Select Federal Agency Requirements Summary

The IRB must consider the review by the investigator’s department relative to the scientific merit of the research. 

• Ensure scientific review discussions are documented in IRB review materials or minutes. 

Research involving classified information must be reviewed by the full convened IRB; requires descriptions and clarifications to be included in the informed consent process (waiver is prohibited); and must be approved by the Secretary of Defense, prior to initiation.

If a DoD-supported study involves survey research or surveys of DoD personnel, an additional level of DoD review is typically required.

Dual compensation rules limit subject payment. Options vary depending on participation on or off active duty and the source of funds for payment. 

• Ensure that the investigator is aware of compensation policies as applied to proposed research if subject payment is involved. 

For DoD-supported research involving more than minimal risk, subjects are provided with an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs, and, if so, what they consist of, or where further information may be obtained. Additional requirements may apply to collaborative research where the DoD component is engaged in the conduct of the research. Additional injury payment rules apply to research conducted by DoD, not research supported by DoD.

Research involving international citizen populations should adhere to any local applicable laws, regulations, customs, and required local ethics review.  Consult the current edition of the International Compilation of Human Research Standards for reference. 

• Ensure the researcher has permission to conduct research in the country by certification or local ethics review. 

Ensure knowledge of the local context is met by a standing or ad hoc IRB member or cultural consultant.

If the study is a clinical investigation including Armed Services personnel, women and minorities must be included as subjects. 

Research with DoD personnel (military or civilian DoD employees) must include a recruitment plan that incorporates safeguards to ensure no undue influence from superiors in the chain of command (i.e., superiors may not be present at the time of recruitment and must be provided a separate opportunity to consider participation themselves).

If research includes military personnel, the HRPO may require PIs to obtain permission from local command to allow the subject’s participation during or off duty, particularly if research could impact the Service members’ ability to perform his/her military duties.

If recruitment for a greater than minimal risk study occurs in a group setting (e.g., involving a percentage of a unit), an IRB-appointed ombudsperson must observe the recruitment and informed consent process to ensure voluntariness and be available to address concerns about participation. The ombudsperson cannot have a conflict of interest with the research or be part of the research team. This is required for military (not civilian), DoD personnel, but the IRB may require use of this safeguard for civilian DoD employees when appropriate. 

The following additional requirements apply only to the sub-category of human research entitled, Research involving Humans as Experimental Subjects. This is a category of research conducted for the purpose of obtaining data regarding the effect of an intervention or interaction. 

• For Research involving Humans as Experimental Subjects, ensure that:  
  • Informed consent is obtained;
  • Waiver of informed consent is never granted (unless prohibition waived by Secretary of Defense based on specific criteria); and
  • The research intends and has the potential to benefit the subjects in studies where consent could be obtained from a subject’s legally authorized representative.

As planned emergency research meets the above definition of research involving humans as experimental subjects, a waiver of informed consent is prohibited unless DoD has issued a waiver.

The DoD has adopted 45 CFR 46 Subpart B (pregnant women, fetuses, and neonates), C (prisoners), and D (children) with limitations and modifications. 

Subpart B: 

• For the purposes of applying Subpart B risk-benefit analysis, DoD replaces the phrase “biomedical knowledge” with “generalizable knowledge”.
• The DoD limits the applicability of Subpart B to research involving:
  •  pregnant women as participants in research that is more than minimal risk and includes interventions or invasive procedures to the woman or the fetus; or
  • fetuses or neonates as participants.
• Fetal research must comply with the US Code Title 42, Chapter 6A, Subchapter III, Part H, 289g. 

Subpart C: 

• For research intended to enroll prisoners, the DoD does not allow review by an expedited mechanism. When the IRB reviews research involving prisoners, at least one prisoner representative is present.
  • Epidemiological research is also allowable when: the research describes the prevalence or incidence of a disease by identifying all cases or studies' potential risk factor association for a disease; the research presents no more than minimal risk; and the research presents no more than an inconvenience to the participant.
  • If a PI attests that it is in the best interest of a subject who becomes a prisoner to continue participation in the research, the DoD allows the IRB chair to make a preliminary determination until the convened IRB (and DoD Component if applicable) can review the request. Otherwise, the IRB may require that all research interactions and interventions with the prisoner-subject (including obtaining identifiable private information) cease until the convened IRB, with consultation from the prisoner representative, can review this request to ensure that the rights and well-being of the human subject, now a prisoner, are not in jeopardy.
  • If the prisoner-participant can continue to consent to participate and is capable of meeting the research protocol requirements, the terms of the prisoner-participant’s confinement does not inhibit the ethical conduct of the research, and there are no other significant issues preventing the research involving human participants from continuing as approved, the convened IRB may approve a change in the study to allow this prisoner-participant to continue.

Subpart D: 

• The DoD does not apply subpart D to active duty personnel under the age of 18, as it considers all active duty military to be adults with legal capacity to participate in DoD-supported research. 

Should the DoD protocol include or have the potential to enroll any vulnerable population protected under the Common Rule subparts, refer to the DoD Instruction 3216.02 and/or the supporting Component for specific determinations required on the part of the IRB.

Determinations authorizing or requiring any action by an official of HHS about any requirements of subparts B-D would be submitted to and authorized by the Assistant Secretary of Defense for Research and Engineering ASD(R&E).

Research with detainees (or prisoners of war) is prohibited. Prohibition of detainee participation may not apply to specific research involving investigational drugs and devices when the same products would be offered to US military personnel in the same location for the same condition. 

Standard requirements apply to multi-site or collaborative research supported by the DoD. 

Ensure that investigators conducting DoD-sponsored multi-site research have provided the IRB with information on the federal assurance(s) held by collaborating institutions, including the existence of any DoD Addendum or other direct DoD assurance.

1. DoD Components may have additional requirements beyond those outlined in the OHRP FWA.   The Component will communicate the unique requirements by providing the investigator with an early communication applicable to the proposed research (common Army practice) or by requiring an FWA Addendum, which conveys the unique requirements (common Navy and Air Force practice).  Once a DoD Addendum is in place, it covers all DoD research sponsored or initiated by that Component.
   • Ensure the investigator has provided the IRB with any specific, unique requirements outlined in DoD Component communication or FWA addendum.
   • Potential additional Component requirements may include:
     • Requirement for an FWA Addendum
     • Specific educational or certification requirements
     • Documentation submission (e.g., meeting minutes for all meetings in which research is reviewed; continuation review approval or materials)
     • Reporting or record retention requirements
     • Additional levels of review
2. The investigator submits documentation of IRB review and approval to the DoD Component. The HRPO provides an administrative review to confirm the protocol is compliant with Federal and DoD requirements and to concur with UK IRB’s determinations (i.e., activity not HSP research; research is exempt; level of risk; protocol approval).
   • Investigator should not initiate the study until approved by HRPO or the relevant Component designee.
3. Standard reporting and recordkeeping procedures apply unless additional requirements are made by the supporting DoD Component.  Any determinations of serious or continuing non-compliance of DoD-supported research must be promptly (no longer than within 30 days) reported to the DoD HRPO. 

• DoD Office for Human Research Protections Email
• Army Human Research Protections Office (AHRPO): includes National Guard and Army Reserve, and will assist with determining the applicability of DoD requirements.
  • Phone: 703-681-5702
  • Email
• Compliance Office of the Vice President for Research, Uniformed Services, University of the Health Sciences Email
• Department of the Air Force Component Office of Human Research Protections

• FERPA (34 CFR 99) is a federal law that protects the privacy of personally identifiable information contained within a student’s educational record at K-12 and postsecondary institutions.
• The University of Kentucky Office of the Registrar FERPA website outlines what information is designated as “directory” information at UK and what information may be released in general without a student’s consent.  Each institution designates what information is considered directory information.
• UK IRB FERPA guidance outlines conditions under which student records can be disclosed without consent for research purposes, as well as guidance for researchers on accessing educational records.
• ORI forwards any protocols that include requests to access information without consent to UK’s legal counsel.  Legal counsel will make the final determination if the study meets the FERPA criteria to release personally identifiable educational information without a signed consent form.  Legal counsel develops appropriate agreements as required by 34 CFR 99.31*. 
  
  *Elements of Written Agreement: (1) Specifies the purpose, scope, and duration of the study or studies and the information to be disclosed; (2) Requires the organization to use personally identifiable information from education records only to meet the purpose or purposes of the study as stated in the written agreement;(3) Requires the organization to conduct the study in a manner that does not permit personal identification of parents and students, as defined in this part, by anyone other than representatives of the organization with legitimate interests; and (4) Requires the organization to destroy all personally identifiable information when the information is no longer needed for the purposes for which the study was conducted and specifies the time period in which the information must be destroyed.

• PPRA (34 CFR 98) is a federal law that affords certain rights to parents of minor students about surveys that ask questions of a personal nature.  It outlines requirements that apply to “protected information” surveys that are funded in whole or in part by the DoED and to surveys that are funded by sources other than the DoED that are administered by or in institutions that receive DoED support.
• Access to instructional material used in a research or experimentation program: All instructional material--including teachers' manuals, films, tapes, or other supplementary instructional material--which will be used in connection with any research or experimentation program or project must be available for inspection by the parents or guardians of the children engaged in such research. Research or experimentation program or project means any program or project in any research that is designed to explore or develop new or unproven teaching methods or techniques. Children are persons enrolled in research not above the elementary or secondary education level, who have not reached the age of majority as determined under state law.
• See the UK IRB PPRA guidance for a list of protected information for survey responses and practical implications in applying IRB-informed consent waiver requirements about the rights and welfare of minor students.

The Principal Investigator (PI) and IRB may refer to the DOE Directive O 443/1C for interpretation of what meets the definition of human subject research relative to DOE-sponsored research. In 2013, the DOE issued a memorandum defining when activities that intentionally modify or manipulate human-occupied environments require IRB review. This memo applies to the following studies:

Human Environments

Generalizable* studies in human environments (e.g., occupied homes and offices, classrooms, and transit centers like subway systems and airports) that use tracer chemicals, particles, and/or other materials, such as perfluorocarbons, to characterize airflow.

Occupied Homes and/or Offices

Generalizable* studies in occupied homes and/or offices that:

• Manipulate the environment to achieve research aims, e.g., increasing humidity and/or reducing influx of outside air through new energy-saving ventilation systems.
• Test new materials (e.g., sequentially changing the filter materials in the HVAC system while monitoring the effects on air quality and energy use).
• Involve collecting information on occupants’ views of appliances, materials, or devices installed in their homes or their energy-saving behaviors through surveys and focus groups. Some surveys may be online surveys administered through providers such as Amazon Mechanical Turk and Survey Monkey.

*Generalizable should be viewed in terms of contribution to knowledge within the field of study.

• For DOE-supported research utilizing or collecting personally identifiable information (PII) or protected health information (PHI), the investigator completes the Investigator Checklist for Verification of Compliance with the Department of Energy (DOE) Requirements for the Protection of PII/PHI. The investigator signs the checklist to indicate understanding and intent to comply with the technical requirements. In general, the IRB uses the information to verify that the investigator has a clear and detailed plan for:
  • protecting PII/PHI , including reasonable safeguards to prevent unauthorized use or disclosure;
  • immediate notification of any incident involving potential compromise or loss of PII data;
  • making no further use or disclosure except when approved by the IRB and DOE; and
  • encryption of any data to be transferred.    
• PII/PHI transferred from one organization to another as part of a human research project (when/as authorized by the approving IRBs, the responsible DOE Program Office, and the research/screening participant) must first be encrypted consistent with PII protection requirements stated in DOE M 205.1-7 using a program as directed by DOE.
• For assistance in complying with technical requirements, the PI may consult departmental Information Technology (IT) personnel or University of Kentucky IT Security personnel.

• The DOE reporting requirements are more stringent than the University of Kentucky (UK) requirements relative to reporting timelines. In addition to reporting to the UK IRB (using UK reporting forms), the investigator notifies the DOE as follows.
• The notification period for reporting unanticipated problems for loss or compromise of data differs, depending on whether PII/PHI is involved.
• The DOE requires prompt reporting (within 48 hours), and coordination with, and approval from, the HSR Program Manager in determining plans to correct any noncompliance or to deal with unanticipated problems.

The investigator notifies the DOE HSP Program Manager immediately (upon discovery) of a suspected or confirmed data breach involving PII or PHI in printed or electronic form and reports to the DOE-Cyber Incident Response Capability in accordance with the requirements of DOE O 206.1. 

The investigator informs the DOE HSP Program Manager regarding any corrective actions planned or taken. 

The investigator notifies the DOE HSP Program Manager in writing within 48 hours, with a description of corrective actions taken, and shall concur on the plan for any remaining corrective actions, following: 

1. significant adverse events, unanticipated problems, and complaints about the research, suspension or termination of IRB approval of research;
   1. known or potential incidents of noncompliance with requirements of this Order, 10 CFR Part 745, 45 CFR Part 46.

The PI is also responsible for implementing any IRB or DOE-required corrective action.

• When conducting classified research, the use of exempt and expedited review is prohibited. The Fact that research meets a particular exemption or expedited category may be noted, but review by a convened IRB is required.
  • When conducting classified research, the IRB must have a voting quorum of at least five members, which must include both a non-scientist and a non-affiliated member.
  • The non-affiliated member cannot be a current federal employee or contractor.
  • An IRB member may appeal a vote to approve research to the institutional Official, Secretary of Energy, and Director of the Office of Science and Technology.
• When the research is classified, the IRB must determine if participants need access to classified information to make a valid consent decision.
• Consent documents must include additional DoE elements of disclosure.
  • The identity of the sponsoring agency, unless the sponsor requests that it 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.
  • When research is classified, consent documents must state that the project is classified and what it means for the purposes of the research project.  
• When conducting classified research that the IRB may not grant a waiver of the consent process or waiver of documentation of consent.

All researchers and research staff are required to sign employee confidentiality statements as a condition of grant or proposal approval by the NIJ. Certificates are maintained by the responsible Research Investigator.

• All NIJ-funded projects are required to have a Privacy Certificate approved by the NIJ human subjects’ protection officer. The Privacy Certificate is the grant applicant’s assurance that he/she understands his/her responsibilities to protect the confidentiality of research and statistical information. In cases where no personally identifiable information will be collected, the Privacy Certificate contains a statement to this effect and a brief project description. Investigators should refer to the NIJ Privacy Certificate and Model Privacy Certificate Guidelines for information that must be included, sample format, and instructions to avoid common problems. Note: The NIJ only accepts the Privacy Certificate.  It does not issue or accept a Certificate of Confidentiality issued by the National Institutes of Health (NIH). 
   

Under a Privacy Certificate, researchers and research staff do not have to report current or past abuse. Since this conflicts with Kentucky child and elder abuse reporting laws, the investigator is obligated to such reporting, and therefore must make available a second consent (addendum) to allow such reporting, should a subject self-disclose or give staff strong reasons to believe the subject may be in a dangerous situation. 

• Sample separate consent form (addendum) for reporting
• If data collection methodology and/or information provided in the privacy certificate changes due to Institutional Review Board (IRB) requirements, a revised privacy certificate must be provided prior to the commencement of research.

• The consent must include a statement describing the extent to which confidentiality of records identifying the subject will be maintained.
• For studies sponsored by NIJ, the subject should be informed that private, identifiable information will be kept confidential and will only be used for research and statistical purposes. However, disclosure of future criminal intent is not covered or protected by DOJ regulations.   
• If, due to sample size or some unique feature, the identity of the individual cannot be maintained, the subjects need to be explicitly notified. If the investigator intends to disclose any information, the subject needs to be explicitly informed what information would be disclosed, under what circumstances, and to whom. The subject must be informed of any potential risks that may result from this disclosure and must explicitly provide prior written consent.
• Subjects must be informed that the study is funded by NIJ.

28 CFR 46.117 allows for waiver of documentation of informed consent when criteria are met.

At the end of the award period, recipients of NIJ funding follow guidelines to submit de-identified data resulting from their projects to NIJ for archiving with the National Archive of Criminal Justice Data (NACJD), including copies of the informed consent document, data collection instruments, surveys, or other relevant research materials. 

• Investigators submit preliminary research proposal for review by the BOP Office of Research and Evaluation. If the study is to be conducted at only one institution, the applicant submits a formal proposal to the warden of that institution. If the study is to be conducted at more than one institution or at any other Bureau location, the applicant submits the research proposal to the Chief, Office of Research and Evaluation.
• When submitting a research proposal to the BOP Office of Research and Evaluation, the researcher applicant provides the following information:
  • A summary statement, which includes:
    • Names and current affiliations of the researchers.
    • Title of the study.
    • Purpose of the study.
    • Location of the study.
    • Methods to be employed.
    • Anticipated results.
    • Duration of the study.
    • Number of participants (staff or inmates) required and the amount of time required from each.
    • Indication of risk or discomfort involved due to participation.
  • A comprehensive statement, which includes:
    • Review of related literature.
    • Detailed description of the research method.
    • Significance of anticipated results and their contribution to the advancement of knowledge. Specific resources required from the Bureau of Prisons.
    • Description of all possible risks, discomforts, and benefits to individual participants or a class of participants, and a discussion of the likelihood that the risks and discomforts will actually occur.
    • Description of steps taken to minimize any risks.
    • Description of physical or administrative procedures to be followed to:
      • Ensure the security of any individually identifiable data that is being collected for the study, and
      • Destroy research records or remove individual identifiers from those records when the research has been completed.
    • Description of any anticipated effects of the research study on organizational programs and operations.
    • Relevant research materials such as vitae, endorsements, sample consent statements, questionnaires, and interview schedules. 

A statement regarding assurances and certification required by federal regulations, if applicable.

• All research proposals must be reviewed by the Bureau Research Review Board (BRRB). The BRRB monitors research projects at least yearly for compliance with Bureau policies. It is the investigator’s responsibility to communicate and submit proposals to the BRRB.
• Implementation of Bureau programmatic or operational initiatives made through pilot projects is not considered by the Bureau to be research.
• A non-employee of the Bureau is limited in access to information available under the Freedom of Information Act. They may receive records in a form not individually identifiable when adequate advance written assurance that the record will be used solely as a statistical research or reporting record is provided to the agency.

• For research sponsored by the Bureau of Prisons, additional required elements of informed consent include:
  • Identification of the researchers.
  • Anticipated uses of the results of the research.
  • 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).
• A statement regarding the confidentiality of the research information and exceptions to any guarantees of confidentiality required by federal or state law. For example, a researcher may not guarantee confidentiality when the participant indicates intent to commit future criminal conduct or harm themself or someone else, or, if the participant is an inmate, indicates intent to leave the facility without authorization.
• A statement that participation in the research project will not affect the inmate participant's release date or parole eligibility. 

In addition, research conducted within or sponsored by the federal Bureau of Prisons (BoP) is subject to additional requirements set forth in 28 CFR 512. 

• 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 the protection of human participants. The researcher must observe the rules of the institution or office in which the research is conducted.
• Any researcher who is a non-employee of the Bureau must sign a statement in which the researcher agrees to adhere to the requirements of 28 CFR 512.
• The project must have an adequate research design and contribute to the advancement of knowledge about corrections.
  • The selection of participants within any one organization must be equitable.
  • Incentives may not be offered to help persuade inmate participants to participate. However, soft drinks and snacks to be consumed at the test setting may be offered.
  • Reasonable accommodations, such as nominal monetary recompense for time and effort, may be offered to non-confined research participants who are both:
    • No longer in Bureau of Prisons custody; and
    • Participating in authorized research being conducted by Bureau employees or contractors.
• Except as noted in the informed consent document presented to the participant, the researcher must not provide research information that identifies a participant to any person without that participant’s prior written consent to release the information. For example, research information identifiable to a particular individual cannot be admitted as evidence or used for any purpose in any action, suit, or other judicial, administrative, or legislative proceeding without the written consent of the individual to whom the data pertain.
• Except for computerized data records maintained at an official Department of Justice site, records that contain non-disclosable information directly traceable to a specific person may not be stored in, or introduced into, an electronic retrieval system.
• If the researcher is conducting a study of special interest to the Office of Research and Evaluation (ORE) but the study is not a joint project involving ORE, the researcher may be asked to provide ORE with the computerized research data, not identifiable to individual participants, accompanied by detailed documentation. These arrangements must be negotiated prior to the beginning of the data collection phase of the project.
• The researcher must have academic preparation or experience in the area of study of the proposed research.
• The researcher must assume responsibility for the actions of any person engaged to participate in the research project as an associate, assistant, or subcontractor to the researcher.
• At least once a year, the researcher shall provide the Chief, Office of Research and Evaluation, with a report on the progress of the research.
• At least 12 working days before any report of findings is to be released, the researcher shall distribute one copy of the report to each of the following: the chairperson of the Bureau Research Review Board, the regional director, and the warden of each institution that provided data or assistance. The researcher shall include an abstract in the report of findings.
• In any publication of results, the researcher shall acknowledge the Bureau's participation in the research project.
• The researcher shall expressly disclaim approval or endorsement of the published material as an expression of the policies or views of the Bureau.
• Prior to submitting for publication the results of a research project conducted under this subpart, the researcher shall provide two copies of the material, for informational purposes only, to the Chief, Office of Research and Evaluation, Central Office, Bureau of Prisons.

• An IRB Reviewer Checklist (DoJ) is available for use by the IRB in conducting a review of DOJ-regulated research.
• NIJ Human Subjects Protection website
  • For additional guidance, refer to the frequently asked questions available at the NIJ FAQ website.
• Requirements for research sponsored by the Bureau of Prisons (BOP) [28 CFR 512]:
  • Regional BOP facilities are identified on the Federal BOP website.

EPA has a categorical ban on research involving intentional exposure of pregnant women, nursing women, or children to any substance. 

Subpart B Prohibition of Research Conducted or Supported by EPA Involving Intentional Exposure of Human Subjects who are Children or Pregnant or Nursing Women

This subpart prohibits intentional exposure research under all circumstances in children and women who are pregnant or nursing. All circumstances include studies involving controlled exposures to neutral substances (such as clean, filtered air), foods, or therapeutic drugs. This prohibition is absolute and does not incorporate reference to either risk level or potential benefit.

EPA extends the provisions of 40 CFR 26 to human research involving intentional exposure of non-pregnant, non-nursing adults to substances.  A substance includes any chemical, biological organism, or physical property tracked or regulated by the EPA or identified in an environmental statute. The Substance Registry Services (SRS) is the EPA’s central system for information about substances that are tracked or regulated by EPA.

Subpart K Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-pregnant, Non-nursing Adults

EPA 2013 Final Rule – Enhanced protections for all other adult subjects in human research involving pesticides. 

Defines pesticide as a substance or mixture of substances intended for pesticidal effect.

Informed Consent Requirements: 

If the research involves intentional exposure of subjects to a pesticide, the subjects of the research must be informed of the identity of the pesticide and the nature of its pesticidal function. In consideration of risks currently unforeseen, the investigator should include any potential risk to the embryo or fetus, should the subject become pregnant. 

Subpart K does not include a provision for consent by a subject’s legally authorized representative (LAR). 
No investigator may involve a human being as a subject in pesticide research unless the investigator has obtained the legally effective informed consent of the subject. 

Subpart L Prohibition of Third-Party Research involving Intentional Exposure to a Pesticide of Human Subjects who are Children or Pregnant or Nursing Women

Observational research supported by or submitted to the EPA may be permitted if conditions outlined in the following regulations are met. 

Subpart C Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in Observational Research Conducted or Supported by EPA

Subpart C establishes rules for studies that involve pregnant women (and thus their fetuses) participating in observational research. 

Research of this nature can be conducted when there is a direct benefit to the woman or the fetus.  However, in the absence of direct benefit, if the risk is no greater than minimal to the fetus and the research is important for biomedical knowledge that cannot be obtained in any other manner, the research is permissible by the EPA.

Subpart D Observational Research: Additional Protections for Children Involved as Subjects in Observational Research Conducted or Supported by EPA

Subpart D establishes rules for studies that involve children participating in observational research. 

Research of this nature, involving no more than minimal risk of this type, can be conducted on children. 

Research involving greater than minimal risk can only be conducted when there is direct benefit to the subject. The IRB reviews and approves observational research involving children that involves greater than minimal risk, but presents the prospect of direct benefit to the individual participants if the IRB finds and documents that: 

• 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 40 CFR 26.406. 

The IRB reviews and approves observational research involving children that does not involve greater than minimal risk only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in 40 CFR 26.406. Permission by parents or guardians shall be documented in accordance with and to the extent required by 40 CFR 26.117.  When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.

There is no provision in the EPA rule for the conduct of research when there is greater than minimal risk and no direct benefit to the child.  Also, EPA regulations do not recognize a category of research on children involving “a minor increase over minimal risk”.

The PI must submit the following documentation to the EPA Human Subjects Research Review Official (HSRRO) for final review and approval before the research can begin: 

• UK’s Federal-wide Assurance (FWA) number 00005295
• Copies of:
  • the IRB approval (or exemption) letter;
  • the study protocol(s) as submitted to the IRB (the pre-award document is not sufficient);
  • the IRB-approved consent forms and subject recruitment materials, if applicable; and
  • all supplementary IRB correspondence between the IRB and the investigator (i.e., submission, requested revisions, etc.). 

• The online course, Human Subjects Research at the Environmental Protection Agency: Ethical Standards and Regulatory Requirements, provides training for investigators involved in human subject research supported by EPA.
• The online manual Scientific and Ethical Approaches for Observational Exposure Studies serves as a resource tool and source of information for researchers involved in the development and conduct of observational human exposure studies.

• 40 CFR 26
• Conducting Human Subjects Research (HSR) at EPA
• Oversight of Human Research Regulated by EPA: Special Considerations for HRPPs, AAHRPP Presentation, 2010
• Human Subjects Research at the Environmental Protection Agency: Ethical Standards and Regulatory Requirements