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Re: Definition of research vs. other sponsored activity Judith Argon 07 Dec 2005 08:18 EST

Hi. You should go back to the definition of research in the regulations
(45 CFR 46). Is the goal of the evaluation to develop "generalizable
knowledge," then they are conducting research. We face this issue in the
medical arena, where we try to distinguish on oging quality assessments
and improvement from research. If the goal is "simply" to review data
and make in-house improvements to systems and processes, then the
activity might be construed as QA or program evaluation. But, if there
is any thought about making the outcomes of the QA process known to
colleagues through presentations or publications, then we consider it to
be research. It is less about the methods being used, and more about the
intent and goal.

This answer deals more with the question from a human subjects point of
view and less with assigning the appropriate indirect cost rate. But, if
the project is considered research by the IRB, it would be research for
the purposes of indirect costs.

Judy

Judith Argon
Vice President, Research Administration
Joseph Stokes Jr., Research Institute
Children's Hospital of Philadelphia
135 Abramson Research Center
3615 Civic Center Blvd.
Philadelphia, PA 19104-4318

Tel: 215-590-2855
Fax: 215-590-3804

>>> xxxxxx@SVCMCNY.ORG 12/05/05 12:58 PM >>>
Hi,

All of the methods you mention are research.  In the first instance,
program evaluation, the investigator is assessing process and/or
outcome
measures.  These would be considered dependent variables, while the
"program" is the independent variable.  This research would be
considered causal field research according to Cook and Campbell.
(Quasi-Experimentation: Design and Analysis Issues for Field Settings;
1979")

Needs Assessments might fall into the above category, but often times,
these use survey designs for data gathering.  The needs assessments
inform program development.  Survey methods are also research.

Focus Groups fall into the category of Qualitative Analysis where the
research data is gathered from transcripts of groups of people
discussing a particular topic with a facilitator.  The data is then
analyzed using qualitative research techniques to generate hypotheses.

Secondary uses of primary data.  There are many research methods used
for this type of work.  Examples are the use of medical charts for
case-control or retrospective cohort studies.  The use of Medicare or
Medicaid data for Cost Benefit/Cost-Effectiveness analyses, and the
use
of published/unpublished research results for Meta-analyses.  All of
these are examples of research that fall within the federal definition
of research.

Steve

Steven Lascher, DVM, MPH
Vice President, Research
Office of Research and Clinical Trials
Saint Vincent Catholic Medical Centers
170 W. 12th Street - Staff House
New York, NY 10011
(v) 212.604.7470
(f) 212.604-7159
e-mail: xxxxxx@svcmcny.org

 -----Original Message-----
 From: Research Administration List [mailto:xxxxxx@HRINET.ORG]

On Behalf Of Maureen McMahon
 Sent: Monday, December 05, 2005 11:12 AM
 To: xxxxxx@HRINET.ORG
 Subject: [RESADM-L] Definition of research vs. other sponsored
activity

 Hello All-

 I am trying to get a read on whether activities such as
conducting a program evaluation or a study including activities such
as
needs assessment, focus groups, and review of secondary data falls
within the federal definition of research or would qualify as "other
sponsored activity." We have a unit on campus that does quite a bit of
this type of activity and insists it falls into the "Other" category.
Any insights would be welcome.

 Thanks,

 Maureen B. McMahon
 Director, Office of Sponsored Programs
 University of Maryland, Baltimore County
 1000 Hilltop Circle
 Baltimore, MD  21250

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