Federal Regulations
- Code of Federal Regulations
(CFR) – The Code of Federal Regulations (CFR) is the codification
of the general and permanent rules published in the Federal Register
by the executive departments and agencies of the Federal Government.
-
45
CFR§46 –
45 CFR§46
applies to all research involving human subjects conducted, supported or
otherwise subject to regulation by any federal department or agency which
takes appropriate administrative action to make the policy applicable to
such research.
-
The
Belmont Report –
Ethical Principles and Guidelines for the Protection of Human Subjects
of Research
-
Expedited Categories –
Categories of Research That May Be Reviewed by the Institutional Review
Board (IRB) through an Expedited Review Procedure
-
Export
Controls –
The Bureau of Industry and Security (BIS) is responsible for implementing
and enforcing the Export Administration Regulations (EAR), which regulate
the export and reexport of most commercial items. We often refer to the
items that BIS regulates as "dual-use" - items that have both commercial and
military or proliferation applications - but purely commercial items without
an obvious military use are also subject to the EAR.
-
Federal Acquisition Regulation (FAR)
– The
FAR is the primary regulation for use by all Federal Executive agencies in
their acquisition of supplies and services with appropriated funds.
- Office of
Management and Budget (OMB) Circulars – OMB establishes government-wide
grants management policies and guidelines through circulars and common
rules. These policies are adopted by each grantmaking agency and inserted
into their federal regulations. The two circulars most pertinent to our
financial accountability concerns are A-110 and A-21.
- OMB
Circular A-21 - Cost Principles for Educational Institutions
- This circular establishes principles for determining costs applicable
to grants, contracts, and other agreements with educational institutions.
- OMB
Circular A-110 - Uniform Administrative Requirements for Grants
and Other Agreements with Institutions of Higher Education, Hospitals
and Other Nonprofit Organizations
- This circular sets forth standards for obtaining consistency and
uniformity among Federal agencies in the administration of grants to
and agreements with institutions of higher education, hospitals, and
other non-profit organizations.
- OMB
Circular A-133 - Audits of States, Local Governments, and Nonprofit
Organizations
- This OMB Circular establishes audit requirements for States, local
governments, and non-profit organizations expending Federal awards.
Responsible Conduct in Research
(RCR)
USI is committed to promoting integrity in the scholarly endeavors of our
faculty, students, and professional staff involved in the pursuit of scientific
inquiry and practice. The Sponsored Research Office (SRO) is responsible
for encouraging all scholarly efforts while preserving compliance with both
ethical and regulated matters.
While responsible and ethical research behavior is generally self-regulated
based on shared ethical principles and generally accepted practices, the
proposed federal requirement for Responsible Conduct of Research (RCR) training
for PHS-funded researchers and national attention to highly publicized cases
of professional misconduct has elevated the importance of RCR education.
To help promote quality research at USI, SRO is maintaining this site dedicated
to RCR training and education.
Responsible Conduct of Research training covers a variety of content areas,
including:
- Data Acquisition, Management, Sharing and Ownership – the
implications that privacy and the integrity of research have for the
storage and retrieval of data.
- Conflict of Interest and Commitment – potential conflicts
between the interests of science and a scientist's own interests, especially
when research has immediate commercial applications.
- Human Subjects – the widely-recognized moral dimension
of research with human subjects, both in avoiding unnecessary harm and
in securing consent from subjects.
- Animal Welfare – when the use of animal subjects can
be justified and of how they can be used humanely.
- Research Misconduct – concern about fraud and other misconduct
is the most obvious motivation for thinking about RCR.
- Publication Practices and Responsible Authorship – a
central mechanism of scientific communication, but it is also a mechanism
for attaining prestige and career advancement. The pressure to publish
may encourage lapses in scientific integrity, and the process of publication
itself raises issues of responsible conduct. Authorship addresses concerns
closely related to publication: the allocation of credit for published
articles.
- Mentor / Trainee Responsibilities – many scientists learn
the practical aspects of RCR from their mentors, but the mentoring relation
raises issues for both the trainee and the mentor.
- Peer Review – key to the integrity of scientific publication,
so the demands of peer review naturally raise issues of responsible conduct.
- Collaborative Science – issues of trust, negotiation,
and conflict-resolution involved in cooperation between scientists.
- Whistleblowing – the issues involved in exposing misconduct.
RCR Training Information & Resources
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