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
Final rule.
CFR Part: "6 CFR Part 46; 7 CFR Part 1c; 10 CFR Part 745; 14 CFR Part 1230; 15 CFR Part 27; 16 CFR Part 1028; 20 CFR Part 431; 22 CFR Part 225; 24 CFR Part 60; 29 CFR Part 21; 32 CFR Part 219; 34 CFR Part 97; 38 CFR Part 16; 40 CFR Part 26; 45 CFR Part 46; 45 CFR Part 690; 49 CFR Part 11"
RIN Number: "RIN 0937-AA05"
Citation: "83 FR 28497"
Page Number: "28497"
"Rules and Regulations"
SUMMARY: In a final rule published on
On
Through this final rule, we are adopting the proposals described in the
EFFECTIVE DATE: Effective date: This rule is effective on
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Background
On
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/
FOOTNOTE 1 See, e.g., the
See the
See also
On
On
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
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
Both sets of comments tended to endorse some type of delay beyond
B. Public Comments on the
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
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
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
Additionally, commenters expressed concern that given the short timeline between the closing of the comment period and the new general implementation date of
[ 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
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 (
Some of the comments relevant to the Common Rule advocated for no additional delay in the implementation of the 2018 Requirements beyond
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 late-breaking announcements of delays in the implementation of the 2018 Requirements ultimately caused more administrative burden within institutions. One large public university system in
[ Response: We agree with interim final rule comments suggesting that we keep the effective date of the 2018 Requirements as
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
FOOTNOTE 2
FOOTNOTE 3 Clinton, WJ. Strengthened Protections for Human Subjects of
[ Response: The
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
A few comments suggested that the general compliance date of the 2018 Requirements should coincide with
[ 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
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 (
[ Response: We disagree with the comments suggesting that the compliance date for the cooperative research provision (
C. Public Comments on the
The
The NPRM proposed to modify the transition provision at
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
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
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
--Information on the
--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
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
Several alternatives were suggested for how a delay might be structured. These included:
--Permitting voluntary compliance with the entirety of the 2018 Requirements between
--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
--Delaying both the effective and general compliance dates beyond
--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
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
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
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
[ 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
One commenter expressed concern with how auditors would handle IRBs reviewing protocols governed by both 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
[ Response: We believe that the
While the NPRM did not solicit comments on the requirement for cooperative research to be reviewed by a single IRB (see
[ Response: We appreciate the comments received on the single IRB of record requirement in cooperative research (
One comment suggested adding the exemption category for secondary use where consent is not required (
[ Response: As explained in the
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
[ Response: This commenter misunderstood the transition provision as written in the first publication of the 2018 Requirements; the transition provision published in the
As with the comments on the interim final rule, a few comments expressed concern with the waiver provision at
[ 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
III. Delay of the General Compliance Date Until
Through this final rule, the general compliance date for the 2018 Requirements is delayed for a 6-month period until
As a result of this rule, regulated entities will be required to comply with the pre-2018 Requirements prior to
The compliance date for the cooperative research provision of the 2018 Requirements (
IV. Optional Flexibility: Implementation of Certain Burden-Reducing Provisions During the Delay Period
As detailed in revised
A. Research Subject to the pre-2018 Requirements (
As a default, studies initiated (i.e., initially approved by an IRB, or for which IRB review was waived by the government pursuant to
B. Research Subject to the 2018 Requirements (
Research initiated (i.e., initially approved by an IRB, or for which IRB review was waived by the government pursuant to
C. Research That Transitions To Comply With the 2018 Requirements on or After
Section __.101(l)(4)(ii) applies to studies following the pre-2018 Requirements that transition to comply with the 2018 Requirements on or after
D. Research That Transitions To Comply With the 2018 Requirements During the 6-Month Delay Period (
As described in
Beginning on the date that the transition determination is documented, through
* Pursuant to
* Pursuant to
* Pursuant to
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
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
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 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 (
1. In applying the definition of research under the 2018 Requirements (
2. In applying
3. The reference to "[r]esearch eligible for expedited review in accordance with
4. The documentation requirements described in
5. Section__.103(d) of the 2018 Requirements will be substituted for
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-by-protocol basis, or for a class of protocols (e.g., all minimal risk research), or for the institution's entire research portfolio.
Section __.101(l)(4)(ii) applies to studies following the pre-2018 Requirements that, at some point on or after
We clarify that the transition provision at
This final rule revises the requirement, now set forth at
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
This final rule has an effective date of
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.
VI. Regulatory Impact Analyses
We have examined the effects of this final rule under Executive Order 12866 on Regulatory Planning and Review (
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
1. Need for This Final Rule and Summary
On
This final rule allows regulated entities to continue to comply with the pre-2018 requirements until
2. Public Comments on the
The
--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
--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
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
As discussed above, one comment noted that if we permitted the exemption at
Finally, we received several comments indicating that the
3. Analysis of Benefits (Cost-Savings) and Costs (Foregone Benefits) /4/
FOOTNOTE 4 Note, that the terms "benefits" and "cost-savings" are used interchangeably in this RIA. Similarly, the terms "costs" and "foregone benefits" are also used interchangeably. END FOOTNOTE
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
Table 1 summarizes the quantified benefits and costs of delaying the general implementation of 2018 Requirements. Over the period of
Table 1--All Benefits and Costs of Delaying the General Compliance Date for the 2018 Requirements by 6 Months [FromJuly 19, 2018 toJanuary 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(5M) Annualized value over 1 year by discount rate (millions of 2016 dollars) Benefits Costs (foregone (cost-savings) benefits) 2018 Requirement RIA Category 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 4.47 4.14 Unaffiliated with an Institution Holding an FWA (impact to IRBs not operated by an FWA-holding institution) Excluding Activities from the 0.95 0.88 Requirements of the Common RuleBecause They Are Not Research 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 8.5 7.9 Grant Application or Proposal Undergo IRB Review and Approval Expansion of Research Activities 0.01 0.01 20.8 19.3 Exempt from Full IRB Review Elimination of Continuing Review of 1.04 0.96 4.10 3.80 Research Under Specific Conditions Amending the Expedited Review 2.66 2.47 ProceduresCooperative Research (single IRB mandate in multi-institutional research)(6M) 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 0.07 0.06 Requirement to Waive Consent in Certain Subject Recruitment Activities Requirement for Posting of Consent 0.85 0.79 Forms for Clinical Trials Conducted or supported by Common Rule Departments or Agencies Alteration in Waiver for Documentation of Informed Consent in Certain Circumstances Cost Savings, as indicated by public Unquantified comments (unable to attribute to particular provisions)
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
FOOTNOTE 5 Zeroes 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. END FOOTNOTE
FOOTNOTE 6 Because compliance with this provision is not required until 2020, benefits and costs here are not included. END FOOTNOTE
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 [
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
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
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 burden-reducing 2018 provisions during the time period of
FOOTNOTE 7 See the RIA to the 2018 Requirements (82 FR 7149) for more information about the labor categories used in this analysis. END FOOTNOTE
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 (
The 2018 Requirements include five new exemption categories and modify 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.
FOOTNOTE 8 See for example, SACHRP Recommendations of
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
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
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
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.
Section 101(l)(4)(i) permits studies to transition to the 2018 Requirements between
This option is described in a revision to
We estimate that approximately 92,084 protocols would take advantage of the voluntary election described in
C. Regulatory Flexibility Act (RFA)
The Regulatory Flexibility Act (5 U.S.C.
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
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
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
Text of the Amended Common Rule
PART__--PROTECTION OF HUMAN SUBJECTS
1. Amend
* * * * *
(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
(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
(ii) Research for which IRB review was waived pursuant to
(iii) Research for which a determination was made that the research was exempt under
(4) Transitioning research. If, on or after
(i) If the determination to transition is documented between
(A) Beginning on the date of such documentation through
( 1) Section ___.102(l) of the 2018 Requirements (definition of research) (instead of
( 2) Section ___.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of
( 3) Section ___.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of
(B) Beginning on
(ii) If the determination to transition is documented on or after
(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
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after
(iii) Research for which a determination is made that the research is exempt on or after
* * * * *
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,
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
* * * * *
(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
(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
(ii) Research for which IRB review was waived pursuant to
(iii) Research for which a determination was made that the research was exempt under
(4) Transitioning research. If, on or after
(i) If the determination to transition is documented between
(A) Beginning on the date of such documentation through
( 1) Section 46.102(l) of the 2018 Requirements (definition of research) (instead of
( 2) Section 46.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of
( 3) Section 46.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of
(B) Beginning on
(ii) If the determination to transition is documented on or after
(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
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after
(iii) Research for which a determination is made that the research is exempt on or after
* * * * *
Deputy Secretary (Acting),
List of Subjects in 7 CFR Part 1c
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble,
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
* * * * *
(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
(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
(ii) Research for which IRB review was waived pursuant to
(iii) Research for which a determination was made that the research was exempt under
(4) Transitioning research. If, on or after
(i) If the determination to transition is documented between
(A) Beginning on the date of such documentation through
( 1) Section 1c.102(l) of the 2018 Requirements (definition of research) (instead of
( 2) Section 1c.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of
( 3) Section 1c.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of
(B) Beginning on
(ii) If the determination to transition is documented on or after
(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
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after
(iii) Research for which a determination is made that the research is exempt on or after
* * * * *
Acting Deputy Under Secretary for Research, Education, and Economics,
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,
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
* * * * *
(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
(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
(ii) Research for which IRB review was waived pursuant to
(iii) Research for which a determination was made that the research was exempt under
(4) Transitioning research. If, on or after
(i) If the determination to transition is documented between
(A) Beginning on the date of such documentation through
( 1) Section 745.102(l) of the 2018 Requirements (definition of research) (instead of
( 2) Section 745.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of
( 3) Section 745.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of
(B) Beginning on
(ii) If the determination to transition is documented on or after
(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
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after
(iii) Research for which a determination is made that the research is exempt on or after
* * * * *
Deputy Secretary of Energy.
List of Subjects in 14 CFR Part 1230
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble,
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
* * * * *
(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
(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
(ii) Research for which IRB review was waived pursuant to
(iii) Research for which a determination was made that the research was exempt under
(4) Transitioning research. If, on or after
(i) If the determination to transition is documented between
(A) Beginning on the date of such documentation through
( 1) Section 1230.102(l) of the 2018 Requirements (definition of research) (instead of
( 2) Section 1230.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of
( 3) Section 1230.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of
(B) Beginning on
(ii) If the determination to transition is documented on or after
(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
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after
(iii) Research for which a determination is made that the research is exempt on or after
* * * * *
Chief Health & Medical Officer,
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,
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
* * * * *
(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
(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
(ii) Research for which IRB review was waived pursuant to
(iii) Research for which a determination was made that the research was exempt under
(4) Transitioning research. If, on or after
(i) If the determination to transition is documented between
(A) Beginning on the date of such documentation through
( 1) Section 27.102(l) of the 2018 Requirements (definition of research) (instead of
( 2) Section 27.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of
( 3) Section 27.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of
(B) Beginning on
(ii) If the determination to transition is documented on or after
(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
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after
(iii) Research for which a determination is made that the research is exempt on or after
* * * * *
Secretary of Commerce.
List of Subjects in 16 CFR Part 1028
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble,
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
* * * * *
(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
(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
(ii) Research for which IRB review was waived pursuant to
(iii) Research for which a determination was made that the research was exempt under
(4) Transitioning research. If, on or after
(i) If the determination to transition is documented between
(A) Beginning on the date of such documentation through
( 1) Section 1028.102(l) of the 2018 Requirements (definition of research) (instead of
( 2) Section 1028.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of
( 3) Section 1028.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of
(B) Beginning on
(ii) If the determination to transition is documented on or after
(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
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after
(iii) Research for which a determination is made that the research is exempt on or after
* * * * *
Secretary,
List of Subjects in 20 CFR Part 431
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble,
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
* * * * *
(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
(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
(ii) Research for which IRB review was waived pursuant to
(iii) Research for which a determination was made that the research was exempt under
(4) Transitioning research. If, on or after
(i) If the determination to transition is documented between
(A) Beginning on the date of such documentation through
( 1) Section 431.102(l) of the 2018 Requirements (definition of research) (instead of
( 2) Section 431.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of
( 3) Section 431.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of
(B) Beginning on
(ii) If the determination to transition is documented on or after
(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
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after
(iii) Research for which a determination is made that the research is exempt on or after
* * * * *
Acting Commissioner of
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,
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
* * * * *
(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
(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
(ii) Research for which IRB review was waived pursuant to
(iii) Research for which a determination was made that the research was exempt under
(4) Transitioning research. If, on or after
(i) If the determination to transition is documented between
(A) Beginning on the date of such documentation through
( 1) Section 225.102(l) of the 2018 Requirements (definition of research) (instead of
( 2) Section 225.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of
( 3) Section 225.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of
(B) Beginning on
(ii) If the determination to transition is documented on or after
(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
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after
(iii) Research for which a determination is made that the research is exempt on or after
* * * * *
Senior Deputy Assistant Administrator for Global Health,
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,
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. 300v-1(b) and 3535(d).
2. Amend
* * * * *
(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
(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
(ii) Research for which IRB review was waived pursuant to
(iii) Research for which a determination was made that the research was exempt under
(4) Transitioning research. If, on or after
(i) If the determination to transition is documented between
(A) Beginning on the date of such documentation through
( 1) Section 60.102(l) of the 2018 Requirements (definition of research) (instead of
( 2) Section 60.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of
( 3) Section 60.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of
(B) Beginning on
(ii) If the determination to transition is documented on or after
(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
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after
(iii) Research for which a determination is made that the research is exempt on or after
* * * * *
Acting General Deputy Assistant Secretary for
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,
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
* * * * *
(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
(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
(ii) Research for which IRB review was waived pursuant to
(iii) Research for which a determination was made that the research was exempt under
(4) Transitioning research. If, on or after
(i) If the determination to transition is documented between
(A) Beginning on the date of such documentation through
( 1) Section 21.102(l) of the 2018 Requirements (definition of research) (instead of
( 2) Section 21.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of
( 3) Section 21.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of
(B) Beginning on
(ii) If the determination to transition is documented on or after
(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
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after
(iii) Research for which a determination is made that the research is exempt on or after
* * * * *
Secretary of Labor.
List of Subjects in 32 CFR Part 219
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble,
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
* * * * *
(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
(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
(ii) Research for which IRB review was waived pursuant to
(iii) Research for which a determination was made that the research was exempt under
(4) Transitioning research. If, on or after
(i) If the determination to transition is documented between
(A) Beginning on the date of such documentation through
( 1) Section 219.102(l) of the 2018 Requirements (definition of research) (instead of
( 2) Section 219.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of
( 3) Section 219.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of
(B) Beginning on
(ii) If the determination to transition is documented on or after
(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
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after
(iii) Research for which a determination is made that the research is exempt on or after
* * * * *
Principal Deputy, Assistant Secretary of Defense for Research and Engineering,
List of Subjects in 34 CFR Part 97
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble,
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
* * * * *
(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
(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
(ii) Research for which IRB review was waived pursuant to
(iii) Research for which a determination was made that the research was exempt under
(4) Transitioning research. If, on or after
(i) If the determination to transition is documented between
(A) Beginning on the date of such documentation through
( 1) Section 97.102(l) of the 2018 Requirements (definition of research) (instead of
( 2) Section 97.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of
( 3) Section 97.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of
(B) Beginning on
(ii) If the determination to transition is documented on or after
(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
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after
(iii) Research for which a determination is made that the research is exempt on or after
* * * * *
Secretary of Education.
List of Subjects in 38 CFR Part 16
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble,
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
* * * * *
(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
(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
(ii) Research for which IRB review was waived pursuant to
(iii) Research for which a determination was made that the research was exempt under
(4) Transitioning research. If, on or after
(i) If the determination to transition is documented between
(A) Beginning on the date of such documentation through
( 1) Section 16.102(l) of the 2018 Requirements (definition of research) (instead of
( 2) Section 16.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of
( 3) Section 16.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of
(B) Beginning on
(ii) If the determination to transition is documented on or after
(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
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after
(iii) Research for which a determination is made that the research is exempt on or after
* * * * *
Acting Chief of Staff,
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,
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
* * * * *
(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
(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
(ii) Research for which IRB review was waived pursuant to
(iii) Research for which a determination was made that the research was exempt under
(4) Transitioning research. If, on or after
(i) If the determination to transition is documented between
(A) Beginning on the date of such documentation through
( 1) Section 26.102(l) of the 2018 Requirements (definition of research) (instead of
( 2) Section 26.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of
( 3) Section 26.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of
(B) Beginning on
(ii) If the determination to transition is documented on or after
(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
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after
(iii) Research for which a determination is made that the research is exempt on or after
* * * * *
Administrator,
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,
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
* * * * *
(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
(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
(ii) Research for which IRB review was waived pursuant to
(iii) Research for which a determination was made that the research was exempt under
(4) Transitioning research. If, on or after
(i) If the determination to transition is documented between
(A) Beginning on the date of such documentation through
( 1) Section 46.102(l) of the 2018 Requirements (definition of research) (instead of
( 2) Section 46.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of
( 3) Section 46.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of
(B) Beginning on
(ii) If the determination to transition is documented on or after
(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
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after
(iii) Research for which a determination is made that the research is exempt on or after
* * * * *
Alex M. Azar II,
Secretary,
List of Subjects in 45 CFR Part 690
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble,
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).
2. Amend
* * * * *
(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
(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
(ii) Research for which IRB review was waived pursuant to
(iii) Research for which a determination was made that the research was exempt under
(4) Transitioning research. If, on or after
(i) If the determination to transition is documented between
(A) Beginning on the date of such documentation through
( 1) Section 690.102(l) of the 2018 Requirements (definition of research) (instead of
( 2) Section 690.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of
( 3) Section 690.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of
(B) Beginning on
(ii) If the determination to transition is documented on or after
(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
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after
(iii) Research for which a determination is made that the research is exempt on or after
* * * * *
General Counsel,
List of Subjects in 49 CFR Part 11
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble,
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
* * * * *
(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
(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
(ii) Research for which IRB review was waived pursuant to
(iii) Research for which a determination was made that the research was exempt under
(4) Transitioning research. If, on or after
(i) If the determination to transition is documented between
(A) Beginning on the date of such documentation through
( 1) Section 11.102(l) of the 2018 Requirements (definition of research) (instead of
( 2) Section 11.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of
( 3) Section 11.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of
(B) Beginning on
(ii) If the determination to transition is documented on or after
(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
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after
(iii) Research for which a determination is made that the research is exempt on or after
* * * * *
Secretary of Transportation.
[FR Doc. 2018-13187 Filed 6-18-18;
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