Research Protocols

Research Protocols 2017-10-20T12:39:01+00:00
All research initially begins with an idea, or a company or organization with a product or an idea, which requires testing to evaluate the efficacy of the product or idea. In order to conduct research at the University of Illinois, specific guidelines must be followed, and documents filed and approved, prior to beginning the research.   
When considering a project it is best to reduce your thoughts to paper. You initial outline might include a statement of purpose for the research, a brief section describing the materials and methods to be used, and a rough budget listing the monetary requirements that will be needed in order to successfully complete the project. Once this has been completed a literature search using OVID-Medline (or another appropriate medical search engine), can be used to determine if any specific or related studies have been completed relative to your desired area of study.  Should you find that your idea is indeed novel, or the questions that you are attempting to answer have not been adequately answered by others, it’s time to develop a research plan, or protocol. 
The research protocol is a specific form designed by the University that it is used to present the research plan in detail. It requests information as to the purpose of the study, it includes a relevant literature review and a step by step method that will be used to successfully accomplish the research objective.  
If you are in the initial stages of your investigation and are interested in developing a small “pilot” study that will be used to determine if a larger study is warranted, statistical justification for the numbers requested in your study may not be required. Pilot studies normally involve a small (N) number of subjects in the study. Conversely, if you are considering a study that is seeking a result that is statistically significant, it is best to consult a statistician regarding your project during the initial protocol planning stages. A good statistician can help clarify your study design, they will be able to choose the appropriate test method to be used to analyze the data, and they can help determine the appropriate number of subjects required to achieve a specific level of significance. Statisticians may live in their own math-modeling world, but when it comes to creating a meaningful study design, they can be your very best of friends.  
All research costs money, either in materials/time (direct costs) or in space/heat/ lights /buildings, etc. (indirect costs). External funding sources such as grants and/or corporate contracts are available for research studies. The University has a dedicated web site that can help you find research dollars for your projects. The site contains a broad range of opportunities including University based institutional grants, NIH grants, private funding sources, as well as organizations that have funds available for specific areas of research. For a complete listing of funding resources please visit  www.uic.edu/depts/ovcr/ors/index.html 
Once you have determined that your project is scientifically sound and have determined how the research will be funded, its time to start tackling the specific University guidelines that are required to legally and ethically conduct both clinical and preclinical research at the U. 
The following section provides information on:
  • Clinical Research Requirements (Investigator Training)
  • Clinical Protocol Research Forms
  • Protocol Review and Approval Process
  • Annual Protocol Update Submission
 
Clinical Research Requirements (Investigator Training) 
The National Institutes of Health requires all investigators and study personnel who conduct clinical research at the University of Illinois at Chicago to complete Investigators 101 training. Investigators 101 training can be completed in one of two ways: 
            A)  Attend a 3 hour presentation, take and pass a quiz at the end of the training session and complete an evaluation form.
             – OR –
            B)  Complete a Web based Collaborative IRB Training Initiative (CITI) education course. The course will require 3 to 6
hours of your time depending on your knowledge and experience with research, ethical principles and regulations about
human subject protections. The web site with instructions is located at
www.uic.edu/depts/ovcr/oprs/Education/citi.html            There are 14 modules in the course and a quiz must be taken and passed after each module. 
For a complete listing of training dates please visit www.uic.edu/depts/ovcr/oprs/Education/initial-fall01.html
 
For those who have already completed Investigator training 101 
All investigators and key research personnel must meet the Human Subject Protections Program (HSPP) continuing education requirements in order to conduct clinical research. Individuals must complete 3 hours of continuing education every 2 years for as long as they are involved in human research. Continuing education may be accomplished in one of two ways:
            A) Individuals can complete a Web based Collaborative IRB Training Initiative (CITI) education course that involves 6
modules and quizzes specific to your research. 
B) Individuals can attend a continuing education course. Training information may be  accessed at www.uic.edu/depts/ovcr/oprs/Education/conted.html.Investigator’s IRB  submissions will not be accepted until investigators and all other study personnel listed on the study protocol have completed their continuing education training.
 
           You will be notified by the Office for the Protection of Research Subjects when additional training is required. 
 
Please be aware that University training requirements
are subject to change at the discretion of the University of Illinois
Clinical research at the University of Illinois at Chicago involving human subjects, or data obtained from or about human subjects for research purposes, is conducted under the supervision of the Institutional Review Board (IRB). Prior to conducting human subject research at the University appropriate documents must be submitted and approved by the IRB. The documents include: 
1.      Health and Biological Sciences Application (IRB Protocol)
2.      Funding Agency Protocol
3.      Consent Form
4.      Departmental Review Committee For Research Involving Human Subjects (Appendix F)
5.      IRB Appendices
6.   Supporting information for protocol procedures/test items (510K and/or FDA submission       and approvals).
7.   Health Insurance and Portability and Accountability Act Forms (HIPPA).

1) The IRB Protocol Form:  
Research involving human subjects requires submission of either a Health and Biological Sciences (for medical related studies) protocol or a Social and Behavioral Sciences Protocol depending on the type of research being conducted. Research that involves obtaining data from patients at the time of treatment is referred to as prospective research, whereas, gathering only existing medical data from a patients medical chart is considered a retrospective study. The type of research being requested will determine the forms that will be required by the IRB. The appropriate IRB protocol and all supporting forms can be downloaded from the Office of the Vice Chancellor for Research website atwww.uic.edu/depts/ovcr/oprs. Specific directions on how to complete the forms are also available at this website. A few samples of some recently submitted and IRB approved protocols (one prospective and one retrospective) are available for review at www. 
 
2) Funding Agency Protocol 
In addition to the IRB protocol each IRB protocol requires a supplementary proposal/protocol that was submitted to the funding agency, committee or sponsor for peer review or scientific merit.  Requirements of the supplementary protocol are listed below.  
  • face page
  • abstract, performance sites, and key personnel
  • biographical sketch (Principal Investigator only)
  • research plan – specific aims
  • background and significance
  • preliminary studies/progress report
  • research design and methods
  • literature cited
  • gender/minority inclusion
  • collaboration/support letters where appropriate
     
3) Consent Form:
Not all clinical studies require a consent form to be completed. Alternatively, some studies need consents to be available in multiple languages and/or specifically geared toward minors depending on the type of study being conducted and the patient populations to be included. The University’s has a template Consent Form available atwww.uic.edu/depts/ovcr/oprs.  
4)  Departmental Review Committee Form (Appendix F-Required). Prior to submitting a clinical protocol two separate faculty members are required to review your research protocol and complete a brief evaluation regarding various issues of the protocol.
5)  Additional appendices that may need to be submitted as part of the protocol include: 
Appendix A – Use of Drugs, Devices and/or Biologic Products in Research.
Appendix B – Involving Children as Subjects in Research
Appendix C – Involving Prisoners as Subjects in Research
Appendix D – Databases/DNA/Tissues/Sample Banks 
Appendix E  Drug Study Registration Form
Appendix H- HIPPA Compliance Application

6)Supporting information that may be required along with your IRB protocol submission include: information on specific test materials to be used, FDA research proposal/protocol that was submitted for funding, Sponsor’s protocol, Questionnaires, Interview guides, Investigational Brochure for drug studies, Text for all advertisements, recruitment materials, supporting committees approvals (when appropriate), 510K notification, etc.

7) HIPPA  (a hoop of it’s own).All hospital personnel who come in contact with patients or patient information are required to take HIPPA training. Investigators performing prospective or retrospective research on Human Subjects or gathering information on patients using Protected Health Information (PHI) are required to take additional training prior to submitting an IRB protocol for review. All individuals who are listed on a protocol must have completed their HIPPA training before the protocol will be reviewed by the IRB committee. To learn more about HIPPA guidelines, gain access to HIPPA forms, to learn about upcoming training dates and online training, or how to become more truly HIPPA, please visit http://www.uic.edu/depts/ovcr/oprs/Education/hipaa.html.
For assistance in preparing your protocol visit: http://www.uic.edu/depts/ovcr/oprs/Forms/index.html
You may also wish to review two previously approved (extremely well written) protocols and Consent Forms to help guide you through the process by visiting www. Be mindful that the IRB committee reviewing your protocol is very conscious and careful about the wording, content, and coverage (in the form of appropriate Appendix and documents) that are required prior to awarding approval. Help regarding protocol preparation, the application process , or the status of a submitted protocol are also available at either the Office for Protection of Research Subjects at: 6-1711 or (as a last resort) contact:    
                                          
 Kevin O’Grady
312-996-6508
Pager: 3040
E-mail:
kogrady@uic.edu