Research: A Basic Overview

Researchers' Handbook

What is Research?

Research includes any systematic investigation (including research development, testing, and evaluation) that has as its primary purpose the development of or contribution to generalizable knowledge.  

How do we define:

Generalizable knowledge.  Generalizable knowledge is knowledge related to health that can be applied to populations either inside or outside the population served by the covered entity.  Knowledge may be generalizable even if a research study only uses protected health information held within SVCMC and the results are generalizable only to the population served by SVCMC.  Research is therefore not limited to clinical trials funded by government (such as the National Institutes of Health) or commercial sponsors.  Quality improvement, quality assurance and utilization management activities do not typically result in generalizable knowledge, and thus ordinarily would not be governed by the Common Rule (45 CFR 46).

Primary purpose.  The development or contribution to generalizable knowledge must be the primary purpose of the investigation for the Common Rule (45 CFR 46) to be applicable.  In some instances, the primary purpose of the activity may change as preliminary results are analyzed.  An activity that was initiated as an internal SVCMC outcomes evaluation, for example, may produce information that SVCMC administration intends to generalize.  If the purpose of a study changes and the results will be generalized, the Vice President for Research or the Privacy Officer or his designee(s) must be notified by the Principal Investigator that the purpose has changed and this must document the change in status of the activity to establish that the requirements of SVCMC policy and federal regulations were not violated.

Example:

An activity that began as an internal SVCMC outcomes or quality evaluation, staff may produce information that SVCMC now wants to publish (generalize).   

If the purpose of a study changes and the results will be generalized, the Principal Investigator must notify the Office of Research and Clinical Trial that the purpose of the activity has changed. He/she must document the change. The Office of Research and Clinical Trials will then establish that the requirements of SVCMC policy and federal regulations were met.

Discussion:

Activities which meet the above definition of research constitute research for all SVCMC policies, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

To assist thoose who are interested in doing research here at St. Vincent's, the Office of Research and Clinical Trials has created a handbook to answer commonly asked questions, and to provide guidelines for research submissions.   Researchers' Handbook .

Implications:

Federal Wide Assurance SVCMC FWA #: 00003886 Expires 10/10/11

As SVCMC policy, all SVCMC research, either on-site or off, will be considered as federally funded, and will be reviewed and conducted in compliance with federal regulations and guidelines. As an academic and research medical institution, SVCMC has entered into an agreement with the US Federal Government called a  Federal Wide Assurance for the Protection of Human Subjects (FWA.)  This agreement states that “ All of the institution's human subject activities and all activities of the Institutional Review Boards (IRBs) designated under the Assurance, regardless of funding source, will be guided by the ethical principles in: (a) The Belmont Report… or (b) other appropriate ethical standards recognized by Federal Departments and Agencies that have adopted the Federal Policy for the Protection of Human Subjects [or Common Rule].”  Our working definition of Research comes from the  Common Rule or 45 CRF 46 .   The contents of the Federal-Wide Assurance can be found at the  Federal Wide Assurance website.SVCMCNY's specific FWA   provides our assurance number (FWA 00003866) and the Institutional Review Boards that are registered under our assurance.  This assurance expires October 11, 2011.  SVCMC's FWA Officer is Dr. Brian Fitzsimmons, Senior Vice President and Executive Director, Behavioral Health.