Study Submission Guidance

Technical instructions for using the eIRB system are found here: eIRB Training

Below are templates, tools, and guidance documents for your IRB submission. Click any header to expand the section.

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 consent 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 eICF, go here.

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.  

Advertisement, Recruitment and Compensation

"Costs" and "In Case of Injury" Policies

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

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 more information.  

Data Security and Mobile (Medical) Apps

For studies taking place at CHOA, please log in to CHOA 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.

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

Clinical Study Tools, Templates and Checklists

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

Drugs, Devices, and Other FDA Regulated Products

HIPAA-Related Guidance

Ancillary Review

Ancillary reviewers (including department reviewers): see this video to know how to submit your reviews

Review by applicable compliance/oversight offices is needed before IRB can issue final approval, or (in the case of Office of Quality) before IRB can issue stamped consent forms. eIRB has integrated approval buttons for each of these offices, but you must submit applications separately to each.

  • Biosafety Review Guidelines. Special Recombinant DNA review is also needed for studies falling under the NIH policy. For more information about human gene transfer studies review this Emory Biosafety Review Guidelines or email EHSO at biosafe@emory.edu for studies using any of the following: microorganisms or infectious materials; human cells, cell lines, serum, stool samples, or any other human source materials; nanomaterials; genetically modified primary cells or cell lines; genetically modified live or live-attenuated microbes; human or non-human primate blood that is brought to a laboratory for further experimentation and transferred to a central lab; arthropods; plant products; toxins; environmental samples. 
  • Conflict of Interest Guidance for Emory University. When you disclose COI in our eIRB smartform, the IRB must receive a determination from the COI office prior to final IRB approval. The IRB also reviews all COI management plans, and may rarely add additional requirements to the plans. 
  • CTRC: Reviews all cancer-related resarch involving Emory (not solely studies taking place at Winship Cancer Institute; includes chart reviews, public health studies, surveys, etc). CTRC approval usually must be in place before the IRB begins our review; eIRB sets this requirement automatically when "Cancer-Related Research" is checked off under "Biomedical Research" section (for chart reviews or other studies that don't trigger that page of the eIRB smartform, you can check it off via the jump-to mention at the top of each page; or, the IRB staff will catch it once the study comes to us and route it at that point). Please see https://winshipcancer.emory.edu/research/clinical-trials-office/clinical-translational-review-committee.html for information and electronic CTRC submission form (submit to CTRC directly, outside of eIRB; may be done prior to eIRB submission but you must have created a new study, to generate an eIRB number). Note: the e-CTRC form only works when logged into the Emory network. 
  • Office of Quality Checklist: The Office of Quality oversees completion of multiple sign-off's required before study initiation, e.g. nursing, pharmacy, laboratory, radiology. Some parts of the checklists for sign-off are now built into eIRB; the radiology and laboratory ones can be found here: http://irb.emory.edu/forms/clinical.html. Office of Quality final sign-off must be in place before the IRB releases stamped consent forms, but does not hold up IRB approval. 
  • RDRC: A radiation subcommittee that reviews basic research using radioactive drugs in humans without an IND (must be 30 or fewer subjects). Contact Ike Hall (mjhall@emory.edu) for the application.

Vulnerable Populations Checklists and Guidance

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

Classroom Research Considerations (FERPA)

For information about research with students and the Family Educational Righsts and Privacy act, 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

Additional Study Documents and Guidance