This document will assist you in preparing a research proposal and completing the necessary IRB forms to conduct human studies research at RUHS.
These instructions have been developed to lead you to successful submission of your research proposal and IRB documents. You must read it prior to starting and submitting any proposal and application to the IRB so we at the IRB can be sure you have been fully informed as to your responsibilities and requirements to conduct research.
Before you start
1. There are three types of approvable research that need to be evaluated in the IRB. Retrospective- often referred to as "chart research" in which you are attempting to answer a research question by using archived information obtained from the patients' medical record. Any type of patients' information that has been collected for clinical purposes such as the chart or x-rays can be used for research purposes but must be submitted for evaluation and approval by the IRB. Prospective- entails actually contacting patients to gather information, examining patients or testing an approved medication or procedure. This type of research always requires a full IRB review and approval and usually requires the development of a consent process with a consent document. Sponsored- these trials are usually funded by pharmaceutical or device companies and provide the center the opportunity to test new medications or devices using our population. These studies are not usually designed by RUHS investigators and the center provides a service to allow access to our patients and conduct of the trial. A Sponsored trial must be reviewed and approved by the IRB.
2. Case reports are not considered research and do not need to be reviewed by the IRB. However you must have them reviewed by your faculty advisor and department chair to assure patient confidentiality.
3. The vast majority of research conducted at RUHS is retrospective.
4. Retrospective studies must be submitted to the IRB using a submission package which consists of a research proposal and a short list of required forms completed for our review
5. The submission package is available through the IRB office.
6. Section secretaries and the IRB are not responsible for completing your forms or proposals and are not responsible for the accuracy of the information that you are providing on the forms. Do not ask them to fill in forms for you.
7. Please be aware that submissions must be typed and electronic- there are no paper submissions. You may type in the form and sign them and then scan the signature page for submission. The IRB office is not responsible for completing incomplete forms or obtaining signatures and we will return the forms to you if not complete. Do NOT leave paper copies of your proposal or completed forms at the IRB office they will be returned to you without review.
8. YOU the investigator are responsible to determine which type of study you would like to conduct not the unit secretary.
9. Protecting the safety of our patients including protecting their health information is the primary mandate of the RUHS IRB. Charts which contain protected health information (PHI) are considered essentially like the patients themselves and require strict controls over how the information is collected and how it is stored and analyzed.
10. If you are interested in conducting research at RUHS, please contact Lisa Chan firstname.lastname@example.org at (951) 486- 4489 or Christopher Firek, email@example.com at (951) 486-2671 for more information. The Comparative Effectiveness and Clinical Outcomes Research Office (CECORC) invites you to present your proposal for feedback prior to IRB submission. We will assist you in guidance with proposal development, identify necessary resources, and review and counsel you on how to prepare and submit the package for IRB review.
11. Research is serious business and not adhering to the mandates and regulations can result in serious consequences for you and RUHS.
12. Most importantly research should be educational and FUN! Hopefully your project will directly result in improving health care outcomes at RUHS and in general.
So let's get started!
Step 1. Human Studies Research Training - All personnel that will be involved with the study MUST complete their human studies research training prior to submission. If you are LLU affiliated and have completed or will complete the CITI training you may submit your completion certificate or if not go to the web address of: http://phrp.nihtraining.com to complete the training. Either way you must submit the training certificate electronically and indicate on the research application the human studies expiration (HSE) date in the column. If these requirements are not met the IRB will NOT review your proposal and application for research.
Step 2. Pose a research question and write the proposal - This is the most important part of any clinical study. You and/ or your research mentor should pose an important and relevant question related to clinical practice. Students, residents and fellows MUST have a designated RUHS faculty member as their Principle Investigator as they are ultimately responsible for the conduct of the study. The proposal should be prepared in collaboration with your faculty advisor and must be approved by them for submission!
Some examples of research questions are, "What risk factors predict poor outcome in ankle surgery?" or "Why do patients miss their follow up appointments?" Answers to these questions improve health outcomes!
Unlike basic scientists we as clinicians focus on what is directly relevant to clinical care and improving outcomes. The research question must be both practical-that is to be able to be answered within a reasonable time frame and relevant- so as to not reproduce other earlier studies.
Step 3. Writing the research proposal is the next step and requires time and effort! It usually requires 1- 2 months to prepare a solid proposal so please allow sufficient time. The proposal preparation guide is to assist you in the development and standardization of proposal submittal. Once the proposal is written it is very easy to then complete the IRB forms and submit.
Please contact CECORC early for direct guidance in initiating and completing your research proposal.
Step 4. The IRB process- All members of the RUHS have signed and are bound by a confidentiality agreement. All discussions within the IRB are confidential and any material submitted to the IRB is privileged information.
Once the proposal is written it is very easy to complete the IRB application and forms. The forms do provide explanations as to the need and completion. The following is instructions on completing the required forms. The instructions below are organized to provide guidance on forms that must be submitted for the retrospective study submissions.
It is very important that you review each document and form and you complete the various required applications completely. If you do not understand either the rational or how to complete the forms please contact the IRB for assistance. Incomplete applications will not be processed.
The following documents are a part of the submission package for retrospective studies. For the initial submission you must submit the following 6 items in addition to your human studies training certificates for IRB review.
1. Your research proposal. This should be submitted in the recommended format.
2. Research Determination Worksheet - Mandatory for non-faculty (students, residents and fellows) and optional for faculty. This is an excellent educational tool to assist you in determining if your study is considered human subjects research
3. HIPAA Waiver - The form has a clear explanation for the need and how to complete.
4. Application form for Archival –Retrospective Data - This is the main application for your study and must be completely and accurately completed. This is best completed after you have finalized your research proposal. Information in this application will be validated by reviewing your research proposal.
5. Operational/Academic Consideration - This form will be submitted to your Chairman or designate for completion. This will help identify how your study will impact resources and time at RUHS.
6. Conflict of Interest and Financial Disclosure - This series of three documents including FAQs is for all investigators. The form must be completed and will be reviewed by the IRB to determine if any financial relationship exists that may be a motivation to conduct research at RUHS including unfunded studies.
At the time of project renewal- usually yearly- you must complete the following forms which are included in your submission package. Please keep these forms in your files for future use.
7. Continuing Review Application - This form will be used if you wish to renew your study. If you are conducting a retrospective study complete only those sections that is applicable to your study. Renewal of a study is NOT automatic and must be approved by the IRB. For most studies the IRB requires a yearly review unless otherwise stipulated in your approval letter. This form must be completed and submitted in advance of your renewal date and failure to do so will result in suspension of your study. If a study is not submitted for renewal you and your faculty co-pi will be notified that your study will be closed out and no further active research can be conducted.
8. Retrospective Progress Report - This form must be submitted when you submit your study for renewal or study completion. It is very straightforward and easy to complete.
The following form must be completed and submitted if there are any changes in your study protocol. These changes will be reviewed for approval and you will be notified by the IRB of the decision. If the studies are not approved you will asked to discuss the disapproval.
9. Changes in Research Application - This form is be submitted with any changes that occur in the conduct of your study protocol, consent or process. The changes must be IRB approved and should also be entered on page 5 of the Continuing Review Application
The following forms are used when the study is finished.
10. Research Completion Report - This form will be completed when you have finished your study and is self- explanatory. If you continue to conduct data analysis you will not fill out this form but submit a Continuing Review Application for scientific analysis only. Once you have filed this report the IRB will issue a final study closure notification. You cannot conduct any additional research in this study including additional data analysis.
11. Request to Publish- Present - This form must be completed by you and signed by your faculty supervisor (co-pi) and your Chairman. It must be then submitted with your presentation for review and approval by the IRB. You are not authorized to publish or present without IRB approval.
The following included documents are important informational and educational tools so please read them!
12. Research Application Instructions - General instructions on IRB process and needs.
13. Definition of Limited Data set/HIPAA subject identifiers (19) and Data Use Agreements - This form explains what a limited data set is and how it may be used. The list of 19 subject identifiers is defined by HIPAA as protected health information and is considered sensitive specific information. The security in collecting and storing of any of these identifiers in a study is extremely important and is addressed in the research application.
14. IRB Reviewing Guide - This form is used by IRB members when they review your proposal. It is included to assist you in what we will be assessing in our study review.
So what do I submit to the IRB for a retrospective project and then what happens?
1. Initial submission - You must submit your proposal and noted forms above and also submit your human studies certificates for ALL study personnel. Completion of the research forms takes an average of 1 ½ hours at most. Failure to submit these documents will result in your project not being reviewed!
2. Research Renewal - You must submit 30 days in advance from your annual renewal your proposal with an updated abstract and forms 8 and 12.
3. Study Closure - If you are requesting to close your study you will again submit your proposal, updated abstract and the form 10 and 11.
What happens once I submit my forms and proposal to the IRB and when should I expect a decision?
1. Now you have carefully reviewed the documents and forms and you have completed and have written a well thought out proposal that has been reviewed and approved by your faculty advisor.
2. You may now e-mail a file with the completed forms, human studies certificates and your proposal electronically named as follows: Date. faculty last name. your last name Title. For example- 3.21.12. Firek.Thara.Diabetes in Hispanic patients. THERE are NO PAPER SUBMISSIONS!
3. IRB action -
- The IRB is striving to review and notify the investigator within 72 hours of electronic submission.
- On receipt of the electronic file we will check for completion and accuracy by both the IRB recorder and IRB chief or designate. We will assign a unique IRB number and enter the study into the research data base.
- If the submission is complete it will then be assigned to review and action and you and your faculty advisor will be informed that the review is in process. The reviewers will not be identified and please do not attempt to determine their identity!
- If the forms are not complete, missing information or no proposal you and your faculty advisor will be notified by e- mail with a check list for completion. No further action will be taken by the IRB until you respond and complete any deficits in the submission package.
- The four most common omissions are not providing the human studies training certificates, not entering the expiration dates in the application column, not obtaining your advisor's and chairman's signatures and not providing a research protocol.
PHI Breach Determination and Notification
If you suspect any protected health information (PHI) has been released in an unauthorized manner (lost, stolen, compromised, misdirected, etc.), you must immediately suspend your study and contact the IRB Chair- Dr. Davalyn Tidwell (951) 486-4529. If you are not able to speak with Dr. Tidwell, please contact one of the following: Christina Quijada, RUHS Safety Officer (951) 486-5109, Wendy Strobach, Compliance Program Manager (951) 486-4442, or Alan Teller, IRB Consultant (201) 694-4261. You will need to speak directly with one of the contacts listed, emailing and/or leaving a voice mail are not acceptable.