[Federal Register Volume 62, Number 217 (Monday, November 10, 1997)]
[Notices]
[Pages 60604-60607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29651]
[[Page 60603]]
_______________________________________________________________________
Part III
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
National Institutes of Health
_______________________________________________________________________
Protection of Human Subjects: Suggested Revisions to the Institutional
Review Board (IRB) Expedited Review List; Request for Comments; Notice
Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 /
Notices
[[Page 60604]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0447]
Protection of Human Subjects: Suggested Revisions to the
Institutional Review Board (IRB) Expedited Review List; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA), in consultation with
the Office for Protection from Research Risks (OPRR), is requesting
written comments relating to the proposed republication of the
Expedited Review List that identifies certain research involving human
subjects that may be reviewed by the Institutional Review Board (IRB)
through the expedited review procedures authorized in FDA's
regulations. 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 to include additional categories of
research. FDA seeks information and suggestions from the research
community and the public on possible revisions to the Expedited Review
List. The proposed list included in this notice is for discussion
purposes only. FDA and OPRR will consider the comments received in
deciding whether to revise the list.
DATES: Submit written comments on or before March 10, 1998.
ADDRESSES: Submit written comments to Dockets Management Branch (HFA-
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857. Because FDA and OPRR are simultaneously publishing
identical lists, comments need not be sent to both agencies.
FOR FURTHER INFORMATION CONTACT: Paul W. Goebel, Office of Health
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1685.
SUPPLEMENTARY INFORMATION: FDA's regulations for protection of human
subjects can be found under part 50 (21 CFR part 50), and the
regulations for IRB's under part 56 (21 CFR part 56). The regulations
require, with limited exceptions, review of research involving human
subjects by an IRB and obtaining and documenting legally effective
informed consent for all human subjects of research.
Section 56.110 provides for expedited review procedures for certain
kinds of research involving no more than minimal risk, and for minor
changes in previously approved research during the period for which
approval is authorized. In the Federal Register of January 26, 1981 (46
FR 8392), FDA published the Expedited Review List that is referenced in
Sec. 56.110(a), which is a list of categories of research that could be
reviewed by an IRB through the expedited review procedures set forth in
FDA's regulations. In the Federal Register of January 27, 1981 (46 FR
8980), a separate Expedited Review List is referenced in 45 CFR part 46
that applies to matters under the Department of Health and Human
Services' (HHS) jurisdiction was published. The HHS and FDA lists that
published in 1981 differ slightly, in that item 9 on the 1981 HHS list
pertains only to 45 CFR 46.110. Because behavioral research was not
regulated by FDA, that category was not included in the list published
by FDA in 1981, which is reproduced here to facilitate comparison with
the proposed list.
Current List: Items Included in the List Published in 1981
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 non-disfiguring
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 at delivery, and amniotic fluid
at the time of rupture of the membrane prior to or during labor.
(3) Recording of data from subjects who are 18 years of age [of]
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 weighting, electrocardiography,
electroencephalography, thermography, detection of naturally
occurring radioactivity, diagnostic echography, and
electroretinography. This category 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 who are 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 drugs or devices for which an investigational
new drug exemption or an investigational device exemption is not
required.
FDA, in consultation with OPRR, is proposing to revise the current
Expedited Review List to include additional procedures or categories of
research that may be reviewed under the expedited review procedure. FDA
seeks comments from the public on procedures or categories of research
involving human subjects that may be amenable to expedited review in
accordance with the procedures outlined in Sec. 56.110(b), instead of
review at a convened meeting of the IRB. The proposed list is being
published for discussion purposes only. FDA and OPRR intend to
determine, after review of comments received, whether any changes
should be made to the current list. FDA and OPRR have not determined
that the suggested additional categories of research in the proposed
list are appropriate for expedited review procedures. The proposed list
does not bind FDA or OPRR to include any of the suggested categories in
a list that is expected to be published after review of comments.
The following is a proposed revision of the current Expedited
Review Lists published in the Federal Register of January 26, 1981 (46
FR 8392), and January 27, 1981 (46 FR 8980). In order to simplify
review, the proposed revision is identical to the list published
elsewhere in this issue of the Federal Register by OPRR. Judgment is
reserved on whether FDA and OPRR will publish identical lists after
comments are received and reviewed. FDA welcomes and encourages
comments from the research community and the public.
Proposed List: 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 Sec. 56.110.
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Research activities (carried out through standard methods) that:
(1) Involve no more than minimal risk, and
[[Page 60605]]
(2) appear in one or more of the following categories may be reviewed
by the IRB through the expedited review procedure authorized in 45 CFR
46.110 and Sec. 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 (lb), in amounts not exceeding 550 milliliters (mL) in an 8-week
period and no more than 2 times per week.
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\2\ Throughout this document, when FDA refers to ``adult,'' FDA
defers to state law for determining the age of majority.
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(b) From healthy, pregnant adults who weigh at least 110 lb, 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/kilograms
(kg) in an 8-week period and no more than 2 times per week.
(d) From medically vulnerable adults who weigh at least 110 lb, 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.
[[Page 60606]]
Comparison of the Proposed List With the Current List
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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'' not
follows: included.
(a) From healthy, nonpregnant Amounts currently limited to 450
adults, in amounts not exceeding 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 ``Prospective'' and ``for research
research purposes of the following purposes'' currently not included.
biological specimens:
(a) Hair and nail clippings in a Currently part of number 1;
nondisfiguring manner. unchanged.
(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'' included
or stimulated by chewing gumbase 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; ``procedure''
plaque and calculus, provided the is not qualified with the word
collection procedure is not more ``collection.''
invasive than routine prophylactic
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, ``The study of existing data,
records, or biological specimens documents, records, pathological
(including pathological or specimens, or diagnostic
diagnostic specimens) where these specimens.``
materials, in their 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 Currently number 3; ``recording''
of the following procedures: instead of ``collection.''
(a) Noninvasive procedures Currently number 3; limited to
routinely employed in clinical subects 18 years of age or older.
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 Currently number 3; limited to
applied either to the surface of subjects 18 years of age or older.
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.
[[Page 60607]]
(c) Weighing, testing sensory Currently number 3; limited to
acuity, electrocardiography, subjects 18 years of age or older;
electroencephalography, limited echography to ``diagnostic
thermography, detection of echography''; does not include
naturally occurring radioactivity, ``sonography, ultrasound, magnetic
electroretinography, echography, resonance imaging (MRI),
sonography, ultrasound, magnetic diagnostic infrared imaging,
resonance imaging (MRI), doppler blood flow, and
diagnostic infrared imaging, echocardiography.''
doppler blood flow, and
echocardiography.
(d) Moderate exercise, muscular Currently number 7; limited to
strength testing, body composition ``Moderate exercise by healthy
assessment, and flexibility volunteers.''
testing involving health subjects.
7. Collection of data from voice, Currently number 6; stated as:
video, or image recordings made ``Voice recordings made for
for research purposes where research purposes such as
identification of the subjects and/ investigations of speech
or their responses would not defects.''
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 Not included.
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 Not included.
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.
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Dated: November 4, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-29651 Filed 11-5-97; 3:51 pm]
BILLING CODE 4160-01-F
