Protection of Human Research Subjects, 62760-62771 [2018-26228]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)]
[Proposed Rules]
[Pages 62760-62771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26228]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 26

[EPA-HQ-ORD-2018-0280; FRL-9987-01-ORD]
RIN 2080-AA13


Protection of Human Research Subjects

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed 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,'' which is based on regulations for the protection 
of human research subjects originally promulgated by the Department of 
Health and Human Services (HHS) that were then revised and jointly 
adopted by multiple departments and agencies that conduct or support 
research involving human subjects. EPA's codification of these 
revisions is in 40 CFR part 26, subpart A. These revisions will go into 
effect 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

[[Page 62761]]

Rule create a discrepancy within some of these EPA-specific 
regulations. This proposed action is to harmonize the EPA-specific 
regulations with revisions to the Common Rule in order to resolve those 
discrepancies.

DATES: Comments must be received on or before February 4, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
ORD-2018-0280, at https://www.regulations.gov. Follow the online 
instructions for submitting comments. Once submitted, comments cannot 
be edited or removed from Regulations.gov. The EPA may publish any 
comment received to its public docket. Do not submit electronically any 
information you consider to be Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. 
Multimedia submissions (audio, video, etc.) must be accompanied by a 
written comment. The written comment is considered the official comment 
and should include discussion of all points you wish to make. The EPA 
will generally not consider comments or comment contents located 
outside of the primary submission (i.e. on the web, cloud, or other 
file sharing system). For additional submission methods, the full EPA 
public comment policy, information about CBI or multimedia submissions, 
and general guidance on making effective comments, please visit https://www2.epa.gov/dockets/commenting-epa-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: 202-560-
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 proposing to amend subparts C, D, K, and M of its 
regulations relating to human research. These changes are intended to 
correct regulatory citation references in subparts C and D that have 
been rendered ineffective by the revisions to the Common Rule, 82 FR 
7149 (Jan. 19, 2017), codified by EPA at 40 CFR part 26, subpart A, and 
to harmonize language in subpart K with those revisions, where 
appropriate. Finally, there is a single typographical error in subpart 
M that should be corrected while this action is being undertaken.
    Subparts C and D refer back to provisions in the Common Rule 
codified at subpart A, and, in light of the revisions to the Common 
Rule, several numerical citations (i.e., regulatory reference numbers) 
in subparts C and D are no longer accurate and need to be updated.
    Subpart K, in establishing a process for review of third-party 
research involving intentional exposure of human subjects, borrows 
heavily from the provisions contained in the previous version of the 
Common Rule. The proposed amendments would allow the Agency to align 
subpart K with the revised Common Rule and maintain consistency of 
Institutional Review Board (IRB) review between agency-conducted or 
agency-sponsored human research and third-party human research.
    Failure to resolve these discrepancies will create confusion and, 
more seriously, potential compliance and/or legal liabilities for 
researchers, institutions, and sponsors who must follow EPA 
regulations. In the absence of the proposed revisions to EPA-specific 
subparts, there will effectively be two conflicting sets of regulations 
to follow, once the Common Rule changes are reflected in subpart A and 
compliance is required. These changes will reduce regulatory burdens 
and potential confusion among the regulated community about which 
standards to apply by enhancing consistency among those standards. In 
addition, as discussed in the final rule amending the Common Rule, the 
proposed amendments would enhance protections for human subjects and 
improving consistency means that similar protections for human subjects 
apply, regardless of who is conducting the study.

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

    The proposed rule described in this document is authorized under 
provisions of the following statutes that EPA administers. The proposed 
amendments to EPA's codification of the Common Rule and other 
provisions regarding first- and second-party research are authorized 
pursuant to 5 U.S.C. 301; the underlying Common Rule also cites to 42 
U.S.C. 300v-1(b) as authority for the revisions to the Common Rule 
provisions. The proposed amendments to regulations governing 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 the following statutory 
provisions. Section 3(a) of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) authorizes EPA to regulate the distribution, 
sale, or use of any unregistered pesticide in any State ``[t]o the 
extent necessary to prevent unreasonable adverse effects on the 
environment'' (defined at FIFRA section 2(bb), in pertinent part, as 
``any unreasonable risk to man or the environment, taking into account 
the economic, social, and environmental costs and benefits of the use 
of any pesticide''). 7 U.S.C. 136a(a) and 136(bb). In addition, section 
25(a) of FIFRA authorizes EPA to ``prescribe regulations to carry out 
the provisions of [FIFRA].'' Id. at Sec.  136w(a). Section 408(e)(1)(C) 
of the Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes the 
Administrator to issue a regulation establishing ``general procedures 
and requirements to implement [Section 408].'' 21 U.S.C. 346a(e)(1)(C).
    EPA has also used the authority provided in section 201 of the 
Department of the Interior, Environment, and Related Agencies 
Appropriations Act, 2006, Public Law 109-54 (2006 Appropriations Act) 
to promulgate the subparts B through Q of EPA's regulations at part 26.
    Public Law 109-54, 201, 119 Stat. 499, 531 (Aug. 2, 2005). In the 
2006 Appropriations Act, Congress directed EPA to promulgate a rule on 
``third-party intentional dosing human toxicity studies for pesticides 
. . . '', prohibiting the use of pregnant women, infants or children as 
subjects, consistent with the principles proposed in the 2004 report of 
the National Academy of Sciences on intentional human dosing and the 
principles of the Nuremberg Code, and establishing an independent Human 
Subjects Review Board. Id.

II. Background

A. Common Rule

    In 1991, 15 federal departments and agencies, including EPA, 
adopted a set of regulations intended to create a uniform body of 
regulations across the federal government for the protection of human 
subjects involved in research. See 56 FR 28003 (June 18, 1991).

[[Page 62762]]

Patterned after the regulations originally promulgated by HHS under 45 
CFR part 46, this set of regulations was titled the ``Federal Policy 
for the Protection of Human Subjects'' and is commonly referred to as 
the ``Common Rule.'' The Common Rule regulations were subsequently 
promulgated into each federal department's or agency's own set of 
regulations and implemented, and are enforced at the individual 
department or agency level. EPA codified the Common Rule provisions at 
40 CFR part 26, subpart A.
    A number of changes in research involving human subjects have 
occurred since the Common Rule was initially adopted in 1991. In 2011, 
the Office of the Secretary of HHS, in coordination with the Executive 
Office of the President's Office of Science and Technology Policy, 
published an advance notice of proposed rulemaking, seeking comment on 
areas where revisions to the Common Rule might be warranted. See 76 FR 
44512 (Jul. 26, 2011). Then in 2015, HHS and the other Common Rule 
agencies issued a notice of proposed rulemaking, proposing and seeking 
comment on several potential regulatory revisions to the Common Rule. 
See 80 FR 53931 (Sept. 8, 2015).
    On January 19, 2017, all Common Rule agencies and departments, 
including EPA, adopted several revisions intended to ``modernize, 
strengthen, and make [the Common Rule] more effective''. See 82 FR 7149 
(Jan. 19, 2017). The preamble to the final rule noted that the 
revisions are ``intended to better protect human subjects involved in 
research, while facilitating valuable research and reducing burden, 
delay, and ambiguity for investigators.'' Id. In brief, the January 
2017 revisions 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 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. There are currently 20 Federal agencies and 
departments that are signatories or have otherwise adopted the Common 
Rule.
    The January 19, 2017 rule stated that its effective date and 
compliance date would be January 19, 2018, with the exception of one 
section (Sec.  _.114(b) (cooperative research)), which would have a 
compliance date of January 20, 2020. Id. at 7274. The effective date 
and January 19, 2018 compliance date were delayed until July 19, 2018, 
through an interim final rule. See 83 FR 2885 (Jan. 22, 2018). Further 
delay of the compliance date until January 21, 2019, was proposed in a 
notice of proposed rulemaking, see 83 FR 17595 (Apr. 20, 2018), and 
finalized on June 19, 2018. See 83 FR 28497.

B. EPA's Human Studies Subparts

    In addition to the Common Rule (subpart A), EPA has adopted several 
additional subparts to the rule at 40 CFR 26 that provide enhanced 
protection for participants in human research conducted or supported by 
EPA, or certain types of third party research. These EPA-specific 
subparts were added in 2006 in response to a Congressional mandate. See 
EPA, Protections for Subjects in Human Research, 71 FR 6138 (Feb. 6, 
2006). Specifically, Congress prohibited EPA use of certain 
appropriated funds until EPA issued a rule on the subject of EPA's 
acceptance, consideration, or reliance on third-party intentional 
dosing human toxicity studies for pesticides. Congress mandated three 
requirements for EPA's rule: (1) Prohibit the use of pregnant women, 
infants or children as subjects; (2) be consistent with the principles 
proposed in the 2004 report of National Academy of Sciences 
``Intentional Human Dosing Studies for EPA Regulatory Purposes: 
Scientific and Ethical Issues'' and the principles of the Nuremberg 
Code; and (3) establish an independent Human Subjects Review Board. See 
Public Law 109-54.
    In accordance with that mandate, EPA created several regulatory 
subparts in addition to subpart A. Subparts B through D govern research 
conducted or sponsored by EPA involving pregnant or nursing women and 
children. Specifically, subpart B categorically prohibits any EPA-
conducted or EPA-sponsored research involving intentional exposure to 
any substance of human subjects who are children or pregnant or nursing 
women; subparts C and D provide extra protections for pregnant women 
and for children who are the subjects of observational research 
conducted or supported by EPA.
    EPA also created several subparts, K through Q, governing third-
party pesticide research and EPA's reliance on research involving 
intentional exposure of human subjects. EPA concluded that it was 
appropriate to apply equivalent ethical standards to EPA-conducted and 
EPA-sponsored research, as well as to third-party research and thus in 
subpart K, extended the Common Rule provisions to third-party human 
research involving intentional exposure of non-pregnant, non-nursing 
adults relevant to pesticide regulatory decision-making. See 70 FR 
53838, 53845 (Sept. 12, 2005). EPA copied the requirements from the 
Common Rule into a new subpart K with a parallel numbering system to 
the Common Rule, making minor modifications that reflected the more 
limited set of human research subject to subpart K. For a discussion of 
those minor modifications, see 71 FR at 6147. The other subparts 
prohibited use of pregnant or nursing women or children as human 
subjects in third-party research involving intentional exposure 
(subpart L); established requirements for submission of information on 
the ethical conduct of completed human research (subpart M); 
established provisions to address noncompliance of an IRB or 
institution (subpart O); established a Human Studies Review Board 
(HSRB) and standards for EPA and HSRB review of proposed and completed 
research involving intentional exposure (subpart P); and standards for 
EPA reliance on such studies (subpart Q).
    Additional modifications to subparts K through Q were made in 2013. 
Among those modifications were broadening its applicability to 
decision-making outside the scope of the pesticide laws and eliminating 
the option for a ``legally authorized representative'' to provide 
informed consent for a human subject within the context of third-party 
research involving intentional exposure to pesticides or submitted for 
pesticide decision making. See 78 FR 10538, 10538-39 (Feb. 14, 2013).

III. Proposed Amendments and Request for Comment

    This section of the preamble provides a description of the proposed 
changes to subparts C, D, K, and M. In sum, the rationale for revisions 
to subparts C, D, and K is to ensure consistency with the revisions to 
40 CFR part 26, subpart A, i.e., the Common Rule; the rationale for the 
revision to subpart M is to correct a minor typographical error.

A. Harmonizing Subparts C and D With the Revised Common Rule

    Subpart C: Subpart C, which sets forth additional protections for 
pregnant women and fetuses involved as subjects in observational 
research conducted or supported by EPA, refers back to subpart A in 
several provisions. First, the text at Sec.  [thinsp]26.301(b) provides 
that the exemptions found in the Common Rule are applicable to the 
observational

[[Page 62763]]

research studies covered by subpart C. The purpose of these exemptions 
is to provide a mechanism to allow for the conduct of research that is 
of such low risk that full IRB review and related processes are not 
warranted and would only serve to inhibit research without adding 
meaningful protections for human subjects. Recognizing this, the Common 
Rule pre-emptively identifies several categories of research (including 
much educational and social science research, simple surveys, and use 
of existing data or records) that are exempt from the full set of 
regulatory requirements that follow. In the revised Common Rule, the 
exempt categories were revised and expanded and moved to a different 
section number. Without a regulatory correction, EPA's regulations 
would no longer reference the section describing exempt research. Thus, 
a study involving an innocuous survey would no longer be eligible for 
exemption, and EPA researchers or grantees for such studies would need 
to comply with the full requirements of the Common Rule, in contrast to 
other federal agencies and grantees, which would be able to proceed 
with such research outside the scope of the Common Rule.
    The second change required to subpart C is found in Sec.  
[thinsp]26.301(c), which refers back to the general provisions of the 
Common Rule. The revised Common Rule contains several new provisions, 
including a new reference to tribal laws in the preemption provision of 
the Common Rule found at Sec.  26.101(f). EPA had initially added a 
provision to its subpart clarifying that tribal laws are not preempted, 
but this addition is no longer necessary, with updates to the Common 
Rule. Specifically, the revised Common Rule provides that: ``This 
policy 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).'' (Emphasis added). The 
italicized language is new, and renders redundant and unnecessary EPA's 
previous statement to the same effect. In addition, the Common Rule 
contains new provisions on the effective and compliance dates of the 
revised Common Rule and severability, that must also be included in 
subpart C for consistency in implementation.
    Subpart D: Like subpart C, subpart D also incorporates by reference 
the exemptions found in subpart A. Specifically, Sec.  
[thinsp]26.401(b) lists the applicable exemptions in subpart A that are 
also applicable to subpart D. Unlike subpart C, however, subpart D, 
which provides additional protections for children involved as subjects 
in observational research conducted or supported by EPA, provides that 
the Common Rule exemption for research involving survey or interview 
procedures or observations of public behavior does not apply to 
research covered by subpart D, except in limited circumstances. Changes 
to the relevant section numbers are needed to preserve access to the 
exemptions incorporated by reference, as well as the provision limiting 
the application in research involving children. In addition, changes 
are needed to Sec.  [thinsp]26.401(a) and (c), respectively, to remove 
the now- unnecessary clarification regarding preemption of tribal laws 
and to include reference to the new general provisions in the Common 
Rule, including the effective date information provision.
    In practice, failing to amend subparts C and D, especially with 
respect to ensuring that the applicable exemptions in subpart A are 
accurately incorporated by reference, would greatly complicate the 
conduct of the above types of studies that have little to no risk, 
without commensurate benefit for their subjects. It would also place 
EPA at odds with the scientists and institutions conducting EPA-
sponsored research, and their IRBs that review the studies, all of whom 
will be applying the new Common Rule.

B. Harmonizing Subpart K With the Revised Common Rule

    As noted above, when establishing new regulations for third-party 
research in 2006, EPA determined that it was appropriate to extend the 
Common Rule provisions to third-party research, so that equivalent 
ethical standards were applied to both research conducted and supported 
by EPA and by third parties. See 70 FR at 53845. At the same time, EPA 
narrowed the extension of the Common Rule provisions by limiting the 
scope of subpart K to third-party research involving intentional 
exposure of human subjects to pesticides and intended to be submitted 
to EPA under the pesticide laws and made minor modifications to those 
provisions to reflect the narrower scope of studies in subpart K. See 
id.
    With the adoption of revisions to the Common Rule, EPA believes 
that many of the Common Rule revisions should again be extended to 
subpart K for the same reasons that EPA adopted Common Rule provisions 
for the original subpart K. The Common Rule amendments, as noted above, 
are intended to accommodate changes in the field of human research and 
to better protect human subjects, while facilitating research and 
reducing burden and delay. Those revisions can similarly apply to 
research subject to subpart K. EPA continues to believe that it is 
appropriate for third-party research to be held to equivalent ethical 
standards as research conducted or supported by EPA. In addition, EPA 
recognizes the efficiencies in having equivalent or similar standards 
for regulating the ethical conduct of research involving human 
subjects, regardless of who conducts that research, and the confusion 
that might arise if standards are different. Many investigators and 
their IRBs will be following the revised Common Rule in non-EPA 
research and in EPA-sponsored research. Increased variability in 
standards will likely impose greater burden on the regulated community 
to keep straight and apply the different standards for review of 
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.
    Accordingly, EPA proposes to adopt the revisions finalized for the 
Common Rule in January 19, 2017, with a few exceptions that are not 
relevant or appropriate given the scope of subpart K. The same 
considerations that informed the original drafting of subpart K and the 
reasons for the 2013 revisions, as mentioned above, inform the 
harmonization of subpart K with the applicable provisions of the 
revised Common Rule. As with the original drafting of subpart K, there 
are some elements of the broader Common Rule that are not applicable to 
the particular subset of research subject to EPA's subpart K, and 
inclusion of these provisions would be confusing and problematic. These 
exceptions include definitions that did not apply to third-party 
studies; categories of exempt research that are not relevant to third-
party studies; requirements for Federal Register notifications that 
would be redundant with the HSRB process; references to research 
involving pregnant women, fetuses or children that would not be allowed 
under subpart L; and provisions for alteration or waiver of informed 
consent. For various reasons, these provisions would generally not be 
appropriate or permissible for intentional exposure studies, so those 
provisions are not included in the proposed amendments to subpart K. 
EPA already determined that waiver of informed consent and consent by 
legally authorized representative are not appropriate for intentional 
exposure studies, nor would such studies be eligible for exemption,

[[Page 62764]]

so these options are not offered under subpart K. See 71 FR at 6148; 76 
FR at 5744-45.
    EPA is proposing to adopt the broad consent provisions, which were 
newly added in the revised Common Rule, with a clarifying statement. 
There was concern that the Common Rule reference to broad consent as an 
``alternative'' to the informed consent requirements might lead to 
mistaken use as a replacement for, rather than an adjunct to, full 
informed consent. Because this would never be appropriate for an 
intentional exposure study of the type regulated under this EPA-
specific subpart, a statement was added to clarify and confirm that the 
option to obtain broad consent for the limited purposes of storage, 
maintenance and secondary research use of identifiable private 
information or identifiable biospecimens is not a replacement for 
obtaining full informed consent for the primary research involving 
intentional exposure of a human subject that is subject to subpart K.
    Another similarity with the Common Rule revisions is that EPA 
intends that the proposed amendments to subpart K to apply 
prospectively, i.e., to research subject to subpart K that is initiated 
after the final rule goes into effect. As such, EPA proposes to replace 
the date in section 26.1101(a) with the date the final rule becomes 
effective. This revision would not eliminate the prior obligation any 
third-party had to comply with subpart K if it was conducting or 
sponsoring research involving intentional exposure to human subjects 
covered by subpart K that was initiated prior to that date; such 
research would have had to comply with the EPA regulations in effect at 
the time the research was initiated. Clarity on this point is 
significant because, in contrast to other Common Rule agencies, EPA's 
regulations also require a retrospective analysis of completed research 
involving intentional exposure to human subjects before EPA may rely on 
any such research. Specifically, section 26.1705 of EPA's regulations 
applies to research that was subject to EPA's rules ``at the time it 
was conducted'' and requires that EPA determine, among other things, 
that certain completed research involving intentional exposure of human 
subjects was conducted in substantial compliance with ``[a]ll 
applicable provisions of subparts A through L . . . .'' 40 CFR 26.1705. 
It is important to be clear about the scope of research subject to this 
retrospective review and to ensure that the research subject to the 
retrospective review is evaluated under the appropriate standards. To 
avoid the misinterpretation that subpart K no longer applies to 
research initiated before the effective date of the final rule and to 
avoid the retrospective application of newer regulatory requirements, 
EPA is proposing to add a new paragraph (h) to Sec.  26.1101, 
clarifying that research initiated before the effective date of the 
final rule would be subject to the standards of EPA's regulations that 
were in effect at the time the research was initiated.

C. Correcting Error in Subpart M

    The existing text at 40 CFR 26.1302 reads, ``[t]he definitions in 
Sec.  26.102 apply to this subpart as well.'' EPA is proposing to amend 
this text to reference the definitions in subpart K, which are found at 
Sec.  26.1102, instead of the definitions in subpart A, found at Sec.  
26.102. With the exception of subpart M, all EPA subparts from L to Q 
refer to the definitions in subpart K, which include terms necessary 
and relevant to these EPA-specific subparts. Subpart M was intended to 
reference the same set of definitions. See 71 FR at 6147 (indicating 
that definition in section 26.1102 was intended to apply to subpart M). 
This was a typographical error at the time of original drafting, which 
EPA is proposing to correct.

IV. FIFRA Review Requirements

    In accordance with FIFRA section 25(a), EPA has submitted a draft 
of the proposed rule to the FIFRA Scientific Advisory Panel (SAP), the 
Secretary of Agriculture (USDA), and appropriate Congressional 
Committees. The SAP waived its review on June 4, 2018. USDA responded 
on July 3, 2018 and had no substantive comments on the proposal. Both 
responses are in the docket for this rulemaking.

V. 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

    This action is a significant regulatory action that was submitted 
to the Office of Management and Budget (OMB) for review. Any changes 
made in response to OMB recommendations have been documented in the 
docket for this rulemaking as required by the Executive Order.
    The incremental costs of these proposed amendments both to industry 
and to EPA are expected to be negligible, including the costs to 
industry related to informed consent documentation and the cost to EPA 
of reviewing research submitted under the revised subpart K 
requirements. Entities who would be impacted by the proposed amendments 
have already been accounted for in previous economic analyses for the 
revised Common Rule and the 2006 and 2013 EPA rulemakings concerning 
human subjects research. EPA has not, therefore, prepared a new 
economic analysis for this rulemaking. The cost estimates for complying 
with the 2006 rule were incremental costs of $39,000 for industry and 
$808,000 for EPA (71 FR at 6166), and the costs for the 2013 amendments 
were estimated to be negligible (76 FR at 5751). The costs and benefits 
associated with implementing these proposed amendments, particularly 
those linked to IRBs, have already been captured by the economic 
analysis for the Common Rule. The costs for this rule include costs for 
some additional parties, i.e., third-party investigators, who may need 
to spend some time familiarizing themselves with the new requirements, 
but these costs will be negligible \1\ and outweighed by the benefits 
to the regulated community of having consistent standards applied to 
third-party studies. In addition to providing equally protective 
ethical standards to the human subjects of third-party intentional 
exposure research, the benefits of greater consistency will improve 
efficiencies in the oversight and review of human research, improve 
understanding of the standards that apply, and reduce the potential for 
misapplication of standards. This proposal provides no basis on which 
to revise the cost estimates that were provided in the economic 
analysis for the 2006 rulemaking or those most recently provided in the 
2013 renewal of the Information Collection Request (ICR) for the 
existing regulation at 40 CFR part 26.
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    \1\ The revised Common Rule economic analysis, which included 
more revisions than proposed in this document, estimated that 
affected individuals would spend five hours to familiarize 
themselves with the changes. See 82 FR at 7238.
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B. Executive Order 13771: Reducing Regulation and Controlling 
Regulatory Costs

    This action is not expected to be subject to Executive Order 13771 
because this proposed rule is expected to result in no more than de 
minimis costs.

[[Page 62765]]

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 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'' (Jan. 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 proposed 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 
proposed amendments.

List of Subjects in 40 CFR Part 26

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

    Dated: November 16, 2018.
Andrew R. Wheeler,
Acting Administrator.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 26--[AMENDED]

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.  [thinsp]26.301  To what does this subpart apply?

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

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


Sec.  [thinsp]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.  [thinsp]26.104(d)(1) and (d)(3) through 
(d)(8) are applicable to this subpart. The exemption at Sec.  
[thinsp]26.104(d)(2) regarding educational tests is also applicable to 
this subpart. However, the exemption at Sec.  [thinsp]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.  [thinsp]26.402   [Amended]

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

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


Sec.  [thinsp]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.  
[thinsp]26.116(e).
* * * * *

0
6. Revise subpart K, consisting of Sec. Sec.  26.1101 through 26.1125, 
to read as follows:

[[Page 62766]]

PART 26--PROTECTION OF HUMAN RESEARCH SUBJECTS

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


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 [effective date 
for final rule] 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), 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 [effective date of final rule] 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

[[Page 62767]]

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 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.

[[Page 62768]]

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 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.

[[Page 62769]]

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.


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

[[Page 62770]]

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;
    (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 paragraph (b) and (c), the following shall 
be provided to each subject:
    (1) The information required in paragraphs (b)(2), (b)(3), (b)(5), 
and (b)(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

[[Page 62771]]

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 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. 2018-26228 Filed 12-4-18; 8:45 am]
 BILLING CODE 6560-50-P