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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.

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 a current conflict of interest disclosure form on file with the Office of University Counsel.

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 New IRB Submission Checklist for all new applications (not needed for continuing review, amendments or data-sharing agreements).

2. Other forms depend on the type of submission:

a. For a new study, all forms indicated on the Overview of IRB Submissions for New Studies for your application type.

You also need to submit a study protocol or a copy of your grant application if it is a funded study. 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.

3.   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.   

4. 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.

5. 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.

6. 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.           

7. 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.