Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations 28497 

DEPARTMENT OF HOMELAND 

SECURITY 

6 CFR Part 46 

DEPARTMENT OF AGRICULTURE 

7 CFR Part 1c 

DEPARTMENT OF ENERGY 

10 CFR Part 745 

NATIONAL AERONAUTICS AND 

SPACE ADMINISTRATION 

14 CFR Part 1230 

DEPARTMENT OF COMMERCE 

15 CFR Part 27 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1028 

SOCIAL SECURITY ADMINISTRATION 

20 CFR Part 431 

AGENCY FOR INTERNATIONAL 

DEVELOPMENT 

22 CFR Part 225 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

24 CFR Part 60 

DEPARTMENT OF LABOR 

29 CFR Part 21 

DEPARTMENT OF DEFENSE 

32 CFR Part 219 

DEPARTMENT OF EDUCATION 

34 CFR Part 97 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 16 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 26 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 46 

RIN 0937–AA05 

NATIONAL SCIENCE FOUNDATION 

45 CFR Part 690 

DEPARTMENT OF TRANSPORTATION 

49 CFR Part 11 

Federal Policy for the Protection of 

Human Subjects: Six Month Delay of 

the General Compliance Date of 

Revisions While Allowing the Use of 

Three Burden-Reducing Provisions 

During the Delay Period 

AGENCY: Department of Homeland 

Security; Department of Agriculture; 

Department of Energy; National 

Aeronautics and Space Administration; 

Department of Commerce; Consumer 

Product Safety Commission; Social 

Security Administration; Agency for 

International Development; Department 

of Housing and Urban Development; 

Department of Labor; Department of 

Defense; Department of Education; 

Department of Veterans Affairs; 

Environmental Protection Agency; 

Department of Health and Human 

Services; National Science Foundation; 

and Department of Transportation. 

ACTION: Final rule. 

SUMMARY: In a final rule published on 

January 19, 2017, a number of federal 

departments and agencies revised to the 

Federal Policy for the Protection of 

Human Subjects (often referred to as the 

‘‘Common Rule’’), which each 

department and agency adopted into 

regulations in its part of the Code of 

Federal Regulations (CFR). The 

Consumer Product Safety Commission 

(CPSC) adopted the same changes in a 

final rule published on September 18, 

2017. The revised Common Rule was 

scheduled to become effective on 

January 19, 2018, with a general 

compliance date of the same date. By an 

interim final rule issued on January 17, 

2018 and published in the Federal 

Register on January 22, 2018, federal 

departments and agencies delayed the 

effective date and the general 

compliance date for the revised 

Common Rule for a 6-month period, 

until July 19, 2018. The Department of 

Housing and Urban Development (HUD) 

published an interim final rule adopting 

the same regulatory changes on January 

26, 2018. The revised Common Rule, 

including technical amendments made 

by the January 22, 2018 interim final 

rule, is referred to here as the ‘‘2018 

Requirements.’’ 

On April 20, 2018, the federal 

departments and agencies listed here 

published a notice of proposed 

rulemaking (NPRM) proposing and 

seeking comments as to whether the 

general compliance date for the 2018 

Requirements should be delayed for an 

additional 6-month period. The NPRM 

also proposed and sought comments on 

whether to allow regulated entities to 

implement certain burden-reducing 

provisions of the 2018 Requirements in 

specified circumstances during such 

continued delay period. 

Through this final rule, we are 

adopting the proposals described in the 

April 20, 2018 NPRM. This rule delays 

the general compliance date for the 2018 

Requirements for an additional 6-month 

period, until January 21, 2019. As a 

result of this delay, regulated entities 

will be required, with an exception, to 

continue to comply with the 

requirements of the pre-2018 version of 

the Federal Policy for the Protection of 

Human Subjects (the ‘‘pre-2018 

Requirements’’) until January 21, 2019. 

The one exception to this general rule 

is that institutions will be permitted 

(but not required) to implement, for 

certain research, three burden-reducing 

provisions of the 2018 Requirements 

during the delay period (July 19, 2018, 

through January 20, 2019). Those three 

provisions are: The revised definition of 

‘‘research,’’ which deems certain 

activities not to be research covered by 

the Common Rule; the elimination of 

the requirement for annual continuing 

review with respect to certain categories 

of research; and the elimination of the 

requirement that institutional review 

boards (IRBs) review grant applications 

or other funding proposals related to the 

research. Institutions taking advantage 

of the three-burden reducing provisions 

must comply with all other pre-2018 

Requirements during the delay period. 

The three burden-reducing provisions of 

the 2018 Requirements can only be 

implemented during the delay period 

with respect to studies initiated prior to 

January 21, 2019 that will transition to 

compliance with the revised Common 

Rule. Any study that implements these 

three burden-reducing provisions 

during the delay period must, beginning 

on January 21, 2019, comply with all of 

the 2018 Requirements for the balance 

of the study’s duration. 

DATES: Effective date: This rule is 

effective on July 19, 2018. Compliance 

dates: The general compliance date for 

the 2018 Requirements in the final rule 

published in the Federal Register (82 

FR 7149, Jan. 19, 2017) and of the final 

rule published by the Consumer Product 

Safety Commission in the Federal 

Register (82 FR 43459, Sept. 18, 2017), 

which were delayed in the interim final 

rule published in the Federal Register 

(83 FR 2885, Jan. 22, 2018), and adopted 

by HUD through an interim final rule 

published in the Federal Register (83 

FR 3589, Jan. 26, 2018), with the 

exception of § lll.114(b), is further 

delayed until January 21, 2019. The 


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1See, e.g., the June 21, 2017 letter to Jerry 

Menikoff from the Association of American Medical 

Colleges, Association of American Universities, 

Association of Public & Land-grant Universities, 

and Council on Governmental Relations, available 

at https://www.aamc.org/download/480840/data/ 

aamcissuesjointletteroncommonrule.pdf. 

See the June 9, 2017 letter to Secretary Thomas 

Price from the American Medical Informatics 

Association at https://www.amia.org/sites/default/ 

files/AMIA%20Letter%20Regarding%20the

%20Common%20Rule.pdf. 

See also August 2, 2017 SACHRP Letter to HHS 

Secretary, Attachment A- Recommendations on 

Compliance Dates and Transition Provisions, 

https://www.hhs.gov/ohrp/sachrp-committee/ 

recommendations/attachment/a/august/2/2017/ 

index.html. 

compliance date for §lll.114(b) 

(cooperative research) remains January 

20, 2020. 

ADDRESSES: Jerry Menikoff, M.D., J.D., 

Office for Human Research Protections, 

1101 Wootton Parkway, Suite 200, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Jerry 

Menikoff, M.D., J.D., Office for Human 

Research Protections (OHRP), 

Department of Health and Human 

Services, 1101 Wootton Parkway, Suite 

200, Rockville, MD 20852; telephone: 

240–453–6900 or 1–866–447–4777; 

facsimile: 301–402–2071; email 

Jerry.Menikoff@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On January 19, 2017, the Department 

of Health and Human Services (HHS) 

and other federal departments and 

agencies published a final rule revising 

the Federal Policy for the Protection of 

Human Subjects (generally referred to as 

‘‘the Common Rule’’). 82 FR 7149. The 

CPSC adopted the same regulatory 

changes in a separate final rule 

published on September 18, 2017. 82 FR 

43459. The revised Common Rule was 

originally scheduled to become effective 

on January 19, 2018, with a general 

compliance date of January 19, 2018 

(with the exception of the revisions to 

the cooperative research provision at 

§ lll.114(b), which has a compliance 

date of January 20, 2020). 

Some representatives of the regulated 

community expressed concern regarding 

their ability to implement all of the 2018 

Requirements by the scheduled general 

compliance date.1

On January 17, 2018, HHS and other 

federal departments and agencies placed 

on display at the Office of the Federal 

Register an interim final rule delaying 

the effective date and general 

compliance date of the 2018 

Requirements to July 19, 2018. 83 FR 

2885 (published January 22, 2018). This 

rule did not impact the compliance date 

for the cooperative research provision at 

§ lll.114(b), which remained 

January 20, 2020. On January 26, 2018, 

HUD published an interim final rule 

adopting the interagency interim final 

rule. 83 FR 3589. 

On April 20, 2018, federal 

departments and agencies published a 

notice of proposed rulemaking (NPRM) 

soliciting comments on two proposals. 

83 FR 17595. The first proposed an 

additional 6-month delay for the general 

compliance date for the 2018 

Requirements (from July 19, 2018 to 

January 21, 2019). The second proposed 

a flexibility that would allow regulated 

entities to take advantage of three 

burden-reducing provisions of the 2018 

Requirements during the delay period. 

Both proposals are described more fully 

below, together with a discussion of the 

public comments submitted, and our 

response to public comments. For the 

reasons provided below, this final rule 

adopts the proposals set forth in the 

NPRM. 

II. Public Comments and Response to 

Comments 

A. 2018 Interim Final Rule and 2018 

NPRM Public Comment Summary 

Public comment was solicited on the 

interim final rule between January 22, 

2018 and March 19, 2018. Public 

comment was solicited on the NPRM to 

delay the implementation of the 2018 

Requirements while permitting the use 

of three burden-reducing provisions of 

the 2018 Requirements between April 

20, 2018 and May 21, 2018. 

We received 62 public comments on 

the interim final rule. Of these, 36 

comments were related to the Common 

Rule. The remaining 26 comments were 

not related to the Common Rule in any 

way. We received 73 comments on the 

NPRM. Five of these comments were not 

related to the Common Rule. 

Several common themes emerged 

from the public comments on the 

interim final rule and the NPRM. These 

included: 

—The need for the regulated community 

to have as much advance notice as 

possible about any delay in 

implementing the 2018 Requirements. 

—The need for guidance to be issued 

promptly. 

—General support for a delay of the 

general compliance date, with more 

limited support for a delay beyond 

January, 2019. This support, however, 

was generally tied to concern with 

whether Common Rule departments 

and agencies will be able to issue 

guidance in a timely fashion prior to 

the new general compliance date of 

January 21, 2019. 

Both sets of comments tended to 

endorse some type of delay beyond July 

19, 2018 in the general compliance date 

for the 2018 Requirements. Comments 

on the interim final rule tended to 

suggest that institutions be permitted to 

voluntarily implement the 2018 

Requirements in their entirety at any 

time after July 19, 2018, while 

comments on the NPRM indicated broad 

support for the narrower approach of 

permitting the voluntary use of three 

burden-reducing provisions during the 

delay period. 

B. Public Comments on the January 22, 

2018 Interim Final Rule and Response 

to Comments 

As well as soliciting comments on the 

delay of the implementation of the 2018 

Requirements, the interim final rule 

solicited comments on the following: 

—Whether or not the interim final rule 

should be considered regulatory or 

de-regulatory. 

—Whether or not our assumption that 

50 percent of regulated entities would 

have gone forward using the new or 

expanded exemption categories, had 

the implementation date of the 2018 

Requirements remained January 19, 

2018, was correct. 

We received no comments on our 

assumption that 50 percent of regulated 

entities would have gone forward using 

the new or expanded exemption 

categories had the implementation date 

of the 2018 Requirements remained 

January 19, 2018. We received one 

comment addressing whether or not the 

interim final rule should be considered 

regulatory or de-regulatory. This 

comment indicated that the 2018 

Requirements should be considered deregulatory, without commenting on the 

regulatory or de-regulatory status of the 

interim final rule. 

Of the 36 comments received on the 

interim final rule related to the Common 

Rule (and more specifically on delaying 

the effective and general compliance 

dates of the 2018 Requirements to July 

19, 2018), several themes were present. 

Many of these comments discussed 

issues with the timing and issuance of 

the interim final rule, claiming that the 

fact that it was put on public display in 

the Federal Register 48 hours before the 

original implementation date caused 

chaos and confusion in the regulated 

community. Several commenters 

described what they categorized as 

chaos that ensued when the interim 

final rule was put on public display 48 

hours before the original effective date 

and general compliance date for the 

2018 Requirements. This rollout created 

administrative burdens for institutions, 


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as many had changed IT systems, 

training programs, and other operational 

tasks and then had to hastily undo these 

changes. Another commenter described 

the issuance of the interim final rule 

and the relative silence from Common 

Rule departments and agencies in the 

period since publication of the 2018 

Requirements (in the January 19, 2017 

final rule) as a betrayal of IRBs. 

Additionally, commenters expressed 

concern that given the short timeline 

between the closing of the comment 

period and the new general 

implementation date of July 19, 2018, 

any further delay of the 2018 

Requirements would similarly create 

chaos and confusion in the regulated 

community. Commenters also generally 

expressed that the 6-month delay 

granted by the interim final rule created 

a situation in which regulated entities 

that were ready to implement the 2018 

Requirements in January 2018 had to 

spend the personnel hours to ‘‘undo’’ 

these changes, which seemed 

contradictory to the overall goal of the 

revisions to the Common Rule of 

reducing administrative burden. A few 

commenters focused entirely on how 

the relative silence by Common Rule 

departments and agencies since 

publication of the 2018 Requirements 

has created a confusing environment for 

this regulated community and requested 

more transparency from the regulating 

departments and agencies in the future. 

[Response: We acknowledge that the 

timing of the interim final rule was not 

ideal and led to frustration within the 

regulated community. We believe that 

the 2018 NPRM and this final rule to 

delay the general compliance date for 

the 2018 Requirements while permitting 

the use of three burden-reducing 

provisions of the 2018 Requirements 

provides the regulated community with 

sufficient notice about when the 2018 

Requirements will go into effect, and 

when regulated entities will be required 

to comply with the 2018 Requirements.] 

Almost half of the comments related 

to the Common Rule advocated for the 

Common Rule departments and 

agencies to retain the July 19, 2018 

effective date for the 2018 

Requirements, and to delay the general 

compliance date. These commenters 

argued that during the period between 

the effective date and delayed general 

compliance date, institutions should be 

permitted to voluntarily comply (on a 

study-by-study basis) with the 2018 

Requirements. A couple of these 

comments advocated for institutions to 

be able to implement select 2018 

Requirements during this voluntary 

compliance period, as opposed to 

choosing to comply with the entirety of 

the 2018 Requirements, in order to 

provide institutions with the most 

flexibility. A majority of the comments 

described in this paragraph advocated 

for delaying the general compliance date 

to January 21, 2019, as these 

commenters did not believe that full 

compliance with the 2018 Requirements 

would be possible by July 19, 2018. A 

few commenters advocated delaying the 

general compliance date beyond January 

21, 2019 to permit institutions as much 

time as possible to comply with the 

2018 Requirements 

One commenter suggested that both 

the effective and general compliance 

dates be delayed by 6 months to one 

year after Common Rule departments 

and agencies issue critical guidance 

documents. Other commenters 

suggested that Common Rule 

departments and agencies should be 

given a date by which they must publish 

key guidance documents. Several 

comments included a description of 

guidance documents that they would 

like for Common Rule departments and 

agencies to focus on initially. 

Suggestions included: OHRP’s decision 

charts, key information in informed 

consent, broad consent, and continuing 

review (§lll.109(f)). 

Some of the comments relevant to the 

Common Rule advocated for no 

additional delay in the implementation 

of the 2018 Requirements beyond July 

19, 2018. These comments argued that 

institutions and Common Rule 

departments and agencies have had 

sufficient time to prepare for the 

implementation of the Rule. One 

comment suggested that while guidance 

would certainly be helpful, it is possible 

to implement the Rule without such 

guidance, as evidenced by the fact that 

many institutions were ready to 

implement the 2018 Requirements 

before the publication of the interim 

final rule. 

Several commenters also addressed 

whether certain aspects of the 2018 

Requirements would be difficult to 

implement in the absence of agency 

guidance. These commenters 

acknowledged the importance of 

guidance to implement many areas of 

the 2018 Requirements but noted that 

the confusion and chaos created by latebreaking announcements of delays in 

the implementation of the 2018 

Requirements ultimately caused more 

administrative burden within 

institutions. One large public university 

system in the United States indicated 

that if guidance is issued after 

institutions have revised their policies, 

procedures, and IT systems, it likely 

will create a burdensome situation 

where policies, procedures, and IT 

systems will need to be revised again to 

comport with department and agency 

guidance. 

[Response: We agree with interim 

final rule comments suggesting that we 

keep the effective date of the 2018 

Requirements as July 19, 2018, while 

delaying the general compliance date. 

While we considered the alternative of 

amending the transition provision to 

permit institutions to voluntarily 

comply with the revised rule beginning 

on July 19, 2018, and not requiring 

compliance with the new rule until 

January 21, 2019 or later, we believe this 

approach could result in confusion 

regarding implementation of the revised 

Common Rule that could be minimized 

with the issuance of guidance from the 

Common Rule departments and 

agencies. By adopting the changes 

proposed in the NPRM, we believe the 

Common Rule departments and 

agencies will be able to issue relevant 

guidance documents that will better 

enable the regulated community to 

comply with the 2018 Requirements. As 

described in the NPRM, we also 

considered a delay to the effective and 

general compliance dates without 

proposing this additional option in the 

interim period. Such an approach 

would be simple to implement. We 

decided against finalizing this 

alternative to be responsive to public 

comments received and in an effort to 

minimize burdens with respect to new 

provisions that will not be difficult to 

implement prior to the general 

compliance date of the 2018 

Requirements. 

We recognize the difficulty in 

implementing the 2018 Requirements in 

the absence of guidance and will strive 

to issue guidance on key aspects of the 

2018 Requirements as quickly as 

possible, while also engaging 

stakeholders.] 

A small subset of comments suggested 

additional revisions to the Common 

Rule. For example, one commenter 

discussed the inclusion of a provision 

that would permit parents to decline 

certain procedures on behalf of their 

children. 

[Response: This comment listed 

several clinical procedures done in the 

routine course of medical care. Such 

activities are outside of the scope of the 

Common Rule, and thus are outside of 

the scope of this rulemaking.] 

Others discussed concerns with the 

waiver provision at §lll.101(i) and 

suggested that this provision be 

strengthened such that departments and 

agencies are only permitted to waive the 

Common Rule with regard to certain 

research activities when such a waiver 


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2National Commission for the Protection of 

Human Subjects of Biomedical and Behavioral 

Research. Ethical Principles and Guidelines for the 

Protection of Human Subjects of Research. April 18, 

1979. https://www.hhs.gov/ohrp/regulations-andpolicy/belmont-report/. 

3Clinton, WJ. Strengthened Protections for 

Human Subjects of Classified Research. 62 FR 

26367–26372. May 13, 1997. https://www.gpo.gov/ 

fdsys/pkg/FR-1997-05-13/pdf/97-12699.pdf. 

is consistent with the Belmont Report.2

One commenter also suggested that the 

Clinton Memorandum3 concerning 

requirements pertaining to classified 

research be fully implemented. These 

comments also referenced concerns 

with the carve-out form the definition of 

research pertaining to authorized 

operational activities in support of 

national security missions. 

[Response: The January 19, 2017 final 

rule preamble stated ‘‘[t]hese authorized 

operational activities, as determined by 

each agency, do not include research 

activities as defined by the Common 

Rule, nor have they ever in the past 

been considered regulated by the 

Common Rule. This category of activity 

is removed from the definition of 

research to make explicit that the 

requirements of the final rule do not 

apply to authorized operational 

activities in support of national security 

missions. This clarification is not 

intended to narrow the scope of the 

Common Rule. We do not believe that 

this category contradicts President 

Clinton’s Memorandum of 1997 

regarding classified research, because 

this category is merely clarifying what 

activities are not considered to meet the 

definition of research. The Clinton 

Memorandum calls for a number of 

requirements to be added to protections 

for classified research activities, but it 

does not address activities that are not 

considered research.’’] 

Some commenters expressed concerns 

with how the transition provision 

essentially creates a dual regulatory 

system for human subjects protections. 

One commenter explicitly advocated for 

the Common Rule to require all research 

subject to the Common Rule to comply 

with the 2018 Requirements by a certain 

date given the additional protections to 

subjects that the revised Common Rule 

affords research participants. 

[Response: We agree that the 

transition provision at §lll.101(l) 

creates a system in which many 

institutions will need to be familiar with 

both versions of the Common Rule (if 

they elect to keep at least some 

previously initiated studies subject to 

the pre-2018 Requirements while their 

newly initiated studies are subject to the 

2018 Requirements). However, we 

believe that the flexibility afforded by 

the transition provision is important for 

institutions to manage their operations 

while implementing the 2018 

Requirements. We do not believe that 

this compromises the protection of 

human subjects.] 

A few comments suggested that the 

general compliance date of the 2018 

Requirements should coincide with 

FDA’s revision of its human subjects 

protection regulations in order for there 

not to be a time period where FDA 

regulations are not harmonized with the 

other Common Rule departments and 

agencies. 

[Response: With respect to the 

comments suggesting that the general 

compliance date of the 2018 

Requirements should be tied to the FDA 

harmonization efforts with the Common 

Rule, we do not believe that this is 

necessary. FDA is currently working to 

harmonize its human subjects 

regulations with the 2018 Requirements, 

to the extent permitted by FDA’s 

statutory authority and mandate. We do 

not believe it is necessary to further 

delay the 2018 Requirements’ general 

compliance date as a result of a separate 

rulemaking effort.] 

One commenter argued that the 2018 

Requirements should not be 

implemented at all, as in their view, the 

pre-2018 Requirements adequately 

protect human subjects. 

[Response: We disagree. We believe 

that the 2018 Requirements will provide 

a meaningful improvement in human 

subjects protection, while reducing 

administrative burden on institutions.] 

A couple of commenters argued that 

the general compliance date for the 

cooperative research provision (§lll

.114) should be delayed to 2022. 

[Response: We disagree with the 

comments suggesting that the 

compliance date for the cooperative 

research provision (§ lll.114(b)) 

needs to be delayed beyond January 

2020. Public comments requesting this 

change have not provided specific 

evidence for why such a delay is 

necessary, nor for the assertion that 

implementing the single IRB of record 

in cooperative research requirement will 

not result in a reduction in burden.] 

C. Public Comments on the April 20, 

2018 NPRM and Response to Comments 

The April 20, 2018 NPRM sought 

comment on two primary proposals: (1) 

The proposal to delay the general 

compliance date for the 2018 

Requirements to January 21, 2019; and 

(2) whether institutions should be 

allowed to implement three burdenreducing provisions in the 2018 

Requirements during the delay period 

from July 19, 2018 to January 21, 2019. 

The NPRM also solicited comment on 

the advisability of two alternative 

approaches to delaying the 2018 

Requirements: (1) The alternative of 

delaying the effective date and general 

compliance date until January 21, 2019, 

but without the option to implement 

certain 2018 Requirements during that 

delay period; and (2) the alternative of 

delaying the effective date and general 

compliance date beyond January 21, 

2019. The NPRM also solicited 

comment on whether the general 

compliance date for the 2018 

Requirements should remain July 19, 

2018. 

The NPRM proposed to modify the 

transition provision at §lll.101(l) to 

permit an institution or IRB (and not 

just an IRB) to document the 

institution’s decision to transition a 

study to comply with the 2018 

Requirements. (We received no public 

comments on this proposal.) 

A majority of comments that 

discussed the NPRM proposals 

supported some kind of delay to the 

implementation of the 2018 

Requirements. A majority supported the 

NPRM proposals as drafted but 

indicated that their support was 

contingent upon the Common Rule 

departments and agencies issuing the 

relevant guidance prior to July 19, 2018 

for the three burden-reducing 

provisions, and all other key guidance 

documents before the January 2019 

general compliance date. In particular, 

commenters noted that critical guidance 

documents would need to be available 

to the regulated community at least four 

months prior to the proposed general 

compliance date of January 21, 2019. 

These commenters specifically stated 

that if critical guidance documents were 

not available by September 19, 2019, 

they would support an additional delay 

of the general compliance date. 

Comments in response to the NPRM 

generally supported the position that 

many institutions need additional time 

to prepare to implement the 2018 

Requirements, and that the Common 

Rule departments and agencies need 

more time to develop and issue 

guidance. Several commenters 

specifically noted that the Department 

of Veterans Affairs is not yet ready to 

implement the 2018 Requirements and 

needs more time. 

Commenters suggested guidance 

documents that should be provided as 

quickly as possible to the regulated 

community. These suggestions included 

revising existing guidance, or issuing 

new guidance, as follows: 

—Revised OHRP decision charts 


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—Information on the §lll.116 

clinical trial consent form posting 

location 

—Limited IRB review 

—Broad consent 

—The new requirement that the 

informed consent give the prospective 

subject the information that a 

reasonable person would want to 

know in order to make an informed 

decision about research participation 

—The new requirement that the 

informed consent begin with a 

concise and focused presentation of 

the key information that is most likely 

to assist a prospective subject or 

legally authorized representative in 

understanding the reasons why one 

might or might not want to participate 

in the research. 

—Identifiability 

—Privacy and confidentiality 

—Benign behavioral interventions 

—Continuing review 

[Response: This final rule adopts the 

April 20, 2018 NPRM proposals, with 

minor changes made to the regulatory 

text for clarification and accuracy. As 

stated above, we agree with the 

comments that the issuance of guidance 

will be useful for institutions to be able 

to implement the 2018 Requirements, 

and are working to issue such guidance 

promptly. We appreciate the commenter 

input on topics for guidance to be 

issued by the departments and 

agencies.] 

One commenter noted that if Common 

Rule departments and agencies 

envisioned a specific way that 

institutions or IRBs should document 

the use of the three burden-reducing 

provisions in the 2018 Requirements or 

document the fact that an ongoing study 

has transitioned to comply with the 

2018 Requirements, that information 

must be communicated to the regulated 

community as soon as possible. 

[Response: We do not believe that 

there is a need to prescribe how 

institutions document the decision to 

use the three burden-reducing 

provisions of the 2018 Requirements or 

the decision to transition a study to 

comply with the 2018 Requirements (on 

or after January 21, 2019), beyond the 

requirement that the institution or an 

IRB must document and date such 

determination. For example, this 

institutional determination could be 

documented in IRB meeting minutes, or 

in an IRB reviewer checklist (if an 

institution uses a checklist system). This 

institutional determination could also 

be documented in an institution’s 

existing electronic system, if one exists, 

or in a spreadsheet created and 

maintained by the institution to keep 

track of which studies have been 

transitioned to the 2018 Requirements.] 

Several alternatives were suggested 

for how a delay might be structured. 

These included: 

—Permitting voluntary compliance with 

the entirety of the 2018 Requirements 

between July 19, 2018 and January 21, 

2019 

—Keeping the NPRM proposals related 

to decoupling the effective and 

general compliance dates and the 

early implementation of the three 

burden-reducing provisions of the 

2018 Requirements, but delaying the 

effective date of the 2018 

Requirements until at least one year 

after Common Rule departments and 

agencies have issued key guidance 

documents 

—Delaying both the effective and 

general compliance dates until 

January 21, 2019 

—Delaying both the effective and 

general compliance dates beyond 

January 21, 2019 

—Permitting the use of the three 

burden-reducing provisions of the 

2018 Requirements, but not requiring 

that studies taking advantage of this 

flexibility comply with the entirety of 

the 2018 Requirements on and after 

January 21, 2019. 

A minority of comments indicated 

concern that the NPRM proposals would 

be confusing for the regulated 

community to implement accurately. 

However, several of these comments 

indicated that if the Common Rule 

departments and agencies determined 

that moving forward with a delay was 

still appropriate, the structure proposed 

in the NPRM would be acceptable. 

Regardless of the delay structure 

endorsed, commenters noted that no 

matter the delay option chosen by 

Common Rule departments and 

agencies, guidance needed to be issued 

in order for the regulated community to 

make use of the delay period and 

prepare their institutions. 

[Response: We acknowledge that there 

were multiple ways that an 

implementation delay of the 2018 

Requirements could be structured. We 

believe that the approach proposed in 

the NPRM and adopted in this final rule 

is the best balance of permitting 

institutions to implement several of the 

more straightforward provisions of the 

2018 Requirements before the general 

compliance date, while granting 

Common Rule departments and 

agencies additional time to develop and 

issue key guidance documents, and 

granting institutions additional time to 

ensure that their operations are ready to 

implement the 2018 Requirements. 

We do not believe a delay of the 

general compliance date beyond January 

21, 2019 is necessary. As discussed in 

the NPRM, we continue to believe that 

the regulated community will not need 

additional time beyond January 2019 to 

comply with the 2018 Requirements. 

Most NPRM comments supported the 

idea that January 2019 would be 

sufficient to allow for implementation of 

the 2018 Requirements, provided that 

the Common Rule departments and 

agencies issued key guidance. 

We recognize that the implementation 

structure in this final rule might be 

confusing to some in the regulated 

community. We intend to engage in 

educational outreach to help the 

regulated community better understand 

what is permitted and what is not under 

the revised transition provision at § ll

.101(l).] 

Several commenters indicated that 

understanding OHRP’s plan for 

modifying the Federalwide Assurance 

(‘‘FWA’’) process to comport with the 

2018 Requirements would also be 

helpful. Specific concerns were raised 

about the deletion of the option to 

‘‘check the box’’ on the FWA and how 

the removal of this option will, in 

certain states with separate human 

subjects requirements, present 

administrative challenges for 

institutions. Another commenter 

expressed concern about whether, after 

January 21, 2019, FWAs would still be 

valid given that they would include 

statements and elections no longer 

required under the 2018 Requirements. 

[Response: We intend to provide the 

regulated community with information 

about how the FWA process will change 

well in advance of any modifications 

that are implemented. The 2018 

Requirements at § lll.103(b) state 

that the ‘‘[assurance] shall be filed in 

such form and manner as the 

department or agency head prescribes.’’ 

To that end, Common Rule departments 

and agencies have significant flexibility 

in what information is requested in the 

assurance process. Questions about nonOHRP assurances will be addressed by 

the relevant Common Rule departments 

and agencies. With respect to OHRP 

issued FWAs, OHRP wishes to make 

clear that assurances on file with the 

office will still be valid on and after 

January 21, 2019 for their effective 

period. Additionally, any changes made 

to the assurance process will take 

account of the fact that some 

institutions might oversee protocols that 

comply with the pre-2018 and 2018 

Requirements.] 

One commenter expressed concern 

with how auditors would handle IRBs 

reviewing protocols governed by both 


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the pre-2018 Requirements and the 2018 

Requirements, given that the 2018 

Requirements do not require that every 

nondiscriminatory effort will be made to 

ensure that no IRB consists entirely of 

men or entirely of women (pre-2018 

Requirements at § lll.107(b)). 

[Response: We believe that the §ll

.107(a) requirements for diversity on 

IRBs serves the same purpose, and thus 

do not see a conflict between the 

diversity requirements for IRBs under 

the pre-2018 Requirements and the 2018 

Requirements.] 

While the NPRM did not solicit 

comments on the requirement for 

cooperative research to be reviewed by 

a single IRB (see §lll.114), we 

received several comments discussing 

this provision. Several asked for an 

additional 2-year delay before the 

changes at § lll.114(b) become 

effective. Others said that this provision 

should be amended such that use of a 

single IRB is voluntary in cooperative 

research. These comments argued that 

the 2018 Requirements’ preamble 

(published in the January 19, 2017 final 

rule) underestimated the costs of the 

single IRB mandate and the confusion 

that implementing this policy would 

create for investigators. Several of these 

comments acknowledged that over time, 

as institutions become accustomed to 

developing reliance agreements and 

managing the single IRB process, the 

costs currently being experienced would 

decrease. 

[Response: We appreciate the 

comments received on the single IRB of 

record requirement in cooperative 

research (§lll.114(b)). We continue 

to believe that a compliance date of 

January 20, 2020 for this provision gives 

institutions sufficient time to prepare 

and implement this requirement. While 

these commenters anecdotally indicated 

that implementing this requirement has 

been more costly to institutions than the 

January 19, 2017 final rule preamble 

estimated, no comment provided data 

about the actual costs to implement this 

provision. In the absence of specific 

data, we retain our cost and benefit 

assumptions related to this provision.] 

One comment suggested adding the 

exemption category for secondary use 

where consent is not required (§ lll

.104(d)(4)) to the burden-reducing 

provisions. This commenter noted that 

because the inability to implement the 

revised exemptions during the delay 

period (i.e., July 19, 2018 through 

January 20, 2018) accounted for the 

majority of the costs estimated in the 

NPRM for this delay, it would be 

preferable for the final rule to permit the 

early implementation of this exemption 

category. 

[Response: As explained in the April 

20, 2018 NPRM, we did not propose 

adding the revised exemption categories 

to §lll.101(l)(4)(i)(A) because 

implementation of these categories 

would involve significantly greater 

complications. For example, we noted 

in the NPRM that these categories use 

terms that are newly defined, or for 

which revised definitions have been 

included in the 2018 Requirements, and 

permitting compliance with these 

categories without also selectively 

adopting revised definitions could be 

problematic. Specifically in regard to 

§ lll.104(d)(4), this exemption 

involves several regulations and statutes 

outside of the scope of the Common 

Rule. As a result, it is a much more 

complicated provision to implement, 

and thus was not included as one of the 

burden-reducing provisions of the 2018 

Requirements that institutions could 

voluntarily implement during the delay 

period. After consideration of the public 

comments received, we continue to 

believe that the approach proposed in 

the NPRM makes the most sense.] 

One commenter argued that the 2018 

Requirements should be withdrawn, 

and that Common Rule departments and 

agencies should issue several smaller 

NPRMs to revise specific aspects of the 

Common Rule. 

[Response: We disagree with this 

comment. We believe that the 2018 

Requirements will provide a meaningful 

improvement in human subjects 

protection, while reducing 

administrative burden on institutions.] 

One commenter proposed that 

institutions or other Common Rule 

departments and agencies be required to 

file interim reports with HHS about 

their status with regard to full 

implementation and compliance with 

the 2018 Requirements. This commenter 

suggested that HHS could issue waivers 

for full implementation of the rule based 

on these interim reports. Additionally, 

such a reporting requirement would 

give HHS and other Common Rule 

departments and agencies the data 

necessary to determine if another 

adjustment to the 2018 Requirements 

might be needed. 

[Response: We believe that this 

approach is impractical and 

unnecessary. We believe that this final 

rule will give institutions sufficient time 

to implement the 2018 Requirements, 

which also precludes the need for such 

a phased approach.] 

One commenter indicated a desire to 

see a final rule containing the flexibility 

included in the original publication of 

the 2018 Requirements, on January 19, 

2017, that institutions be permitted to 

implement provisions of the 2018 

Requirements at any time before the 

effective date. 

[Response: This commenter 

misunderstood the transition provision 

as written in the first publication of the 

2018 Requirements; the transition 

provision published in the January 19, 

2017 final rule revising the Common 

Rule did not include the ability for 

institutions to implement all provisions 

of the 2018 Requirements before the 

effective date and general compliance 

date.] 

As with the comments on the interim 

final rule, a few comments expressed 

concern with the waiver provision at 

§ lll.101(i) allowing federal 

departments and agencies to waive 

some or all provisions of the Common 

Rule (which could allow research to be 

conducted on people without their 

informed consent). These comments 

additionally expressed concern with 

institutions being permitted to 

implement the exclusion of certain 

operational activities conducted by 

intelligence agencies during the delay 

period and suggested that this carve-out 

from the definition of research be 

removed from the 2018 Requirements. 

[Response: We are not contemplating 

modifying the carve-outs from the 

definition of research. Regarding the 

carve-out from the definition of research 

pertaining to authorized operational 

activities in support of national security 

missions, the January 19, 2017 final rule 

preamble noted that ‘‘[t]hese authorized 

operational activities, as determined by 

each agency, do not include research 

activities as defined by the Common 

Rule, nor have they ever in the past 

been considered regulated by the 

Common Rule. This category of activity 

is removed from the definition of 

research to make explicit that the 

requirements of the final rule do not 

apply to authorized operational 

activities in support of national security 

missions. This clarification is not 

intended to narrow the scope of the 

Common Rule.’’] 

III. Delay of the General Compliance 

Date Until January 21, 2019 

Through this final rule, the general 

compliance date for the 2018 

Requirements is delayed for a 6-month 

period until January 21, 2019. Section 

ll.101(l)(2) is revised to make this 

delay explicit. The dates included in the 

transition provision, set forth at § lll

.101(l)(3), (4), and (5), are also modified 

to reflect this revised general 

compliance date. 

As a result of this rule, regulated 

entities will be required to comply with 

the pre-2018 Requirements prior to 

January 21, 2019 (putting aside the 


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burden-reducing provisions discussed 

in section III below). Regulated entities 

may not, prior to January 21, 2019, 

comply with all provisions of the 2018 

Requirements, with the exception of the 

three burden-reducing provisions, in 

lieu of all provisions of the pre-2018 

Requirements. Of course, regulated 

entities are permitted to adopt 

provisions that do not conflict with the 

pre-2018 Requirements, prior to January 

21, 2019. For example, institutions may 

choose to incorporate additional 

elements of informed consent that 

happen to be found in the 2018 

Requirements, or elsewhere, so long as 

such implementation does not conflict 

with the pre-2018 Requirements. In 

other words, institutions have the same 

flexibility they have always had (i.e., to 

exceed the minimum requirements set 

by the regulations). 

The compliance date for the 

cooperative research provision of the 

2018 Requirements (§ lll.114(b)) 

remains January 20, 2020. 

IV. Optional Flexibility: 

Implementation of Certain BurdenReducing Provisions During the Delay 

Period 

As detailed in revised §lll

.101(l)(4) and as set forth below in more 

detail, during the additional 6-month 

period that the general compliance date 

for the 2018 Requirements is delayed 

(July 19, 2018 through January 20, 

2019), institutions may transition a 

research study to the 2018 Requirements 

in order to take advantage of three 

burden-reducing provisions of the 2018 

Requirements. This final rule also 

restructures §lll.101(l)(3) and (4) 

(now numbered (5)) to aid readability. A 

new section (now §lll.101(1)(4)) 

describes how the requirements apply to 

research transitioning to take advantage 

of the burden-reducing provisions 

during different time periods. Below, we 

provide an overview of the revised 

transition provision to clarify its 

application to different types of studies, 

including studies taking early advantage 

of the three burden-reducing provisions 

of the 2018 Requirements. 

A. Research Subject to the pre-2018 

Requirements (§lll.101(l)(3)) 

As a default, studies initiated (i.e., 

initially approved by an IRB, or for 

which IRB review was waived by the 

government pursuant to § lll.101(i) 

or determined to be exempt) before 

January 21, 2019 (the new general 

compliance date for the 2018 

Requirements) will continue to be 

subject to the pre-2018 Requirements. 

This approach will maintain the ability 

of institutions to hold such studies to 

the same set of standards throughout 

their duration and will avoid a 

circumstance in which such research is 

subject to two sets of rules. However, as 

described below, institutions may elect 

to transition such studies to comply 

with the 2018 Requirements. 

B. Research Subject to the 2018 

Requirements (§lll.101(l)(5)) 

Research initiated (i.e., initially 

approved by an IRB, or for which IRB 

review was waived by the government 

pursuant to § lll.101(i), or 

determined to be exempt) on or after 

January 21, 2019 (the new general 

compliance date for the 2018 

Requirements) must be conducted in 

compliance with the 2018 

Requirements. 

C. Research That Transitions To Comply 

With the 2018 Requirements on or After 

January 21, 2019 (§lll.101(l)(4)(ii)) 

Section ll.101(l)(4)(ii) applies to 

studies following the pre-2018 

Requirements that transition to comply 

with the 2018 Requirements on or after 

January 21, 2019. In such 

circumstances, the study must be 

conducted in compliance with the 2018 

Requirements beginning on the 

transition date (i.e., the date the 

transition determination is documented, 

on or after January 21, 2019) for its 

duration. 

D. Research That Transitions To 

Comply With the 2018 Requirements 

During the 6-Month Delay Period (§ ll

.101(l)(4)(i)) 

As described in §lll

.101(l)(4)(i)(A), the option of applying 

the three burden-reducing provisions of 

the 2018 Requirements during the 6- 

month delay period is only available 

with respect to studies that transition to 

comply with the 2018 Requirements 

between July 19, 2018 through January 

20, 2019. 

Beginning on the date that the 

transition determination is documented, 

through January 20, 2019, such studies 

must comply with the pre-2018 

Requirements, except that the studies 

will comply with the three burdenreducing provisions instead of or in 

addition to the comparable pre-2018 

Requirements (specified in § lll

.101(l)(4)(i)(A)(1)–(3)). 

• Pursuant to § lll

.101(l)(4)(i)(A)(1), §lll.102(l) of the 

2018 Requirements (definition of 

research) will apply instead of § lll

.102(d) of the pre-2018 Requirements). 

• Pursuant to § lll

.101(l)(4)(i)(A)(2), §lll.103(d) of the 

2018 Requirements (revised certification 

requirement that eliminates IRB review 

of application or proposal) will apply 

instead of § lll.103(f) of the pre-2018 

Requirements. 

• Pursuant to § ll.101(l)(4)(i)(A)(3), 

§ lll.109(f)(1)(i) and (iii) of the 2018 

Requirements (exceptions to mandated 

continuing review) will apply instead of 

§ lll.103(b) of the pre-2018 

Requirements (as related to the 

requirement for continuing review) and 

in addition to §lll.109 of the pre2018 Requirements. 

This approach is designed to afford 

institutions additional time before they 

are required to comply with all 

provisions of the 2018 Requirements, 

while enabling them to take advantage 

of the three burden-reducing provisions 

during the delay period. 

In addition, beginning on January 21, 

2019, such studies must, for the balance 

of their duration, comply with the 2018 

Requirements in their entirety. 

We believe this rule strikes an 

appropriate balance of permitting 

voluntary early adoption of provisions 

that reduce burdens without creating 

significant complexities. An 

institution’s decision about whether to 

transition a study to the 2018 

Requirements to take advantage of the 

three burden-reducing provisions might 

vary depending on the nature and 

progress of the study, including any 

elements of the study to be conducted 

on or after January 21, 2019. For 

example, studies planning to recruit 

some subjects on or after January 21, 

2019 would have to meet the new 

requirements for obtaining the informed 

consent of those subjects. In contrast, for 

studies in which the remaining 

activities consist only of completing 

data analyses, the new requirements for 

informed consent generally would not 

be applicable. 

While the three burden-reducing 

provisions are a regulatory package, an 

institution that takes advantage of this 

flexibility may, as a matter of 

institutional policy, adopt a more 

stringent standard (such as that of the 

pre-2018 Requirements) for any or all of 

the circumstances addressed by these 

three provisions. For example, if an 

institution chooses to adopt a policy 

that studies that qualify for expedited 

review under a certain category should 

continue to be subject to annual 

continuing review, this rule does not 

prevent the institution from adopting 

and implementing that policy. 

Given that studies taking advantage of 

this flexibility will be complying with 

provisions from both the pre-2018 

Requirements and the 2018 

Requirements during the delay period, 

we explain how some provisions 

interact and clarify our intended 


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interpretations of particular regulatory 

provisions that will apply during the 6- 

month delay period. For studies electing 

to transition to comply with the 2018 

Requirements during the 6-month delay 

period (July 19, 2018 through January 

20, 2019), once the decision to 

transition the study is documented: 

1. In applying the definition of 

research under the 2018 Requirements 

(§ lll.102(l)(3)), the reference to a 

‘‘public health authority’’ will be given 

the meaning provided in the definition 

of ‘‘public health authority’’ in the 2018 

Requirements (§lll.102(k)). This 

interpretation arises because ‘‘public 

health authority’’ is defined in the 2018 

Requirements, but not in the pre-2018 

Requirements. 

2. In applying §lll.103(d) of the 

2018 Requirements, the reference to 

research ‘‘exempted under § ll.104’’ 

will be interpreted to refer to research 

exempted under § lll.101(b) of the 

pre-2018 Requirements. This 

interpretation arises given that only the 

exemptions set forth in the pre-2018 

Requirements will be in effect during 

the 6-month delay period. 

3. The reference to ‘‘[r]esearch eligible 

for expedited review in accordance with 

§ lll.110’’ in §lll.109(f)(1)(i) of 

the 2018 Requirements will be 

interpreted to refer to §lll.110 of the 

pre-2018 Requirements. 

4. The documentation requirements 

described in § lll.115(a)(3) of the 

2018 Requirements (documenting an 

IRB’s rationale for conducting 

continuing review not otherwise 

required) are not applicable during this 

period. 

5. Sectionll.103(d) of the 2018 

Requirements will be substituted for 

§ lll.103(f) of the pre-2018 

Requirements. Both sections address the 

requirement for certification of research 

supported by a federal department or 

agency. In addition to removing the 

requirement that IRBs review grant 

applications or proposals, § lll

.103(d) of the 2018 Requirements 

reflects other minor wording changes 

necessary to accommodate the removal 

of the grant application or proposal 

review requirement or to provide 

additional clarifications. 

E. General Transition Issues 

The regulatory provisions are not 

prescriptive regarding how an 

institution chooses to make its 

transition decisions. An institution may 

elect to transition research protocols to 

the 2018 Requirements on a protocol-byprotocol basis, or for a class of protocols 

(e.g., all minimal risk research), or for 

the institution’s entire research 

portfolio. 

Section ll.101(l)(4)(ii) applies to 

studies following the pre-2018 

Requirements that, at some point on or 

after January 21, 2019, transition to 

comply with the 2018 Requirements. If 

the determination to transition a study 

to the 2018 Requirements is 

documented on or after January 21, 

2019, as of the date of documentation 

the study must be conducted in 

compliance with the 2018 Requirements 

for its duration. 

We clarify that the transition 

provision at § lll.101(l)(4) of the 

2018 Requirements extends to research 

newly initiated during the delay period. 

Research newly initiated between July 

19, 2018 and January 20, 2019 may be 

either conducted under the pre-2018 

Requirements, in accordance with §ll

.101(l)(3); or, an institution may 

transition research newly initiated 

during the delay period to the 2018 

Requirements, in accordance with §ll

.101(l)(4), in which event the research 

would be conducted under the pre-2018 

Requirements, with substitution of the 

three burden-reducing provisions of the 

2018 Requirements for the comparable 

provisions of the pre-2018 

Requirements. In addition, on or after 

January 21, 2019, an institution may 

choose to transition research initiated 

during the delay period that was 

initially conducted under the pre-2018 

Requirements, to compliance with the 

2018 Requirements. In the NPRM, 

proposed §lll.101(l)(4) referenced 

application by an institution ‘‘engaged 

in research’’ to ‘‘ongoing’’ research. In 

order to clarify the Common Rule 

departments’ and agencies’ intention 

that research newly initiated during the 

delay period may transition to the 2018 

Requirements, this final rule no longer 

includes the qualifier of ‘‘ongoing’’ to 

describe research that transitions to the 

2018 Requirements in accordance with 

§ lll.101(l)(4). The final rule at 

§ lll.101(l)(4) also includes the 

additional wording ‘‘planning or’’ before 

‘‘engaged in research’’ to clarify that 

institutions are allowed to take 

advantage of the 2018 Requirements’ 

carve-outs from the definition of 

research for studies newly initiated 

during the delay period (which would 

allow a study that qualifies for one of 

the carve-outs to be conducted without 

prior IRB review and approval or 

application of the other regulatory 

requirements). 

This final rule revises the 

requirement, now set forth at § lll

.101(l)(4), regarding which entity may 

document an institution’s decision to 

transition research. This change will 

offer institutions greater flexibility 

regarding who documents the transition 

determination. Under the January 19, 

2017 final rule, an institutional 

determination that research would 

transition to comply with the 2018 

Requirements had to be documented by 

an IRB. Under this rule, such a 

determination may be documented 

either by an IRB or an institution 

(through officials who have the 

authority to make such determinations 

on behalf of the institution). Such 

documentation must include the date of 

the transition determination, and 

records documenting the transition 

decision must be retained in accordance 

with §lll.115(b). 

As a general matter, once an 

institution decides to transition a study 

to the 2018 Requirements and that 

determination is documented, the date 

of documentation will serve as the de 

facto compliance date for either the 

three-burden reducing provisions for 

transition determinations documented 

between July 19, 2018 and January 20, 

2019, or the 2018 Requirements as 

applied to the study for transition 

determinations documented on or after 

January 21, 2019. 

This final rule has an effective date of 

July 19, 2018, to enable regulated 

entities to take advantage of the three 

burden-reducing provisions during the 

delay period. However, as explained in 

this rule, the requirements a study must 

comply with beginning on July 19, 2018 

are detailed in the transition provision 

codified at § lll.101(l)(1)–(5). 

Finally, for consistency, headings were 

added to § lll.101(l)(1) and (2). 

V. Legal Authorities 

The legal authorities for the 

departments and agencies that are 

signatories to this action are as follows: 

Department of Homeland Security, 5 

U.S.C. 301; Public Law 107–296, sec. 

102, 306(c); Public Law 108–458, sec. 

8306. Department of Agriculture, 5 

U.S.C. 301; 42 U.S.C. 300v–1(b). 

Department of Energy, 5 U.S.C. 301; 42 

U.S.C. 7254; 42 U.S.C. 300v–1(b). 

National Aeronautics and Space 

Administration, 5 U.S.C. 301; 42 U.S.C. 

300v–1(b). Department of Commerce, 5 

U.S.C. 301; 42 U.S.C. 300v–1(b). 

Consumer Product Safety Commission, 

5 U.S.C. 301; 42 U.S.C. 300v–1(b). 

Social Security Administration, 5 U.S.C. 

301; 42 U.S.C. 289(a). Agency for 

International Development, 5 U.S.C. 

301; 42 U.S.C. 300v–1(b), unless 

otherwise noted. Department of Housing 

and Urban Development, 5 U.S.C. 301; 

42 U.S.C. 300v–1(b); 3535(d). 

Department of Labor, 5 U.S.C. 301; 29 

U.S.C. 551. Department of Defense, 5 

U.S.C. 301. Department of Education, 5 

U.S.C. 301; 20 U.S.C. 1221e–3, 3474. 


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Department of Veterans Affairs, 5 U.S.C. 

301; 38 U.S.C. 501, 7331, 7334; 42 

U.S.C. 300v–1(b). Environmental 

Protection Agency, 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, Public Law 109– 

54, 119 Stat. 531; and 42 U.S.C. 300v– 

1(b). Department of Health and Human 

Services, 5 U.S.C. 301; 42 U.S.C. 289(a); 

42 U.S.C. 300v–1(b). National Science 

Foundation, 5 U.S.C. 301; 42 U.S.C. 

300v–1(b). Department of 

Transportation, 5 U.S.C. 301; 42 U.S.C. 

300v–1(b). 

VI. Regulatory Impact Analyses 

We have examined the effects of this 

final rule under Executive Order 12866 

on Regulatory Planning and Review 

(September 30, 1993), Executive Order 

13563 on Improving Regulation and 

Regulatory Review (January 18, 2011), 

Executive Order 13771 on Reducing 

Regulation and Controlling Regulatory 

Costs (January 30, 2017), the Paperwork 

Reduction Act of 1995 (Pub. L. 104–13), 

the Regulatory Flexibility Act (Pub. L. 

96–354, September 19, 1980), the 

Unfunded Mandates Reform Act of 1995 

(Pub. L. 104–4), and Executive Order 

13132 on Federalism (August 4, 1999). 

A. Executive Orders 12866, 13563, and 

13771 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects; distributive impacts; and 

equity). Executive Order 13563 is 

supplemental to and reaffirms the 

principles, structures, and definitions 

governing regulatory review as 

established in Executive Order 12866, 

emphasizing the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. In 

accordance with the provisions of 

Executive Order 12866, this rule was 

submitted to the Office of Management 

and Budget (OMB) for review and has 

been determined to be a ‘‘significant’’ 

regulatory action. This regulation has 

been designated as ‘‘regulatory’’ under 

Executive Order 13771 (Reducing 

Regulation and Controlling Regulatory 

Costs, issued on January 30, 2017). We 

estimate that this rule generates $2.02 

million in annualized costs at a 7% 

discount rate, discounted relative to 

year 2016, over a perpetual time 

horizon. Details on the estimated costs 

of this final rule can be found in the 

economic analysis below. 

1. Need for This Final Rule and 

Summary 

On January 19, 2017, HHS and 15 

other federal departments and agencies 

published the 2018 Requirements 

designed to more thoroughly address 

the broader types of research conducted 

or otherwise supported by all of the 

Common Rule departments and 

agencies. In addition, the CPSC adopted 

the same regulatory changes on 

September 18, 2017. This rule was 

amended in a final rule published in the 

Federal Register on January 22, 2018 

and adopted by HUD through a final 

rule published on January 26, 2018. 

This final rule allows regulated 

entities to continue to comply with the 

pre-2018 requirements until January 21, 

2019. As discussed above, this final rule 

also permits institutions, during the 

period between July 19, 2018 and 

January 21, 2019, to take advantage of 

three provisions in the 2018 

Requirements intended to minimize 

burdens on regulated entities. Those 

three burden-reducing 2018 

Requirements are (1) the 2018 

Requirements’ definition of ‘‘research,’’ 

which deems certain activities not to be 

research, (2) the elimination of the 

requirement for annual continuing 

review of certain categories of research, 

and (3) the elimination of the 

requirement that IRBs review grant 

applications or proposals related to the 

research. As described in section III 

above, this flexibility is permitted for 

studies for which an institution makes 

a choice to have those studies be subject 

to the 2018 Requirements. 

2. Public Comments on the April 20, 

2018 NPRM RIA and Response to 

Comments 

The April 20, 2018 NPRM RIA 

solicited comment on the following 

assumptions: 

—That in almost all categories described 

in the RIA for the 2018 Requirements, 

the foregone benefits (costs) of 

delaying the 2018 Requirements by 

six months are what would have been 

the benefits of implementing the 2018 

Requirements during the period of 

July 2018 through January of 2019. 

Similarly, the assumption that, in 

almost all categories described in the 

RIA for the 2018 Requirements, the 

benefits (cost-savings) associated with 

delaying the 2018 Requirements by 

six months are what would have been 

the costs of implementing the 2018 

Requirements during the period of 

July 2018 through January of 2019. 

—That some entities will experience 

cost savings as a result of this rule, 

and some entities would experience 

costs as a result of this rule. 

—That 50 percent of regulated entities 

will take advantage of the option to 

implement three burden-reducing 

provisions of the 2018 Requirements 

early. Additionally, the NPRM sought 

comment that would provide insight 

into entities’ views regarding the 

interconnectedness of the 2018 

Requirements’ provisions and thus 

allow for refinement of the 50 percent 

estimate. 

—That this rulemaking will not have 

a significant economic impact on a 

substantial number of small entities. 

We received several comments on the 

costs and benefits associated with the 

April 20, 2018 NPRM to delay the 2018 

Requirements. None of these comments 

provided specific feedback on the cost 

and benefit assumptions included in the 

NPRM. 

These comments indicated that the 

timing and implementation of the 

interim final rule created additional 

administrative burden on institutions 

that were prepared to implement the 

2018 Requirements on January 19, 2018. 

As discussed above, one comment 

noted that if we permitted the 

exemption at § lll.104(d)(4) for 

secondary research where consent is not 

required to be implemented prior to the 

general compliance date, this delay 

would essentially be cost neutral. While 

we appreciate that there might be 

economic benefits to permitting the 

early implementation of one or more of 

the new or revised exemption 

categories, we did not include the 

exemptions as one of the provisions of 

the 2018 Requirements institutions can 

utilize during the delay period finalized 

in this rule because of the added 

complexity of implementing the 

exemptions in the absence of guidance. 

Finally, we received several 

comments indicating that the January 

19, 2017 final rule preamble 

underestimated the costs of 

implementing the cooperative research 

provision at § lll.114. These 

comments argued that, at best, this 

provision would represent a shifting of 

administrative costs and burdens, but 

would not represent an overall cost 

savings. We continue to believe that the 

original compliance date of this 

provision in January 2020 gives 

institutions sufficient time to prepare 

and implement this requirement. While 

these commenters anecdotally indicated 

that implementing this requirement has 

been more costly to institutions than the 

January 19, 2017 final rule preamble 

estimated, no commenter provided data 

about the actual costs to implement this 

provision. In the absence of specific 


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4Note, that the terms ‘‘benefits’’ and ‘‘costsavings’’ are used interchangeably in this RIA. 

Similarly, the terms ‘‘costs’’ and ‘‘foregone benefits’’ 

are also used interchangeably. 

data, we continue with our cost and 

benefit assumptions related to this 

provision. 

3. Analysis of Benefits (Cost-Savings) 

and Costs (Foregone Benefits) 4

The RIA for the 2018 Requirements 

described the benefits and costs of 16 

broad categories of changes finalized. 

The RIA for this final rule uses the 

information and calculations described 

in the preamble to the 2018 

Requirements as a base for estimating 

benefits and costs of delaying the 

general implementation of the 2018 

Requirements by six months. The time 

period for the analysis in this RIA is the 

6-month period from July 2018 to 

January 2019. 

Table 1 summarizes the quantified 

benefits and costs of delaying the 

general implementation of 2018 

Requirements. Over the period of July 

2018 to January 2019, annualized 

benefits of $6.4 million are estimated 

using a 3 percent discount rate; 

annualized benefits of $5.9 million are 

estimated using a 7 percent discount 

rate. Annualized costs of $37.2 million 

are estimated using a 3 percent discount 

rate; annualized costs of $34.4 million 

are estimated using a 7 percent discount 

rate. Note that all values are represented 

in millions of 2016 dollars, and 2016 is 

used as the frame of reference for 

discounting. 

TABLE 1—ALL BENEFITS AND COSTS OF DELAYING THE GENERAL COMPLIANCE DATE FOR THE 2018 REQUIREMENTS BY 6 

MONTHS

[From July 19, 2018 to January 21, 2019] 

Annualized value by 

discount rate 

(millions of 2016 dollars) 

3 Percent 7 Percent 

Benefits (Cost-Savings): 

Quantified Benefits ........................................................................................................................................... 6.4 5.9 

Costs (Foregone Benefits): 

Quantified Costs ............................................................................................................................................... 37.4 34.7 

The estimated benefits and costs of 

delaying the general implementation 

date of the 2018 Requirements by 6 

months are shown in Table 2 below. 

Note that the categorization shown 

below includes the same 16 categories 

used in the RIA of the 2018 

Requirements. 

TABLE 2—ACCOUNTING TABLE OF QUANTIFIED BENEFITS (COST-SAVINGS) AND COSTS (FOREGONE BENEFITS) OF

DELAYING COMPLIANCE WITH THE 2018 REQUIREMENTS BY 6 MONTHS 5

2018 Requirement RIA Category 

Annualized value over 1 year by discount rate 

(millions of 2016 dollars) 

Benefits (cost-savings) Costs (foregone benefits) 

3% 7% 3% 7% 

Regulated Community Learning New Requirements and Developing Training Materials; OHRP Developing Training and Guidance Materials, and 

Implementing the 2018 Requirements ......................................................... ........................ ........................ ........................ ........................

Extending Oversight to IRBs Unaffiliated with an Institution Holding an FWA 

(impact to IRBs not operated by an FWA-holding institution) ..................... 4.47 4.14 ........................ ........................

Excluding Activities from the Requirements of the Common Rule Because 

They Are Not Research ............................................................................... ........................ ........................ 0.95 0.88 

Clarifying and Harmonizing Regulatory Requirements and Agency Guidance ........................ ........................ ........................ ........................

Modifying the Assurance Requirements .......................................................... ........................ ........................ 0.31 0.29 

Requirement for Written Procedures and Agreements for Reliance on IRBs 

Not Operated by the Engaged Institution (impact to FWA-holding institutions) ............................................................................................................. ........................ ........................ ........................ ........................

Eliminating the Requirement that the Grant Application or Proposal Undergo 

IRB Review and Approval ............................................................................ ........................ ........................ 8.5 7.9 

Expansion of Research Activities Exempt from Full IRB Review ................... 0.01 0.01 20.8 19.3 

Elimination of Continuing Review of Research Under Specific Conditions .... 1.04 0.96 4.10 3.80 

Amending the Expedited Review Procedures ................................................. ........................ ........................ 2.66 2.47 

Cooperative Research (single IRB mandate in multi-institutional research) 6 ........................ ........................ ........................ ........................

Changes in the Basic Elements of Consent, Including Documentation .......... ........................ ........................ ........................ ........................

Obtaining Consent to Secondary Use of Identifiable Biospecimens and 

Identifiable Private Information .................................................................... ........................ ........................ ........................ ........................

Elimination of Pre-2018 Rule Requirement to Waive Consent in Certain 

Subject Recruitment Activities ..................................................................... ........................ ........................ 0.07 0.06 

Requirement for Posting of Consent Forms for Clinical Trials Conducted or 

supported by Common Rule Departments or Agencies .............................. 0.85 0.79 ........................ ........................

Alteration in Waiver for Documentation of Informed Consent in Certain Circumstances .................................................................................................. ........................ ........................ ........................ ........................


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5Zeroes in Table 2 (represented by —) signify that 

the category has been unaffected by the 6-month 

delay of the 2018 Requirements. The category could 

be unaffected for one of two reasons: (1) No costs 

or benefits were associated with the category in the 

RIA for the 2018 Requirements; or (2) the costs and 

benefits of the provision during the 6-month delay 

are the same as those estimated in the RIA for the 

2018 Requirements. 

6Because compliance with this provision is not 

required until 2020, benefits and costs here are not 

included. 

7See the RIA to the 2018 Requirements (82 FR 

7149) for more information about the labor 

categories used in this analysis. 

TABLE 2—ACCOUNTING TABLE OF QUANTIFIED BENEFITS (COST-SAVINGS) AND COSTS (FOREGONE BENEFITS) OF

DELAYING COMPLIANCE WITH THE 2018 REQUIREMENTS BY 6 MONTHS 5—Continued 

2018 Requirement RIA Category 

Annualized value over 1 year by discount rate 

(millions of 2016 dollars) 

Benefits (cost-savings) Costs (foregone benefits) 

3% 7% 3% 7% 

Cost Savings, as indicated by public comments (unable to attribute to particular provisions) ......................................................................................... Unquantified ........................ ........................

We assume that in almost all 

categories described in the RIA for the 

2018 Requirements the foregone benefits 

(costs) of delaying the 2018 

Requirements by 6 months are what 

would have been the benefits of 

implementing the 2018 Requirements 

during the period of July 2018 through 

January 2019. Similarly, we assume 

that, in almost all categories described 

in the RIA for the 2018 Requirements, 

the benefits (cost-savings) associated 

with delaying the 2018 Requirements by 

6 months are what would have been the 

costs of implementing the 2018 

Requirements during the period of July 

2018 through January 2019. We assume 

this because regulated entities likely 

would not have difficulty implementing 

these provisions in the absence of 

guidance from Common Rule 

departments or agencies, and thus could 

have been implemented as assumed in 

the economic analysis contained in the 

RIA for the 2018 Requirements.5 6

Categories with different assumptions 

are described below. 

a. Regulated Community Learning 

New Requirements and Developing 

Training Materials; OHRP Developing 

Training and Guidance Materials, and 

Implementing the 2018 Requirements 

We assume that even with the 

proposed 6-month delay, regulated 

entities and OHRP will still assume 

costs related to learning the new 

requirements and developing training 

materials. Thus, there are no effects 

estimated here. 

We expect that some entities would 

experience cost savings as a result of 

this final rule, and some entities will 

experience costs as a result of this rule, 

but we lack data to quantify these 

effects. 

b. Early Implementation of the Three 

Burden-Reducing Provisions of the 2018 

Requirements (Explicit Carve-Outs of 

Activities From the Definition of 

Research [§lll.102(l)]; Eliminating 

the Requirement That the Grant 

Application or Other Funding Proposal 

Undergo IRB Review and Approval [Pre2018 Rule at §lll.103(f)]; 

Elimination of Continuing Review of 

Research Under Specific Conditions 

[§§ lll.109(f) and lll.115(a)(3)] 

We assume that 50 percent of 

regulated entities will take advantage of 

the option included in this final rule to 

implement three burden-reducing 

provisions of the 2018 Requirements 

prior to the general compliance date. We 

assume this because an institution’s 

decision about whether to transition a 

study to the 2018 Requirements to take 

advantage of the three burden-reducing 

provisions might vary depending on the 

nature and progress of the study, 

including any elements of the study to 

be conducted on or after January 21, 

2019. For example, studies planning to 

recruit some subjects on or after January 

21, 2019 would have to meet the new 

requirements for obtaining the informed 

consent of those subjects. In contrast, for 

studies whose remaining activities 

consist only of completing data 

analyses, the new requirements for 

informed consent would generally not 

be applicable. Therefore, we assume 

that there are situations in which an 

institution would want to take 

advantage of the three burden-reducing 

provisions, and situations in which an 

institution would not want to take 

advantage of this flexibility. We note 

that we intend to publish guidance on 

the carve-outs from the definition of 

research prior to July 19, 2018, which 

may also impact an institution’s 

decision to elect to implement the three 

burden-reducing provisions or not. 

Thus, these entities will still obtain 

the benefits and costs described in the 

RIA for the 2018 Requirements, 

implying no effects of this rule for 50 

percent of regulated entities. For the 

regulated entities that do not take 

advantage of these flexibilities, we 

assume that the foregone benefits (costs) 

of delaying implementation of these 

provisions are what would have been 

the benefits of implementing these 

provisions in January 2018. Similarly, 

we assume that the benefits (costsavings) associated with delaying the 

implementation of these provisions are 

what would have been the costs of 

implementing these provisions in July 

2018. We assume that these regulated 

entities account for 50 percent of the 

costs and benefits that would have been 

experienced in 2018 absent this delay. 

We also assume that institutional or 

IRB staff at the IRB Administrative staff 

level 7 will spend 5 minutes per 

protocol documenting the voluntary 

election to use the three burdenreducing 2018 provisions during the 

time period of July 19, 2018 to January 

21, 2019. 

Some members of the regulated 

community have indicated that even 

though the 2018 Requirements yield 

cost savings, these institutions are still 

hesitant to transition ongoing research 

to the 2018 Requirements, largely 

because of the burden of making studies 

already in compliance with the pre-2018 

requirements comply with the 2018 

requirements. Also, some institutions 

seem inclined to make all of the 

transitions at once. This 

interconnectedness is key to some of the 

assumptions noted elsewhere in this 

analysis. For example, if the three 

burden-reducing provisions are 

considered on their own, a reasonable 

assumption would be that 100 percent 

of affected entities would realize the 

associated cost savings as soon as 

possible. The use, instead, of a 50 

percent estimate reflects entities’ 

possible inclinations to make all 

transitions at once. 

c. Expansion of Research Activities 

Exempt From Full IRB Review (§ lll

.104(d)) 

The 2018 Requirements include five 

new exemption categories and modify 


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8See for example, SACHRP Recommendations of 

August 2, 2017: https://www.hhs.gov/ohrp/sachrpcommittee/recommendations/sachrprecommendations/index.html. 

all but one exemption that exist in the 

pre-2018 Requirements. We have 

received feedback from SACHRP that 

guidance will be useful for regulated 

entities to implement many of the 

exemption categories.8 Areas where 

significant guidance will be helpful 

include: Applying the categories of the 

new exemptions themselves, conducting 

limited IRB review (as required in four 

exemptions), developing and using 

broad consent (as required in two 

exemptions), utilizing the exemption for 

certain HIPAA covered activities, and 

understanding which federally 

supported or conducted nonresearch 

information collections qualify for 

exemption. 

Because the guidance documents that 

would be helpful to assist regulated 

entities in implementing these 

provisions of the 2018 Requirements 

have not yet been issued, we assume 

that 50 percent of the regulated entities 

would not have taken advantage of the 

expansion in exemptions during this six 

month-delay. For these entities, we 

assume that there are no benefits and 

costs of the proposed delay, because 

they would not have changed their 

operations. We assume that 50 percent 

of the regulated entities would have 

gone forward with using the new or 

expanded exemption categories under 

the 2018 Requirements; for these 

entities, there are costs of delaying the 

implementation of this provision during 

the six-month delay proposed in this 

NPRM. 

We do not have data to support our 

assumption of what percent of regulated 

entities would have gone forward with 

the implementation of these provisions 

in the absence of additional guidance, 

and what percent would not have gone 

forward. 

4. Analysis of Final Rule Alternative 

An alternative to the proposal 

finalized in this rule was to delay the 

effective date and general compliance 

date to January 21, 2019. 

Table 3 summarizes the quantified 

benefits and costs of the alternative 

proposal of delaying the general 

implementation of 2018 Requirements 

without the option to implement certain 

provisions of the 2018 Requirements. 

Over the period of July 2018 to January 

2019, annualized benefits of $7.4 

million are estimated using a 3 percent 

discount rate; annualized benefits of 

$6.9 million are estimated using a 7 

percent discount rate. Annualized costs 

of $50.8 million are estimated using a 3 

percent discount rate; annualized costs 

of $47.0 million are estimated using a 7 

percent discount rate. Note that all 

values are represented in millions of 

2016 dollars, and 2016 is used as the 

frame of reference for discounting. 

TABLE 3—ALL BENEFITS AND COSTS OF DELAYING COMPLIANCE WITH THE 2018 REQUIREMENTS UNDER THE

ALTERNATIVE PROPOSAL

Annualized value by 

discount rate 

(millions of 2016 dollars) 

3 Percent 7 Percent 

Benefits (Cost–Savings): 

Quantified Benefits: .......................................................................................................................................... 7.4 6.9 

Costs (Foregone Benefits): 

Quantified Costs ............................................................................................................................................... 50.8 47.0 

B. Paperwork Reduction Act (PRA) 

This final rule contains collections of 

information that are subject to review 

and approval by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act (PRA), as 

amended (44 U.S.C. 3501–3520). A 

description of these provisions is given 

in this document with an estimate of the 

annual reporting and recordkeeping 

burden. 

Title: Federal Policy for the Protection 

of Human Subjects. 

Description: In this document is a 

discussion of the regulatory provisions 

we believe are subject to the PRA and 

the probable information collection 

burden associated with these 

provisions. In general, the following 

actions trigger the PRA: (i) Reporting; 

(ii) Recordkeeping. 

Description of Respondents: The 

reporting and recordkeeping 

requirements in this document are 

imposed on institutions, institutional 

review boards, and investigators 

involved in human subjects research 

conducted or supported or otherwise 

subject to regulation by any federal 

department or agency that takes 

administrative action that makes the 

policy applicable to such research. 

§ lll.101(l)(4) Compliance Date and 

Transition Provision (OMB Control No 

0990–0260) 

Section 101(l)(4)(i) permits studies to 

transition to the 2018 Requirements 

between July 19, 2018 and January 21, 

2019 (which would be the new general 

compliance date for the 2018 

Requirements). Between July 19, 2018 

and January 21, 2019, institutions that 

elect to transition studies to the 2018 

Requirements would, after the decision 

to transition has been documented, be 

able to take advantage of the three 

burden-reducing 2018 Requirements. 

This option is described in a revision 

to §lll.101(l)(4)(i). As described, 

studies taking advantage of this option 

would be subject to the three burdenreducing 2018 Requirements instead of, 

or in addition to, the comparable 

provisions of the pre-2018 

Requirements. As discussed above, the 

three burden-reducing 2018 

Requirements are (1) the 2018 

Requirements’ definition of ‘‘research’’ 

at §lll.102(l) (instead of §lll

.102(d) of the pre-2018 Requirements), 

which deems certain activities not to be 

research, (2) the elimination of the 

requirement that an IRB review the 

grant application or proposal related to 

the research at §lll.103(d) of the 

2018 Requirements (instead of §lll

.103(f) of the pre-2018 Requirements), 

and (3) the elimination of the 

requirement for annual continuing 

review of certain categories of research 

at §lll.109(f)(1)(i) and (iii) of the 

2018 Requirements (instead of §lll

.103(b), as related to the requirement for 

continuing review, and in addition to 

§ lll.109 of the pre-2018 

Requirements). 


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We estimate that approximately 

92,084 protocols would take advantage 

of the voluntary election described in 

§ lll.101(l)(4)(i). We estimate that 

institutional staff would spend 5 

minutes per protocol documenting that 

the study will be subject to the three 

burden-reducing provisions of the 2018 

Requirements during the time period of 

July 19, 2018 through January 21, 2019. 

We estimate that this provision includes 

7,674 burden hours. 

C. Regulatory Flexibility Act (RFA) 

The Regulatory Flexibility Act (5 

U.S.C. 601 et seq.) (RFA) and the Small 

Business Regulatory Enforcement and 

Fairness Act of 1996, which amended 

the RFA, require agencies that issue a 

regulation to analyze options for 

regulatory relief for small businesses. If 

a rule has a significant economic impact 

on a substantial number of small 

entities, agencies must specifically 

consider the economic effect of the rule 

on small entities and analyze regulatory 

options that could lessen the impact of 

the rule. The RFA generally defines a 

‘‘small entity’’ as (1) a proprietary firm 

meeting the size standards of the Small 

Business Administration (SBA); (2) a 

nonprofit organization that is not 

dominant in its field; or (3) a small 

government jurisdiction with a 

population of less than 50,000 (states 

and individuals are not included in the 

definition of ‘‘small entity’’). HHS 

considers a rule to have a significant 

economic impact on a substantial 

number of small entities if at least 5 

percent of small entities experience an 

impact of more than 3 percent of 

revenue. 

We have determined that this final 

rule will not have a significant 

economic impact on a substantial 

number of small entities under the RFA. 

In making this determination, the 

impact of concern is any significant 

adverse economic impact on small 

entities. An agency may certify that a 

rule will not have a significant 

economic impact on a substantial 

number of small entities if the rule 

relieves regulatory burden, has no net 

burden or otherwise has a positive 

economic effect on the small entities 

subject to the rule. This final rule would 

not impose a regulatory burden for 

regulated small entities because it 

would delay the general compliance 

date for the 2018 Requirements, 

allowing the status quo to be retained 

for the period of delay. Additionally, 

regulated small entities are permitted to 

comply voluntarily with those aspects 

of the 2018 Requirements that do not 

conflict with the pre-2018 

Requirements, prior to January 21, 2019. 

We have therefore concluded that this 

action will have no net regulatory 

burden for all directly regulated small 

entities. 

D. Unfunded Mandates Reform Act 

(UMRA) 

Federal mandate that may result in 

the expenditure by State, local, and 

tribal governments, in the aggregate, or 

by the private sector, of $100,000,000 or 

more (adjusted annually for inflation) in 

any one year.’’ In 2018, that threshold 

is approximately $150 million. We do 

not expect this rule to result in 

expenditures that will exceed this 

amount. 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.2 U.S.C. 1531–1538, and 

does not significantly or uniquely affect 

small governments. 

E. Executive Order 13132: Federalism 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a rule 

that imposes substantial direct 

requirement costs on state and local 

governments or has federalism 

implications. We have determined that 

this rule would not contain policies that 

would have substantial direct effects on 

the States, on the relationship between 

the Federal Government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government. The changes in 

this rule represent the Federal 

Government regulating its own program. 

Accordingly, we conclude that the rule 

does not propose policies that have 

federalism implications as defined in 

Executive Order 13132 and, 

consequently, a federalism summary 

impact statement is not required. 

For the reasons set forth in the 

preamble, the Federal Policy for the 

Protection of Human Subjects, as 

published in the Federal Register on 

January 19, 2017 (82 FR 7149) and as 

adopted in a final rule published by the 

CPSC on September 18, 2017 (82 FR 

43459), and as amended in a final rule 

published in the Federal Register on 

January 22, 2018 (83 FR 2885) and 

adopted by HUD through a final rule 

published on January 26, 2018 (83 FR 

3589), is further amended as follows: 

Text of the Amended Common Rule 

PARTll—PROTECTION OF HUMAN 

SUBJECTS 

1. Amend § lll.101 by adding a 

heading for paragraph (l)(1), revising 

paragraphs (l)(2), (3), and (4), and 

adding paragraph (l)(5) to read as 

follows: 

§ lll.101 To what does this policy 

apply? 

* * * * * 

(l) * * * 

(1) Pre-2018 Requirements. * * * 

(2) 2018 Requirements. For purposes 

of this section, the 2018 Requirements 

means the Federal Policy for the 

Protection of Human Subjects 

requirements contained in this [part/ 

subpart]. The general compliance date 

for the 2018 Requirements is January 21, 

2019. The compliance date for § lll

.114(b) (cooperative research) of the 

2018 Requirements is January 20, 2020. 

(3) Research subject to pre-2018 

requirements. The pre-2018 

Requirements shall apply to the 

following research, unless the research 

is transitioning to comply with the 2018 

Requirements in accordance with 

paragraph (l)(4) of this section: 

(i) Research initially approved by an 

IRB under the pre-2018 Requirements 

before January 21, 2019; 

(ii) Research for which IRB review 

was waived pursuant to §lll.101(i) 

of the pre-2018 Requirements before 

January 21, 2019; and 

(iii) Research for which a 

determination was made that the 

research was exempt under § .101(b) of 

the pre-2018 Requirements before 

January 21, 2019. 

(4) Transitioning research. If, on or 

after July 19, 2018, an institution 

planning or engaged in research 

otherwise covered by paragraph (l)(3) of 

this section determines that such 

research instead will transition to 

comply with the 2018 Requirements, the 

institution or an IRB must document 

and date such determination. 

(i) If the determination to transition is 

documented between July 19, 2018, and 

January 20, 2019, the research shall: 

(A) Beginning on the date of such 

documentation through January 20, 

2019, comply with the pre-2018 

Requirements, except that the research 

shall comply with the following: 

(1) Section lll.102(l) of the 2018 

Requirements (definition of research) 

(instead of § lll.102(d) of the pre2018 Requirements); 

(2) Section lll.103(d) of the 2018 

Requirements (revised certification 

requirement that eliminates IRB review 

of application or proposal) (instead of 

§ lll.103(f) of the pre-2018 

Requirements); and 

(3) Section lll.109(f)(1)(i) and (iii) 

of the 2018 Requirements (exceptions to 

mandated continuing review) (instead of 

§ lll.103(b), as related to the 

requirement for continuing review, and 


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in addition to §lll.109, of the pre2018 Requirements); and 

(B) Beginning on January 21, 2019, 

comply with the 2018 Requirements. 

(ii) If the determination to transition 

is documented on or after January 21, 

2019, the research shall, beginning on 

the date of such documentation, comply 

with the 2018 Requirements. 

(5) Research subject to 2018 

Requirements. The 2018 Requirements 

shall apply to the following research: 

(i) Research initially approved by an 

IRB on or after January 21, 2019; 

(ii) Research for which IRB review is 

waived pursuant to paragraph (i) of this 

section on or after January 21, 2019; and 

(iii) Research for which a 

determination is made that the research 

is exempt on or after January 21, 2019. 

* * * * * 

DEPARTMENT OF HOMELAND 

SECURITY 

List of Subjects in 6 CFR Part 46 

Human research subjects, Reporting 

and recordkeeping requirements, 

Research. 

For the reasons stated in the 

preamble, Department of Homeland 

Security further amends 6 CFR part 46 

as published in the Federal Register on 

January 19, 2017 (82 FR 7149), and as 

amended in an interim final rule 

published in the Federal Register on 

January 22, 2018 (83 FR 2885), as 

follows: 

PART 46—PROTECTION OF HUMAN 

SUBJECTS 

■ 1. The authority citation for part 46 

continues to read as follows: 

Authority: 5 U.S.C. 301; Pub. L. 107–296, 

sec. 102, 306(c); Pub. L. 108–458, sec. 8306. 

■ 2. Amend § 46.101 by adding a 

heading for paragraph (l)(1), revising 

paragraphs (l)(2), (3), and (4), and 

adding paragraph (l)(5) to read as 

follows: 

§ 46.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(1) Pre-2018 Requirements. * * * 

(2) 2018 Requirements. For purposes 

of this section, the 2018 Requirements 

means the Federal Policy for the 

Protection of Human Subjects 

requirements contained in this part. The 

general compliance date for the 2018 

Requirements is January 21, 2019. The 

compliance date for § 46.114(b) 

(cooperative research) of the 2018 

Requirements is January 20, 2020. 

(3) Research subject to pre-2018 

requirements. The pre-2018 

Requirements shall apply to the 

following research, unless the research 

is transitioning to comply with the 2018 

Requirements in accordance with 

paragraph (l)(4) of this section: 

(i) Research initially approved by an 

IRB under the pre-2018 Requirements 

before January 21, 2019; 

(ii) Research for which IRB review 

was waived pursuant to § 46.101(i) of 

the pre-2018 Requirements) before 

January 21, 2019; and 

(iii) Research for which a 

determination was made that the 

research was exempt under § 46.101(b) 

of the pre-2018 Requirements before 

January 21, 2019. 

(4) Transitioning research. If, on or 

after July 19, 2018, an institution 

planning or engaged in research 

otherwise covered by paragraph (l)(3) of 

this section determines that such 

research instead will transition to 

comply with the 2018 Requirements, the 

institution or an IRB must document 

and date such determination. 

(i) If the determination to transition is 

documented between July 19, 2018, and 

January 20, 2019, the research shall: 

(A) Beginning on the date of such 

documentation through January 20, 

2019, comply with the pre-2018 

Requirements, except that the research 

shall comply with the following: 

(1) Section 46.102(l) of the 2018 

Requirements (definition of research) 

(instead of § 46.102(d) of the pre-2018 

Requirements); 

(2) Section 46.103(d) of the 2018 

Requirements (revised certification 

requirement that eliminates IRB review 

of application or proposal) (instead of 

§ 46.103(f) of the pre-2018 

Requirements); and 

(3) Section 46.109(f)(1)(i) and (iii) of 

the 2018 Requirements (exceptions to 

mandated continuing review) (instead of 

§ 46.103(b), as related to the 

requirement for continuing review, and 

in addition to § 46.109, of the pre-2018 

Requirements); and 

(B) Beginning on January 21, 2019, 

comply with the 2018 Requirements. 

(ii) If the determination to transition 

is documented on or after January 21, 

2019, the research shall, beginning on 

the date of such documentation, comply 

with the 2018 Requirements. 

(5) Research subject to 2018 

Requirements. The 2018 Requirements 

shall apply to the following research: 

(i) Research initially approved by an 

IRB on or after January 21, 2019; 

(ii) Research for which IRB review is 

waived pursuant to paragraph (i) of this 

section on or after January 21, 2019; and 

(iii) Research for which a 

determination is made that the research 

is exempt on or after January 21, 2019. 

* * * * * 

Claire M. Grady, 

Deputy Secretary (Acting), Department of 

Homeland Security. 

DEPARTMENT OF AGRICULTURE 

List of Subjects in 7 CFR Part 1c 

Human research subjects, Reporting 

and recordkeeping requirements, 

Research. 

For the reasons stated in the 

preamble, Department of Agriculture 

further amends 7 CFR part 1c as 

published in the Federal Register on 

January 19, 2017 (82 FR 7149), and as 

amended in an interim final rule 

published in the Federal Register on 

January 22, 2018 (83 FR 2885), as 

follows: 

PART 1c—PROTECTION OF HUMAN 

SUBJECTS 

■ 1. The authority citation for part 1c 

continues to read as follows: 

Authority: 5 U.S.C. 301; 42 U.S.C. 300v– 

1(b). 

■ 2. Amend § 1c.101 by adding a 

heading for paragraph (l)(1), revising 

paragraphs (l)(2), (3), and (4), and 

adding paragraph (l)(5) to read as 

follows: 

§ 1c.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(1) Pre-2018 Requirements. * * * 

(2) 2018 Requirements. For purposes 

of this section, the 2018 Requirements 

means the Federal Policy for the 

Protection of Human Subjects 

requirements contained in this part. The 

general compliance date for the 2018 

Requirements is January 21, 2019. The 

compliance date for § 1c.114(b) 

(cooperative research) of the 2018 

Requirements is January 20, 2020. 

(3) Research subject to pre-2018 

requirements. The pre-2018 

Requirements shall apply to the 

following research, unless the research 

is transitioning to comply with the 2018 

Requirements in accordance with 

paragraph (l)(4) of this section: 

(i) Research initially approved by an 

IRB under the pre-2018 Requirements 

before January 21, 2019; 

(ii) Research for which IRB review 

was waived pursuant to § 1c.101(i) of 

the pre-2018 Requirements before 

January 21, 2019; and 

(iii) Research for which a 

determination was made that the 

research was exempt under § 1c.101(b) 


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of the pre-2018 Requirements before 

January 21, 2019. 

(4) Transitioning research. If, on or 

after July 19, 2018, an institution 

planning or engaged in research 

otherwise covered by paragraph (l)(3) of 

this section determines that such 

research instead will transition to 

comply with the 2018 Requirements, the 

institution or an IRB must document 

and date such determination. 

(i) If the determination to transition is 

documented between July 19, 2018, and 

January 20, 2019, the research shall: 

(A) Beginning on the date of such 

documentation through January 20, 

2019, comply with the pre-2018 

Requirements, except that the research 

shall comply with the following: 

(1) Section 1c.102(l) of the 2018 

Requirements (definition of research) 

(instead of § 1c.102(d) of the pre-2018 

Requirements); 

(2) Section 1c.103(d) of the 2018 

Requirements (revised certification 

requirement that eliminates IRB review 

of application or proposal) (instead of 

§ 1c.103(f) of the pre-2018 

Requirements); and 

(3) Section 1c.109(f)(1)(i) and (iii) of 

the 2018 Requirements (exceptions to 

mandated continuing review) (instead of 

§ 1c.103(b), as related to the requirement 

for continuing review, and in addition 

to § 1c.109, of the pre-2018 

Requirements); and 

(B) Beginning on January 21, 2019, 

comply with the 2018 Requirements. 

(ii) If the determination to transition 

is documented on or after January 21, 

2019, the research shall, beginning on 

the date of such documentation, comply 

with the 2018 Requirements. 

(5) Research subject to 2018 

Requirements. The 2018 Requirements 

shall apply to the following research: 

(i) Research initially approved by an 

IRB on or after January 21, 2019; 

(ii) Research for which IRB review is 

waived pursuant to paragraph (i) of this 

section on or after January 21, 2019; and 

(iii) Research for which a 

determination is made that the research 

is exempt on or after January 21, 2019. 

* * * * * 

Chavonda Jacobs-Young, 

Acting Deputy Under Secretary for Research, 

Education, and Economics, USDA. 

DEPARTMENT OF ENERGY 

List of Subjects in 10 CFR Part 745 

Human research subjects, Reporting 

and recordkeeping requirements, 

Research. 

For the reasons stated in the 

preamble, Department of Energy further 

amends 10 CFR part 745 as published in 

the Federal Register on January 19, 

2017 (82 FR 7149), and as amended in 

an interim final rule published in the 

Federal Register on January 22, 2018 

(83 FR 2885), as follows: 

PART 745—PROTECTION OF HUMAN 

SUBJECTS 

■ 1. The authority citation for part 745 

continues to read as follows: 

Authority: 5 U.S.C. 301; 42 U.S.C. 7254; 

42 U.S.C. 300v–1(b). 

■ 2. Amend § 745.101 by adding a 

heading for paragraph (l)(1), revising 

paragraphs (l)(2), (3), and (4), and 

adding paragraph (l)(5) to read as 

follows: 

§ 745.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(1) Pre-2018 Requirements. * * * 

(2) 2018 Requirements. For purposes 

of this section, the 2018 Requirements 

means the Federal Policy for the 

Protection of Human Subjects 

requirements contained in this part. The 

general compliance date for the 2018 

Requirements is January 21, 2019. The 

compliance date for § 745.114(b) 

(cooperative research) of the 2018 

Requirements is January 20, 2020. 

(3) Research subject to pre-2018 

requirements. The pre-2018 

Requirements shall apply to the 

following research, unless the research 

is transitioning to comply with the 2018 

Requirements in accordance with 

paragraph (l)(4) of this section: 

(i) Research initially approved by an 

IRB under the pre-2018 Requirements 

before January 21, 2019; 

(ii) Research for which IRB review 

was waived pursuant to § 745.101(i) of 

the pre-2018 Requirements before 

January 21, 2019; and 

(iii) Research for which a 

determination was made that the 

research was exempt under § 745.101(b) 

of the pre-2018 Requirements before 

January 21, 2019. 

(4) Transitioning research. If, on or 

after July 19, 2018, an institution 

planning or engaged in research 

otherwise covered by paragraph (l)(3) of 

this section determines that such 

research instead will transition to 

comply with the 2018 Requirements, the 

institution or an IRB must document 

and date such determination. 

(i) If the determination to transition is 

documented between July 19, 2018, and 

January 20, 2019, the research shall: 

(A) Beginning on the date of such 

documentation through January 20, 

2019, comply with the pre-2018 

Requirements, except that the research 

shall comply with the following: 

(1) Section 745.102(l) of the 2018 

Requirements (definition of research) 

(instead of § 745.102(d) of the pre-2018 

Requirements); 

(2) Section 745.103(d) of the 2018 

Requirements (revised certification 

requirement that eliminates IRB review 

of application or proposal) (instead of 

§ 745.103(f) of the pre-2018 

Requirements); and 

(3) Section 745.109(f)(1)(i) and (iii) of 

the 2018 Requirements (exceptions to 

mandated continuing review) (instead of 

§ 745.103(b), as related to the 

requirement for continuing review, and 

in addition to § 745.109, of the pre-2018 

Requirements); and 

(B) Beginning on January 21, 2019, 

comply with the 2018 Requirements. 

(ii) If the determination to transition 

is documented on or after January 21, 

2019, the research shall, beginning on 

the date of such documentation, comply 

with the 2018 Requirements. 

(5) Research subject to 2018 

Requirements. The 2018 Requirements 

shall apply to the following research: 

(i) Research initially approved by an 

IRB on or after January 21, 2019; 

(ii) Research for which IRB review is 

waived pursuant to paragraph (i) of this 

section on or after January 21, 2019; and 

(iii) Research for which a 

determination is made that the research 

is exempt on or after January 21, 2019. 

* * * * * 

Dan Brouillette, 

Deputy Secretary of Energy. 

NATIONAL AERONAUTICS AND 

SPACE ADMINISTRATION 

List of Subjects in 14 CFR Part 1230 

Human research subjects, Reporting 

and recordkeeping requirements, 

Research. 

For the reasons stated in the 

preamble, National Aeronautics and 

Space Administration further amends 

14 CFR part 1230 as published in the 

Federal Register on January 19, 2017 

(82 FR 7149), and as amended in an 

interim final rule published in the 

Federal Register on January 22, 2018 

(83 FR 2885), as follows: 

PART 1230—PROTECTION OF HUMAN 

SUBJECTS 

■ 1. The authority citation for part 1230 

continues to read as follows: 

Authority: 5 U.S.C. 301; 42 U.S.C. 300v– 

1(b). 

■ 2. Amend § 1230.101 by adding a 

heading for paragraph (l)(1), revising 

paragraphs (l)(2), (3), and (4), and 

adding paragraph (l)(5) to read as 

follows: 


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§ 1230.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(1) Pre-2018 Requirements. * * * 

(2) 2018 Requirements. For purposes 

of this section, the 2018 Requirements 

means the Federal Policy for the 

Protection of Human Subjects 

requirements contained in this part. The 

general compliance date for the 2018 

Requirements is January 21, 2019. The 

compliance date for § 1230.114(b) 

(cooperative research) of the 2018 

Requirements is January 20, 2020. 

(3) Research subject to pre-2018 

requirements. The pre-2018 

Requirements shall apply to the 

following research, unless the research 

is transitioning to comply with the 2018 

Requirements in accordance with 

paragraph (l)(4) of this section: 

(i) Research initially approved by an 

IRB under the pre-2018 Requirements 

before January 21, 2019; 

(ii) Research for which IRB review 

was waived pursuant to § 1230.101(i) of 

the pre-2018 Requirements before 

January 21, 2019; and 

(iii) Research for which a 

determination was made that the 

research was exempt under 

§ 1230.101(b) of the pre-2018 

Requirements before January 21, 2019. 

(4) Transitioning research. If, on or 

after July 19, 2018, an institution 

planning or engaged in research 

otherwise covered by paragraph (l)(3) of 

this section determines that such 

research instead will transition to 

comply with the 2018 Requirements, the 

institution or an IRB must document 

and date such determination. 

(i) If the determination to transition is 

documented between July 19, 2018, and 

January 20, 2019, the research shall: 

(A) Beginning on the date of such 

documentation through January 20, 

2019, comply with the pre-2018 

Requirements, except that the research 

shall comply with the following: 

(1) Section 1230.102(l) of the 2018 

Requirements (definition of research) 

(instead of § 1230.102(d) of the pre-2018 

Requirements); 

(2) Section 1230.103(d) of the 2018 

Requirements (revised certification 

requirement that eliminates IRB review 

of application or proposal) (instead of 

§ 1230.103(f) of the pre-2018 

Requirements); and 

(3) Section 1230.109(f)(1)(i) and (iii) 

of the 2018 Requirements (exceptions to 

mandated continuing review) (instead of 

§ 1230.103(b), as related to the 

requirement for continuing review, and 

in addition to § 1230.109, of the pre2018 Requirements); and 

(B) Beginning on January 21, 2019, 

comply with the 2018 Requirements. 

(ii) If the determination to transition 

is documented on or after January 21, 

2019, the research shall, beginning on 

the date of such documentation, comply 

with the 2018 Requirements. 

(5) Research subject to 2018 

Requirements. The 2018 Requirements 

shall apply to the following research: 

(i) Research initially approved by an 

IRB on or after January 21, 2019; 

(ii) Research for which IRB review is 

waived pursuant to paragraph (i) of this 

section on or after January 21, 2019; and 

(iii) Research for which a 

determination is made that the research 

is exempt on or after January 21, 2019. 

* * * * * 

James D. Polk, 

Chief Health & Medical Officer, National 

Aeronautics and Space Administration. 

DEPARTMENT OF COMMERCE 

List of Subjects in 15 CFR Part 27 

Human research subjects, Reporting 

and recordkeeping requirements, 

Research. 

For the reasons stated in the 

preamble, Department of Commerce 

further amends 15 CFR part 27 as 

published in the Federal Register on 

January 19, 2017 (82 FR 7149), and as 

amended in an interim final rule 

published in the Federal Register on 

January 22, 2018 (83 FR 2885), as 

follows: 

PART 27—PROTECTION OF HUMAN 

SUBJECTS 

■ 1. The authority citation for part 27 

continues to read as follows: 

Authority: 5 U.S.C. 301; 42 U.S.C. 300v– 

1(b). 

■ 2. Amend § 27.101 by adding a 

heading for paragraph (l)(1), revising 

paragraphs (l)(2), (3), and (4), and 

adding paragraph (l)(5) to read as 

follows: 

§ 27.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(1) Pre-2018 Requirements. * * * 

(2) 2018 Requirements. For purposes 

of this section, the 2018 Requirements 

means the Federal Policy for the 

Protection of Human Subjects 

requirements contained in this part. The 

general compliance date for the 2018 

Requirements is January 21, 2019. The 

compliance date for § 27.114(b) 

(cooperative research) of the 2018 

Requirements is January 20, 2020. 

(3) Research subject to pre-2018 

requirements. The pre-2018 

Requirements shall apply to the 

following research, unless the research 

is transitioning to comply with the 2018 

Requirements in accordance with 

paragraph (l)(4) of this section: 

(i) Research initially approved by an 

IRB under the pre-2018 Requirements 

before January 21, 2019; 

(ii) Research for which IRB review 

was waived pursuant to § 27.101(i) of 

the pre-2018 Requirements before 

January 21, 2019; and 

(iii) Research for which a 

determination was made that the 

research was exempt under § 27.101(b) 

of the pre-2018 Requirements before 

January 21, 2019. 

(4) Transitioning research. If, on or 

after July 19, 2018, an institution 

planning or engaged in research 

otherwise covered by paragraph (l)(3) of 

this section determines that such 

research instead will transition to 

comply with the 2018 Requirements, the 

institution or an IRB must document 

and date such determination. 

(i) If the determination to transition is 

documented between July 19, 2018, and 

January 20, 2019, the research shall: 

(A) Beginning on the date of such 

documentation through January 20, 

2019, comply with the pre-2018 

Requirements, except that the research 

shall comply with the following: 

(1) Section 27.102(l) of the 2018 

Requirements (definition of research) 

(instead of § 27.102(d) of the pre-2018 

Requirements); 

(2) Section 27.103(d) of the 2018 

Requirements (revised certification 

requirement that eliminates IRB review 

of application or proposal) (instead of 

§ 27.103(f) of the pre-2018 

Requirements); and 

(3) Section 27.109(f)(1)(i) and (iii) of 

the 2018 Requirements (exceptions to 

mandated continuing review) (instead of 

§ 27.103(b), as related to the 

requirement for continuing review, and 

in addition to § 27.109, of the pre-2018 

Requirements); and 

(B) Beginning on January 21, 2019, 

comply with the 2018 Requirements. 

(ii) If the determination to transition 

is documented on or after January 21, 

2019, the research shall, beginning on 

the date of such documentation, comply 

with the 2018 Requirements. 

(5) Research subject to 2018 

Requirements. The 2018 Requirements 

shall apply to the following research: 

(i) Research initially approved by an 

IRB on or after January 21, 2019; 

(ii) Research for which IRB review is 

waived pursuant to paragraph (i) of this 

section on or after January 21, 2019; and 


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(iii) Research for which a 

determination is made that the research 

is exempt on or after January 21, 2019. 

* * * * * 

Wilbur L. Ross, 

Secretary of Commerce. 

CONSUMER PRODUCT SAFETY 

COMMISSION 

List of Subjects in 16 CFR Part 1028 

Human research subjects, Reporting 

and recordkeeping requirements, 

Research. 

For the reasons stated in the 

preamble, Consumer Product Safety 

Commission further amends 16 CFR 

part 1028 as published in the Federal 

Register on January 19, 2017 (82 FR 

7149) and as adopted in a final rule 

published by the CPSC on September 

18, 2017 (82 FR 43459), and as amended 

in an interim final rule published in the 

Federal Register on January 22, 2018 

(83 FR 2885), as follows: 

PART 1028—PROTECTION OF HUMAN 

SUBJECTS 

■ 1. The authority citation for part 1028 

continues to read as follows: 

Authority: 5 U.S.C. 301; 42 U.S.C. 300v– 

1(b). 

■ 2. Amend § 1028.101 by adding a 

heading for paragraph (l)(1), revising 

paragraphs (l)(2), (3), and (4), and 

adding paragraph (l)(5) to read as 

follows: 

§ 1028.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(1) Pre-2018 Requirements. * * * 

(2) 2018 Requirements. For purposes 

of this section, the 2018 Requirements 

means the Federal Policy for the 

Protection of Human Subjects 

requirements contained in this part. The 

general compliance date for the 2018 

Requirements is January 21, 2019. The 

compliance date for § 1028.114(b) 

(cooperative research) of the 2018 

Requirements is January 20, 2020. 

(3) Research subject to pre-2018 

requirements. The pre-2018 

Requirements shall apply to the 

following research, unless the research 

is transitioning to comply with the 2018 

Requirements in accordance with 

paragraph (l)(4) of this section: 

(i) Research initially approved by an 

IRB under the pre-2018 Requirements 

before January 21, 2019; 

(ii) Research for which IRB review 

was waived pursuant to § 1028.101(i) of 

the pre-2018 Requirements before 

January 21, 2019; and 

(iii) Research for which a 

determination was made that the 

research was exempt under 

§ 1028.101(b) of the pre-2018 

Requirements before January 21, 2019. 

(4) Transitioning research. If, on or 

after July 19, 2018, an institution 

planning or engaged in research 

otherwise covered by paragraph (l)(3) of 

this section determines that such 

research instead will transition to 

comply with the 2018 Requirements, the 

institution or an IRB must document 

and date such determination. 

(i) If the determination to transition is 

documented between July 19, 2018, and 

January 20, 2019, the research shall: 

(A) Beginning on the date of such 

documentation through January 20, 

2019, comply with the pre-2018 

Requirements, except that the research 

shall comply with the following: 

(1) Section 1028.102(l) of the 2018 

Requirements (definition of research) 

(instead of § 1028.102(d) of the pre-2018 

Requirements); 

(2) Section 1028.103(d) of the 2018 

Requirements (revised certification 

requirement that eliminates IRB review 

of application or proposal) (instead of 

§ 1028.103(f) of the pre-2018 

Requirements); and 

(3) Section 1028.109(f)(1)(i) and (iii) 

of the 2018 Requirements (exceptions to 

mandated continuing review) (instead of 

§ 1028.103(b), as related to the 

requirement for continuing review, and 

in addition to § 1028.109, of the pre2018 Requirements); and 

(B) Beginning on January 21, 2019, 

comply with the 2018 Requirements. 

(ii) If the determination to transition 

is documented on or after January 21, 

2019, the research shall, beginning on 

the date of such documentation, comply 

with the 2018 Requirements. 

(5) Research subject to 2018 

Requirements. The 2018 Requirements 

shall apply to the following research: 

(i) Research initially approved by an 

IRB on or after January 21, 2019; 

(ii) Research for which IRB review is 

waived pursuant to paragraph (i) of this 

section on or after January 21, 2019; and 

(iii) Research for which a 

determination is made that the research 

is exempt on or after January 21, 2019. 

* * * * * 

Alberta E. Mills, 

Secretary, Consumer Product Safety 

Commission. 

SOCIAL SECURITY ADMINISTRATION 

List of Subjects in 20 CFR Part 431 

Human research subjects, Reporting 

and recordkeeping requirements, 

Research. 

For the reasons stated in the 

preamble, Social Security 

Administration further amends 20 CFR 

part 431 as published in the Federal 

Register on January 19, 2017 (82 FR 

7149), and as amended in an interim 

final rule published in the Federal 

Register on January 22, 2018 (83 FR 

2885), as follows: 

PART 431—PROTECTION OF HUMAN 

SUBJECTS 

■ 1. The authority citation for part 431 

continues to read as follows: 

Authority: 5 U.S.C. 301; 42 U.S.C. 289(a). 

■ 2. Amend § 431.101 by adding a 

heading for paragraph (l)(1), revising 

paragraphs (l)(2), (3), and (4), and 

adding paragraph (l)(5) to read as 

follows: 

§ 431.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(1) Pre-2018 Requirements. * * * 

(2) 2018 Requirements. For purposes 

of this section, the 2018 Requirements 

means the Federal Policy for the 

Protection of Human Subjects 

requirements contained in this part. The 

general compliance date for the 2018 

Requirements is January 21, 2019. The 

compliance date for § 431.114(b) 

(cooperative research) of the 2018 

Requirements is January 20, 2020. 

(3) Research subject to pre-2018 

requirements. The pre-2018 

Requirements shall apply to the 

following research, unless the research 

is transitioning to comply with the 2018 

Requirements in accordance with 

paragraph (l)(4) of this section: 

(i) Research initially approved by an 

IRB under the pre-2018 Requirements 

before January 21, 2019; 

(ii) Research for which IRB review 

was waived pursuant to § 431.101(i) of 

the pre-2018 Requirements before 

January 21, 2019; and 

(iii) Research for which a 

determination was made that the 

research was exempt under § 431.101(b) 

of the pre-2018 Requirements before 

January 21, 2019. 

(4) Transitioning research. If, on or 

after July 19, 2018, an institution 

planning or engaged in research 

otherwise covered by paragraph (l)(3) of 

this section determines that such 

research instead will transition to 

comply with the 2018 Requirements, the 

institution or an IRB must document 

and date such determination. 

(i) If the determination to transition is 

documented between July 19, 2018, and 

January 20, 2019, the research shall: 

(A) Beginning on the date of such 

documentation through January 20, 

2019, comply with the pre-2018 


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Requirements, except that the research 

shall comply with the following: 

(1) Section 431.102(l) of the 2018 

Requirements (definition of research) 

(instead of § 431.102(d) of the pre-2018 

Requirements); 

(2) Section 431.103(d) of the 2018 

Requirements (revised certification 

requirement that eliminates IRB review 

of application or proposal) (instead of 

§ 431.103(f) of the pre-2018 

Requirements); and 

(3) Section 431.109(f)(1)(i) and (iii) of 

the 2018 Requirements (exceptions to 

mandated continuing review) (instead of 

§ 431.103(b), as related to the 

requirement for continuing review, and 

in addition to § 431.109, of the pre-2018 

Requirements); and 

(B) Beginning on January 21, 2019, 

comply with the 2018 Requirements. 

(ii) If the determination to transition 

is documented on or after January 21, 

2019, the research shall, beginning on 

the date of such documentation, comply 

with the 2018 Requirements. 

(5) Research subject to 2018 

Requirements. The 2018 Requirements 

shall apply to the following research: 

(i) Research initially approved by an 

IRB on or after January 21, 2019; 

(ii) Research for which IRB review is 

waived pursuant to paragraph (i) of this 

section on or after January 21, 2019; and 

(iii) Research for which a 

determination is made that the research 

is exempt on or after January 21, 2019. 

* * * * * 

Nancy Berryhill, 

Acting Commissioner of Social Security. 

AGENCY FOR INTERNATIONAL 

DEVELOPMENT 

List of Subjects in 22 CFR Part 225 

Human research subjects, Reporting 

and recordkeeping requirements, 

Research. 

For the reasons stated in the 

preamble, Agency for International 

Development further amends 22 CFR 

part 225 as published in the Federal 

Register on January 19, 2017 (82 FR 

7149), and as amended in an interim 

final rule published in the Federal 

Register on January 22, 2018 (83 FR 

2885), as follows: 

PART 225—PROTECTION OF HUMAN 

SUBJECTS 

■ 1. The authority citation for part 225 

continues to read as follows: 

Authority: 5 U.S.C. 301; 42 U.S.C. 300v– 

1(b), unless otherwise noted. 

■ 2. Amend § 225.101 by adding a 

heading for paragraph (l)(1), revising 

paragraphs (l)(2), (3), and (4), and 

adding paragraph (l)(5) to read as 

follows: 

§ 225.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(1) Pre-2018 Requirements. * * * 

(2) 2018 Requirements. For purposes 

of this section, the 2018 Requirements 

means the Federal Policy for the 

Protection of Human Subjects 

requirements contained in this part. The 

general compliance date for the 2018 

Requirements is January 21, 2019. The 

compliance date for § 225.114(b) 

(cooperative research) of the 2018 

Requirements is January 20, 2020. 

(3) Research subject to pre-2018 

requirements. The pre-2018 

Requirements shall apply to the 

following research, unless the research 

is transitioning to comply with the 2018 

Requirements in accordance with 

paragraph (l)(4) of this section: 

(i) Research initially approved by an 

IRB under the pre-2018 Requirements 

before January 21, 2019; 

(ii) Research for which IRB review 

was waived pursuant to § 225.101(i) of 

the pre-2018 Requirements before 

January 21, 2019; and 

(iii) Research for which a 

determination was made that the 

research was exempt under § 225.101(b) 

of the pre-2018 Requirements before 

January 21, 2019. 

(4) Transitioning research. If, on or 

after July 19, 2018, an institution 

planning or engaged in research 

otherwise covered by paragraph (l)(3) of 

this section determines that such 

research instead will transition to 

comply with the 2018 Requirements, the 

institution or an IRB must document 

and date such determination. 

(i) If the determination to transition is 

documented between July 19, 2018, and 

January 20, 2019, the research shall: 

(A) Beginning on the date of such 

documentation through January 20, 

2019, comply with the pre-2018 

Requirements, except that the research 

shall comply with the following: 

(1) Section 225.102(l) of the 2018 

Requirements (definition of research) 

(instead of § 225.102(d) of the pre-2018 

Requirements); 

(2) Section 225.103(d) of the 2018 

Requirements (revised certification 

requirement that eliminates IRB review 

of application or proposal) (instead of 

§ 225.103(f) of the pre-2018 

Requirements); and 

(3) Section 225.109(f)(1)(i) and (iii) of 

the 2018 Requirements (exceptions to 

mandated continuing review) (instead of 

§ 225.103(b), as related to the 

requirement for continuing review, and 

in addition to § 225.109, of the pre-2018 

Requirements); and 

(B) Beginning on January 21, 2019, 

comply with the 2018 Requirements. 

(ii) If the determination to transition 

is documented on or after January 21, 

2019, the research shall, beginning on 

the date of such documentation, comply 

with the 2018 Requirements. 

(5) Research subject to 2018 

Requirements. The 2018 Requirements 

shall apply to the following research: 

(i) Research initially approved by an 

IRB on or after January 21, 2019; 

(ii) Research for which IRB review is 

waived pursuant to paragraph (i) of this 

section on or after January 21, 2019; and 

(iii) Research for which a 

determination is made that the research 

is exempt on or after January 21, 2019. 

* * * * * 

Irene Koek, 

Senior Deputy Assistant Administrator for 

Global Health, U.S. Agency for International 

Development. 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

List of Subjects in 24 CFR Part 60 

Human research subjects, Reporting 

and recordkeeping requirements, 

Research. 

For the reasons stated in the 

preamble, Department of Housing and 

Urban Development further amends 24 

CFR part 60 as published in the Federal 

Register on January 19, 2017 (82 FR 

7149), and as amended in an interim 

final rule published in the Federal 

Register on January 22, 2018 (83 FR 

2885), and adopted by HUD through an 

interim final rule published on January 

26, 2018 (83 FR 3589), as follows: 

PART 60—PROTECTION OF HUMAN 

SUBJECTS 

■ 1. The authority citation for part 60 

continues to read as follows: 

Authority: 5 U.S.C. 301; 42 U.S.C. 300v1(b) and 3535(d). 

■ 2. Amend § 60.101 by adding a 

heading for paragraph (l)(1), revising 

paragraphs (l)(2), (3), and (4), and 

adding paragraph (l)(5) to read as 

follows: 

§ 60.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(1) Pre-2018 Requirements. * * * 

(2) 2018 Requirements. For purposes 

of this section, the 2018 Requirements 

means the Federal Policy for the 

Protection of Human Subjects 

requirements contained in this part. The 

general compliance date for the 2018 

Requirements is January 21, 2019. The 

compliance date for § 60.114(b) 


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(cooperative research) of the 2018 

Requirements is January 20, 2020. 

(3) Research subject to pre-2018 

requirements. The pre-2018 

Requirements shall apply to the 

following research, unless the research 

is transitioning to comply with the 2018 

Requirements in accordance with 

paragraph (l)(4) of this section: 

(i) Research initially approved by an 

IRB under the pre-2018 Requirements 

before January 21, 2019; 

(ii) Research for which IRB review 

was waived pursuant to § 60.101(i) of 

the pre-2018 Requirements before 

January 21, 2019; and 

(iii) Research for which a 

determination was made that the 

research was exempt under § 60.101(b) 

of the pre-2018 Requirements before 

January 21, 2019. 

(4) Transitioning research. If, on or 

after July 19, 2018, an institution 

planning or engaged in research 

otherwise covered by paragraph (l)(3) of 

this section determines that such 

research instead will transition to 

comply with the 2018 Requirements, the 

institution or an IRB must document 

and date such determination. 

(i) If the determination to transition is 

documented between July 19, 2018, and 

January 20, 2019, the research shall: 

(A) Beginning on the date of such 

documentation through January 20, 

2019, comply with the pre-2018 

Requirements, except that the research 

shall comply with the following: 

(1) Section 60.102(l) of the 2018 

Requirements (definition of research) 

(instead of § 60.102(d) of the pre-2018 

Requirements); 

(2) Section 60.103(d) of the 2018 

Requirements (revised certification 

requirement that eliminates IRB review 

of application or proposal) (instead of 

§ 60.103(f) of the pre-2018 

Requirements); and 

(3) Section 60.109(f)(1)(i) and (iii) of 

the 2018 Requirements (exceptions to 

mandated continuing review) (instead of 

§ 60.103(b), as related to the 

requirement for continuing review, and 

in addition to § 60.109, of the pre-2018 

Requirements); and 

(B) Beginning on January 21, 2019, 

comply with the 2018 Requirements. 

(ii) If the determination to transition 

is documented on or after January 21, 

2019, the research shall, beginning on 

the date of such documentation, comply 

with the 2018 Requirements. 

(5) Research subject to 2018 

Requirements. The 2018 Requirements 

shall apply to the following research: 

(i) Research initially approved by an 

IRB on or after January 21, 2019; 

(ii) Research for which IRB review is 

waived pursuant to paragraph (i) of this 

section on or after January 21, 2019; and 

(iii) Research for which a 

determination is made that the research 

is exempt on or after January 21, 2019. 

* * * * * 

Todd M. Richardson, 

Acting General Deputy Assistant Secretary 

for Policy Development and Research, U.S. 

Department of Housing and Urban 

Development. 

DEPARTMENT OF LABOR 

List of Subjects in 29 CFR Part 21 

Human research subjects, Reporting 

and recordkeeping requirements, 

Research. 

For the reasons stated in the 

preamble, Department of Labor further 

amends 29 CFR part 21 as published in 

the Federal Register on January 19, 

2017 (82 FR 7149), and as amended in 

an interim final rule published in the 

Federal Register on January 22, 2018 

(83 FR 2885), as follows: 

PART 21—PROTECTION OF HUMAN 

SUBJECTS 

■ 1. The authority citation for part 21 

continues to read as follows: 

Authority: 5 U.S.C. 301; 29 U.S.C. 551. 

■ 2. Amend § 21.101 by adding a 

heading for paragraph (l)(1), revising 

paragraphs (l)(2), (3), and (4), and 

adding paragraph (l)(5) to read as 

follows: 

§ 21.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(1) Pre-2018 Requirements. * * * 

(2) 2018 Requirements. For purposes 

of this section, the 2018 Requirements 

means the Federal Policy for the 

Protection of Human Subjects 

requirements contained in this part. The 

general compliance date for the 2018 

Requirements is January 21, 2019. The 

compliance date for § 21.114(b) 

(cooperative research) of the 2018 

Requirements is January 20, 2020. 

(3) Research subject to pre-2018 

requirements. The pre-2018 

Requirements shall apply to the 

following research, unless the research 

is transitioning to comply with the 2018 

Requirements in accordance with 

paragraph (l)(4) of this section: 

(i) Research initially approved by an 

IRB under the pre-2018 Requirements 

before January 21, 2019; 

(ii) Research for which IRB review 

was waived pursuant to § 21.101(i) of 

the pre-2018 Requirements before 

January 21, 2019; and 

(iii) Research for which a 

determination was made that the 

research was exempt under § 21.101(b) 

of the pre-2018 Requirements before 

January 21, 2019. 

(4) Transitioning research. If, on or 

after July 19, 2018, an institution 

planning or engaged in research 

otherwise covered by paragraph (l)(3) of 

this section determines that such 

research instead will transition to 

comply with the 2018 Requirements, the 

institution or an IRB must document 

and date such determination. 

(i) If the determination to transition is 

documented between July 19, 2018, and 

January 20, 2019, the research shall: 

(A) Beginning on the date of such 

documentation through January 20, 

2019, comply with the pre-2018 

Requirements, except that the research 

shall comply with the following: 

(1) Section 21.102(l) of the 2018 

Requirements (definition of research) 

(instead of § 21.102(d) of the pre-2018 

Requirements); 

(2) Section 21.103(d) of the 2018 

Requirements (revised certification 

requirement that eliminates IRB review 

of application or proposal) (instead of 

§ 21.103(f) of the pre-2018 

Requirements); and 

(3) Section 21.109(f)(1)(i) and (iii) of 

the 2018 Requirements (exceptions to 

mandated continuing review) (instead of 

§ 21.103(b), as related to the 

requirement for continuing review, and 

in addition to § 21.109, of the pre-2018 

Requirements); and 

(B) Beginning on January 21, 2019, 

comply with the 2018 Requirements. 

(ii) If the determination to transition 

is documented on or after January 21, 

2019, the research shall, beginning on 

the date of such documentation, comply 

with the 2018 Requirements. 

(5) Research subject to 2018 

Requirements. The 2018 Requirements 

shall apply to the following research: 

(i) Research initially approved by an 

IRB on or after January 21, 2019; 

(ii) Research for which IRB review is 

waived pursuant to paragraph (i) of this 

section on or after January 21, 2019; and 

(iii) Research for which a 

determination is made that the research 

is exempt on or after January 21, 2019. 

* * * * * 

R. Alexander Acosta, 

Secretary of Labor. 

DEPARTMENT OF DEFENSE 

List of Subjects in 32 CFR Part 219 

Human research subjects, Reporting 

and recordkeeping requirements, 

Research. 

For the reasons stated in the 

preamble, Department of Defense 


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further amends 32 CFR part 219 as 

published in the Federal Register on 

January 19, 2017 (82 FR 7149), and as 

amended in an interim final rule 

published in the Federal Register on 

January 22, 2018 (83 FR 2885), as 

follows: 

PART 219—PROTECTION OF HUMAN 

SUBJECTS 

■ 1. The authority citation for part 219 

continues to read as follows: 

Authority: 5 U.S.C. 301; 42 U.S.C. 300v– 

1(b). 

■ 2. Amend § 219.101 by adding a 

heading for paragraph (l)(1), revising 

paragraphs (l)(2), (3), and (4), and 

adding paragraph (l)(5) to read as 

follows: 

§ 219.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(1) Pre-2018 Requirements. * * * 

(2) 2018 Requirements. For purposes 

of this section, the 2018 Requirements 

means the Federal Policy for the 

Protection of Human Subjects 

requirements contained in this part. The 

general compliance date for the 2018 

Requirements is January 21, 2019. The 

compliance date for § 219.114(b) 

(cooperative research) of the 2018 

Requirements is January 20, 2020. 

(3) Research subject to pre-2018 

requirements. The pre-2018 

Requirements shall apply to the 

following research, unless the research 

is transitioning to comply with the 2018 

Requirements in accordance with 

paragraph (l)(4) of this section: 

(i) Research initially approved by an 

IRB under the pre-2018 Requirements 

before January 21, 2019; 

(ii) Research for which IRB review 

was waived pursuant to § 219.101(i) of 

the pre-2018 Requirements before 

January 21, 2019; and 

(iii) Research for which a 

determination was made that the 

research was exempt under § 219.101(b) 

of the pre-2018 Requirements before 

January 21, 2019. 

(4) Transitioning research. If, on or 

after July 19, 2018, an institution 

planning or engaged in research 

otherwise covered by paragraph (l)(3) of 

this section determines that such 

research instead will transition to 

comply with the 2018 Requirements, the 

institution or an IRB must document 

and date such determination. 

(i) If the determination to transition is 

documented between July 19, 2018, and 

January 20, 2019, the research shall: 

(A) Beginning on the date of such 

documentation through January 20, 

2019, comply with the pre-2018 

Requirements, except that the research 

shall comply with the following: 

(1) Section 219.102(l) of the 2018 

Requirements (definition of research) 

(instead of § 219.102(d) of the pre-2018 

Requirements); 

(2) Section 219.103(d) of the 2018 

Requirements (revised certification 

requirement that eliminates IRB review 

of application or proposal) (instead of 

§ 219.103(f) of the pre-2018 

Requirements); and 

(3) Section 219.109(f)(1)(i) and (iii) of 

the 2018 Requirements (exceptions to 

mandated continuing review) (instead of 

§ 219.103(b), as related to the 

requirement for continuing review, and 

in addition to § 219.109, of the pre-2018 

Requirements); and 

(B) Beginning on January 21, 2019, 

comply with the 2018 Requirements. 

(ii) If the determination to transition 

is documented on or after January 21, 

2019, the research shall, beginning on 

the date of such documentation, comply 

with the 2018 Requirements. 

(5) Research subject to 2018 

Requirements. The 2018 Requirements 

shall apply to the following research: 

(i) Research initially approved by an 

IRB on or after January 21, 2019; 

(ii) Research for which IRB review is 

waived pursuant to paragraph (i) of this 

section on or after January 21, 2019; and 

(iii) Research for which a 

determination is made that the research 

is exempt on or after January 21, 2019. 

* * * * * 

Mary J. Miller, 

Principal Deputy, Assistant Secretary of 

Defense for Research and Engineering, U.S. 

Department of Defense. 

DEPARTMENT OF EDUCATION 

List of Subjects in 34 CFR Part 97 

Human research subjects, Reporting 

and recordkeeping requirements, 

Research. 

For the reasons stated in the 

preamble, Department of Education 

further amends 34 CFR part 97 as 

published in the Federal Register on 

January 19, 2017 (82 FR 7149), and as 

amended in an interim final rule 

published in the Federal Register on 

January 22, 2018 (83 FR 2885), as 

follows: 

PART 97—PROTECTION OF HUMAN 

SUBJECTS 

■ 1. The authority citation for part 97 

continues to read as follows: 

Authority: 5 U.S.C. 301; 20 U.S.C. 1221e– 

3, 3474; 42 U.S.C. 300v–1(b). 

■ 2. Amend § 97.101 by adding a 

heading for paragraph (l)(1), revising 

paragraphs (l)(2), (3), and (4), and 

adding paragraph (l)(5) to read as 

follows: 

§ 97.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(1) Pre-2018 Requirements. * * * 

(2) 2018 Requirements. For purposes 

of this section, the 2018 Requirements 

means the Federal Policy for the 

Protection of Human Subjects 

requirements contained in this subpart. 

The general compliance date for the 

2018 Requirements is January 21, 2019. 

The compliance date for § 97.114(b) 

(cooperative research) of the 2018 

Requirements is January 20, 2020. 

(3) Research subject to pre-2018 

requirements. The pre-2018 

Requirements shall apply to the 

following research, unless the research 

is transitioning to comply with the 2018 

Requirements in accordance with 

paragraph (l)(4) of this section: 

(i) Research initially approved by an 

IRB under the pre-2018 Requirements 

before January 21, 2019; 

(ii) Research for which IRB review 

was waived pursuant to § 97.101(i) of 

the pre-2018 Requirements before 

January 21, 2019; and 

(iii) Research for which a 

determination was made that the 

research was exempt under § 97.101(b) 

of the pre-2018 Requirements before 

January 21, 2019. 

(4) Transitioning research. If, on or 

after July 19, 2018, an institution 

planning or engaged in research 

otherwise covered by paragraph (l)(3) of 

this section determines that such 

research instead will transition to 

comply with the 2018 Requirements, the 

institution or an IRB must document 

and date such determination. 

(i) If the determination to transition is 

documented between July 19, 2018, and 

January 20, 2019, the research shall: 

(A) Beginning on the date of such 

documentation through January 20, 

2019, comply with the pre-2018 

Requirements, except that the research 

shall comply with the following: 

(1) Section 97.102(l) of the 2018 

Requirements (definition of research) 

(instead of § 97.102(d) of the pre-2018 

Requirements); 

(2) Section 97.103(d) of the 2018 

Requirements (revised certification 

requirement that eliminates IRB review 

of application or proposal) (instead of 

§ 97.103(f) of the pre-2018 

Requirements); and 

(3) Section 97.109(f)(1)(i) and (iii) of 

the 2018 Requirements (exceptions to 

mandated continuing review) (instead of 

§ 97.103(b), as related to the 

requirement for continuing review, and 


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in addition to § 97.109, of the pre-2018 

Requirements); and 

(B) Beginning on January 21, 2019, 

comply with the 2018 Requirements. 

(ii) If the determination to transition 

is documented on or after January 21, 

2019, the research shall, beginning on 

the date of such documentation, comply 

with the 2018 Requirements. 

(5) Research subject to 2018 

Requirements. The 2018 Requirements 

shall apply to the following research: 

(i) Research initially approved by an 

IRB on or after January 21, 2019; 

(ii) Research for which IRB review is 

waived pursuant to paragraph (i) of this 

section on or after January 21, 2019; and 

(iii) Research for which a 

determination is made that the research 

is exempt on or after January 21, 2019. 

* * * * * 

Betsy DeVos, 

Secretary of Education. 

DEPARTMENT OF VETERANS 

AFFAIRS 

List of Subjects in 38 CFR Part 16 

Human research subjects, Reporting 

and recordkeeping requirements, 

Research. 

For the reasons stated in the 

preamble, Department of Veterans 

Affairs further amends 38 CFR part 16 

as published in the Federal Register on 

January 19, 2017 (82 FR 7149), and as 

amended in an interim final rule 

published in the Federal Register on 

January 22, 2018 (83 FR 2885), as 

follows: 

PART 16—PROTECTION OF HUMAN 

SUBJECTS 

■ 1. The authority citation for part 16 

continues to read as follows: 

Authority: 5 U.S.C. 301; 38 U.S.C. 501, 

7331, 7334; 42 U.S.C. 300v–1(b). 

■ 2. Amend § 16.101 by adding a 

heading for paragraph (l)(1), revising 

paragraphs (l)(2), (3), and (4), and 

adding paragraph (l)(5) to read as 

follows: 

§ 16.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(1) Pre-2018 Requirements. * * * 

(2) 2018 Requirements. For purposes 

of this section, the 2018 Requirements 

means the Federal Policy for the 

Protection of Human Subjects 

requirements contained in this part. The 

general compliance date for the 2018 

Requirements is January 21, 2019. The 

compliance date for § 16.114(b) 

(cooperative research) of the 2018 

Requirements is January 20, 2020. 

(3) Research subject to pre-2018 

requirements. The pre-2018 

Requirements shall apply to the 

following research, unless the research 

is transitioning to comply with the 2018 

Requirements in accordance with 

paragraph (l)(4) of this section: 

(i) Research initially approved by an 

IRB under the pre-2018 Requirements 

before January 21, 2019; 

(ii) Research for which IRB review 

was waived pursuant to § 16.101(i) of 

the pre-2018 Requirements before 

January 21, 2019; and 

(iii) Research for which a 

determination was made that the 

research was exempt under § 16.101(b) 

of the pre-2018 Requirements before 

January 21, 2019. 

(4) Transitioning research. If, on or 

after July 19, 2018, an institution 

planning or engaged in research 

otherwise covered by paragraph (l)(3) of 

this section determines that such 

research instead will transition to 

comply with the 2018 Requirements, the 

institution or an IRB must document 

and date such determination. 

(i) If the determination to transition is 

documented between July 19, 2018, and 

January 20, 2019, the research shall: 

(A) Beginning on the date of such 

documentation through January 20, 

2019, comply with the pre-2018 

Requirements, except that the research 

shall comply with the following: 

(1) Section 16.102(l) of the 2018 

Requirements (definition of research) 

(instead of § 16.102(d) of the pre-2018 

Requirements); 

(2) Section 16.103(d) of the 2018 

Requirements (revised certification 

requirement that eliminates IRB review 

of application or proposal) (instead of 

§ 16.103(f) of the pre-2018 

Requirements); and 

(3) Section 16.109(f)(1)(i) and (iii) of 

the 2018 Requirements (exceptions to 

mandated continuing review) (instead of 

§ 16.103(b), as related to the 

requirement for continuing review, and 

in addition to § 16.109, of the pre-2018 

Requirements); and 

(B) Beginning on January 21, 2019, 

comply with the 2018 Requirements. 

(ii) If the determination to transition 

is documented on or after January 21, 

2019, the research shall, beginning on 

the date of such documentation, comply 

with the 2018 Requirements. 

(5) Research subject to 2018 

Requirements. The 2018 Requirements 

shall apply to the following research: 

(i) Research initially approved by an 

IRB on or after January 21, 2019; 

(ii) Research for which IRB review is 

waived pursuant to paragraph (i) of this 

section on or after January 21, 2019; and 

(iii) Research for which a 

determination is made that the research 

is exempt on or after January 21, 2019. 

* * * * * 

Jacquelyn Hayes-Byrd, 

Acting Chief of Staff, Department of Veterans 

Affairs. 

ENVIRONMENTAL PROTECTION 

AGENCY 

List of Subjects in 40 CFR Part 26 

Human research subjects, Reporting 

and recordkeeping requirements, 

Research. 

For the reasons stated in the 

preamble, Environmental Protection 

Agency further amends 40 CFR part 26 

as published in the Federal Register on 

January 19, 2017 (82 FR 7149), and as 

amended in an interim final rule 

published in the Federal Register on 

January 22, 2018 (83 FR 2885), as 

follows: 

PART 26—PROTECTION OF HUMAN 

SUBJECTS 

■ 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). 

■ 2. Amend § 26.101 by adding a 

heading for paragraph (l)(1), revising 

paragraphs (l)(2), (3), and (4), and 

adding paragraph (l)(5) to read as 

follows: 

§ 26.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(1) Pre-2018 Requirements. * * * 

(2) 2018 Requirements. For purposes 

of this section, the 2018 Requirements 

means the Federal Policy for the 

Protection of Human Subjects 

requirements contained in this subpart. 

The general compliance date for the 

2018 Requirements is January 21, 2019. 

The compliance date for § 26.114(b) 

(cooperative research) of the 2018 

Requirements is January 20, 2020. 

(3) Research subject to pre-2018 

requirements. The pre-2018 

Requirements shall apply to the 

following research, unless the research 

is transitioning to comply with the 2018 

Requirements in accordance with 

paragraph (l)(4) of this section: 

(i) Research initially approved by an 

IRB under the pre-2018 Requirements 

before January 21, 2019; 

(ii) Research for which IRB review 

was waived pursuant to § 26.101(i) of 

the pre-2018 Requirements before 

January 21, 2019; and 


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(iii) Research for which a 

determination was made that the 

research was exempt under § 26.101(b) 

of the pre-2018 Requirements before 

January 21, 2019. 

(4) Transitioning research. If, on or 

after July 19, 2018, an institution 

planning or engaged in research 

otherwise covered by paragraph (l)(3) of 

this section determines that such 

research instead will transition to 

comply with the 2018 Requirements, the 

institution or an IRB must document 

and date such determination. 

(i) If the determination to transition is 

documented between July 19, 2018, and 

January 20, 2019, the research shall: 

(A) Beginning on the date of such 

documentation through January 20, 

2019, comply with the pre-2018 

Requirements, except that the research 

shall comply with the following: 

(1) Section 26.102(l) of the 2018 

Requirements (definition of research) 

(instead of § 26.102(d) of the pre-2018 

Requirements); 

(2) Section 26.103(d) of the 2018 

Requirements (revised certification 

requirement that eliminates IRB review 

of application or proposal) (instead of 

§ 26.103(f) of the pre-2018 

Requirements); and 

(3) Section 26.109(f)(1)(i) and (iii) of 

the 2018 Requirements (exceptions to 

mandated continuing review) (instead of 

§ 26.103(b), as related to the 

requirement for continuing review, and 

in addition to § 26.109, of the pre-2018 

Requirements); and 

(B) Beginning on January 21, 2019, 

comply with the 2018 Requirements. 

(ii) If the determination to transition 

is documented on or after January 21, 

2019, the research shall, beginning on 

the date of such documentation, comply 

with the 2018 Requirements. 

(5) Research subject to 2018 

Requirements. The 2018 Requirements 

shall apply to the following research: 

(i) Research initially approved by an 

IRB on or after January 21, 2019; 

(ii) Research for which IRB review is 

waived pursuant to paragraph (i) of this 

section on or after January 21, 2019; and 

(iii) Research for which a 

determination is made that the research 

is exempt on or after January 21, 2019. 

* * * * * 

E. Scott Pruitt, 

Administrator, Environmental Protection 

Agency. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

List of Subjects in 45 CFR Part 46 

Human research subjects, Reporting 

and recordkeeping requirements, 

Research. 

For the reasons stated in the 

preamble, Department of Health and 

Human Services further amends 45 CFR 

part 46 as published in the Federal 

Register on January 19, 2017 (82 FR 

7149), and as amended in an interim 

final rule published in the Federal 

Register on January 22, 2018 (83 FR 

2885), as follows: 

PART 46—PROTECTION OF HUMAN 

SUBJECTS 

■ 1. The authority citation for part 46 

continues to read as follows: 

Authority: 5 U.S.C. 301; 42 U.S.C. 289(a); 

42 U.S.C. 300v–1(b). 

■ 2. Amend § 46.101 by adding a 

heading for paragraph (l)(1), revising 

paragraphs (l)(2), (3), and (4), and 

adding paragraph (l)(5) to read as 

follows: 

§ 46.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(1) Pre-2018 Requirements. * * * 

(2) 2018 Requirements. For purposes 

of this section, the 2018 Requirements 

means the Federal Policy for the 

Protection of Human Subjects 

requirements contained in this subpart. 

The general compliance date for the 

2018 Requirements is January 21, 2019. 

The compliance date for § 46.114(b) 

(cooperative research) of the 2018 

Requirements is January 20, 2020. 

(3) Research subject to pre-2018 

requirements. The pre-2018 

Requirements shall apply to the 

following research, unless the research 

is transitioning to comply with the 2018 

Requirements in accordance with 

paragraph (l)(4) of this section: 

(i) Research initially approved by an 

IRB under the pre-2018 Requirements 

before January 21, 2019; 

(ii) Research for which IRB review 

was waived pursuant to § 46.101(i) of 

the pre-2018 Requirements before 

January 21, 2019; and 

(iii) Research for which a 

determination was made that the 

research was exempt under § 46.101(b) 

of the pre-2018 Requirements before 

January 21, 2019. 

(4) Transitioning research. If, on or 

after July 19, 2018, an institution 

planning or engaged in research 

otherwise covered by paragraph (l)(3) of 

this section determines that such 

research instead will transition to 

comply with the 2018 Requirements, the 

institution or an IRB must document 

and date such determination. 

(i) If the determination to transition is 

documented between July 19, 2018, and 

January 20, 2019, the research shall: 

(A) Beginning on the date of such 

documentation through January 20, 

2019, comply with the pre-2018 

Requirements, except that the research 

shall comply with the following: 

(1) Section 46.102(l) of the 2018 

Requirements (definition of research) 

(instead of § 46.102(d) of the pre-2018 

Requirements); 

(2) Section 46.103(d) of the 2018 

Requirements (revised certification 

requirement that eliminates IRB review 

of application or proposal) (instead of 

§ 46.103(f) of the pre-2018 

Requirements); and 

(3) Section 46.109(f)(1)(i) and (iii) of 

the 2018 Requirements (exceptions to 

mandated continuing review) (instead of 

§ 46.103(b), as related to the 

requirement for continuing review, and 

in addition to § 46.109, of the pre-2018 

Requirements); and 

(B) Beginning on January 21, 2019, 

comply with the 2018 Requirements. 

(ii) If the determination to transition 

is documented on or after January 21, 

2019, the research shall, beginning on 

the date of such documentation, comply 

with the 2018 Requirements. 

(5) Research subject to 2018 

Requirements. The 2018 Requirements 

shall apply to the following research: 

(i) Research initially approved by an 

IRB on or after January 21, 2019; 

(ii) Research for which IRB review is 

waived pursuant to paragraph (i) of this 

section on or after January 21, 2019; and 

(iii) Research for which a 

determination is made that the research 

is exempt on or after January 21, 2019. 

* * * * * 

Alex M. Azar II, 

Secretary, U.S. Department of Health and 

Human Services. 

NATIONAL SCIENCE FOUNDATION 

List of Subjects in 45 CFR Part 690 

Human research subjects, Reporting 

and recordkeeping requirements, 

Research. 

For the reasons stated in the 

preamble, National Science Foundation 

further amends 45 CFR part 690 as 

published in the Federal Register on 

January 19, 2017 (82 FR 7149), and as 

amended in an interim final rule 

published in the Federal Register on 

January 22, 2018 (83 FR 2885), as 

follows: 

PART 690—PROTECTION OF HUMAN 

SUBJECTS 

■ 1. The authority citation for part 690 

continues to read as follows: 

Authority: 5 U.S.C. 301; 42 U.S.C. 300v– 

1(b). 


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Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations 28519 

■ 2. Amend § 690.101 by adding a 

heading for paragraph (l)(1), revising 

paragraphs (l)(2), (3), and (4), and 

adding paragraph (l)(5) to read as 

follows: 

§ 690.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(1) Pre-2018 Requirements. * * * 

(2) 2018 Requirements. For purposes 

of this section, the 2018 Requirements 

means the Federal Policy for the 

Protection of Human Subjects 

requirements contained in this part. The 

general compliance date for the 2018 

Requirements is January 21, 2019. The 

compliance date for § 690.114(b) 

(cooperative research) of the 2018 

Requirements is January 20, 2020. 

(3) Research subject to pre-2018 

requirements. The pre-2018 

Requirements shall apply to the 

following research, unless the research 

is transitioning to comply with the 2018 

Requirements in accordance with 

paragraph (l)(4) of this section: 

(i) Research initially approved by an 

IRB under the pre-2018 Requirements 

before January 21, 2019; 

(ii) Research for which IRB review 

was waived pursuant to § 690.101(i) of 

the pre-2018 Requirements before 

January 21, 2019; and 

(iii) Research for which a 

determination was made that the 

research was exempt under § 690.101(b) 

of the pre-2018 Requirements before 

January 21, 2019. 

(4) Transitioning research. If, on or 

after July 19, 2018, an institution 

planning or engaged in research 

otherwise covered by paragraph (l)(3) of 

this section determines that such 

research instead will transition to 

comply with the 2018 Requirements, the 

institution or an IRB must document 

and date such determination. 

(i) If the determination to transition is 

documented between July 19, 2018, and 

January 20, 2019, the research shall: 

(A) Beginning on the date of such 

documentation through January 20, 

2019, comply with the pre-2018 

Requirements, except that the research 

shall comply with the following: 

(1) Section 690.102(l) of the 2018 

Requirements (definition of research) 

(instead of § 690.102(d) of the pre-2018 

Requirements); 

(2) Section 690.103(d) of the 2018 

Requirements (revised certification 

requirement that eliminates IRB review 

of application or proposal) (instead of 

§ 690.103(f) of the pre-2018 

Requirements); and 

(3) Section 690.109(f)(1)(i) and (iii) of 

the 2018 Requirements (exceptions to 

mandated continuing review) (instead of 

§ 690.103(b), as related to the 

requirement for continuing review, and 

in addition to § 690.109, of the pre-2018 

Requirements); and 

(B) Beginning on January 21, 2019, 

comply with the 2018 Requirements. 

(ii) If the determination to transition 

is documented on or after January 21, 

2019, the research shall, beginning on 

the date of such documentation, comply 

with the 2018 Requirements. 

(5) Research subject to 2018 

Requirements. The 2018 Requirements 

shall apply to the following research: 

(i) Research initially approved by an 

IRB on or after January 21, 2019; 

(ii) Research for which IRB review is 

waived pursuant to paragraph (i) of this 

section on or after January 21, 2019; and 

(iii) Research for which a 

determination is made that the research 

is exempt on or after January 21, 2019. 

* * * * * 

Lawrence Rudolph, 

General Counsel, National Science 

Foundation. 

DEPARTMENT OF TRANSPORTATION 

List of Subjects in 49 CFR Part 11 

Human research subjects, Reporting 

and recordkeeping requirements, 

Research. 

For the reasons stated in the 

preamble, Department of Transportation 

further amends 49 CFR part 11 as 

published in the Federal Register on 

January 19, 2017 (82 FR 7149), and as 

amended in an interim final rule 

published in the Federal Register on 

January 22, 2018 (83 FR 2885), as 

follows: 

PART 11—PROTECTION OF HUMAN 

SUBJECTS 

■ 1. The authority citation for part 11 

continues to read as follows: 

Authority: 5 U.S.C. 301; 42 U.S.C. 300v– 

1(b). 

■ 2. Amend § 11.101 by adding a 

heading for paragraph (l)(1), revising 

paragraphs (l)(2), (3), and (4), and 

adding paragraph (l)(5) to read as 

follows: 

§ 11.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(1) Pre-2018 Requirements. * * * 

(2) 2018 Requirements. For purposes 

of this section, the 2018 Requirements 

means the Federal Policy for the 

Protection of Human Subjects 

requirements contained in this part. The 

general compliance date for the 2018 

Requirements is January 21, 2019. The 

compliance date for § 11.114(b) 

(cooperative research) of the 2018 

Requirements is January 20, 2020. 

(3) Research subject to pre-2018 

requirements. The pre-2018 

Requirements shall apply to the 

following research, unless the research 

is transitioning to comply with the 2018 

Requirements in accordance with 

paragraph (l)(4) of this section: 

(i) Research initially approved by an 

IRB under the pre-2018 Requirements 

before January 21, 2019; 

(ii) Research for which IRB review 

was waived pursuant to § 11.101(i) of 

the pre-2018 Requirements before 

January 21, 2019; and 

(iii) Research for which a 

determination was made that the 

research was exempt under § 11.101(b) 

of the pre-2018 Requirements before 

January 21, 2019. 

(4) Transitioning research. If, on or 

after July 19, 2018, an institution 

planning or engaged in research 

otherwise covered by paragraph (l)(3) of 

this section determines that such 

research instead will transition to 

comply with the 2018 Requirements, the 

institution or an IRB must document 

and date such determination. 

(i) If the determination to transition is 

documented between July 19, 2018, and 

January 20, 2019, the research shall: 

(A) Beginning on the date of such 

documentation through January 20, 

2019, comply with the pre-2018 

Requirements, except that the research 

shall comply with the following: 

(1) Section 11.102(l) of the 2018 

Requirements (definition of research) 

(instead of § 11.102(d) of the pre-2018 

Requirements); 

(2) Section 11.103(d) of the 2018 

Requirements (revised certification 

requirement that eliminates IRB review 

of application or proposal) (instead of 

§ 11.103(f) of the pre-2018 

Requirements); and 

(3) Section 11.109(f)(1)(i) and (iii) of 

the 2018 Requirements (exceptions to 

mandated continuing review) (instead of 

§ 11.103(b), as related to the 

requirement for continuing review, and 

in addition to § 11.109, of the pre-2018 

Requirements); and 

(B) Beginning on January 21, 2019, 

comply with the 2018 Requirements. 

(ii) If the determination to transition 

is documented on or after January 21, 

2019, the research shall, beginning on 

the date of such documentation, comply 

with the 2018 Requirements. 

(5) Research subject to 2018 

Requirements. The 2018 Requirements 

shall apply to the following research: 

(i) Research initially approved by an 

IRB on or after January 21, 2019; 


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28520 Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations 

(ii) Research for which IRB review is 

waived pursuant to paragraph (i) of this 

section on or after January 21, 2019; and 

(iii) Research for which a 

determination is made that the research 

is exempt on or after January 21, 2019. 

* * * * * 

Elaine L. Chao, 

Secretary of Transportation. 

[FR Doc. 2018–13187 Filed 6–18–18; 8:45 am] 

BILLING CODE 4150–36–P 


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