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Ethical and Safe Conduct
in Science and Organizational Operations
NIH grants are subject to requirements intended to ensure that
organizations are responsible in their handling of Federal awards,
and to minimize the opportunity for improper financial gain on
the part of grantees and their employees and limit the potential
for research results to be tainted by possible personal financial
or other gain. In addition, NIH grantees are expected to provide
safe and healthful working conditions for their employees and
foster work environments conducive to high-quality research.
CONFLICT OF INTEREST
Grantees must establish safeguards to prevent employees, consultants,
members of governing bodies, and others who may be involved in
grant-supported activities from using their positions for purposes
that are, or give the appearance of being, motivated by a desire
for private financial gain for themselves or others, such as those
with whom they have family, business, or other ties. These safeguards
must be reflected in written standards of conduct. Except as provided
below, NIH does not require a grantee to establish separate standards
of conduct if it maintains such standards for its non-grant-supported
activities, as long as those standards are consistent with State
and local laws and cover, at a minimum, expected conduct in regard
to financial interests, gifts, gratuities, and favors; nepotism;
and such other areas as political participation and bribery. The
standards must also:
- Address the conditions under which outside activities, relationships,
or financial interests are proper or improper;
- Provide for advance notification of outside activities, relationships,
or financial interests to a responsible institutional official;
- Include a process for notification and review by the responsible
official of potential or actual violations of the standards; and
- Specify the nature of penalties that the grantee may impose.
These penalties would be in addition to any penalties that may
be imposed by NIH or a cognizant Federal agency for infractions
that also violate the terms or conditions of award.
The grantee is not required to submit its general standards of
conduct to NIH for review or approval; however, a copy must be
made available to each officer of the grantee, each employee and
consultant working on the grant-supported project or activity,
each member of the governing board, if applicable, and, upon request,
the NIH awarding office. The grantee is responsible for enforcing
its standards of conduct, taking appropriate action on individual
infractions, and informing NIH if the infraction is related to
an NIH award. If a suspension or separation action is taken by
a grantee against a PI or other key personnel under an NIH grant,
the IC GMO must be notified as specified in "Administrative
Requirements
Changes in Project and
Budget".
NIH also requires grantees and investigators to comply with the
requirements of 42 CFR Part 50, Subpart F, "Responsibility
of Applicants for Promoting Objectivity in Research for which
NIH Funding is Sought," pertaining to investigators' actual
or potential financial conflicts of interests. These requirements
do not apply to grants under Phase I of the SBIR/STTR programs.
The signature of the authorized organizational official on the
face page of the application serves as certification of compliance
with the requirements of 42 CFR Part 50, Subpart F, including
that:
- There is in effect, at that organization, a written and enforced
administrative process to identify and manage, reduce, or eliminate
conflicting financial interests with respect to research projects
for which NIH funding is sought;
- Prior to the expenditure of any NIH funds awarded under a
new award, the organization will inform NIH of the existence of
any conflicting financial interests of the type covered by 42
CFR 50.605 it identified and assure that the interest has been
managed, reduced, or eliminated in accordance with the regulations;
- It will continue to make similar reports on subsequently identified
conflicts; and
- It will make information available to NIH, upon request, as
to how identified conflicting interests have been handled.
DEBARMENT AND SUSPENSION
HHS regulations published at 45 CFR Part 76 implement the government-wide
debarment and suspension system for HHS's nonprocurement transactions.
"Nonprocurement transactions" include grants, cooperative
agreements, scholarships, fellowships, and loans. Accordingly,
applicants for NIH grants ("primary covered transactions")
are required to certify1 that, to
the best of their knowledge and
belief, they and their principals (including PIs and other key
personnel):
- Are not presently debarred, suspended, proposed for debarment,
declared ineligible, or voluntarily excluded from covered transactions
by any Federal department or agency;
- Have not, within the 3-year period preceding the application,
been convicted of, or had a civil judgment rendered against them
for, commission of fraud or a criminal offense in connection with
obtaining, attempting to obtain, or performing a public (Federal,
State, or local) transaction or contract under a public transaction,
for violation of a Federal or State antitrust statute; for commission
of embezzlement, theft, forgery, bribery, falsification or destruction
of records, or for making false statements or receiving stolen
property;
- Are not presently indicted or otherwise criminally or civilly
charged by a governmental entity (Federal, State, or local) with
commission of any of the offenses enumerated above; and
- Have not, within a 3-year period preceding the application,
had any public transaction (Federal, State, or local) terminated
for cause or default.
If the applicant is unable to certify to these statements, it
must, nonetheless, submit the certification and attach an explanation.
The inability to certify does not automatically disqualify an
organization from receiving an NIH award; however, failure to
submit the required certification or the necessary explanation
will cause NIH not to make an award. The full text of the instructions
and the certification are included in Appendix A to 45 CFR Part
76.
Contractors under grants (where the contract requires the provision
of goods or services that will equal or exceed $100,000) and all
consortium participants must certify that neither they nor their
principals are presently debarred, suspended, proposed for debarment,
declared ineligible, or voluntarily excluded from participation
in this transaction by any Federal agency, and, if unable to certify,
the grantee must attach an explanation to the application or provide
the information to the GMO prior to awarding the contract or entering
into the agreement.
DRUG-FREE WORKPLACE
The Drug-Free Workplace Act of 1988 (Public Law 100-690, Title
V, Subtitle D, as amended) requires that all grantees receiving
grants from any Federal agency agree that they will maintain a
drug-free workplace. By signing the application, the authorized
institutional official agrees that the grantee will provide a
drug-free workplace and will comply with requirements to notify
NIH in the event that an employee is convicted of violating a
criminal drug statute. Failure to comply with these requirements
may be cause for debarment. HHS implementing regulations are set
forth in 45 CFR Part 76, "Government-wide Debarment and Suspension
(Nonprocurement)and Government-wide Requirements for Drug-Free
Workplace (Grants)."
HEALTH AND SAFETY GUIDELINES
Grantees are responsible for meeting Federal, State, and local
health and safety standards and for establishing and implementing
necessary measures to minimize their employees' risk of injury
or illness in activities related to NIH grants. The following
standards and guidelines are recommended for use in developing
and implementing health and safety operating procedures and practices
for both personnel and facilities, and they serve to supplement
prevailing Federal, State, and local laws and regulations:
- Biosafety in Microbiological and Biomedical Laboratories,
U.S. Department of Health and Human Services, Centers for Disease
Control and Prevention, and the National Institutes of Health.
HHS Publication No. (CDC) 93-8395. This publication is available
at
http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm.
- 29 CFR 1910.1030, Bloodborne Pathogens; 29 CFR 1910.1450,
Occupational Exposure to Hazardous Chemicals in Laboratories;
and other applicable occupational health and safety standards
issued by the Occupational Health and Safety Administration (OSHA)
and included in 29 CFR Part 1910. Copies of these regulations
may be obtained from OSHA Office of Publications, U.S. Department
of Labor, Room N3101, 200 Constitution Avenue, NW, Washington
DC 20210; telephone: (202) 219-4667.
- Prudent Practices for Safety in Laboratories (1995),
National Research Council. National Academy Press, 2101 Constitution
Avenue, NW, Lockbox 285, Washington, DC 20418; telephone: 1-800-624-6242.
- 42 CFR Part 72, Interstate Shipment of Etiological Agents,
and, in particular, 72.2, Additional Requirements for
Facilities Transferring or Receiving Select Agents. Copies
of these regulations are available from the Office of Health and
Safety, Centers for Disease Control and Prevention, 1600 Clifton
Road, Atlanta, GA 30333; telephone: (404) 639-2453.
- Procedures for Domestic Handling and Transport of Diagnostic
Specimens and Etiologic Agents, 1994 (3rd ed.), H5a3doc.75,
National Committee for Clinical Laboratory Standards. Copies may
be obtained from NCCLS Ordering Department, 940 West Valley Road,
Suite 1400, Wayne, PA 19087-1898; telephone: (610) 688-6400.
- Nuclear Regulatory Commission Standards and Regulations, pursuant
to the Energy Reorganization Act of 1974 (42 U.S.C. 5801 et seq.)
Copies may be obtained from the U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001.
Grantee organizations are not required to submit documented assurance
of their compliance with or implementation of the above standards.
However, if so requested by the IC, grantees should be able to
provide evidence that appropriate Federal, State, and local health
and safety standards have been considered and have been put into
practice, as appropriate.
LIMITATION ON USE OF FUNDS FOR PROMOTION OR
LEGALIZATION OF CONTROLLED SUBSTANCES
NIH officials are prohibited from knowingly using appropriated
funds to support activities that promote the legalization of any
drug or other substance included in schedule I of the schedule
of controlled substances established by section 202 of the Controlled
Substances Act, 21 U.S.C. 812. This limitation does not apply
if it is made known to the Federal official having authority to
obligate funds, in this case the GMO, that there is significant
medical evidence of a therapeutic advantage to the use of such
drug or other substance or that federally sponsored clinical trials
are being conducted to determine therapeutic advantage (see "Requirements
Affecting the Rights and Welfare of Individuals as Research Subjects,
Patients, or Recipients of Services
Controlled Substances"
in this section).
LOBBYING
Recipients of Federal grants, cooperative agreements, contracts,
and loans are prohibited by 31 U.S.C. 1352, "Limitation on
Use of Appropriated Funds to Influence Certain Federal Contracting
and Financial Transactions," from using Federal (appropriated)
funds to pay any person for influencing or attempting to influence
any officer or employee of an agency, a Member of Congress, an
officer or employee of Congress, or an employee of a Member of
Congress with respect to the award, continuation, renewal, amendment,
or modification of any of these instruments. These requirements
are implemented for HHS in 45 CFR Part 93, which also describes
types of activities, such as legislative liaison activities and
professional and technical services, that are not subject to this
prohibition.
Applicants for NIH awards with total costs expected to exceed
$100,000 are required to certify that they have not made, and
will not make, such a prohibited payment, they will be responsible
for reporting the use of non-appropriated funds for such purposes,
and they will include these requirements in consortium agreements
and contracts under grants that will exceed $100,000 and obtain
necessary certifications from those consortium participants and
contractors. The signature of the authorized institutional official
on the application serves as the required certification of compliance.
Disclosure reporting is addressed in "Administrative
Requirements Monitoring
Reporting".
NIH appropriated funds may not be used to pay the salary or expenses
of an employee of a grantee or contractor or those of an agent
related to any activity designed to influence legislation or appropriations
pending before Congress or any State legislature. This prohibition
extends to the use of funds for publicity or propaganda purposes,
including the preparation, distribution, or use of any kit, pamphlet,
booklet, publication, radio, television, or video presentation
designed to support or defeat legislation pending before Congress
or a State legislature except in presentation to the Congress
or State legislature itself or as part of normal, recognized legislative-executive
relationships. See also "Cost Considerations
Allowability of Costs/Activities
Selected Items of Cost".
MISCONDUCT IN SCIENCE
The grantee will inquire into and, if necessary, investigate and
resolve promptly and fairly all instances of alleged or apparent
misconduct in science. Regulations at 42 CFR Part 50, Subpart
A, "Responsibilities for PHS Awardee and Applicant Institutions
for Dealing with and Reporting Possible Misconduct in Science,"
specify grantee responsibilities in dealing with and reporting
possible misconduct in science. Organizations applying for or
receiving NIH research grants are required to certify in their
applications that they have established administrative policies
as required by 42 CFR 50, Subpart A, and will comply with those
policies and the requirements of the regulations. The regulations
are available from the Office of Research Integrity (ORI) on its
home page and, in hard copy,
at the address shown in Part IV.
As stated throughout this NIH GPS, the primary responsibility
for ensuring that an NIH-funded project is being conducted in
accordance with the approved application and budget and the terms
and conditions of the award rests with the grantee. These responsibilities
must be carried out with extra care where misconduct in science
has been found or where a misconduct in science investigation
has been initiated, as specified in 42 CFR 50.103 and 50.104.
The grantee shall report promptly to ORI any incident of alleged
or apparent misconduct in science that it judges as warranting
investigation and must advise ORI of any decision to initiate
an investigation. The regulations also require that the grantee
submit an annual report (see "Administrative Requirements
Monitoring
Reporting").
Where a misconduct investigation has been initiated, the grantee
must take any necessary steps, in addition to its normal and ongoing
responsibilities under the grant, to protect the scientific integrity
of the project(s), protect human subjects and animals, provide
reports to ORI, and ensure the proper expenditure of funds and
continuation of the project during the conduct of the investigation,
if appropriate. ORI staff are available to assist grantees with
respect to misconduct in science investigations and reporting,
and IC staff are available to provide technical assistance and
to work jointly with grantees to protect funded projects from
the adverse effects of misconduct in science.
When a finding of misconduct in science has been made regarding
conduct by an individual(s) working on an NIH grant-supported
project, the grantee must assess the effect of that finding on
the ability to continue that project, as originally approved by
NIH, and promptly obtain NIH approval of any intended change of
PI or other key personnel. A finding of misconduct in science
may result in a range of possible sanctions by NIH, including,
but not limited to, withdrawal of approval of the PI or other
key personnel, debarment, disallowance of costs associated with
the invalid or unreliable research, withholding of all or part
of a continuation award, and/or suspension or termination, in
whole or in part, of the current award. These actions are described
in "Administrative Requirements
Enforcement
Actions".
The grantee is responsible for the actions of its employees and
other research collaborators involved in the project. Where the
validity or reliability of data has been affected by misconduct
in science, the grantee and its employee/collaborator authors
are responsible for submitting a correction or retraction of the
data to a journal, as appropriate, and/or publishing the corrected
data, if required. Corrections or retractions may be required
by ORI or NIH. If the grantee does not comply with this requirement,
NIH may invoke its rights, under 45 CFR Part 74 or 92, to access
the data, including copyrightable material developed under the
award, have the data reviewed, and submit the correction.
Issues involving potential criminal violations, such as misappropriation
of Federal funds, must be promptly reported to the
HHS Office
of the Inspector General (see Part IV).
NONDELINQUENCY ON FEDERAL DEBT
The Federal Debt Collection Procedure Act, 28 U.S.C. 3201(e),
provides that an organization or individual that is indebted to
the United States, and has a judgment lien filed against it, is
ineligible to receive a Federal grant. Before a grant can be awarded,
the applicant organization must certify that neither it nor any
person to be paid from grant funds is delinquent in repaying any
Federal debt. If the applicant discloses delinquency on a debt
owed to the Federal Government, NIH may not award the grant until
the debt is satisfied or satisfactory arrangements are made with
the agency to which the debt is owed. In addition, once the debt
is repaid or satisfactory arrangements made, NIH will still take
that delinquency into account when determining whether the applicant
would be responsible with respect to an NIH grant, if awarded.
Anyone who has been judged to be in default on a Federal debt
and who has had a judgment lien filed against him or her should
not be listed as a participant in an application for NIH support
until the judgment is paid in full or is otherwise satisfied.
No funds may be rebudgeted following an award to pay such an individual.
NIH will disallow costs charged to awards that provide funds to
individuals in violation of this Act.
These requirements apply to all types of organizations and awards,
including foreign grants.
RECOMBINANT DNA AND INSTITUTIONAL BIOSAFETY COMMITTEES
All research involving recombinant DNA techniques that is supported
by NIH must meet the requirements of the NIH Guidelines for
Research Involving Recombinant DNA Molecules (the Guidelines)
(59 FR 34496, July 5, 1994 or latest revision). As defined by
the Guidelines, recombinant DNA molecules are either (1) molecules
that are constructed outside of living cells by joining natural
or synthetic DNA segments to DNA molecules that can replicate
in a living cell, or (2) DNA molecules that result from the replication
of those described in (1).
Each institution that conducts (or will conduct) research involving
recombinant DNA technology, including contractors under grants,
must establish a standing Institutional Biosafety Committee. The
composition requirements of these committees are specified in
section IV of the Guidelines, which also discusses the roles and
responsibilities of PIs and grantees. The committee is required
to review each proposed nonexempt project for recombinant DNA
experiments and certify that it has found the procedures, project,
personnel, and facilities adequate and in compliance with the
Guidelines. A roster of the members of the Institutional Biosafety
Committee must be submitted to the
Office of
Recombinant DNA Activities
(see Part IV for address). At a minimum, the roster should include
the names, addresses, occupations, and qualifications of the chairperson
and members of the committee.
The Guidelines, available from the Office of Recombinant DNA Activities,
should be consulted for complete requirements for the conduct
of projects involving recombinant DNA technology, including requirements
for submission of information to other Federal agencies, such
as the Food and Drug Administration.
RESTRICTION ON DISTRIBUTION OF STERILE NEEDLES
NIH appropriated funds may not be used to carry out any program
involving distribution of sterile needles or syringes for the
hypodermic injection of any illegal drug unless the Secretary,
HHS, determines that exchange projects are effective in preventing
the spread of HIV and do not encourage the use of illegal drugs,
and the project is operated in accordance with criteria established
by the Secretary for preventing the spread of HIV and ensuring
that the project does not encourage the use of illegal drugs.
SEAT BELT USE
Pursuant to Executive Order 13043 (April 16, 1997), Increasing
the Use of Seat Belts in the U.S., NIH encourages grantees to
adopt and enforce on-the-job seat belt policies and programs for
their employees when operating organizationally owned or rented,
or personally owned vehicles.
SMOKE-FREE WORKPLACE
NIH strongly encourages all recipients of its grants to provide
smoke-free workplaces and promote the nonuse of tobacco products.
NIH defines the term "workplace" to mean office space
(including private offices and other work space), conference or
meeting rooms, corridors, stairways, lobbies, rest rooms, cafeterias,
and other public spaces.
Requirements Affecting the Rights and Welfare of
Individuals as Research Subjects, Patients, or Recipients of Services
BAN ON HUMAN EMBRYO RESEARCH AND CLONING
NIH appropriated funds may not be used to support human embryo
research under any extramural award instrument. NIH funds may
not be used for the creation of a human embryo(s) for research
purposes or for research in which a human embryo(s) is destroyed,
discarded, or knowingly subjected to risk of injury or death greater
than that allowed for research on fetuses in utero under 45 CFR
46.208(a)(2) and section 498(b) of the PHS Act. The term "human
embryo(s)" includes any organism not protected as a human
subject under 45 CFR 46, as of the date of enactment of the governing
appropriations act, that is derived by fertilization, parthenogenesis,
cloning, or any other means from one or more human gametes or
human diploid cells.
In addition to the statutory restrictions on human fetal research
under section 498(b) of the PHS Act, by Presidential memorandum
of March 4, 1997, NIH is prohibited from using Federal funds for
cloning of human beings.
CONFIDENTIALITY OF PATIENT RECORDS
Section 543 of the PHS Act requires that records of substance
abuse patients be kept confidential except under specified circumstances
and purposes. The covered records are those that include the identity,
diagnosis, prognosis, or treatment of any patient maintained in
connection with any program or activity relating to substance
abuse education, prevention, training, treatment, rehabilitation,
or research that is conducted, regulated, or directly or indirectly
assisted by any department or agency of the United States. This
requirement is implemented at 42 CFR Parts 2 and 2a.
CONTROLLED SUBSTANCES
If controlled substances are proposed to be administered as part
of a research protocol or if research is to be conducted on the
drugs themselves, applicants/grantees must ensure that the requirements
of the Drug Enforcement Administration (DEA), including registration,
inspection, and certification, as applicable, are met. Regional
DEA offices can supply forms and information concerning the type
of registration required for a particular substance for research
use. The main registration office in Washington, DC may be reached
at (202) 254-8255. Information is also available from the National
Institute on Drug Abuse at (301) 443-6300.
HUMAN SUBJECTS
HHS regulations for the protection of human subjects, at 45 CFR
Part 46, implement section 491(a) of the PHS Act and provide a
systematic means, based on established, internationally recognized
ethical principles, to safeguard the rights and welfare of individuals
who participate as subjects in research activities supported or
conducted by NIH or other HHS components. They stipulate that
the applicant/grantee, whether domestic or foreign, is responsible
for safeguarding the rights and welfare of human subjects involved
in NIH grant-supported research activities. Subpart A of the HHS
regulations constitutes the Federal policy (common rule) for the
protection of human subjects.
Applicant organizations proposing to involve human subjects in
nonexempt research must file (or have previously filed) a written
Assurance of Compliance with the Office for Protection from Research
Risks (OPRR) setting forth the commitment of the organization
to establish appropriate policies and procedures for the protection
of human subjects. Affiliated organizations or organizations that
will serve as other performance sites for the grant-supported
research must also file an Assurance. OPRR is responsible for
approving the Assurance, which may be a Multiple Project Assurance
(MPA), a Single Project Assurance (SPA), or other type of Assurance,
as appropriate. OPRR may also negotiate an Inter-Institutional
Amendment if employees of an organization with an MPA routinely
conduct their grant-supported research at an affiliated institution,
thereby avoiding the need for an SPA for each separate project
performed at such sites.
NIH will not award any grant for nonexempt research involving
human subjects unless the organization is operating under an approved
Assurance and, if operating under an MPA, provides certification,
as part of its application, that an appropriate Institutional
Review Board (IRB) has, within 12 months of the budget period
start date, reviewed and approved the proposed activity in accordance
with the regulatory requirements. SPA organizations must provide
certification of IRB approval to OPRR as part of the SPA. In addition,
no human subjects may be involved in research at an affiliated
institution prior to approval by OPRR of an applicable Assurance
for that organization. If an MPA organization submits an application
with the knowledge that human subjects may be involved within
the project period, but definite plans are not set forth in the
application, the research activity must be reviewed and approved
by an IRB and a certification submitted to NIH before human subjects
may be involved in covered research activities supported by the
award.
As specified in 45 CFR 46.111, the IRB review must include a determination
that, for research covered by the regulations:
- The procedures to be used will minimize risks to subjects;
- Risks to subjects are reasonable in relation to expected benefits,
if any, to subjects and the importance of the knowledge that may
reasonably be expected to result;
- Selection of subjects is equitable;
- Informed consent is sought from each prospective subject or
the subject's legally authorized representative and is appropriately
documented in accordance with, and to the extent required by,
the regulation;
- Where appropriate, the research plan makes adequate provision
for monitoring the data collected to ensure the safety of subjects,
the protection of privacy, and the confidentiality of data; and
- Where some or all of the subjects are likely to be vulnerable
to coercion or undue influence, such as persons with acute or
severe physical or mental illness or persons who are economically
or educationally disadvantaged, appropriate additional safeguards
are included in the study to protect the rights and welfare of
these subjects.
The regulations specify additional protections for research involving
fetuses, pregnant women, and human in vitro fertilization (Subpart
B); prisoners (Subpart C); and children (Subpart D).
No individual may receive NIH grant funds for covered research
involving human subjects unless the individual is affiliated with
or sponsored by an organization that assumes responsibility for
the research under an applicable written Assurance or the individual
makes other arrangements with OPRR.
For purposes of this public policy requirement, the definitions
at 45 CFR 46.102 apply. A "human subject" is defined
as a living individual about whom an investigator (whether professional
or student) conducting research obtains (1) data through intervention
or interaction with the individual or (2) identifiable private
information. The regulations extend to the use of human organs,
tissues, and body fluids from individually identifiable human
subjects as well as to graphic, written, or recorded information
derived from individually identifiable human subjects. The use
of autopsy materials is governed by applicable State and local
law and is not directly regulated by 45 CFR 46.
"Research" is defined as "systematic investigation
designed to develop or contribute to generalizable knowledge."
Unless an activity is "exempt" (see 45 CFR 46.101),
any activity meeting the regulatory definition of "research"
constitutes research for purposes of applying the regulations,
even if supported by a grant that might have as its overall purpose
an activity that is not primarily research. (For example, some
training programs may include research activities.) OPRR should
also be consulted if there is any question concerning the classification
of research as exempt or nonexempt.
Information concerning the preparation and negotiation of Assurances,
as well as copies of the regulation, may be obtained from OPRR
at the address shown in Part IV or from its
home page.
OPRR has also produced a publication available through the Government
Printing Office2 and an instructional videotape.
INVESTIGATIONAL NEW DRUG APPLICATIONS
All clinical research involving investigational new drugs (IND),
drugs approved for a different indication, or experimental combinations
of drugs, must meet the Food and Drug Administration's (FDA) IND
regulations, FDA's human subjects protection requirements, and
the HHS human subjects' requirements (as described above) to be
eligible for funding.
The official sponsor of the IND, whether NIH, a grantee, or a
third party, is legally responsible for meeting the FDA IND requirements.
If a third party, such as a pharmaceutical company or research
organization under contract to a grantee or to a pharmaceutical
company, is the IND sponsor, the legal responsibility for monitoring
the clinical trial and reporting to FDA rests with the IND sponsor
rather than the grantee, which will generally be the case for
larger, multi-site clinical trials. If the grantee is the IND
holder, commonly referred to as an "investigator-initiated
IND," the grantee or the investigator serves as the IND sponsor
and assumes the legal responsibility. In any case, the grantee
is ultimately responsible to NIH for ensuring compliance with
the requirements for protection of human subjects, including compliance
with FDA's IND requirements.
Following the filing of an IND, FDA has a 30-day period in which
to review the IND. FDA may allow the IND to proceed or may defer
approval of the IND until changes it deems acceptable are made.
FDA may also order a clinical trial to be suspended or terminated,
at any time, based on information it receives about that clinical
trial. The FDA regulations are published at 21 CFR Parts 50 and
312.
PRO-CHILDREN ACT OF 1994
Public Law 103-227, Title X, Part C-Environmental Tobacco Smoke,
also known as the Pro-Children Act of 1994 (Act), imposes restrictions
on smoking in facilities where federally funded children's services
are provided. NIH grants are subject to these requirements only
if they meet the Act's specified coverage. The Act specifies that
smoking is prohibited in any indoor facility owned, leased, or
contracted for and used for the routine or regular provision of
kindergarten, elementary, or secondary education or library services
to children under the age of 18. In addition, smoking is prohibited
in any indoor facility or portion of a facility owned, leased,
or contracted for and used for the routine or regular provision
of federally funded health care, day care, or early childhood
development (Head Start) services to children under the age of
18. The statutory prohibition also applies if such facilities
are constructed, operated, or maintained with Federal funds. The
statute does not apply to children's services provided in private
residences, facilities funded solely by Medicare or Medicaid funds,
portions of facilities used for inpatient drug or alcohol treatment,
or facilities where Women, Infants, and Children (WIC) coupons are redeemed.
Failure to comply
with the provisions of the law may result in the imposition of
a civil monetary penalty of up to $1,000 per violation and/or
the imposition of an administrative compliance order on the responsible
entity.
Because of the nature of NIH programs and funding, individual
transactions, rather than entire programs, may be subject to these
requirements. Therefore, NIH does not require a separate certification
of intent to comply with the Act. The signature of the applicant's
authorized official will indicate the intent to comply. Any questions
concerning the applicability of these provisions to an NIH grant
should be directed to the IC GMO.
PROTECTION OF RESEARCH SUBJECTS' IDENTITY
Section 301(d) of the PHS Act provides that the Secretary may
authorize persons engaged in biomedical, behavioral, clinical,
or other research activities to protect the privacy of research
subjects by withholding the names and other identifying characteristics
of those subjects from individuals not engaged in the research.
Authorized persons may not be compelled to disclose subjects'
identities in any Federal, State, or local civil, criminal, administrative,
legislative or other proceeding. An applicant may request a certificate
of confidentiality to protect research subjects' identities under
a specific research project. The request should be submitted to
the IC GMO, and, subject to IC review and approval, a certificate
may be issued pursuant to 42 CFR 2a.
RESEARCH ON TRANSPLANTATION OF FETAL TISSUE
In submitting an application to NIH, the authorized institutional
official that signs the application is certifying that, if research
on the transplantation of human fetal tissue is conducted under
the grant-supported project, the organization will make available
for audit by the Secretary, HHS, or designee, the physician statements
and informed consents required by subsections 498A(b)(2) and (c)
of the PHS Act or will ensure HHS access to those records, if
maintained by an entity other than the grantee. This requirement
is in addition to the human subjects in research requirements
specified above.
Animal Welfare
The PHS Policy on
Humane Care and Use of Laboratory (the
Policy) requires that applicant organizations proposing to use
vertebrate animals in NIH-supported activities file a written
Animal Welfare Assurance with the Office for Protection from Research
Risks (OPRR), NIH. The Policy, which defines "animal"
as "any live, vertebrate animal used or intended for use
in research, research training, experimentation, or biological
testing or for related purposes," stipulates that the applicant/grantee
bears responsibility for the humane care and use of animals in
NIH-supported research activities. The Policy implements and supplements
the U.S. Government Principles for the Utilization and Care of
Vertebrate Animals Used in Testing, Research, and Training, and
requires the applicant to establish appropriate policies and procedures
for humane care and use of animals, based on the NIH Guide
for the Care and Use of Laboratory Animals, and to comply
with the Animal Welfare Act and its implementing regulations.
This includes appointment of an Institutional Animal Care and
Use Committee (IACUC) with specified responsibilities.
No NIH award for research involving live vertebrate animals will
be made unless the applicant organization and all performance
sites are operating in accordance with an approved Animal Welfare
Assurance and provide verification that the IACUC has reviewed
and approved those sections of the application that involve use
of vertebrate animals, in accordance with the requirements of
the Policy. Applications from organizations with approved Assurances
will be considered incomplete if they do not include verification
of IACUC review or do not contain the information concerning the
use of vertebrate animals required as part of the application's
research plan (see instructions for completion of the PHS-398
for the five specific points that need to be addressed). In the
case of apparent or potential violations of the Policy, NIH may
refer applications back to the applicant for further IACUC review.
Foreign organizations proposing activities involving vertebrate
animals are required to comply with the Policy or provide evidence
that acceptable standards for the humane care and use of animals
will be met. NIH will not make an award for research involving
live vertebrate animals to an individual unless that individual
is affiliated with an organization that accepts responsibility
for compliance with the Policy and has filed the necessary assurance
with OPRR.
The Policy does not affect applicable State or local laws or regulations
that impose more stringent standards for the care and use of laboratory
animals. All organizations are required to comply, as applicable,
with the Animal Welfare Act, as amended, 7 U.S.C. 2131 et seq.,
and other Federal statutes and regulations relating to animals.
Information concerning the preparation and submission of Animal
Welfare Assurances as well as copies of the Policy and other relevant
materials are available from the Division of Animal Welfare, OPRR.
Requirements for Inclusiveness in Research Design
NIH has adopted policies requiring grant-supported research projects
to be as inclusive in design as possible in order to extend the
validity of research findings and allow for enhancement of the
health status of all population groups.
INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN
CLINICAL RESEARCH
Research involving human subjects of any age must comply with
the NIH Guidelines on the Inclusion of Women and Minorities
as Subjects in Clinical Research (NIH Guide for Grants and Contracts,
Vol. 23, No. 11, March 18, 1994, and Federal Register,
59 FR 14508-14513, March 28, 1994), implementing section 492B
of the PHS Act. These guidelines require that women and members
of minority groups and their subpopulations be included in any
NIH-supported research project involving human subjects, unless
a clear and compelling rationale and justification establishes,
to the satisfaction of the IC Director, that inclusion is inappropriate
with respect to the health of the subjects, the purpose of the
research, or other circumstances. Cost is not an acceptable reason
for exclusion, except when the research would duplicate data already
available from other sources. Women of child-bearing potential
should not be routinely excluded from participation in clinical
research; i.e., any biomedical or behavioral research involving
human subjects. The guidelines should be reviewed for policy concerning
inclusion of these groups in Phase III clinical trials.
Peer reviewers will evaluate proposed plans for inclusion of members
of minority groups and both genders, the design of clinical trials,
and recruitment and outreach as part of the scientific assessment.
Failure to comply with this policy may result in NIH not making
an award. Grantees are required to report annually on the enrollment
of individuals by gender and racial or ethnic minority group as
part of the noncompeting continuation request or other annual
progress reporting (see "Administrative Requirements
Monitoring
Reporting").
INCLUSION OF CHILDREN AS SUBJECTS IN CLINICAL
RESEARCH
NIH has developed a separate policy on inclusion of children as
subjects in clinical research that is similar to the policy regarding
inclusion of women and minorities (see above). Any new application
involving human subjects research submitted for a receipt date
after October 1, 1998 must include children (i.e., individuals
under the age of 21) in the research design unless there are scientific
or ethical reasons not to include them. If children will be excluded
from the research, the application must present an acceptable
justification for the exclusion. This policy applies to both exempt
and nonexempt research activities (see "Human Subjects"
in this section). The inclusion of children as subjects in research
must comply with all applicable provisions of 45 CFR part 46 and
other pertinent Federal laws and regulations. This policy is not
mandatory for awards made prior to October 1, 1998 and for new
applications submitted for earlier receipt dates.
Civil Rights
Before an NIH IC may make an award to any domestic applicant organization,
the organization must affirm that it has an Assurance of Compliance
with the statutes described below on file with the Office of Civil
Rights (OCR), Office of the Secretary, HHS. The Assurance, Form
HHS-690, is filed on an institutional basis and is not required
for each application; however, the certification is required with
each application. If the application has been recommended for
funding and the applicant organization does not have an Assurance
on file, it will receive, from the responsible IC, the required
form and instructions for completion and submission. The Form
HHS-690 is also available from grantsinfo@nih.gov or by telephone
at (301) 435-0714.
Domestic organizations that receive funding from grantees rather
than directly from NIH, including contractors under grants, are
also required to file this Assurance, and the applicant/grantee
is responsible for determining whether those organizations have
the required Assurance on file or, if not, ensuring that it is
filed with OCR.
AGE DISCRIMINATION ACT OF 1975
The Age Discrimination Act of 1975 prohibits discrimination on
the basis of age in any program or activity receiving Federal
financial assistance. The HHS implementing regulations are codified
at 45 CFR Part 91.
CIVIL RIGHTS ACT OF 1964
Title VI of the Civil Rights Act of 1964 provides that no person
in the U.S. shall, on the grounds of race, color, or national
origin, be excluded from participation in, be denied the benefits
of, or be subjected to discrimination under any program or activity
receiving Federal financial assistance. The HHS implementing regulations
are codified at 45 CFR Part 80.
EDUCATION AMENDMENTS OF 1972
Title IX of the Education Amendments of 1972 provides that no
person in the U.S. shall, on the basis of sex, be excluded from
participation in, be denied the benefits of, or be subjected to
discrimination under any educational program or activity receiving
Federal financial assistance. The HHS implementing regulations
are codified at 45 CFR Part 86.
REHABILITATION ACT OF 1973
Section 504 of the Rehabilitation Act of 1973, as amended, provides
that no otherwise qualified handicapped individual in the United
States shall, solely by reason of the handicap, be excluded from
participation in, be denied the benefits of, or be subjected to
discrimination under any program or activity receiving Federal
financial assistance. These requirements pertain to the provision
of benefits or services as well as to employment. The HHS implementing
regulations are codified at 45 CFR Parts 84 and 85.
Environmental Impact and Other Requirements
Related to Acquisition, Alteration and Renovation, and Construction of
Facilities
Public policy requirements that apply to "construction activities"
are described in "Construction
Grants" in Part III.
However, they may also apply to alteration and renovation (A&R)
activities. A grantee undertaking an A&R project under a non-construction
award should consult the GMO concerning potential applicability.
Availability of Information
With the exception of certain types of information that may be
considered proprietary or private information that cannot be released,
after the grant is funded, most grant-related information submitted
to NIH by the applicant or grantee in the application or postaward
phase is considered public information and is subject to possible
release to individuals or organizations outside NIH. The statutes
and policies that require this information to be made public are
intended to foster an open system of Government and accountability
for governmental programs and expenditures, and, in the case of
research, to provide information about federally funded activities.
NIH routinely makes information about awarded grants, including
project title, the name of the PI, and the amount of the award,
available to the public through the NIH Computer Retrieval of
Information on Scientific Projects (CRISP) system. The project
description provided by an applicant for a funded research grant
application is sent to the National Technical Information Service
(NTIS), U.S. Department of Commerce, where the information is
used for dissemination of scientific information and scientific
classification and program analysis purposes. The public may request
these descriptions from NTIS. Other information may be released
on a case-by-case basis as provided below.
Several policies require acknowledgment of support and a disclaimer
for publications, inventions, and other research products, as
provided in "Administrative Requirements
Availability of
Research Results: Publications and Intellectual Property Rights,
Including Unique Research Resources" and elsewhere in this
policy statement. The disclosure requirement stated below
("Acknowledgment
of Federal Funding") is included in HHS appropriations statutes
and applies government-wide.
ACKNOWLEDGMENT OF FEDERAL FUNDING
All grantees must acknowledge Federal funding when issuing statements,
press releases, requests for proposals, bid solicitations, and
other documents describing projects or programs funded in whole
or in part with Federal money. Grantees are required to state
(1) the percentage and dollar amounts of the total program or
project costs financed with Federal money, and (2) the percentage
and dollar amount of the total costs financed by nongovernmental
sources.
THE FREEDOM OF INFORMATION ACT
The Freedom of Information Act (FOIA), 5 U.S.C. 552, and implementing
HHS regulations (45 CFR Part 5) require NIH to release certain
grant documents and records requested by members of the public,
regardless of the intended use of the information. These policies
and regulations apply to information in the possession of NIH
and do not require grantees or contractors under grants to permit
public access to their records. The regulations also indicate
types of information that are generally exempt from release.
The following types of material will generally be released:
- Funded applications;
- Pending and funded noncompeting continuations;
- Grant progress reports; and
- Final reports of any audit, survey, review, or evaluation
of grantee performance that have been transmitted to the grantee.
This includes information of this type maintained in electronic
format.
The following types of records or information will generally be
withheld in response to an FOIA request:
- Pending competing grant applications;
- Unfunded new and competing continuations and competing supplemental
applications;
- Financial information regarding a person, such as salary information
pertaining to project personnel;
- Information pertaining to an individual, the disclosure of
which would constitute a clearly unwarranted invasion of personal
privacy;
- Predecisional opinions in interagency or intra-agency memoranda
or letters expressed by Government officers, employees, or consultants;
- Evaluative portions of site visit reports and peer review
summary statements, including priority scores;
- Trade secrets and commercial, financial, and otherwise intrinsically
valuable items of information that are obtained from a person
or organization and are privileged or confidential;
- Information which, if released, would adversely affect the
competitive position of the person or organization; and
- Patent or other valuable commercial rights of the person or
organization.
If NIH has substantial reason to believe that information in its
records could reasonably be considered exempt, before the information
is released in response to an FOIA request, the applicant or grantee
will be notified of the request by the appropriate NIH FOIA office,
through the PI, and will be given an opportunity to identify potentially
patentable or commercially valuable information that should not
be disclosed. After NIH consideration of the grantee's response, if any,
the grantee will be informed of the agency's decision as to what
documents will be released and to whom. If a document contains
both disclosable and nondisclosable information, the nondisclosable
information will be deleted by a designated NIH or HHS FOIA Officer,
and the balance of the document will be disclosed.
THE PRIVACY ACT
The Privacy Act of 1974, 5 U.S.C. 552a, and its implementing regulations
(45 CFR Part 5b) provide certain safeguards for information about
individuals maintained in a system of records, as identified by
the Act (i.e., information may be retrieved by the individual's
name or other identifying information). These safeguards include
the rights of individuals to determine what information about
them is maintained in Federal agencies' files (hard copy or electronic)
and how it is used, to have access to such records, and to correct,
amend, or request deletion of information in their records that
is inaccurate, irrelevant, or outdated.
Records maintained by NIH with respect to grant applications,
grant awards, and the administration of grants are subject to
the provisions of the Privacy Act. NIH has two Privacy Act systems
of records that cover NIH grant records:
- 09-25-0036, Extramural Awards and Chartered Advisory Committees:
IMPAC (Grant/Contract/Cooperative Agreement Information/Chartered
Advisory Committee Information), HHS/NIH/OER and HHS/NIH/CMO.
- 09-25-0112, Grants and Cooperative Agreements: Research, Research
Training, Fellowship and Construction Applications and Related
Awards, HHS/NIH/OD.
These two systems provide guidance on requirements for the management
of grant records in the possession of NIH and include appropriate
routine uses of such information. They also include requirements
for safeguarding the records and for record retention and disposal.
In considering a request for information concerning an individual
made by a party other than that individual, NIH must take into
account both the requester's right to know under FOIA and the
individual's right to privacy under the Privacy Act.
Records maintained by grantees ordinarily are not subject to the
requirements of 45 CFR Part 5b.
Other Public Policy Requirements
and Objectives
METRIC
SYSTEM
Consistent with Executive Order 12770 (July 25, 1991), Metric
Usage in Federal Government Programs, measurement values in applications
and grantee-prepared reports, publications, and other grant-related
documents should be in metric. See "Construction Grants"
in Part III for requirements for metric
usage in construction
activities.
MILITARY RECRUITING AND RESERVE OFFICER TRAINING CORPS
PROGRAM ACCESS TO INSTITUTIONS OF HIGHER EDUCATIONS
NIH is subject to section 588 of the National Defense Authorization
Act of 1995, as implemented in 32 CFR Parts 23 and 216, that precludes
grant awards to schools that the Department of Defense (DOD) determines
have an anti-ROTC (Reserve Officer Training Corps) policy or practice
(regardless of when implemented) that either prohibits or, in
effect, prevents, the Secretary of Defense from gaining entry
to campuses or access to students or information for military
recruiting purposes. DOD publishes each determination of ineligibility
in the Federal Register as well as publishing, once every
6 months, a list of all currently ineligible schools. If DOD makes
its determination of ineligibility during an ongoing project period,
NIH may either continue the award or take an action to end the
award as provided in "Administrative Requirements
Enforcement Actions
Suspension, Termination, and Withholding
of Support". Funding eligibility may be restored on the basis
of new information provided to DOD.
YEAR 2000 COMPLIANCE
As part of their responsibilities for the scientific, administrative,
and financial aspects of the grant-supported activity, grantees
are responsible for taking all steps necessary to anticipate and
mitigate potential problems that might be caused by the advent
of the Year 2000. NIH grantees are expected to ensure that the
NIH activity being supported is not adversely affected by the
Year 2000 problem, including any applicable computer systems,
software applications, databases, and equipment.
All electronic data submitted to NIH by grantee organizations
must be Year 2000 compliant. Data that is noncompliant will not
be accepted. Organizations exchanging electronic data with NIH
will also need to be able to interface with the systems being
developed by NIH under its Electronic Research Administration
(ERA) initiative. Further information may be obtained from the
Inventions and Extramural Reporting Branch, the
designated focal
point in OPERA (see Part IV), and at
http://grants.nih.gov/grants/oer.htm.
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