Study Submission Guidance

 

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Prepare using the required templates, tools, and guidance below. 

 

Initial Submission Decision Charts

Lay Summary Requirements

Lay summaries are actually very important for efficient IRB review, throughout the life of the study. Please use the guidelines below. Studies may be returned if lay summary is inadequate.

Protocol Templates and Protocol Checklists - Required

Which Protocol Template and Protocol checklist should I use?

Use our Biomedical template and Biomedical Protocol Checklist if your study involves clinical procedures or tests (except for behavioral studies where the only collected sample is obtained via a non-invasive method, for example, saliva for cortisol tests).  Last Version 3/15/2021

Use our Supplement to Sponsor Protocol and Checklist for studies that are industry-sponsored and industry-initiated, or when we are one of the sites in a multisite study we are not leading. You will be required to attach these forms plus the main protocol from the sponsor to the submission.  Last Version 3/12/2021

Use our Sociobehavioral template and Sociobehavioral Protocol Checklist if your study involves interviews, surveys, focus groups, or behavioral interventions. Last Version 3/15/2021

Use our Chart Review template and Chart Review Checklist for studies involving solely a review of medical charts. If your study involves solely the review of charts at CHOA, submit to the CHOA IRB instead. Last Version 3/12/2021

Use our Registry, Repository, or Database and Checklist for projects creating a registry, biospecimen repositories, or databases created, even if partially, to conduct research projects in the future. If this registry, repository, or database will only include data or biospecimens from CHOA participants, submit to the CHOA IRB instead.  Last Version 3/12/2021

Use our Secondary Data/Biospecimen Analysis template and Checklist for studies that are solely using previously collected data or biospecimens.  Last Version 3/15/2021

If you are using a Humanitarian Use Device for treatment purposes, use our HUD for Treatment Use template. 

 

Winship Cancer Institute

Use the Winship Clinical Protocol Template and our Biomedical Protocol Checklist for clinical trials conducted at the Winship Cancer Institute.

 

Guidance Information

  • NIH Protocol building tool for Phase 2 or 3 IND/IDE Trials: Highly encouraged to refer to this when submitting NIH grants for these types of studies. Ensure that you are covering all these elements when creating your protocol using our templates.  If NIH requires you to use their template, you will be required to create a supplement to Sponsor Protocol with your protocol.

Informed Consent Forms, Assents and HIPAA authorizations

Access our current templates for Informed Consent Forms, HIPAA authorizations, and Assents, click here.

For informed consent guidance, including the use of electronic Informed Consent, go here.

Advertisement, Recruitment and Compensation

Ancillary Reviews

Ancillary reviewers (including department reviewers): see 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 page-level help.

Clinical Study Tools, Templates and Checklists

Please see the "Clinical Study Initiation" section at left.

Community Engagement for Subject Recruitment

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.  

"Costs" and "In Case of Injury" Policies

These policies are the basis for the required language you find in our consent form templates.

Data Security, e-Consent, and Mobile (Medical) Apps

For studies taking place at Children's Healthcare, please log in to their intranet (Careforce) and access this link for information on how to submit for security review. Please refer all questions to BISRA@choa.org.

For studies taking place at Grady: 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.

DSMP, Site Monitoring and DSMB Guidance

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 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).
      • Site Monitoring conducted via Self-monitoring: a process for self-assessment of protocol compliance and data integrity which can be part of an overall DSMP.  For medium-complexity studies, the IRB may approve a monitoring plan relying on self-monitoring. Click here for a Self-Monitoring 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.

Check this guidance for details on what the IRB will be looking for in your DSMP.  

Department of Defense, Department of Energy, and ICH-GCP Checklists

Drugs, Devices, and Other FDA Regulated Products

HIPAA and FERPA Guidance

 

For information about research with students and the Family Educational Righsts and Privacy Act (FERPA), please access the Emory IRB Family Educational Rights and Privacy Act (FERPA) Guidance and Worksheet.

Access additional links to other Emory Offices' FERPA policies at http://registrar.emory.edu/records-transcripts/ferpa.html

Modifications for Adding New Funding

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. Thank you!

Vulnerable Populations Checklists and Guidance

Children's Healthcare of Atlanta, Grady and St. Josephs Hospital Studies

Additional Study Documents and Guidance