Investigator Initiated? Start Here!
First, review this information as not all research requires an IRB submission.
We call "Emory Investigator-Initiated" studies, those that are designed by Emory investigators, even if those are sponsored by industry or grants. The majority of the studies we reviewed are Emory investigator-initiated. With the following information, we want to help you find what you need while planning/designing your study. When ready to submit, look at additional information under the "Study Submission Guidance" tab.
Before starting any project, you need to use the correct templates, and also ensure that all the research staff is trained adequately according to the Emory IRB Policies and Procedures and Emory training mandate for clinical research staff.
Documents needed for IRB submissions
- Protocol Templates and Protocol Checklists: Find them under this page, and click on "Protocol Templates and Protocol Checklists-Required"
- Brief Description/Lay Summary: Find them under this page, and click on "Lay Summary Requirements"
- Informed Consents: Find them under this page, and click on:
- Clinical Consent/HIPAA templates: for consents used for clinical trials that also contain HIPAA language
- Sociobehavioral Consent Template: used for studies involving surveys, focus groups, psychology, or public health type interventions.
- Assent templates: required if enrolling children ages 11 to 17.
- Verbal Consent and HIPAA Authorization Template: if your study fits the criteria and you are seeking a waiver of documentation of consent (more information about what this means here).
Training for all Research Staff
Everyone conducting research, meaning accessing individually identifiable information or interacting with participants is considered part of the research study. At Emory, we require the following:
- CITI Training: find details of how to enroll in this online training here.
- Clinical Research Training: required for FDA-regulated clinical trials conducted at Emory. Find more information here.
- School of Medicine's Hitchhiker's Guide to Navigating Mandatory Research Compliances and Approvals at Emory
- Research Administration's Investigator's Guide Home
- School of Medicine's Research Tools for New Investigators
It is important to plan how to reach the population you need to make your study a success. At Emory, we want our investigators to be mindful when planning subject recruitment to ensure an adequate representation of all genders, and minorities, as appropriate according to the area of study.
To find information on how to reach your enrollment goals, please review this information from the Georgia CTSA.
We a lot of information on how to fill out the initial eIRB submission (as well as other follow-on submissions) here.
You can also find useful navigation videos here.
The IRB staff is also available for questions. Email us at firstname.lastname@example.org, indicating you want help with your initial submission. If you need help with follow-on submissions, reach out to your study analyst via email or phone, or by logging a comment in the initial, approved submission.
Studies involving risk for participants would include some of the following:
- Randomization deciding medical treatment
- Use of drug, biologic, or device (even if the investigational agent is FDA approved), when you are deciding the treatment
- Observational studies may not be considered as adding risk for participants if the treatment is being only observed and the study team is not influencing the treatment decisions.
- Diagnostic tests that involve radiation
- Psychological test that may create stress
- Studies involving deception when the participants will not be informed that deception may occur in the study.
For studies using Drugs, Biologics or Devices:
FDA-unapproved drugs, biologics, or devices can be used for research with FDA "permission" to use these agents for research. In these cases, you will need to submit an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) to the FDA. Also, you are required to receive special training and provide more information. This information can be found on this page.
Also, if using drugs or biologics, you may be required to use Emory's Investigational Drug Service (Research Pharmacy). Find more information here.
You may need to submit documentation to the Office for Clinical Research (OCR) and the Office of Sponsored Programs (OSP).
Review the OCR Decision Tree to determine if your study requires OCR submission for either a Prospective Reimbursement Analysis (PRA), budget development, ClinicalTrials.gov, and OCR Invoicing. If your study has any billable items or services from Emory Healthcare or Grady a PRA is required and the study needs to be submitted to OCR. If the study has non-federal or internal funding, OCR can help with budget development and negotiation if needed. Find additional information here.
To submit your documentation to OSP for a grant (federally-sponsored) or a contract (industry-sponsored) look at this page to use the right electronic system.