.000017: adverse event that is unexpected and substantively impacts the human subjects. A serious adverse event (Unanticipated
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000018: Order, in consultation with NNSA, as appropriate.
p.000018:
p.000018: l. Exemption from the Requirements of DOE Order 443.1C. A request for partial or full exemption from the
p.000018: requirements outlined in this Order (see Section 3.c.). Must be submitted to the DOE HSP Program Manager, or when an
p.000018: NNSA element is involved, the NNSA HSP Program Manager. Requires DOE IO concurrence and Secretarial or Secretarial
p.000018: designee (DOE IO) approval.
p.000018:
p.000018: m. Exempt Human Subjects Research (HSR). HSR that is minimal risk and meets one of the exempt categories
p.000018: outlined in 10 CFR Part 745. Within DOE, the initial exemption determination is made by the appropriate central DOE or
p.000018: DOE site IRB. Note that exempt HSR is a category of HSR and has nothing to do with a request for an exemption from the
p.000018: requirements of this Order (as described in definition l. above).
p.000018:
p.000018: n. Federalwide Assurance. The written documentation, satisfactory to the Secretary of Energy, required from the
p.000018: prospective performing institution, that ensures
p.000018:
p.000018: DOE O 443.1C
p.000019: 19
p.000019: 11-26-2019
p.000019:
p.000019: institutional compliance with and implementation of DOE and Department of Health and Human Services (DHHS) regulations
p.000019: for the protection of human research subjects. See: http://ohrp.cit.nih.gov/efile/FwaStart.aspx.
p.000019:
p.000019: o. Generalizable. Information/research findings that are intended to be applied to populations or situations
p.000019: beyond that studied/will have meaning and impact outside of the single immediate activity itself.
p.000019:
p.000019: p. Human Subject. A living individual about whom an investigator (whether professional or student) conducting
p.000019: research:
p.000019:
p.000019: (1) Obtains information or biospecimens through intervention or interaction with the individual, and uses,
p.000019: studies, or analyzes the information or biospecimens; or
p.000019:
p.000019: (2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
p.000019:
p.000019: Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations
p.000019: of the subject or the subject’s environment that are performed for research purposes.
p.000019:
p.000019: Interaction includes communication or interpersonal contact between investigator and subject.
p.000019:
p.000019: Private information includes information about behavior that occurs in a context in which an individual can reasonably
p.000019: expect that no observation or recording is taking place, and information that has been provided for specific purposes
p.000019: by an individual and that the individual can reasonably expect will not be made public (for example, a medical record).
p.000019:
p.000019: Identifiable private information is private information for which the identity of the subject is or may readily be
p.000019: ascertained by the investigator or associated with the information.
p.000019:
p.000019: An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by
p.000019: the investigator or associated with the biospecimen.
p.000019:
p.000019: q. Human Subjects Research (HSR). Any activity meeting the definitions of both: 1) research, and 2) human
p.000019: subject, as defined in this section.
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.000007: and (3) above:
p.000007:
p.000007: (a) unanticipated problems, significant adverse events, and complaints about the research, as well as suspension
p.000007: or termination of IRB approval of research; and
p.000007:
p.000007: (b) known or potential incidents of noncompliance with requirements of this Order, 10 CFR Part 745, or 45 CFR
p.000007: Part 46.
p.000007:
p.000008: 8
p.000008: DOE O 443.1C
p.000008: 11-26-2019
p.000008:
p.000008: (5) Immediately upon the appointment of a new DOE or NNSA Site IRB Chair, Co-Chair or IO.
p.000008:
p.000008: e. Human Subjects Research Database (HSRD) Reporting. HSR projects (excluding classified and/or
p.000008: intelligence-related HSR) must be reported annually to the HSR Projects Database (HSRD) in accordance with directions
p.000008: and schedules provided by the appropriate HSP Program Manager. Such reporting is also required when HSR is minimal
p.000008: risk (exempt) and the IRB has determined a continuing review is not required.
p.000008:
p.000008: f. Records. Project- and meeting-specific record keeping for all DOE/NNSA site and central IRBs must be done
p.000008: via the DOE Headquarters-provided electronic IRB protocol system. Additionally, all records related to IRB
p.000008: review/approval of classified HSR and key research records must be maintained permanently, subject to NARA
p.000008: requirements, but not less than 100 years. During and following the completion of the research, copies of all signed
p.000008: classified consent forms must be stored in a separate but secure central location (e.g., security policy officer or IRB
p.000008: office), other than the researchers’ office, and participants of such research must be notified during the consenting
p.000008: process regarding how to access a copy of their individual signed classified consent forms should they want to in the
p.000008: future.
p.000008:
p.000008: g. Protected Classes. Research involving prisoners, children, and individuals with impaired decision making
p.000008: must be conducted in accordance with the appropriate Subpart(s) of 45 CFR Part 46. Care should also be taken to ensure
p.000008: the proper protections are in place for DOE/NNSA federal and/or contractor employees who become human subjects of
p.000008: research and may be subject to coercion or undue influence.
p.000008:
p.000008: h. IRB Registration. Each IRB that is designated by an institution under an assurance of compliance approved
p.000008: for Federalwide use by the Office for Human Research Protections (OHRP) under 45 CFR Part §46.103(a) and that reviews
p.000008: research involving human subjects conducted or supported by the Department of Health and Human Services (HHS) must be
p.000008: registered with HHS in accordance with 45 CFR Part 46 Subpart E.
p.000008:
p.000008: 5. RESPONSIBILITIES.
p.000008:
p.000008: All DOE employees, contractors, financial assistance recipients, and parties to other DOE agreements share the
...
p.000012:
p.000012: (4) Works with the DOE HSP Program Manager, as outlined in Section 5.e.
p.000012:
p.000012: (5) Serves as one of the Co-Chairs of the Central DOE IRB-C.
p.000012:
p.000012: g. Office of Intelligence and Counterintelligence.
p.000012:
p.000012: (1) Reviews and approves, prior to initiation, statements of work for HSR and HTM projects received from members
p.000012: of the intelligence community.
p.000012:
p.000012: (2) Collaborates with the DOE IO, and with the DOE and NNSA HSP Program Managers, in overseeing the Central DOE
p.000012: IRB-Classified, and provides the Vice Chair and the Administrator for this IRB.
p.000012:
p.000012: (3) Reviews and, in coordination with the DOE and NNSA HSP Program Managers, approves requests for waivers, on a
p.000012: project by project basis, from the additional requirements for classified research (Section 4.a.(14)), if the Central
p.000012: DOE IRB-Classified determines that an intelligence-related HSR project that is classified, in whole or in part, can be
p.000012: reviewed in an unclassified manner.
p.000012:
p.000012: h. Secretarial Officers or their Designees.
p.000012:
p.000012: (1) Ensure that all proposals for research, studies, tests, surveys, surveillance, or other data collection are
p.000012: reviewed to identify research involving human subjects.
p.000012:
p.000012: (2) Ensure that any questions or uncertainties regarding the applicability of human research subjects protection
p.000012: requirements to such proposals, and any other issues and concerns regarding the requirements of this Order, are
p.000012: promptly referred to the appropriate HSP Program Manager for resolution.
p.000012:
p.000012: (3) Ensure that the contracting officer is advised when work statements for proposed agreements include HSR to
p.000012: ensure that the CRD or its requirements (as appropriate) will be applied to HSR conducted with DOE/NNSA funding, at
p.000012: DOE/NNSA institutions, or by DOE/NNSA personnel under agreements other than site/facility management contracts,
p.000012:
p.000012: DOE O 443.1C
p.000013: 13
p.000013: 11-26-2019
p.000013:
p.000013: such as support services contracts, grants, cooperative agreements, work- for-others agreements, and interagency
p.000013: agreements.
p.000013:
p.000013: (4) Ensure that the contracting officer, after being notified of the affected contracts, incorporates the CRD
p.000013: into the affected contracts by way of the Department of Energy Acquisition Regulations (DEAR) Laws, regulations, and
p.000013: directives clauses included in those contracts. In the case of contracts or other agreements requiring contractor
p.000013: performance of activities covered by the CRD, but which do not contain the Laws, regulations, and DOE directives
p.000013: clause, the contracting officer will work to include the requirements as appropriate.
p.000013:
p.000013: (5) Ensure their staffs and field elements comply with the requirements of this Order, including the notification
p.000013: requirements in paragraph 4.d.
p.000013:
p.000013: (6) Ensure relevant personnel actively participate in human research subjects protection training and educational
p.000013: programs.
p.000013:
p.000013: (7) Ensure that routine informal reviews are conducted to verify compliance with the requirements of this Order.
p.000013: Support, as needed, HSP Program Managers’ triennial QA consultations.
p.000013:
p.000013: (8) At their discretion, conduct further review and approve or disapprove research that has been approved by the
p.000013: IRB. (Note: Secretarial Officers or their designees may not approve HSR that has not been approved by an IRB. See 10
p.000013: CFR Part 745.112.)
p.000013:
p.000013: (9) Ensure appropriate oversight of the administration of research subjects protection programs of contractors
p.000013: and financial assistance recipients under their cognizance, and other parties to DOE agreements, to ensure compliance
p.000013: with applicable human research subjects protection requirements.
p.000013:
p.000013: (10) Ensure that the DOE HSP Program Manager and the NNSA HSP Program Manager are involved in negotiating those
p.000013: portions of interagency agreements that address HSR.
p.000013:
p.000013: (11) Appoint a point of contact for interacting with the appropriate HSP Program Manager on program-related and/or
p.000013: Department-wide issues.
p.000013:
p.000013: i. DOE Field/Site Offices.
p.000013:
...
p.000022: of classified HSR is approved for a
p.000022:
p.000022: DOE O 443.1C
p.000023: 23
p.000023: 11-26-2019
p.000023:
p.000023: particular project, all other Federal and DOE-specific HSR requirements must still be met.
p.000023:
p.000023: 9. CONTACT. Questions regarding this Order should be addressed to the DOE Program Manager, HSP Program, Office
p.000023: of Science, Office of Biological and Environmental Research, telephone 301-903-3213; or the DOE NNSA HSP Program
p.000023: Manager, as appropriate. Information about the DOE HSP program may be found at
p.000023: https://science.osti.gov/ber/human-subjects.
p.000023:
p.000023: BY ORDER OF THE SECRETARY OF ENERGY:
p.000023:
p.000023: DAN BROUILETTE
p.000023: Deputy Secretary
p.000023:
p.000023:
p.000023:
p.000023: DOE O 443.1C
p.000023: Attachment 1
p.000023: 11-26-2019
p.000023: Page 1
p.000023:
p.000023: CONTRACTOR REQUIREMENTS DOCUMENT
p.000023:
p.000023: DOE O 443.1C, PROTECTION OF HUMAN RESEARCH SUBJECTS
p.000023:
p.000023: Regardless of the performer of the work, the contractor is responsible for compliance with the requirements of this
p.000023: Contractor Requirements Document (CRD).
p.000023:
p.000023: The contractor is responsible for flowing down the requirements of this CRD to subcontracts at any tier to the extent
p.000023: necessary to ensure the contractor's compliance with the requirements.
p.000023:
p.000023: Note: Throughout this CRD, the term "Human Subjects Protection Program Manager (HSP Program Manager)" refers either to
p.000023: the DOE HSP Program Manager or to the NNSA HSP Program Manager except where otherwise noted.
p.000023:
p.000023: As directed by the contracting officer, the contractor must—
p.000023:
p.000023: 1. Notify the DOE HSP Program Manager (and, when an NNSA element is involved, the NNSA HSP Program Manager):
p.000023:
p.000023: a. Prior to initiation of any new HSR project, even if it meets the regulatory definition of exempt HSR as
p.000023: outlined in 10 CFR Part 745.104, involving:
p.000023:
p.000023: (1) an institution without an established Institutional Review Board (IRB);
p.000023:
p.000023: (2) a foreign country;
p.000023:
p.000023: (3) the potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight
p.000023: groups);
p.000023:
p.000023: (4) research subjects in a protected class (prisoners, children, individuals with impaired decision making
p.000023: capability, or DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to
p.000023: coercion and undue influence to participate) that is outside of the reviewing IRB’s typical range/scope; or
p.000023:
p.000023: (5) the generation or use of classified information.
p.000023:
p.000023: b. Within 48 hours of the following, and provide a description of corrective actions taken immediately
p.000023: following the incident and consult with the HSP Program Manager(s) regarding additional corrective actions to be taken
p.000023: in the case of:
p.000023:
...
p.000023: Information about the DOE HSP program may be found athttps://science.osti.gov/ber/human-subjects.
p.000023:
p.000023: 18. Perform informal internal review(s) of the HSP Program, or portions of the HSP Program, at least annually,
p.000023: consulting with the site office as appropriate. Participate in triennial (or biennial for sites that perform
p.000023: classified HSR) QA consultation led by the appropriate DOE HSP program manager, which will be designed to provide each
p.000023: site with useful information and understanding of HSP program requirements, including any changes in those requirements
p.000023: and recommendations for continuous improvement.
p.000023:
p.000023: 19. Provide data for the HSR Projects Database (HSRD), and separately transmit data on unclassified intelligence
p.000023: projects and, in accordance with directions and schedules provided by the appropriate HSP Program Manager. Such
p.000023: reporting is also required when HSR is minimal risk (including exempt) and the IRB has determined a continuing review
p.000023: is not required.
p.000023:
p.000023: 20. DOE/NNSA site and central IRBs must keep key project- specific and meeting-specific records in the DOE
p.000023: Headquarters-provided electronic IRB protocol system. Additionally, all records related to IRB review/approval of
p.000023: classified HSR as well as key researcher records must be maintained permanently, subject to NARA requirements, but not
p.000023: less than 100 years. During and following the completion of classified research, copies of all signed classified
p.000023: consent forms must be stored in a separate but secure central location (e.g., security policy officer or IRB office),
p.000023: other than the researchers’ office, and participants of such research must be notified during the consenting process
p.000023: regarding how to access a copy of their individual signed classified consent forms should they want to in the future.
p.000023:
p.000023: 21. Submit requests for exemptions from the requirements of this Order in writing through the contracting officer
...
Social / Soldier
Searching for indicator armedXforces:
(return to top)
p.000019:
p.000019: Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations
p.000019: of the subject or the subject’s environment that are performed for research purposes.
p.000019:
p.000019: Interaction includes communication or interpersonal contact between investigator and subject.
p.000019:
p.000019: Private information includes information about behavior that occurs in a context in which an individual can reasonably
p.000019: expect that no observation or recording is taking place, and information that has been provided for specific purposes
p.000019: by an individual and that the individual can reasonably expect will not be made public (for example, a medical record).
p.000019:
p.000019: Identifiable private information is private information for which the identity of the subject is or may readily be
p.000019: ascertained by the investigator or associated with the information.
p.000019:
p.000019: An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by
p.000019: the investigator or associated with the biospecimen.
p.000019:
p.000019: q. Human Subjects Research (HSR). Any activity meeting the definitions of both: 1) research, and 2) human
p.000019: subject, as defined in this section.
p.000019:
p.000019: r. Human Terrain Mapping. Research and data gathering activities primarily conducted for military or
p.000019: intelligence purposes to understand the “human terrain,”—the social, ethnographic, cultural, and political elements of
p.000019: the people among whom the U.S. Armed Forces are operating and/or in countries prone to political instability. This
p.000019: work includes observations, questionnaires, and interviews of groups of individuals, as well as modeling and analysis
p.000019: of collected
p.000019:
p.000020: 20
p.000020: DOE O 443.1C
p.000020: 11-26-2019
p.000020:
p.000020: data, and may become the basis for U.S. military actions in such locations. In addition to Human Terrain Mapping
p.000020: (HTM), such activities are often referred to as human social culture behavior (HSCB) studies. It is DOE policy that
p.000020: HTM activities will be managed as HSR.
p.000020:
p.000020: s. HTM Data. Data collected or used as part of HTM efforts, as described above, as well as any auxiliary data
p.000020: on the same group(s) of individuals.
p.000020:
p.000020: t. Institution. Any public or private entity or agency (including Federal, State, and other agencies). This
p.000020: term refers to laboratories and other facilities managed by DOE, DOE contractors, or DOE financial assistance
p.000020: recipients.
p.000020:
p.000020: u. Institutional Review Board (IRB). A committee or board established by an institution that performs initial
p.000020: and continuing reviews of research involving human subjects, and is registered with the Office for Human Research
p.000020: Protections (OHRP) and designated on an FWA.
p.000020:
p.000020: v. Minimal Risk. The probability and magnitude of harm or discomfort anticipated in the research are not
p.000020: greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine
...
Searching for indicator military:
(return to top)
p.000019: research:
p.000019:
p.000019: (1) Obtains information or biospecimens through intervention or interaction with the individual, and uses,
p.000019: studies, or analyzes the information or biospecimens; or
p.000019:
p.000019: (2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
p.000019:
p.000019: Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations
p.000019: of the subject or the subject’s environment that are performed for research purposes.
p.000019:
p.000019: Interaction includes communication or interpersonal contact between investigator and subject.
p.000019:
p.000019: Private information includes information about behavior that occurs in a context in which an individual can reasonably
p.000019: expect that no observation or recording is taking place, and information that has been provided for specific purposes
p.000019: by an individual and that the individual can reasonably expect will not be made public (for example, a medical record).
p.000019:
p.000019: Identifiable private information is private information for which the identity of the subject is or may readily be
p.000019: ascertained by the investigator or associated with the information.
p.000019:
p.000019: An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by
p.000019: the investigator or associated with the biospecimen.
p.000019:
p.000019: q. Human Subjects Research (HSR). Any activity meeting the definitions of both: 1) research, and 2) human
p.000019: subject, as defined in this section.
p.000019:
p.000019: r. Human Terrain Mapping. Research and data gathering activities primarily conducted for military or
p.000019: intelligence purposes to understand the “human terrain,”—the social, ethnographic, cultural, and political elements of
p.000019: the people among whom the U.S. Armed Forces are operating and/or in countries prone to political instability. This
p.000019: work includes observations, questionnaires, and interviews of groups of individuals, as well as modeling and analysis
p.000019: of collected
p.000019:
p.000020: 20
p.000020: DOE O 443.1C
p.000020: 11-26-2019
p.000020:
p.000020: data, and may become the basis for U.S. military actions in such locations. In addition to Human Terrain Mapping
p.000020: (HTM), such activities are often referred to as human social culture behavior (HSCB) studies. It is DOE policy that
p.000020: HTM activities will be managed as HSR.
p.000020:
p.000020: s. HTM Data. Data collected or used as part of HTM efforts, as described above, as well as any auxiliary data
p.000020: on the same group(s) of individuals.
p.000020:
p.000020: t. Institution. Any public or private entity or agency (including Federal, State, and other agencies). This
p.000020: term refers to laboratories and other facilities managed by DOE, DOE contractors, or DOE financial assistance
p.000020: recipients.
p.000020:
p.000020: u. Institutional Review Board (IRB). A committee or board established by an institution that performs initial
p.000020: and continuing reviews of research involving human subjects, and is registered with the Office for Human Research
p.000020: Protections (OHRP) and designated on an FWA.
p.000020:
p.000020: v. Minimal Risk. The probability and magnitude of harm or discomfort anticipated in the research are not
p.000020: greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine
p.000020: physical or psychological examinations or tests.
p.000020:
p.000020: w. Modification of the Human Environment. Research:
p.000020:
p.000020: (1) in which people have their environment intentionally changed or manipulated for the purposes of the research,
p.000020: with or without their knowledge; and/or
p.000020:
p.000020: (2) that cannot be validly conducted without people present (other than those conducting the research),
...
Social / Student
Searching for indicator student:
(return to top)
p.000018: requirements outlined in this Order (see Section 3.c.). Must be submitted to the DOE HSP Program Manager, or when an
p.000018: NNSA element is involved, the NNSA HSP Program Manager. Requires DOE IO concurrence and Secretarial or Secretarial
p.000018: designee (DOE IO) approval.
p.000018:
p.000018: m. Exempt Human Subjects Research (HSR). HSR that is minimal risk and meets one of the exempt categories
p.000018: outlined in 10 CFR Part 745. Within DOE, the initial exemption determination is made by the appropriate central DOE or
p.000018: DOE site IRB. Note that exempt HSR is a category of HSR and has nothing to do with a request for an exemption from the
p.000018: requirements of this Order (as described in definition l. above).
p.000018:
p.000018: n. Federalwide Assurance. The written documentation, satisfactory to the Secretary of Energy, required from the
p.000018: prospective performing institution, that ensures
p.000018:
p.000018: DOE O 443.1C
p.000019: 19
p.000019: 11-26-2019
p.000019:
p.000019: institutional compliance with and implementation of DOE and Department of Health and Human Services (DHHS) regulations
p.000019: for the protection of human research subjects. See: http://ohrp.cit.nih.gov/efile/FwaStart.aspx.
p.000019:
p.000019: o. Generalizable. Information/research findings that are intended to be applied to populations or situations
p.000019: beyond that studied/will have meaning and impact outside of the single immediate activity itself.
p.000019:
p.000019: p. Human Subject. A living individual about whom an investigator (whether professional or student) conducting
p.000019: research:
p.000019:
p.000019: (1) Obtains information or biospecimens through intervention or interaction with the individual, and uses,
p.000019: studies, or analyzes the information or biospecimens; or
p.000019:
p.000019: (2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
p.000019:
p.000019: Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations
p.000019: of the subject or the subject’s environment that are performed for research purposes.
p.000019:
p.000019: Interaction includes communication or interpersonal contact between investigator and subject.
p.000019:
p.000019: Private information includes information about behavior that occurs in a context in which an individual can reasonably
p.000019: expect that no observation or recording is taking place, and information that has been provided for specific purposes
p.000019: by an individual and that the individual can reasonably expect will not be made public (for example, a medical record).
p.000019:
p.000019: Identifiable private information is private information for which the identity of the subject is or may readily be
p.000019: ascertained by the investigator or associated with the information.
p.000019:
p.000019: An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by
p.000019: the investigator or associated with the biospecimen.
p.000019:
p.000019: q. Human Subjects Research (HSR). Any activity meeting the definitions of both: 1) research, and 2) human
p.000019: subject, as defined in this section.
p.000019:
p.000019: r. Human Terrain Mapping. Research and data gathering activities primarily conducted for military or
...
p.000021:
p.000021: (3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for
p.000021: activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
p.000021:
p.000021: (4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland
p.000021: security, defense, or other national security missions.
p.000021:
p.000021: bb. Strategic Intelligence Partnership Program (SIPP). SIPP, formerly the Intelligence Work for Others (IWFO)
p.000021: program, is the mechanism by which DOE provides highly-specialized scientific and technical services and products to
p.000021: non-DOE Intelligence Community (IC) and other agencies for intelligence and intelligence-related activities carried out
p.000021: under unique IC authorities held
p.000021:
p.000022: 22
p.000022: DOE O 443.1C
p.000022: 11-26-2019
p.000022:
p.000022: by DOE’s Office of Intelligence and Counterintelligence and sponsoring IC agencies.
p.000022:
p.000022: cc. Strategic Partnership Projects (SPPs). SPP, formerly the Work for Others (WFO) program, is the mechanism by
p.000022: which non-DOE entities fund DOE/NNSA and/or their contractors or use DOE/NNSA facilities for work that is not directly
p.000022: funded by DOE/NNSA appropriations.
p.000022:
p.000022: dd. Unaffiliated IRB Member. For review of unclassified protocols, must not have a direct affiliation (employee,
p.000022: contractor, student in a fellowship, volunteer at the institution, or business related to the IRB, and must not have an
p.000022: immediate family member who is affiliated with the institution). For review of classified protocols, must be a
p.000022: nongovernmental member (not currently a Federal employee or a DOE site contractor employee) with the appropriate
p.000022: security clearance.
p.000022:
p.000022: ee. Unanticipated Problem. In general, to be classified as an unanticipated problem, any incident, experience, or
p.000022: outcome should meet all three of the following criteria:
p.000022:
p.000022: (1) Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described
p.000022: in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b)
p.000022: the characteristics of the subject population being studied
p.000022:
p.000022: (2) Related or possibly related to participation in the research (possibly related means there is a reasonable
p.000022: possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research)
p.000022:
p.000022: (3) Likely to place subjects or others at greater risk of harm (including physical, psychological, economic, or
p.000022: social harm) than was previously known or recognized.
p.000022:
p.000022: ff. Waiver from the Additional Requirements for Classified HSR. In certain cases, when classified projects can
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.000015: administration and management of basic and applied research financial award agreements awarded by the Office of
p.000015: Science.
p.000015:
p.000015: c. 10 CFR Part 745, Protection of Human Subjects, which set Federal requirements for DOE for the protection of
p.000015: human subjects involved in research activities.
p.000015:
p.000015: d. 10 CFR Part 1008, Records Maintained on Individuals (Privacy Act), which establishes the procedures to
p.000015: implement the Privacy Act of 1974 (PL. 93-579, 5
p.000015: U.S.C. 552a) within DOE of Energy.
p.000015:
p.000015: e. 45 CFR Part 46, Protection of Human Subjects, Subparts B, C, and D, which sets out DOE prescribed DHHS
p.000015: requirements for protected classes of human research subjects and Subpart E for IRB registration.
p.000015:
p.000015: f. Presidential Memorandum, Strengthened Protections for Human Subjects of Classified Research, dated March
p.000015: 27, 1997 and published in the Federal Register on May 13, 1997 (62 Fed. Reg. 26369).
p.000015:
p.000015: g. The Freedom of Information Act, 5 USC Section 552, as amended, which establishes the right of citizens to
p.000015: request information from Federal agencies and establishes a framework of procedures to implement this right.
p.000015:
p.000015: h. The National Nuclear Security Administration Act, Title 32 of the National Defense Authorization Act for
p.000015: Fiscal Year 2000, Public Law No. 106-65; 50 USC 2401 et seq.
p.000015:
p.000015: i. European Union (EU) General Data Protection Regulation (GDPR), dated 04-14- 2016. The GDPR not only applies
p.000015: to organizations located within the EU but also may apply to organizations located outside of the EU if they offer
p.000015: goods or services to, or monitor the behavior of, EU data subjects. It may apply to U.S. organizations processing and
p.000015: holding the personal data of data subjects residing in the European Union, regardless of the company’s location.
p.000015:
p.000016: 16
p.000016: DOE O 443.1C
p.000016: 11-26-2019
p.000016:
p.000016: j. 21st Century Cures Act, dated December 13, 2016, expands researchers’ ability to obtain a Certificate of
p.000016: Confidentiality by making the issuance of a Certificate of Confidentiality mandatory for investigators engaged in
p.000016: federally funded research involving certain sensitive, identifiable information about research subjects.
p.000016:
p.000016: k. DOE Policy Memorandum on Research Involving Intentional Modification of the Human Environment, dated
p.000016: 4-25-13.
p.000016:
p.000016: l. DOE O 206.1, Department of Energy Privacy Program, current version, which ensures compliance with privacy
p.000016: requirements; establishes a Departmental training and awareness program for all DOE Federal and contractor employees to
p.000016: ensure personnel are cognizant of their responsibilities for safeguarding Personally Identifiable Information (PII) and
p.000016: complying with the Privacy Act; and provides Departmental oversight to ensure compliance.
p.000016:
p.000016: m. DOE P 481.1, DOE's Policy Regarding Laboratories, Plants and Sites Engaging in Strategic Partnership Projects
p.000016: with Other Federal Agencies, Independent Organizations, and the Private Sector, current version, which sets the context
p.000016: in which DOE and its laboratories, plants, and sites should pursue Strategic Partnership Projects (SPPs) with other
p.000016: Federal government agencies, state and local institutions, universities, foreign entities and/or private companies. The
p.000016: Policy is applicable to the DOE laboratories, plants, and sites, and to the DOE programs that own them and facilitate
p.000016: their work.
p.000016:
...
Social / education
Searching for indicator education:
(return to top)
p.000014:
p.000014: (g) Sending HSR involving multiple DOE sites (members of the research team from more than one DOE site and/or
p.000014: human subjects from more than one DOE site) to the appropriate Central DOE IRB for review and approval prior to
p.000014: initiation, or, if authorized by the DOE and/or NNSA HSP Program Manager, other appropriate IRB of record. In all
p.000014: cases, an IAA or MOU must be in place between the organization(s) conducting the HSR and the organization responsible
p.000014: for IRB review.
p.000014:
p.000014: (h) Training relevant personnel in HSP requirements.
p.000014:
p.000014: (i) Conducting routine informal internal reviews of the HSP Program or portions of the Program.
p.000014:
p.000014: (3) Attend the triennial (or biennial for sites that perform classified HSR) Headquarters-led QA consultations.
p.000014:
p.000014: 6. INVOKED TECHNICAL STANDARDS. This Order does not invoke any DOE technical standards or industry standards as
p.000014: required methods. Note: DOE O 251.1D, Appendix J provides a definition for “invoked technical standard.”
p.000014:
p.000014: DOE O 443.1C
p.000015: 15
p.000015: 11-26-2019
p.000015:
p.000015: 7. REFERENCES.
p.000015:
p.000015: a. 10 CFR Part 600, Financial Assistance Rules, which provides the policies and procedures for administration
p.000015: and management of all DOE financial assistance activities.
p.000015:
p.000015: a. 10 CFR Part 602, Epidemiology and Other Health Studies Financial Assistance Program, which sets forth the
p.000015: policies and procedures applicable to the award and administration of financial assistance agreements and cooperative
p.000015: agreements for health-related research, education/training, conferences, communication, and related activities.
p.000015:
p.000015: b. 10 CFR Part 605, Office of Science (formerly Office of Energy Research) Financial Assistance Program, as
p.000015: explained at https://science.energy.gov/grants/policy-and-guidance/605/, which provides policies and procedures for the
p.000015: administration and management of basic and applied research financial award agreements awarded by the Office of
p.000015: Science.
p.000015:
p.000015: c. 10 CFR Part 745, Protection of Human Subjects, which set Federal requirements for DOE for the protection of
p.000015: human subjects involved in research activities.
p.000015:
p.000015: d. 10 CFR Part 1008, Records Maintained on Individuals (Privacy Act), which establishes the procedures to
p.000015: implement the Privacy Act of 1974 (PL. 93-579, 5
p.000015: U.S.C. 552a) within DOE of Energy.
p.000015:
p.000015: e. 45 CFR Part 46, Protection of Human Subjects, Subparts B, C, and D, which sets out DOE prescribed DHHS
p.000015: requirements for protected classes of human research subjects and Subpart E for IRB registration.
p.000015:
p.000015: f. Presidential Memorandum, Strengthened Protections for Human Subjects of Classified Research, dated March
p.000015: 27, 1997 and published in the Federal Register on May 13, 1997 (62 Fed. Reg. 26369).
p.000015:
p.000015: g. The Freedom of Information Act, 5 USC Section 552, as amended, which establishes the right of citizens to
p.000015: request information from Federal agencies and establishes a framework of procedures to implement this right.
p.000015:
...
p.000020: and continuing reviews of research involving human subjects, and is registered with the Office for Human Research
p.000020: Protections (OHRP) and designated on an FWA.
p.000020:
p.000020: v. Minimal Risk. The probability and magnitude of harm or discomfort anticipated in the research are not
p.000020: greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine
p.000020: physical or psychological examinations or tests.
p.000020:
p.000020: w. Modification of the Human Environment. Research:
p.000020:
p.000020: (1) in which people have their environment intentionally changed or manipulated for the purposes of the research,
p.000020: with or without their knowledge; and/or
p.000020:
p.000020: (2) that cannot be validly conducted without people present (other than those conducting the research),
p.000020: regardless of whether identifiable private information is collected about them. Before such research begins, the
p.000020: potential risks to those individuals must be considered by the appropriate DOE IRB.
p.000020:
p.000020: x. NNSA Human Subjects Protection Designee (NNSA HSP Program Manager). The program manager responsible for
p.000020: overseeing the Human Subjects Protection Program for NNSA elements.
p.000020:
p.000020: y. Personally Identifiable Information. Any information collected or maintained about an individual, including
p.000020: but not limited to, education, financial transactions, medical history and criminal or employment history, and
p.000020: information that can be used to distinguish or trace an individual’s identity, such as his/her name, Social Security
p.000020: number, date and place of birth, mother’s maiden name, biometric data, and any other personal information that is
p.000020: linked or linkable to a specific individual.
p.000020:
p.000020: z. Protected Class of Human Subjects. Populations who may be more vulnerable to coercion or undue influence
p.000020: when participating as research subjects,
p.000020:
p.000020: DOE O 443.1C
p.000021: 21
p.000021: 11-26-2019
p.000021:
p.000021: including children, prisoners, decisionally impaired individuals, economically or educationally disadvantaged persons,
p.000021: and other vulnerable populations, who are thus afforded additional protections by the Federal regulations (see
p.000021: additional subparts of 45 CFR Part 46) and/or the IRB. DOE and DOE site employees are considered vulnerable subjects
p.000021: when participating in research and additional care must be taken to ensure their participation is truly voluntary
p.000021: (e.g., by ensuring they do not report to members of the research team) and that data collected about them is kept
p.000021: confidential.
p.000021:
...
Searching for indicator educational:
(return to top)
p.000010:
p.000010: e. DOE HSP Program Manager.
p.000010:
p.000010: (1) Resides within the DOE Office of Biological and Environment Research (BER) and reports to the DOE IO.
p.000010:
p.000010: (2) Develops procedures for the HSP program in consultation with the NNSA HSP Program Manager, as appropriate.
p.000010:
p.000010: (3) Prepares and updates guidance to be followed for obtaining approval for HSR in consultation with the NNSA HSP
p.000010: Program Manager, as appropriate.
p.000010:
p.000010: (4) Reviews and coordinates with DOE Site Offices and Site IRBs regarding plans to correct any noncompliance or
p.000010: to mitigate adverse study events, ensuring they comply with applicable HSP requirements.
p.000010:
p.000010: (5) Reviews and approves statements of work for HTM projects submitted by DOE’s non-NNSA sites. Ensures
p.000010: compliance with DOE requirements [see paragraph 4.a.(12)], and, for HTM projects that are Strategic Partnership
p.000010: Projects (SPPs) and Strategic Intelligence Partnership Program (SIPP) projects, coordinates with appropriate
p.000010: Headquarters SPP/SIPP leads prior
p.000010:
p.000010: DOE O 443.1C
p.000011: 11
p.000011: 11-26-2019
p.000011:
p.000011: to approving such statements of work for initiation. Ensures Site Offices and M&O contractors are aware of decisions
p.000011: concerning proposed HTM work.
p.000011:
p.000011: (6) Provides advice and guidance on evolving Departmental and national bioethics and regulatory issues regarding
p.000011: human research subject protection and helps identify and resolve program/project concerns in consultation with the NNSA
p.000011: HSP Program Manager, as appropriate.
p.000011:
p.000011: (7) Develops and conducts educational programs on bioethics and human research subjects protection requirements,
p.000011: practices, and procedures relevant to DOE employees, DOE contractor personnel, financial assistance recipients, and the
p.000011: public in consultation with the NNSA HSP Program Manager, as appropriate.
p.000011:
p.000011: (8) Regularly (at least every three years, or every two years for sites that perform classified HSR), conducts
p.000011: institutional performance reviews, or quality assurance (QA) consultations, to assess compliance with human research
p.000011: subject protection requirements, in consultation with the NNSA HSP Program Manager, as appropriate.
p.000011:
p.000011: (9) Serves as the Chair of the DOE Human Subjects Working Group and as official DOE representative to groups with
p.000011: bioethics and HSP interests. The NNSA HSP Program Manager shall be invited to attend all such meetings and to co-chair
p.000011: meetings, as appropriate.
p.000011:
p.000011: (10) Reviews and, in coordination with the NNSA HSP Program Manager and the Office of Intelligence and
p.000011: Counterintelligence (IN), approves requests for waivers, on a project by project basis, from the requirements for
p.000011: classified research (Section 4.a.(14)), if the reviewing IRB determines that a project that is classified, in whole or
p.000011: in part, can be reviewed in an unclassified manner.
p.000011:
p.000011: (11) Makes recommendations to the Secretary, after concurrence from, and through the Institutional Official,
p.000011: regarding requests for exemptions from any other requirements of this Order and satisfies the advance notice and
...
p.000012: promptly referred to the appropriate HSP Program Manager for resolution.
p.000012:
p.000012: (3) Ensure that the contracting officer is advised when work statements for proposed agreements include HSR to
p.000012: ensure that the CRD or its requirements (as appropriate) will be applied to HSR conducted with DOE/NNSA funding, at
p.000012: DOE/NNSA institutions, or by DOE/NNSA personnel under agreements other than site/facility management contracts,
p.000012:
p.000012: DOE O 443.1C
p.000013: 13
p.000013: 11-26-2019
p.000013:
p.000013: such as support services contracts, grants, cooperative agreements, work- for-others agreements, and interagency
p.000013: agreements.
p.000013:
p.000013: (4) Ensure that the contracting officer, after being notified of the affected contracts, incorporates the CRD
p.000013: into the affected contracts by way of the Department of Energy Acquisition Regulations (DEAR) Laws, regulations, and
p.000013: directives clauses included in those contracts. In the case of contracts or other agreements requiring contractor
p.000013: performance of activities covered by the CRD, but which do not contain the Laws, regulations, and DOE directives
p.000013: clause, the contracting officer will work to include the requirements as appropriate.
p.000013:
p.000013: (5) Ensure their staffs and field elements comply with the requirements of this Order, including the notification
p.000013: requirements in paragraph 4.d.
p.000013:
p.000013: (6) Ensure relevant personnel actively participate in human research subjects protection training and educational
p.000013: programs.
p.000013:
p.000013: (7) Ensure that routine informal reviews are conducted to verify compliance with the requirements of this Order.
p.000013: Support, as needed, HSP Program Managers’ triennial QA consultations.
p.000013:
p.000013: (8) At their discretion, conduct further review and approve or disapprove research that has been approved by the
p.000013: IRB. (Note: Secretarial Officers or their designees may not approve HSR that has not been approved by an IRB. See 10
p.000013: CFR Part 745.112.)
p.000013:
p.000013: (9) Ensure appropriate oversight of the administration of research subjects protection programs of contractors
p.000013: and financial assistance recipients under their cognizance, and other parties to DOE agreements, to ensure compliance
p.000013: with applicable human research subjects protection requirements.
p.000013:
p.000013: (10) Ensure that the DOE HSP Program Manager and the NNSA HSP Program Manager are involved in negotiating those
p.000013: portions of interagency agreements that address HSR.
p.000013:
p.000013: (11) Appoint a point of contact for interacting with the appropriate HSP Program Manager on program-related and/or
p.000013: Department-wide issues.
p.000013:
p.000013: i. DOE Field/Site Offices.
p.000013:
p.000013: (1) Ensure contracts and other agreements involving HSR require compliance with the requirements set forth in the
p.000013: CRD associated with this Order (Attachment 1), 10 CFR Part 745, and 45 CFR Part 46 (all subparts).
p.000013:
p.000013: (2) Ensure that contractors establish and maintain a process for:
p.000013:
p.000014: 14
p.000014: DOE O 443.1C
p.000014: 11-26-2019
p.000014:
...
Social / employees
Searching for indicator employees:
(return to top)
p.000002: subjects involved in DOE research, and DOE procedures and responsibilities for implementing the policy and requirements
p.000002: set forth in Title 45 Code of Federal Regulations (CFR) Part 46, Protection of Human Subjects, and 10 CFR Part 745,
p.000002: Protection of Human Subjects, and the 1997 Presidential Memorandum, “Strengthened Protections for Human Subjects of
p.000002: Classified Research,” dated March 27, 1997.
p.000002:
p.000002: 2. CANCELS/SUPERSEDES. This Order cancels DOE O 443.1B Chg. 1, Protection of Human Subjects, dated 04-21-16,
p.000002: and DOE N 443.1, Protection of Human Subjects in Classified Research, dated 01-21-16.
p.000002:
p.000002: Cancellation of a directive does not, by itself, modify or otherwise affect any contractual or regulatory obligation to
p.000002: comply with the Order. Contractor Requirements Documents (CRDs) that have been incorporated into a contract remain in
p.000002: effect throughout the term of the contract unless and until the contract or regulatory commitment is modified to either
p.000002: eliminate requirements that are no longer applicable or substitute a new set of requirements.
p.000002:
p.000002: 3. APPLICABILITY.
p.000002:
p.000002: a. Departmental Applicability. Except for exemption in paragraph 3.c., this Order applies to all Departmental
p.000002: elements.
p.000002:
p.000002: (1) The Administrator of the National Nuclear Security Administration (NNSA) is responsible for ensuring that
p.000002: NNSA employees, contractors, and elements comply with their respective responsibilities under this directive. Nothing
p.000002: in this Order should be construed to interfere with the NNSA Administrator's authority under Section 3212(d) of Public
p.000002: Law (P.L.) 106-65 to establish Administration-specific policies, unless disapproved by the Secretary.
p.000002:
p.000002: (2) In accordance with the responsibilities and authorities assigned by Executive Order 12344, codified at 50 CFR
p.000002: Parts 2406 and 2511, and to ensure consistency throughout the joint Navy/DOE Naval Nuclear Propulsion Program, the
p.000002: Deputy Administrator for Naval Reactors (Director) will implement and oversee requirements and practices pertaining to
p.000002: this Directive for activities under the Director’s cognizance, as deemed appropriate.
p.000002:
p.000002:
p.000002:
p.000002: AVAILABLE ONLINE AT:
p.000002: INITIATED BY:
p.000002: www.directives.doe.gov
p.000002: Office of Science
p.000002:
p.000002: 2
p.000002: DOE O 443.1C
p.000002: 11-26-2019
p.000002:
p.000002: b. DOE Contractors. Except for the exemption in paragraph 3.c., the Contractor Requirements Document (CRD),
p.000002: Attachment 1, sets forth the requirements of this Order that apply to contracts that include the CRD. The CRD must be
p.000002: included in contracts (i.e., those contracts that include the clause at 48 CFR Part (DEAR) 970.5204-2, Laws,
p.000002: Regulations, and DOE Directives) for the management or operation of a DOE-owned or –leased facility that involves human
p.000002: subjects research (HSR) as defined in paragraph 8.m., and comprehensively explained in paragraph 4.a., irrespective of
p.000002: the party conducting the HSR under the contract. For all other contracts that involve HSR, the applicable requirements
...
p.000002: CFR Part 46), Protection of Human Subjects, in 10 CFR Part 745 (DOE’s implementation of Subpart A of 45 CFR Part 46),
p.000002: and in this Order.
p.000002:
p.000002: a. Requirement Criteria.
p.000002:
p.000002: (1) No HSR conducted with DOE funding, at DOE institutions (regardless of funding source), or by DOE or DOE
p.000002: contractor personnel (regardless of funding source or location conducted), whether done domestically or in an
p.000002: international environment, including classified and proprietary research, may be initiated without both a Federalwide
p.000002: Assurance (FWA) or comparable assurance (e.g., Department of Defense assurance) of compliance and approval by the
p.000002: cognizant Institutional Review Board (IRB) in accordance with 10 CFR Part 745.103.
p.000002:
p.000002: (2) Informed consent will be documented or waived in accordance with 10 CFR Part 745.117.
p.000002:
p.000002: (3) HSR involving multiple DOE sites (e.g., members of the research team from more than one DOE site and/or data
p.000002: or human subjects from more
p.000002:
p.000002: DOE O 443.1C
p.000003: 3
p.000003: 11-26-2019
p.000003:
p.000003: than one DOE site) must be reviewed and approved by one of the Central DOE IRBs prior to initiation, or if authorized
p.000003: by the DOE and/or NNSA HSP Program Manager, other appropriate IRB of record. In all cases, an IRB Authorization
p.000003: Agreement (IAA) or Memorandum of Understanding (MOU) must be in place between the organization(s) conducting the HSR
p.000003: and the organization responsible for IRB review.
p.000003:
p.000003: (4) HSR that involves DOE Federal and/or contractor employees must first be reviewed and approved by the
p.000003: appropriate DOE IRB (the DOE site IRB or one of the Central DOE IRBs), or if deemed more fitting by the Federally
p.000003: assured DOE site or Headquarters, other appropriate IRB of record, in accordance with an IAA or MOU negotiated between
p.000003: the DOE site or Headquarters and the organization responsible for IRB review.
p.000003:
p.000003: (5) Research that uses social media data must be submitted to the appropriate IRB for HSR review and
p.000003: determination.
p.000003:
p.000003: (6) Research that involves the study of humans in a systematically modified environment must be submitted to the
p.000003: appropriate IRB for HSR review and determination.
p.000003:
p.000003: (7) Classified and unclassified HSR that is funded through the Strategic Intelligence Partnership Program (SIPP)
p.000003: must be reviewed and approved by the Central DOE IRB-Classified.
p.000003:
p.000003: (8) All exempt HSR determinations must be made by the appropriate IRB and/or IRB office.
p.000003:
p.000003: (9) In order for a DOE IRB to vote on a new or amended protocol that requires full board review, there must be a
p.000003: minimum of five members present, including a scientist, a nonscientist, and an unaffiliated member.
p.000003:
p.000003: (10) Personally identifiable information collected and/or used during HSR projects must be protected in accordance
p.000003: with the requirements of DOE Order 206.1, Department of Energy Privacy Program, current version.
p.000003:
p.000003: (11) If applicable, Federally funded HSR must comply with the requirements of the Paperwork Reduction Act.
p.000003:
p.000003: (12) It is Departmental policy that Human Terrain Mapping (HTM), defined in paragraph 8.r., is managed as HSR and
p.000003: is subject to this Order.
p.000003:
...
p.000006:
p.000006: c. Contracts, Financial Assistance Agreements, and Other Agreements. Any DOE contract, financial assistance
p.000006: agreement, or other agreement involving HSR must require compliance with the requirements set forth in this Order
p.000006: and/or the CRD associated with this Order (Attachment 1), as well as with 10 CFR Part 745 and 45 CFR Part 46.
p.000006:
p.000006:
p.000006:
p.000006: 2 The Presidential Memorandum, Strengthened Protections for Human Subjects of Classified Research, dated March 27,
p.000006: 1997, requires such an appeal process.
p.000006:
p.000006: DOE O 443.1C
p.000007: 7
p.000007: 11-26-2019
p.000007:
p.000007: d. Notification. The Human Subjects Protection (HSP) Program Manager (and when an NNSA element is involved, the
p.000007: NNSA HSP Program Manager) must be notified in writing:
p.000007:
p.000007: (1) Prior to initiation of the HSR portion of a new project, even if it meets the regulatory definition of exempt
p.000007: HSR as outlined in 10 CFR Part 745.104, that involves:
p.000007:
p.000007: (a) an institution without an established IRB;
p.000007:
p.000007: (b) a foreign country;
p.000007:
p.000007: (c) a potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight
p.000007: groups);
p.000007:
p.000007: (d) research subjects in a protected class (prisoners, children, individuals with impaired decision making, or
p.000007: DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to coercion and undue
p.000007: influence to participate) that is outside of the reviewing IRB’s typical range/scope; or
p.000007:
p.000007: (e) the generation or use of classified information.
p.000007:
p.000007: (2) Immediately upon a finding of a suspected or confirmed data breach involving Personally Identifiable
p.000007: Information (PII) in printed or electronic form, and the incident must be reported to the DOE-Cyber Incident Response
p.000007: Capability in accordance with the requirements of DOE O
p.000007: 206.1. The appropriate HSP Program Manager must also be notified of any corrective actions taken and consulted
p.000007: regarding the plan for any remaining corrective actions.
p.000007:
p.000007: (3) Immediately upon learning of a serious adverse event. The appropriate HSP Program Manager must also be
p.000007: informed of any corrective actions taken and consulted regarding the plan for any remaining corrective actions.
p.000007:
p.000007: (4) Within 48 hours, with a description of corrective actions taken. The appropriate HSP Program Manager must
p.000007: also be consulted regarding the plan for any remaining corrective actions, following other incidents not covered in (2)
p.000007: and (3) above:
p.000007:
p.000007: (a) unanticipated problems, significant adverse events, and complaints about the research, as well as suspension
p.000007: or termination of IRB approval of research; and
p.000007:
p.000007: (b) known or potential incidents of noncompliance with requirements of this Order, 10 CFR Part 745, or 45 CFR
p.000007: Part 46.
p.000007:
p.000008: 8
p.000008: DOE O 443.1C
p.000008: 11-26-2019
p.000008:
...
p.000008: risk (exempt) and the IRB has determined a continuing review is not required.
p.000008:
p.000008: f. Records. Project- and meeting-specific record keeping for all DOE/NNSA site and central IRBs must be done
p.000008: via the DOE Headquarters-provided electronic IRB protocol system. Additionally, all records related to IRB
p.000008: review/approval of classified HSR and key research records must be maintained permanently, subject to NARA
p.000008: requirements, but not less than 100 years. During and following the completion of the research, copies of all signed
p.000008: classified consent forms must be stored in a separate but secure central location (e.g., security policy officer or IRB
p.000008: office), other than the researchers’ office, and participants of such research must be notified during the consenting
p.000008: process regarding how to access a copy of their individual signed classified consent forms should they want to in the
p.000008: future.
p.000008:
p.000008: g. Protected Classes. Research involving prisoners, children, and individuals with impaired decision making
p.000008: must be conducted in accordance with the appropriate Subpart(s) of 45 CFR Part 46. Care should also be taken to ensure
p.000008: the proper protections are in place for DOE/NNSA federal and/or contractor employees who become human subjects of
p.000008: research and may be subject to coercion or undue influence.
p.000008:
p.000008: h. IRB Registration. Each IRB that is designated by an institution under an assurance of compliance approved
p.000008: for Federalwide use by the Office for Human Research Protections (OHRP) under 45 CFR Part §46.103(a) and that reviews
p.000008: research involving human subjects conducted or supported by the Department of Health and Human Services (HHS) must be
p.000008: registered with HHS in accordance with 45 CFR Part 46 Subpart E.
p.000008:
p.000008: 5. RESPONSIBILITIES.
p.000008:
p.000008: All DOE employees, contractors, financial assistance recipients, and parties to other DOE agreements share the
p.000008: responsibility to protect the rights and welfare of human research subjects.
p.000008:
p.000008: a. The Secretary of Energy.
p.000008:
p.000008: (1) Responsible for oversight of the conduct of DOE-related human subject research. Delegates this responsibility
p.000008: to a Senior DOE Institutional Official (IO) for HSR. For the DOE, the IO is the Associate Director of Science for the
p.000008: Office of Biological and Environmental Research.
p.000008:
p.000008: DOE O 443.1C
p.000009: 9
p.000009: 11-26-2019
p.000009:
p.000009: (2) Approves, or defers to the DOE IO to approve, requests for partial or full exemptions from the requirements
p.000009: of this Order, when deemed appropriate by the DOE IO and the DOE HSP Program Manager (or the NNSA HSP Program Manager
p.000009: when an NNSA element is involved).
p.000009:
p.000009: (3) If elevated to the Secretary of Energy, reviews and adjudicates IRB member appeals of IRB approval
p.000009: determinations for classified projects.
p.000009:
p.000009: b. Under Secretary for Science.
p.000009:
p.000009: (1) Monitors compliance with this Order, 10 CFR Part 745, and 45 CFR Part 46, within DOE in accordance with
p.000009: policy established by the Secretary and in consultation with the NNSA, as appropriate.
p.000009:
p.000009: (2) Designates the DOE IO. For DOE, the IO is the Associate Director for Biological and Environmental Research,
p.000009: Office of Science.
p.000009:
p.000009: (3) Designates the DOE HSP Program Manager. For DOE, the HSP Program Manager resides within the Office of
p.000009: Science’s Office of Biological and Environmental Research.
p.000009:
...
p.000010:
p.000010: (3) Prepares and updates guidance to be followed for obtaining approval for HSR in consultation with the NNSA HSP
p.000010: Program Manager, as appropriate.
p.000010:
p.000010: (4) Reviews and coordinates with DOE Site Offices and Site IRBs regarding plans to correct any noncompliance or
p.000010: to mitigate adverse study events, ensuring they comply with applicable HSP requirements.
p.000010:
p.000010: (5) Reviews and approves statements of work for HTM projects submitted by DOE’s non-NNSA sites. Ensures
p.000010: compliance with DOE requirements [see paragraph 4.a.(12)], and, for HTM projects that are Strategic Partnership
p.000010: Projects (SPPs) and Strategic Intelligence Partnership Program (SIPP) projects, coordinates with appropriate
p.000010: Headquarters SPP/SIPP leads prior
p.000010:
p.000010: DOE O 443.1C
p.000011: 11
p.000011: 11-26-2019
p.000011:
p.000011: to approving such statements of work for initiation. Ensures Site Offices and M&O contractors are aware of decisions
p.000011: concerning proposed HTM work.
p.000011:
p.000011: (6) Provides advice and guidance on evolving Departmental and national bioethics and regulatory issues regarding
p.000011: human research subject protection and helps identify and resolve program/project concerns in consultation with the NNSA
p.000011: HSP Program Manager, as appropriate.
p.000011:
p.000011: (7) Develops and conducts educational programs on bioethics and human research subjects protection requirements,
p.000011: practices, and procedures relevant to DOE employees, DOE contractor personnel, financial assistance recipients, and the
p.000011: public in consultation with the NNSA HSP Program Manager, as appropriate.
p.000011:
p.000011: (8) Regularly (at least every three years, or every two years for sites that perform classified HSR), conducts
p.000011: institutional performance reviews, or quality assurance (QA) consultations, to assess compliance with human research
p.000011: subject protection requirements, in consultation with the NNSA HSP Program Manager, as appropriate.
p.000011:
p.000011: (9) Serves as the Chair of the DOE Human Subjects Working Group and as official DOE representative to groups with
p.000011: bioethics and HSP interests. The NNSA HSP Program Manager shall be invited to attend all such meetings and to co-chair
p.000011: meetings, as appropriate.
p.000011:
p.000011: (10) Reviews and, in coordination with the NNSA HSP Program Manager and the Office of Intelligence and
p.000011: Counterintelligence (IN), approves requests for waivers, on a project by project basis, from the requirements for
p.000011: classified research (Section 4.a.(14)), if the reviewing IRB determines that a project that is classified, in whole or
p.000011: in part, can be reviewed in an unclassified manner.
p.000011:
p.000011: (11) Makes recommendations to the Secretary, after concurrence from, and through the Institutional Official,
p.000011: regarding requests for exemptions from any other requirements of this Order and satisfies the advance notice and
p.000011: publication requirements of 10 CFR Part 745.101(i) prior to the granting of any exemption (in consultation with the
p.000011: NNSA HSP Program Manager, as appropriate).
p.000011:
p.000011: (12) Concurs on HSP provisions in interagency agreements, in consultation with the NNSA HSP Program Manager, as
p.000011: appropriate.
p.000011:
...
p.000013: and financial assistance recipients under their cognizance, and other parties to DOE agreements, to ensure compliance
p.000013: with applicable human research subjects protection requirements.
p.000013:
p.000013: (10) Ensure that the DOE HSP Program Manager and the NNSA HSP Program Manager are involved in negotiating those
p.000013: portions of interagency agreements that address HSR.
p.000013:
p.000013: (11) Appoint a point of contact for interacting with the appropriate HSP Program Manager on program-related and/or
p.000013: Department-wide issues.
p.000013:
p.000013: i. DOE Field/Site Offices.
p.000013:
p.000013: (1) Ensure contracts and other agreements involving HSR require compliance with the requirements set forth in the
p.000013: CRD associated with this Order (Attachment 1), 10 CFR Part 745, and 45 CFR Part 46 (all subparts).
p.000013:
p.000013: (2) Ensure that contractors establish and maintain a process for:
p.000013:
p.000014: 14
p.000014: DOE O 443.1C
p.000014: 11-26-2019
p.000014:
p.000014: (a) Identifying, reporting, and managing HTM work in accordance with the requirements in the CRD (Attachment 1,
p.000014: paragraph 10) associated with this Order.
p.000014:
p.000014: (b) Managing classified HSR in accordance with the requirements in the CRD (Attachment 1, paragraph 11)
p.000014: associated with this Order.
p.000014:
p.000014: (c) Maintaining records in accordance with the requirements in the CRD (Attachment 1, paragraph 20) associated
p.000014: with this Order.
p.000014:
p.000014: (d) Notifying the HSP Program Manager(s) as required in paragraph 1 of the CRD associated with this Order.
p.000014:
p.000014: (e) Ensuring that HSR involving site Federal and/or contractor employees is reviewed by the appropriate DOE IRB
p.000014: (the DOE site IRB or one of the Central IRBs) or, if deemed more fitting by the Federally assured DOE site or
p.000014: Headquarters, other appropriate IRB of record, in accordance with an IAA or MOU negotiated between the DOE site or
p.000014: Headquarters and the organization responsible for IRB review.
p.000014:
p.000014: (f) Ensuring that HSR that falls under the SIPP program is reviewed by the Central DOE IRB-Classified.
p.000014:
p.000014: (g) Sending HSR involving multiple DOE sites (members of the research team from more than one DOE site and/or
p.000014: human subjects from more than one DOE site) to the appropriate Central DOE IRB for review and approval prior to
p.000014: initiation, or, if authorized by the DOE and/or NNSA HSP Program Manager, other appropriate IRB of record. In all
p.000014: cases, an IAA or MOU must be in place between the organization(s) conducting the HSR and the organization responsible
p.000014: for IRB review.
p.000014:
p.000014: (h) Training relevant personnel in HSP requirements.
p.000014:
p.000014: (i) Conducting routine informal internal reviews of the HSP Program or portions of the Program.
p.000014:
p.000014: (3) Attend the triennial (or biennial for sites that perform classified HSR) Headquarters-led QA consultations.
p.000014:
p.000014: 6. INVOKED TECHNICAL STANDARDS. This Order does not invoke any DOE technical standards or industry standards as
p.000014: required methods. Note: DOE O 251.1D, Appendix J provides a definition for “invoked technical standard.”
p.000014:
p.000014: DOE O 443.1C
p.000015: 15
p.000015: 11-26-2019
p.000015:
p.000015: 7. REFERENCES.
p.000015:
p.000015: a. 10 CFR Part 600, Financial Assistance Rules, which provides the policies and procedures for administration
...
p.000015:
p.000015: h. The National Nuclear Security Administration Act, Title 32 of the National Defense Authorization Act for
p.000015: Fiscal Year 2000, Public Law No. 106-65; 50 USC 2401 et seq.
p.000015:
p.000015: i. European Union (EU) General Data Protection Regulation (GDPR), dated 04-14- 2016. The GDPR not only applies
p.000015: to organizations located within the EU but also may apply to organizations located outside of the EU if they offer
p.000015: goods or services to, or monitor the behavior of, EU data subjects. It may apply to U.S. organizations processing and
p.000015: holding the personal data of data subjects residing in the European Union, regardless of the company’s location.
p.000015:
p.000016: 16
p.000016: DOE O 443.1C
p.000016: 11-26-2019
p.000016:
p.000016: j. 21st Century Cures Act, dated December 13, 2016, expands researchers’ ability to obtain a Certificate of
p.000016: Confidentiality by making the issuance of a Certificate of Confidentiality mandatory for investigators engaged in
p.000016: federally funded research involving certain sensitive, identifiable information about research subjects.
p.000016:
p.000016: k. DOE Policy Memorandum on Research Involving Intentional Modification of the Human Environment, dated
p.000016: 4-25-13.
p.000016:
p.000016: l. DOE O 206.1, Department of Energy Privacy Program, current version, which ensures compliance with privacy
p.000016: requirements; establishes a Departmental training and awareness program for all DOE Federal and contractor employees to
p.000016: ensure personnel are cognizant of their responsibilities for safeguarding Personally Identifiable Information (PII) and
p.000016: complying with the Privacy Act; and provides Departmental oversight to ensure compliance.
p.000016:
p.000016: m. DOE P 481.1, DOE's Policy Regarding Laboratories, Plants and Sites Engaging in Strategic Partnership Projects
p.000016: with Other Federal Agencies, Independent Organizations, and the Private Sector, current version, which sets the context
p.000016: in which DOE and its laboratories, plants, and sites should pursue Strategic Partnership Projects (SPPs) with other
p.000016: Federal government agencies, state and local institutions, universities, foreign entities and/or private companies. The
p.000016: Policy is applicable to the DOE laboratories, plants, and sites, and to the DOE programs that own them and facilitate
p.000016: their work.
p.000016:
p.000016: n. DOE O 481.1E, Strategic Partnership Projects [Formerly Known as Work for Others (Non-Department of Energy
p.000016: Funded Work)], current version, which establishes the policy, requirements, responsibilities, and procedures for
p.000016: authorizing, administering, and performing work for non-DOE entities by DOE/National Nuclear Security Administration
p.000016: (NNSA) and/or their respective contractor personnel or the use of DOE/NNSA facilities that is not directly funded by
p.000016: DOE appropriations.
p.000016:
p.000016: o. DOE O 483.1B, DOE Cooperative Research and Development Agreements, current version, which establishes
p.000016: requirements for the performance of technology transfer through the use of Cooperative Research and Development
p.000016: Agreements (CRADAs).
p.000016:
p.000016: p. DOE O 484.1, Reimbursable Work for the Department of Homeland Security, current version, establishes DOE
...
p.000020: overseeing the Human Subjects Protection Program for NNSA elements.
p.000020:
p.000020: y. Personally Identifiable Information. Any information collected or maintained about an individual, including
p.000020: but not limited to, education, financial transactions, medical history and criminal or employment history, and
p.000020: information that can be used to distinguish or trace an individual’s identity, such as his/her name, Social Security
p.000020: number, date and place of birth, mother’s maiden name, biometric data, and any other personal information that is
p.000020: linked or linkable to a specific individual.
p.000020:
p.000020: z. Protected Class of Human Subjects. Populations who may be more vulnerable to coercion or undue influence
p.000020: when participating as research subjects,
p.000020:
p.000020: DOE O 443.1C
p.000021: 21
p.000021: 11-26-2019
p.000021:
p.000021: including children, prisoners, decisionally impaired individuals, economically or educationally disadvantaged persons,
p.000021: and other vulnerable populations, who are thus afforded additional protections by the Federal regulations (see
p.000021: additional subparts of 45 CFR Part 46) and/or the IRB. DOE and DOE site employees are considered vulnerable subjects
p.000021: when participating in research and additional care must be taken to ensure their participation is truly voluntary
p.000021: (e.g., by ensuring they do not report to members of the research team) and that data collected about them is kept
p.000021: confidential.
p.000021:
p.000021: aa. Research. A systematic investigation, including research development, testing and evaluation, designed to
p.000021: contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this
p.000021: policy, whether or not they are conducted or supported under a program which is considered research for other purposes.
p.000021: For example, some demonstration and service programs may include research activities. For purposes of this part, the
p.000021: following activities are deemed not to be research:
p.000021:
p.000021: (1) Scholarly or journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal
p.000021: research, and historical scholarship), including the collection and use of information, that focus directly on the
p.000021: specific individuals about whom the information is collected.
p.000021:
p.000021: (2) Public health surveillance activities, including the collection and testing of information or biospecimens,
p.000021: conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are
p.000021: limited to those necessary to allow a public health authority to identify, monitory, assess, or investigate potential
p.000021: public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends,
...
p.000023: Contractor Requirements Document (CRD).
p.000023:
p.000023: The contractor is responsible for flowing down the requirements of this CRD to subcontracts at any tier to the extent
p.000023: necessary to ensure the contractor's compliance with the requirements.
p.000023:
p.000023: Note: Throughout this CRD, the term "Human Subjects Protection Program Manager (HSP Program Manager)" refers either to
p.000023: the DOE HSP Program Manager or to the NNSA HSP Program Manager except where otherwise noted.
p.000023:
p.000023: As directed by the contracting officer, the contractor must—
p.000023:
p.000023: 1. Notify the DOE HSP Program Manager (and, when an NNSA element is involved, the NNSA HSP Program Manager):
p.000023:
p.000023: a. Prior to initiation of any new HSR project, even if it meets the regulatory definition of exempt HSR as
p.000023: outlined in 10 CFR Part 745.104, involving:
p.000023:
p.000023: (1) an institution without an established Institutional Review Board (IRB);
p.000023:
p.000023: (2) a foreign country;
p.000023:
p.000023: (3) the potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight
p.000023: groups);
p.000023:
p.000023: (4) research subjects in a protected class (prisoners, children, individuals with impaired decision making
p.000023: capability, or DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to
p.000023: coercion and undue influence to participate) that is outside of the reviewing IRB’s typical range/scope; or
p.000023:
p.000023: (5) the generation or use of classified information.
p.000023:
p.000023: b. Within 48 hours of the following, and provide a description of corrective actions taken immediately
p.000023: following the incident and consult with the HSP Program Manager(s) regarding additional corrective actions to be taken
p.000023: in the case of:
p.000023:
p.000023: (1) any significant adverse events, unanticipated problems, and complaints about the research;
p.000023:
p.000023: (2) any suspension or termination of IRB approval of research; and/or
p.000023:
p.000023: (3) any significant non-compliance with HSP Program procedures or other requirements.
p.000023:
p.000023: Attachment 1
p.000023: DOE O 443.1C
p.000023: Page 2
p.000023: 11-26-2019
p.000023:
p.000023: c. Immediately, upon finding of a suspected or confirmed data breach involving PII in printed or electronic
p.000023: form, and additionally immediately notify the DOE-Cyber Incident Response Capability, in accordance with the
p.000023: requirements of the CRD associated with DOE O 206.1. The HSP Program Manager(s) shall also be notified of any
p.000023: corrective actions taken and consulted regarding the plan for any remaining corrective actions.
p.000023:
p.000023: d. Immediately upon learning of a serious adverse event. The HSP Program Manager(s) shall also be informed of
p.000023: any corrective actions taken and consulted regarding the plan for any remaining corrective actions.
p.000023:
...
p.000023: with applicable Federal, DOE-specific, sponsor-specific, and other applicable requirements, including relevant
p.000023: international requirements. (See also 10 CFR Part 745 and 45 CFR Part 46.)1
p.000023: 3. Ensure that contractor-issued solicitations or proposals for research, studies, tests, surveys,
p.000023: surveillance, or other data collection are reviewed to identify research involving human subjects and that any
p.000023: resulting agreements include the substance of the requirements in this CRD.
p.000023:
p.000023: 4. Ensure that no research involving human subjects, regardless of funding source, is initiated without prior
p.000023: IRB approval under the terms of an approved assurance covering the research.
p.000023:
p.000023: 5. Ensure that all exempt HSR determinations are made by the appropriate IRB and/or IRB office.
p.000023:
p.000023: 6. Ensure that informed consent is documented or waived in accordance with 10 CFR Part 745.117.
p.000023:
p.000023: 7. Ensure that HSR involving multiple DOE sites (e.g., members of the research team from more than one DOE site
p.000023: and/or data or human subjects from more than one DOE site) is reviewed and approved by one of the Central DOE IRBs
p.000023: prior to initiation, or if authorized by the DOE and/or NNSA HSP Program Manager, other appropriate IRB of record. In
p.000023: all cases, an IRB Authorization Agreement (IAA) or Memorandum of Understanding (MOU) must be in place between the
p.000023: organization(s) conducting the HSR and the organization responsible for IRB review.
p.000023:
p.000023: 8. Ensure that HSR that involves DOE Federal and/or contractor employees is first reviewed and approved by the
p.000023: appropriate DOE IRB (the DOE site IRB or one of the Central DOE IRBs), or if deemed more fitting by the Federally
p.000023: assured DOE site or Headquarters,
p.000023:
p.000023: 1 Ensure that research is reviewed at intervals appropriate to the degree of risk, but not less than once per year, to
p.000023: assess the risk to test subjects and to assure the risk is reasonable in relation to anticipated benefits.
p.000023:
p.000023: DOE O 443.1C
p.000023: Attachment 1
p.000023: 11-26-2019
p.000023: Page 3
p.000023:
p.000023: other appropriate IRB of record, in accordance with an IAA or MOU negotiated between the DOE site or Headquarters and
p.000023: the organization responsible for IRB review.
p.000023:
p.000023: 9. Ensure that classified and unclassified HSR that is funded through the Strategic Intelligence Partnership
p.000023: Program is reviewed and approved by the Central DOE IRB- Classified.
p.000023:
p.000023: 10. Ensure that any Human Terrain Mapping (HTM) work is managed as HSR and complies with DOE requirements
p.000023: specified below:
p.000023:
p.000023: a. HTM projects, conducted with DOE funding, at DOE sites/institutions (regardless of funding source), or by
p.000023: DOE or DOE contractor personnel (regardless of funding source or location conducted), whether done domestically or in
p.000023: an international environment, including classified and proprietary research, must be strictly limited to only those
p.000023: projects involving the analysis and modeling of de- identified data.
p.000023:
p.000023: b. Statements of work for HTM projects must be submitted to the HSP Program Manager (and when an NNSA element
...
General/Other / Incapacitated
Searching for indicator incapacity:
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p.000017: program within DOE and NNSA to identify certain unclassified controlled information as Official Use Only (OUO) (e.g.,
p.000017: PII and proprietary information) and to identify, mark, and protect documents containing such information to ensure it
p.000017: is protected according to legal and Departmental requirements.
p.000017:
p.000017: s. DOE M 471.3-1, Manual for Identifying and Protecting Official Use Only Information, current version, which
p.000017: provides detailed requirements to supplement DOE O 471.3.
p.000017:
p.000017: 8. DEFINITIONS.
p.000017:
p.000017: a. Adverse Event. Any unfavorable medical occurrence in a human subject, including any abnormal sign (for
p.000017: example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s
p.000017: participation in the research, whether or not considered related to the subject’s participation in the research
p.000017: (Unanticipated Problems Involving Risk and Adverse Events Guidance, OHRP, 2007). A significant adverse event is an
p.000017: adverse event that is unexpected and substantively impacts the human subjects. A serious adverse event (Unanticipated
p.000017: Problems Involving Risk Adverse Events Guidance, OHRP, 2007) is any adverse event temporally associated with the
p.000017: subject’s participation in research that meets any of the following criteria: a) results in death; b) is
p.000017: life-threatening; c) requires inpatient hospitalization or prolongation of existing hospitalization; d) results in a
p.000017: persistent or significant disability/incapacity; e) results in a congenital anomaly/birth defect, or f) based upon
p.000017: appropriate medical judgment, may jeopardize the subject’s health and may require medical or surgical intervention to
p.000017: prevent one of the other outcomes listed in this definition.
p.000017:
p.000017: b. Appropriate HSP Program Manager. The DOE HSP Program Manager (and when an NNSA element is involved, the NNSA
p.000017: HSP Program Manager).
p.000017:
p.000017: c. Assurance. The written documentation, satisfactory to the Secretary of Energy, required from the prospective
p.000017: performing institution, that ensures institutional compliance with and implementation of DOE and Department of Health
p.000017: and Human Services (DHHS) regulations for the protection of human research subjects. The only documentation currently
p.000017: meeting this requirement is a Federalwide Assurance (FWA). See: http://ohrp.cit.nih.gov/efile/FwaStart.aspx. Also see
p.000017: definition of Federalwide Assurance in this section.
p.000017:
p.000017: d. Certificate of Confidentiality. Authorizes persons engaged in Federally-funded research to protect the
p.000017: privacy of human subjects of sensitive research against
p.000017:
p.000018: 18
p.000018: DOE O 443.1C
p.000018: 11-26-2019
p.000018:
p.000018: compulsory disclosure in any Federal, State, or local judicial, administrative, or legislative proceeding.
p.000018:
p.000018: e. Classified Human Subjects Research. Research involving human subjects that is classified, in whole or in
p.000018: part, in accordance with the Federal sponsor and/or DOE criteria.
p.000018:
...
General/Other / Manipulable
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p.000019: of collected
p.000019:
p.000020: 20
p.000020: DOE O 443.1C
p.000020: 11-26-2019
p.000020:
p.000020: data, and may become the basis for U.S. military actions in such locations. In addition to Human Terrain Mapping
p.000020: (HTM), such activities are often referred to as human social culture behavior (HSCB) studies. It is DOE policy that
p.000020: HTM activities will be managed as HSR.
p.000020:
p.000020: s. HTM Data. Data collected or used as part of HTM efforts, as described above, as well as any auxiliary data
p.000020: on the same group(s) of individuals.
p.000020:
p.000020: t. Institution. Any public or private entity or agency (including Federal, State, and other agencies). This
p.000020: term refers to laboratories and other facilities managed by DOE, DOE contractors, or DOE financial assistance
p.000020: recipients.
p.000020:
p.000020: u. Institutional Review Board (IRB). A committee or board established by an institution that performs initial
p.000020: and continuing reviews of research involving human subjects, and is registered with the Office for Human Research
p.000020: Protections (OHRP) and designated on an FWA.
p.000020:
p.000020: v. Minimal Risk. The probability and magnitude of harm or discomfort anticipated in the research are not
p.000020: greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine
p.000020: physical or psychological examinations or tests.
p.000020:
p.000020: w. Modification of the Human Environment. Research:
p.000020:
p.000020: (1) in which people have their environment intentionally changed or manipulated for the purposes of the research,
p.000020: with or without their knowledge; and/or
p.000020:
p.000020: (2) that cannot be validly conducted without people present (other than those conducting the research),
p.000020: regardless of whether identifiable private information is collected about them. Before such research begins, the
p.000020: potential risks to those individuals must be considered by the appropriate DOE IRB.
p.000020:
p.000020: x. NNSA Human Subjects Protection Designee (NNSA HSP Program Manager). The program manager responsible for
p.000020: overseeing the Human Subjects Protection Program for NNSA elements.
p.000020:
p.000020: y. Personally Identifiable Information. Any information collected or maintained about an individual, including
p.000020: but not limited to, education, financial transactions, medical history and criminal or employment history, and
p.000020: information that can be used to distinguish or trace an individual’s identity, such as his/her name, Social Security
p.000020: number, date and place of birth, mother’s maiden name, biometric data, and any other personal information that is
p.000020: linked or linkable to a specific individual.
p.000020:
p.000020: z. Protected Class of Human Subjects. Populations who may be more vulnerable to coercion or undue influence
p.000020: when participating as research subjects,
p.000020:
p.000020: DOE O 443.1C
p.000021: 21
p.000021: 11-26-2019
p.000021:
...
General/Other / Other Country
Searching for indicator foreign country:
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p.000006: signed by the submitting IRB’s Chair(s), and reviewed and approved by the appropriate HSP Program Manager (and if the
p.000006: waiver request relates to an intelligence-related project, also the DOE Office of Intelligence and Counterintelligence
p.000006: (IN)). A list of study-specific waiver requests and the actions taken will be provided monthly to the DOE IO.
p.000006:
p.000006: b. Solicitations. Any solicitation issued by a DOE element for HSR must require compliance with the
p.000006: requirements of this Order, 10 CFR Part 745, and 45 CFR Part 46.
p.000006:
p.000006: c. Contracts, Financial Assistance Agreements, and Other Agreements. Any DOE contract, financial assistance
p.000006: agreement, or other agreement involving HSR must require compliance with the requirements set forth in this Order
p.000006: and/or the CRD associated with this Order (Attachment 1), as well as with 10 CFR Part 745 and 45 CFR Part 46.
p.000006:
p.000006:
p.000006:
p.000006: 2 The Presidential Memorandum, Strengthened Protections for Human Subjects of Classified Research, dated March 27,
p.000006: 1997, requires such an appeal process.
p.000006:
p.000006: DOE O 443.1C
p.000007: 7
p.000007: 11-26-2019
p.000007:
p.000007: d. Notification. The Human Subjects Protection (HSP) Program Manager (and when an NNSA element is involved, the
p.000007: NNSA HSP Program Manager) must be notified in writing:
p.000007:
p.000007: (1) Prior to initiation of the HSR portion of a new project, even if it meets the regulatory definition of exempt
p.000007: HSR as outlined in 10 CFR Part 745.104, that involves:
p.000007:
p.000007: (a) an institution without an established IRB;
p.000007:
p.000007: (b) a foreign country;
p.000007:
p.000007: (c) a potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight
p.000007: groups);
p.000007:
p.000007: (d) research subjects in a protected class (prisoners, children, individuals with impaired decision making, or
p.000007: DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to coercion and undue
p.000007: influence to participate) that is outside of the reviewing IRB’s typical range/scope; or
p.000007:
p.000007: (e) the generation or use of classified information.
p.000007:
p.000007: (2) Immediately upon a finding of a suspected or confirmed data breach involving Personally Identifiable
p.000007: Information (PII) in printed or electronic form, and the incident must be reported to the DOE-Cyber Incident Response
p.000007: Capability in accordance with the requirements of DOE O
p.000007: 206.1. The appropriate HSP Program Manager must also be notified of any corrective actions taken and consulted
p.000007: regarding the plan for any remaining corrective actions.
p.000007:
p.000007: (3) Immediately upon learning of a serious adverse event. The appropriate HSP Program Manager must also be
p.000007: informed of any corrective actions taken and consulted regarding the plan for any remaining corrective actions.
p.000007:
p.000007: (4) Within 48 hours, with a description of corrective actions taken. The appropriate HSP Program Manager must
...
p.000023: https://science.osti.gov/ber/human-subjects.
p.000023:
p.000023: BY ORDER OF THE SECRETARY OF ENERGY:
p.000023:
p.000023: DAN BROUILETTE
p.000023: Deputy Secretary
p.000023:
p.000023:
p.000023:
p.000023: DOE O 443.1C
p.000023: Attachment 1
p.000023: 11-26-2019
p.000023: Page 1
p.000023:
p.000023: CONTRACTOR REQUIREMENTS DOCUMENT
p.000023:
p.000023: DOE O 443.1C, PROTECTION OF HUMAN RESEARCH SUBJECTS
p.000023:
p.000023: Regardless of the performer of the work, the contractor is responsible for compliance with the requirements of this
p.000023: Contractor Requirements Document (CRD).
p.000023:
p.000023: The contractor is responsible for flowing down the requirements of this CRD to subcontracts at any tier to the extent
p.000023: necessary to ensure the contractor's compliance with the requirements.
p.000023:
p.000023: Note: Throughout this CRD, the term "Human Subjects Protection Program Manager (HSP Program Manager)" refers either to
p.000023: the DOE HSP Program Manager or to the NNSA HSP Program Manager except where otherwise noted.
p.000023:
p.000023: As directed by the contracting officer, the contractor must—
p.000023:
p.000023: 1. Notify the DOE HSP Program Manager (and, when an NNSA element is involved, the NNSA HSP Program Manager):
p.000023:
p.000023: a. Prior to initiation of any new HSR project, even if it meets the regulatory definition of exempt HSR as
p.000023: outlined in 10 CFR Part 745.104, involving:
p.000023:
p.000023: (1) an institution without an established Institutional Review Board (IRB);
p.000023:
p.000023: (2) a foreign country;
p.000023:
p.000023: (3) the potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight
p.000023: groups);
p.000023:
p.000023: (4) research subjects in a protected class (prisoners, children, individuals with impaired decision making
p.000023: capability, or DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to
p.000023: coercion and undue influence to participate) that is outside of the reviewing IRB’s typical range/scope; or
p.000023:
p.000023: (5) the generation or use of classified information.
p.000023:
p.000023: b. Within 48 hours of the following, and provide a description of corrective actions taken immediately
p.000023: following the incident and consult with the HSP Program Manager(s) regarding additional corrective actions to be taken
p.000023: in the case of:
p.000023:
p.000023: (1) any significant adverse events, unanticipated problems, and complaints about the research;
p.000023:
p.000023: (2) any suspension or termination of IRB approval of research; and/or
p.000023:
p.000023: (3) any significant non-compliance with HSP Program procedures or other requirements.
p.000023:
p.000023: Attachment 1
p.000023: DOE O 443.1C
p.000023: Page 2
p.000023: 11-26-2019
p.000023:
p.000023: c. Immediately, upon finding of a suspected or confirmed data breach involving PII in printed or electronic
...
Searching for indicator other country:
(return to top)
p.000004: prior to initiation. The HSP Program Manager(s) and the Office of Intelligence must engage the recognized DOE site IRB,
p.000004: and as needed, the principal investigator (PI) and/or sponsor, in clarifying whether the proposed project is HTM and if
p.000004: so, that the data to be used will be de-identified. Additionally, the PI will be asked to provide written verification
p.000004: that only de-identified HTM data (as defined in paragraph 8.g.) will be used.
p.000004:
p.000004: (c) The recognized DOE site IRB (or in the case of HSR funded through SIPP, the Central DOE IRB-Classified) is
p.000004: the only entity authorized to determine whether the HTM data received by the PI after project initiation meets DOE
p.000004: criteria for de-identification. If the DOE site does not have a designated site IRB, then the Central DOE IRB(s) must
p.000004: be the responsible IRB.
p.000004:
p.000004: (d) All projects funded by other entities, including HTM activities, must comply with the applicable DOE O
p.000004: 481.1E, Strategic Partnership Projects [Formerly Known as Work for Others (Non- Department of Energy Funded Work)],
p.000004: current version, or DOE O 484.1, Reimbursable Work for the Department of Homeland Security, current version.
p.000004:
p.000004: (e) In a case where the sponsor requests assistance in the de- identification of HTM data prior to using the
p.000004: data and/or re- identification of the data following completion of the project, DOE sites may provide such services
p.000004: under a separate contract and/or task order with the sponsor by following the appropriate DOE standard operating
p.000004: procedure approved by the DOE IO.1
p.000004:
p.000004: (13) International HSR: Researchers conducting HSR in any other country or on citizens or other individuals
p.000004: residing in that country must be cognizant
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: 1 It should be noted that: 1) only limited communications, if needed, may take place between the organization de-
p.000004: identifying and/or re-identifying the sponsor’s data and the organization performing work on the sponsor’s task;
p.000004: 2) the identified dataset shall not be shared with the individual who will perform work on the sponsor’s task; and
p.000004: 3) the de-identified dataset shall be sent directly by the sponsor to the individual performing work on the sponsor’s
p.000004: task and not by the organization at the DOE site that de-identified it.
p.000004:
p.000004: DOE O 443.1C
p.000005: 5
p.000005: 11-26-2019
p.000005:
p.000005: of country-specific HSR requirements and consult the IRB regarding applicability of such requirements.
p.000005:
p.000005: (14) Classified HSR:
p.000005:
p.000005: (a) All information related to classified HSR must be managed in accordance with applicable DOE directives and
p.000005: other requirements (Executive Orders, laws, regulations).
p.000005:
p.000005: (b) HSR that is classified, in whole or in part, must not be initiated without IRB approval, which must be
p.000005: followed by DOE IO approval. The DOE IO, in consultation with the HSP Program Managers, will determine whether he/she
p.000005: will approve/disapprove the project or brief the Secretary about the project prior to his/her approval/disapproval.
p.000005:
p.000005: (c) Informed consent may only be waived for classified HSR if the work meets one of the categories of the
p.000005: minimal risk HSR addressed at 10 CFR Part 745.104.
p.000005:
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000002: set forth in Title 45 Code of Federal Regulations (CFR) Part 46, Protection of Human Subjects, and 10 CFR Part 745,
p.000002: Protection of Human Subjects, and the 1997 Presidential Memorandum, “Strengthened Protections for Human Subjects of
p.000002: Classified Research,” dated March 27, 1997.
p.000002:
p.000002: 2. CANCELS/SUPERSEDES. This Order cancels DOE O 443.1B Chg. 1, Protection of Human Subjects, dated 04-21-16,
p.000002: and DOE N 443.1, Protection of Human Subjects in Classified Research, dated 01-21-16.
p.000002:
p.000002: Cancellation of a directive does not, by itself, modify or otherwise affect any contractual or regulatory obligation to
p.000002: comply with the Order. Contractor Requirements Documents (CRDs) that have been incorporated into a contract remain in
p.000002: effect throughout the term of the contract unless and until the contract or regulatory commitment is modified to either
p.000002: eliminate requirements that are no longer applicable or substitute a new set of requirements.
p.000002:
p.000002: 3. APPLICABILITY.
p.000002:
p.000002: a. Departmental Applicability. Except for exemption in paragraph 3.c., this Order applies to all Departmental
p.000002: elements.
p.000002:
p.000002: (1) The Administrator of the National Nuclear Security Administration (NNSA) is responsible for ensuring that
p.000002: NNSA employees, contractors, and elements comply with their respective responsibilities under this directive. Nothing
p.000002: in this Order should be construed to interfere with the NNSA Administrator's authority under Section 3212(d) of Public
p.000002: Law (P.L.) 106-65 to establish Administration-specific policies, unless disapproved by the Secretary.
p.000002:
p.000002: (2) In accordance with the responsibilities and authorities assigned by Executive Order 12344, codified at 50 CFR
p.000002: Parts 2406 and 2511, and to ensure consistency throughout the joint Navy/DOE Naval Nuclear Propulsion Program, the
p.000002: Deputy Administrator for Naval Reactors (Director) will implement and oversee requirements and practices pertaining to
p.000002: this Directive for activities under the Director’s cognizance, as deemed appropriate.
p.000002:
p.000002:
p.000002:
p.000002: AVAILABLE ONLINE AT:
p.000002: INITIATED BY:
p.000002: www.directives.doe.gov
p.000002: Office of Science
p.000002:
p.000002: 2
p.000002: DOE O 443.1C
p.000002: 11-26-2019
p.000002:
p.000002: b. DOE Contractors. Except for the exemption in paragraph 3.c., the Contractor Requirements Document (CRD),
p.000002: Attachment 1, sets forth the requirements of this Order that apply to contracts that include the CRD. The CRD must be
p.000002: included in contracts (i.e., those contracts that include the clause at 48 CFR Part (DEAR) 970.5204-2, Laws,
p.000002: Regulations, and DOE Directives) for the management or operation of a DOE-owned or –leased facility that involves human
p.000002: subjects research (HSR) as defined in paragraph 8.m., and comprehensively explained in paragraph 4.a., irrespective of
p.000002: the party conducting the HSR under the contract. For all other contracts that involve HSR, the applicable requirements
p.000002: set forth in this CRD must be included in the contract terms and conditions as appropriate.
p.000002:
p.000002: c. Exemptions for DOE O 443.1C.
p.000002:
...
p.000021: and other vulnerable populations, who are thus afforded additional protections by the Federal regulations (see
p.000021: additional subparts of 45 CFR Part 46) and/or the IRB. DOE and DOE site employees are considered vulnerable subjects
p.000021: when participating in research and additional care must be taken to ensure their participation is truly voluntary
p.000021: (e.g., by ensuring they do not report to members of the research team) and that data collected about them is kept
p.000021: confidential.
p.000021:
p.000021: aa. Research. A systematic investigation, including research development, testing and evaluation, designed to
p.000021: contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this
p.000021: policy, whether or not they are conducted or supported under a program which is considered research for other purposes.
p.000021: For example, some demonstration and service programs may include research activities. For purposes of this part, the
p.000021: following activities are deemed not to be research:
p.000021:
p.000021: (1) Scholarly or journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal
p.000021: research, and historical scholarship), including the collection and use of information, that focus directly on the
p.000021: specific individuals about whom the information is collected.
p.000021:
p.000021: (2) Public health surveillance activities, including the collection and testing of information or biospecimens,
p.000021: conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are
p.000021: limited to those necessary to allow a public health authority to identify, monitory, assess, or investigate potential
p.000021: public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends,
p.000021: signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities
p.000021: include those associated with providing timely situational awareness and priority setting during the course of an event
p.000021: or crisis that threatens public health (including natural or man-made disasters).
p.000021:
p.000021: (3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for
p.000021: activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
p.000021:
p.000021: (4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland
p.000021: security, defense, or other national security missions.
p.000021:
p.000021: bb. Strategic Intelligence Partnership Program (SIPP). SIPP, formerly the Intelligence Work for Others (IWFO)
p.000021: program, is the mechanism by which DOE provides highly-specialized scientific and technical services and products to
p.000021: non-DOE Intelligence Community (IC) and other agencies for intelligence and intelligence-related activities carried out
p.000021: under unique IC authorities held
p.000021:
p.000022: 22
p.000022: DOE O 443.1C
p.000022: 11-26-2019
p.000022:
p.000022: by DOE’s Office of Intelligence and Counterintelligence and sponsoring IC agencies.
p.000022:
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.000008:
p.000008: f. Records. Project- and meeting-specific record keeping for all DOE/NNSA site and central IRBs must be done
p.000008: via the DOE Headquarters-provided electronic IRB protocol system. Additionally, all records related to IRB
p.000008: review/approval of classified HSR and key research records must be maintained permanently, subject to NARA
p.000008: requirements, but not less than 100 years. During and following the completion of the research, copies of all signed
p.000008: classified consent forms must be stored in a separate but secure central location (e.g., security policy officer or IRB
p.000008: office), other than the researchers’ office, and participants of such research must be notified during the consenting
p.000008: process regarding how to access a copy of their individual signed classified consent forms should they want to in the
p.000008: future.
p.000008:
p.000008: g. Protected Classes. Research involving prisoners, children, and individuals with impaired decision making
p.000008: must be conducted in accordance with the appropriate Subpart(s) of 45 CFR Part 46. Care should also be taken to ensure
p.000008: the proper protections are in place for DOE/NNSA federal and/or contractor employees who become human subjects of
p.000008: research and may be subject to coercion or undue influence.
p.000008:
p.000008: h. IRB Registration. Each IRB that is designated by an institution under an assurance of compliance approved
p.000008: for Federalwide use by the Office for Human Research Protections (OHRP) under 45 CFR Part §46.103(a) and that reviews
p.000008: research involving human subjects conducted or supported by the Department of Health and Human Services (HHS) must be
p.000008: registered with HHS in accordance with 45 CFR Part 46 Subpart E.
p.000008:
p.000008: 5. RESPONSIBILITIES.
p.000008:
p.000008: All DOE employees, contractors, financial assistance recipients, and parties to other DOE agreements share the
p.000008: responsibility to protect the rights and welfare of human research subjects.
p.000008:
p.000008: a. The Secretary of Energy.
p.000008:
p.000008: (1) Responsible for oversight of the conduct of DOE-related human subject research. Delegates this responsibility
p.000008: to a Senior DOE Institutional Official (IO) for HSR. For the DOE, the IO is the Associate Director of Science for the
p.000008: Office of Biological and Environmental Research.
p.000008:
p.000008: DOE O 443.1C
p.000009: 9
p.000009: 11-26-2019
p.000009:
p.000009: (2) Approves, or defers to the DOE IO to approve, requests for partial or full exemptions from the requirements
p.000009: of this Order, when deemed appropriate by the DOE IO and the DOE HSP Program Manager (or the NNSA HSP Program Manager
p.000009: when an NNSA element is involved).
p.000009:
p.000009: (3) If elevated to the Secretary of Energy, reviews and adjudicates IRB member appeals of IRB approval
p.000009: determinations for classified projects.
p.000009:
p.000009: b. Under Secretary for Science.
p.000009:
...
p.000009: (4) Delegates review and approval of statements of work for HTM projects submitted by DOE’s non-NNSA sites to the
p.000009: DOE HSP Program Manager.
p.000009:
p.000009: c. Under Secretary for Nuclear Security and Administrator of the National Nuclear Security Administration.
p.000009:
p.000009: (1) Designates the NNSA HSP Program Manager and delegates review and approval of statements of work for HTM
p.000009: projects submitted by DOE’s NNSA sites to the NNSA HSP Program Manager. The NNSA HSP Program Manager resides within
p.000009: the Office of Strategic Partnership Programs.
p.000009:
p.000009: (2) In consultation with the Under Secretary for Science, monitors compliance with this Order.
p.000009:
p.000009: d. The DOE Institutional Official (IO).
p.000009:
p.000009: (1) Resides within the Office of Science, and serves both as the Associate Director of Science for Biological and
p.000009: Environmental Research and the Senior DOE Official responsible for overseeing and monitoring Departmental
p.000009: implementation of the requirements of this Order, 10 CFR Part 745, 45 CFR Part 46, as well as related Executive Orders,
p.000009: Presidential Memoranda, and other Presidential directives and international requirements, as applicable, in
p.000009: consultation with the NNSA, as appropriate.
p.000009:
p.000010: 10
p.000010: DOE O 443.1C
p.000010: 11-26-2019
p.000010:
p.000010: (2) Reports to the Secretary of Energy for purposes of this function and determines what constitutes Departmental
p.000010: HSR, in consultation with the NNSA.
p.000010:
p.000010: (3) Allocates resources for the DOE HSPP and ensures that policies are in place that support research review
p.000010: processes that are independent and free of coercion or undue influence.
p.000010:
p.000010: (4) Establishes a process to receive and act on complaints and allegations regarding the HSPP.
p.000010:
p.000010: (5) Oversees the Central DOE Institutional Review Boards (IRBs) and formally appoints all members of the Central
p.000010: IRBs.
p.000010:
p.000010: (6) Approves classified research to be conducted at DOE sites/laboratories after IRB approval and prior to
p.000010: initiation.
p.000010:
p.000010: (7) Reviews and adjudicates IRB member appeals of IRB approval determinations for classified projects.
p.000010:
p.000010: (8) Must concur on all requests from Departmental Elements for partial or full exemptions from the requirements
p.000010: of this Order, in order for such requests to be considered for approval.
p.000010:
p.000010: (9) Approves and rescinds authorization agreements with other DOE and outside organizations for IRB review.
p.000010:
p.000010: e. DOE HSP Program Manager.
p.000010:
p.000010: (1) Resides within the DOE Office of Biological and Environment Research (BER) and reports to the DOE IO.
p.000010:
p.000010: (2) Develops procedures for the HSP program in consultation with the NNSA HSP Program Manager, as appropriate.
p.000010:
p.000010: (3) Prepares and updates guidance to be followed for obtaining approval for HSR in consultation with the NNSA HSP
p.000010: Program Manager, as appropriate.
p.000010:
p.000010: (4) Reviews and coordinates with DOE Site Offices and Site IRBs regarding plans to correct any noncompliance or
p.000010: to mitigate adverse study events, ensuring they comply with applicable HSP requirements.
p.000010:
p.000010: (5) Reviews and approves statements of work for HTM projects submitted by DOE’s non-NNSA sites. Ensures
p.000010: compliance with DOE requirements [see paragraph 4.a.(12)], and, for HTM projects that are Strategic Partnership
...
p.000020:
p.000020: (1) in which people have their environment intentionally changed or manipulated for the purposes of the research,
p.000020: with or without their knowledge; and/or
p.000020:
p.000020: (2) that cannot be validly conducted without people present (other than those conducting the research),
p.000020: regardless of whether identifiable private information is collected about them. Before such research begins, the
p.000020: potential risks to those individuals must be considered by the appropriate DOE IRB.
p.000020:
p.000020: x. NNSA Human Subjects Protection Designee (NNSA HSP Program Manager). The program manager responsible for
p.000020: overseeing the Human Subjects Protection Program for NNSA elements.
p.000020:
p.000020: y. Personally Identifiable Information. Any information collected or maintained about an individual, including
p.000020: but not limited to, education, financial transactions, medical history and criminal or employment history, and
p.000020: information that can be used to distinguish or trace an individual’s identity, such as his/her name, Social Security
p.000020: number, date and place of birth, mother’s maiden name, biometric data, and any other personal information that is
p.000020: linked or linkable to a specific individual.
p.000020:
p.000020: z. Protected Class of Human Subjects. Populations who may be more vulnerable to coercion or undue influence
p.000020: when participating as research subjects,
p.000020:
p.000020: DOE O 443.1C
p.000021: 21
p.000021: 11-26-2019
p.000021:
p.000021: including children, prisoners, decisionally impaired individuals, economically or educationally disadvantaged persons,
p.000021: and other vulnerable populations, who are thus afforded additional protections by the Federal regulations (see
p.000021: additional subparts of 45 CFR Part 46) and/or the IRB. DOE and DOE site employees are considered vulnerable subjects
p.000021: when participating in research and additional care must be taken to ensure their participation is truly voluntary
p.000021: (e.g., by ensuring they do not report to members of the research team) and that data collected about them is kept
p.000021: confidential.
p.000021:
p.000021: aa. Research. A systematic investigation, including research development, testing and evaluation, designed to
p.000021: contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this
p.000021: policy, whether or not they are conducted or supported under a program which is considered research for other purposes.
p.000021: For example, some demonstration and service programs may include research activities. For purposes of this part, the
p.000021: following activities are deemed not to be research:
p.000021:
p.000021: (1) Scholarly or journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal
...
p.000023: necessary to ensure the contractor's compliance with the requirements.
p.000023:
p.000023: Note: Throughout this CRD, the term "Human Subjects Protection Program Manager (HSP Program Manager)" refers either to
p.000023: the DOE HSP Program Manager or to the NNSA HSP Program Manager except where otherwise noted.
p.000023:
p.000023: As directed by the contracting officer, the contractor must—
p.000023:
p.000023: 1. Notify the DOE HSP Program Manager (and, when an NNSA element is involved, the NNSA HSP Program Manager):
p.000023:
p.000023: a. Prior to initiation of any new HSR project, even if it meets the regulatory definition of exempt HSR as
p.000023: outlined in 10 CFR Part 745.104, involving:
p.000023:
p.000023: (1) an institution without an established Institutional Review Board (IRB);
p.000023:
p.000023: (2) a foreign country;
p.000023:
p.000023: (3) the potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight
p.000023: groups);
p.000023:
p.000023: (4) research subjects in a protected class (prisoners, children, individuals with impaired decision making
p.000023: capability, or DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to
p.000023: coercion and undue influence to participate) that is outside of the reviewing IRB’s typical range/scope; or
p.000023:
p.000023: (5) the generation or use of classified information.
p.000023:
p.000023: b. Within 48 hours of the following, and provide a description of corrective actions taken immediately
p.000023: following the incident and consult with the HSP Program Manager(s) regarding additional corrective actions to be taken
p.000023: in the case of:
p.000023:
p.000023: (1) any significant adverse events, unanticipated problems, and complaints about the research;
p.000023:
p.000023: (2) any suspension or termination of IRB approval of research; and/or
p.000023:
p.000023: (3) any significant non-compliance with HSP Program procedures or other requirements.
p.000023:
p.000023: Attachment 1
p.000023: DOE O 443.1C
p.000023: Page 2
p.000023: 11-26-2019
p.000023:
p.000023: c. Immediately, upon finding of a suspected or confirmed data breach involving PII in printed or electronic
p.000023: form, and additionally immediately notify the DOE-Cyber Incident Response Capability, in accordance with the
p.000023: requirements of the CRD associated with DOE O 206.1. The HSP Program Manager(s) shall also be notified of any
p.000023: corrective actions taken and consulted regarding the plan for any remaining corrective actions.
p.000023:
p.000023: d. Immediately upon learning of a serious adverse event. The HSP Program Manager(s) shall also be informed of
p.000023: any corrective actions taken and consulted regarding the plan for any remaining corrective actions.
p.000023:
p.000023: e. Upon appointment of a new DOE or NNSA Site IRB Chair, Co-Chair, or Institutional Official (IO).
p.000023:
p.000023: 2. Ensure that research involving human subjects, regardless of source of funding, is conducted in accordance
...
General/Other / decisionally impaired
Searching for indicator decisionally impaired:
(return to top)
p.000020: regardless of whether identifiable private information is collected about them. Before such research begins, the
p.000020: potential risks to those individuals must be considered by the appropriate DOE IRB.
p.000020:
p.000020: x. NNSA Human Subjects Protection Designee (NNSA HSP Program Manager). The program manager responsible for
p.000020: overseeing the Human Subjects Protection Program for NNSA elements.
p.000020:
p.000020: y. Personally Identifiable Information. Any information collected or maintained about an individual, including
p.000020: but not limited to, education, financial transactions, medical history and criminal or employment history, and
p.000020: information that can be used to distinguish or trace an individual’s identity, such as his/her name, Social Security
p.000020: number, date and place of birth, mother’s maiden name, biometric data, and any other personal information that is
p.000020: linked or linkable to a specific individual.
p.000020:
p.000020: z. Protected Class of Human Subjects. Populations who may be more vulnerable to coercion or undue influence
p.000020: when participating as research subjects,
p.000020:
p.000020: DOE O 443.1C
p.000021: 21
p.000021: 11-26-2019
p.000021:
p.000021: including children, prisoners, decisionally impaired individuals, economically or educationally disadvantaged persons,
p.000021: and other vulnerable populations, who are thus afforded additional protections by the Federal regulations (see
p.000021: additional subparts of 45 CFR Part 46) and/or the IRB. DOE and DOE site employees are considered vulnerable subjects
p.000021: when participating in research and additional care must be taken to ensure their participation is truly voluntary
p.000021: (e.g., by ensuring they do not report to members of the research team) and that data collected about them is kept
p.000021: confidential.
p.000021:
p.000021: aa. Research. A systematic investigation, including research development, testing and evaluation, designed to
p.000021: contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this
p.000021: policy, whether or not they are conducted or supported under a program which is considered research for other purposes.
p.000021: For example, some demonstration and service programs may include research activities. For purposes of this part, the
p.000021: following activities are deemed not to be research:
p.000021:
p.000021: (1) Scholarly or journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal
p.000021: research, and historical scholarship), including the collection and use of information, that focus directly on the
p.000021: specific individuals about whom the information is collected.
p.000021:
p.000021: (2) Public health surveillance activities, including the collection and testing of information or biospecimens,
...
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p.000017: prevent one of the other outcomes listed in this definition.
p.000017:
p.000017: b. Appropriate HSP Program Manager. The DOE HSP Program Manager (and when an NNSA element is involved, the NNSA
p.000017: HSP Program Manager).
p.000017:
p.000017: c. Assurance. The written documentation, satisfactory to the Secretary of Energy, required from the prospective
p.000017: performing institution, that ensures institutional compliance with and implementation of DOE and Department of Health
p.000017: and Human Services (DHHS) regulations for the protection of human research subjects. The only documentation currently
p.000017: meeting this requirement is a Federalwide Assurance (FWA). See: http://ohrp.cit.nih.gov/efile/FwaStart.aspx. Also see
p.000017: definition of Federalwide Assurance in this section.
p.000017:
p.000017: d. Certificate of Confidentiality. Authorizes persons engaged in Federally-funded research to protect the
p.000017: privacy of human subjects of sensitive research against
p.000017:
p.000018: 18
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p.000018:
p.000018: compulsory disclosure in any Federal, State, or local judicial, administrative, or legislative proceeding.
p.000018:
p.000018: e. Classified Human Subjects Research. Research involving human subjects that is classified, in whole or in
p.000018: part, in accordance with the Federal sponsor and/or DOE criteria.
p.000018:
p.000018: f. Clinical trial. Research study in which one or more human subjects are prospectively assigned to one or
p.000018: more interventions (which may include placebo or other control) to evaluate the effects of the interventions on
p.000018: biomedical or behavioral health-related outcomes.
p.000018:
p.000018: g. De-identified Data. Records that have had enough personally identifiable data removed or obscured such that
p.000018: the remaining information does not identify an individual and there is no reasonable basis to believe that the
p.000018: information can be used to identify an individual.
p.000018:
p.000018: h. DOE Human Subjects Protection Program Manager (DOE HSP Program Manager). The program manager responsible for
p.000018: overseeing the non-NNSA components of DOE’s Human Subjects Protection Program.
p.000018:
p.000018: i. DOE Human Subjects Research Projects Database (HSRD). An unclassified compilation of summary information,
p.000018: which is available on the DOE HSP website and updated annually, on HSR projects funded by DOE, conducted at DOE
p.000018: institutions or facilities, or performed with DOE or contractor personnel.
p.000018:
p.000018: j. DOE IRB. One of the DOE site IRBs or Central DOE IRBs.
p.000018:
p.000018: k. DOE Institutional Official (IO). The Senior DOE Official responsible for overseeing and monitoring
p.000018: Departmental implementation of the requirements of 45 CFR Part 46, 10 CFR 745, Protection of Human Subjects, and this
p.000018: Order, in consultation with NNSA, as appropriate.
p.000018:
p.000018: l. Exemption from the Requirements of DOE Order 443.1C. A request for partial or full exemption from the
p.000018: requirements outlined in this Order (see Section 3.c.). Must be submitted to the DOE HSP Program Manager, or when an
...
Orphaned Trigger Words
p.000002: NNSA employees, contractors, and elements comply with their respective responsibilities under this directive. Nothing
p.000002: in this Order should be construed to interfere with the NNSA Administrator's authority under Section 3212(d) of Public
p.000002: Law (P.L.) 106-65 to establish Administration-specific policies, unless disapproved by the Secretary.
p.000002:
p.000002: (2) In accordance with the responsibilities and authorities assigned by Executive Order 12344, codified at 50 CFR
p.000002: Parts 2406 and 2511, and to ensure consistency throughout the joint Navy/DOE Naval Nuclear Propulsion Program, the
p.000002: Deputy Administrator for Naval Reactors (Director) will implement and oversee requirements and practices pertaining to
p.000002: this Directive for activities under the Director’s cognizance, as deemed appropriate.
p.000002:
p.000002:
p.000002:
p.000002: AVAILABLE ONLINE AT:
p.000002: INITIATED BY:
p.000002: www.directives.doe.gov
p.000002: Office of Science
p.000002:
p.000002: 2
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p.000002:
p.000002: b. DOE Contractors. Except for the exemption in paragraph 3.c., the Contractor Requirements Document (CRD),
p.000002: Attachment 1, sets forth the requirements of this Order that apply to contracts that include the CRD. The CRD must be
p.000002: included in contracts (i.e., those contracts that include the clause at 48 CFR Part (DEAR) 970.5204-2, Laws,
p.000002: Regulations, and DOE Directives) for the management or operation of a DOE-owned or –leased facility that involves human
p.000002: subjects research (HSR) as defined in paragraph 8.m., and comprehensively explained in paragraph 4.a., irrespective of
p.000002: the party conducting the HSR under the contract. For all other contracts that involve HSR, the applicable requirements
p.000002: set forth in this CRD must be included in the contract terms and conditions as appropriate.
p.000002:
p.000002: c. Exemptions for DOE O 443.1C.
p.000002:
p.000002: Any requests for partial or full exemptions by Departmental Elements from the requirements of this Order must be
p.000002: submitted in writing to the DOE Human Subjects Protection (HSP) Program Manager (and when an NNSA element is involved,
p.000002: the NNSA HSP Program Manager). An exemption may be recommended to the Secretary by the DOE HSP Program Manager (or by
p.000002: the NNSA HSP Program Manager when an NNSA element is involved) after concurrence by the DOE Institutional Official (IO,
p.000002: see paragraph 8.k.). The basis for granting or denying exemption requests must be set forth in writing.
p.000002:
p.000002: Exemption. Bonneville Power Administration is exempt from the requirements of DOE O 443.1C.
p.000002:
p.000002: 4. REQUIREMENTS. Research using human subjects provides important medical and scientific benefits to
p.000002: individuals and to society. The need for this research does not, however, outweigh the need to protect individual
p.000002: rights and interests. DOE requirements are established in the Federal Policy for the Protection of Human Subjects, (45
p.000002: CFR Part 46), Protection of Human Subjects, in 10 CFR Part 745 (DOE’s implementation of Subpart A of 45 CFR Part 46),
p.000002: and in this Order.
p.000002:
p.000002: a. Requirement Criteria.
p.000002:
p.000002: (1) No HSR conducted with DOE funding, at DOE institutions (regardless of funding source), or by DOE or DOE
p.000002: contractor personnel (regardless of funding source or location conducted), whether done domestically or in an
p.000002: international environment, including classified and proprietary research, may be initiated without both a Federalwide
p.000002: Assurance (FWA) or comparable assurance (e.g., Department of Defense assurance) of compliance and approval by the
p.000002: cognizant Institutional Review Board (IRB) in accordance with 10 CFR Part 745.103.
p.000002:
p.000002: (2) Informed consent will be documented or waived in accordance with 10 CFR Part 745.117.
p.000002:
p.000002: (3) HSR involving multiple DOE sites (e.g., members of the research team from more than one DOE site and/or data
p.000002: or human subjects from more
p.000002:
p.000002: DOE O 443.1C
p.000003: 3
p.000003: 11-26-2019
p.000003:
p.000003: than one DOE site) must be reviewed and approved by one of the Central DOE IRBs prior to initiation, or if authorized
p.000003: by the DOE and/or NNSA HSP Program Manager, other appropriate IRB of record. In all cases, an IRB Authorization
p.000003: Agreement (IAA) or Memorandum of Understanding (MOU) must be in place between the organization(s) conducting the HSR
p.000003: and the organization responsible for IRB review.
p.000003:
p.000003: (4) HSR that involves DOE Federal and/or contractor employees must first be reviewed and approved by the
p.000003: appropriate DOE IRB (the DOE site IRB or one of the Central DOE IRBs), or if deemed more fitting by the Federally
p.000003: assured DOE site or Headquarters, other appropriate IRB of record, in accordance with an IAA or MOU negotiated between
p.000003: the DOE site or Headquarters and the organization responsible for IRB review.
p.000003:
p.000003: (5) Research that uses social media data must be submitted to the appropriate IRB for HSR review and
p.000003: determination.
p.000003:
p.000003: (6) Research that involves the study of humans in a systematically modified environment must be submitted to the
p.000003: appropriate IRB for HSR review and determination.
p.000003:
p.000003: (7) Classified and unclassified HSR that is funded through the Strategic Intelligence Partnership Program (SIPP)
p.000003: must be reviewed and approved by the Central DOE IRB-Classified.
p.000003:
p.000003: (8) All exempt HSR determinations must be made by the appropriate IRB and/or IRB office.
p.000003:
p.000003: (9) In order for a DOE IRB to vote on a new or amended protocol that requires full board review, there must be a
p.000003: minimum of five members present, including a scientist, a nonscientist, and an unaffiliated member.
p.000003:
p.000003: (10) Personally identifiable information collected and/or used during HSR projects must be protected in accordance
p.000003: with the requirements of DOE Order 206.1, Department of Energy Privacy Program, current version.
p.000003:
p.000003: (11) If applicable, Federally funded HSR must comply with the requirements of the Paperwork Reduction Act.
p.000003:
p.000003: (12) It is Departmental policy that Human Terrain Mapping (HTM), defined in paragraph 8.r., is managed as HSR and
p.000003: is subject to this Order.
p.000003:
p.000003: (a) HTM projects, conducted with DOE funding, at DOE sites/institutions (regardless of funding source), or by
p.000003: DOE or DOE contractor personnel (regardless of funding source or location conducted), whether done domestically or in
p.000003: an international environment, including classified and proprietary
p.000003:
p.000004: 4
p.000004: DOE O 443.1C
p.000004: 11-26-2019
p.000004:
p.000004: research, must be strictly limited to only those projects involving the analysis and modeling of de-identified data.
p.000004:
p.000004: (b) Statements of work for HTM projects must be submitted to the HSP Program Manager (and when an NNSA element is
p.000004: involved, the NNSA HSP Program Manager), for DOE Headquarters review and approval prior to initiation. If the project
p.000004: is to be conducted by or for the intelligence community, the Office of Intelligence must also review and approve it
p.000004: prior to initiation. The HSP Program Manager(s) and the Office of Intelligence must engage the recognized DOE site IRB,
p.000004: and as needed, the principal investigator (PI) and/or sponsor, in clarifying whether the proposed project is HTM and if
p.000004: so, that the data to be used will be de-identified. Additionally, the PI will be asked to provide written verification
p.000004: that only de-identified HTM data (as defined in paragraph 8.g.) will be used.
p.000004:
p.000004: (c) The recognized DOE site IRB (or in the case of HSR funded through SIPP, the Central DOE IRB-Classified) is
p.000004: the only entity authorized to determine whether the HTM data received by the PI after project initiation meets DOE
p.000004: criteria for de-identification. If the DOE site does not have a designated site IRB, then the Central DOE IRB(s) must
p.000004: be the responsible IRB.
p.000004:
p.000004: (d) All projects funded by other entities, including HTM activities, must comply with the applicable DOE O
p.000004: 481.1E, Strategic Partnership Projects [Formerly Known as Work for Others (Non- Department of Energy Funded Work)],
p.000004: current version, or DOE O 484.1, Reimbursable Work for the Department of Homeland Security, current version.
p.000004:
p.000004: (e) In a case where the sponsor requests assistance in the de- identification of HTM data prior to using the
p.000004: data and/or re- identification of the data following completion of the project, DOE sites may provide such services
p.000004: under a separate contract and/or task order with the sponsor by following the appropriate DOE standard operating
p.000004: procedure approved by the DOE IO.1
p.000004:
p.000004: (13) International HSR: Researchers conducting HSR in any otherXcountry or on citizens or other individuals
p.000004: residing in that country must be cognizant
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: 1 It should be noted that: 1) only limited communications, if needed, may take place between the organization de-
p.000004: identifying and/or re-identifying the sponsor’s data and the organization performing work on the sponsor’s task;
p.000004: 2) the identified dataset shall not be shared with the individual who will perform work on the sponsor’s task; and
p.000004: 3) the de-identified dataset shall be sent directly by the sponsor to the individual performing work on the sponsor’s
p.000004: task and not by the organization at the DOE site that de-identified it.
p.000004:
p.000004: DOE O 443.1C
p.000005: 5
p.000005: 11-26-2019
p.000005:
p.000005: of country-specific HSR requirements and consult the IRB regarding applicability of such requirements.
p.000005:
p.000005: (14) Classified HSR:
p.000005:
p.000005: (a) All information related to classified HSR must be managed in accordance with applicable DOE directives and
p.000005: other requirements (Executive Orders, laws, regulations).
p.000005:
p.000005: (b) HSR that is classified, in whole or in part, must not be initiated without IRB approval, which must be
p.000005: followed by DOE IO approval. The DOE IO, in consultation with the HSP Program Managers, will determine whether he/she
p.000005: will approve/disapprove the project or brief the Secretary about the project prior to his/her approval/disapproval.
p.000005:
p.000005: (c) Informed consent may only be waived for classified HSR if the work meets one of the categories of the
p.000005: minimal risk HSR addressed at 10 CFR Part 745.104.
p.000005:
p.000005: (d) The use of the expedited review process is prohibited. The fact that research meets a particular expedited
p.000005: category may be noted, but a full IRB review will be required.
p.000005:
p.000005: (e) HSR exemptions (as per 10 CFR Part 745.104) will not be used. The fact that research meets a particular
p.000005: exemption category may be noted, but a full IRB review will be required.
p.000005:
p.000005: (f) The identity of the sponsoring Federal agency must be disclosed to subjects, unless the sponsor requests it
p.000005: not be done. The only acceptable reason for non-disclosure is that disclosure could compromise intelligence sources or
p.000005: methods. Additionally, the research must be no more than minimal risk, and the IRB must determine that not disclosing
p.000005: the identity will not adversely affect the subjects.
p.000005:
p.000005: (g) The informed consent document will state that the project is classified, what that means for the purposes of
p.000005: that project, and what part of the research that applies to. The IRB must determine whether the potential human
p.000005: subjects need access to classified information in order to make a valid informed consent decision.
p.000005:
p.000005: (h) When reviewing classified HSR, the unaffiliated member of a DOE or DOE site IRB must be a nongovernmental
p.000005: member (not currently a Federal employee or a DOE site contractor employee) with the appropriate security clearance.
p.000005:
p.000006: 6
p.000006: DOE O 443.1C
p.000006: 11-26-2019
p.000006:
p.000006: (i) Any IRB member can appeal an IRB decision to approve a project to the DOE IO, and if not resolved to the IRB
p.000006: member’s satisfaction, to the Secretary of Energy. If still dissatisfied, the IRB member can appeal that approval
p.000006: decision to the Director of the Office of Science and Technology Policy (OSTP) or that Director’s designee, or the
p.000006: Director of National Intelligence (ODNI), or that Director’s designee.2 The Director of OSTP, or that Director’s
p.000006: designee, or the Director of National Intelligence, or that Director’s designee will review and approve or disapprove
p.000006: the research, or will convene or designate an IRB that is, to the extent possible, made up of unaffiliated members with
p.000006: the appropriate qualifications and clearance to approve or disapprove the research.
p.000006:
p.000006: (j) Information on each HSR project that is classified must be submitted annually, or in accordance with the
p.000006: directions and schedules provided by the appropriate HSP program manager. The HSP program managers will compile this
p.000006: information and prepare a summary document, for signature by the DOE IO and delivery to OSTP and/or ODNI, in accordance
p.000006: with Executive Orders (see Reference 7g.) and other Federal requirements.
p.000006:
p.000006: (k) An IRB that believes that an HSR project which is classified, in whole or in part, can be thoroughly reviewed
p.000006: in an unclassified manner, may submit a request for a waiver from some or all of the requirements of this section
p.000006: (specific to classified HSR) for the purpose of that particular study. The study-specific waiver request must be
p.000006: signed by the submitting IRB’s Chair(s), and reviewed and approved by the appropriate HSP Program Manager (and if the
p.000006: waiver request relates to an intelligence-related project, also the DOE Office of Intelligence and Counterintelligence
p.000006: (IN)). A list of study-specific waiver requests and the actions taken will be provided monthly to the DOE IO.
p.000006:
p.000006: b. Solicitations. Any solicitation issued by a DOE element for HSR must require compliance with the
p.000006: requirements of this Order, 10 CFR Part 745, and 45 CFR Part 46.
p.000006:
p.000006: c. Contracts, Financial Assistance Agreements, and Other Agreements. Any DOE contract, financial assistance
p.000006: agreement, or other agreement involving HSR must require compliance with the requirements set forth in this Order
p.000006: and/or the CRD associated with this Order (Attachment 1), as well as with 10 CFR Part 745 and 45 CFR Part 46.
p.000006:
p.000006:
p.000006:
p.000006: 2 The Presidential Memorandum, Strengthened Protections for Human Subjects of Classified Research, dated March 27,
p.000006: 1997, requires such an appeal process.
p.000006:
p.000006: DOE O 443.1C
p.000007: 7
p.000007: 11-26-2019
p.000007:
p.000007: d. Notification. The Human Subjects Protection (HSP) Program Manager (and when an NNSA element is involved, the
p.000007: NNSA HSP Program Manager) must be notified in writing:
p.000007:
p.000007: (1) Prior to initiation of the HSR portion of a new project, even if it meets the regulatory definition of exempt
p.000007: HSR as outlined in 10 CFR Part 745.104, that involves:
p.000007:
p.000007: (a) an institution without an established IRB;
p.000007:
p.000007: (b) a foreignXcountry;
p.000007:
p.000007: (c) a potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight
p.000007: groups);
p.000007:
p.000007: (d) research subjects in a protected class (prisoners, children, individuals with impaired decision making, or
p.000007: DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to coercion and undue
p.000007: influence to participate) that is outside of the reviewing IRB’s typical range/scope; or
p.000007:
p.000007: (e) the generation or use of classified information.
p.000007:
p.000007: (2) Immediately upon a finding of a suspected or confirmed data breach involving Personally Identifiable
p.000007: Information (PII) in printed or electronic form, and the incident must be reported to the DOE-Cyber Incident Response
p.000007: Capability in accordance with the requirements of DOE O
p.000007: 206.1. The appropriate HSP Program Manager must also be notified of any corrective actions taken and consulted
p.000007: regarding the plan for any remaining corrective actions.
p.000007:
p.000007: (3) Immediately upon learning of a serious adverse event. The appropriate HSP Program Manager must also be
p.000007: informed of any corrective actions taken and consulted regarding the plan for any remaining corrective actions.
p.000007:
p.000007: (4) Within 48 hours, with a description of corrective actions taken. The appropriate HSP Program Manager must
p.000007: also be consulted regarding the plan for any remaining corrective actions, following other incidents not covered in (2)
p.000007: and (3) above:
p.000007:
p.000007: (a) unanticipated problems, significant adverse events, and complaints about the research, as well as suspension
p.000007: or termination of IRB approval of research; and
p.000007:
p.000007: (b) known or potential incidents of noncompliance with requirements of this Order, 10 CFR Part 745, or 45 CFR
p.000007: Part 46.
p.000007:
p.000008: 8
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p.000008:
p.000008: (5) Immediately upon the appointment of a new DOE or NNSA Site IRB Chair, Co-Chair or IO.
p.000008:
p.000008: e. Human Subjects Research Database (HSRD) Reporting. HSR projects (excluding classified and/or
p.000008: intelligence-related HSR) must be reported annually to the HSR Projects Database (HSRD) in accordance with directions
p.000008: and schedules provided by the appropriate HSP Program Manager. Such reporting is also required when HSR is minimal
p.000008: risk (exempt) and the IRB has determined a continuing review is not required.
p.000008:
p.000008: f. Records. Project- and meeting-specific record keeping for all DOE/NNSA site and central IRBs must be done
p.000008: via the DOE Headquarters-provided electronic IRB protocol system. Additionally, all records related to IRB
p.000008: review/approval of classified HSR and key research records must be maintained permanently, subject to NARA
p.000008: requirements, but not less than 100 years. During and following the completion of the research, copies of all signed
p.000008: classified consent forms must be stored in a separate but secure central location (e.g., security policy officer or IRB
p.000008: office), other than the researchers’ office, and participants of such research must be notified during the consenting
p.000008: process regarding how to access a copy of their individual signed classified consent forms should they want to in the
p.000008: future.
p.000008:
p.000008: g. Protected Classes. Research involving prisoners, children, and individuals with impaired decision making
p.000008: must be conducted in accordance with the appropriate Subpart(s) of 45 CFR Part 46. Care should also be taken to ensure
p.000008: the proper protections are in place for DOE/NNSA federal and/or contractor employees who become human subjects of
p.000008: research and may be subject to coercion or undueXinfluence.
p.000008:
p.000008: h. IRB Registration. Each IRB that is designated by an institution under an assurance of compliance approved
p.000008: for Federalwide use by the Office for Human Research Protections (OHRP) under 45 CFR Part §46.103(a) and that reviews
p.000008: research involving human subjects conducted or supported by the Department of Health and Human Services (HHS) must be
p.000008: registered with HHS in accordance with 45 CFR Part 46 Subpart E.
p.000008:
p.000008: 5. RESPONSIBILITIES.
p.000008:
p.000008: All DOE employees, contractors, financial assistance recipients, and parties to other DOE agreements share the
p.000008: responsibility to protect the rights and welfare of human research subjects.
p.000008:
p.000008: a. The Secretary of Energy.
p.000008:
p.000008: (1) Responsible for oversight of the conduct of DOE-related human subject research. Delegates this responsibility
p.000008: to a Senior DOE Institutional Official (IO) for HSR. For the DOE, the IO is the Associate Director of Science for the
p.000008: Office of Biological and Environmental Research.
p.000008:
p.000008: DOE O 443.1C
p.000009: 9
p.000009: 11-26-2019
p.000009:
p.000009: (2) Approves, or defers to the DOE IO to approve, requests for partial or full exemptions from the requirements
p.000009: of this Order, when deemed appropriate by the DOE IO and the DOE HSP Program Manager (or the NNSA HSP Program Manager
p.000009: when an NNSA element is involved).
p.000009:
p.000009: (3) If elevated to the Secretary of Energy, reviews and adjudicates IRB member appeals of IRB approval
p.000009: determinations for classified projects.
p.000009:
p.000009: b. Under Secretary for Science.
p.000009:
p.000009: (1) Monitors compliance with this Order, 10 CFR Part 745, and 45 CFR Part 46, within DOE in accordance with
p.000009: policy established by the Secretary and in consultation with the NNSA, as appropriate.
p.000009:
p.000009: (2) Designates the DOE IO. For DOE, the IO is the Associate Director for Biological and Environmental Research,
p.000009: Office of Science.
p.000009:
p.000009: (3) Designates the DOE HSP Program Manager. For DOE, the HSP Program Manager resides within the Office of
p.000009: Science’s Office of Biological and Environmental Research.
p.000009:
p.000009: (4) Delegates review and approval of statements of work for HTM projects submitted by DOE’s non-NNSA sites to the
p.000009: DOE HSP Program Manager.
p.000009:
p.000009: c. Under Secretary for Nuclear Security and Administrator of the National Nuclear Security Administration.
p.000009:
p.000009: (1) Designates the NNSA HSP Program Manager and delegates review and approval of statements of work for HTM
p.000009: projects submitted by DOE’s NNSA sites to the NNSA HSP Program Manager. The NNSA HSP Program Manager resides within
p.000009: the Office of Strategic Partnership Programs.
p.000009:
p.000009: (2) In consultation with the Under Secretary for Science, monitors compliance with this Order.
p.000009:
p.000009: d. The DOE Institutional Official (IO).
p.000009:
p.000009: (1) Resides within the Office of Science, and serves both as the Associate Director of Science for Biological and
p.000009: Environmental Research and the Senior DOE Official responsible for overseeing and monitoring Departmental
p.000009: implementation of the requirements of this Order, 10 CFR Part 745, 45 CFR Part 46, as well as related Executive Orders,
p.000009: Presidential Memoranda, and other Presidential directives and international requirements, as applicable, in
p.000009: consultation with the NNSA, as appropriate.
p.000009:
p.000010: 10
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p.000010:
p.000010: (2) Reports to the Secretary of Energy for purposes of this function and determines what constitutes Departmental
p.000010: HSR, in consultation with the NNSA.
p.000010:
p.000010: (3) Allocates resources for the DOE HSPP and ensures that policies are in place that support research review
p.000010: processes that are independent and free of coercion or undueXinfluence.
p.000010:
p.000010: (4) Establishes a process to receive and act on complaints and allegations regarding the HSPP.
p.000010:
p.000010: (5) Oversees the Central DOE Institutional Review Boards (IRBs) and formally appoints all members of the Central
p.000010: IRBs.
p.000010:
p.000010: (6) Approves classified research to be conducted at DOE sites/laboratories after IRB approval and prior to
p.000010: initiation.
p.000010:
p.000010: (7) Reviews and adjudicates IRB member appeals of IRB approval determinations for classified projects.
p.000010:
p.000010: (8) Must concur on all requests from Departmental Elements for partial or full exemptions from the requirements
p.000010: of this Order, in order for such requests to be considered for approval.
p.000010:
p.000010: (9) Approves and rescinds authorization agreements with other DOE and outside organizations for IRB review.
p.000010:
p.000010: e. DOE HSP Program Manager.
p.000010:
p.000010: (1) Resides within the DOE Office of Biological and Environment Research (BER) and reports to the DOE IO.
p.000010:
p.000010: (2) Develops procedures for the HSP program in consultation with the NNSA HSP Program Manager, as appropriate.
p.000010:
p.000010: (3) Prepares and updates guidance to be followed for obtaining approval for HSR in consultation with the NNSA HSP
p.000010: Program Manager, as appropriate.
p.000010:
p.000010: (4) Reviews and coordinates with DOE Site Offices and Site IRBs regarding plans to correct any noncompliance or
p.000010: to mitigate adverse study events, ensuring they comply with applicable HSP requirements.
p.000010:
p.000010: (5) Reviews and approves statements of work for HTM projects submitted by DOE’s non-NNSA sites. Ensures
p.000010: compliance with DOE requirements [see paragraph 4.a.(12)], and, for HTM projects that are Strategic Partnership
p.000010: Projects (SPPs) and Strategic Intelligence Partnership Program (SIPP) projects, coordinates with appropriate
p.000010: Headquarters SPP/SIPP leads prior
p.000010:
p.000010: DOE O 443.1C
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p.000011: 11-26-2019
p.000011:
p.000011: to approving such statements of work for initiation. Ensures Site Offices and M&O contractors are aware of decisions
p.000011: concerning proposed HTM work.
p.000011:
p.000011: (6) Provides advice and guidance on evolving Departmental and national bioethics and regulatory issues regarding
p.000011: human research subject protection and helps identify and resolve program/project concerns in consultation with the NNSA
p.000011: HSP Program Manager, as appropriate.
p.000011:
p.000011: (7) Develops and conducts educational programs on bioethics and human research subjects protection requirements,
p.000011: practices, and procedures relevant to DOE employees, DOE contractor personnel, financial assistance recipients, and the
p.000011: public in consultation with the NNSA HSP Program Manager, as appropriate.
p.000011:
p.000011: (8) Regularly (at least every three years, or every two years for sites that perform classified HSR), conducts
p.000011: institutional performance reviews, or quality assurance (QA) consultations, to assess compliance with human research
p.000011: subject protection requirements, in consultation with the NNSA HSP Program Manager, as appropriate.
p.000011:
p.000011: (9) Serves as the Chair of the DOE Human Subjects Working Group and as official DOE representative to groups with
p.000011: bioethics and HSP interests. The NNSA HSP Program Manager shall be invited to attend all such meetings and to co-chair
p.000011: meetings, as appropriate.
p.000011:
p.000011: (10) Reviews and, in coordination with the NNSA HSP Program Manager and the Office of Intelligence and
p.000011: Counterintelligence (IN), approves requests for waivers, on a project by project basis, from the requirements for
p.000011: classified research (Section 4.a.(14)), if the reviewing IRB determines that a project that is classified, in whole or
p.000011: in part, can be reviewed in an unclassified manner.
p.000011:
p.000011: (11) Makes recommendations to the Secretary, after concurrence from, and through the Institutional Official,
p.000011: regarding requests for exemptions from any other requirements of this Order and satisfies the advance notice and
p.000011: publication requirements of 10 CFR Part 745.101(i) prior to the granting of any exemption (in consultation with the
p.000011: NNSA HSP Program Manager, as appropriate).
p.000011:
p.000011: (12) Concurs on HSP provisions in interagency agreements, in consultation with the NNSA HSP Program Manager, as
p.000011: appropriate.
p.000011:
p.000011: (13) Maintains the HSRD, the list of unclassified intelligence-related HSR projects, and the unclassified list of
p.000011: classified HSR projects for DOE.
p.000011:
p.000011: (14) Serves as one of the Co-Chairs of the Central DOE IRB-C.
p.000011:
p.000012: 12
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p.000012:
p.000012: f. NNSA HSP Program Manager.
p.000012:
p.000012: (1) Resides within NA-10.1, the Office of Strategic Partnership Programs, and reports functionally to the DOE IO.
p.000012:
p.000012: (2) When an NNSA element or project is involved, the responsibilities of the NNSA HSP Program Manager are
p.000012: identical to those of the DOE HSP Program Manager.
p.000012:
p.000012: (3) Ensures compliance with the DOE/NNSA requirements.
p.000012:
p.000012: (4) Works with the DOE HSP Program Manager, as outlined in Section 5.e.
p.000012:
p.000012: (5) Serves as one of the Co-Chairs of the Central DOE IRB-C.
p.000012:
p.000012: g. Office of Intelligence and Counterintelligence.
p.000012:
p.000012: (1) Reviews and approves, prior to initiation, statements of work for HSR and HTM projects received from members
p.000012: of the intelligence community.
p.000012:
p.000012: (2) Collaborates with the DOE IO, and with the DOE and NNSA HSP Program Managers, in overseeing the Central DOE
p.000012: IRB-Classified, and provides the Vice Chair and the Administrator for this IRB.
p.000012:
p.000012: (3) Reviews and, in coordination with the DOE and NNSA HSP Program Managers, approves requests for waivers, on a
p.000012: project by project basis, from the additional requirements for classified research (Section 4.a.(14)), if the Central
p.000012: DOE IRB-Classified determines that an intelligence-related HSR project that is classified, in whole or in part, can be
p.000012: reviewed in an unclassified manner.
p.000012:
p.000012: h. Secretarial Officers or their Designees.
p.000012:
p.000012: (1) Ensure that all proposals for research, studies, tests, surveys, surveillance, or other data collection are
p.000012: reviewed to identify research involving human subjects.
p.000012:
p.000012: (2) Ensure that any questions or uncertainties regarding the applicability of human research subjects protection
p.000012: requirements to such proposals, and any other issues and concerns regarding the requirements of this Order, are
p.000012: promptly referred to the appropriate HSP Program Manager for resolution.
p.000012:
p.000012: (3) Ensure that the contracting officer is advised when work statements for proposed agreements include HSR to
p.000012: ensure that the CRD or its requirements (as appropriate) will be applied to HSR conducted with DOE/NNSA funding, at
p.000012: DOE/NNSA institutions, or by DOE/NNSA personnel under agreements other than site/facility management contracts,
p.000012:
p.000012: DOE O 443.1C
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p.000013:
p.000013: such as support services contracts, grants, cooperative agreements, work- for-others agreements, and interagency
p.000013: agreements.
p.000013:
p.000013: (4) Ensure that the contracting officer, after being notified of the affected contracts, incorporates the CRD
p.000013: into the affected contracts by way of the Department of Energy Acquisition Regulations (DEAR) Laws, regulations, and
p.000013: directives clauses included in those contracts. In the case of contracts or other agreements requiring contractor
p.000013: performance of activities covered by the CRD, but which do not contain the Laws, regulations, and DOE directives
p.000013: clause, the contracting officer will work to include the requirements as appropriate.
p.000013:
p.000013: (5) Ensure their staffs and field elements comply with the requirements of this Order, including the notification
p.000013: requirements in paragraph 4.d.
p.000013:
p.000013: (6) Ensure relevant personnel actively participate in human research subjects protection training and educational
p.000013: programs.
p.000013:
p.000013: (7) Ensure that routine informal reviews are conducted to verify compliance with the requirements of this Order.
p.000013: Support, as needed, HSP Program Managers’ triennial QA consultations.
p.000013:
p.000013: (8) At their discretion, conduct further review and approve or disapprove research that has been approved by the
p.000013: IRB. (Note: Secretarial Officers or their designees may not approve HSR that has not been approved by an IRB. See 10
p.000013: CFR Part 745.112.)
p.000013:
p.000013: (9) Ensure appropriate oversight of the administration of research subjects protection programs of contractors
p.000013: and financial assistance recipients under their cognizance, and other parties to DOE agreements, to ensure compliance
p.000013: with applicable human research subjects protection requirements.
p.000013:
p.000013: (10) Ensure that the DOE HSP Program Manager and the NNSA HSP Program Manager are involved in negotiating those
p.000013: portions of interagency agreements that address HSR.
p.000013:
p.000013: (11) Appoint a point of contact for interacting with the appropriate HSP Program Manager on program-related and/or
p.000013: Department-wide issues.
p.000013:
p.000013: i. DOE Field/Site Offices.
p.000013:
p.000013: (1) Ensure contracts and other agreements involving HSR require compliance with the requirements set forth in the
p.000013: CRD associated with this Order (Attachment 1), 10 CFR Part 745, and 45 CFR Part 46 (all subparts).
p.000013:
p.000013: (2) Ensure that contractors establish and maintain a process for:
p.000013:
p.000014: 14
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p.000014:
p.000014: (a) Identifying, reporting, and managing HTM work in accordance with the requirements in the CRD (Attachment 1,
p.000014: paragraph 10) associated with this Order.
p.000014:
p.000014: (b) Managing classified HSR in accordance with the requirements in the CRD (Attachment 1, paragraph 11)
p.000014: associated with this Order.
p.000014:
p.000014: (c) Maintaining records in accordance with the requirements in the CRD (Attachment 1, paragraph 20) associated
p.000014: with this Order.
p.000014:
p.000014: (d) Notifying the HSP Program Manager(s) as required in paragraph 1 of the CRD associated with this Order.
p.000014:
p.000014: (e) Ensuring that HSR involving site Federal and/or contractor employees is reviewed by the appropriate DOE IRB
p.000014: (the DOE site IRB or one of the Central IRBs) or, if deemed more fitting by the Federally assured DOE site or
p.000014: Headquarters, other appropriate IRB of record, in accordance with an IAA or MOU negotiated between the DOE site or
p.000014: Headquarters and the organization responsible for IRB review.
p.000014:
p.000014: (f) Ensuring that HSR that falls under the SIPP program is reviewed by the Central DOE IRB-Classified.
p.000014:
p.000014: (g) Sending HSR involving multiple DOE sites (members of the research team from more than one DOE site and/or
p.000014: human subjects from more than one DOE site) to the appropriate Central DOE IRB for review and approval prior to
p.000014: initiation, or, if authorized by the DOE and/or NNSA HSP Program Manager, other appropriate IRB of record. In all
p.000014: cases, an IAA or MOU must be in place between the organization(s) conducting the HSR and the organization responsible
p.000014: for IRB review.
p.000014:
p.000014: (h) Training relevant personnel in HSP requirements.
p.000014:
p.000014: (i) Conducting routine informal internal reviews of the HSP Program or portions of the Program.
p.000014:
p.000014: (3) Attend the triennial (or biennial for sites that perform classified HSR) Headquarters-led QA consultations.
p.000014:
p.000014: 6. INVOKED TECHNICAL STANDARDS. This Order does not invoke any DOE technical standards or industry standards as
p.000014: required methods. Note: DOE O 251.1D, Appendix J provides a definition for “invoked technical standard.”
p.000014:
p.000014: DOE O 443.1C
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p.000015:
p.000015: 7. REFERENCES.
p.000015:
p.000015: a. 10 CFR Part 600, Financial Assistance Rules, which provides the policies and procedures for administration
p.000015: and management of all DOE financial assistance activities.
p.000015:
p.000015: a. 10 CFR Part 602, Epidemiology and Other Health Studies Financial Assistance Program, which sets forth the
p.000015: policies and procedures applicable to the award and administration of financial assistance agreements and cooperative
p.000015: agreements for health-related research, education/training, conferences, communication, and related activities.
p.000015:
p.000015: b. 10 CFR Part 605, Office of Science (formerly Office of Energy Research) Financial Assistance Program, as
p.000015: explained at https://science.energy.gov/grants/policy-and-guidance/605/, which provides policies and procedures for the
p.000015: administration and management of basic and applied research financial award agreements awarded by the Office of
p.000015: Science.
p.000015:
p.000015: c. 10 CFR Part 745, Protection of Human Subjects, which set Federal requirements for DOE for the protection of
p.000015: human subjects involved in research activities.
p.000015:
p.000015: d. 10 CFR Part 1008, Records Maintained on Individuals (Privacy Act), which establishes the procedures to
p.000015: implement the Privacy Act of 1974 (PL. 93-579, 5
p.000015: U.S.C. 552a) within DOE of Energy.
p.000015:
p.000015: e. 45 CFR Part 46, Protection of Human Subjects, Subparts B, C, and D, which sets out DOE prescribed DHHS
p.000015: requirements for protected classes of human research subjects and Subpart E for IRB registration.
p.000015:
p.000015: f. Presidential Memorandum, Strengthened Protections for Human Subjects of Classified Research, dated March
p.000015: 27, 1997 and published in the Federal Register on May 13, 1997 (62 Fed. Reg. 26369).
p.000015:
p.000015: g. The FreedomXofXInformation Act, 5 USC Section 552, as amended, which establishes the right of citizens to
p.000015: request information from Federal agencies and establishes a framework of procedures to implement this right.
p.000015:
p.000015: h. The National Nuclear Security Administration Act, Title 32 of the National Defense Authorization Act for
p.000015: Fiscal Year 2000, Public Law No. 106-65; 50 USC 2401 et seq.
p.000015:
p.000015: i. European Union (EU) General Data Protection Regulation (GDPR), dated 04-14- 2016. The GDPR not only applies
p.000015: to organizations located within the EU but also may apply to organizations located outside of the EU if they offer
p.000015: goods or services to, or monitor the behavior of, EU data subjects. It may apply to U.S. organizations processing and
p.000015: holding the personal data of data subjects residing in the European Union, regardless of the company’s location.
p.000015:
p.000016: 16
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p.000016:
p.000016: j. 21st Century Cures Act, dated December 13, 2016, expands researchers’ ability to obtain a Certificate of
p.000016: Confidentiality by making the issuance of a Certificate of Confidentiality mandatory for investigators engaged in
p.000016: federally funded research involving certain sensitive, identifiable information about research subjects.
p.000016:
p.000016: k. DOE Policy Memorandum on Research Involving Intentional Modification of the Human Environment, dated
p.000016: 4-25-13.
p.000016:
p.000016: l. DOE O 206.1, Department of Energy Privacy Program, current version, which ensures compliance with privacy
p.000016: requirements; establishes a Departmental training and awareness program for all DOE Federal and contractor employees to
p.000016: ensure personnel are cognizant of their responsibilities for safeguarding Personally Identifiable Information (PII) and
p.000016: complying with the Privacy Act; and provides Departmental oversight to ensure compliance.
p.000016:
p.000016: m. DOE P 481.1, DOE's Policy Regarding Laboratories, Plants and Sites Engaging in Strategic Partnership Projects
p.000016: with Other Federal Agencies, Independent Organizations, and the Private Sector, current version, which sets the context
p.000016: in which DOE and its laboratories, plants, and sites should pursue Strategic Partnership Projects (SPPs) with other
p.000016: Federal government agencies, state and local institutions, universities, foreign entities and/or private companies. The
p.000016: Policy is applicable to the DOE laboratories, plants, and sites, and to the DOE programs that own them and facilitate
p.000016: their work.
p.000016:
p.000016: n. DOE O 481.1E, Strategic Partnership Projects [Formerly Known as Work for Others (Non-Department of Energy
p.000016: Funded Work)], current version, which establishes the policy, requirements, responsibilities, and procedures for
p.000016: authorizing, administering, and performing work for non-DOE entities by DOE/National Nuclear Security Administration
p.000016: (NNSA) and/or their respective contractor personnel or the use of DOE/NNSA facilities that is not directly funded by
p.000016: DOE appropriations.
p.000016:
p.000016: o. DOE O 483.1B, DOE Cooperative Research and Development Agreements, current version, which establishes
p.000016: requirements for the performance of technology transfer through the use of Cooperative Research and Development
p.000016: Agreements (CRADAs).
p.000016:
p.000016: p. DOE O 484.1, Reimbursable Work for the Department of Homeland Security, current version, establishes DOE
p.000016: policies and procedures for the acceptance, performance, and administration of reimbursable work directly funded by the
p.000016: Department of Homeland Security.
p.000016:
p.000016: q. DOE O 475.2B, Identifying Classified Information, current version, establishes the program to identify
p.000016: information classified under the Atomic Energy Act [Restricted Data (RD), Formerly Restricted Data (FRD), and
p.000016: Transclassified Foreign Nuclear Information (TFNI)] or Executive Order (E.O.) 13526 [National
p.000016:
p.000016: DOE O 443.1C
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p.000017:
p.000017: Security Information (NSI)], so that it can be protected against unauthorized dissemination in accordance with legal
p.000017: and Departmental requirements.
p.000017:
p.000017: r. DOE O 471.3, Identifying and Protecting Official Use Only Information, current version, which establishes a
p.000017: program within DOE and NNSA to identify certain unclassified controlled information as Official Use Only (OUO) (e.g.,
p.000017: PII and proprietary information) and to identify, mark, and protect documents containing such information to ensure it
p.000017: is protected according to legal and Departmental requirements.
p.000017:
p.000017: s. DOE M 471.3-1, Manual for Identifying and Protecting Official Use Only Information, current version, which
p.000017: provides detailed requirements to supplement DOE O 471.3.
p.000017:
p.000017: 8. DEFINITIONS.
p.000017:
p.000017: a. Adverse Event. Any unfavorable medical occurrence in a human subject, including any abnormal sign (for
p.000017: example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s
p.000017: participation in the research, whether or not considered related to the subject’s participation in the research
p.000017: (Unanticipated Problems Involving Risk and Adverse Events Guidance, OHRP, 2007). A significant adverse event is an
p.000017: adverse event that is unexpected and substantively impacts the human subjects. A serious adverse event (Unanticipated
p.000017: Problems Involving Risk Adverse Events Guidance, OHRP, 2007) is any adverse event temporally associated with the
p.000017: subject’s participation in research that meets any of the following criteria: a) results in death; b) is
p.000017: life-threatening; c) requires inpatient hospitalization or prolongation of existing hospitalization; d) results in a
p.000017: persistent or significant disability/incapacity; e) results in a congenital anomaly/birth defect, or f) based upon
p.000017: appropriate medical judgment, may jeopardize the subject’s health and may require medical or surgical intervention to
p.000017: prevent one of the other outcomes listed in this definition.
p.000017:
p.000017: b. Appropriate HSP Program Manager. The DOE HSP Program Manager (and when an NNSA element is involved, the NNSA
p.000017: HSP Program Manager).
p.000017:
p.000017: c. Assurance. The written documentation, satisfactory to the Secretary of Energy, required from the prospective
p.000017: performing institution, that ensures institutional compliance with and implementation of DOE and Department of Health
p.000017: and Human Services (DHHS) regulations for the protection of human research subjects. The only documentation currently
p.000017: meeting this requirement is a Federalwide Assurance (FWA). See: http://ohrp.cit.nih.gov/efile/FwaStart.aspx. Also see
p.000017: definition of Federalwide Assurance in this section.
p.000017:
p.000017: d. Certificate of Confidentiality. Authorizes persons engaged in Federally-funded research to protect the
p.000017: privacy of human subjects of sensitive research against
p.000017:
p.000018: 18
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p.000018:
p.000018: compulsory disclosure in any Federal, State, or local judicial, administrative, or legislative proceeding.
p.000018:
p.000018: e. Classified Human Subjects Research. Research involving human subjects that is classified, in whole or in
p.000018: part, in accordance with the Federal sponsor and/or DOE criteria.
p.000018:
p.000018: f. Clinical trial. Research study in which one or more human subjects are prospectively assigned to one or
p.000018: more interventions (which may include placebo or other control) to evaluate the effects of the interventions on
p.000018: biomedical or behavioral health-related outcomes.
p.000018:
p.000018: g. De-identified Data. Records that have had enough personally identifiable data removed or obscured such that
p.000018: the remaining information does not identify an individual and there is no reasonable basis to believe that the
p.000018: information can be used to identify an individual.
p.000018:
p.000018: h. DOE Human Subjects Protection Program Manager (DOE HSP Program Manager). The program manager responsible for
p.000018: overseeing the non-NNSA components of DOE’s Human Subjects Protection Program.
p.000018:
p.000018: i. DOE Human Subjects Research Projects Database (HSRD). An unclassified compilation of summary information,
p.000018: which is available on the DOE HSP website and updated annually, on HSR projects funded by DOE, conducted at DOE
p.000018: institutions or facilities, or performed with DOE or contractor personnel.
p.000018:
p.000018: j. DOE IRB. One of the DOE site IRBs or Central DOE IRBs.
p.000018:
p.000018: k. DOE Institutional Official (IO). The Senior DOE Official responsible for overseeing and monitoring
p.000018: Departmental implementation of the requirements of 45 CFR Part 46, 10 CFR 745, Protection of Human Subjects, and this
p.000018: Order, in consultation with NNSA, as appropriate.
p.000018:
p.000018: l. Exemption from the Requirements of DOE Order 443.1C. A request for partial or full exemption from the
p.000018: requirements outlined in this Order (see Section 3.c.). Must be submitted to the DOE HSP Program Manager, or when an
p.000018: NNSA element is involved, the NNSA HSP Program Manager. Requires DOE IO concurrence and Secretarial or Secretarial
p.000018: designee (DOE IO) approval.
p.000018:
p.000018: m. Exempt Human Subjects Research (HSR). HSR that is minimal risk and meets one of the exempt categories
p.000018: outlined in 10 CFR Part 745. Within DOE, the initial exemption determination is made by the appropriate central DOE or
p.000018: DOE site IRB. Note that exempt HSR is a category of HSR and has nothing to do with a request for an exemption from the
p.000018: requirements of this Order (as described in definition l. above).
p.000018:
p.000018: n. Federalwide Assurance. The written documentation, satisfactory to the Secretary of Energy, required from the
p.000018: prospective performing institution, that ensures
p.000018:
p.000018: DOE O 443.1C
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p.000019: 11-26-2019
p.000019:
p.000019: institutional compliance with and implementation of DOE and Department of Health and Human Services (DHHS) regulations
p.000019: for the protection of human research subjects. See: http://ohrp.cit.nih.gov/efile/FwaStart.aspx.
p.000019:
p.000019: o. Generalizable. Information/research findings that are intended to be applied to populations or situations
p.000019: beyond that studied/will have meaning and impact outside of the single immediate activity itself.
p.000019:
p.000019: p. Human Subject. A living individual about whom an investigator (whether professional or student) conducting
p.000019: research:
p.000019:
p.000019: (1) Obtains information or biospecimens through intervention or interaction with the individual, and uses,
p.000019: studies, or analyzes the information or biospecimens; or
p.000019:
p.000019: (2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
p.000019:
p.000019: Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations
p.000019: of the subject or the subject’s environment that are performed for research purposes.
p.000019:
p.000019: Interaction includes communication or interpersonal contact between investigator and subject.
p.000019:
p.000019: Private information includes information about behavior that occurs in a context in which an individual can reasonably
p.000019: expect that no observation or recording is taking place, and information that has been provided for specific purposes
p.000019: by an individual and that the individual can reasonably expect will not be made public (for example, a medical record).
p.000019:
p.000019: Identifiable private information is private information for which the identity of the subject is or may readily be
p.000019: ascertained by the investigator or associated with the information.
p.000019:
p.000019: An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by
p.000019: the investigator or associated with the biospecimen.
p.000019:
p.000019: q. Human Subjects Research (HSR). Any activity meeting the definitions of both: 1) research, and 2) human
p.000019: subject, as defined in this section.
p.000019:
p.000019: r. Human Terrain Mapping. Research and data gathering activities primarily conducted for military or
p.000019: intelligence purposes to understand the “human terrain,”—the social, ethnographic, cultural, and political elements of
p.000019: the people among whom the U.S. ArmedXForces are operating and/or in countries prone to political instability. This
p.000019: work includes observations, questionnaires, and interviews of groups of individuals, as well as modeling and analysis
p.000019: of collected
p.000019:
p.000020: 20
p.000020: DOE O 443.1C
p.000020: 11-26-2019
p.000020:
p.000020: data, and may become the basis for U.S. military actions in such locations. In addition to Human Terrain Mapping
p.000020: (HTM), such activities are often referred to as human social culture behavior (HSCB) studies. It is DOE policy that
p.000020: HTM activities will be managed as HSR.
p.000020:
p.000020: s. HTM Data. Data collected or used as part of HTM efforts, as described above, as well as any auxiliary data
p.000020: on the same group(s) of individuals.
p.000020:
p.000020: t. Institution. Any public or private entity or agency (including Federal, State, and other agencies). This
p.000020: term refers to laboratories and other facilities managed by DOE, DOE contractors, or DOE financial assistance
p.000020: recipients.
p.000020:
p.000020: u. Institutional Review Board (IRB). A committee or board established by an institution that performs initial
p.000020: and continuing reviews of research involving human subjects, and is registered with the Office for Human Research
p.000020: Protections (OHRP) and designated on an FWA.
p.000020:
p.000020: v. Minimal Risk. The probability and magnitude of harm or discomfort anticipated in the research are not
p.000020: greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine
p.000020: physical or psychological examinations or tests.
p.000020:
p.000020: w. Modification of the Human Environment. Research:
p.000020:
p.000020: (1) in which people have their environment intentionally changed or manipulated for the purposes of the research,
p.000020: with or without their knowledge; and/or
p.000020:
p.000020: (2) that cannot be validly conducted without people present (other than those conducting the research),
p.000020: regardless of whether identifiable private information is collected about them. Before such research begins, the
p.000020: potential risks to those individuals must be considered by the appropriate DOE IRB.
p.000020:
p.000020: x. NNSA Human Subjects Protection Designee (NNSA HSP Program Manager). The program manager responsible for
p.000020: overseeing the Human Subjects Protection Program for NNSA elements.
p.000020:
p.000020: y. Personally Identifiable Information. Any information collected or maintained about an individual, including
p.000020: but not limited to, education, financial transactions, medical history and criminal or employment history, and
p.000020: information that can be used to distinguish or trace an individual’s identity, such as his/her name, Social Security
p.000020: number, date and place of birth, mother’s maiden name, biometric data, and any other personal information that is
p.000020: linked or linkable to a specific individual.
p.000020:
p.000020: z. Protected Class of Human Subjects. Populations who may be more vulnerable to coercion or undueXinfluence
p.000020: when participating as research subjects,
p.000020:
p.000020: DOE O 443.1C
p.000021: 21
p.000021: 11-26-2019
p.000021:
p.000021: including children, prisoners, decisionallyXimpaired individuals, economically or educationally disadvantaged persons,
p.000021: and other vulnerable populations, who are thus afforded additional protections by the Federal regulations (see
p.000021: additional subparts of 45 CFR Part 46) and/or the IRB. DOE and DOE site employees are considered vulnerable subjects
p.000021: when participating in research and additional care must be taken to ensure their participation is truly voluntary
p.000021: (e.g., by ensuring they do not report to members of the research team) and that data collected about them is kept
p.000021: confidential.
p.000021:
p.000021: aa. Research. A systematic investigation, including research development, testing and evaluation, designed to
p.000021: contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this
p.000021: policy, whether or not they are conducted or supported under a program which is considered research for other purposes.
p.000021: For example, some demonstration and service programs may include research activities. For purposes of this part, the
p.000021: following activities are deemed not to be research:
p.000021:
p.000021: (1) Scholarly or journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal
p.000021: research, and historical scholarship), including the collection and use of information, that focus directly on the
p.000021: specific individuals about whom the information is collected.
p.000021:
p.000021: (2) Public health surveillance activities, including the collection and testing of information or biospecimens,
p.000021: conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are
p.000021: limited to those necessary to allow a public health authority to identify, monitory, assess, or investigate potential
p.000021: public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends,
p.000021: signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities
p.000021: include those associated with providing timely situational awareness and priority setting during the course of an event
p.000021: or crisis that threatens public health (including natural or man-made disasters).
p.000021:
p.000021: (3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for
p.000021: activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
p.000021:
p.000021: (4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland
p.000021: security, defense, or other national security missions.
p.000021:
p.000021: bb. Strategic Intelligence Partnership Program (SIPP). SIPP, formerly the Intelligence Work for Others (IWFO)
p.000021: program, is the mechanism by which DOE provides highly-specialized scientific and technical services and products to
p.000021: non-DOE Intelligence Community (IC) and other agencies for intelligence and intelligence-related activities carried out
p.000021: under unique IC authorities held
p.000021:
p.000022: 22
p.000022: DOE O 443.1C
p.000022: 11-26-2019
p.000022:
p.000022: by DOE’s Office of Intelligence and Counterintelligence and sponsoring IC agencies.
p.000022:
p.000022: cc. Strategic Partnership Projects (SPPs). SPP, formerly the Work for Others (WFO) program, is the mechanism by
p.000022: which non-DOE entities fund DOE/NNSA and/or their contractors or use DOE/NNSA facilities for work that is not directly
p.000022: funded by DOE/NNSA appropriations.
p.000022:
p.000022: dd. Unaffiliated IRB Member. For review of unclassified protocols, must not have a direct affiliation (employee,
p.000022: contractor, student in a fellowship, volunteer at the institution, or business related to the IRB, and must not have an
p.000022: immediate family member who is affiliated with the institution). For review of classified protocols, must be a
p.000022: nongovernmental member (not currently a Federal employee or a DOE site contractor employee) with the appropriate
p.000022: security clearance.
p.000022:
p.000022: ee. Unanticipated Problem. In general, to be classified as an unanticipated problem, any incident, experience, or
p.000022: outcome should meet all three of the following criteria:
p.000022:
p.000022: (1) Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described
p.000022: in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b)
p.000022: the characteristics of the subject population being studied
p.000022:
p.000022: (2) Related or possibly related to participation in the research (possibly related means there is a reasonable
p.000022: possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research)
p.000022:
p.000022: (3) Likely to place subjects or others at greater risk of harm (including physical, psychological, economic, or
p.000022: social harm) than was previously known or recognized.
p.000022:
p.000022: ff. Waiver from the Additional Requirements for Classified HSR. In certain cases, when classified projects can
p.000022: be fully reviewed in an unclassified form (e.g., because the protocol and consent form are unclassified), the IRB may
p.000022: submit, for consideration by the appropriate HSP Program Manager (and for intelligence-related HSR, also in
p.000022: consultation with the DOE Office of Intelligence and Counterintelligence), a request for a project-specific waiver from
p.000022: some or all of the additional requirements for classified HSR specified in Section 4.a.(14) of this Order. Such a
p.000022: waiver might be approved, for example, if only the sponsor or the ultimate use of a particular technology were
p.000022: classified, but everything else about the study were not. Note that even if a waiver from the additional requirements
p.000022: of classified HSR is approved for a
p.000022:
p.000022: DOE O 443.1C
p.000023: 23
p.000023: 11-26-2019
p.000023:
p.000023: particular project, all other Federal and DOE-specific HSR requirements must still be met.
p.000023:
p.000023: 9. CONTACT. Questions regarding this Order should be addressed to the DOE Program Manager, HSP Program, Office
p.000023: of Science, Office of Biological and Environmental Research, telephone 301-903-3213; or the DOE NNSA HSP Program
p.000023: Manager, as appropriate. Information about the DOE HSP program may be found at
p.000023: https://science.osti.gov/ber/human-subjects.
p.000023:
p.000023: BY ORDER OF THE SECRETARY OF ENERGY:
p.000023:
p.000023: DAN BROUILETTE
p.000023: Deputy Secretary
p.000023:
p.000023:
p.000023:
p.000023: DOE O 443.1C
p.000023: Attachment 1
p.000023: 11-26-2019
p.000023: Page 1
p.000023:
p.000023: CONTRACTOR REQUIREMENTS DOCUMENT
p.000023:
p.000023: DOE O 443.1C, PROTECTION OF HUMAN RESEARCH SUBJECTS
p.000023:
p.000023: Regardless of the performer of the work, the contractor is responsible for compliance with the requirements of this
p.000023: Contractor Requirements Document (CRD).
p.000023:
p.000023: The contractor is responsible for flowing down the requirements of this CRD to subcontracts at any tier to the extent
p.000023: necessary to ensure the contractor's compliance with the requirements.
p.000023:
p.000023: Note: Throughout this CRD, the term "Human Subjects Protection Program Manager (HSP Program Manager)" refers either to
p.000023: the DOE HSP Program Manager or to the NNSA HSP Program Manager except where otherwise noted.
p.000023:
p.000023: As directed by the contracting officer, the contractor must—
p.000023:
p.000023: 1. Notify the DOE HSP Program Manager (and, when an NNSA element is involved, the NNSA HSP Program Manager):
p.000023:
p.000023: a. Prior to initiation of any new HSR project, even if it meets the regulatory definition of exempt HSR as
p.000023: outlined in 10 CFR Part 745.104, involving:
p.000023:
p.000023: (1) an institution without an established Institutional Review Board (IRB);
p.000023:
p.000023: (2) a foreignXcountry;
p.000023:
p.000023: (3) the potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight
p.000023: groups);
p.000023:
p.000023: (4) research subjects in a protected class (prisoners, children, individuals with impaired decision making
p.000023: capability, or DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to
p.000023: coercion and undueXinfluence to participate) that is outside of the reviewing IRB’s typical range/scope; or
p.000023:
p.000023: (5) the generation or use of classified information.
p.000023:
p.000023: b. Within 48 hours of the following, and provide a description of corrective actions taken immediately
p.000023: following the incident and consult with the HSP Program Manager(s) regarding additional corrective actions to be taken
p.000023: in the case of:
p.000023:
p.000023: (1) any significant adverse events, unanticipated problems, and complaints about the research;
p.000023:
p.000023: (2) any suspension or termination of IRB approval of research; and/or
p.000023:
p.000023: (3) any significant non-compliance with HSP Program procedures or other requirements.
p.000023:
p.000023: Attachment 1
p.000023: DOE O 443.1C
p.000023: Page 2
p.000023: 11-26-2019
p.000023:
p.000023: c. Immediately, upon finding of a suspected or confirmed data breach involving PII in printed or electronic
p.000023: form, and additionally immediately notify the DOE-Cyber Incident Response Capability, in accordance with the
p.000023: requirements of the CRD associated with DOE O 206.1. The HSP Program Manager(s) shall also be notified of any
p.000023: corrective actions taken and consulted regarding the plan for any remaining corrective actions.
p.000023:
p.000023: d. Immediately upon learning of a serious adverse event. The HSP Program Manager(s) shall also be informed of
p.000023: any corrective actions taken and consulted regarding the plan for any remaining corrective actions.
p.000023:
p.000023: e. Upon appointment of a new DOE or NNSA Site IRB Chair, Co-Chair, or Institutional Official (IO).
p.000023:
p.000023: 2. Ensure that research involving human subjects, regardless of source of funding, is conducted in accordance
p.000023: with applicable Federal, DOE-specific, sponsor-specific, and other applicable requirements, including relevant
p.000023: international requirements. (See also 10 CFR Part 745 and 45 CFR Part 46.)1
p.000023: 3. Ensure that contractor-issued solicitations or proposals for research, studies, tests, surveys,
p.000023: surveillance, or other data collection are reviewed to identify research involving human subjects and that any
p.000023: resulting agreements include the substance of the requirements in this CRD.
p.000023:
p.000023: 4. Ensure that no research involving human subjects, regardless of funding source, is initiated without prior
p.000023: IRB approval under the terms of an approved assurance covering the research.
p.000023:
p.000023: 5. Ensure that all exempt HSR determinations are made by the appropriate IRB and/or IRB office.
p.000023:
p.000023: 6. Ensure that informed consent is documented or waived in accordance with 10 CFR Part 745.117.
p.000023:
p.000023: 7. Ensure that HSR involving multiple DOE sites (e.g., members of the research team from more than one DOE site
p.000023: and/or data or human subjects from more than one DOE site) is reviewed and approved by one of the Central DOE IRBs
p.000023: prior to initiation, or if authorized by the DOE and/or NNSA HSP Program Manager, other appropriate IRB of record. In
p.000023: all cases, an IRB Authorization Agreement (IAA) or Memorandum of Understanding (MOU) must be in place between the
p.000023: organization(s) conducting the HSR and the organization responsible for IRB review.
p.000023:
p.000023: 8. Ensure that HSR that involves DOE Federal and/or contractor employees is first reviewed and approved by the
p.000023: appropriate DOE IRB (the DOE site IRB or one of the Central DOE IRBs), or if deemed more fitting by the Federally
p.000023: assured DOE site or Headquarters,
p.000023:
p.000023: 1 Ensure that research is reviewed at intervals appropriate to the degree of risk, but not less than once per year, to
p.000023: assess the risk to test subjects and to assure the risk is reasonable in relation to anticipated benefits.
p.000023:
p.000023: DOE O 443.1C
p.000023: Attachment 1
p.000023: 11-26-2019
p.000023: Page 3
p.000023:
p.000023: other appropriate IRB of record, in accordance with an IAA or MOU negotiated between the DOE site or Headquarters and
p.000023: the organization responsible for IRB review.
p.000023:
p.000023: 9. Ensure that classified and unclassified HSR that is funded through the Strategic Intelligence Partnership
p.000023: Program is reviewed and approved by the Central DOE IRB- Classified.
p.000023:
p.000023: 10. Ensure that any Human Terrain Mapping (HTM) work is managed as HSR and complies with DOE requirements
p.000023: specified below:
p.000023:
p.000023: a. HTM projects, conducted with DOE funding, at DOE sites/institutions (regardless of funding source), or by
p.000023: DOE or DOE contractor personnel (regardless of funding source or location conducted), whether done domestically or in
p.000023: an international environment, including classified and proprietary research, must be strictly limited to only those
p.000023: projects involving the analysis and modeling of de- identified data.
p.000023:
p.000023: b. Statements of work for HTM projects must be submitted to the HSP Program Manager (and when an NNSA element
p.000023: is involved, the NNSA HSP Program Manager), for DOE Headquarters review and approval prior to initiation. If the
p.000023: project is to be conducted by or for the intelligence community, the Office of Intelligence must also review and
p.000023: approve it prior to initiation. The HSP Program Manager(s) and the Office of Intelligence must engage the recognized
p.000023: DOE site IRB, and as needed, the principal investigator (PI) and/or sponsor, in clarifying whether the proposed project
p.000023: is HTM and if so, that the data to be used will be de- identified. Additionally, the PI will be asked to provide
p.000023: written verification that only de-identified HTM data (as defined in paragraph 8.g.) will be used.
p.000023:
p.000023: c. The recognized DOE site IRB (or in the case of SIPP-funded HSR, the Central DOE IRB-Classified) is the only
p.000023: entity authorized to determine whether the HTM data received by the PI after project initiation meets DOE criteria for
p.000023: de- identification. If the DOE site does not have a designated site IRB, then the Central DOE IRB(s) must be the
p.000023: responsible IRB.
p.000023:
p.000023: d. All projects funded by other entities, including HTM activities, must comply with the applicable DOE O
p.000023: 481.1E, Strategic Partnership Projects [Formerly Known as Work for Others (Non-Department of Energy Funded Work)],
p.000023: current version, or DOE O 484.1, Reimbursable Work for the Department of Homeland Security, current version.
p.000023:
p.000023: e. In a case where the sponsor requests assistance in the de-identification of HTM data prior to using the data
p.000023: and/or re-identification of the data following completion of the project, DOE sites may provide such services under a
p.000023: separate
p.000023:
p.000023: Attachment 1
p.000023: DOE O 443.1C
p.000023: Page 4
p.000023: 11-26-2019
p.000023:
p.000023: contract and/or task order with the sponsor by following the appropriate DOE standard operating procedure approved by
p.000023: the DOE IO, DOE Office of Science.2
p.000023: 11. Ensure that any classified HSR complies with the additional requirements specified below:
p.000023:
p.000023: a. All information related to classified HSR must be managed in accordance with applicable DOE directives and
p.000023: other requirements (Executive Orders, laws, regulations).
p.000023:
p.000023: b. HSR that is classified, in whole or in part, must not be initiated without IRB approval, which must be
p.000023: followed by DOE IO approval. The DOE IO, in consultation with the HSP Program Managers, will determine whether he/she
p.000023: will approve/disapprove the project or brief the Secretary about the project prior to his/her approval/disapproval.
p.000023:
p.000023: c. Informed consent may only be waived for classified HSR if the work meets one of the categories of minimal
p.000023: risk HSR addressed at 10 CFR Part 745.104.
p.000023:
p.000023: d. The use of the expedited review process is prohibited. The fact that research meets a particular expedited
p.000023: category may be noted, but a full IRB review will be required.
p.000023:
p.000023: e. HSR exemptions (as per 10 CFR Part 745.104) will not be used. The fact that research meets a particular
p.000023: exemption category may be noted, but a full IRB review will be required.
p.000023:
p.000023: f. The identity of the sponsoring Federal agency must be disclosed to subjects, unless the sponsor requests it
p.000023: not be done. The only acceptable reason for non- disclosure is that disclosure could compromise intelligence sources
p.000023: or methods. Additionally, the research must be no more than minimal risk, and the IRB must determine that not
p.000023: disclosing the identity will not adversely affect the subjects.
p.000023:
p.000023: g. The informed consent document will state that the project is classified, what that means for the purposes of
p.000023: that project, and what part of the research that applies to. The IRB must determine whether the potential human
p.000023: subjects need access to classified information in order to make a valid informed consent decision.
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: 2 It should be noted that: 1) only limited communications, if needed, may take place between the organization de-
p.000023: identifying and/or re-identifying the sponsor’s data and the organization performing work on the sponsor’s task;
p.000023: 2) the identified dataset shall not be shared with the individual who will perform work on the sponsor’s task; and
p.000023: 3) the de-identified dataset shall be sent directly by the sponsor to the individual performing work on the sponsor’s
p.000023: task and not by the organization at the DOE site that de-identified it.
p.000023:
p.000023: DOE O 443.1C
p.000023: Attachment 1
p.000023: 11-26-2019
p.000023: Page 5
p.000023:
p.000023: h. When reviewing classified HSR, the unaffiliated member of a DOE or DOE site IRB must be a nongovernmental
p.000023: member (not currently a Federal employee or a DOE site contractor employee) with the appropriate security clearance.
p.000023:
p.000023: i. Any IRB member can appeal an IRB decision to approve a project to the DOE IO, and if not resolved to the
p.000023: IRB member’s satisfaction, to the Secretary of Energy. If still dissatisfied, the IRB member can appeal that approval
p.000023: decision to the Director of the Office of Science and Technology Policy (OSTP) or that Director’s designee, or the
p.000023: Director of National Intelligence (ODNI), or that Director’s designee.3 The Director of OSTP, or that Director’s
p.000023: designee, or the Director of National Intelligence, or that Director’s designee will review and approve or disapprove
p.000023: the research, or will convene or designate an IRB that is, to the extent possible, made up of unaffiliated members with
p.000023: the appropriate qualifications and clearance to approve or disapprove the research.
p.000023:
p.000023: j. Information on each HSR project that is classified must be submitted annually, or in accordance with the
p.000023: directions and schedules provided by the appropriate HSP program manager. The HSP program managers will compile this
p.000023: information and prepare a summary document, for signature by the DOE IO and delivery to OSTP and/or ODNI, in accordance
p.000023: with Executive Orders (see the Presidential Memorandum, Strengthened Protections for Human Subjects of Classified
p.000023: Research, dated March 27, 1997, and published in the Federal Register on May 13, 1997 (62 Federal Register 26369)) and
p.000023: other Federal requirements.
p.000023:
p.000023: k. An IRB that believes that an HSR project which is classified, in whole or in part, can be thoroughly
p.000023: reviewed in an unclassified manner, may submit a request for a waiver from some or all of the requirements of this
p.000023: section (specific to classified HSR) for the purpose of that particular study. The study-specific waiver request must
p.000023: be signed by the submitting IRB’s Chair(s), and reviewed and approved by the appropriate HSP Program Manager (and if
p.000023: the waiver request relates to an intelligence-related project, also the DOE Office of Intelligence and
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| armedXforces | Soldier |
| authority | Relationship to Authority |
| children | Child |
| criminal | criminal |
| decisionally impaired | decisionally impaired |
| disability | Mentally Disabled |
| education | education |
| educational | education |
| employees | employees |
| family | Motherhood/Family |
| foreign country | Other Country |
| freedomXofXinformation | Access to information |
| impaired | Cognitive Impairment |
| incapacity | Incapacitated |
| manipulated | Manipulable |
| military | Soldier |
| officer | Police Officer |
| other country | Other Country |
| party | political affiliation |
| placebo | participants in a control group |
| political | political affiliation |
| prisoners | Criminal Convictions |
| restricted | Incarcerated |
| single | Marital Status |
| student | Student |
| substance | Drug Usage |
| undue influence | Undue Influence |
| union | Trade Union Membership |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| armedXforces | ['military'] |
| education | ['educational'] |
| educational | ['education'] |
| foreign country | ['otherXcountry'] |
| military | ['armedXforces'] |
| other country | ['foreignXcountry'] |
| party | ['political'] |
| political | ['party'] |
Trigger Words
coercion
consent
cultural
harm
justice
protect
protection
risk
sensitive
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input