[Federal Register Volume 62, Number 217 (Monday, November 10, 1997)]
[Notices]
[Pages 60607-60611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29652]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Protection of Human Subjects: Suggested Revisions to the
Institutional Review Board (IRB) Expedited Review List
AGENCY: Office for Protection from Research Risks, National Institutes
of Health, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Office for Protection from Research Risks (OPRR), in
consultation with the Food and Drug Administration (FDA), is requesting
written comments relating to the proposed republication of the list
that identifies certain research involving human subjects which may be
reviewed by the Institutional Review Board (IRB) through the expedited
review procedure authorized in Sec. 46.110 of 45 CFR Part 46. This list
was originally published in 1981 and subsequently referenced in the
Federal Policy (Common Rule) for the Protection of Human Subjects (56
FR 28003). Pursuant to Sec. 46.110(a), the Secretary, HHS, has the
authority to amend and republish the list. In the 16 years since the
list was created, significant advances have been made in medicine and
biological technology such that it is appropriate to consider revising
this list
[[Page 60608]]
to include additional procedures or categories of research. OPRR seeks
information and suggestions from the research community and public on
possible revisions to the expedited review list.
DATES: Submit written comments on or before March 10, 1998.
ADDRESSES: Comments should be sent to Michele Russell-Einhorn, Director
of Regulatory Affairs, Office for Protection from Research Risks,
National Institutes of Health, 6100 Executive Blvd., Suite 3B01,
Rockville, Md. 20892-7507. Since OPRR and FDA are simultaneously
publishing identical lists, comments need not be sent to both agencies.
FOR FURTHER INFORMATION CONTACT: Michele Russell-Einhorn at the address
above, or telephone (301) 435-5649 (not a toll-free number).
SUPPLEMENTARY INFORMATION: The Federal Policy (Common Rule) for the
Protection of Human Subjects was published in the Federal Register on
June 18, 1991 (56 FR 28003) and is employed by 17 Executive Branch
agencies. This Federal Policy requires adherence to certain
requirements by Federal agencies or institutions receiving Federal
support for research activities involving human subjects. The Federal
Policy has three cornerstones: review of any research involving human
subjects by an Institutional Review Board (IRB); with limited
exceptions, informed consent of all research subjects; and formal,
written assurance of institutional compliance with the Policy. The
Department of Health and Human Services' (HHS) codification of the
Federal Policy can be found at 45 CFR Part 46.
Section ____.110 of the Federal Policy provides for expedited
review procedures for certain kinds of research involving no more than
minimal risk, and for minor changes in approved research. This same
section gives the Secretary, HHS, the authority to amend and republish
the Expedited Review List as needed after consultation with the
departments and agencies that are subject to the Federal Policy. The
expedited review list that is referenced in the Federal Policy was
originally published by the Secretary, HHS in 1981 as a Notice in the
Federal Register of a list of categories of research that could be
reviewed by the IRB through an expedited review procedure. The Food and
Drug Administration (FDA) also references an expedited review list (21
CFR Part 56) for matters under FDA's jurisdiction. The HHS and FDA
lists differ slightly, in that item 9 on the 1981 HHS expedited review
list regarding certain types of behavioral research is not included in
the list referenced in 21 CFR Part 56.110.
The current (1981) list allows an IRB to utilize the expedited
review procedure for research activities involving no more than minimal
risk and in which the only involvement of human subjects will be in one
or more of the following categories (carried out through standard
methods):
(1) Collection of hair and nail clippings, in a nondisfiguring
manner; deciduous teeth; and permanent teeth if patient care indicates
a need for extraction. (2) Collection of excreta and external
secretions including sweat, uncannulated saliva, placenta removed at
delivery, and amniotic fluid at the time of rupture of the membrane
prior to or during labor. (3) Recording of data from subjects 18 years
of age or older using noninvasive procedures routinely employed in
clinical practice. This includes the use of physical sensors that are
applied either to the surface of the body or at a distance and do not
involve input of matter or significant amounts of energy into the
subject or an invasion of the subject's privacy. It also includes such
procedures as weighing, testing sensory acuity, electrocardiography,
electroencephalography, thermography, detection of naturally occurring
radioactivity, diagnostic echography, and electroretinography. It does
not include exposure to electromagnetic radiation outside the visible
range (for example, x-rays, microwaves). (4) Collection of blood
samples by venipuncture, in amounts not exceeding 450 milliliters in an
eight-week period and no more often than two times per week, from
subjects 18 years of age or older and who are in good health and not
pregnant. (5) Collection of both supra-and subgingival dental plaque
and calculus, provided the procedure is not more invasive than routine
prophylactic scaling of the teeth and the process is accomplished in
accordance with accepted prophylactic techniques. (6) Voice recordings
made for research purposes such as investigations of speech defects.
(7) Moderate exercise by healthy volunteers. (8) The study of existing
data, documents, records, pathological specimens, or diagnostic
specimens. (9) Research on individual or group behavior or
characteristics of individuals, such as studies of perception,
cognition, game theory, or test development, where the investigator
does not manipulate subjects' behavior and the research will not
involve stress to subjects. (10) Research on drugs or devices for which
an investigational new drug exemption or an investigational device
exemption is not required.
OPRR, in consultation with FDA, is proposing to revise the
expedited review list to include additional procedures or categories of
research that may be reviewed under the expedited review procedure.
Since 1981, OPRR has received some suggestions to this effect and has
incorporated several into the proposed revision of the list that is
published herein. OPRR seeks additional comments from the public on
procedures or categories of research involving human subjects that may
be amenable to review by the IRB chairperson or other designated IRB
member instead of review by a convened meeting of the IRB.
The following is a proposed revision of the current expedited
review list found at 46 FR 8392 (Jan. 26, 1981) and 46 FR 8980 (Jan.
27, 1981). FDA is simultaneously publishing an identical list. Judgment
is reserved on whether OPRR and FDA will publish identical lists after
comments are received and reviewed. OPRR welcomes and encourages
comments from the research community and public.
Research Activities Which May Be Reviewed Through Expedited Review
Procedures 1
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\1\ The expedited review procedure consists of a review of
research involving human subjects by the IRB chairperson or by one
or more experienced reviewers designated by the chairperson from
among members of the IRB in accordance with the requirements set
forth in Section ____.110.
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Research activities (carried out through standard methods) which
involve (1) no more than minimal risk, and (2) appear in one or more of
the following categories may be reviewed by the Institutional Review
Board through the expedited review procedure authorized in 45 CFR
46.110 and 21 CFR 56.110. The activities that appear on this list
should not be deemed to be of minimal risk simply because they are
included on this list. Appearance on this list merely means that the
activity is eligible for review through the expedited process when the
specific circumstances of the proposed research involve no more than
minimal risk to the human subjects. The categories in this list apply
regardless of the age of subjects, except as noted.
(1) Research on drugs or devices for which an investigational new
drug exemption or an investigational device exemption is not required.
(2) Collection of blood samples by finger stick or venipuncture as
follows:
(a) From healthy, nonpregnant adults 2 who weigh at
least 110 pounds, in
[[Page 60609]]
amounts not exceeding 550 ml in an 8 week period and no more than 2
times per week.
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\2\ Throughout this document, when OPRR refers to ``adult,''
OPRR defers to state law for determining the age of majority.
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(b) From healthy, pregnant adults who weigh at least 110 pounds, in
amounts not exceeding 100 ml in an 8 week period and no more than 2
times per week.
(c) From healthy children, in amounts not exceeding 3 ml/kg in an 8
week period and no more than 2 times per week.
(d) From medically vulnerable adults who weigh at least 110 pounds,
in amounts not exceeding 50 ml in an 8 week period and no more than 2
times per week.
(3) Prospective collection for research purposes of the following
biological specimens:
(a) Hair and nail clippings in a nondisfiguring manner.
(b) Deciduous teeth at time of exfoliation, or if routine patient
care indicates a need for extraction.
(c) Permanent teeth if routine patient care indicates a need for
extraction.
(d) Excreta and external secretions (including sweat).
(e) Uncannulated saliva collected either in an unstimulated fashion
or stimulated by chewing gumbase or wax or by applying a dilute citric
solution to the tongue.
(f) Placenta removed at delivery.
(g) Amniotic fluid obtained at the time of rupture of the membrane
prior to or during labor.
(h) Supra- and subgingival dental plaque and calculus, provided the
collection procedure is not more invasive than routine prophylactic
scaling of the teeth and the process is accomplished in accordance with
accepted prophylactic techniques.
(i) Stool cultures obtained by rectal swab.
(j) Mucosal and skin cells collected by buccal scraping or swab,
skin swab, or mouth washings.
(k) Sputum collected after saline mist nebulization.
(4) Research involving existing identifiable data, documents,
records, or biological specimens (including pathological or diagnostic
specimens) where these materials, in their entirety, have been
collected prior to the research, for a purpose other than the proposed
research.
(5) Research involving solely (a) prospectively collected
identifiable residual or discarded specimens, or (b) prospectively
collected identifiable data, documents, or records, where (a) or (b)
has been generated for nonresearch purposes.
(6) Collection of data through use of the following procedures:
(a) Noninvasive procedures routinely employed in clinical practice
and not involving exposure to electromagnetic radiation outside the
visible range (i.e., not involving x-rays, microwaves, etc.).
(b) Physical sensors that are applied either to the surface of the
body or at a distance and do not involve input of significant amounts
of energy into the subject or an invasion of the subject's privacy.
(c) Weighing, testing sensory acuity, electrocardiography,
electroencephalography, thermography, detection of naturally occurring
radioactivity, electroretinography, echography, sonography, ultrasound,
magnetic resonance imaging (MRI), diagnostic infrared imaging, doppler
blood flow, and echocardiography.
(d) Moderate exercise, muscular strength testing, body composition
assessment, and flexibility testing involving healthy subjects.
(7) Collection of data from voice, video, or image recordings made
for research purposes where identification of the subjects and/or their
responses would not reasonably place them at risk of criminal or civil
liability or be damaging to the subjects' financial standing,
employability, or reputation.
(8) Research on individual or group characteristics or behavior
(including but not limited to research involving perception, cognition,
surveys, interviews, and focus groups) as follows:
(a) Involving adults, where (i) the research does not involve
stress to subjects, and (ii) identification of the subjects and/or
their responses would not reasonably place them at risk of criminal or
civil liability or be damaging to the subjects' financial standing,
employability, or reputation.
(b) Involving children, where (i) the research involves neither
stress to subjects nor sensitive information about themselves, or their
family; (ii) no alteration or waiver of regulatory requirements for
parental permission has been proposed; and (iii) identification of the
subjects and/or their responses would not reasonably place them or
their family members at risk of criminal or civil liability or be
damaging to the financial standing, employability, or reputation of
themselves or their family members.
(9) Research previously approved by the convened IRB as follows:
(a) Where (i) the research is permanently closed to the enrollment
of new subjects; (ii) all subjects have completed all research-related
interventions; and (iii) the research remains active only for long-term
follow-up of subjects; or
(b) Where the research remains active only for the purposes of data
analysis; or
(c) Where the IRB has determined that the research involves no
greater than minimal risk and no additional risks have been identified;
or
(d) Where no subjects have been enrolled and no additional risks
have been identified.
The following tabulation of changes is included to enable readers
to more easily compare the categories of research included in both
lists.
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1981 (Current) expedited review
Proposed expedited review list list
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1. Research on drugs or devices for Unchanged; currently number 9.
which an investigational new drug
exemption or an investigational device
exemption is not required.
2. Collection of blood samples by Currently number 4, limited to
finger stick or venipuncture as venipuncture; ``finger stick''
follows: not included
(a) From healthy, nonpregnant Amounts currently limited to
adults, in amounts not exceeding 450 ml
550 ml in an 8 week period and no
more than 2 times per week.
(b) From healthy, pregnant adults, Not included.
in amounts not exceeding 100 ml in
an 8 week period and no more than
2 times per week.
(c) From healthy children, in Not included.
amounts not exceeding 3 ml/kg in
an 8 week period and no more than
2 times per week.
(d) From medically vulnerable Not included.
adults, in amounts not exceeding
50 ml in an 8 week period and no
more than 2 times per week.
3. Prospective collection for research ``Prospective'' and ``for
purposes of the following biological research purposes'' currently
specimens: not included.
(a) Hair and nail clippings in a Currently part of number 1;
nondisfiguring manner. unchanged.
[[Page 60610]]
(b) Deciduous teeth at time of Currently part of number 1;
exfoliation, or if routine patient ``deciduous teeth'' included
care indicates a need for without qualifiers.
extraction.
(c) Permanent teeth if routine Currently part of number 1;
patient care indicates a need for ``routine'' not included.
extraction.
(d) Excreta and external secretions Currently part of number 2;
(including sweat). unchanged.
(e) Uncannulated saliva collected Currently part of number 2;
either in an unstimulated fashion ``uncannulated saliva''
or stimulated by chewing gumbase included without qualifiers.
or wax or by applying a dilute
citric solution to the tongue.
(f) Placenta removed at delivery... Currently part of number 2;
unchanged.
(g) Amniotic fluid obtained at the Currently part of number 2;
time of rupture of the membrane unchanged.
prior to or during labor.
(h) Supra- and subgingival dental Currently number 5;
plaque and calculus, provided the ``procedure'' was not
collection procedure is not more qualified with the word
invasive than routine prophylactic ``collection.''
scaling of the teeth and the
process is accomplished in
accordance with accepted
prophylactic techniques.
(i) Stool cultures obtained by Not included.
rectal swab.
(j) Mucosal and skin cells Not included.
collected by buccal scraping or
swab, skin swab, or mouth washings.
(k) Sputum collected after saline Not included.
mist nebulization.
4. Research involving existing Currently number 8; stated as:
identifiable data, documents, records, ``The study of existing data,
or biological specimens (including documents, records,
pathological or diagnostic specimens) pathological specimens, or
where these materials, in their diagnostic specimens.''
entirety, have been collected prior to
the research, for a purpose other than
the proposed research.
5. Research involving solely (a) Not included.
prospectively collected identifiable
residual or discarded specimens, or
(b) prospectively collected
identifiable data, documents, or
records, where (a) or (b) has been
generated for nonresearch purposes.
6. Collection of data through use of Currently number 3;
the following procedures: ``recording'' instead of
``collection.''
(a) Noninvasive procedures Currently number 3; limited to
routinely employed in clinical subjects 18 years of age or
practice and not involving older.
exposure to electromagnetic
radiation outside the visible
range (i.e., not involving x-rays,
microwaves, etc.).
(b) Physical sensors that are Currently number 3; limited to
applied either to the surface of subjects 18 years of age or
the body or at a distance and do older.
not involve input of significant
amounts of energy into the subject
or an invasion of the subject's
privacy.
(c) Weighing, testing sensory Currently number 3; limited to
acuity, electrocardiography, subjects 18 years of age or
electroencephalography, older; limited echography to
thermography, detection of ``diagnostic echography'';
naturally occurring radioactivity, does not include ``sonography,
electroretinography, echography, ultrasound, magnetic resonance
sonography, ultrasound, magnetic imaging (MRI), diagnostic
resonance imaging (MRI), infrared imaging, doppler
diagnostic infrared imaging, blood flow, and
doppler blood flow, and echocardiography.''
echocardiography.
(d) Moderate exercise, muscular Currently number 7; limited to
strength testing, body composition ``Moderate exercise by healthy
assessment, and flexibility volunteers.''
testing involving healthy subjects.
7. Collection of data from voice, Currently number 6; stated as:
video, or image recordings made for ``Voice recordings made for
research purposes where identification research purposes such as
of the subjects and/or their responses investigations of speech
would not reasonably place them at defects.''
risk of criminal or civil liability or
be damaging to the subjects' financial
standing, employability, or reputation.
8. Research on individual or group Currently number 9, stated as
characteristics or behavior (including follows: Research on
but not limited to research involving individual or group behavior
perception, cognition, surveys, or characteristics of
interviews, and focus groups) as individuals, such as studies
follows: of perception, cognition, game
theory, or test development,
where the investigator does
not manipulate subjects'
behavior and the research will
not involve stress to
subjects.''
(a) Involving adults, where (i) the
research does not involve stress
to subjects, and (ii)
identification of the subjects and/
or their responses would not
reasonably place them at risk of
criminal or civil liability or be
damaging to the subjects'
financial standing, employability,
or reputation.
(b) Involving children, where (i)
the research involves neither
stress to subjects nor sensitive
information about themselves, or
their family; (ii) no alteration
or waiver of regulatory
requirements for parental
permission has been proposed; and
(iii) identification of the
subjects and/or their responses
would not reasonably place them or
their family members at risk of
criminal or civil liability or be
damaging to the financial
standing, employability, or
reputation of themselves or their
family members.
9. Research previously approved by the Not Included.
convened IRB as follows:
(a) Where (i) the research is
permanently closed to the
enrollment of new subjects; (ii)
all subjects have completed all
research-related interventions;
and (iii) the research remains
active only for long-term follow-
up of subjects; or
(b) Where the research remains
active only for the purposes of
data analysis; or
[[Page 60611]]
(c) Where the IRB has determined
that the research involves no
greater than minimal risk and no
additional risks have been
identified; or
(d) Where no subjects have been
enrolled and no additional risks
have been identified
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Dated: October 31, 1997.
Gary B. Ellis,
Director, Office for Protection from Research Risks.
[FR Doc. 97-29652 Filed 11-5-97; 3:51 pm]
BILLING CODE 4140-01-P
