60604 Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Notices

1The 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 § 56.110.

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.

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 § 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 § 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

Research activities (carried out

through standard methods) that: (1)

Involve no more than minimal risk, and
Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Notices 60605

2Throughout this document, when FDA refers to

‘‘adult,’’ FDA defers to state law for determining the

age of majority.

(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 § 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.

(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.
60606 Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Notices

COMPARISON OF THE PROPOSED LIST WITH THE CURRENT LIST

Proposed Expedited Review List 1981 (Current) Expedited Review List

1. Research on drugs or devices for which an investigational new drug

exemption or an investigational device exemption is not required.

Unchanged; currently number 9.

2. Collection of blood samples by finger stick or venipuncture as follows:Currently number 4, limited to venipuncture; ‘‘finger stick’’ not included.

(a) From healthy, nonpregnant adults, in amounts not exceeding 550

mL in an 8-week period and no more than 2 times per week.

Amounts currently limited to 450 ml.

(b) From healthy, pregnant adults, in amounts not exceeding 100 mL in

an 8-week period and no more than 2 times per week.

Not included.

(c) From healthy children, in amounts not exceeding 3 mL/kg in an 8-

week period and no more than 2 times per week.

Not included.

(d) From medically vulnerable adults, in amounts not exceeding 50 mL

in an 8-week period and no more than 2 times per week.

Not included.

3. Prospective collection for research purposes of the following biological specimens:‘‘Prospective’’ and ‘‘for research purposes’’ currently not included.

(a) Hair and nail clippings in a nondisfiguring manner. Currently part of number 1; unchanged.

(b) Deciduous teeth at time of exfoliation, or if routine patient care indicates a need for extraction.Currently part of number 1; ‘‘deciduous teeth’’ included without qualifiers.

(c) Permanent teeth if routine patient care indicates a need for extraction.Currently part of number 1; ‘‘routine’’ not included.

(d) Excreta and external secretions (including sweat). Currently part of number 2; unchanged.

(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.

Currently part of number 2; ‘‘uncannulated saliva’’ included without

qualifiers.

(f) Placenta removed at delivery. Currently part of number 2; unchanged.

(g) Amniotic fluid obtained at the time of rupture of the membrane prior

to or during labor.

Currently part of number 2; unchanged.

(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.

Currently number 5; ‘‘procedure’’ is not qualified with the word ‘‘collection.’’

(i) Stool cultures obtained by rectal swab. Not included.

(j) Mucosal and skin cells collected by buccal scraping or swab, skin

swab, or mouth washings.

Not included.

(k) Sputum collected after saline mist nebulization. Not Included.

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.

Currently number 8; stated as: ‘‘The study of existing data, documents,

records, pathological specimens, or diagnostic specimens.‘‘

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.Not included.

6. Collection of data through use of the following procedures: Currently number 3; ‘‘recording’’ instead of ‘‘collection.’’

(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.).

Currently number 3; limited to subects 18 years of age or older.

(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.

Currently number 3; limited to subjects 18 years of age or older.
Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Notices 60607

COMPARISON OF THE PROPOSED LIST WITH THE CURRENT LIST—Continued

Proposed Expedited Review List 1981 (Current) Expedited Review List

(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.

Currently number 3; limited to subjects 18 years of age or older; limited

echography to ‘‘diagnostic echography’’; does not include

‘‘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 health subjects.Currently number 7; limited to ‘‘Moderate exercise by healthy volunteers.’’

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.

Currently number 6; stated as: ‘‘Voice recordings made for research

purposes such as investigations of speech defects.’’

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:Not included.

(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: Not included.

(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.

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

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.

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 § 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 § 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