Working with your Sponsored
Programs Office…
July 21, 2009
Presented by Anita Blankenship,
SWOSU
1
Working with your
Sponsored Programs
Office…
Your Sponsored Programs Office can
July 21, 2009
Presented by Anita Blankenship,
SWOSU
2
Working with your Sponsored
Programs Office…
 Purpose of the Sponsored Programs
Office:

Sponsored Programs Office should
facilitate the grant process for the faculty
and the institution
 The
institution will establish the role the
Sponsored Programs Office is to perform
 Each university Sponsored Programs Office
will be structured somewhat differently
 Centralized or departmentalized or both
July 21, 2009
Presented by Anita Blankenship,
SWOSU
3
Working with your Sponsored
Programs Office…
 Responsibilities of the Sponsored
Programs Office:




July 21, 2009
Encourage, facilitate, and expedite research;
not be obstacles to overcome
Assist, serve, collaborate with faculty
Create a Positive Atmosphere
Build a faculty client base and support them
by continually disseminating targeted
information on funding opportunities
Presented by Anita Blankenship,
SWOSU
4
Working with your Sponsored
Programs Office…
 Sponsored Programs Offices assist with:






July 21, 2009
Finding sources of funds
Maintain databases
Manage application, assurances and certification
forms
Maintain information on federal, state, and
private sponsors
Proposal Preparation including Budgets
Internal Review and Approval Process
Presented by Anita Blankenship,
SWOSU
5
Working with your Sponsored
Programs Office…

Sponsored Programs Offices assist with:




Electronic Submission Administration
Award Negotiations and Contracting
Track proposal submissions, awards, rejections,
and resubmissions
Ensuring Ethical and Safety Compliance
July 21, 2009
Presented by Anita Blankenship,
SWOSU
6
Working with your Sponsored
Programs Office…

Sponsored Programs Offices assist with:




Post-Award Financial Management
Reports and Close Out
Proposal writing workshops and informational
sessions
Publicity and faculty recognition of accomplishments
July 21, 2009
Presented by Anita Blankenship,
SWOSU
7
Working with your Sponsored
Programs Office…
 Don’t expect them to do your work for you; they




should only assist and facilitate.
Don’t be afraid to ask questions. No question is too
simple or unimportant.
Take notes of conversations or instructions for later
reference.
Trust them to know what is best in most
circumstances. They’ve probably dealt with the
issue before.
Let them help you through the process before there
is an issue that requires their assistance.
July 21, 2009
Presented by Anita Blankenship,
SWOSU
8
Working with your Sponsored
Programs Office…
REMEMBER…
IF YOU DON’T SUBMIT,
YOU WON’T GET.
July 21, 2009
Presented by Anita Blankenship,
SWOSU
9
COMPLIANCE
ISSUES
July 21, 2009
Presented by Anita Blankenship,
SWOSU
10
DEFINITION OF
COMPLIANCE
 The act or process of complying to a
desire, demand, proposal or regimen or
to coercion
 Conformity in fulfilling official
requirements
-Merriam-Webster’s Online Dictionary
July 21, 2009
Presented by Anita Blankenship,
SWOSU
11
GRANT COMPLIANCE
 Compliance is the cost of doing business with the
government:

Compliance is IMPORTANT!

It’s required, it’s regulated, it’s tough, it costs money.
 Non-Compliance can produce:

Suspension of federal funds -- can harm research and
university credibility.

The university can be fined!

A faculty member can be banned from research, fined, or even
go to jail!!
July 21, 2009
Presented by Anita Blankenship,
SWOSU
12
COMPLIANCE ISSUES
 Protection of Human Subjects
 Animal Welfare (Vertebrate Animals)
 Intellectual Property
 BioSafety (Biohazards)
 Conflict of Interest
 RCR (Responsible Conduct in Research)
 Other Compliance Issues


July 21, 2009
Radiation Safety (Radioisotopes)
Recombinant DNA
Presented by Anita Blankenship,
SWOSU
13
WHAT IS HUMAN SUBJECTS
RESEARCH?
“any systematic investigation that is designed to
develop or contribute to generalizeable
knowledge, and which uses living humans or
identifiable information about living humans”
- 45 CFR Part 46 (known as “The Common Rule”)
(Federal Policy = Code of Federal Regulations – CFR)
Human Subject s CFR:
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm or
http://gpoaccess.gov/cfr/index.html (search “Human Subjects”)
July 21, 2009
Presented by Anita Blankenship,
SWOSU
14
PROTECTION OF HUMAN
SUBJECTS
 University Layman’s Definition:

Any research involving human subjects or use of data on
human subjects including survey research that will be
conducted on your university campus and/or conducted
by you, other university faculty, staff or students and
might be published must be reviewed.
 Human subject:

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.
July 21, 2009
Presented by Anita Blankenship,
SWOSU
15
PROTECTION OF HUMAN SUBJECTS
RESOURCES
 Dept. of Health and Human Subjects, Office of Human Research Protection
(OHRP)
Website: http://www.hhs.gov/ohrp
 Revised Expedited Review Criteria (1998)
Website: http://hhs.gov/ohrp/humansubjects/guidance/expedited98.htm
 Food and Drug Administration (FDA)
Website: http://www.fda.gov
 Health Insurance Portability and Accountability Act (HIPAA)
Website: http://aspe.hhs.gov/admnsimp/
July 21, 2009
Presented by Anita Blankenship,
SWOSU
16
PROTECTION OF HUMAN SUBJECTS
RESOURCES

Office of Human Research Protection (OHRP)
 Website: http://www.hhs.gov/ohrp/
 Guidance by Topics by Subject
 Compliance Activities: Common Findings and Guidance

Office of Research Integrity
 Website: http://www.ori.dhhs.gov/

Bioethics Research on the Web—National Institutes of Health
 Website: http://bioethics.od.nih.gov/

“Protecting Human Research Participants” an NIH online tutorial
 Website: http://phrp.nihtraining.com

IRB BOOK
 Bankert E., Amdur RJ (eds.). Institutional Review Board: Management and
Function, 2nd ed. Sudbury, MA: Jones and Bartlett, 2006.
July 21, 2009
Presented by Anita Blankenship,
SWOSU
17
IRB (What is it?)
(INSTITUTIONAL REVIEW BOARD)
 An IRB is an institutional body with responsibility for review
and oversight of the human subject protection program.
 The IRB supports, facilitates, and promotes ethical use of
human subjects by upholding the standards set forth in all
applicable laws, policies & guidance.
 Per federal policy, the IRB must consist of no fewer than
five members, including one practicing scientist, one
member whose primary vocation is in a non-scientific area,
and one member unaffiliated with the institution.
July 21, 2009
Presented by Anita Blankenship,
SWOSU
18
LEVELS of REVIEW by IRB
 Exempt
 Expedited
 Full Board
July 21, 2009
Presented by Anita Blankenship,
SWOSU
19
IRB DEFINITIONS
 Exempt Research = Research which does not
require an IRB review either by Expedited or Full
Board Review. Usually the IRB makes the
determination that the research is exempt.

Regulation provides six categories of exempt research.





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Normal Educational Practices and Settings
Anonymous Educational Tests, Surveys, Interviews, or
Observations
Identifiable Subjects in Special Circumstances
Collections or Study of Existing Data
Public Benefit or Service Programs
Taste and Food Evaluation and Acceptance Studies
[Federal Policy -- 45 CFR 46.101(b)]
July 21, 2009
Presented by Anita Blankenship,
SWOSU
20
IRB DEFINITIONS (continued)
 Expedited Research = Review of proposed
research by the IRB chair or a designated
voting member or group of voting members
rather than by the entire IRB. Federal rules
permit expedited review for certain kinds of
research involving no more than (1) minimal
risk and for (2) minor changes in approved
research.
[Federal Policy -- 45 CFR 46.110]
July 21, 2009
Presented by Anita Blankenship,
SWOSU
21
IRB DEFINITIONS (continued)
 Full Board Research = Review of proposed
research at a convened meeting at which a
majority of the membership of the IRB are
present, including at least one member
whose primary concerns are in nonscientific
areas. For the research to be approved, it
must receive the approval of a majority of
those members present at the meeting.
[Federal Policy – 45 CFR 46.108]
July 21, 2009
Presented by Anita Blankenship,
SWOSU
22
GENERAL IRB APPROVAL
PROCESS
 Complete University Application Form
 Submit Application and Supporting Documents to IRB
 IRB Will Determine Level of Review
 IRB Review Held as Expedited or Full Board Review
 If needed, Revisions are Requested by IRB
 Approval Letter is Issued
 Approved Application Requires Annual Renewal
 Approved Application Requires Resubmission After
Three Years
July 21, 2009
Presented by Anita Blankenship,
SWOSU
23
ANIMALS in RESEARCH
July 21, 2009
Presented by Anita Blankenship,
SWOSU
24
WHAT IS ANIMAL CARE AND USE?
 For the purpose of animal research regulation, the
word “animals” means live, vertebrate animals used
in research, testing, teaching, health surveillance, or
for related purposes.
 The phrase “care and use” means procurement,
housing, transport, husbandry, health maintenance,
experimentation, treatment and humane euthanasia.
July 21, 2009
Presented by Anita Blankenship,
SWOSU
25
IACUC (What is it?)
(Institutional Animal Care and Use Committee)
 The IACUC is the institutional body with responsibility for review
and oversight of the institution’s program for the humane care and
use of animals.
 The IACUC supports, facilitates, and promotes ethical and
humane use of animals by upholding the standards set forth in all
applicable laws, policies & guidance.
 Per PHS Policy, IACUC must consist of no fewer than five
members, including a Veterinarian, one practicing scientist
experienced in research involving animals, one member whose
primary vocation is in a non-scientific area, and one member
unaffiliated with the institution.
July 21, 2009
Presented by Anita Blankenship,
SWOSU
26
IACUC (continued)
 Federal law mandates that all individuals who
work with animals in biomedical research be
appropriately qualified and trained.
 Training programs should be available to all
investigators, fellows, students, and
technicians who work with research animals.
 Various training media can be used: web-
based, in-person, brochure, hands-on,
classroom style, etc.
July 21, 2009
Presented by Anita Blankenship,
SWOSU
27
ENFORCEMENT FOR ANIMAL
WELFARE
 USDA (regulations) (U.S. Dept. of Agriculture)
 OLAW (regulations) (Office of Animal Laboratory Welfare)
 AAALAC, Int. (voluntary accreditation standards)
(Assoc. for Assessment and Accreditation of Laboratory Animal Care
International)




States (statutes)
Local Municipalities (laws)
Institutions (policies)
Attending Veterinarian/Institutional Animal Care
Personnel
 Local IACUCs (policies & procedures)
July 21, 2009
Presented by Anita Blankenship,
SWOSU
28
U.S. REGULATIONS
RESOURCES
 Animal Welfare Information Center
http://awic.nal.usda.gov
 OLAW – Office of Laboratory Animal Welfare
http://grants.nih.gov/grants/olaw/olaw.htm
 Code of Federal Regulations – Search: “Animal Welfare”
http://gpoaccess.gov/cfr.index.html
July 21, 2009
Presented by Anita Blankenship,
SWOSU
29
U.S. REGULATIONS
RESOURCES
 Animal Welfare Act, 1966 [USC Title 7, Sections 2131 to 2156] as
amended in 1970, 1976, 1985 and 1990.
 Animal Welfare Regulations [Title 9 CFR, Subchapter A, Animal
Welfare, Parts 1, 2 and 3]
 Guide for the Care and Use of Laboratory Animals (Guide) [NRC,
5th Ed., 1996]
July 21, 2009
Presented by Anita Blankenship,
SWOSU
30
INTELLECTUAL PROPERTY
 Products of the human intellect that are unique, new and
innovative, have some value in the market place, and the creation
of a single person or a team.
 Can be an idea, an invention, a patented work, an expression or
literary creation, a copyrighted work, a trademark (unique name),
an industrial process, a chemical formula, a medicinal, a computer
program, a presentation, or data of digital magnetic origin.
 Check with your university administration regarding
your university’s Intellectual Property Policy.
July 21, 2009
Presented by Anita Blankenship,
SWOSU
31
BIOSAFETY
 BioSafety: Development and implementation of administrative
policies, work practices, facility design, and safety equipment
to prevent transmission of biologic agents to workers, other
persons, and the environment.
 Check with your Institutional BioSafety Committee or
appropriate University Office at your institution
 Centers for Disease Control & Prevention
http://www.cdc.gov/OD/OHS/biosfty/biosfty.htm
 National Institutes of Health Office of Biotechnology Activities
http://www4.od.nih.gov/oba/
 American Biological Safety Association
www.absa.org
July 21, 2009
Presented by Anita Blankenship,
SWOSU
32
RESEARCH MISCONDUCT
 “Research misconduct is defined as fabrication,
falsification, or plagiarism in proposing, performing, or
reviewing research, or in reporting research
results….Research misconduct does not include honest
error or differences of opinion.”
Federal Policy on Research Misconduct
National Science and Technology Council (NSTC)
Executive Office of the President
 Federal Policy on Research Misconduct
http://www.ostp.gov/cs/federal_policy_on_research_misconduct
July 21, 2009
Presented by Anita Blankenship,
SWOSU
33
THE RESPONSIBLE CONDUCT of
RESEARCH (RCR)
The Department of Health and Human Services Office of
Research Integrity (ORI)
ORI supports programs designed to promote education and
training in responsible conduct of research. Training modules
are available on the ORI website.
http://ori.dhhs.gov/education/
 Data Acquisition, Management,




Sharing and Ownership
Conflict of Interest & Commitment
Human Subjects
Animal Welfare
Research Misconduct
July 21, 2009
 Publication Practices and
Responsible Authorship
 Mentor/Trainee Relationships
 Peer Review
 Collaborative Science
Presented by Anita Blankenship,
SWOSU
34
THE RESPONSIBLE CONDUCT of
RESEARCH (RCR)
 Compliance Training Mandates are coming!
 Effective October 1, 2009, NSF will require that at the time
of proposal submission to NSF: …the proposing institution
“must certify that it has a plan to provide appropriate
training and oversight in the responsible and ethical
conduct of research to undergraduates, graduate students
and postdoctoral researchers who will be supported by
NSF to conduct research.”
July 21, 2009
Presented by Anita Blankenship,
SWOSU
35
THE RESPONSIBLE CONDUCT of
RESEARCH (RCR) RESOURCES
 Responsible Conduct of Research Committee (RCRC)




July 21, 2009
Resources for Research Ethics Education Page
http://www.research-ethics.net/
HHS Office of Research Integrity RCT Resources
http://ori.dhhs.gov/education/products/
Columbia University RCR Modules
http://ccnmtl.columbia.edu/projects/rcr/
The Collaborative Institutes Training Initiative Responsible
Conduct of Research Course
http://www.citiprogram.org/
National Academy of Engineering Online Ethics Center
http://onlineethics.org/
Presented by Anita Blankenship,
SWOSU
36
COMPLIANCE?
 Don’t let compliance issues
stress you.
 Allow plenty of time to handle
compliance details.
 Rely on your university
compliance office or other
appropriate university offices
to assist you.
July 21, 2009
Presented by Anita Blankenship,
SWOSU
37
QUESTIONS?
July 21, 2009
Presented by Anita Blankenship,
SWOSU
38
THANKS
 Thanks to various NCURA Workshops and
Workshop Instructors for providing basic
information regarding Compliance Issues.
 Thanks to Susan Sedwick, Ph.D.
Director, Office of Research Administration
while at OU for providing Compliance Overview
information.
July 21, 2009
Presented by Anita Blankenship,
SWOSU
39
If you don’t submit,
you won’t get!!!
Anita Blankenship, M.Ed., CRA
Director, Office of Sponsored Programs
Southwestern Oklahoma State University
Weatherford, OK
580-774-7010
anita.blankenship@swosu.edu
July 21, 2009
Presented by Anita Blankenship,
SWOSU
40