Research Application and Review
All research performed under the auspices of Providence-Providence Park 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.
There are three 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. Download the General Research Application or contact Linda Matenky by phone at 248-849-3324 or email at Linda.Matenky@ascension.org.
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. For more information, go to our IRB page. IRB applications are submitted via IRBNet.org. Click on the links for registering and getting started for information about how to register and submit applications at IRBNet.org.
Please note: Application is in PDF format and requires Adobe Acrobat Reader. Click here to download.
Basic Biomedical Research Application:
The Animal Care Committee
meets the fourth Monday of every month at 10:00 a.m. in the Biomedical Research Department conference room. You must present your project to the Animal Care Committee, and be present to discuss it. This committee examines the justification for and humane use of animals used in research.
It is advisable to see the licensed veterinary technician, Milessa Decker, before you complete this protocol. She can assist you with animal care issues related to the surgery, diagnostics, animal models, post operative care, and other animal aspects of your protocol design.
The protocol paperwork for this committee is not the same as the one you filed with the Research Committee. You will be given a training manual that contains a disk with all necessary forms, instructions for completing the forms, contact people who can help you with your project, and information you will need to complete your project.
The lab hours are from 7:00 a.m. - 3:30 p.m., Monday through Friday. Major survival surgery is performed Monday through Thursday only, and no later than 48 hours before a national holiday. There is no full-time weekend staff for postoperative care.
Download the Application to Use Vertebrate Animals (MS Word document) or contact Milessa Decker by phone at 248-849-3077 or email at Milessa.Decker@ascension.org.
Please note: Your protocol, or research design plan, must be presented to the Research Committee before it goes to the Animal Care Committee.
Please note: You can expect the approval process for your project to take 6-8 weeks to complete. So please start contacting people in the Biomedical Research Department before your research begins.
The Review Process
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 applications must be turned in no later than 15 days prior to presentation to enable sufficient time for all committee members to adequately review the application. This committee, co-chaired by David Svinarich, Ph.D. and Jeff Flynn, Ph.D., 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 four 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 Committee's decision. Research may not commence until written notification has been received by the Primary Investigator and all other necessary committee and/or board approvals have been obtained.
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 applications 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, chaired by Howard Schubiner, M.D., 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 four 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, case series [3 or more cases], 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 business 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.