Research Application and Review Process

All research performed under the auspices of Providence Hospital and it's treatment centers and collaborating affiliates, must undergo review before permission is granted to conduct this research. Research typically consists of, but is not limited to, research on human subjects or clinical trials including surveys and questionnaires, non-basic and basic biomedical research. All applications are available through this web site, or may be emailed directly to investigators.

Application Types

There are two types of applications that are used, depending upon the nature of the research being conducted.

General Research Application: All researchers must first apply using this application. This application asks detailed questions concerning the experimental design, methodology, statistical treatment of data, use of controls, budget or sources of external funding, etc. Researchers performing basic biomedical research, which does not require consenting patients for specimens or obtaining tissue, need only use this application. For a General Research Application contact Barbara R. Baumgart at: 248.849.3326.

Human (IRB) Research Application: Researchers conducting clinical trials, drug studies, surveys, questionnaires, collecting human blood or tissues, must fill out a Human Research Application in addition to the General Research Application. This application is especially concerned with treatment and safety of human subjects. This includes the risk/benefit ratio of the study, appropriateness of inclusion and exclusion criteria, appropriateness of the population being studied, quality of the informed consent, protection of confidential information, etc. Click for IRB application.

Please note: Application is in PDF format and requires Adobe Acrobat Reader. Click here to download.

The Review Process

Research Committee

All research is first presented to the Research Committee for their evaluation and approval. Meetings are typically held on the first Wednesday of each month and all application must be turned in no later that 15 days prior to presentation to enable sufficient time for all board members to adequately review the application. This committee chaired by Shukri David, M.D. and consists of physicians, scientists, other health care professionals and laypersons. The presentations are usually only 10 to 15 minutes in duration and provide an opportunity for the researcher to directly address any questions that the board may have about the study. After all researchers have presented their proposed studies, they are asked to leave and the studies are voted upon. There are three general outcomes following presentation. The study may be accepted "as is" without modification, the study may be accepted with revision, the study may be tabled pending extensive modification and re-presentation or the study may be turned down. Applicants will receive (generally within 10 days), written notification of the Board's decision. Research may not commence until written notification has been received by the Primary Investigator.

Institutional Review Board (IRB)

Any research involving human subjects must also be evaluated by the IRB committee. Meetings are typically held on the first Wednesday of each month and all application must be turned in no later that 15 days prior to presentation to enable sufficient time for all board members to adequately review the application. The IRB committee is chaired by David Svinarich, Ph.D., and consists of scientists, physicians, other members of the health care profession, clergy and lay persons. The researcher is not present at this meeting and no formal presentation is given. There are three general outcomes following review of the proposed work. The project and informed consent may be accepted without modification, the study may be accepted pending minor revision, the study may be tabled pending extensive revision or the study may be tabled indefinitely. Applicants will receive (generally within 10 days), written notification of the board's decision. Research may not commence until written notification has been received by the Primary Investigator.

Studies which are of minimal risk to the patient (e.g. questionnaires, surveys, retrospective studies, etc.), may require only an expedited review. These are performed on an ad hoc basis by the Chairman of the IRB and have a turn around time of 10 days or less. Researchers will be informed in writing about the status of the study and must have a favorable written notification in hand before beginning the study. All human studies are reviewed at least annually and in instances where there is significant risk to the patient, every 3 or 6 months.