that poses minimal risk to the subjects, in-
cluding whether there are any types of 
such research for which some aspect of the 
requirement of informed consent or docu-
mentation of informed consent should 
apply differently. 
‘‘(VI) Whether Institutional Review 
Boards include sufficient numbers of mi-
nority individuals (as defined in section 
485E(c)) as Board members when review-
ing proposals designed to have a popu-
lation of human subjects a majority of 
whom are minority individuals. 
‘‘(VII) Such additional matters as the 
Secretary determines to be appropriate. 
‘‘(D) AGENCY-SPECIFIC ADDITIONAL PRO-
TECTIONS.—With respect to human subject re-
search that is conducted, supported, or other-
wise subject to regulation under a provision of 
Federal law (other than this section), the Sec-
retary may under subparagraph (A) permit the 
Federal agency involved to establish additional 
protections for the protection of human subjects 
if the Secretary determines that such additional
protections are not in conflict with protections 
established under this section. 
‘‘(d) RIGHT OF INFORMED CONSENT.—
‘‘(1) IN GENERAL.—For purposes of subsection 
(a), a principal investigator, may not, except as pro-
vided in the Common Rule, involve an individual as 
a subject in human subject research unless the in-
vestigator or other knowledgeable person has ob-
tained the informed consent of the individual to be 
a subject. 
‘‘(2) 
LEGALLY
AUTHORIZED
REPRESENTA-
TIVE.—References in this section to obtaining con-
sent from an individual shall be considered to be ref-
erences to obtaining consent from the legally author-
ized representative of the individual in any case in 
which the individual lacks legal competence to pro-
vide consent. 
‘‘(3) CERTAIN REQUIREMENTS REGARDING DIS-
CLOSURE
AND
UNDERSTANDING.—The Secretary 
shall establish criteria regarding consent under para-
graph (1) that—
‘‘(A) provide for the provision of full and 
complete information relevant to the research to 
a prospective human subject;
‘‘(B) require such information to be pro-
vided in language understandable to such sub-
ject; 
‘‘(C) require that only individuals knowl-
edgeable about the research provide such infor-
mation to the subject and answer questions 
from the subject; and 
‘‘(D) require that information be provided 
to the subject on how to contact the Office for 
Human Research Protections to submit ques-
tions about the rights of subjects or to report 
concerns regarding the research. 
‘‘(4) WRITTEN
ATTESTATION
BY
INVESTI-
GATOR.—A principal investigator who involves a 
human subject in research shall, in accordance with 
the criteria of the Secretary, file with the Institu-
tional Review Board for the research a written attes-
tation that the investigator is familiar with require-
ments for the protection of human subjects, includ-
ing the requirement of informed consent, and agrees 
to comply with such requirements. 
‘‘(e) INSTITUTIONAL REVIEW BOARDS.—
‘‘(1) REQUIREMENTS
FOR
BOARDS.—Human 
subject research may not be conducted unless an In-
stitutional Review Board has, for purposes of the
Common Rule (and the vulnerable-populations rules, 
as applicable), approved the proposal for such re-
search. With respect to the research involved, the 
approval by the Board of the proposal for the re-
search is not effective unless, in addition to condi-
tions established by the Secretary, the following con-
ditions are met: 
‘‘(A) Of the membership of such Board: 
‘‘(i) Not fewer than two members or 
25 percent of all members, whichever is 
greater, are individuals whose primary ex-
pertise is in scientific areas. 
‘‘(ii) Not fewer than two members or 
20 percent of all members (whichever is 
greater) are individuals whose primary ex-
pertise is in nonscientific areas. 
‘‘(iii) Not fewer than two members or 
20 percent of all members (whichever is 
greater) are individuals who are not affili-
ated with the institution served by the 
Board (other than by serving on the 
Board), who are not immediate family 
members of any individual who is affiliated 
with the institution, and who do not have
a significant conflict of interest, as defined 
by applicable Federal regulations. 
The appointment of a member of the Board to 
meet the requirement of clause (iii) also quali-
fies toward meeting the requirement of clause 
(ii) if the primary expertise of such member is 
in a nonscientific area. 
‘‘(B) In reviewing a proposal for research, 
the Board does not consider a quorum to have 
been established for a meeting unless the mem-
bers present at the meeting include one or more 
members from each of the three categories de-
scribed in subparagraph (A). 
‘‘(C) The institution served by the Board 
ensures that the Board has an orientation pro-
gram for new members and a continuing edu-
cation program for existing members of the 
Board, and with respect to ethical matters that 
relate to research, a continuing education pro-
gram for all members of the Board. 
‘‘(D) The institution served by the Board 
has submitted to the Secretary a registration 
informing the Secretary of the existence of the 
Board, and the registration was in such form, 
was made in such manner, and contained such
information as the Secretary requested regard-
ing functions of the Board under this section. 
‘‘(E) In the case of a proposal for a high-
risk research project, the Board reviews the 
data safety and monitoring plan (pursuant to 
subsection (f)) as a part of the review by the 
Board of the proposal. 
‘‘(F) With respect to the research involved, 
each member of the Board has disclosed any 
significant financial interests, as defined by ap-
plicable Federal regulations, to the institution 
served by the Board, and such institution has 
disclosed any such disclosures to the Board. 
‘‘(G) A member of the Board does not par-
ticipate in the review by the Board of a pro-
posal for research if the member has a signifi-
cant conflict of interest, as defined by applica-
ble Federal regulations, in the research. The 
provision by such member of information to 
other members of the Board does not constitute 
Board participation for purposes of this sub-
paragraph. 
‘‘(H) The institution served by the Board 
annually submits to the Secretary a report that 
compiles data on the number of new research
proposals reviewed, the number of continuing 
research projects reviewed, the number of re-
viewed biomedical research proposals, the num-
ber of reviewed behaviorial or social sciences re-
search proposals, and any additional informa-
tion determined appropriate by the Secretary. 
‘‘(I) The institution served by the Board 
submits to the Secretary such reports regarding 
the Board as the Secretary determines to be ap-
propriate. 
‘‘(2) NOTIFICATION OF INSTITUTIONAL REVIEW 
BOARD BY INVESTIGATORS.—In submitting to an In-
stitutional Review Board a proposal for human sub-
ject research, the investigators for the research shall 
notify the institution served by the Board—
‘‘(A) of any significant financial conflicts 
of interest, as defined by applicable Federal 
regulations; 
‘‘(B) whether the investigators have been 
disqualified or restricted by any Federal entity 
in their ability to conduct human subject re-
search, including being ineligible to conduct 
human subject research with investigational 
new drugs, being ineligible for approval of new
drug applications, or agreeing to some other 
form of restriction regarding research; and 
‘‘(C) whether the proposal has been sub-
mitted by the principal investigator to any other 
Institutional Review Board. 
‘‘(3) INSTITUTION REVIEW OF CONFLICTS OF 
INTEREST.—The institution served by an Institu-
tional Review Board shall review such significant fi-
nancial conflicts of interest as are submitted under 
paragraph (2) to determine whether such interests 
create or may reasonably appear to create conflicts 
of interest, and then shall seek to manage, reduce, 
or eliminate such conflicts of interest. 
‘‘(4) PROJECTS
INVOLVING
MULTIPLE
LOCA-
TIONS.—For purposes of meeting the Common Rule 
requirements for review and supervision of research 
by an Institutional Review Board, such activities 
may be performed by an Institutional Review Board 
or a lead Institutional Review Board, at the option 
of the institution where the research is conducted. 
‘‘(5) VOLUNTARY
ACCREDITATION.—The Sec-
retary may in accordance with this paragraph facili-
tate the accreditation of institutions and Institu-
tional Review Boards by recognizing a private ac-
crediting entity or entities. For purposes of the pre-
ceding sentence: 
‘‘(A) The Secretary may recognize an ac-
crediting entity if—
‘‘(i) such entity submits to the Sec-
retary the standards and procedures that 
the entity requires institutions and Institu-
tional Review Boards to meet in order to 
be accredited by the entity; 
‘‘(ii) the Secretary determines that 
such standards and procedures include 
standards and procedures ensuring that 
the policies and procedures of institutions 
and Institutional Review Boards accredited 
by the entity are in compliance with Fed-
eral regulations governing human subject 
research; and 
‘‘(iii) the entity annually submits to 
the Secretary a report describing any 
changes in the standards and procedures 
described in clause (ii). 
‘‘(B) The Secretary may not require that 
any institution, Institutional Review Board, or 
program for the protection of human subjects
in research, or any component thereof, be ac-
credited. 
‘‘(C) Nothing in this section may be con-
strued as authorizing the Secretary—
‘‘(i) to establish or approve accredita-
tion standards or procedures for institu-
tions, Institutional Review Boards, or pro-
grams for the protection of human subjects 
in research, or any component thereof; or 
‘‘(ii) to recognize any standards or 
procedures for institutions or Institutional 
Review Boards other than the standards 
and procedures described in subparagraph 
(A)(ii). 
‘‘(6) COST
RECOVERY.—Institutions may re-
cover costs associated with compliance for human 
subject protections under this part from government 
sponsors of research as direct costs. 
‘‘(f) IMPROVED MONITORING
OF HIGH-RISK RE-
SEARCH.—With respect to high-risk human subject re-
search projects: 
‘‘(1) The Secretary shall establish criteria for 
identifying proposals for such projects that require 
a data safety and monitoring plan. The criteria shall 
include—
‘‘(A) a provision that the Secretary may 
require the sponsor of the project to utilize a 
data safety and monitoring committee in affili-
ation with the research project; 
‘‘(B) minimum requirements for the re-
porting by the principal investigator of informa-
tion on such plan to the Institutional Review 
Board for the research project and to the insti-
tution served by the Board; and 
‘‘(C) the requirement that such committee 
provide reports on the findings of the com-
mittee regarding the research project to such 
investigator, Board, and institution. 
‘‘(2) The Secretary shall require that an ad-
verse event in the research project be reported by 
the principal investigator to the Institutional Review 
Board for the research project, and to the sponsor 
of the research project, in a timely manner appro-
priate to the severity of the event and whether the 
event is unexpected. Such events shall in addition be 
reported by the principal investigator as directed by 
the Secretary. Such regulations shall ensure com-
prehensive and coordinated reporting to all relevant 
parties.
‘‘(g) INSTITUTIONAL PROGRAMS OF EDUCATION.—
For fiscal year 2004 and subsequent fiscal years, the Sec-
retary may not make an award of a grant, cooperative 
agreement, or contract under this Act to a public entity 
or a private academic institution, or make an award of 
a grant, cooperative agreement, or contract under this Act 
for the conduct of research at or through or in affiliation 
with a public entity or a private academic institution, un-
less the public entity or private academic institution (as 
the case may be) maintains or contracts for a comprehen-
sive and ongoing program to educate investigators and 
Board members on the protection of human subjects in 
research. 
‘‘(h) CERTAIN CLASSIFIED HUMAN SUBJECT RE-
SEARCH.—Notwithstanding any other provision of law, 
Federal funds may not be expended for the conduct of 
classified human subject research if—
‘‘(1) the Institutional Review Board reviewing 
the proposal for the research pursuant to this sec-
tion has under the Common Rule waived the re-
quirement to obtain the informed consent of the 
human subjects in the research; or 
‘‘(2) the research is exempt from the require-
ment under the Common Rule that the proposal for 
the research be reviewed by such a Board.