HOW TO SUBMIT AN IRB PROPOSALAT COOPER UNIVERSITY HOSPITAL:

A STEP-BY-STEP GUIDE This document contains information to guide you in the preparation and submission of your research protocol for IRB approval. Instructions for individuals who are not Cooper employees differ in some respects. Contact the IRB office for guidance if you are not a Cooper employee.

These guidelines are divided into the following sections. Please use ‘Ctrl-Left Click’ on the Headers to go to the appropriate section of this document.

Pre-Application PreparationsResearch Education RequirementsIRIS/Imedris Access and TrainingPre-Submission Document Preparation

Investigator-Initiated ProjectsIndustry-Initiated ProjectsConsent Form and HIPAA AddendumData Collection FormsIndividual Investigator AgreementsSubject Recruitment and Retention Materials

MentorshipDepartmental collaboration

Application and Submission ProcessLog on to IRIS/ImedrisAdd a New StudyStudy Set-UpStudy ApplicationInitial Review Submission Form

Approvals, Sign-Off, and Submission Process.Co-investigator and Other Study PersonnelDepartment Chiefs and Other Departmental Collaborators

Financial Disclosure ProcessNotifications.Post-Application Process

Administrative Pre-ReviewTypes of IRB ReviewReviewer AssignmentTrack WorkflowIRB Presentation

Post IRB Review.Outcome LettersModifications

Resubmission.Re-Review.Institutional Approvals.Staff Contact Information

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Pre-Application PreparationsThe information and steps listed below are offered to assist you in preparation of documents that are necessary for IRB review.

Research Education Requirements. All key study personnel (principal investigator, co-investigators, research coordinators, research assistants, fellows, residents, medical students, other students) must complete an IRB–approved education program in the protection of human research subjects before they may conduct research at Cooper. When you have completed the course, print out the Human Subjects Training certificate. Keep a copy for your files, and submit a paper copy to the IRB at E&R Building, Room 128 or fax the certificate to 856 757-9795.

Initial Education RequirementNew Residents and Fellows should attend the IRB Director’s session on Protection of Human Research Subjects during their orientation program in June and July of their first year at Cooper. New Residents and Fellows are also required to take either the NIH web-based education module or the CITI course as noted below to complete their initial education requirement.

All study personnel must submit a Human Subjects Training certificate from a training module that is approved by Cooper University Hospital IRB. Researchers at Cooper have two options to complete their education requirement – the NIH Course or the CITI course.

1) NIH Computer Course for ResearchersTo take the course, go to http://phrp.nihtraining.com/users/login.php  

Select the second option, Human Participant Protection Education for Research Teams.  The course takes about one or two hours.  You can complete it over several sessions.  

New User If you have never taken the course before , register as a New User.  You enter your

own name and make up a password. Review the modules and take the quiz at the end of each module. When you have completed the course, send a copy of the certificate that can be

printed out to the IRB office, E&R Building, Room 128 or fax the certificate to 856 757-9795.

Returning User (for re-certification) If you have taken the course previously you will log on as a Returning User. If you do

not remember your log-on password click on “Having Trouble Logging In?” and the NIH will email your password to you.

On the Returning User screen: type in your email address and your password On the Welcome Back screen: click on Edit User Info Scroll down and Click on Retake Course Review the modules and take the quiz at the end of each module. When you have completed the course, send a copy of the certificate that can be

printed out to the IRB office, E&R Building, Room 128 or fax the certificate to 856 757-9795.

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2) Collaborative IRB Training Institute (CITI) CourseCITI course instructions : The CITI Basic Course for all Investigators and Other Study Personnel is the only CITI course that meets the Cooper IRB education requirement for certification in the protection of human subjects. This course takes 4-6 hours.  You can complete it over several sessions. Some sponsors require the CITI course and it is available to any Cooper employee.  Also you can obtain 4-6 CME or CEU credits for taking and passing the course.  To take the course, go to  https://www.citiprogram.org/Default.asp   

Do not take the CITI Refresher Course for Cooper without checking with the IRB staff first to find out if the original CITI course you took qualifies you to take the refresher course Cooper requires.

1. The first time you go to the CITI website select New Users Register Here or Log on with your established User ID and Password if this is not your first session.

2. Enter or answer the pre-established Security Question and Answer.3. Select Cooper University Hospital from the drop-down menu under Participating

Centers. Click on ‘View Cooper University Hospital Instruction Page’.4. If you are a Cooper employee you must use your Cooper email address.  Non-

Cooper employees may use their personal email address. 5. Under 6 you may register for CME/CEU credits.6. Choose All Investigators and Other Study Personnel – Human Subjects - Basic

Course.  *This is the only course that meets the IRB education requirement for certification in protection of human subjects. 

To Start the Course:1. Cooper University Hospital has prescribed your course curriculum.2. The Main Menu lists the courses you have chosen.  The Main Menu also provides a

number of Course Utilities designed to help you.3. The red link (Enter or Re-Enter) will permit you to Begin/Continue the Course.4. Please complete the Integrity Assurance module presented at the top.  The system

will allow you to start taking the courses after completing it.5. Complete the required modules and associated quizzes.6. When you complete all required modules successfully, you may print your

completion report through the "Print" link in the Learner's menu. 7. A copy of the completion certificate will automatically be sent to the Cooper IRB if

you have taken the ‘Cooper’ CITI course.  However, if you are taking the course to qualify for a new IRB online account, an online account will not automatically be sent up for you. You must email the IRB at IRBonlinehelp@cooperhealth.edu to request an account and provide your position at Cooper, your degree and your Cooper department/division affiliation.

Additional Modules: When you complete all Required Modules in your curriculum, you will be shown a

link to "Optional Modules" in the Optional Course Catalog. You may return to the course site at a future time to review these modules.

You may take the ‘Responsible Conduct of Research’ course and/or the ‘Good Clinical Practice’ course in addition to the Basic Course if you want to.  Some sponsors require these courses.  However, they are not required by the IRB and they do not fulfill the IRB education requirement for education in protection of human subjects.  

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To Complete the Course: The minimum "passing" aggregate score for the quizzes has been set by your

institution.  A running tally is compiled in the Grade Book.   If you want to improve a score on a quiz, you may repeat any quiz in which you didn't score 100 % correct. 

Print or download a Course Completion Report as evidence that you have met your institutional requirements.  A copy will be sent automatically to your institutional administrator. However the institutional administrator will not automatically create a new IRB online account at the receipt of the certificate (See establishing an IRB account below.)

You may return to the course site in the future to obtain a copy of the completion report.

Submit a voluntary, anonymous user satisfaction survey.

Recertification Requirement: CHS requires re-certification of education every three years. The date of renewal is calculated on a yearly basis rather than timing renewal from the actual date of initial education for each researcher. Completion of either the NIH web-based course or the CITI course fulfills the requirement.

External Investigators (Investigators who are not Cooper employees): Education requirements for investigators or study personnel who are not Cooper employees differ depending on their interaction with Cooper subjects or Cooper subject’s identified data and whether the institution they are affiliated with has a Federalwide Assurance. Contact the IRB Office for guidance.

IRIS/Imedris Access and Training How to Obtain Access: IRIS/Imedris is the IRB’s on-line submission system. In order for you to be considered key study personnel on any research study at Cooper you must first obtain IRIS/Imedris access. After proof of research education certification is submitted to the IRB, you must email the IRB (via IRBonlinehelp@cooperhealth.edu ) and request that you be given IRIS/Imedris access. You must supply your position at Cooper (MD, DO, RN, etc.), your department/division affiliation, and your email address if other than Cooper email. The IRB will then send you an email with your User ID and password. This process takes a couple of days.

External Investigators (Investigators who are not Cooper employees):The I.T. department at Cooper requires all non-Cooper employees to sign a Certificate of Confidentiality in order to have an online account in Imedris.  Email the IRB (via IRBonlinehelp@cooperhealth.edu ) to obtain one. Please sign it and return it to the IRB office at E&R Building Room 128. You may also fax a copy to 856 757-9795 but a hard copy must be received by the IRB. When the IRB office has both the certificate of confidentiality and the education certification, the IRB will create the external investigator Imedris account. .

Imedris Training Opportunities: You are encouraged to attend one of the monthly IRIS/Imedris training sessions held in the MCC Conference Room on the 4th Floor of the Dorrance building on the first Thursday of each month. You must be registered to attend. The course information and registration link is on the Cooper intranet home page. Click on the link under Events on the Cooper intranet home page.

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The IRB Staff are also available for one-on-one instruction and assistance with all submissions. Appointments are encouraged.

Pre-Submission Document PreparationAll research projects are submitted to the IRB through the IRIS/Imedris online system. The “heart” of the submission is the Study Application. This is created in IRIS/Imedris. It contains a number of sections. There are templates for some of the sections. All of the forms and templates that investigators need to prepare their submission to the IRB are available on IRIS/Imedris. Templates and instructions are available on IRIS/Imedris by clicking on My Assistant, then clicking on Operating Procedures. Many of the templates for the IRB application are also available on the Cooper intranet. To reach the IRB section of the Cooper intranet: Go to the home screen of the Cooper intranet, click on Departments, click on Medical Affairs Department and click on Institutional Review Board.

Investigator-Initiated Research ProjectsThese are research projects that are initiated by an investigator at Cooper. The Cooper investigator writes or has written the protocol. The project may be funded, i.e. the investigator is seeking or has received funding from a federal or private funding agency or from industry. The project may be funded by the investigator’s department (internal funding) or may have no funding.

Unfunded and Internally (Cooper) Funded Projects Protocol and Protocol Template: If you are writing (or have written) your own protocol, use the Investigator Initiated Protocol Template to create a Word document to assist in preparing the IRIS/Imedris Study Application. The template is in the exact order of the investigator initiated protocol section of the IRIS/Imedris Study Application; therefore, you will find it easy to cut and paste information from your Word version into the Study Application.

You may attach the Word version of your Study Protocol, as well as complete the Investigator Initiated Protocol section in the IRIS/Imedris Study Application. If applicable, you will have to complete the Project Summary section of the Study Application (see below).

Investigator Initiated Protocol Summary section: The investigator initiated protocol summary section includes the study’s objectives/purpose, hypotheses, research plan, study design, recruitment methods, procedures to maintain privacy and confidentiality, etc. We recommend that you complete the summary in Word first, making it easy to cut and paste information into the Study Application.

Funded Projects Investigator Initiated Protocol Summary section: If your investigator initiated protocol is funded, you probably have already written a proposal for submission to the funding agency. In this case, you would not need to write a Protocol using the IRIS/Imedris template. However, you are required to fill out the Project Summary section of the IRIS/Imedris Study Application. You should first create a Project Summary in Word. The Word Project Summary template is in the exact order of the Project Summary section of the

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IRIS/Imedris Study Application; therefore, you will find it easy to cut and paste information from your Word version into the Study Application.

Grant Proposals: A Word or PDF version of the full grant proposal must be attached to the Study Application. The grant application should have the budget information removed before it is attached to the IRIS/Imedris Study Application.

Industry-Initiated Funded Projects

Project Summary: The Study Application requires that the Project Summary section of IRIS/Imedris be completed for all projects where the sponsor provides the protocol. You should first create a Project Summary in Word. The Word Project Summary template is in the exact order of the Project Summary section of the IRIS/Imedris Study Application; therefore, you will find it easy to cut and paste information from your Word version into the Study Application. Sponsor’s Protocol: A Word or PDF version of the sponsor’s full protocol must be attached to the Study Application.

Consent Form and HIPAA Authorization A consent form and a HIPAA authorization must be created for studies prospectively enrolling subjects. Each consent form must be tailored to fit the particular study. The following consent form templates are available.

Consent Form Template for Studies that are Greater than Minimal Risk and involve Substituted Consent.

Consent Form Template for Studies that are Greater than Minimal Risk and do not involve Substituted ConsentUse the appropriate template for Studies that are Greater than Minimal Risk to tailor the consent form to include Cooper-required standard language. Save the template to your hard drive. You may cut and paste the sponsor-supplied study information into the template or use the template to tailor your own investigator-initiated study consent form.

HIPAA Authorization Template Use this template for studies that are greater than minimal risk. You may use it for minimal risk studies as well but we recommend you use the Combined Consent Form and HIPAA Authorization for Minimal Risk Studies template. Save the template to your hard drive and use it to tailor your own consent form.

Combined Consent Form/HIPAA Authorization for Minimal Risk Studies Use this template for studies that involve no greater than minimal risk. Save the template to your hard drive and use it to tailor your own consent form.

Consent Form Template for Sim-Lab Studies Use this template for studies that involve participation in Sim-Lab studies

Do not use the HIPAA authorization information in the combined consent form/HIPAA authorization for minimal risk studies in a consent form for a study that is greater than

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minimal risk. If the study is greater than minimal risk and you intend to combine the consent form and HIPAA authorization into one document be sure to cut and paste the information from the HIPAA Authorization Template into the consent form.

Cooper letterhead. All consent forms and HIPAA addenda are required to be on Cooper letterhead. Instructions for branding these documents are on the IRIS/ImedRis Operating Procedures Home Page – Cooper Letterhead.

When you have made all of the required formatting, you will upload the consent form and HIPAA authorization into the electronic study file so that they can be attached to the Initial Review Submission Form. Instructions for submission are included in the Application Submission section below.

Data collection forms A copy of all data collection forms, surveys, diaries, inventories, and questionnaires that will be used in the study must be attached to the Initial Review Submission Form. These forms must be in either Word or PDF format so that the IRB online system is able to apply the electronic approval stamp.

External Investigators - Individual Investigator Agreements The activities of external research investigators (not employees of CHS) may be covered under the CHS FWA and reviewed by the CHS IRB only in accordance with a formal, written agreement of commitment to relevant human subject protection policies and CHS IRB oversight. The Individual Investigator Agreement (IIA) is used for this purpose. The external investigator must sign the IIA. The signed IIA must be scanned as a PDF document and uploaded into the Other Study Document section of your electronic study file so that it can be attached to the Initial Review Submission Form. Be sure to describe the role of the external investigators when completing the External Investigator section of the Study Application.

Subject Recruitment Materials (Advertisements) A copy of all subject recruitment and subject retention materials such as, but not limited to, subject brochures, print advertisements, and radio or TV advertisement scripts must be attached to the Initial Review Submission Form.

Mentorship (residents, fellows, medical students) If you are a resident, fellow, or medical student, a faculty member must sponsor your research project. The Faculty Advisor must review your Protocol, Study Application, and other documents. The Faculty Advisor is required to sign off on the protocol. For studies that involve greater than minimal risk, the Faculty Advisor is required to accompany you to the IRB meeting at which your project is reviewed.

In the event that you leave Cooper without closing the study, responsibilities for ongoing IRB requirements are assumed by the Faculty Advisor.

The Sample Size Calculation and Data Analysis section of your protocol must be complete and reviewed by an appropriate mentor with experience in research methods and statistics prior to submission to the IRB. Statistical mentorship is available through Krystal Hunter, Statistician, with the Cooper Research Institute (hunter-krystal@cooperhealth.edu).

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Departmental Collaboration If your study involves recruiting subjects from departments other than your own, or will require involvement of personnel in another department, you are advised to discuss your intentions with each Department Chair prior to IRB submission. All studies involving subjects recruited from the Emergency Department must first be cleared with Brigitte Baumann, MD, (968-7347, baumann-b@cooperhealth.edu). The Chair of each department involved in the study, as well as, if applicable, Dr. Baumann (if the study involves ED subjects) and Jacqueline Sutton, Pharm.D., Director of Pharmacy Services, (if the study involves drugs that will be dispensed by the hospital pharmacy) are required to apply their electronic signature and approval. Instructions for the submission sign-off are included in the Application Submission section below. If the study involves drugs that will be dispensed by the hospital pharmacy, Dr. Sutton requires a hard copy of the protocol prior to the submission process. Contact Dr. Sutton at 342-2339.

Application and Submission ProcessThe information and steps that are listed below are offered to assist you in the submission of your project to the IRB. Make sure to click on “Save and Continue” in the upper right-hand corner of your screen frequently so that the data that has been entered is not lost. IRIS/Imedris will time out after a set period of inactivity (40 minutes). The system identifies Inactivity as staying on the same screen for more than 40 minutes. Even if you are typing or pasting into a particular section of the study application, the system will identify your work on that section as Inactivity after 40 minutes. Remember to ‘Save and Continue’ often. You can go back to that section if needed.

Log onto the IRIS/Imedris system at: https://cooper.imedris.net

Add new study Under Research Assistant, click on Add a New Project.

Study Set-Up The Study Set-Up section initiates the electronic study file for your study and requires you to add the basic study information, including the study title, departments of all key study personnel, and key study personnel names and roles. The information that you enter here is automatically attached to any subsequent submission. Begin entering data into the fields as instructed.

Multiple departmental affiliations. Make sure to add the departments of all the study personnel who will be involved in the study. Some investigators have more than one departmental affiliation. Click on ‘Add” for the list of Departments, check the box next to the department and click on “Save Changes.”

Study contact. Please note that the system sends all electronic correspondence automatically to the Principal Investigator and the Study Contact. The Principal Investigator is routinely listed as a Study Contact. However, you may add other personnel as Study Contact. The Study Contact is not limited to co-investigators or coordinators. Administrative personnel who have Imedris accounts may be added as Study Contact. If the Study Contact has no other role in the study he/she is not required to submit a financial disclosure in the event of a funded study and he/she is not required to meet the research education requirements. Individuals who have no other role than Study Contact will only receive system notifications. They cannot access the study file in IRIS/Imedris.

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Financial Disclosure. At the end of the Study Set-Up you are given a choice to start either the Financial Disclosure process or the Study Application. Financial Disclosures must be submitted by all key study personnel for any study in which Cooper receives outside funding, equipment, or services.

Study Application If you did not choose to start the Study Application at the end of Study Set-Up and are returning later to complete the application, you may begin the Study Application by clicking on My Studies under Study Assistant. Click on “Click to Open” to the left of the study you wish to open. Under Protocol Items, click on Application to view the incomplete application template.

Complete all required information, clicking on Save and Continue as you proceed through each section of the application form. Remember, IRIS/Imedris will ‘time out’ after a set period of inactivity (staying on the same section) and you will lose any data entered after the last Save. Depending on the information that you give in the Study Application, the form will branch to the required sections for the type of study you are submitting.

Investigator-Initiated Protocols: If you are writing your own protocol you must complete the Investigator Initiated Protocol section of the Study Application. An Investigator Initiated Protocol Template is available on the Cooper IRB webpage or on the Operating Procedure screen of Imedris for you to use as the basis for your Word version of the Protocol document (See Investigator-Initiated protocol and Protocol Template above.). The template is in the exact order of this section of the Study Application so that you will find it easy to cut and paste information from your Word version into the Study Application.

Industry-sponsored Protocols/Grant Proposals: A Protocol Summary is required for all projects where the sponsor provides the protocol or where there is a grant proposal. You should cut and paste from the Word version of your Project Summary (see relevant sections above.)

Completing the Study Application does not indicate that the IRB has received your application for IRB approval. After you have completed the last section of the Study Application and clicked on ‘Save and Continue’ the application will automatically take you to the Initial Review Submission Form. The Initial Review Submission Form is the submission form that you will use to attach all of the documents for this study and is the vehicle by which your study and its supporting documents are transported to the IRB for review.

Initial Review Submission FormClick on ‘Save and Continue’ to proceed through each section of the submission form. Depending on the information provided in the Study Application the Initial Review Submission Form will provide a section for attaching applicable documents. (e.g. consent form and HIPAA addendum in the Informed Consent section, a Sponsor’s Protocol in the Protocol section, an Investigator Brochure or 1572 in the Study Document section) Save and Continue through each section of the Initial Review Submission Form and clicking on the green bar in each section will open the section of

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the electronic study file where your documents are housed. Click the checkbox to the left of that document and then click ‘save attachments.’ Attach all of your documents in the appropriate sections of the Initial Review Submission form. Make sure you attach the Study Protocol, Project Summary, Sponsor’s Protocol, and grant application, as they apply. Make sure that you give the file names descriptive titles. For example, if you have a cover letter, you should name it “Cover letter.”

Approvals, Sign-Off, and Submission Process Your submission will not reach the IRB queue until all key study personnel and all department chiefs and other departmental collaborators have completed the approval and sign-off process.

Co-investigators and Study Personnel Click on “Sign and Submit” when you reach the end of the Initial Review

Submission Form. If you are the PI, read the Investigator’s Assurance Statement and, if applicable to

your study, the Preparatory to Research Statement, Declaration of De-Identification, and Limited Data Set Agreement Statement and Assurance. Indicate your approval and apply your electronic sign off (your IRIS/Imedris User ID and Password) to the Investigator Assurance and click on Save Signoff. The Investigator Assurance Statement is your assurance that you will follow Cooper’s policies and procedures regarding research with human subjects and that you accept responsibility for the conduct of the study.

Click yes to the question ‘Does this submission require additional routing for approval’ and then click Save and Continue. If you added all of the study personnel correctly back in the Study Application then all of their names will appear here. (Names of all Co-investigators and other Key Study Personnel must be added in the Study Application.) Once the study application or financial disclosures have been submitted, no other study personnel may be added or removed until after the study’s final approval.

Click the check box to the left of their names to include them in the sign off and then click Save and Continue.

Department Chiefs and other Departmental CollaboratorsThe next screen asks if additional personnel have to be added to the sign off. This is where you add the Department Chiefs and other departmental collaborator approvals. There are often co-investigators from different departments on a study. If this is the case, the Department Chief from each department is required to apply his electronic approval and sign off. Click on Add Reviewer Type the last name of each Department Chief (i.e. Parrillo for the Department of

Medicine). Select that person by clicking ‘select’ to the left of their name, and then click the ‘Select Users’ in the right upper corner.

Choose their role from the drop down box below their name. Continue this process until all additional reviewer names are added. Each of these additional people who have been added for approval can receive the

submission simultaneously if they are all given a ‘#1’ in the ‘order to sign’ section. Click on Save and Continue

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The Green Bar asks if you have completed your selection of sign-offs. If they are not correct, click on the ‘click here to add/remove’ button on the left side of screen. If they are correct, click yes and then click on Save and Continue.

Financial Disclosure Process Financial Disclosure Statements are required from all co-investigators and other study personnel for any study in which Cooper receives funds, study drug, equipment, or services. The financial disclosure process can be started as soon as the Study Application is complete and all study personnel names have been recorded. The Financial Disclosure forms will not automatically be routed to key study personnel. The Financial Disclosure Statement process is a separate submission process from IRB submission. The IRB will not proceed with the review of a funded project until the Research Development Office gives financial disclosure clearance to the IRB.

Step #1- Creating a Financial Disclosure form for Routing1. Under “submission forms” select the financial disclosure link.2. Select “add a new form”3. Enter project information (including that this is a Research Project), then click on

‘sign and submit’ tab.4. The Yes or No question will appear: “Does this submission require additional routing

for approval?” Select Yes.5. Select names of study members required to submit a financial disclosure form; then

click save and continue.6. The Yes or No question will appear: “Have you completed your selection of required

signatures?” Select Yes. (Department Chiefs are not required to do a Financial Disclosure Statement unless they are also an investigator on the study.)

7. Your own financial disclosure form will appear for you to complete. Click on all of the statements that apply.

8. For the submission, select the “Approve” option; enter your User ID and Password.9. Click on Save Signoff.10. The Financial disclosures will be sent to the requested study members. 11. Submission of the Financial Disclosures is complete.

Step #2- Completing a Financial Disclosure form: 1. On the Home screen for this study in Imedris under Incomplete Tasks - click on the

open icon for the Financial Disclosure Form.2. Your own financial disclosure form will appear for you to complete. Click on the

statements that apply.3. For the submission, select the “Approve” option; enter User ID and Password.4. Click on Save Signoff.5. Submission of your own Financial Disclosure is complete.

Notifications When the submission has been routed an email notification from IRIS/Imedris (Iris-Cooper) will be sent to all study personnel informing them that a study is awaiting their sign off. They should:

Log onto IRIS/Imedris. Click on the “signature signoff’ task in the Incomplete Task section on the study’s

IRIS/Imedris Home Page to go directly to the required sign off page.

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Study documents can be reviewed by the other investigators or the Department Chief by clicking on ‘click here to review study documents’ at the top of the screen.

Only when all study personnel have successfully signed off, will the submission proceed to the Department Chiefs and other departmental collaborators for their approval and sign off. The principal investigator and study contact will receive system-generated notifications that a key study personnel has not signed off.

The submission will not reach the IRB queue until all of the required sign-offs have been accomplished. You will not receive a notification when the submission reaches the IRB office. You must check Track Workflow to determine this. (See below.)

If the study is funded, separate email notifications will be sent to all study personnel that a financial disclosure statement is awaiting their sign off. You must be sure to go into the application and complete the Financial Disclosure process described above. The Financial Disclosure forms will not automatically be routed to key personnel. The IRB will not proceed with the review of a funded project until the Cooper Research Institute Office gives financial disclosure clearance to the IRB.

Post-Application Process

Administrative pre-review When your submission reaches the IRB queue it will be pre-reviewed by the IRB staff. The administrative pre-review insures that the submission is complete, all supporting documentation has been attached and is in order, and all required approvals and sign-offs have been accomplished. If the IRB staff discovers during Administrative Pre-Review that some key study personnel, department chief, or departmental collaborator have not approved and signed-off on the submission, the submission will be returned. You must correct the deficiencies and return the submission to the IRB before review of your application by a board member can proceed. Any deficiencies identified in this pre-review will be delineated in a Pre-Review Changes Requested letter that will be emailed to you and the submission will be returned. When the corrections are made the study can be resubmitted to the IRB. Any document that needs to be revised must be ‘checked out’ to your hard drive and then checked back in to the document section of IRIS/Imedris. Detailed instructions for revising documents and re-submission of the application are found below in the modifications section.

Types of IRB Review Exempt: Examples of activities that may or may not be exempt from further IRB review and that must be reviewed by the IRB for a determination of exemption include survey studies, studies using existing databases, and research activities in connection with performance improvement or quality assurance projects.

Expedited: Only research that is no greater than minimal risk and that falls within the categories published in the November, 1998 Federal Register may be reviewed using the expedited review process. (See 45 CFR 46.100 on the CHS Operating Procedures page of IRIS/Imedris.) This means that only one member of the IRB reviews the project.

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Convened Full Board: All research projects that involve greater than minimal risk must be reviewed by the Full Board.

*Case Reports. The CHS IRB no longer requires investigators to seek IRB review and approval of case reports unless five or more subjects are involved.

Reviewer assignment When the administrative pre-review, signatures, and financial disclosures (if required) are all complete, the IRB staff will assign the submission to one or more IRB reviewers. These reviewers are experienced members of the Board. Based on the information obtained in the administrative pre-review, the IRB staff and the IRB Director determine the type of IRB review (i.e., Exempt, Expedited, or Convened Full Board).

Track Workflow You can track the progress of your submission at any time. For example, you can see who has signed off on your application and whether it has reached the IRB office. Log onto IRIS/Imedris Go to My Studies – Click the “Open” icon for the study In the Outstanding Submission section on the home screen of your study click on

the Green Box under Track Location that says Routing in Progress to track the progress of your submission.

IRB presentation All studies that are greater than minimal risk must be presented to the convened Full Board. The submission deadline for greater than minimal risk studies is three weeks prior to the IRB meeting. The IRB meeting and submission deadline schedule can be found on Imedris under My Assistant – Review Board Meetings.

A system generated notice will be emailed to you when the study is assigned to a particular IRB meeting. The IRB Staff will also contact you with a presentation time one week prior to the scheduled meeting. Principal investigators are strongly encouraged to present their study in person. However, telephone teleconference presentation can be arranged in special circumstances. Residents and Fellows are required to be accompanied by an attending (co-investigator or Faculty Advisor).

The PI is required to make a brief (5 minute) presentation which will be followed by questions from the Primary and Consent Form Reviewers and other members of the Full Board. The PI should include the following information in his presentation: Purpose and rationale for the study Study design Risks and benefits due to study participation How risks to subjects will be minimized How subjects will be recruited and selected Circumstances for obtaining consent Whether there is a Data Monitoring Board

Post IRB Review The IRB post-review process consists of the following: an outcome letter communicating the IRB’s decision regarding approval and required minor changes; document modifications: resubmission: re-review by the IRB reviewer(s): and institutional approvals.

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Outcome Letter. Regardless of the type of review the project receives, you will receive an outcome letter emailed to you via the IRIS/Imedris system. This letter will give the IRB’s decision. It will either grant approval for the study to begin or it will outline the reviewer’s comments and the changes that are required. If changes are required the submission will be sent back to you so that you can make the modifications.

Modifications Consent/HIPAA modifications. If there are requirements or recommendations to

change your consent form and/or HIPAA Authorization form, you will need to revise the documents by checking them out of IRIS/Imedris for editing and then checking them back in. All editing is done in Word on your p.c., not within Imedris. Instructions for editing are also given below if you are unfamiliar with the editing features of Word.

To make a change to a document you have submitted previously.1. Click the Add Revision icon under the Create a Revised Document column in

the Informed Consent section of the electronic study file. This option will take your original document and create a copy of it that you can then download or ‘check out’ to your computer, edit, accept all changes in the document, and then upload or ‘check back in” to the system. You will then attach this new version of the study document to the Initial Review Submission form.

Investigator-Initiated Protocol and Project Summary Modifications . Your Study Application form will have either an Investigator-Initiated Protocol or a Project Summary section. You probably also have a Word version of the Protocol or the Project Summary. If changes to the Protocol or the Project Summary are required, the IRB requires that you make them within the Study Application.

To Revise the Study Application: Go to the Home Screen of your study. Under Protocol Items, click on Application Click on the ‘Create a Revised Application’ icon on the right side of the

screen. Go to the appropriate section of the Study Application and make the

required revisions. Click on Save and Continue in the upper right corner to assure that your

revisions are saved. The system automatically applies a new Version number to the Study

Application. You will attach the new version of the Study Application to the Initial

Review Submission Form as described below.

We strongly recommend that you make the same revisions to the Word version of the Protocol or Project Summary in order to maintain uniformity. Follow the same process described above for revising the consent form.

Review Response Submission Form . Once you have made all of the revisions required to the Study Application and other forms click on “The IRB has requested a Submission Response for an Initial Review Submission Form” in the Outstanding Submissions section of your study’s home page to open the Review

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Response Submission Form. This form has a Response Comments section that allows you to write a response to the issues identified during the review process and stated in your outcome letter(s). If you did not make some of the revisions requested by the IRB, be sure to explain why in the Comments section. You also need to attach all of your revised documents to this form. The revised Study Application is not automatically attached to this form. You need to attach it as well as other documents that you revised. You use this form to send the entire submission back to the IRB for re-review

Resubmission When you have completed the revisions, attached all required documents, and completed each section of the Review Response Submission Form send your Resubmission back to the IRB by the following process:

Click on Save and Signoff for Workflow Routing Apply your Electronic Approval and Sign-Off Save Sign-Off Click ‘No’ to bypass additional personnel for routing

Your Resubmission will now be routed to the IRB for review. The system does not require that the PI or any co-investigators sign off on re-submissions. Only the person preparing the resubmission is required to sign off. However, the principal investigator may require that he/she sign off on all submissions to the IRB. In that case, the person preparing the resubmission must route the resubmission to the principal investigator for submission approval and sign off.

Re-Review When the IRB receives your Resubmission with the revised documents the IRB Coordinator will perform an administrative pre-review to make sure that all items that were requested are attached. The IRB Coordinator will then assign the resubmission packet to the original IRB reviewer(s) so that they can re-review the items to see that changes that were made are adequate.

Institutional ApprovalsAfter each of the original reviewers has completed their Re-Review and approved the changes, the IRB Coordinator routes a Final Administrative Approval Letter to Harry Mazurek in the Cooper Research Institute Office and to Dr. Bekes for institutional approval. When this letter is electronically signed by both parties the IRB Coordinator stamp-approves the consent documents; gives the study an ‘Open” status; and sends a Final Approval Letter to the PI.

Research activity on the study may not begin until the investigator has received the final IRB approval letter.

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