Protection of Human Research Subjects, 35315-35324 [2019-15665]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 84, Number 141 (Tuesday, July 23, 2019)]
[Rules and Regulations]
[Pages 35315-35324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15665]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 26

[EPA-HQ-ORD-2018-0280; FRL-9996-48-ORD]
RIN 2080-AA13


Protection of Human Research Subjects

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: On January 19, 2017, the Environmental Protection Agency 
(EPA), acting in concert with other agencies, promulgated revisions to 
the ``Common Rule.'' EPA's codification of these revisions is in 40 CFR 
part 26, subpart A. These revisions went into effect on July 19, 2018, 
and compliance with the new provisions was required beginning on 
January 21, 2019. In addition to the core protections found in the 
Common Rule, EPA has promulgated regulations that are specific to 
research involving human subjects conducted or sponsored by EPA or 
submitted to EPA for regulatory purposes. The revisions to the Common 
Rule create discrepancies within some of these EPA-specific 
regulations. This final rule harmonizes the EPA-specific regulations 
with revisions to the Common Rule in order to resolve those 
discrepancies.

DATES: This rule is effective on September 23, 2019.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-ORD-2018-0280, is available at 
https://www.regulations.gov or at the OPP Docket in the Environmental 
Protection Agency Docket Center (EPA/DC), located in the EPA WJC West 
Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20004. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Tom Sinks, Director, Office of Science 
Advisor, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460 (Mail Code: 8105R); telephone number: 202-564-
3099; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may, 
however, be of particular interest to those who conduct human research 
on substances regulated by EPA. Since other entities may also be 
interested, the Agency has not attempted to describe all the specific 
entities that may be affected by this action. If you have any questions 
regarding the applicability of this action to a particular entity, 
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. What action is the Agency taking?

    The Agency is finalizing the amendments to its human studies rules 
as proposed in December 2018 (83 FR 62760) (FRL-9987-01-ORD). These 
amendments include the following:
     Revisions to regulatory citation references in subparts C 
and D;
     Harmonization, where appropriate, of language in subpart K 
with revisions in subpart A due to revisions to the Common Rule, 82 FR 
7149 (January 19, 2017); and
     Correction of a typographical error in subpart M.

C. What is the Agency's authority for taking this action?

    These amendments are authorized under the following legal 
authorities. The amendments to subparts C and D, which relate to 
research conducted or sponsored by EPA are authorized pursuant to 5 
U.S.C. 301. The amendments to subparts K and M, which govern third-
party research involving intentional human exposure to pesticides or to 
other substances where such research is used for purposes of pesticide 
decision-making are authorized under sections 3(a) and

[[Page 35316]]

25(a) of the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA), 7 U.S.C. 136a(a) and 136w(a), and section 408(e)(1)(C) of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e)(1)(C).
    In response to a comment received, the Agency is clarifying that it 
is not relying on the section 201 of the Department of the Interior, 
Environment, and Related Agencies Appropriations Act, 2006, Public Law 
109-54 (``2006 Appropriations Act'') as authority for this rulemaking. 
The reference to the 2006 Appropriations Act included in the preamble 
to the December 2018 proposed rule was to explain in part the authority 
for EPA's initial promulgation in 2006 of its rules governing research 
with human subjects beyond the provisions contained in the Common Rule, 
including the subparts being updated herein. As noted in the Agency's 
Response to Comments Document prepared as part of the record for the 
2013 revisions to EPA's human studies rule, the Agency has determined 
that the 2006 Appropriations Act is no longer in effect and does not 
provide authority for new regulatory provisions. See https://www.regulations.gov, in Docket No. EPA-HQ-OPP-2010-0785, document 
number 38.

II. Background

    As discussed in the preamble to the proposed rule, on January 19, 
2017, several federal departments and agencies, including EPA, adopted 
revisions to the provisions of the Common Rule, a set of regulations 
intended to create a uniformity across the federal government for the 
protection of human subjects involved in research. See 82 FR 7149 
(January 19, 2017). Those revisions, which were intended to 
``modernize, strengthen, and make [the Common Rule] more effective'', 
established new requirements for the informed consent process; allowed 
the use of broad consent (i.e., seeking prospective consent to 
unspecified future research) from a subject for storage, maintenance, 
and secondary research use of identifiable private information and 
identifiable biospecimens; established new exempt categories of 
research based on their risk profile; required the use of a single 
institutional review board (IRB) for U.S.-based cooperative research; 
and removed the continuing review requirement for certain research, in 
addition to making minor changes intended to improve the clarity and 
accuracy of the rule. Id. at 7150. EPA's codification of the Common 
Rule provisions is located in 40 CFR part 26, subpart A. Compliance 
with these revisions was required starting on January 21, 2019. See 83 
FR 28497.
    In addition to the provisions of the subpart A, EPA's regulations 
governing human studies research include several additional subparts at 
40 CFR 26, including subparts B through D, which govern research 
conducted or sponsored by EPA involving pregnant or nursing women and 
children, and subparts, K through Q, which govern third-party pesticide 
research involving intentional exposure of human subjects and EPA's 
reliance on research involving intentional exposure of human subjects. 
In particular, EPA's provisions in subpart K, which govern the conduct 
of pesticide-related third-party research involving intentional 
exposure of human subjects, borrowed heavily from the Common Rule 
provisions based on the Agency's conclusion that it would be 
appropriate to apply ethical standards to third-party research that 
were equivalent to the protections for human subjects participating in 
research conducted or sponsored by EPA. See 70 FR 53838, 53845 
(September 12, 2005).

III. The Final Rule

    EPA is finalizing revisions to its human studies regulations as 
proposed. As discussed in the preamble to the proposed rule, these 
revisions include updating numerical references in subparts C and D to 
accurately refer to exemption text in subpart A and to eliminate 
language concerning tribal laws that is no longer necessary due to the 
revisions in subpart A. These revisions are necessary to ensure that 
the exemptions will apply as intended to research conducted or 
sponsored by EPA and avoid unnecessary confusion about the 
applicability of tribal law.
    In addition, this final rule also includes revisions as proposed to 
subpart K to harmonize, as appropriate, language governing third-party 
research with the revisions in subpart A and to clarify the timing and 
applicability of these revisions. These revisions are important to 
encourage equivalency in protections of human subjects between research 
conducted or sponsored by federal departments and agencies and third-
party research, wherever appropriate. Furthermore, the harmonization of 
provisions allows investigators and IRBs to follow equivalent or 
similar standards for regulating the ethical conduct of research 
involving human subjects, regardless of who conducts that research. 
Consistency in standards will result in greater clarity and less 
regulatory burden as well as less potential for confusion and 
misapplication of standards for the regulated community.
    Finally, EPA is correcting a typographical error in subpart M, as 
discussed in the preamble.

IV. Public Comments on the Proposed Amendments

    Public comments on the proposed rule are discussed here, in general 
terms, along with EPA's response to the comments. EPA received a total 
of nine public comments during the 60-day comment period. All comments 
were submitted by individuals, two self-identified and seven anonymous. 
The docket (ID Number EPA-HQ-ORD-2018-0280) includes all the comments 
submitted to EPA on the proposed amendments.

A. Comments on Proposal To Maintain Exemptions Limiting the Application 
in Research Involving Children

    One commenter described the changes concerning Subpart D the 
commenter considers necessary (1) to maintain access to the exemptions 
integrated by reference and the provision limiting the application (of 
exemptions) in research involving children; (2) to withdraw the 
clarification concerning preemption of tribal laws; and (3) to comprise 
reference to the new general provisions in the Common Rule. EPA agrees 
that these changes are necessary and, indeed, are reflected in the 
revisions to Subpart D as proposed.

B. Comments on the Legal Authority of the Rule

    One person commented on references to the 2006 Appropriations Act 
in the preamble to the proposal and in the regulatory citation to legal 
authorities. As explained above, this final rulemaking is being 
promulgated under 5 U.S.C. 301, FIFRA sections 3(a) and 25(a), and 
FFDCA section 408(e)(1)(C), not the 2006 Appropriations Act. The 
commenter asserts that changes to the authorities citation in the 
regulatory text are necessary to enable the Agency to make potential, 
future revisions to part 26. The Agency disagrees that the authority 
citation needs to be revised in this action in order to facilitate 
future revisions, as such questions can be taken up in relevant future 
actions. As explained above, this action is limited to revisions in 
subparts C, D, K, and M; changes that may impact other subparts of part 
26 or part 26 more broadly are considered to be beyond the limited 
scope of the revisions in this rulemaking.

[[Page 35317]]

C. Comments on the Requirement for Mixed-Gender, Professionally Diverse 
IRBs

    One commenter drew attention to the proposed changes in Subpart K 
to harmonize IRB membership requirements with those in the revised 
Common Rule (Subpart A). As noted in the comment, the revised Common 
Rule removes the language that had been found in 40 CFR 26.107(b), 
requiring that ``[e]very nondiscriminatory effort . . . be made to 
ensure that no IRB consists entirely of men or entirely of women, 
including the IRB's consideration of qualified persons of both sexes, 
so long as no selection is made on the basis of gender'' and 
prohibiting IRBs from consisting entirely of members of one profession. 
The commenter expressed concern that because third-party research 
subject to subpart K may be more likely to be conducted overseas and 
subject to IRB review outside the United States than research conducted 
or sponsored by EPA, it is appropriate to retain the pre-2018 Common 
Rule language in 26.1107(b), rather than harmonize with the revised 
Common Rule language, in order to ensure that the same membership 
diversity continue to be required of the overseas IRBs.
    EPA disagrees with the comment that IRB membership requirements for 
IRBs that review third-party research subject to subpart K warrant a 
divergence from the harmonization objectives of this action. EPA 
acknowledges that some research subject to subpart K may be conducted 
overseas and subject to the membership requirements and foreign 
procedures of international IRBs. EPA already has provisions in place 
that permit EPA to approve of the use of the foreign procedures in lieu 
of the procedural requirements in subpart K upon determining that those 
procedures are at least as protective as EPA's regulations. See 40 CFR 
26.1603(f). Under this current language, EPA may approve research 
conducted in a foreign country that does not meet the current diversity 
requirements in 26.1107(b), as long as it determines the protections 
are at least equivalent to EPA's procedures for protecting human 
subjects. In that way, EPA does not view the revisions to the 
membership diversity requirements concerning gender and professional 
diversity as likely to meaningfully impact the integrity of the IRB 
reviews and approvals for research conducted overseas that is subject 
to subpart K. In any event, if EPA determines that the membership of 
the overseas IRB is so deficient that EPA cannot support a 
determination that the protections afforded by the foreign procedures 
are at least equivalent to subpart K, EPA would not be required to 
approve of the use of those procedures.
    In addition, for the same reasons that were stated in the preamble 
to the Common Rule, EPA views the language in 26.107(a), which requires 
members to have varying backgrounds and such diversity of the members, 
including gender, as to promote respect for its advice, and in the 
revised 26.107(b), which requires IRBs to consist of at least one 
member whose primary concerns are scientific and one member whose 
primary concerns are nonscientific, to be sufficient to accomplish the 
same goal of diversity in IRB membership. See 82 FR 7149, 7203 (January 
19, 2017). To the extent EPA considers the gender and professional 
diversity of an international IRB to be relevant to whether that IRB 
has protections in place that are at least equivalent to EPA's 
protections, EPA is not required to accept the use of those foreign 
procedures. For the rest of the third-party studies subject to subpart 
K, e.g., those conducted within the United States and reviewed by 
domestic IRBs, EPA sees no reason to deviate from the overall goal of 
harmonizing IRB requirements to reduce the potential for confusion and 
regulatory burden caused by conflicting requirements. Consequently, EPA 
is harmonizing 26.1107 with the revised language in 26.107 as proposed.

D. Request for Extension of the Comment Period

    One commenter requested an extension of the comment period, but EPA 
did not do so. There were relatively few comments submitted, most 
supported the rulemaking, and the one commenter that requested 
additional time appeared to be concerned about issues that were not 
only outside the scope of this rulemaking, but primarily concerned with 
another federal agency.

E. Other Comments

    The remaining comments were either supportive of the proposed 
amendments or were beyond the scope of this rule; as such, they 
provided no basis for any changes to the rule as proposed.

V. Conclusion

    EPA received relatively few comments on the proposed rule. EPA 
considered the comments but ultimately concluded that none raised any 
issues that merit any change to the amendments as proposed. 
Accordingly, EPA is finalizing the amendments as proposed for the 
reasons stated herein.

VI. FIFRA Review Requirements

    In accordance with FIFRA section 25(a), EPA has submitted a draft 
of the rule to the FIFRA Scientific Advisory Panel (SAP), the Secretary 
of Agriculture (USDA), and appropriate Congressional Committees. The 
SAP waived its review on May 20, 2019. USDA responded on June 4, 2019 
and had no substantive comments on the proposal. Both responses are in 
the docket for this rulemaking.

VII. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    Because OMB considered this rulemaking to be a significant 
regulatory action when EPA issued its proposal, the Notice of Proposed 
Rule Making was reviewed by OMB under Executive Order 12866. Any 
changes made in response to OMB recommendations have been documented in 
the docket for this rulemaking as required by the Executive Order. 
After the proposed rule, OMB changed its determination to non-
significant. This rule is expected to result in no more than de minimis 
costs since its purpose is to resolve internal discrepancies created by 
the recent revision to the Common Rule to avoid confusion, and 
potential compliance issues for researchers, institutions and sponsors 
who must follow EPA regulations.

B. Executive Order 13771: Reducing Regulation and Controlling 
Regulatory Costs

    This action is not an Executive Order 13771 regulatory action 
because this action is not significant under Executive Order 12866.

C. Paperwork Reduction Act

    This action does not impose any new information collection burden 
that would require additional review or approval by OMB under the 
Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. OMB previously 
approved the information collection requirements contained in the 
existing regulations at 40 CFR part 26 under OMB Control No. 2070-0169.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic 
impact on a

[[Page 35318]]

substantial number of small entities under the RFA.
    The Agency has not identified any small entities subject to the 
requirements in this proposal, but it is possible that some small 
pesticide registrants may initiate research subject to EPA's Human 
Studies rule. The Agency has determined that impacted small entities, 
if any, may experience an impact of 0.02% as indicated in the 
``Economic Analysis of Final Rule: Protections for Human Research 
Participants'' (January 12, 2006). The Agency does not have any 
information to support revising that analysis.

E. Unfunded Mandates Reform Act

    This action does not contain any unfunded mandate as described in 
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect 
small governments.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have 
substantial direct effects on the states, on the relationship between 
the national government and the states, or on the distribution of power 
and responsibilities among the various levels of government.

G. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications as specified in 
Executive Order 13175. This action is not expected to have substantial 
direct effects on Indian Tribes, will not significantly or uniquely 
affect the communities of Indian Tribal governments, and does not 
involve or impose any requirements that affect Indian Tribes. Thus, 
Executive Order 13175 does not apply to this action.

H. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 as applying only to those 
regulatory actions that concern health or safety risks that the EPA has 
reason to believe may disproportionately affect children, per the 
definition of ``covered regulatory action'' in section 2-202 of the 
Executive Order. This action is not subject to Executive Order 13045 
because it does not concern an environmental health risk or safety 
risk. This action is not subject to Executive Order 13045 because it 
does not establish an environmental standard intended to mitigate 
health or safety risks. EPA's regulations governing research involving 
human subjects applies to the conduct and review of research involving 
intentional exposure of human subjects, and prohibits the conduct of or 
EPA reliance on any such research involving subjects who are children, 
or pregnant or nursing women. These provisions remain in effect and 
would not be affected by the amendments.

I. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' because it is 
not likely to have any effect on the supply, distribution, or use of 
energy.

J. National Technology Transfer and Advancement Act

    This action does not involve any technical standards.

K. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    This action does not entail special considerations of environmental 
justice-related issues as delineated by Executive Order 12898. The 
strengthened protections for human subjects participating in covered 
research established in the 2006 rule would not be altered by these 
amendments.

L. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule 
report to each House of the Congress and to the Comptroller General of 
the United States. This action is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 26

    Environmental protection, Administrative practice and procedures, 
Human research, Pesticides and pests.

    Dated: July 3, 2019.
Andrew R. Wheeler,
Administrator.

    Therefore, 40 CFR chapter I is amended as follows:

PART 26--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for part 26 continues to read as follows:

    Authority: 5 U.S.C. 301; 7 U.S.C. 136a(a) and 136w(a)(1); 21 
U.S.C. 346a(e)(1)(C); sec. 201, Pub. L. 109-54, 119 Stat. 531; and 
42 U.S.C. 300v-1(b).


0
2. Amend Sec.  26.301 by revising paragraphs (b) and (c) to read as 
follows:


Sec.  26.301  To what does this subpart apply?

* * * * *
    (b) The exemptions at Sec.  26.104(d) are applicable to this 
subpart.
    (c) The provisions of Sec.  26.101(c) through (m) are applicable to 
this subpart.
* * * * *

0
3. Amend Sec.  26.401 by revising paragraphs (a) and (b) to read as 
follows:


Sec.  26.401  To what does this subpart apply?

    (a) This subpart applies to all observational research involving 
children as subjects, conducted or supported by EPA. This includes 
research conducted in EPA facilities by any person and research 
conducted in any facility by EPA employees.
    (b) Exemptions at Sec.  26.104(d)(1) and (d)(3) through (8) are 
applicable to this subpart. The exemption at Sec.  26.104(d)(2) 
regarding educational tests is also applicable to this subpart. 
However, the exemption at Sec.  26.104(d)(2) for research involving 
survey or interview procedures or observations of public behavior does 
not apply to research covered by this subpart, except for research 
involving observation of public behavior when the investigator(s) do 
not participate in the activities being observed.
* * * * *


Sec.  26.402  [Amended]

0
4. Amend Sec.  26.402 by removing paragraph (g).

0
5. Amend Sec.  26.406 by revising the last sentence of paragraph (a) to 
read as follows:


Sec.  26.406  Requirements for permission by parents or guardians and 
for assent by children.

    (a) * * * Even where the IRB determines that the subjects are 
capable of assenting, the IRB may still waive the assent requirement 
under circumstances in which consent may be waived in accord with Sec.  
26.116(e).
* * * * *

0
6. Revise subpart K, consisting of Sec. Sec.  26.1101 through 26.1125, 
to read as follows:
Subpart K--Basic Ethical Requirements for Third-Party Human Research 
for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-
Nursing Adults
Sec.
26.1101 To what does this subpart apply?
26.1102 Definitions.
26.1103-26.1106 [Reserved]
26.1107 IRB membership.
26.1108 IRB functions and operations.
26.1109 IRB review of research.
26.1110 Expedited review procedures for certain kinds of research 
involving no

[[Page 35319]]

more than minimal risk, and for minor changes in approved research.
26.1111 Criteria for IRB approval of research.
26.1112 Review by institution.
26.1113 Suspension or termination of IRB approval of research.
26.1114 Cooperative research.
26.1115 IRB records.
26.1116 General requirements for informed consent.
26.1117 Documentation of informed consent.
26.1118-26.1122 [Reserved]
26.1123 Early termination of research.
26.1124 [Reserved]
26.1125 Prior submission of proposed human research for EPA review.

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


Sec.  26.1101  To what does this subpart apply?

    (a) Except as provided in paragraph (c) of this section, this 
subpart applies to all research initiated on or after September 23, 
2019 involving intentional exposure of a human subject to:
    (1) Any substance if, at any time prior to initiating such 
research, any person who conducted or supported such research intended 
either to submit results of the research to EPA for consideration in 
connection with any action that may be performed by EPA under the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 
136-136y) or section 408 of the Federal Food, Drug, and Cosmetic Act 
(FFDCA) (21 U.S.C. 346a), or to hold the results of the research for 
later inspection by EPA under FIFRA or section 408 of FFDCA; or
    (2) A pesticide if, at any time prior to initiating such research, 
any person who conducted or supported such research intended either to 
submit results of the research to EPA for consideration in connection 
with any action that may be performed by EPA under any regulatory 
statute administered by EPA other than those statutes designated in 
paragraph (a)(1) of this section, or to hold the results of the 
research for later inspection by EPA under any regulatory statute 
administered by EPA other than those statutes designated in paragraph 
(a)(1) of this section.
    (b) For purposes of determining a person's intent under paragraph 
(a) of this section, EPA may consider any available and relevant 
information. EPA must rebuttably presume the existence of intent if:
    (1) The person or the person's agent has submitted or made 
available for inspection the results of such research to EPA; or
    (2) The person is a member of a class of people who, or whose 
products or activities, are regulated by EPA and, at the time the 
research was initiated, the results of such research would be relevant 
to EPA's exercise of its regulatory authority with respect to that 
class of people, products, or activities.
    (c) Unless otherwise required by the Administrator, research is 
exempt from this subpart if it involves only the collection or study of 
existing data, documents, records, pathological specimens, or 
diagnostic specimens from previously conducted studies, and if these 
sources are publicly available or if the information is recorded by the 
investigator in such a manner that subjects cannot be identified, 
directly or through identifiers linked to the subjects.
    (d) The EPA Administrator retains final judgment as to whether a 
particular activity is covered by this subpart and this judgment shall 
be exercised consistent with the
    ethical principles of the Belmont Report.
    (e) Compliance with this subpart requires compliance with pertinent 
Federal laws or regulations that provide additional protections for 
human subjects.
    (f) This subpart does not affect any state or local laws or 
regulations (including tribal law passed by the official governing body 
of an American Indian or Alaska Native tribe) that may otherwise be 
applicable and that provide additional protections for human subjects.
    (g) This subpart does not affect any foreign laws or regulations 
that may otherwise be applicable and that provide additional 
protections to human subjects of research.
    (h) Notwithstanding paragraph (a) of this section, nothing in this 
section alters the previous obligation to comply with EPA regulations 
in this subpart that governed research involving intentional exposure 
of human subjects initiated prior to September 23, 2019 and that were 
in effect and applicable to such research at the time it was initiated.


Sec.  26.1102  Definitions.

    (a) Administrator means the Administrator of the Environmental 
Protection Agency (EPA) and any other officer or employee of EPA to 
whom authority has been delegated.
    (b) Common Rule refers to the Federal Policy for the Protection of 
Human Subjects as established in 1991 and codified by EPA and 14 other 
Federal departments and agencies (see the Federal Register issue of 
June 18, 1991 (56 FR 28003)) and its subsequent revisions as adopted by 
EPA and other federal departments and agencies (see the Federal 
Register issue of January 19, 2017 (82 FR 7149)). The Common Rule 
contains a widely accepted set of standards for conducting ethical 
research with human subjects, together with a set of procedures 
designed to ensure that the standards are met. Once codified or adopted 
by a Federal department or agency, the requirements of the Common Rule 
apply to research conducted or sponsored by that Federal department or 
agency. EPA's codification of the Common Rule appears in 40 CFR part 
26, subpart A.
    (c) Federal department or agency refers to a federal department or 
agency (the department or agency itself rather than its bureaus, 
offices or divisions) that takes appropriate administrative action to 
make the Common Rule applicable to the research involving human 
subjects it conducts, supports, or otherwise regulates (e.g., the U.S. 
Department of Health and Human Services, the U.S. Department of 
Defense, or the Central Intelligence Agency).
    (d)(1) Human subject means a living individual about whom an 
investigator (whether professional or student) conducting research:
    (i) Obtains information or biospecimens through intervention or 
interaction with the individual, and uses, studies, or analyzes the 
information or biospecimens, or
    (ii) Obtains, uses, studies, analyzes, or generates identifiable 
private information or identifiable biospecimens.
    (2) Intervention includes both physical procedures by which 
information or biospecimens are gathered (e.g., venipuncture) and 
manipulations of the subject or the subject's environment that are 
performed for research purposes.
    (3) Interaction includes communication or interpersonal contact 
between investigator and subject.
    (4) Private information includes information about behavior that 
occurs in a context in which an individual can reasonably expect that 
no observation or recording is taking place, and information which has 
been provided for specific purposes by an individual and which the 
individual can reasonably expect will not be made public (e.g., a 
medical record).
    (5) Identifiable private information is private information for 
which the identity of the subject is or may readily

[[Page 35320]]

be ascertained by the investigator or associated with the information.
    (6) An identifiable biospecimen is a biospecimen for which the 
identity of the subject is or may readily be ascertained by the 
investigator or associated with the biospecimen.
    (e) Institution means any public or private entity or agency 
(including federal, state, and other agencies).
    (f) IRB means an institutional review board established in accord 
with and for the purposes expressed in this part.
    (g) IRB approval means the determination of the IRB that the 
research has been reviewed and may be conducted at an institution 
within the constraints set forth by the IRB and by other institutional 
and federal requirements.
    (h) Minimal risk means that the probability and magnitude of harm 
or discomfort anticipated in the research are not greater in and of 
themselves than those ordinarily encountered in daily life or during 
the performance of routine physical or psychological examinations or 
tests.
    (i) Person means any person, as that term is defined in FIFRA 
section 2(s) (7 U.S.C. 136), except:
    (1) A Federal agency that is subject to the provisions of the 
Federal Policy for the Protection of Human Subjects of Research, and
    (2) A person when performing human research supported by a federal 
agency covered by paragraph (i)(1) of this section.
    (j) Pesticide means any substance or mixture of substances meeting 
the definition in 7 U.S.C. 136(u) (Federal Insecticide, Fungicide, and 
Rodenticide Act, section 2(u)).
    (k) Research means a systematic investigation, including research, 
development, testing and evaluation, designed to develop or contribute 
to generalizable knowledge. Activities that meet this definition 
constitute research for purposes of this subpart, whether or not they 
are considered research for other purposes. For example, some 
demonstration and service programs may include research activities.
    (l) Research involving intentional exposure of a human subject 
means a study of a substance in which the exposure to the substance 
experienced by a human subject participating in the study would not 
have occurred but for the human subject's participation in the study.
    (m) Written, or in writing, for purposes of this subpart refers to 
writing on a tangible medium (e.g., paper) or in an electronic format.


Sec.  Sec.  26.1103-26.1106   [Reserved]


Sec.  26.1107  IRB membership.

    (a) Each IRB shall have at least five members, with varying 
backgrounds to promote complete and adequate review of research 
activities that are presented for its approval. The IRB shall be 
sufficiently qualified through the experience and expertise of its 
members (professional competence), and the diversity of the members, 
including consideration of race, gender, and cultural backgrounds and 
sensitivity to such issues as community attitudes, to promote respect 
for its advice and counsel in safeguarding the rights and welfare of 
human subjects. The IRB shall be able to ascertain the acceptability of 
proposed research in terms of institutional commitments (including 
policies and resources) and regulations, applicable law, and standards 
of professional conduct and practice. The IRB shall therefore include 
persons knowledgeable in these areas. If an IRB regularly reviews 
research that involves a category of subjects vulnerable to coercion or 
undue influence, such as prisoners, individuals with impaired decision-
making capacity, or economically or educationally disadvantaged 
persons, consideration shall be given to the inclusion of one or more 
individuals who are knowledgeable about and experienced in working with 
these categories of subjects.
    (b) Each IRB shall include at least one member whose primary 
concerns are in scientific areas and at least one member whose primary 
concerns are in nonscientific areas.
    (c) Each IRB shall include at least one member who is not otherwise 
affiliated with the institution and who is not part of the immediate 
family of a person who is affiliated with the institution.
    (d) No IRB may have a member participate in the IRB's initial or 
continuing review of any project in which the member has a conflicting 
interest, except to provide information requested by the IRB.
    (e) An IRB may, in its discretion, invite individuals with 
competence in special areas to assist in the review of issues that 
require expertise beyond or in addition to that available on the IRB. 
These individuals may not vote with the IRB.


Sec.  26.1108  IRB functions and operations.

    (a) In order to fulfill the requirements of this subpart each IRB 
shall:
    (1) Have access to meeting space and sufficient staff to support 
the IRB's review and recordkeeping duties;
    (2) Prepare and maintain a current list of the IRB members 
identified by name; earned degrees; representative capacity; 
indications of experience such as board certifications or licenses 
sufficient to describe each member's chief anticipated contributions to 
IRB deliberations; and any employment or other relationship between 
each member and the institution, for example, full-time employee, part-
time employee, member of governing panel or board, stockholder, paid or 
unpaid consultant;
    (3) Establish and follow written procedures for:
    (i) Conducting its initial and continuing review of research and 
for reporting its findings and actions to the investigator and the 
institution;
    (ii) Determining which projects require review more often than 
annually and which projects need verification from sources other than 
the investigator that no material changes have occurred since previous 
IRB review;
    (iii) Ensuring prompt reporting to the IRB of proposed changes in 
research activity, and for ensuring that investigators will conduct the 
research activity in accordance with the terms of the IRB approval 
until any proposed changes have been reviewed and approved by the IRB, 
except when necessary to eliminate apparent immediate hazards to the 
subject.
    (4) Establish and follow written procedures for ensuring prompt 
reporting to the IRB, appropriate institutional officials, and the 
Environmental Protection Agency of:
    (i) Any unanticipated problems involving risks to human subjects or 
others or any instance of serious or continuing noncompliance with this 
subpart or the requirements or determinations of the IRB; and
    (ii) Any suspension or termination of IRB approval.
    (b) Except when an expedited review procedure is used (see Sec.  
26.1110), an IRB must review proposed research at convened meetings at 
which a majority of the members of the IRB are present, including at 
least one member whose primary concerns are in nonscientific areas. In 
order for the research to be approved, it shall receive the approval of 
a majority of those members present at the meeting.


Sec.  26.1109  IRB review of research.

    (a) An IRB shall review and have authority to approve, require 
modifications in (to secure approval), or disapprove all research 
activities covered by this subpart.
    (b) An IRB shall require that information given to subjects as part 
of

[[Page 35321]]

informed consent is in accordance with Sec.  26.1116. The IRB may 
require that information, in addition to that specifically mentioned in 
Sec.  26.1116, be given to the subjects when, in the IRB's judgment, 
the information would meaningfully add to the protection of the rights 
and welfare of subjects.
    (c) An IRB shall require documentation of informed consent in 
accordance with Sec.  26.1117.
    (d) An IRB shall notify investigators and the institution in 
writing of its decision to approve or disapprove the proposed research 
activity, or of modifications required to secure IRB approval of the 
research activity. If the IRB decides to disapprove a research 
activity, it shall include in its written notification a statement of 
the reasons for its decision and give the investigator an opportunity 
to respond in person or in writing.
    (e) An IRB shall conduct continuing review of research requiring 
review by the convened IRB at intervals appropriate to the degree of 
risk, not less than once per year, except as described in paragraph (f) 
of this section.
    (f)(1) Unless an IRB determines otherwise, continuing review of 
research is not required in the following circumstances:
    (i) Research eligible for expedited review in accordance with Sec.  
26.1110;
    (ii) Research that has progressed to the point that it involves 
only one or both of the following, which are part of the IRB-approved 
study:
    (A) Data analysis, including analysis of identifiable private 
information or identifiable biospecimens, or
    (B) Accessing follow-up clinical data from procedures that subjects 
would undergo as part of clinical care.
    (2) [Reserved]
    (g) An IRB shall have authority to observe or have a third party 
observe the consent process and the research.


Sec.  26.1110  Expedited review procedures for certain kinds of 
research involving no more than minimal risk, and for minor changes in 
approved research.

    (a) The Secretary of HHS, has established, and published as a 
notice in the Federal Register, a list of categories of research that 
may be reviewed by the IRB through an expedited review procedure. The 
Secretary will evaluate the list at least every 8 years and amend it, 
as appropriate after consultation with other federal departments and 
agencies and after publication in the Federal Register for public 
comment. A copy of the list is available from the Office for Human 
Research Protections, HHS, or any successor office.
    (b)(1) An IRB may use the expedited review procedure to review the 
following:
    (i) Some or all of the research appearing on the list described in 
paragraph (a) of this section, unless the reviewer finds that the study 
involves more than minimal risk.
    (ii) Minor changes in previously approved research during the 
period for which approval is authorized.
    (2) Under an expedited review procedure, the review may be carried 
out by the IRB chairperson or by one or more experienced reviewers 
designated by the chairperson from among members of the IRB. In 
reviewing the research, the reviewers may exercise all of the 
authorities of the IRB except that the reviewers may not disapprove the 
research. A research activity may be disapproved only after review in 
accordance with the non-expedited procedure set forth in Sec.  
26.1108(b).
    (c) Each IRB that uses an expedited review procedure shall adopt a 
method for keeping all members advised of research proposals that have 
been approved under the procedure.
    (d) The Administrator may restrict, suspend, terminate, or choose 
not to authorize an institution's or IRB's use of the expedited review 
procedure for research covered by this subpart.


Sec.  26.1111  Criteria for IRB approval of research.

    (a) In order to approve research covered by this subpart the IRB 
shall determine that all of the following requirements are satisfied:
    (1) Risks to subjects are minimized:
    (i) By using procedures that are consistent with sound research 
design and that do not unnecessarily expose subjects to risk, and
    (ii) Whenever appropriate, by using procedures already being 
performed on the subjects for diagnostic or treatment purposes.
    (2) Risks to subjects are reasonable in relation to anticipated 
benefits, if any, to subjects, and the importance of the knowledge that 
may reasonably be expected to result. In evaluating risks and benefits, 
the IRB should consider only those risks and benefits that may result 
from the research (as distinguished from risks and benefits of 
therapies subjects would receive even if not participating in the 
research). The IRB should not consider possible long-range effects of 
applying knowledge gained in the research (e.g., the possible effects 
of the research on public policy) as among those research risks that 
fall within the purview of its responsibility.
    (3) Selection of subjects is equitable. In making this assessment 
the IRB should take into account the purposes of the research and the 
setting in which the research will be conducted. The IRB should be 
particularly cognizant of the special problems of research that 
involves a category of subjects who are vulnerable to coercion or undue 
influence, such as prisoners, individuals with impaired decision-making 
capacity, or economically or educationally disadvantaged persons.
    (4) Informed consent will be sought from each prospective subject, 
in accordance with, and to the extent required by Sec.  26.1116.
    (5) Informed consent will be appropriately documented in accordance 
with Sec.  26.1117.
    (6) When appropriate, the research plan makes adequate provision 
for monitoring the data collected to ensure the safety of subjects.
    (7) When appropriate, there are adequate provisions to protect the 
privacy of subjects and to maintain the confidentiality of data.
    (b) When some or all of the subjects are likely to be vulnerable to 
coercion or undue influence, such as prisoners, individuals with 
impaired decision-making capacity, or economically or educationally 
disadvantaged persons, additional safeguards have been included in the 
study to protect the rights and welfare of these subjects.


Sec.  26.1112  Review by institution.

    Research covered by this subpart that has been approved by an IRB 
may be subject to further appropriate review and approval or 
disapproval by officials of the institution. However, those officials 
may not approve the research if it has not been approved by an IRB.


Sec.  26.1113  Suspension or termination of IRB approval of research.

    An IRB shall have authority to suspend or terminate approval of 
research that is not being conducted in accordance with the IRB's 
requirements or that has been associated with unexpected serious harm 
to subjects. Any suspension or termination of approval shall include a 
statement of the reasons for the IRB's action and shall be reported 
promptly to the investigator, appropriate institutional officials, and 
the Administrator of EPA.


Sec.  26.1114  Cooperative research.

    In complying with this subpart, sponsors, investigators, or 
institutions involved in multi-institutional studies may use joint 
review, reliance upon the review of another qualified IRB, or similar 
arrangements aimed at avoidance of duplication of effort.

[[Page 35322]]

Sec.  26.1115  IRB records.

    (a) An institution, or when appropriate an IRB, shall prepare and 
maintain adequate documentation of IRB activities, including the 
following:
    (1) Copies of all research proposals reviewed, scientific 
evaluations, if any, that accompany the proposals, approved sample 
consent documents, progress reports submitted by investigators, and 
reports of injuries to subjects.
    (2) Minutes of IRB meetings, which shall be in sufficient detail to 
show attendance at the meetings; actions taken by the IRB; the vote on 
these actions including the number of members voting for, against, and 
abstaining; the basis for requiring changes in or disapproving 
research; and a written summary of the discussion of controverted 
issues and their resolution.
    (3) Records of continuing review activities, including the 
rationale for conducting continuing review of research that otherwise 
would not require continuing review as described in Sec.  
26.1109(f)(1).
    (4) Copies of all correspondence between the IRB and the 
investigators.
    (5) A list of IRB members in the same detail as described in Sec.  
26.1108(a)(2).
    (6) Written procedures for the IRB in the same detail as described 
in Sec.  26.1108(a)(3) and (4).
    (7) Statements of significant new findings provided to subjects, as 
required by Sec.  26.1116(c)(5).
    (8) The rationale for an expedited reviewer's determination under 
Sec.  26.1110(b)(1)(i) that research appearing on the expedited review 
list described in Sec.  26.1110(a) is more than minimal risk.
    (9) Documentation specifying the responsibilities that an 
institution and an organization operating an IRB each will undertake to 
ensure compliance with the requirements of this subpart.
    (b) The records required by this subpart shall be retained for at 
least 3 years, and records relating to research which is conducted 
shall be retained for at least 3 years after completion of the 
research. The institution or IRB may maintain the records in printed 
form or electronically. All records shall be accessible for inspection 
and copying by authorized representatives of EPA at reasonable times 
and in a reasonable manner.


Sec.  26.1116  General requirements for informed consent.

    (a) General. General requirements for informed consent, whether 
written or oral, are set forth in this paragraph and apply to consent 
obtained in accordance with the requirements set forth in paragraphs 
(b) and (c) of this section. Except as provided elsewhere in this 
subpart:
    (1) Before involving a human subject in research covered by this 
subpart, an investigator shall obtain the legally effective informed 
consent of the subject.
    (2) An investigator shall seek informed consent only under 
circumstances that provide the prospective subject sufficient 
opportunity to discuss and consider whether or not to participate and 
that minimize the possibility of coercion or undue influence.
    (3) The information that is given to the subject shall be in 
language understandable to the subject.
    (4) The prospective subject must be provided with the information 
that a reasonable person would want to have in order to make an 
informed decision about whether to participate, and an opportunity to 
discuss that information.
    (5)(i) Informed consent must begin with a concise and focused 
presentation of the key information that is most likely to assist a 
prospective subject in understanding the reasons why one might or might 
not want to participate in the research. This part of the informed 
consent must be organized and presented in a way that facilitates 
comprehension.
    (ii) Informed consent as a whole must present information in 
sufficient detail relating to the research and must be organized and 
presented in a way that does not merely provide lists of isolated 
facts, but rather facilitates the prospective subject's understanding 
of the reasons why one might or might not want to participate.
    (6) No informed consent may include any exculpatory language 
through which the subject is made to waive or appear to waive any of 
the subject's legal rights, or releases or appears to release the 
investigator, the sponsor, the institution, or its agents from 
liability for negligence.
    (b) Basic elements of informed consent. In seeking informed consent 
the following information shall be provided to each subject:
    (1) A statement that the study involves research, an explanation of 
the purposes of the research and the expected duration of the subject's 
participation, a description of the procedures to be followed, and 
identification of any procedures that are experimental;
    (2) A description of any reasonably foreseeable risks or 
discomforts to the subject;
    (3) A description of any benefits to the subject or to others that 
may reasonably be expected from the research;
    (4) A disclosure of appropriate alternative procedures or courses 
of treatment, if any, that might be advantageous to the subject;
    (5) A statement describing the extent, if any, to which 
confidentiality of records identifying the subject will be maintained;
    (6) For research involving more than minimal risk, 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;
    (7) An explanation of whom to contact for answers to pertinent 
questions about the research and research subjects' rights, and whom to 
contact in the event of a research- related injury to the subject;
    (8) A statement that participation is voluntary, refusal to 
participate will involve no penalty or loss of benefits to which the 
subject is otherwise entitled, and the subject may discontinue 
participation at any time without penalty or loss of benefits to which 
the subject is otherwise entitled; and
    (9) One of the following statements about any research that 
involves the collection of identifiable private information or 
identifiable biospecimens:
    (i) A statement that identifiers might be removed from the 
identifiable private information or identifiable biospecimens and that, 
after such removal, the information or biospecimens could be used for 
future research studies or distributed to another investigator for 
future research studies without additional informed consent from the 
subject, if this might be a possibility; or
    (ii) A statement that the subject's information or biospecimens 
collected as part of the research, even if identifiers are removed, 
will not be used or distributed for future research studies.
    (c) Additional elements of informed consent. One or more of the 
following elements of information, when appropriate, shall also be 
provided to each subject:
    (1) A statement that the particular treatment or procedure may 
involve risks to the subject (or to the embryo or fetus, if the subject 
may become pregnant) that are currently unforeseeable;
    (2) Anticipated circumstances under which the subject's 
participation may be terminated by the investigator without regard to 
the subject's consent;

[[Page 35323]]

    (3) Any additional costs to the subject that may result from 
participation in the research;
    (4) The consequences of a subject's decision to withdraw from the 
research and procedures for orderly termination of participation by the 
subject;
    (5) A statement that significant new findings developed during the 
course of the research that may relate to the subject's willingness to 
continue participation will be provided to the subject;
    (6) The approximate number of subjects involved in the study;
    (7) A statement that the subject's biospecimens (even if 
identifiers are removed) may be used for commercial profit and whether 
the subject will or will not share in this commercial profit;
    (8) A statement regarding whether clinically relevant research 
results, including individual research results, will be disclosed to 
subjects, and if so, under what conditions; and
    (9) For research involving biospecimens, whether the research will 
(if known) or might include whole genome sequencing (i.e., sequencing 
of a human germline or somatic specimen with the intent to generate the 
genome or exome sequence of that specimen).
    (d) Elements of broad consent for the storage, maintenance, and 
secondary research use of identifiable private information or 
identifiable biospecimens. Broad consent for the storage, maintenance, 
and secondary research use of identifiable private information or 
identifiable biospecimens (collected for either research studies other 
than the proposed research or non-research purposes) is permitted as an 
alternative to the informed consent requirements in paragraphs (b) and 
(c) of this section. Broad consent is only permitted for the purposes 
mentioned and may not be substituted for the elements of informed 
consent in paragraphs (b) and (c) of this section, as required for the 
intentional exposure research subject to this subpart. If the subject 
is asked to provide broad consent, in addition to providing the 
informed consent required in paragraphs (b) and (c), the following 
shall be provided to each subject:
    (1) The information required in paragraphs (b)(2), (3), (5), and 
(8) and, when appropriate, (c)(7) and (9) of this section;
    (2) A general description of the types of research that may be 
conducted with the identifiable private information or identifiable 
biospecimens. This description must include sufficient information such 
that a reasonable person would expect that the broad consent would 
permit the types of research conducted;
    (3) A description of the identifiable private information or 
identifiable biospecimens that might be used in research, whether 
sharing of identifiable private information or identifiable 
biospecimens might occur, and the types of institutions or researchers 
that might conduct research with the identifiable private information 
or identifiable biospecimens;
    (4) A description of the period of time that the identifiable 
private information or identifiable biospecimens may be stored and 
maintained (which period of time could be indefinite), and a 
description of the period of time that the identifiable private 
information or identifiable biospecimens may be used for research 
purposes (which period of time could be indefinite);
    (5) Unless the subject will be provided details about specific 
research studies, a statement that they will not be informed of the 
details of any specific research studies that might be conducted using 
the subject's identifiable private information or identifiable 
biospecimens, including the purposes of the research, and that they 
might have chosen not to consent to some of those specific research 
studies;
    (6) Unless it is known that clinically relevant research results, 
including individual research results, will be disclosed to the subject 
in all circumstances, a statement that such results may not be 
disclosed to the subject; and
    (7) An explanation of whom to contact for answers to questions 
about the subject's rights and about storage and use of the subject's 
identifiable private information or identifiable biospecimens, and whom 
to contact in the event of a research-related harm.
    (e) Screening, recruiting, or determining eligibility. An IRB may 
approve a research proposal in which an investigator will obtain 
information or biospecimens for the purpose of screening, recruiting, 
or determining the eligibility of prospective subjects without the 
informed consent of the prospective subject, if either of the following 
conditions are met:
    (1) The investigator will obtain information through oral or 
written communication with the prospective subject, or
    (2) The investigator will obtain identifiable private information 
or identifiable biospecimens by accessing records or stored 
identifiable biospecimens.
    (f) Preemption. The informed consent requirements in this subpart 
are not intended to preempt any applicable Federal, state, or local 
laws (including tribal laws passed by the official governing body of an 
American Indian or Alaska Native tribe) that require additional 
information to be disclosed in order for informed consent to be legally 
effective.
    (g) Emergency medical care. Nothing in this subpart is intended to 
limit the authority of a physician to provide emergency medical care, 
to the extent the physician is permitted to do so under applicable 
Federal, state, or local law (including tribal law passed by the 
official governing body of an American Indian or Alaska Native tribe).
    (h) Additional information for subjects when research involves a 
pesticide. 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.


Sec.  26.1117  Documentation of informed consent.

    (a) Informed consent shall be documented by the use of a written 
consent form approved by the IRB and signed (including in an electronic 
format) by the subject. A written copy shall be given to the subject.
    (b) The informed consent form may be either of the following:
    (1) A written informed consent form that meets the requirements of 
Sec.  26.1116. The investigator shall give the subject adequate 
opportunity to read the informed consent form before it is signed; 
alternatively, this form may be read to the subject.
    (2) A short form written informed consent form stating that the 
elements of informed consent required by Sec.  26.1116 have been 
presented orally to the subject, and that the key information required 
by Sec.  26.1116(a)(5)(i) was presented first to the subject, before 
other information, if any, was provided. The IRB shall approve a 
written summary of what is to be said to the subject. When this method 
is used, there shall be a witness to the oral presentation. Only the 
short form itself is to be signed by the subject. However, the witness 
shall sign both the short form and a copy of the summary, and the 
person actually obtaining consent shall sign a copy of the summary. A 
copy of the summary must be given to the subject, in addition to a copy 
of the short form.


Sec.  Sec.  26.1118-26.1122  [Reserved]


Sec.  26.1123  Early termination of research.

    The Administrator may require that any project covered by this 
subpart be terminated or suspended when the

[[Page 35324]]

Administrator finds that an IRB, investigator, sponsor, or institution 
has materially failed to comply with the terms of this subpart.


Sec.  26.1124  [Reserved]


Sec.  26.1125  Prior submission of proposed human research for EPA 
review.

    Any person or institution who intends to conduct or sponsor human 
research covered by Sec.  26.1101(a) shall, after receiving approval 
from all appropriate IRBs, submit to EPA prior to initiating such 
research all information relevant to the proposed research specified by 
Sec.  26.1115(a), and the following additional information, to the 
extent not already included:
    (a) A discussion of:
    (1) The potential risks to human subjects;
    (2) The measures proposed to minimize risks to the human subjects;
    (3) The nature and magnitude of all expected benefits of such 
research, and to whom they would accrue;
    (4) Alternative means of obtaining information comparable to what 
would be collected through the proposed research; and
    (5) The balance of risks and benefits of the proposed research.
    (b) All information for subjects and written informed consent 
agreements as originally provided to the IRB, and as approved by the 
IRB.
    (c) Information about how subjects will be recruited, including any 
advertisements proposed to be used.
    (d) A description of the circumstances and methods proposed for 
presenting information to potential human subjects for the purpose of 
obtaining their informed consent.
    (e) All correspondence between the IRB and the investigators or 
sponsors.
    (f) Official notification to the sponsor or investigator, in 
accordance with the requirements of this subpart, that research 
involving human subjects has been reviewed and approved by an IRB.

0
7. Revise Sec.  26.1302 to read as follows:


Sec.  [thinsp]26.1302  Definitions.

    The definitions in Sec.  26.1102 apply to this subpart as well.

[FR Doc. 2019-15665 Filed 7-22-19; 8:45 am]
BILLING CODE 6560-50-P