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