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The IRB Process and IRB Approval For Your Human Subjects Research

The IRB Process and IRB Approval for Your Human Subjects Research:
Frequently Asked Questions

Research is defined as a systematic investigation designed to produce or contribute to generalizable knowledge. This includes research development, testing, evaluation, AND pilot studies. This means that your QI project is research if you intend it be generalizable beyond just improving quality at a particular site or for a particular program.

Use the IRB's OHR-34 checklist to determine whether your research requires IRB review.  

You must have IRB approval prior to beginning your research.

All investigators and personnel on an IRB submission must complete IRB training and must have submitted a conflict of interest (COI) disclosure.

To submit your COI disclosure, please go to https://jefferson.coi-smart.com, and sign in with your campus key and password. If you experience difficulty please contact JeffCOISmart@jefferson.edu with a description of the problem. If you have been newly added to the system, it may take a full 24hours before you can access the system. If you cannot access right way, please try again the next day. If after 24 hours, you cannot access the system, please email JeffCOISmart@jefferson.edu

If you are a student at Jefferson or at another medical school, or a non-TJU employee from another healthcare or academic medical center, please contact JeffCOISmart@jefferson.edu, and provide your name, email address, your role (i.e., student, clinician, post doc, resident, clinician outside entity, volunteer faculty, etc.) and the institution or school you are associated with . Explain that you are on a protocol or grant and need to submit a coi disclosure so you can be set up for a different access link. Once you are set up, you will receive an email from the COI-SMART System with instructions to gain access to submit your disclosure.

To determine what forms are needed for your IRB proposal, see the Overview of IRB Submissions for New Studies. IRB forms and submission materials can be found here. In general terms, there are 3 types of application reviews: exempt, expedited review, and full review.

1. a. For a new study, all forms indicated on the Overview of IRB Submissions for New Studies for your application type. For most new studies (except for exempt, unfunded studies), you need to submit a study protocol or a copy of your grant application. The IRB has a sample protocol template available. Your study protocol should include details on all of the important elements of the planned research, including:

1. A sentence or two describing the current state of the literature, and the addition that the current study will make (If there is very little/no previous research done in the area, this is an acceptable justification);

2. The number and nature of the proposed research participants, including where they will come from, how they will be recruited into participation, if, when and how they will be consented, and the measures taken to protect their anonymity or confidentiality;

3. The methods of the study, including where, when and how data collection will take place, all the procedures for storing and maintaining the data and;

 4. The data analysis plan. The protocol should address the balance between  risks to participants and potential knowledge or other benefit gained. Remember, even things like inconvenience and boredom count as risks!

b. For an amendment (e.g., to add study personnel or change the study protocol), complete an OHR-12, 12B or 12C depending on the type of amendment.

c. For a continuing review, complete the OHR-9 and submit with the required additional documents indicated in the OHR-9 instructions.

d. For a data-sharing agreement, complete either the OHR-6A or 6B. Although this does not require Chair and Administrator signatures, please submit it for DFCM review.

2.  For new studies, create a study record in JeffTrial and upload the documents to the IRB portal. This notifies the IRB of your upcoming submission. You can upload the documents prior to getting signatures.   

3. Get all required signatures from investigators and personnel. If you have collaborators from outside the department, get those signatures first, including their department administrators and chairs.

4. If faculty members are being added to a new, unfunded study, please provide a statement of their percent effort (e.g., an email from them stating that they estimate spending XX% effort on this study). This is a DFCM requirement.

5. If students are on the IRB, please ensure that student has received needed clearance to participate in the study-- for medical students/unaffiliated students, contact Katherine Paul; for College within a College students, contact Abbie Santana; for MPH clerkship/capstone students contact Amy Cunningham.           

6. Complete the appropriate DFCM checklist for departmental review:

DFCM Checklist: Exempt Study

DFCM Checklist: Expedited Study

DFCM Checklist: Full Review

DFCM Checklist: Amendment Adding Study Personnel

DFCM Checklist: Amendment Removing Study Personnel

DFCM Checklist: Amendment Revising Study Protocol

1. The Department of Family and Community Medicine review process begins with Amy Cunningham, who will review the application for completion and accuracy and forward it to the departmental senior administrator, Laurel Giobbie.

2. Laurel Giobbie will review the application and if complete and appropriate, forwards it to the Department Chair for signature.

3. Joan Giampetro then makes a copy for the Department’s files and notifies the PI/application contact person that their paperwork is ready for pick-up.                                

4. The PI/application contact should make a copy for his or her records and submits the required number of copies to the IRB office:

Office of Human Research
Thomas Jefferson University
1015 Chestnut Street
Suite 1100
Philadelphia, PA 19107

5. The application then goes on the IRB for review. You will receive notification from the IRB when your application has been assigned a review date and when review is complete.

Please contact Amy Cunningham with questions about DFCM IRB applications.