Study Submission Guidance
Before submitting in eIRB, review our eIRB smartform helpful tips.
Additionally, here are helpful submission tools and templates.
Please see our Lay Summary Requirements
Access our current templates for Informed Consent Forms, HIPAA authorizations, and Assents.
For informed consent guidance, including the use of electronic Informed Consent, visit Consent Instructions and Guidance.
- Can raffles be used as compensation? Only if you offer to everyone. See here: Office of the General Counsel - Raffles and Giveaways (PDF)
ResearchMatch.org: A useful tool to match up with people who have signed up to find opportunities to participate in studies
Ancillary reviewers (including department reviewers): watch this video to know how to submit your reviews
For instructions on which ancillary reviews are required (e.g. biosafety, radiation safety, department review, etc...), please see the section "Overview: Submitting a Study in eIRB" on our New Study Application panel on page-level help.
Community engagement is vital to ensure the recruitment of all populations, especially those that are marginalized or who do not participate in research for lack of trust.
Emory has a great partner in the Georgia CTSA, who provide guidance and resources to ensure that participation in research is more equitable.
These policies are the basis for the required language you find in our consent form templates.
- Emory OIT Information Security Architecture Site can guide you through security review considerations
- Note: Seperate security reviews are required for each IRB submission as there are unique considerations for each project.
- Email encryption information: email encryption is required if emailing sensitive information to people outside Emory or consents (even if empty) to study participants
- Use of Electronic Informed Consent
- NOTE: if using RedCap, use their eConsent framework!
- Use a Part 11-compliant platform for FDA-regulated studies!
For studies taking place at Children's Healthcare, Please complete Children's Research Risk Assessment Intake Form. This routes directly to the Children's teams and they will reach back out to the requestor for consultation. For further information, please see Children's Information Security Risk Assessment Process Document. If you have questions, please contact Carol Price at (Carol.Price@choa.org) or Jonathan Park (Jonathan.Park@choa.org).
For studies taking place at Grady: Please email the device and data use information to the Grady privacy officer, D’Andrea Morning, at djmorning@GMH.EDU for her review and approval. Upload the email in the study history for our records.
Grady Security Review would be needed if:
- Grady data is going to be exported from Grady managed applications for use outside of Grady direct control
- Users that don’t have access to the required research data as part of their everyday responsibilities at Grady will need access to this data
- New application(s) will need to be installed in the Grady environment to support research activity
- Devices that are not under direct Grady IT management need to be installed on the Grady network in support of research activity
- Any changes to an existing research project that meets the criteria listed above
Every study requires a plan with some level of data and safety monitoring. Monitoring, an ongoing process of overseeing the progress of a study from start to finish, is a quality control tool for determining whether study activities are being carried out as planned and whether there are any unexpected safety concerns. Monitoring enables study teams to identify and correct any deficiencies in the conduct, record keeping, or reporting. The Data and Safety Monitoring Plan (DSMP) should be based on a risk assessment of critical data and processes that are necessary for human participant protection and integrity of the investigation.
A study that involves no more than minimal risk will require a plan to protect data and ensure the safety and confidentiality of research participants. A study that involves more than minimal risk (reviewed at the full board) will have additional requirements depending on the level of complexity. The IRB will consider the level of risk and burden a participant may experience in a study when determining additional requirements for a plan.
After reviewing the complexity of a study, the IRB will require the following for medium and high-complexity studies:
- Data Safety Monitoring Plan (DSMP): Must include a plan for both (1) review of participant safety, welfare; and data integrity; and (2) site monitoring conducted by a person independent from the study, ensuring data accuracy and protocol compliance.
- (1) Review of participant’s data for safety, welfare, and to ensure data integrity: Study teams should have a process to review data during initial data collection.
- (2) Site Monitoring: study teams should have a process to ensure that the study is following the protocol, including a review of study procedures, study intervention, and data collection processes.
- For high-complexity studies, monitoring should be conducted by a designated study monitor, an experienced, knowledgeable person who is, ideally, independent of the study team. The responsibility for site monitoring may be delegated by the study sponsor to a Contract Research Organization (CRO).
- For medium-complexity studies, the IRB may approve a site monitoring plan via self-monitoring. Click here for a Self-Assessment Tool
High-complexity clinical trials with international sites
Besides all the above, as applicable, these studies are required to engage a CRO working in the study country, and/or to consult with legal counsel regarding compliance with the country’s clinical research regulations.
Related Guidance
- Data and Safety Monitoring Plan Requirements: This document outlines the DSM requirements for all studies reviewed by the Emory IRB. This latest version is dated 03-26-2024.
- Data and Safety Monitoring Table Requirements: The DSM questionnaire has been integrated into the latest Biomedical Protocol Template (see section 22). Use this table to determine the appropriate Data Safety Monitoring Table to insert into your study protocol.
- Data Safety Monitoring Tables: This contains the tables to insert into your protocol. This latest version is titled DSMT-2024-09.
- Data Safety Monitoring Buard Guidance: This document provides a primer on DSMBs. The latest version is dated 01-11-2022.
- NIH Policy on Data and Safety Monitoring: This is a copy of the National Institutes of Health policy, released June 10, 1998.
Guidance and FAQs
- e-Maintenance of Clinical trials documents: new guidance to give you a step by step of how to certify your hard-copy documents electronically for storing purposes
- Emory IRB Medical Device Guidance
- Dietary Supplements FAQ
- FDA-CDER Chronicles: Drug, Not a drug, or More
- Treatment Use (Expanded Access Use) - Drugs or Devices
- HUD Patient Information Sheet
- Investigational Drugs and Devices
Worksheets and Forms
- Mobile Medical apps worksheet: if using a mobile app during a study, you are required to fill this form.
- REMS Checklist: for studies using a drug or biologic under REMS program
- Dietary Supplements and/or Medical Foods Worksheet: required to document if using as a drug
- Humanitarian Use Device (HUD) Checklist: useful to remind you of HUD requirements
- Emory IRB Device Checklist: required for documenting IDE exemption, non-significant and significant risk device under an abbreviated IDE or an IDE, respectively.
- Investigator Justification for IND Exemption (ver 6-28-23)
- Investigator Checklist for the Use of Schedule I Controlled Substances: Please submit a filled form to Margaret Huber at mhuber@emory.edu in the Office of Research and Compliance (ORIC) for review of any research study using a controlled substance. The ORIC will perform a compliance review to ensure that processes are in place to meet state and federal requirements (ver 6-18-2018).
- Emory HIPAA Policy Guidance (PDF): FAQ plus scenarios to apply Emory HIPAA policy according to study activities (ver 4-12-2021)
- Identifiers: Examples (PDF)
For information about research with students and the Family Educational Rights and Privacy Act (FERPA), please access the Emory IRB Family Educational Rights and Privacy Act (FERPA) Guidance and Worksheet (DOCX).
Access additional links to other Emory Offices' FERPA policies at FERPA
Externally funded: EPEX is required. See OSP site for additional guidance.
Federal funding: There are requirements related to federal funding. All submission related federal funding needs to be reported in the IRB submission. The complete grant application should be uploaded.
If there are multiple performance sites, then single IRB requirements may apply. Contact the reliance listserv at irb.reliance@emory.edu. See our collaborative research page for more information.
Immediate source of funding may not be a federal agency, but funding could be a pass-through award, and federal funding requirements would still apply.
Complete grant must include:
- Grant Cover Sheet
- Performance Sites
- Research/Project Summary and Narrative
- Research Plan and Research Aims/Strategy
- Human Subjects (“Human Subjects and Clinical Trials Information”)
Aims and objectives should align with the protocol.
Modifications:
General modification submission instructions are found here: Modification page-level help
If you or a colleague have a new grant, please use this guidance before trying to add it to an ongoing IRB-approved study:
Please also note that Supplements and Competing Renewals need to be submitted to the IRB as well, along with corresponding updates to the protocol and/or consent form as needed. Supplements may or may not need to be submitted as new IRB protocols instead. Please see the guidance above for connecting new grants to existing protocols.
Resources:
- Children's Healthcare of Atlanta is an entity distinct from Emory. When doing research that involves CHOA, please see the "Collaborative Research" section at left (CHOA information at bottom of page), and always submit this form to the CHOA IRB even when Emory is the IRB of record: CHOA IAA Acknowledgement Form
- CHOA-IRB Application for Medical Imaging Dose Estimate (DOCX)
- Forms and Contact Information from Grady's Office of Research Administration
- Emory-St. Joseph's Hospital Clinical Research Procedures (DOCX)