SRA
Video Conference September 13
Conducting Research Responsibly
According to SRA, the core areas of Responsible
Conduct of Research "…are critical for all institutions concerned with responsible
research, regardless of whether or not research is conducted with PHS sponsorship.
The teleconference will provide a forum for defining these core areas and
practical suggestions for developing training programs that will comply with
the NIH, OHRP, and ORI policies."
October
1 -- MAJOR Proposal Deadline!
Some of the agencies that have an October
1 deadline are listed below.
Agency
for Healthcare Research and Quality (AHRQ)
American Association of Critical Care Nurses
American Association for Dental Research
American Cancer Society (ACS)
American College of Obstetricians and Gynecologists (ACOG)
American Diabetes Association (ADA)
American Lung Association
Burroughs Wellcome Fund
Centers for Disease
Control Cystic Fibrosis Foundation
Guggenheim Memorial Foundation Helene Fuld Health Trust
Leukemia & Lymphoma Society
March of Dimes
NAPNAP
National Historical Publications & Records Commission (NHPRC)
National Institute of Justice
National Institute of Standards and Technology (NIST)
National Institutes of Health (NIH)
National Science Foundation (NSF)
National Endowment for the Humanities (NEH)
National Multiple Sclerosis Society
Pfizer, Inc.
PhRMA
Research Corporation
Robert Wood Johnson Foundation
Whitehall Foundation
U.S. Department of Agriculture
U.S. Department of Defense
U.S. Department of Justice
Task
Force Continues Focus on IUPUI/Clarian Operating Procedures for Human Subjects
Human
Subject Research Awareness Message #2
HSROTF What's this?
This human research quality and compliance awareness message focuses on
the Human Subjects Research Oversight Task Force (HSROTF). The mission of
the Human Subjects Research Oversight Task Force is to enhance research activities
at IUPUI/Clarian by:
- Developing standard operating procedures that
are appropriate for all facets of research involving human subjects;
- Creating an "Awareness Program" that communicates
reasons for regulations and University polices and procedures thereby fostering
a "culture of compliance" within the IUPUI/Clarian research community;
- Developing instructional materials and programs
for investigators and staff that are effective and user friendly;
- Delivering important and relevant information
to researchers in a timely manner;
- Implementing a plan for department-based assistance
with oversight monitoring and also independent auditing of human subject
research; and
- Laying a solid foundation for an ongoing IUPUI/Clarian
compliance program for human subject research that is abreast with changing
agency regulations, university policies, and "best practice" standards in
the field.
The membership represents the diversity of organizations
and units involved in research with human subjects at IUPUI/Clarian. The HSROTF
membership is listed below:
| Chairperson: |
Michael Schmidt, Ph.D.
Advisor to Indiana University-Purdue University Indianapolis on Research
Compliance
Director (Retired), Worldwide Quality Assurance, Eli Lilly and Company
|
|
| Members: |
Joan Austin, D.N.S., R.N., F.A.A.N.
Distinguished Professor
School of Nursing
|
|
| |
Shelley Bizila
Director, Research Compliance Administration
Research and Sponsored Programs
|
|
| |
Pam DeWeese, M.A.T., C.C.R.P.
Administrative Director
Clinical Trials Program
|
|
| |
Sara Ellis
Assistant Director, Research Compliance Administration
Research and Sponsored Programs
|
|
| |
Judy Jackson, R.N.
Study Coordinator
Methodist Research Institute
|
|
| |
Melissa Mau, B.S., C.C.R.C.
Director, Clinical Core
Oral Health Research Institute
Indiana University School of Dentistry
|
|
| |
Sharon Moe, M.D.
Assistant Dean for Research Support
Indiana University School of Medicine
Medical Director, DOM Clinical Trials Program
|
|
| |
Munro Peacock, M.D.
Professor of Medicine
Director, General Clinical Research Center
School of Medicine
|
|
| |
Marta Sears, RN, C.C.R.C.
Administrator Indiana University, Outpatient Clinical Research Facility
|
|
| |
Shannon Walden
Coordinator of Educational Programs for Responsible Conduct in Research
Research and Graduate Education
|
|
| |
Eric Wright, Ph.D.
Assistant Professor, Department of Sociology
School of Liberal Arts |
|
The first major product of this group will be
a revised set of standard operating procedures (SOPs) to guide IUPUI/Clarian
researchers. Various members of the Task Force are writing SOPs, which are
then reviewed by the Director, Research Compliance Administration (Shelley
Bizila), the Assistant Director, Research Compliance Administration (Sara
Ellis), and our Research Compliance Advisor (Michael J. Schmidt).
The next installment of human subject research
quality and compliance awareness [to be featured in the October issue of the
R&SP Communicator] will discuss in detail the SOPs that are being written
and the process by which each SOP will move through the IUPUI/Clarian system
prior to final approval and implementation in operational areas.
Michael J. Schmidt, Ph.D.
Research Compliance Advisor
R&SP
Issues IUPUI 2000-2001 Award Report
| Unit |
99-00
|
00-01
|
Change
|
Percent Change
|
|
Art
|
17,158
|
18,725
|
1,567
|
9.1%
|
|
Business
|
0
|
314,070
|
314,070
|
n/a
|
|
Continuing Studies
|
0
|
0
|
0
|
n/a
|
|
Dentistry
|
4,158,998
|
5,647,582
|
1,488,584
|
35.8%
|
|
Education
|
500,055
|
377,374
|
(122,681)
|
(24.5%)
|
|
Engineering & Technology
|
1,934,368
|
2,688,627
|
754,259
|
39.0%
|
|
Informatics
|
0
|
0
|
0
|
n/a
|
|
IUPUI Columbus
|
788,191
|
222,727
|
(565,464)
|
(71.7%)
|
|
Journalism
|
0
|
0
|
0
|
n/a
|
|
Law
|
1,249,422
|
796,539
|
(452,883)
|
(36.2%)
|
|
Liberal Arts
|
5,866,042
|
11,734,539
|
5,868,497
|
100.0%
|
|
Library & Information
Science
|
0
|
0
|
0
|
n/a
|
|
Medicine (1)
|
133,245,606
|
253,599,583
|
120,353,977
|
90.3%
|
|
Music
|
0
|
0
|
0
|
n/a
|
|
Nursing
|
4,086,712
|
8,320,535
|
4,233,823
|
103.6%
|
|
Physical Education (2)
|
2,473
|
9,924
|
7,451
|
301.3%
|
|
Public & Environmental
Affairs
|
4,437,502
|
2,456,449
|
(1,981,053)
|
(44.6%)
|
|
Science
|
6,348,691
|
6,922,969
|
574,278
|
9.0%
|
|
Social Work
|
302,179
|
400,761
|
98,582
|
32.6%
|
|
University College
|
1,159,508
|
1,488,485
|
328,977
|
28.3%
|
|
|
|
|
|
|
|
Administrative Units:
|
|
|
|
|
|
Academic Affairs
|
98,000
|
236,794
|
|
|
|
Community Learning Network
|
180,016
|
52,000
|
|
|
|
Enrollment Services
|
25,000
|
0
|
|
|
|
International Affairs
|
0
|
6,993
|
|
|
|
Library
|
5,000
|
157,186
|
|
|
|
Planning & Inst. Improvement
|
76,817
|
80,600
|
|
|
|
|
|
|
|
|
|
Subtotal
|
384,833
|
533,573
|
148,740
|
38.7%
|
|
|
|
|
|
|
|
Totals
|
$164,481,738
|
$295,532,462
|
$131,050,724
|
79.7%
|
|
(1) Includes Bloomington
Medical Sciences, Centers for Medical Education, and School of Allied
Health Sciences
|
|
|
|
|
|
(2) Includes Restaurant,
Hotel, and Institutional Management
|
|
|
|
|
|
|
Research and Sponsored
Programs
UN 618
General - 274-8285
Research Compliance - 274-8289
Sponsored Program Development - 278-0249
|
|
|
|
Please send comments,
requests to subscribe or unsubscribe, to RSPCOMMU@iupui.edu.
|
