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
60608 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 Section ll.110.

2Throughout this document, when OPRR refers to

‘‘adult,’’ OPRR defers to state law for determining

the age of majority.

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 ll.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

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
Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Notices 60609

amounts not exceeding 550 ml in an 8

week period and no more than 2 times

per week.

(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.

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.
60610 Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Notices

Proposed expedited review list 1981 (Current) expedited review list

(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’’ was 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 subjects 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.

(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 healthy 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:Currently number 9, stated as follows: 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.’’

(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
Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Notices 60611

Proposed expedited review list 1981 (Current) expedited review list

(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: 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