Other Federal Agency Requirements

Researchers must obtain HRPO administrative approval BEFORE the activities that involve human subjects can begin. This includes the following:

• After Initial IRB approval;
• When significant changes to the research protocol are approved by the IRB; or
• When the continuing review has been approved by the IRB.

Protocol Directors must submit a copy of the Stanford IRB Approval letter, all documents submitted to the IRB for review, and the eProtocol Modification or Continuing Review form as appropriate to the appropriate DoD HRPO.

Per DoD Instruction 3216.02, Protocol Directors from non-DoD institutions (e.g., Stanford, etc.) must submit institutional documentation of the determination that the research is either not HSR, exempt HSR, or limited IRB review to the HRPO, including all protocol documents.

Research that fits into exempt categories are exempt from the requirements of 32 CFR Part 219 (e.g., CLAR approval, scientific review, etc.), except that such activities must comply with the requirements of section 219.104 and as specified in each exempt category.

• The informed consent must include a statement that the DoD is providing funding for the study.
• The informed consent must include a statement in the Confidentiality section that representatives of the DoD are authorized to review research records.
• For greater than minimal risk research, consent documents include the disclosure that participants may, for the duration of the study, be eligible for health care services for research-related injuries at a military treatment facility, and this eligibility for health care services extends beyond participants’ participation in the study to such time after the study has ended.
• For greater than minimal risk research, consent documents include how organizations will care for participants with research-related injuries, including injuries that are the direct result of activities performed by DoD-affiliated personnel in studies that are collaborative with a non-DoD institution.
• DoD is listed as an entity in the Who May Receive or Use PHI section of the HIPAA Authorization.
• If a Research Monitor is used, they are listed as an entity in the Who May Receive or Use PHI section of the HIPAA Authorization.

Service members and DoD-affiliated personnel are considered to be vulnerable to coercion and undue influence by the DoD due to the nature of the command structure of the organization. Therefore, additional protections for DoD-affiliated personnel are required when Stanford conducts research on DoD-affiliated personnel and the IRB, and VA R&D as applicable, must approve their participation. DoD Directive 3216.02, 3.9 (f)) 

U.S. military personnel - minimizing undue influence: Military and civilian supervisors, officers, supervisors, senior noncommissioned officers (NCOs), and others in the chain of command shall not influence the decisions of their subordinates to participate and shall not be present at the time of research recruitment sessions and consent involving members of units under their command. Excluded supervisors or those in the chain of command may participate in separate recruitment sessions, if applicable.

• If the research involves DoD-affiliated personnel as participants, in addition to the basic and required consent disclosures, consent documents must include:
  • If the research involves risks to their fitness for duty (e.g., health, availability to perform job, data breach), the informed consent document (ICD) must inform DoD-affiliated personnel about these risks and that they should seek command or Component guidance before participating.
  • If applicable, a statement of potential risks for the revocation of clearance, credentials, or other privileged access or duty. o A statement that the DoD or a DoD organization is funding the study.
  • A statement that representatives of the DoD are authorized to review research records.
  • For greater than minimal risk research, consent documents must include the disclosure that participants may, for the duration of the study, be eligible for health care services for research-related injuries at a military treatment facility, and this eligibility for health care services extends beyond participants’ participation in the study to such time after the study has ended, including injuries that are the direct result of activities performed by DoD-affiliated personnel in studies that are collaborative with a non-DoD institution. The PD describes the care in the IRB protocol for the IRB to review.
• If the research involves DoD-affiliated personnel, the key investigator must receive command or Component approval to execute the research.
• Service members and all Reserve component and National Guard members in a federal duty status are considered to be adults. If a Service member, Reserve component or National Guard member in federal duty status, student at a Service Academy, or trainee is under 18 years of age, the IRB must carefully consider the HSR recruitment process and the necessity of including such member as a human participant.
• For greater than minimal risk research involving DoD-personnel, when recruitment and consent occurs in a group setting, the IRB must appoint an ombudsperson. The ombudsperson:
  • Must not have a conflict of interest with the research or be a part of the research team.
  • Must be present during the HSR recruitment, monitoring that the recruitment and informed consent explain that participation is voluntary, and that the information provided about the research is consistent with the IRB-approved script and materials, including digitally provided materials.
  • Should be available to address DoD-affiliated personnel’s concerns about participation.
• In order to approve research involving DoD-affiliated personnel, the IRB must determine the consent documentation includes, if applicable, potential risks for revocation of clearance, credentials, or other privileged access or duty.
• Civilian investigators attempting to access military volunteers should seek collaboration with a military investigator familiar with service-specific requirements.

DoD Directive 3216.02, 7.e.(1)(b), (d), (2)(d) SECNAVINST 3900.39E, para. 6a(6) [AAHRPP elements I.2, II.2.E, II.2.F., II.3.C, II.3. E., II.4.A]

DoD component-level administrative review (CLAR) must be conducted when: 

(i) Human participants research is conducted in a foreign country, unless conducted by a DoD overseas institution, or only involves DoD-affiliated personnel who are US citizens.

(ii) The research requires a waiver of informed consent pursuant to 10 USC 980, Subsection (b).

(iii) The research is fetal research, as described in 42 USC 289g-2.

(iv) Large scale genomic data (LSGD) is collected from DoD-affiliated personnel. LSDG includes data derived from genome- wide association studies; single nucleotide polymorphisms arrays; genome sequencing; transcriptomic, metagenomic, epigenomic analyses; and gene expression data; etc. DoD Directive 3216.02, G.2 Definitions

(v) The research constitutes classified research involving human participants DoD Directive 3216.02, 3.13

(vi) The research is required to be approved by the DOHRP (in addition to the COHRP) in accordance with DoD Directive 3216.02.

Component review includes review of reliance agreements. DoD Directive 3216.02, 3.6 [AAHRPP element I.2.]. The Protocol Director contacts the DoD Component Level Administrative Review (CLAR) office to secure approval from DoD and attach to their protocol before Stanford IRB approval is issued.

Research involving large-scale genomic data from DoD-affiliated personnel is subject to additional requirements DoD Directive 3216.02, 3.10:

(i) The disclosure of DoD-affiliated personnel’s genomic data may pose a risk to national security; accordingly, written materials must describe administrative, technical, and physical safeguards commensurate with risk, including the secondary use or sharing of de-identified data or specimens.

(ii) All research involving large-scale genomic data collected from DoD-affiliated personnel must have a certificate of confidentiality from DHHS (Title 42, U.S.C., and Public Law 114-255). [AAHRPP element II.3.E.]

(iii) Research involving large-scale genomic data collected from DoD-affiliated personnel is subject to DoD component security review to ensure the adequacy of the proposed administrative, technical, and physical safeguards, including the secondary use or sharing of de-identified data or specimens. [AAHRPP element II.4.A.]

The phrase “ordinarily encountered in daily life or during the performance of routine physical or physiological examinations or tests” in the definition of minimal risk shall not be interpreted to include the inherent risks certain categories of human subjects face in their everyday life, such as those:

(i) Encountered by Service members, law enforcement, or first responders while on duty.

(ii) Resulting from or associated with high-risk behaviors or pursuits

(iii) Experienced by individuals whose medical conditions involve frequent tests or constant pain.

DoD Directive 3216.02, 6.b. [AAHRPP element II.3.A.]

Additional safeguards shall be provided for participants who may be considered vulnerable to coercion or undue influence because of their age, health, employment, financial status, or other circumstances. DoD Directive 3216.02, 7

Other groups warranting additional protection include severely ill patients, those in employer-employee, student-teacher, or supervisor-subordinate relationships, or deployed active duty personnel. Research involving pregnant women, prisoners, and children are subject to the DHHS Subparts B, C, and D, except where modified by DoDI 3216.02. DoD Directive 3216.02, 3.9 [AAHRPP element II.4.A.]

Research involving pregnant women, and children are subject to the DHHS Subparts Band D except where modified by DoD Directive 3216.02:

• The applicability of Subpart B is limited to research involving pregnant women as participants in research that is more than minimal risk and included interventions or invasive procedures to the woman or the fetus or involving fetuses or neonates as participants.
• For human participant research that would not otherwise be approved but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates, written approval from the DOHRP must be obtained through the COHPR prior to research starting.
• DHHS 45 CFR 46 Subpart B applies, replacing the phrase “biomedical knowledge” with “generalizable knowledge” in 46.204 and 46.205 (i.e., conditions that must be met in order to involve pregnant women and neonates in research, respectively).
• Fetal research must comply with the US Code Title 42, Chapter 6A, Subchapter III, Part H, 289g:

(A) Research or experimentation may not be conducted, in the United States or in any other country, on a nonviable living human fetus ex utero or a living human fetus ex utero for whom viability has not been ascertained unless the research or experimentation: (1) May enhance the well-being or meet the health needs of the fetus or enhance the probability of its survival to viability; or (2) Will pose no added risk of suffering, injury, or death to the fetus and the purpose of the research or experimentation is the development of important biomedical knowledge which cannot be obtained by other means.

(B) The risk standard must be the same for fetuses which are intended to be aborted and fetuses which are intended to be carried to term. DoD Directive 3216.02, 7.a. 10 USC 980 [AAHRPP elements II.2.E., II.4.A]

DHHS 45 CFR 46 Subpart C applies, but note that all prisoner research must be reviewed and approved at a convened IRB meeting, including research which meets the criteria for exemption.

• In addition to activities permissible under Subpart C, two additional categories are permissible:
  • Epidemiological research is permitted under the following conditions:
    • Where the sole purpose of the research is to describe the prevalence or incidence of a disease by identifying all cases, or study potential risk factor associations for a disease.
    • The research presents no more than minimal risk.
    • The research involves no more than inconvenience to the prisoner-participants.
    • Prisoners are not a particular focus of the research.
  • Human participant research involving prisoners that would otherwise meet exemption criteria may be conducted but must first be approved by an IRB and meet the requirements of Subpart C and DoD Directive 3216.02.
• DoD organizations conducting research involving prisoners must demonstrate to the senior designated official that the IRB has fulfilled its duties in accordance with Subpart C.
• When a previously enrolled human participant becomes a prisoner, and the protocol has not been reviewed and approved by the IRB in accordance with Subpart C, the key investigator must promptly notify the IRB.
  • For DoD-supported research, the non-DoD organization must notify the DoD HRPO, COHRP, and other federal agencies.
  • The DOHRP must concur with the IRB before the participant can continue to participate while a prisoner.
• Research involving a detainee or a prisoner of war as a human participant is prohibited.
  • This prohibition does not apply to activities covered by investigational new drug or investigational device provisions of FDA regulations, when the purpose is for diagnosis or treatment of a medical condition in a patient.
    • Such treatment may be offered to detainees or prisoners of war with their informed consent when the medical products are subject to FDA regulations, and only when the same product may be available to DoD-affiliated personnel consistent with established medical practices. DoD Directive 3216.02, 7.b. [AAHRPP element II.4.A.]

1. The following must be promptly reported (no longer than within 30 days) to the Human Research Protection Official (HRPO) of the funding agency:

Investigator makes report-

• When significant changes to the research protocol are approved by the IRB (significant changes, in this context, include changes to investigators or institutions, decreased benefit or increased risk to participants in greater than minimal risk research, addition of vulnerable populations as participants, or addition of DoD-affiliated personnel as participants);
• Change of reviewing IRB;
• The results of the IRB’s continuing review, if required;
• Change in status when a previously enrolled participant becomes pregnant, or when the investigator learns that a previously enrolled participant is pregnant and the protocol was not reviewed and approved by the IRB in accordance with 45 CFR 46, Subpart B;
• Closure of a DoD-supported study.

Institution/IRB makes report-

• Any Unanticipated Problems (UPs), suspensions, terminations, and serious or continuing noncompliance regarding DoD-supported research involving human Any problems involving risks to participants or others, suspension, or termination of IRB approval, or any serious or continuing noncompliance pertaining to DoD-supported human participant research;
• Change in status when a previously enrolled participant becomes a prisoner, and the protocol was not reviewed and approved by the IRB in accordance with 32 CFR 219, Subpart C;

• When Stanford is notified by any federal body, state agency, official governing body of a Native American or Alaskan native tribe, other entity, or foreign government that any part of the HRPP is under investigation for cause involving a DoD-supported research protocol.

   

2. The following must be promptly reported (within 30 days) to the Component Office of Human Research Protections (COHRP):

Institution/IRB makes report-

• Reports of audits of DoD-conducted or DoD-supported human participant research by another federal or state agency, official governing body of a Native American or Alaskan native tribe, other official entity, or foreign government, within five business days of discovering that such audit reports exist;
• Unanticipated problems involving risks to participants or others and any subsequent actions taken based on the findings, within five days of completion of the report;
• Allegations of serious or continuing noncompliance related to research involving human participants that are substantiated by investigation, and subsequent actions taken based on the findings, within five business days of completion of the report;
• Suspensions or terminations of IRB approval, within five days of the IRB action; and
• Substantiated allegations related to classified HSR must be reported immediately.

DoD Directive 3216.02, 3.6. [AAHRPP elements I.5.D., II.2.E., II.2.G, II.2.H.]

For research involving a human being as an experimental subject*, waivers of the consent process are prohibited unless granted by Assistant Secretary of Defense for Research and Engineering (or for DON, the Secretary of the Navy).

• If the research involves a human being as an experimental subject and is supported by DoD- appropriated funds, informed consent must be obtained from the participant in advance, in accordance with 10 USC 980. If the participant is unable to provide informed consent and consent will be obtained in advance from the participant’s legal representative, the research must be intended to benefit the individual participants.
• An IRB may waive or alter some elements of informed consent for research involving human beings as experimental subjects, as long as it preserves the informed consent of the participant or the participant’s legal representative (i.e., the consent indicates that participation in the research is voluntary, and the participant/representative is informed of research risks).
• Waivers of consent are prohibited for DoD classified research (Section 2.10 of Executive Order 12333).
• The DOHRP may waive the requirements for prospective consent for research involving human beings as experimental subjects when all of the following are met:
  • The research is necessary to advance the development of a medical product for the Military Services;
  • The research may directly benefit the individual experimental subject; and
  • The research is conducted in compliance with all other applicable laws and regulations. [AAHRPP element I.2, II.3.G., II.4.C.]
• Research under an IND or Emergency Use Authorization in a Force Health Protection Program requires the approval of the Assistant Secretary of Defense for Health Affairs. “Force Health Protection” Program is an organized program of healthcare preventive or therapeutic treatment, or preparations for such treatment, designed to meet the needs of a group of military personnel in relation to military missions.

*Research Involving a Human Being as an Experimental Subject (subset of research involving human subjects) is defined as an activity, for research purposes, where there is an intervention or interaction with a living human being for the primary purpose of obtaining data regarding the effect of the intervention or interaction (32 CFR 219.102(f)). Research involving “experimental subjects” is a subset of research involving human participants. Stanford conducts research involving experimental subjects. DoD Directive 3216.02, 9.b. SC 980 SECNAVINST 3900.39E, para. 6a(3) and 7a(l) [AAHRPP element I.1.A., II.3.F., II.3.G., II.4.B.]

Stanford does not review for DoD Institutions. DoD institutions collaborating with non-DoD institutions may rely on a collaborating non-DoD institution’s IRB if the following conditions are met DoD Directive 3216.02, 3.5:

(i) Each institution engaged in non-exempt human participant research must have a current federal assurance of compliance.

(ii) The non-DoD institution’s IRB is registered in accordance with Subpart E of 45 CFR 46.

(iii) The DoD institution reviews the protocol to ensure all applicable local and DoD requirements are addressed in the protocol.

(iv) The DoD institution, non-DoD institution, and the non-DoD institution’s IRB have a written agreement defining the responsibilities and authorities of each institution in complying with all legal requirements. This agreement must specify that the non-DoD IRB will apply the DoD requirements specified in DoD Directive 3216.02, including but not limited to non-DoD institutional responsibilities defined under DoD Directive 3216.02, 3.6(b).

DoD organizations must demonstrate to the senior designated official that the IRB has fulfilled its duties in accordance with DHHS Subpart D, 45 CFR 46. 407 and 21 CFR 50.54. If conducting multi-site research, a formal agreement between organizations is required to specify the roles and responsibilities of each party. [AAHRPP element I.9., II.3.F]

US Army and USAMRMC-supported studies: Additional Requirements

Other DoD Requirements that are Congruent with Current HRPP Policies

• Requires inspection of instructional materials by parents or guardians;
• Limits on survey, analysis, or evaluations;
• Local policies concerning student privacy, parental access to information, and administration of certain physical examinations to minors.

20 U.S.C. Ch.31, Subchapter III, Part 4, § 1232h especially (a),(b),(c)(1) (as was amended by PUBLIC LAW 107–110—JAN. 8, 2002, 115 STAT. 2083) [AAHRPP element II.4.B.]

Other Department of Education Requirements that are Congruent with Current HRPP Policies

Consent documents must include additional DOE element of disclosure:

The identity of the sponsoring agency, unless the sponsor requests that it not be done, because doing so could compromise intelligence sources or methods; the research involves no more than minimal risk to participants; and the IRB determines that by not disclosing the identity, the investigators will not adversely affect the participants. [AAHRPP element II.3.F.]

Researchers submit a checklist for IRBs to use in verifying that HS research protocols comply with DOE requirements, including those for protection of Personally Identifiable Information

• DOE Checklist to Verify Compliance with DOE Requirements

[AAHRPP elements II.3.E., III.2.C.]

Researchers must report the following to the DOE Human Subjects Protection Program Manager (or as appropriate, the National Nuclear Security Administration (NNSA) HSP Program Manager):

Promptly (within 48 hours):

• Any significant adverse events, unanticipated risks; and complaints about the research, with a description of any corrective actions taken or to be taken;
• Any suspension or termination of IRB approval of research;
• Any significant non-compliance with HRPP procedures or other requirements.

Immediately (as soon as the breach is discovered):

• Any finding of a suspected or confirmed data breach involving personally identifiable information in printed or electronic form.
• Provide a description of corrective actions to be taken within 48 hours for concurrence by the appropriate HSP Program Manager.
• Report to the DOE-Cyber Incident Response Capability.

DOE 443.1C [Attachment 1: Contractor Requirements Document: Protection of Human Research Subjects] [AAHRPP elements I.5.D., II.2.H III.2.D.]

The HRP Program Manager at DOE or NNSA must be notified:

(i) Immediately upon learning of a serious adverse event. The HSP Program Manager(s) shall also be informed of any corrective actions taken and consulted regarding the plan for any remaining corrective actions.

(ii) Within 48 hours, with a description of corrective actions taken, of:

• Unanticipated problems
• Significant adverse events, and
• Complaints about the research.

[AAHRPP element II.2.H.]

The Human Subjects Protection (HSP) Program Manager (and when an NNSA element is involved, the NNSA HSP Program Manager) must be notified in writing prior to initiation of the HSR portion of a new project, even if it meets the regulatory definition of exempt HSR as outlined in 10 CFR Part 745.104, that involves (DOE 0 443.1C, section 4(d)):

(i) An institution without an established IRB.

(ii) A foreign country.

(iii) A potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight groups).

(iv) Research subjects in a protected class (prisoners, children, individuals with impaired decision making, or DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to coercion and undue influence to participate) that is outside of the reviewing IRB’s typical range/scope.

(v) The generation or use of classified information.

• The HSP Program Manager at DOE or NNSA must be notified within 48 hours, with a description of corrective actions taken, of any known or potential incidents of noncompliance.
• The HSP Program Manager at DOE or NNSA must be notified within 48 hours, with a description of corrective actions taken, of:

(i) Suspensions of IRB approval

(ii) Terminations of IRB approval

• Researchers must report the following within 48 hours to the HSP Program Manager:

(i) Any significant adverse events, unanticipated problems, and complaints about the research, with a description of any corrective actions taken or to be taken.

(ii) Any suspension or termination of IRB approval of research.

(iii) Any significant noncompliance with HRPP procedures or other requirements.

• Researchers must report the following immediately to the HSP Program Manager:

(i) Any suspected or confirmed compromise of personally identifiable information, with a description of any corrective actions taken or to be taken. The incident must also be immediately reported to the DOE-Cyber Incident Response Capability.

(ii) Any serious adverse event, with a description of any corrective actions taken or to be taken.

[AAHRPP element I.1.B., I.5.D., II.2.H]

Research involving human participants involving multiple DOE sites (e.g., members of the research team from more than one DOE site and/or data or human subjects from more than one DOE site) must be reviewed and approved by one of the Central DOE IRBs prior to initiation, unless review by another appropriate IRB of record is authorized by the DOE and/or NNSA HSP Program Manager.

If authorized by the DOE and/or NNSA HSP Program Manager, research may be reviewed by other appropriate IRB of record. In all cases, an IRB Authorization Agreement (IAA) or Memorandum of Understanding (MOU) must be in place between the organization(s) conducting the HSR and the organization responsible for IRB review. [AAHRPP element I.9.]

(a) Personally identifiable information collected and/or used during human participant research projects must be protected in accordance with the requirements of DOE Order 206.1, Department of Energy Privacy Program.

(b) Any breach involving Personally Identifiable Information must be reported: (i) Immediately upon a finding of a suspected or confirmed data breach involving Personally Identifiable Information (PII) in printed or electronic form, the incident must be reported to the DOE- Cyber Incident Response Capability in accordance with the requirements of DOE O 206.1; (ii) Within 48 hours the DOE or NNSA HSP Program Manager must also be notified of any corrective actions taken and consulted regarding the plan for any remaining corrective actions. [AAHRPP element II.3.D.]

(a) DOE site employees are considered vulnerable subjects when participating in research and additional care must be taken to ensure their participation is truly voluntary (e.g., by ensuring they do not report to members of the research team) and that data collected about them is kept confidential.

(b) Policies must include direction for the IRB to consider if additional protections are required for research involving employees and contractors. [AAHRPP element II.4.A.]

For research conducted within the Bureau of Prisons, Stanford, the IRB, and investigators and research staff must follow the requirements of 28 CFR 512, including:

• The project must not involve medical experimentation, cosmetic research, or pharmaceutical testing;
• The research design must be compatible with both the operation of prison facilities and protection of human participants. The investigator must observe the rules of the institution or office in which the research is conducted;
• Any investigator who is a non-employee of the Bureau must sign a statement in which the investigator agrees to adhere to the provisions of 28 CFR 512; and
• All research proposals will be reviewed by the Bureau Research Review Board.

The researcher, in addition to presenting the statement of informed consent to the subject, shall obtain the subject's signature on the statement of informed consent prior to initiating the research activity. The researcher may not be required to obtain the signature if the researcher can demonstrate that the only link to the subject's identity is the signed statement of informed consent or that there is significantly more risk to the subject if the statement is signed. The signed statement shall be submitted to the chairperson of the appropriate local research review board.

Required elements for the written consent document include:

• A statement that participation is completely voluntary and that the participant may withdraw consent and end participation in the project at any time without penalty or prejudice (the inmate will be returned to regular assignment or activity by staff as soon as practicable);
• Anticipated uses of the results of the research;
• A researcher may not guarantee confidentiality when the subject indicates an intent to commit future criminal conduct or harm himself/herself or someone else, or, if the subject is an inmate, indicates an intent to leave the facility without authorization.
• A statement that participation in the research project will have no effect on the inmate participant's release date or parole eligibility.

• EPA prohibits research involving the intentional exposure of pregnant women, nursing women, or children to any substance.
• EPA requires application of 40 CFR 26 Subparts C and D to provide additional protections to pregnant women and children as participants in observational research, i.e., research that does not involve intentional exposure to any substance.

Before the research can begin, IRB determinations and approval must be submitted to the EPA Human Subjects Research Review official for final review and approval. For research not conducted or supported by any federal agency that has regulations for protecting human research participants and for which the intention of the research is submission to the EPA, the EPA regulations protecting human research participants apply, including:

• The provisions of 40 CFR 26 are extended to human research involving the intentional exposure of non-pregnant, non-nursing adults to any substance,
• The intentional exposure of pregnant women, nursing women, or children to any substance is prohibited.

40 CFR 26, 40 CFR 26.201-203, 40 CFR 26.304, 404-405; 40 CFR 26.1101-1125 (Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-pregnant, Non-nursing Adults); 40 CFR 26.1201-1203 (Subpart L—Prohibition of Third-Party Research for Pesticides Involving Intentional Exposure of Human Subjects who are Children or Pregnant or Nursing Women) [AAHRPP element I.1.D.]

Such research is allowable if:

• The intervention or procedure holds out the prospect of direct benefit to the individual participant or is likely to contribute to the participant's well-being.
• The risk is justified by the anticipated benefit to the participants.
• The relation of the anticipated benefit to the risk is at least as favorable to the participants as that presented by available alternative approaches.
• Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in §26.406. 40 CFR 26.304, 40 CFR 26.404-405

40 CFR 26, 40 CFR 26.201-203 (Subpart B—Prohibition of Research Conducted or Supported by EPA Involving Intentional Exposure of Human Subjects who are Children or Pregnant or Nursing Women); 40 CFR 26.304 (Additional protections for pregnant women and fetuses involved in observational research) [AAHRPP element II.4.A.]

• Department of Defense (DoD) 32 CFR 219; DoD Directive 3216.02; 10 USC 980
• Department of the Navy (DON) SECNAVINST 3900.39E
• Department of the Army (DA) AR 40-7; AR 40-38; AR 70-25
• Department of the Air Force (DoAF) Air Force Instruction 40-402
• Department of Education (ED) 34 CFR 99 [FERPA];34 CFR 98
• Department of Energy (DOE) DOE 443.1C
• Department of Justice (DOJ) 28 CFR 22; 28 CFR 512; NIJ Confidentiality & Privacy Protections
• Environmental Protection Agency (EPA) 40 CFR 26
• National Science Foundation (NSF) 45 CFR 690

• CHK-42DOD Checklist for Departments of Defense (DoD)
• CHK-42ED Checklist for Department of Education (ED)
• CHK-42DOE Checklist for Department of Energy (DOE)
  • Supplement to eProtocol application for DOE: APP-14 DOE Requirements for the Protection of Personally Identifiable Information (PII)
• CHK-42DOJ Checklist for Department of Justice (DOJ)
• CHK-42EPA Checklist for Environmental Protection Agency (EPA