[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Rules and Regulations]
[Pages 43459-43470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19737]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1028


Protection of Human Subjects

AGENCY: Consumer Product Safety Commission.

ACTION: Final rule.

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SUMMARY: On January 19, 2017, the Federal departments and agencies that 
are subject to the Federal Policy for the Protection of Human Subjects 
(referred to as the Common Rule) published a final rule amending the 
Common Rule. The Consumer Product Safety Commission (CPSC or 
Commission) adopts the Common Rule.

DATES: The rule is effective on January 19, 2018. The compliance date 
for this rule, except for Sec.  1028.114(b) (cooperative research), is 
January 19, 2018. The compliance date for Sec.  1028.114(b) 
(cooperative research) is January 20, 2020.

FOR FURTHER INFORMATION CONTACT: Alice Thaler, Associate Executive 
Director for Health Sciences, Consumer Product Safety Commission, 5 
Research Place, Rockville, MD 20850: 301-987-2240, or by email to: 
<a href="/cdn-cgi/l/email-protection#90f1e4f8f1fcf5e2d0f3e0e3f3bef7ffe6"><span class="__cf_email__" data-cfemail="5233263a333e372012312221317c353d24">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: On June 18, 1991, the U.S. Department of 
Health and Human Services (HHS) issued a rule setting forth the Common 
Rule requirements for the protection of human subjects. (56 FR 28003). 
The HHS regulations are codified at 45 CFR part 46. At that time, 15 
other agencies, including CPSC, joined HHS in adopting a uniform set of 
rules for the protection of human subjects, identical to subpart A of 
45 CFR part 46. The Common Rule is codified in CPSC's regulations at 16 
CFR part 1028. The basic provisions of the Common Rule include, among 
other things, requirements related to the review of human subjects 
research by an institutional review board, obtaining and documenting 
informed consent of human subjects, and submitting written assurance of 
institutional compliance with the Common Rule.
    On September 8, 2015 (80 FR 53933), HHS, on behalf of many of the 
same agencies that were signatories to the original Common Rule, 
proposed revisions to the Common Rule to modernize and strengthen the 
rule. Although CPSC was not a signatory to the Common Rule NPR, CPSC 
proposed to amend the Commission's regulations at 16 CFR part 1028, to 
cross-reference the HHS regulations in 45 CFR part 46, subpart A. 80 FR 
57548 (Sept. 24, 2015). In addition, CPSC directed that any comments on 
the proposed Common Rule be sent to the HHS docket for the proceeding 
at HHS-OPHS-2015-0008.
    On January 19, 2017, HHS issued a final rule on the Common Rule, 
which, among other things, establishes new requirements regarding the 
information that must be given to prospective research subjects as part 
of the informed consent process. 82 FR 7149. HHS also reviewed and 
addressed more than 2,100 comments. Although CPSC instructed that any 
comment on the Common Rule be submitted in the HHS docket, 22 comments 
were submitted, instead, to the CPSC docket. CPSC reviewed the comments 
and determined that all of the substantive issues were addressed in the 
Common Rule final rule.
    Because CPSC's current regulations on the protection of human 
subjects, codified at 16 CFR part 1028, follow the

[[Page 43460]]

HHS regulations in 45 CFR part 46, subpart A, CPSC proposed to adopt 
the amended regulatory text provided in the Common Rule final rule by 
providing a cross-reference to the HHS regulations in 45 CFR part 46, 
subpart A, rather than restating the text of HHS's regulation in CPSC's 
rule. However, at the direction of the Office of the Federal Register, 
for the final rule, CPSC is codifying the text of the revised Common 
Rule in CPSC's regulations at 16 CFR part 1028. CPSC's final rule is 
substantively identical to the HHS regulations in 45 CFR part 46, 
subpart A. Accordingly, CPSC now adopts the final Common Rule. The 
effective date of the Common Rule is January 19, 2018, with a 
compliance date of January 19, 2018, except for the section on 
cooperative research (Sec.  1028.114), which has a compliance date of 
January 20, 2020.

List of Subjects in 16 CFR Part 1028

    Human research subjects, Reporting and recordkeeping requirements, 
Research.

    For the reasons stated in the preamble, the Consumer Product Safety 
Commission amends Title 16 of the Code of Federal Regulations by 
revising part 1028 to read as follows:

PART 1028--PROTECTION OF HUMAN SUBJECTS

Sec.
1028.101 To what does this policy apply?
1028.102 Definitions for purposes of this policy.
1028.103 Assuring compliance with this policy--research conducted or 
supported by any Federal department or agency.
1028.104 Exempt research.
1028.105 [Reserved]
1028.106 [Reserved]
1028.107 IRB membership.
1028.108 IRB functions and operations.
1028.109 IRB review of research.
1028.110 Expedited review procedures for certain kinds of research 
involving no more than minimal risk, and for minor changes in 
approved research.
1028.111 Criteria for IRB approval of research.
1028.112 Review by institution.
1028.113 Suspension or termination of IRB approval of research.
1028.114 Cooperative research.
1028.115 IRB records.
1028.116 General requirements for informed consent.
1028.117 Documentation of informed consent.
1028.118 Applications and proposals lacking definite plans for 
involvement of human subjects.
1028.119 Research undertaken without the intention of involving 
human subjects.
1028.120 Evaluation and disposition of applications and proposals 
for research to be conducted or supported by a Federal department or 
agency.
1028.121 [Reserved]
1028.122 Use of Federal funds.
1028.123 Early termination of research support: Evaluation of 
applications and proposals.
1028.124 Conditions.

    Authority:  5 U.S.C. 301; 42 U.S.C. 300v-1(b).


Sec.  1028.101   To what does this policy apply?

    (a) Except as detailed in Sec.  1028.104, this policy applies to 
all research involving human subjects conducted, supported, or 
otherwise subject to regulation by any Federal department or agency 
that takes appropriate administrative action to make the policy 
applicable to such research. This includes research conducted by 
Federal civilian employees or military personnel, except that each 
department or agency head may adopt such procedural modifications as 
may be appropriate from an administrative standpoint. It also includes 
research conducted, supported, or otherwise subject to regulation by 
the Federal Government outside the United States. Institutions that are 
engaged in research described in this paragraph and institutional 
review boards (IRBs) reviewing research that is subject to this policy 
must comply with this policy.
    (b) [Reserved]
    (c) Department or agency heads retain final judgment as to whether 
a particular activity is covered by this policy and this judgment shall 
be exercised consistent with the ethical principles of the Belmont 
Report.\1\
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    \1\ The National Commission for the Protection of Human Subjects 
of Biomedical and Behavioral Research--Belmont Report. Washington, 
DC: U.S. Department of Health and Human Services. 1979.
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    (d) Department or agency heads may require that specific research 
activities or classes of research activities conducted, supported, or 
otherwise subject to regulation by the Federal department or agency but 
not otherwise covered by this policy comply with some or all of the 
requirements of this policy.
    (e) Compliance with this policy requires compliance with pertinent 
federal laws or regulations that provide additional protections for 
human subjects.
    (f) This policy does not affect any state or local laws or 
regulations (including tribal law passed by the official governing body 
of an American Indian or Alaska Native tribe) that may otherwise be 
applicable and that provide additional protections for human subjects.
    (g) This policy does not affect any foreign laws or regulations 
that may otherwise be applicable and that provide additional 
protections to human subjects of research.
    (h) When research covered by this policy takes place in foreign 
countries, procedures normally followed in the foreign countries to 
protect human subjects may differ from those set forth in this policy. 
In these circumstances, if a department or agency head determines that 
the procedures prescribed by the institution afford protections that 
are at least equivalent to those provided in this policy, the 
department or agency head may approve the substitution of the foreign 
procedures in lieu of the procedural requirements provided in this 
policy. Except when otherwise required by statute, Executive Order, or 
the department or agency head, notices of these actions as they occur 
will be published in the Federal Register or will be otherwise 
published as provided in department or agency procedures.
    (i) Unless otherwise required by law, department or agency heads 
may waive the applicability of some or all of the provisions of this 
policy to specific research activities or classes of research 
activities otherwise covered by this policy, provided the alternative 
procedures to be followed are consistent with the principles of the 
Belmont Report.\2\ Except when otherwise required by statute or 
Executive Order, the department or agency head shall forward advance 
notices of these actions to the Office for Human Research Protections, 
Department of Health and Human Services (HHS), or any successor office, 
or to the equivalent office within the appropriate Federal department 
or agency, and shall also publish them in the Federal Register or in 
such other manner as provided in department or agency procedures. The 
waiver notice must include a statement that identifies the conditions 
under which the waiver will be applied and a justification as to why 
the waiver is appropriate for the research, including how the decision 
is consistent with the principles of the Belmont Report.
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    \2\ Id.
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    (j) Federal guidance on the requirements of this policy shall be 
issued only after consultation, for the purpose of harmonization (to 
the extent appropriate), with other Federal departments and agencies 
that have adopted this policy, unless such consultation is not 
feasible.
    (k) [Reserved]
    (l) Compliance dates and transition provisions:
    (1) For purposes of this section, the pre-2018 Requirements means 
this

[[Page 43461]]

subpart as published in the 2016 edition of the Code of Federal 
Regulations.
    (2) For purposes of this section, the 2018 Requirements means the 
Federal Policy for the Protection of Human Subjects requirements 
contained in this subpart. The compliance date for Sec.  1028.114(b) 
(cooperative research) of the 2018 Requirements is January 20, 2020.
    (3) Research initially approved by an IRB, for which such review 
was waived pursuant to Sec.  1028.101(i), or for which a determination 
was made that the research was exempt before January 19, 2018, shall 
comply with the pre-2018 Requirements, except that an institution 
engaged in such research on or after January 19, 2018, may instead 
comply with the 2018 Requirements if the institution determines that 
such ongoing research will comply with the 2018 Requirements and an IRB 
documents such determination.
    (4) Research initially approved by an IRB, for which such review 
was waived pursuant to Sec.  1028.101(i), or for which a determination 
was made that the research was exempt on or after January 19, 2018, 
shall comply with the 2018 Requirements.
    (m) Severability: Any provision of this part held to be invalid or 
unenforceable by its terms, or as applied to any person or 
circumstance, shall be construed so as to continue to give maximum 
effect to the provision permitted by law, unless such holding shall be 
one of utter invalidity or unenforceability, in which event the 
provision shall be severable from this part and shall not affect the 
remainder thereof or the application of the provision to other persons 
not similarly situated or to other dissimilar circumstances.


Sec.  1028.102   Definitions for purposes of this policy.

    (a) Certification means the official notification by the 
institution to the supporting Federal department or agency component, 
in accordance with the requirements of this policy, that a research 
project or activity involving human subjects has been reviewed and 
approved by an IRB in accordance with an approved assurance.
    (b) Clinical trial means a research study in which one or more 
human subjects are prospectively assigned to one or more interventions 
(which may include placebo or other control) to evaluate the effects of 
the interventions on biomedical or behavioral health-related outcomes.
    (c) Department or agency head means the head of any Federal 
department or agency, for example, the Secretary of HHS, and any other 
officer or employee of any Federal department or agency to whom the 
authority provided by these regulations to the department or agency 
head has been delegated.
    (d) Federal department or agency refers to a federal department or 
agency (the department or agency itself rather than its bureaus, 
offices or divisions) that takes appropriate administrative action to 
make this policy applicable to the research involving human subjects it 
conducts, supports, or otherwise regulates (e.g., the U.S. Department 
of Health and Human Services, the U.S. Department of Defense, or the 
Central Intelligence Agency).
    (e)(1) Human subject means a living individual about whom an 
investigator (whether professional or student) conducting research:
    (i) Obtains information or biospecimens through intervention or 
interaction with the individual, and uses, studies, or analyzes the 
information or biospecimens; or
    (ii) Obtains, uses, studies, analyzes, or generates identifiable 
private information or identifiable biospecimens.
    (2) Intervention includes both physical procedures by which 
information or biospecimens are gathered (e.g., venipuncture) and 
manipulations of the subject or the subject's environment that are 
performed for research purposes.
    (3) Interaction includes communication or interpersonal contact 
between investigator and subject.
    (4) Private information includes information about behavior that 
occurs in a context in which an individual can reasonably expect that 
no observation or recording is taking place, and information that has 
been provided for specific purposes by an individual and that the 
individual can reasonably expect will not be made public (e.g., a 
medical record).
    (5) Identifiable private information is private information for 
which the identity of the subject is or may readily be ascertained by 
the investigator or associated with the information.
    (6) An identifiable biospecimen is a biospecimen for which the 
identity of the subject is or may readily be ascertained by the 
investigator or associated with the biospecimen.
    (7) Federal departments or agencies implementing this policy shall:
    (i) Upon consultation with appropriate experts (including experts 
in data matching and re-identification), reexamine the meaning of 
``identifiable private information,'' as defined in paragraph (e)(5) of 
this section, and ``identifiable biospecimen,'' as defined in paragraph 
(e)(6) of this section. This reexamination shall take place within 1 
year and regularly thereafter (at least every 4 years). This process 
will be conducted by collaboration among the Federal departments and 
agencies implementing this policy. If appropriate and permitted by law, 
such Federal departments and agencies may alter the interpretation of 
these terms, including through the use of guidance.
    (ii) Upon consultation with appropriate experts, assess whether 
there are analytic technologies or techniques that should be considered 
by investigators to generate ``identifiable private information,'' as 
defined in paragraph (e)(5) of this section, or an ``identifiable 
biospecimen,'' as defined in paragraph (e)(6) of this section. This 
assessment shall take place within 1 year and regularly thereafter (at 
least every 4 years). This process will be conducted by collaboration 
among the Federal departments and agencies implementing this policy. 
Any such technologies or techniques will be included on a list of 
technologies or techniques that produce identifiable private 
information or identifiable biospecimens. This list will be published 
in the Federal Register after notice and an opportunity for public 
comment. The Secretary, HHS, shall maintain the list on a publicly 
accessible Web site.
    (f) Institution means any public or private entity, or department 
or agency (including federal, state, and other agencies).
    (g) IRB means an institutional review board established in accord 
with and for the purposes expressed in this policy.
    (h) IRB approval means the determination of the IRB that the 
research has been reviewed and may be conducted at an institution 
within the constraints set forth by the IRB and by other institutional 
and federal requirements.
    (i) Legally authorized representative means an individual or 
judicial or other body authorized under applicable law to consent on 
behalf of a prospective subject to the subject's participation in the 
procedure(s) involved in the research. If there is no applicable law 
addressing this issue, legally authorized representative means an 
individual recognized by institutional policy as acceptable for 
providing consent in the nonresearch context on behalf of the 
prospective subject to the subject's participation in the procedure(s) 
involved in the research.
    (j) Minimal risk means that the probability and magnitude of harm 
or discomfort anticipated in the research are not greater in and of 
themselves than those ordinarily encountered in daily

[[Page 43462]]

life or during the performance of routine physical or psychological 
examinations or tests.
    (k) Public health authority means an agency or authority of the 
United States, a state, a territory, a political subdivision of a state 
or territory, an Indian tribe, or a foreign government, or a person or 
entity acting under a grant of authority from or contract with such 
public agency, including the employees or agents of such public agency 
or its contractors or persons or entities to whom it has granted 
authority, that is responsible for public health matters as part of its 
official mandate.
    (l) Research means a systematic investigation, including research 
development, testing, and evaluation, designed to develop or contribute 
to generalizable knowledge. Activities that meet this definition 
constitute research for purposes of this policy, whether or not they 
are conducted or supported under a program that is considered research 
for other purposes. For example, some demonstration and service 
programs may include research activities. For purposes of this part, 
the following activities are deemed not to be research:
    (1) Scholarly and journalistic activities (e.g., oral history, 
journalism, biography, literary criticism, legal research, and 
historical scholarship), including the collection and use of 
information, that focus directly on the specific individuals about whom 
the information is collected.
    (2) Public health surveillance activities, including the collection 
and testing of information or biospecimens, conducted, supported, 
requested, ordered, required, or authorized by a public health 
authority. Such activities are limited to those necessary to allow a 
public health authority to identify, monitor, assess, or investigate 
potential public health signals, onsets of disease outbreaks, or 
conditions of public health importance (including trends, signals, risk 
factors, patterns in diseases, or increases in injuries from using 
consumer products). Such activities include those associated with 
providing timely situational awareness and priority setting during the 
course of an event or crisis that threatens public health (including 
natural or man-made disasters).
    (3) Collection and analysis of information, biospecimens, or 
records by or for a criminal justice agency for activities authorized 
by law or court order solely for criminal justice or criminal 
investigative purposes.
    (4) Authorized operational activities (as determined by each 
agency) in support of intelligence, homeland security, defense, or 
other national security missions.
    (m) Written, or in writing, for purposes of this part, refers to 
writing on a tangible medium (e.g., paper) or in an electronic format.


Sec.  1028.103  Assuring compliance with this policy--research 
conducted or supported by any Federal department or agency.

    (a) Each institution engaged in research that is covered by this 
policy, with the exception of research eligible for exemption under 
Sec.  1028.104, and that is conducted or supported by a Federal 
department or agency, shall provide written assurance satisfactory to 
the department or agency head that it will comply with the requirements 
of this policy. In lieu of requiring submission of an assurance, 
individual department or agency heads shall accept the existence of a 
current assurance, appropriate for the research in question, on file 
with the Office for Human Research Protections, HHS, or any successor 
office, and approved for Federal-wide use by that office. When the 
existence of an HHS-approved assurance is accepted in lieu of requiring 
submission of an assurance, reports (except certification) required by 
this policy to be made to department and agency heads shall also be 
made to the Office for Human Research Protections, HHS, or any 
successor office. Federal departments and agencies will conduct or 
support research covered by this policy only if the institution has 
provided an assurance that it will comply with the requirements of this 
policy, as provided in this section, and only if the institution has 
certified to the department or agency head that the research has been 
reviewed and approved by an IRB (if such certification is required by 
paragraph (d) of this section).
    (b) The assurance shall be executed by an individual authorized to 
act for the institution and to assume on behalf of the institution the 
obligations imposed by this policy and shall be filed in such form and 
manner as the department or agency head prescribes.
    (c) The department or agency head may limit the period during which 
any assurance shall remain effective or otherwise condition or restrict 
the assurance.
    (d) Certification is required when the research is supported by a 
Federal department or agency and not otherwise waived under Sec.  
1028.101(i) or exempted under Sec.  1028.104. For such research, 
institutions shall certify that each proposed research study covered by 
the assurance and this section has been reviewed and approved by the 
IRB. Such certification must be submitted as prescribed by the Federal 
department or agency component supporting the research. Under no 
condition shall research covered by this section be initiated prior to 
receipt of the certification that the research has been reviewed and 
approved by the IRB.
    (e) For nonexempt research involving human subjects covered by this 
policy (or exempt research for which limited IRB review takes place 
pursuant to Sec.  1028.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8)) 
that takes place at an institution in which IRB oversight is conducted 
by an IRB that is not operated by the institution, the institution and 
the organization operating the IRB shall document the institution's 
reliance on the IRB for oversight of the research and the 
responsibilities that each entity will undertake to ensure compliance 
with the requirements of this policy (e.g., in a written agreement 
between the institution and the IRB, by implementation of an 
institution-wide policy directive providing the allocation of 
responsibilities between the institution and an IRB that is not 
affiliated with the institution, or as set forth in a research 
protocol).


(Approved by the Office of Management and Budget under Control Number 
0990-0260)


Sec.  1028.104   Exempt research.

    (a) Unless otherwise required by law or by department or agency 
heads, research activities in which the only involvement of human 
subjects will be in one or more of the categories in paragraph (d) of 
this section are exempt from the requirements of this policy, except 
that such activities must comply with the requirements of this section 
and as specified in each category.
    (b) Use of the exemption categories for research subject to the 
requirements of 45 CFR part 46, subparts B, C, and D: Application of 
the exemption categories to research subject to the requirements of 45 
CFR part 46, subparts B, C, and D, is as follows:
    (1) Subpart B. Each of the exemptions at this section may be 
applied to research subject to subpart B if the conditions of the 
exemption are met.
    (2) Subpart C. The exemptions at this section do not apply to 
research subject to subpart C, except for research aimed at involving a 
broader subject population that only incidentally includes prisoners.
    (3) Subpart D. The exemptions at paragraphs (d)(1) and (d)(4) 
through (8) of this section may be applied to

[[Page 43463]]

research subject to subpart D if the conditions of the exemption are 
met. Paragraphs (d)(2)(i) and (ii) of this section only may apply to 
research subject to subpart D involving educational tests or the 
observation of public behavior when the investigator(s) do not 
participate in the activities being observed. Paragraph (d)(2)(iii) of 
this section may not be applied to research subject to subpart D.
    (c) [Reserved.]
    (d) Except as described in paragraph (a) of this section, the 
following categories of human subjects research are exempt from this 
policy:
    (1) Research, conducted in established or commonly accepted 
educational settings, that specifically involves normal educational 
practices that are not likely to adversely impact students' opportunity 
to learn required educational content or the assessment of educators 
who provide instruction. This includes most research on regular and 
special education instructional strategies, and research on the 
effectiveness of or the comparison among instructional techniques, 
curricula, or classroom management methods.
    (2) Research that only includes interactions involving educational 
tests (cognitive, diagnostic, aptitude, achievement), survey 
procedures, interview procedures, or observation of public behavior 
(including visual or auditory recording) if at least one of the 
following criteria is met:
    (i) The information obtained is recorded by the investigator in 
such a manner that the identity of the human subjects cannot readily be 
ascertained, directly or through identifiers linked to the subjects;
    (ii) Any disclosure of the human subjects' responses outside the 
research would not reasonably place the subjects at risk of criminal or 
civil liability or be damaging to the subjects' financial standing, 
employability, educational advancement, or reputation; or
    (iii) The information obtained is recorded by the investigator in 
such a manner that the identity of the human subjects can readily be 
ascertained, directly or through identifiers linked to the subjects, 
and an IRB conducts a limited IRB review to make the determination 
required by Sec.  1028.111(a)(7).
    (3)(i) Research involving benign behavioral interventions in 
conjunction with the collection of information from an adult subject 
through verbal or written responses (including data entry) or 
audiovisual recording if the subject prospectively agrees to the 
intervention and information collection and at least one of the 
following criteria is met:
    (A) The information obtained is recorded by the investigator in 
such a manner that the identity of the human subjects cannot readily be 
ascertained, directly or through identifiers linked to the subjects;
    (B) Any disclosure of the human subjects' responses outside the 
research would not reasonably place the subjects at risk of criminal or 
civil liability or be damaging to the subjects' financial standing, 
employability, educational advancement, or reputation; or
    (C) The information obtained is recorded by the investigator in 
such a manner that the identity of the human subjects can readily be 
ascertained, directly or through identifiers linked to the subjects, 
and an IRB conducts a limited IRB review to make the determination 
required by Sec.  1028.111(a)(7).
    (ii) For the purpose of this provision, benign behavioral 
interventions are brief in duration, harmless, painless, not physically 
invasive, not likely to have a significant adverse lasting impact on 
the subjects, and the investigator has no reason to think the subjects 
will find the interventions offensive or embarrassing. Provided all 
such criteria are met, examples of such benign behavioral interventions 
would include having the subjects play an online game, having them 
solve puzzles under various noise conditions, or having them decide how 
to allocate a nominal amount of received cash between themselves and 
someone else.
    (iii) If the research involves deceiving the subjects regarding the 
nature or purposes of the research, this exemption is not applicable 
unless the subject authorizes the deception through a prospective 
agreement to participate in research in circumstances in which the 
subject is informed that he or she will be unaware of or misled 
regarding the nature or purposes of the research.
    (4) Secondary research for which consent is not required: Secondary 
research uses of identifiable private information or identifiable 
biospecimens, if at least one of the following criteria is met:
    (i) The identifiable private information or identifiable 
biospecimens are publicly available;
    (ii) Information, which may include information about biospecimens, 
is recorded by the investigator in such a manner that the identity of 
the human subjects cannot readily be ascertained directly or through 
identifiers linked to the subjects, the investigator does not contact 
the subjects, and the investigator will not re-identify subjects;
    (iii) The research involves only information collection and 
analysis involving the investigator's use of identifiable health 
information when that use is regulated under 45 CFR parts 160 and 164, 
subparts A and E, for the purposes of ``health care operations'' or 
``research'' as those terms are defined at 45 CFR 164.501 or for 
``public health activities and purposes'' as described under 45 CFR 
164.512(b); or
    (iv) The research is conducted by, or on behalf of, a Federal 
department or agency using government-generated or government-collected 
information obtained for nonresearch activities, if the research 
generates identifiable private information that is or will be 
maintained on information technology that is subject to and in 
compliance with section 208(b) of the E-Government Act of 2002, 44 
U.S.C. 3501 note, if all of the identifiable private information 
collected, used, or generated as part of the activity will be 
maintained in systems of records subject to the Privacy Act of 1974, 5 
U.S.C. 552a, and, if applicable, the information used in the research 
was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 
3501 et seq.
    (5) Research and demonstration projects that are conducted or 
supported by a Federal department or agency, or otherwise subject to 
the approval of department or agency heads (or the approval of the 
heads of bureaus or other subordinate agencies that have been delegated 
authority to conduct the research and demonstration projects), and that 
are designed to study, evaluate, improve, or otherwise examine public 
benefit or service programs, including procedures for obtaining 
benefits or services under those programs, possible changes in or 
alternatives to those programs or procedures, or possible changes in 
methods or levels of payment for benefits or services under those 
programs. Such projects include, but are not limited to, internal 
studies by Federal employees, and studies under contracts or consulting 
arrangements, cooperative agreements, or grants. Exempt projects also 
include waivers of otherwise mandatory requirements using authorities 
such as sections 1115 and 1115A of the Social Security Act, as amended.
    (i) Each Federal department or agency conducting or supporting the 
research and demonstration projects must establish, on a publicly 
accessible Federal Web site or in such other manner as the department 
or agency head may determine, a list of the research and demonstration 
projects that the Federal department or agency conducts or supports 
under this

[[Page 43464]]

provision. The research or demonstration project must be published on 
this list prior to commencing the research involving human subjects.
    (ii) [Reserved]
    (6) Taste and food quality evaluation and consumer acceptance 
studies:
    (i) If wholesome foods without additives are consumed, or
    (ii) If a food is consumed that contains a food ingredient at or 
below the level and for a use found to be safe, or agricultural 
chemical or environmental contaminant at or below the level found to be 
safe, by the Food and Drug Administration or approved by the 
Environmental Protection Agency or the Food Safety and Inspection 
Service of the U.S. Department of Agriculture.
    (7) Storage or maintenance for secondary research for which broad 
consent is required: Storage or maintenance of identifiable private 
information or identifiable biospecimens for potential secondary 
research use if an IRB conducts a limited IRB review and makes the 
determinations required by Sec.  1028.111(a)(8).
    (8) Secondary research for which broad consent is required: 
Research involving the use of identifiable private information or 
identifiable biospecimens for secondary research use, if the following 
criteria are met:
    (i) Broad consent for the storage, maintenance, and secondary 
research use of the identifiable private information or identifiable 
biospecimens was obtained in accordance with Sec.  1028.116(a)(1) 
through (4), (a)(6), and (d);
    (ii) Documentation of informed consent or waiver of documentation 
of consent was obtained in accordance with Sec.  1028.117;
    (iii) An IRB conducts a limited IRB review and makes the 
determination required by Sec.  1028.111(a)(7) and makes the 
determination that the research to be conducted is within the scope of 
the broad consent referenced in paragraph (d)(8)(i) of this section; 
and
    (iv) The investigator does not include returning individual 
research results to subjects as part of the study plan. This provision 
does not prevent an investigator from abiding by any legal requirements 
to return individual research results.


(Approved by the Office of Management and Budget under Control Number 
0990-0260)


Sec.  1028.105  [Reserved.]


Sec.  1028.106  [Reserved]


Sec.  1028.107  IRB membership.

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


Sec.  1028.108  IRB functions and operations.

    (a) In order to fulfill the requirements of this policy each IRB 
shall:
    (1) Have access to meeting space and sufficient staff to support 
the IRB's review and recordkeeping duties;
    (2) Prepare and maintain a current list of the IRB members 
identified by name; earned degrees; representative capacity; 
indications of experience such as board certifications or licenses 
sufficient to describe each member's chief anticipated contributions to 
IRB deliberations; and any employment or other relationship between 
each member and the institution, for example, full-time employee, part-
time employee, member of governing panel or board, stockholder, paid or 
unpaid consultant;
    (3) Establish and follow written procedures for:
    (i) Conducting its initial and continuing review of research and 
for reporting its findings and actions to the investigator and the 
institution;
    (ii) Determining which projects require review more often than 
annually and which projects need verification from sources other than 
the investigators that no material changes have occurred since previous 
IRB review; and
    (iii) Ensuring prompt reporting to the IRB of proposed changes in a 
research activity, and for ensuring that investigators will conduct the 
research activity in accordance with the terms of the IRB approval 
until any proposed changes have been reviewed and approved by the IRB, 
except when necessary to eliminate apparent immediate hazards to the 
subject.
    (4) Establish and follow written procedures for ensuring prompt 
reporting to the IRB; appropriate institutional officials; the 
department or agency head; and the Office for Human Research 
Protections, HHS, or any successor office, or the equivalent office 
within the appropriate Federal department or agency of
    (i) Any unanticipated problems involving risks to subjects or 
others or any serious or continuing noncompliance with this policy or 
the requirements or determinations of the IRB; and (ii) Any suspension 
or termination of IRB approval.
    (b) Except when an expedited review procedure is used (as described 
in Sec.  1028.110), an IRB must review proposed research at convened 
meetings at which a majority of the members of the IRB are present, 
including at least one member whose primary concerns are in 
nonscientific areas. In order for the research to be approved, it shall 
receive the approval of a majority of those members present at the 
meeting.


(Approved by the Office of Management and Budget under Control Number 
0990-0260)

[[Page 43465]]

Sec.  1028.109  IRB review of research.

    (a) An IRB shall review and have authority to approve, require 
modifications in (to secure approval), or disapprove all research 
activities covered by this policy, including exempt research activities 
under Sec.  1028.104 for which limited IRB review is a condition of 
exemption (under Sec.  1028.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or 
(8)).
    (b) An IRB shall require that information given to subjects (or 
legally authorized representatives, when appropriate) as part of 
informed consent is in accordance with Sec.  1028.116. The IRB may 
require that information, in addition to that specifically mentioned in 
Sec.  1028.116, be given to the subjects when in the IRB's judgment the 
information would meaningfully add to the protection of the rights and 
welfare of subjects.
    (c) An IRB shall require documentation of informed consent or may 
waive documentation in accordance with Sec.  1028.117.
    (d) An IRB shall notify investigators and the institution in 
writing of its decision to approve or disapprove the proposed research 
activity, or of modifications required to secure IRB approval of the 
research activity. If the IRB decides to disapprove a research 
activity, it shall include in its written notification a statement of 
the reasons for its decision and give the investigator an opportunity 
to respond in person or in writing.
    (e) An IRB shall conduct continuing review of research requiring 
review by the convened IRB at intervals appropriate to the degree of 
risk, not less than once per year, except as described in paragraph (f) 
of this section.
    (f)(1) Unless an IRB determines otherwise, continuing review of 
research is not required in the following circumstances:
    (i) Research eligible for expedited review in accordance with Sec.  
1028.110;
    (ii) Research reviewed by the IRB in accordance with the limited 
IRB review described in Sec.  1028.104(d)(2)(iii), (d)(3)(i)(C), or 
(d)(7) or (8);
    (iii) Research that has progressed to the point that it involves 
only one or both of the following, which are part of the IRB-approved 
study:
    (A) Data analysis, including analysis of identifiable private 
information or identifiable biospecimens, or
    (B) Accessing follow-up clinical data from procedures that subjects 
would undergo as part of clinical care.
    (2) [Reserved.]
    (g) An IRB shall have authority to observe or have a third party 
observe the consent process and the research.


(Approved by the Office of Management and Budget under Control Number 
0990-0260)


Sec.  1028.110  Expedited review procedures for certain kinds of 
research involving no more than minimal risk, and for minor changes in 
approved research.

    (a) The Secretary of HHS has established, and published as a Notice 
in the Federal Register, a list of categories of research that may be 
reviewed by the IRB through an expedited review procedure. The 
Secretary will evaluate the list at least every 8 years and amend it, 
as appropriate, after consultation with other Federal departments and 
agencies and after publication in the Federal Register for public 
comment. A copy of the list is available from the Office for Human 
Research Protections, HHS, or any successor office.
    (b)(1) An IRB may use the expedited review procedure to review the 
following:
    (i) Some or all of the research appearing on the list described in 
paragraph (a) of this section, unless the reviewer determines that the 
study involves more than minimal risk;
    (ii) Minor changes in previously approved research during the 
period for which approval is authorized; or
    (iii) Research for which limited IRB review is a condition of 
exemption under Sec.  1028.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and 
(8).
    (2) Under an expedited review procedure, the review may be carried 
out by the IRB chairperson or by one or more experienced reviewers 
designated by the chairperson from among members of the IRB. In 
reviewing the research, the reviewers may exercise all of the 
authorities of the IRB except that the reviewers may not disapprove the 
research. A research activity may be disapproved only after review in 
accordance with the nonexpedited procedure set forth in Sec.  
1028.108(b).
    (c) Each IRB that uses an expedited review procedure shall adopt a 
method for keeping all members advised of research proposals that have 
been approved under the procedure.
    (d) The department or agency head may restrict, suspend, terminate, 
or choose not to authorize an institution's or IRB's use of the 
expedited review procedure.


Sec.  1028.111  Criteria for IRB approval of research.

    (a) In order to approve research covered by this policy the IRB 
shall determine that all of the following requirements are satisfied:
    (1) Risks to subjects are minimized:
    (i) By using procedures that are consistent with sound research 
design and that do not unnecessarily expose subjects to risk, and
    (ii) Whenever appropriate, by using procedures already being 
performed on the subjects for diagnostic or treatment purposes.
    (2) Risks to subjects are reasonable in relation to anticipated 
benefits, if any, to subjects, and the importance of the knowledge that 
may reasonably be expected to result. In evaluating risks and benefits, 
the IRB should consider only those risks and benefits that may result 
from the research (as distinguished from risks and benefits of 
therapies subjects would receive even if not participating in the 
research). The IRB should not consider possible long-range effects of 
applying knowledge gained in the research (e.g., the possible effects 
of the research on public policy) as among those research risks that 
fall within the purview of its responsibility.
    (3) Selection of subjects is equitable. In making this assessment 
the IRB should take into account the purposes of the research and the 
setting in which the research will be conducted. The IRB should be 
particularly cognizant of the special problems of research that 
involves a category of subjects who are vulnerable to coercion or undue 
influence, such as children, prisoners, individuals with impaired 
decision-making capacity, or economically or educationally 
disadvantaged persons.
    (4) Informed consent will be sought from each prospective subject 
or the subject's legally authorized representative, in accordance with, 
and to the extent required by, Sec.  1028.116.
    (5) Informed consent will be appropriately documented or 
appropriately waived in accordance with Sec.  1028.117.
    (6) When appropriate, the research plan makes adequate provision 
for monitoring the data collected to ensure the safety of subjects.
    (7) When appropriate, there are adequate provisions to protect the 
privacy of subjects and to maintain the confidentiality of data.
    (i) The Secretary of HHS will, after consultation with the Office 
of Management and Budget's privacy office and other Federal departments 
and agencies that have adopted this policy, issue guidance to assist 
IRBs in assessing what provisions are adequate to protect the privacy 
of subjects and to maintain the confidentiality of data.
    (ii) [Reserved.]

[[Page 43466]]

    (8) For purposes of conducting the limited IRB review required by 
Sec.  1028.104(d)(7)), the IRB need not make the determinations at 
paragraphs (a)(1) through (7) of this section, and shall make the 
following determinations:
    (i) Broad consent for storage, maintenance, and secondary research 
use of identifiable private information or identifiable biospecimens is 
obtained in accordance with the requirements of Sec.  1028.116(a)(1)-
(4), (a)(6), and (d);
    (ii) Broad consent is appropriately documented or waiver of 
documentation is appropriate, in accordance with Sec.  1028.117; and
    (iii) If there is a change made for research purposes in the way 
the identifiable private information or identifiable biospecimens are 
stored or maintained, there are adequate provisions to protect the 
privacy of subjects and to maintain the confidentiality of data.
    (b) When some or all of the subjects are likely to be vulnerable to 
coercion or undue influence, such as children, prisoners, individuals 
with impaired decision-making capacity, or economically or 
educationally disadvantaged persons, additional safeguards have been 
included in the study to protect the rights and welfare of these 
subjects.


Sec.  1028.112  Review by institution.

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


Sec.  1028.113  Suspension or termination of IRB approval of research.

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


Sec.  1028.114  Cooperative research.

    (a) Cooperative research projects are those projects covered by 
this policy that involve more than one institution. In the conduct of 
cooperative research projects, each institution is responsible for 
safeguarding the rights and welfare of human subjects and for complying 
with this policy.
    (b)(1) Any institution located in the United States that is engaged 
in cooperative research must rely upon approval by a single IRB for 
that portion of the research that is conducted in the United States. 
The reviewing IRB will be identified by the Federal department or 
agency supporting or conducting the research or proposed by the lead 
institution subject to the acceptance of the Federal department or 
agency supporting the research.
    (2) The following research is not subject to this provision:
    (i) Cooperative research for which more than single IRB review is 
required by law (including tribal law passed by the official governing 
body of an American Indian or Alaska Native tribe); or
    (ii) Research for which any Federal department or agency supporting 
or conducting the research determines and documents that the use of a 
single IRB is not appropriate for the particular context.
    (c) For research not subject to paragraph (b) of this section, an 
institution participating in a cooperative project may enter into a 
joint review arrangement, rely on the review of another IRB, or make 
similar arrangements for avoiding duplication of effort.


Sec.  1028.115  IRB Records.

    (a) An institution, or when appropriate an IRB, shall prepare and 
maintain adequate documentation of IRB activities, including the 
following:
    (1) Copies of all research proposals reviewed, scientific 
evaluations, if any, that accompany the proposals, approved sample 
consent forms, progress reports submitted by investigators, and reports 
of injuries to subjects.
    (2) Minutes of IRB meetings, which shall be in sufficient detail to 
show attendance at the meetings; actions taken by the IRB; the vote on 
these actions including the number of members voting for, against, and 
abstaining; the basis for requiring changes in or disapproving 
research; and a written summary of the discussion of controverted 
issues and their resolution.
    (3) Records of continuing review activities, including the 
rationale for conducting continuing review of research that otherwise 
would not require continuing review as described in Sec.  
1028.109(f)(1).
    (4) Copies of all correspondence between the IRB and the 
investigators.
    (5) A list of IRB members in the same detail as described in Sec.  
1028.108(a)(2).
    (6) Written procedures for the IRB in the same detail as described 
in Sec.  1028.108(a)(3) and (4).
    (7) Statements of significant new findings provided to subjects, as 
required by Sec.  1028.116(c)(5).
    (8) The rationale for an expedited reviewer's determination under 
Sec.  1028.110(b)(1)(i) that research appearing on the expedited review 
list described in Sec.  1028.110(a) is more than minimal risk.
    (9) Documentation specifying the responsibilities that an 
institution and an organization operating an IRB each will undertake to 
ensure compliance with the requirements of this policy, as described in 
Sec.  1028.103(e).
    (b) The records required by this policy shall be retained for at 
least 3 years, and records relating to research that is conducted shall 
be retained for at least 3 years after completion of the research. The 
institution or IRB may maintain the records in printed form, or 
electronically. All records shall be accessible for inspection and 
copying by authorized representatives of the Federal department or 
agency at reasonable times and in a reasonable manner.


Sec.  1028.116  General requirements for informed consent.

    (a) General. General requirements for informed consent, whether 
written or oral, are set forth in this paragraph and apply to consent 
obtained in accordance with the requirements set forth in paragraphs 
(b) through (d) of this section. Broad consent may be obtained in lieu 
of informed consent obtained in accordance with paragraphs (b) and (c) 
of this section only with respect to the storage, maintenance, and 
secondary research uses of identifiable private information and 
identifiable biospecimens. Waiver or alteration of consent in research 
involving public benefit and service programs conducted by or subject 
to the approval of state or local officials is described in paragraph 
(e) of this section. General waiver or alteration of informed consent 
is described in paragraph (f) of this section. Except as provided 
elsewhere in this policy:
    (1) Before involving a human subject in research covered by this 
policy, an investigator shall obtain the legally effective informed 
consent of the subject or the subject's legally authorized 
representative.
    (2) An investigator shall seek informed consent only under 
circumstances that provide the prospective subject or the legally 
authorized representative sufficient opportunity to discuss and 
consider

[[Page 43467]]

whether or not to participate and that minimize the possibility of 
coercion or undue influence.
    (3) The information that is given to the subject or the legally 
authorized representative shall be in language understandable to the 
subject or the legally authorized representative.
    (4) The prospective subject or the legally authorized 
representative must be provided with the information that a reasonable 
person would want to have in order to make an informed decision about 
whether to participate, and an opportunity to discuss that information.
    (5) Except for broad consent obtained in accordance with paragraph 
(d) of this section:
    (i) Informed consent must 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. This part of the informed consent must be 
organized and presented in a way that facilitates comprehension.
    (ii) Informed consent as a whole must present information in 
sufficient detail relating to the research, and must be organized and 
presented in a way that does not merely provide lists of isolated 
facts, but rather facilitates the prospective subject's or legally 
authorized representative's understanding of the reasons why one might 
or might not want to participate.
    (6) No informed consent may include any exculpatory language 
through which the subject or the legally authorized representative is 
made to waive or appear to waive any of the subject's legal rights, or 
releases or appears to release the investigator, the sponsor, the 
institution, or its agents from liability for negligence.
    (b) Basic elements of informed consent. Except as provided in 
paragraph (d), (e), or (f) of this section, in seeking informed consent 
the following information shall be provided to each subject or the 
legally authorized representative:
    (1) A statement that the study involves research, an explanation of 
the purposes of the research and the expected duration of the subject's 
participation, a description of the procedures to be followed, and 
identification of any procedures that are experimental;
    (2) A description of any reasonably foreseeable risks or 
discomforts to the subject;
    (3) A description of any benefits to the subject or to others that 
may reasonably be expected from the research;
    (4) A disclosure of appropriate alternative procedures or courses 
of treatment, if any, that might be advantageous to the subject;
    (5) A statement describing the extent, if any, to which 
confidentiality of records identifying the subject will be maintained;
    (6) For research involving more than minimal risk, an explanation 
as to whether any compensation and an explanation as to whether any 
medical treatments are available if injury occurs and, if so, what they 
consist of, or where further information may be obtained;
    (7) An explanation of whom to contact for answers to pertinent 
questions about the research and research subjects' rights, and whom to 
contact in the event of a research-related injury to the subject;
    (8) A statement that participation is voluntary, refusal to 
participate will involve no penalty or loss of benefits to which the 
subject is otherwise entitled, and the subject may discontinue 
participation at any time without penalty or loss of benefits to which 
the subject is otherwise entitled; and
    (9) One of the following statements about any research that 
involves the collection of identifiable private information or 
identifiable biospecimens:
    (i) A statement that identifiers might be removed from the 
identifiable private information or identifiable biospecimens and that, 
after such removal, the information or biospecimens could be used for 
future research studies or distributed to another investigator for 
future research studies without additional informed consent from the 
subject or the legally authorized representative, if this might be a 
possibility; or
    (ii) A statement that the subject's information or biospecimens 
collected as part of the research, even if identifiers are removed, 
will not be used or distributed for future research studies.
    (c) Additional elements of informed consent. Except as provided in 
paragraphs (d), (e), or (f) of this section, one or more of the 
following elements of information, when appropriate, shall also be 
provided to each subject or the legally authorized representative:
    (1) A statement that the particular treatment or procedure may 
involve risks to the subject (or to the embryo or fetus, if the subject 
is or may become pregnant) that are currently unforeseeable;
    (2) Anticipated circumstances under which the subject's 
participation may be terminated by the investigator without regard to 
the subject's or the legally authorized representative's consent;
    (3) Any additional costs to the subject that may result from 
participation in the research;
    (4) The consequences of a subject's decision to withdraw from the 
research and procedures for orderly termination of participation by the 
subject;
    (5) A statement that significant new findings developed during the 
course of the research that may relate to the subject's willingness to 
continue participation will be provided to the subject;
    (6) The approximate number of subjects involved in the study;
    (7) A statement that the subject's biospecimens (even if 
identifiers are removed) may be used for commercial profit and whether 
the subject will or will not share in this commercial profit;
    (8) A statement regarding whether clinically relevant research 
results, including individual research results, will be disclosed to 
subjects, and if so, under what conditions; and
    (9) For research involving biospecimens, whether the research will 
(if known) or might include whole genome sequencing (i.e., sequencing 
of a human germline or somatic specimen with the intent to generate the 
genome or exome sequence of that specimen).
    (d) Elements of broad consent for the storage, maintenance, and 
secondary research use of identifiable private information or 
identifiable biospecimens. Broad consent for the storage, maintenance, 
and secondary research use of identifiable private information or 
identifiable biospecimens (collected for either research studies other 
than the proposed research or nonresearch purposes) is permitted as an 
alternative to the informed consent requirements in paragraphs (b) and 
(c) of this paragraph. If the subject or the legally authorized 
representative is asked to provide broad consent, the following shall 
be provided to each subject or the subject's legally authorized 
representative:
    (1) The information required in paragraphs (b)(2), (3), (5), and 
(8) and, when appropriate, (c)(7) and (9) of this section;
    (2) A general description of the types of research that may be 
conducted with the identifiable private information or identifiable 
biospecimens. This description must include sufficient information such 
that a reasonable person would expect that the broad consent would 
permit the types of research conducted;
    (3) A description of the identifiable private information or 
identifiable biospecimens that might be used in

[[Page 43468]]

research, whether sharing of identifiable private information or 
identifiable biospecimens might occur, and the types of institutions or 
researchers that might conduct research with the identifiable private 
information or identifiable biospecimens;
    (4) A description of the period of time that the identifiable 
private information or identifiable biospecimens may be stored and 
maintained (which period of time could be indefinite), and a 
description of the period of time that the identifiable private 
information or identifiable biospecimens may be used for research 
purposes (which period of time could be indefinite);
    (5) Unless the subject or legally authorized representative will be 
provided details about specific research studies, a statement that they 
will not be informed of the details of any specific research studies 
that might be conducted using the subject's identifiable private 
information or identifiable biospecimens, including the purposes of the 
research, and that they might have chosen not to consent to some of 
those specific research studies;
    (6) Unless it is known that clinically relevant research results, 
including individual research results, will be disclosed to the subject 
in all circumstances, a statement that such results may not be 
disclosed to the subject; and
    (7) An explanation of whom to contact for answers to questions 
about the subject's rights and about storage and use of the subject's 
identifiable private information or identifiable biospecimens, and whom 
to contact in the event of a research-related harm.
    (e) Waiver or alteration of consent in research involving public 
benefit and service programs conducted by or subject to the approval of 
state or local officials--(1) Waiver. An IRB may waive the requirement 
to obtain informed consent for research under paragraphs (a), (b), and 
(c) of this section, provided the IRB satisfies the requirements of 
paragraph (e)(3) of this section. If an individual was asked to provide 
broad consent for the storage, maintenance, and secondary research use 
of identifiable private information or identifiable biospecimens in 
accordance with the requirements at paragraph (d) of this section, and 
refused to consent, an IRB cannot waive consent for the storage, 
maintenance, or secondary research use of the identifiable private 
information or identifiable biospecimens.
    (2) Alteration. An IRB may approve a consent procedure that omits 
some, or alters some or all, of the elements of informed consent set 
forth in paragraphs (b) and (c) of this section provided the IRB 
satisfies the requirements of paragraph (e)(3) of this section. An IRB 
may not omit or alter any of the requirements described in paragraph 
(a) of this section. If a broad consent procedure is used, an IRB may 
not omit or alter any of the elements required under paragraph (d) of 
this section.
    (3) Requirements for waiver and alteration. In order for an IRB to 
waive or alter consent as described in this subsection, the IRB must 
find and document that:
    (i) The research or demonstration project is to be conducted by or 
subject to the approval of state or local government officials and is 
designed to study, evaluate, or otherwise examine:
    (A) Public benefit or service programs;
    (B) Procedures for obtaining benefits or services under those 
programs;
    (C) Possible changes in or alternatives to those programs or 
procedures; or
    (D) Possible changes in methods or levels of payment for benefits 
or services under those programs; and
    (ii) The research could not practicably be carried out without the 
waiver or alteration.
    (f) General waiver or alteration of consent--(1) Waiver. An IRB may 
waive the requirement to obtain informed consent for research under 
paragraphs (a), (b), and (c) of this section, provided the IRB 
satisfies the requirements of paragraph (f)(3) of this section. If an 
individual was asked to provide broad consent for the storage, 
maintenance, and secondary research use of identifiable private 
information or identifiable biospecimens in accordance with the 
requirements at paragraph (d) of this section, and refused to consent, 
an IRB cannot waive consent for the storage, maintenance, or secondary 
research use of the identifiable private information or identifiable 
biospecimens.
    (2) Alteration. An IRB may approve a consent procedure that omits 
some, or alters some or all, of the elements of informed consent set 
forth in paragraphs (b) and (c) of this section provided the IRB 
satisfies the requirements of paragraph (f)(3) of this section. An IRB 
may not omit or alter any of the requirements described in paragraph 
(a) of this section. If a broad consent procedure is used, an IRB may 
not omit or alter any of the elements required under paragraph (d) of 
this section.
    (3) Requirements for waiver and alteration. In order for an IRB to 
waive or alter consent as described in this subsection, the IRB must 
find and document that:
    (i) The research involves no more than minimal risk to the 
subjects;
    (ii) The research could not practicably be carried out without the 
requested waiver or alteration;
    (iii) If the research involves using identifiable private 
information or identifiable biospecimens, the research could not 
practicably be carried out without using such information or 
biospecimens in an identifiable format;
    (iv) The waiver or alteration will not adversely affect the rights 
and welfare of the subjects; and
    (v) Whenever appropriate, the subjects or legally authorized 
representatives will be provided with additional pertinent information 
after participation.
    (g) Screening, recruiting, or determining eligibility. An IRB may 
approve a research proposal in which an investigator will obtain 
information or biospecimens for the purpose of screening, recruiting, 
or determining the eligibility of prospective subjects without the 
informed consent of the prospective subject or the subject's legally 
authorized representative, if either of the following conditions are 
met:
    (1) The investigator will obtain information through oral or 
written communication with the prospective subject or legally 
authorized representative, or
    (2) The investigator will obtain identifiable private information 
or identifiable biospecimens by accessing records or stored 
identifiable biospecimens.
    (h) Posting of clinical trial consent form. (1) For each clinical 
trial conducted or supported by a Federal department or agency, one 
IRB-approved informed consent form used to enroll subjects must be 
posted by the awardee or the Federal department or agency component 
conducting the trial on a publicly available Federal Web site that will 
be established as a repository for such informed consent forms.
    (2) If the Federal department or agency supporting or conducting 
the clinical trial determines that certain information should not be 
made publicly available on a Federal Web site (e.g. confidential 
commercial information), such Federal department or agency may permit 
or require redactions to the information posted.
    (3) The informed consent form must be posted on the Federal Web 
site after the clinical trial is closed to recruitment, and no later 
than 60 days after the last study visit by any subject, as required by 
the protocol.
    (i) Preemption. The informed consent requirements in this policy 
are not intended to preempt any applicable Federal, state, or local 
laws (including

[[Page 43469]]

tribal laws passed by the official governing body of an American Indian 
or Alaska Native tribe) that require additional information to be 
disclosed in order for informed consent to be legally effective.
    (j) Emergency medical care. Nothing in this policy is intended to 
limit the authority of a physician to provide emergency medical care, 
to the extent the physician is permitted to do so under applicable 
Federal, state, or local law (including tribal law passed by the 
official governing body of an American Indian or Alaska Native tribe).


(Approved by the Office of Management and Budget under Control Number 
0990-0260)


Sec.  1028.117  Documentation of informed consent.

    (a) Except as provided in paragraph (c) of this section, informed 
consent shall be documented by the use of a written informed consent 
form approved by the IRB and signed (including in an electronic format) 
by the subject or the subject's legally authorized representative. A 
written copy shall be given to the person signing the informed consent 
form.
    (b) Except as provided in paragraph (c) of this section, the 
informed consent form may be either of the following:
    (1) A written informed consent form that meets the requirements of 
Sec.  1028.116. The investigator shall give either the subject or the 
subject's legally authorized representative adequate opportunity to 
read the informed consent form before it is signed; alternatively, this 
form may be read to the subject or the subject's legally authorized 
representative.
    (2) A short form written informed consent form stating that the 
elements of informed consent required by Sec.  1028.116 have been 
presented orally to the subject or the subject's legally authorized 
representative, and that the key information required by Sec.  
1028.116(a)(5)(i) was presented first to the subject, before other 
information, if any, was provided. The IRB shall approve a written 
summary of what is to be said to the subject or the legally authorized 
representative. When this method is used, there shall be a witness to 
the oral presentation. Only the short form itself is to be signed by 
the subject or the subject's legally authorized representative. 
However, the witness shall sign both the short form and a copy of the 
summary, and the person actually obtaining consent shall sign a copy of 
the summary. A copy of the summary shall be given to the subject or the 
subject's legally authorized representative, in addition to a copy of 
the short form.
    (c)(1) An IRB may waive the requirement for the investigator to 
obtain a signed informed consent form for some or all subjects if it 
finds any of the following:
    (i) That the only record linking the subject and the research would 
be the informed consent form and the principal risk would be potential 
harm resulting from a breach of confidentiality. Each subject (or 
legally authorized representative) will be asked whether the subject 
wants documentation linking the subject with the research, and the 
subject's wishes will govern;
    (ii) That the research presents no more than minimal risk of harm 
to subjects and involves no procedures for which written consent is 
normally required outside of the research context; or
    (iii) If the subjects or legally authorized representatives are 
members of a distinct cultural group or community in which signing 
forms is not the norm, that the research presents no more than minimal 
risk of harm to subjects and provided there is an appropriate 
alternative mechanism for documenting that informed consent was 
obtained.
    (2) In cases in which the documentation requirement is waived, the 
IRB may require the investigator to provide subjects or legally 
authorized representatives with a written statement regarding the 
research.


Sec.  1028.118  Applications and proposals lacking definite plans for 
involvement of human subjects.

    Certain types of applications for grants, cooperative agreements, 
or contracts are submitted to Federal departments or agencies with the 
knowledge that subjects may be involved within the period of support, 
but definite plans would not normally be set forth in the application 
or proposal. These include activities such as institutional type grants 
when selection of specific projects is the institution's 
responsibility; research training grants in which the activities 
involving subjects remain to be selected; and projects in which human 
subjects' involvement will depend upon completion of instruments, prior 
animal studies, or purification of compounds. Except for research 
waived under Sec.  1028.101(i) or exempted under Sec.  1028.104, no 
human subjects may be involved in any project supported by these awards 
until the project has been reviewed and approved by the IRB, as 
provided in this policy, and certification submitted, by the 
institution, to the Federal department or agency component supporting 
the research.


Sec.  1028.119   Research undertaken without the intention of involving 
human subjects.

    Except for research waived under Sec.  1028.101(i) or exempted 
under Sec.  1028.104, in the event research is undertaken without the 
intention of involving human subjects, but it is later proposed to 
involve human subjects in the research, the research shall first be 
reviewed and approved by an IRB, as provided in this policy, a 
certification submitted by the institution to the Federal department or 
agency component supporting the research, and final approval given to 
the proposed change by the Federal department or agency component.


Sec.  1028.120   Evaluation and disposition of applications and 
proposals for research to be conducted or supported by a Federal 
department or agency.

    (a) The department or agency head will evaluate all applications 
and proposals involving human subjects submitted to the Federal 
department or agency through such officers and employees of the Federal 
department or agency and such experts and consultants as the department 
or agency head determines to be appropriate. This evaluation will take 
into consideration the risks to the subjects, the adequacy of 
protection against these risks, the potential benefits of the research 
to the subjects and others, and the importance of the knowledge gained 
or to be gained.
    (b) On the basis of this evaluation, the department or agency head 
may approve or disapprove the application or proposal, or enter into 
negotiations to develop an approvable one.


Sec.  1028.121  [Reserved]


Sec.  1028.122  Use of Federal funds.

    Federal funds administered by a Federal department or agency may 
not be expended for research involving human subjects unless the 
requirements of this policy have been satisfied.


Sec.  1028.123  Early termination of research support: Evaluation of 
applications and proposals.

    (a) The department or agency head may require that Federal 
department or agency support for any project be terminated or suspended 
in the manner prescribed in applicable program requirements, when the 
department or agency head finds an institution has materially failed to 
comply with the terms of this policy.
    (b) In making decisions about supporting or approving applications 
or

[[Page 43470]]

proposals covered by this policy the department or agency head may take 
into account, in addition to all other eligibility requirements and 
program criteria, factors such as whether the applicant has been 
subject to a termination or suspension under paragraph (a) of this 
section and whether the applicant or the person or persons who would 
direct or has/have directed the scientific and technical aspects of an 
activity has/have, in the judgment of the department or agency head, 
materially failed to discharge responsibility for the protection of the 
rights and welfare of human subjects (whether or not the research was 
subject to federal regulation).


Sec.  1028.124  Conditions

    With respect to any research project or any class of research 
projects the department or agency head of either the conducting or the 
supporting Federal department or agency may impose additional 
conditions prior to or at the time of approval when in the judgment of 
the department or agency head additional conditions are necessary for 
the protection of human subjects.

Alberta E. Mills,
Acting Secretary, Consumer Product Safety Commission.
[FR Doc. 2017-19737 Filed 9-15-17; 8:45 am]
 BILLING CODE 6355-01-P


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