New Study Application

Please see the sections below for information and instructions

 

How to Obtain an eIRB Account

Users with an Emory or Emory Healthcare NetID can log into eIRB using their NetID and password.

Old eIRB: Once you log in, your account will be created automatically.

New eIRB:

If you have never used eIRB (old or new system) or eIACUC before, you may need to log into eIACUC once (eIRB and eIACUC share a user database). Once logged in, you can go back to eIRB. 

If you did have an account in the old eIRB, you should be able to log into the new eIRB seamlessly.

Please note that eIRB will only send notifications to the email address listed on your account properties page. 

New University Employees/students without an Emory Account:

After you attend employee orientation you can obtain an Emory NetID.   Once you have an Emory NetID, follow the above steps for those who have an EU/EHC account to log into eIRB.

If you are in the process of being hired as an Emory University employee and do not yet have your NetID, DO NOT request a sponsored account. Please contact your HR department and have them start the process of creating your Emory University or Emory Healthcare credentials. Once those have been established, please follow the instructions for those who have an EU/EHC account to log into eIRB. More information about Sponsored Accounts and who is eligible can be found at https://emory.service-now.com/kb_view.do?sysparm_article=KB00188

Overview and Ancillary Reviews

To create a new study in eIRB:

  • Go to SaaS eIRB and log in using your Emory NetID and password.
  • Under the "My Inbox" tab, click on "Create New Study"

The application space for your study will open:

  • Answer all relevant questions - See further below for guidance specific to each page.
  • Keep clicking "Continue" at the bottom right of each page to move to the next page
  • When finished with all pages, click the "Finish" button at the bottom right
  • The study workspace will appear
  • The PI must Click "Submit" at left to submit the study to the IRB. 
    • The PI should "Assign a PI Proxy" (or several) who will have PI privileges throughout the rest of the study's lifespan.
    • This must be done by the PI.  If a study team member assigns themselves as the PI of a new study submission before assigning a study PI, our staff will ask for an email from the PI to approve the submission for the specific study.  Please, refrain from doing this, and have the PI assigning the PI proxy themselves.

 

Ancillary Review Selection:

The PI or PI Proxy may use the “Manage Ancillary Reviews” in the study workspace, if you know which reviews are needed (see below). The IRB staff will do this otherwise, based on the protocol and smartform responses. 

  • Department Review: Required for all studies except RSPH grad student studies. The IRB staff can select for you, or you may do it as well. In question 1, select your Organization (I.e. department or division) for this spreadsheet of departments with approvers: Departmental Approvers list. Do not choose a specific person. Then select “Department Review” from the “Review Type” dropdown. Select “Yes” for “Is a response required?” This will trigger a notification to all approvers associated with that department/division.
  • Faculty Advisor Review: Do not use Ancillary Reviews for this. Instead, please list your faculty advisor as PI and we will request Department Approval. For RSPH, the student can be PI, with the advisor as "Co-Investigator" in the Local Study Team Members section of the smartform. RSPH advisors will be asked to log a comment issuing their approval. 
Note:  For other undergraduate and graduate projects, the faculty advisor needs to be listed as PI, and the study will go through department review.   SOM requires a faculty member to be the PI, and studies to go through department review. 
  • Conflict of Interest: Required if an investigator or their immediate family member meets the threshold for financial interest (see Help on the first page of smartform, in question about PI financial interest.) In question 1, select “Conflict of Interest.” Do not choose a specific person. Then select “Conflict of Interest” from the “Review Type” dropdown. Select “Yes” for “Is a response required?”  This will trigger a notification to the COI office. 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.
  • Controlled Substance Consult: Required if protocol includes the use of any controlled substances (see http://compliance.emory.edu/controlled-substances/index.html). In question 1, select “Controlled Substance Consult.” Do not choose a specific person. Then select “Controlled Substance Consult” from the “Review Type” dropdown. Select “Yes” for “Is a response required?” This will trigger a notification to the Emory Office of Compliance, who will reach out to the study team if needed.
  • EHSO Biosafety: required if you answered "Yes"  to any of the two options under question 2, in the "Ancillary Review Information" section.  For more information about human gene transfer studies review this Emory Biosafety Review Guidelines or email EHSO at biosafe@emory.edu if you selected the second checkbox (Any of the following: microorganisms or infectious materials; human cells...).  To add this ancillary review, select “Biosafety - EHSO" under question 1. Do not choose a specific person. Then select “EHSO - Biosafety” from the “Review Type” dropdown. Select “Yes” for “Is a response required?” This will trigger a notification to the EHSO office.
    • If this is a study conducted only at the VA, do not select this ancillary reviewer as the VA radiation safety officer has a separate process.
  • PRMC: Required for all cancer-related research involving Emory (not solely studies taking place at Winship Cancer Institute; includes chart reviews, public health studies, surveys, etc.). Please see https://winshipcancer.emory.edu/research/clinical-trials-office/clinical-translational-review-committee.html for information and electronic PRMC submission form (submit to PRMC directly, outside of eIRB; may be done prior to eIRB submission but you must have first created a new study, to generate an eIRB number). In question 1, select “PRMC.” Do not choose a specific person. Then select “PRMC (Human Cancer Studies)” from the “Review Type” dropdown. Select “Yes” for “Is a response required?” This will trigger a notification to the PRMC.
  • EHSO - Radiation Safety: Required for protocols that include any type of radiation, whether scans, radioactive drugs, or radiation therapy. See http://irb.emory.edu/forms/Study%20Submission.html for guidance. In question 1, select “Radiation Safety – EHSO.” Do not choose a specific person. Then select “EHSO – Radiation Safety” from the “Review Type” dropdown. Select “Yes” for “Is a response required?” This will trigger a notification to the EHSO office.
    • If this is a study conducted only at the VA, do not select this ancillary reviewer as the VA radiation safety officer has a separate process. 
  • HIPAA Waiver Review: For IRB office use only.
  • Office of Quality: Required for studies that meet certain criteria referenced at http://irb.emory.edu/forms/clinical.html. The Office of Quality oversees the completion of multiple signoffs required before study initiation, e.g. nursing, pharmacy, laboratory, radiology.  In question 1, select “EHC Office of Quality.” Do not choose a specific person. Then select “Office of Quality (Emory Healthcare)” from the “Review Type” dropdown. Select “No” for “Is a response required?” This will trigger a notification to the Office of Quality. IRB approval and consent-form finalization will no longer depend on this approval.
  • REMS Consult: Required for all protocols using a drug under a REMS (Risk Evaluation and Mitigation Strategy, imposed by the FDA). In question 1, select “REMS Consult.” Do not choose a specific person. Then select “REMS Consult” from the “Review Type” dropdown. Select “Yes” for “Is a response required?” This will trigger a notification to the Emory Office of Compliance, who will reach out to the study team if needed.
  • Scientific: For IRB office use only.
  • S-I Advisory: For IRB office use only, when an Emory researcher holds an IND or IDE.
  • VA R&D: Required for all Atlanta VA Research. The Atlanta VA’s Research and Development Committee must review all VA Research after it is approved by the IRB. In question 1, select” Veterans Affairs Medical Center, Atlanta.” Do not choose a specific person. Then select “VA R&D” from the “Review Type” dropdown. Select “No” to “Is a response required?”.

Basic Study Information

  • Title of Study: Title from Protocol/Grant. 
  • Short title: Choose a short title that you will find helpful to use when referring to your study.
    • If using WCG or CIRB: add the prefix “CIRB” or “WCG” before the short title of your study. 
    • If we will rely on an external IRB besides WGC or CIRB: add the “XIRB” prefix, then the initials of the reviewing IRB (Example: use MUSC for Medical University of South Carolina), and then the short title.
    • If Emory is the reviewing IRB for external sites that are enrolling participants (not external collaborators) add the prefix “sIRB” to the short title.
    • If this is a chart review: add the prefix “Chart Review” to your short tittle.
    • If this is an S-I (Emory Sponsor-Investigator) study: add the prefix “S-I” to your short tittle. An S-I study is a study with an Emory investigator holding IND or IDE.
  • Brief Description (Lay Summary): Always use our  Biomedical Guidelines or Sociobehavioral Guidelines.
    • The study will be sent back if the Lay Summary does not include the required elements
  • What kind of study is this?
    • Multi-site or Collaborative study: for studies with at least one other non-Emory-affiliated site. Select this option for WCG/CIRB, XIRB and sIRB studies.
    • Single-site study: only taking place at Emory University, Emory Healthcare facilities, or our closely affiliated sites where Emory faculty conduct research (Grady, Atlanta VA, or Children's Healthcare).  
    • Will an external IRB act as the IRB of record for this study? Say "Yes" if WCG, NCI CIRB, or if another external IRB will be reviewing your study.  Find more information about the reliance process here.
      • If Yes, a question will appear regarding the Lead Principal Investigator. This is not a required question, so if not applicable, leave blank. 
      • If you selected multi-site or collaborative as the study type, and No for "Will an external IRB act as the IRB of record for this study?", you will be asked if our IRB (Emory) will serve as the single IRB of record for other participating sites.  Make sure you have documentation that Emory has agreed to serve as the single IRB of record before marking yes to that question. See the Collaborative Research and External IRBs page for more information.  See below for information on how to fill out the "Basic Local Site Information" page. 
  • Lead Principal Investigator: This is not a required question, and should be left blank if it is a non-Emory person.
  • Local Principal Investigator: This defaults to the person who is creating the submission. If not correct, please revise
    • If the PI is leaving/coming from another institution, fill out this form only when 1) taking or bringing IRB approved studies to/from the other institution, or 2) will remain engaged in research (with the other institution) to be able to continue the study at Emory/Other Institution or 3) if they are taking/bringing the study grant with them.  Attach this form with your submission. Your analyst will let you know if you require an institutional agreement in these cases.
  • Does the local principal investigator have a financial interest related to this research? See the Conflict of Interest Emory Policy in addition to the question’s help text, to see if you have a financial interest.
  • Attach Protocol: make sure you always use our Protocol Templates located in our “Forms and Guidance” tab.  If you do not, the IRB will send the submission back for changes.
    • For multisite protocols that cannot be modified, you must use the Supplement to Sponsor Protocol and attach it with the main protocol. 
    • If the study will be reviewed by an external IRB, provide the protocol that has already been approved by the reviewing IRB. 
    • Note: To receive approval for the use of the Emory IRB short forms, please indicate in your study protocol that you will be enrolling subjects with LEP.  Excluding subjects on the base of their lack of English proficiency should be justified in the protocol.
  • Basic Local Site Information

    If the study will be reviewed by an external IRB, briefly describe research activities that will be conducted by this site. If this site will perform all procedures included in the protocol, enter “ALL.”

    External IRB

    Question 1 asks for the name of the reviewing IRB. Click on the ellipsis (…) to open the options for IRBs. Filter by “Is Eligible sIRB” and select the radio button for the reviewing IRB.

    Question 2 asks for an external study ID. Enter the reviewing IRB’s study ID number. This should be found on the reviewing IRB approval letter.

    Question 3 asks for the reason the study should be reviewed by an external IRB. Indicate if the use of a single IRB is required by the NIH Single IRB Mandate, the Revised Common Rule or by the sponsor.  If none of these are the reasons, describe why the use of a single IRB is desired.

Study Funding Sources

Study Funding Sources

Add all the funding sources for your study.  For example, if the study is funded by NIH, it will be supported by an industry sponsor and Emory will receive a subcontract from the prime awardee institution, include all of these sources in this section. To add a funding source, click on the “+ Add” and enter the information requested for questions 1 – 3.

NOTE: to search for a funder, use our "wildcard" character (%) in case it is not worded as you expected in our database. Example: Searching for NIAID...

Search as

%NIAID (so it will pull up even if it appears as "NIH - NIAID")

If it does not come up, try 

%Allergies and Infectious

If your funding source is not on the list - email us at irb@emory.edu so we can add the name to the list. Please, include the sponsor organization's legal Name, Address, Phone number, and Website/URL (if any).  We will not be able to move forward without this information.

Our analyst will first review a database to make sure the source is truly not there, then submit a form to ORA-IT to get the source added via OSP.  This will need verification from multiple offices before the request is completed.

Question 4 asks for the funding document from the organization listed in question 1. If your study has a federal grant, you need to upload it here.  A Notice of Award (NOA) is not adequate.  The IRB must ensure that the aim(s) of the protocol match the aims in the associated grant application.  See our guidance entitled Guidance to Connect Grants and IRB Approved Protocols for more information.

Repeat the steps for each funding source.

Local Study Team Members

Question 1 asks for the local study team members.  This includes anyone who will be involved in the "design, conduct or reporting of the research” at Emory-affiliated sites.  Do not add anyone who will neither interact/intervene with research subjects nor work with HIPAA-identifiable private information. Make sure everyone is CITI certified and has obtained their additional training for FDA-regulated clinical studies per Emory Policy, if applicable.  Find more information on our Training page.

If using a volunteer in a SOM/SON study, make sure you have received approval by the SOM. Refer to http://www.med.emory.edu/research/resources/internship_program.html before adding to the study.

Question 2 asks to add External team member information. 

These are individuals that are working at Emory or non-Emory sites under the oversight of Emory researchers, who are not directly affiliated with Emory, and who do not have their own IRB review. (If international, see guidance further below.)

As in Question 1, only add people involved in the "design, conduct or reporting of the research,” with the above exceptions. 

  1. Click on "Add" and a new window will open. 
  2. Attach a file created using our External Study Team Members template.
  3. Separately, attach CITI training records for the individual(s), and the IRB Authorization (or Independent Investigator) Agreement (IAA/IIA), if applicable.

An IAA will be required if the external collaborator is working at an institution that regularly conducts human research, and for which Emory does not have an agreement already in place for research. An IIA will be required for independent contractors or individuals from organizations who do not routinely conduct human research). If you are adding more than one External study team member, you may attach a file with all the names of the collaborators, and their institutions; add their training files separately. For more information about this process, go to our Collaborative Research and External IRBs page.

This is also the place to add collaborators from CHOA, the VA, and Grady who do not have an Emory affiliation. 

For studies with international sites: 

Include collaborating study team members at international sites that are under the Emory PI’s oversight, but who are not directly employed attender affiliated with Emory University. For example, these may be independent enumerators, interviewers, research assistants, co-investigators, or research nurses that are hired by the Emory study team under a sub-contract.  Adding study team members at international sites may or may not require IRB Authorization Agreements or Independent Investigator Agreements. 

If the collaborating study team member activities are reviewed by a local ethics committee, and not under the oversight of Emory, you should not list them under question 2.

Study Scope

Question 1- answer yes if you are using a drug or biologic, FDA approved or not, or are using a food or dietary supplement as a drug (to diagnose, cure, treat or mitigate a disease or condition).  

Question 2*- answer yes if using a device (FDA approved or not) in a research study. Also, say yes if you are using a HUD device to treat patients or in a research study.  If you are not sure if you should click yes to this question, please review our device guidance

Add Local Research Locations

NOTE: Ignore the contact information for "Rebecca Rousselle" listed on each site. This was to fill a required field that is not applicable for Emory.

Add all local sites where human research activities will be conducted.

  • This also includes the locations where the data will be stored physically. 
  • You do not need to add a "site" for Emory-approved cloud storage (Emory Box or Emory 365 OneDrive), but please include the information in your protocol.
  • CHOA, Atlanta VA, and Grady can be listed as local sites. You may also add the Proton Therapy Center.
  • Other non-Emory sites in an Emory-led study should just be listed in the protocol (if Emory will serve as the IRB of record for those sites, instructions will be provided to add those as "pSites" outside of this smartform).
  • Non-Emory sites in a sponsor-led study do not need to be listed in the Emory IRB submission 
  • International sites: please include specific details in your research protocol document instead of in "Local Research Sites." 

 

Drugs

Question 1- Please add all the drugs (FDA-approved or not) used as part of this research study.  Drugs used for treatment not described in the study protocol (for example, a subject may receive pain medicine during their hospital stay, dosing and timing not dictated by the study protocol) do not need to be listed. A new window will pop up when clicking on "+Add":

  • Under Question 1, please select the name of the drug from the dropdown menu.  If the drug is not listed, you may add it.  Please, make sure you check the drug spelling when adding it to the submission as any new drugs added will become part of the eIRB database for others to select.
  • Under Question 2, attach Investigational Brochures (for drugs under an IND) or packet inserts (for FDA-approved drugs).

Question 2- Select if your study will be under an IND.  As a reminder, if you are using a medical food or dietary supplement for research, you may need to obtain an IND if the food or supplement is being used as a "drug".  See our Dietary Supplements FAQ or our Dietary Supplements and/or Medical Foods Checklist and attach it to the submission (under Attach Files question in this section) if applicable. 

If you say Yes to this question, a new question will appear for IND-related information. Select "Sponsor" as the IND holder if this is a person or entity outside Emory. Select "Investigator" if the IND holder is the Emory PI or a person associated with Emory. Please identify the IND holder in the study protocol as well.

“Attach Files” Question - Please attach FDA “may proceed” letters, or the IND exemption form if you are using an approved drug for another indication but you think the use in the study should be IND exempt.  If you are a Sponsor Investigator(S-I), attach here your S-I IND Responsibilities Checklist (or S-I IND Responsibilities Checklist Multi-site Trials if applicable).  For more information about S-I responsibilities go to this page.

Also, attach the Investigator Checklist for the Use of Schedule I Controlled Substances or the REMS Checklist if applicable.

Devices

Question 1- Add all the devices (FDA-approved or not) that are being studied.  Do not include FDA approved devices used per their approved indications to simply collect data about subjects, such as X-rays or MRIs, unless they are being evaluated for safety or effectiveness. Click on "+Add" to add a new device:

  • Under Question 1, please select the name of the device from the dropdown menu.  If the device is not listed, you may add it.  Please, make sure you check the device spelling when adding it to the submission.
  • Under Question 2, attach device manuals or other related information for devices
  • Select if the device is under a HUD or not.

Question 2- Select as appropriate.  If you are claiming that your study is under an abbreviated IDE or Exempt from IDE requirements, please complete our device checklist and attach it under the "Attach Files" question.  If you selected that the study is under an IDE or HDE, a new question will be available:

  • Select "Sponsor" as the IDE holder if this is a person or entity outside Emory. Select "Investigator" if the IDE holder is the Emory PI or a person associated with Emory. Please identify the IDE holder in the study protocol as well.

“Attach Files” Question - Please attach FDA “may proceed” letters, or our device checklist if you believe the use of the device should be IDE exempt or is non-significant risk. If you are a Sponsor-Investigator (S-I), attach your S-I IDE Responsibilities Checklist(or S-I IDE Responsibilities Checklist Multi-site Trials if applicable). For more information about S-I responsibilities go to this page.

Study Related Documents- Only for studies using an external IRB

Question 1- For studies that will be reviewed by an external IRB other than WIRB and CIRB, upload the model consent and assent forms approved by the reviewing IRB. If the reviewing IRB does not have approved model consent forms (Example: recruitment will only happen at Emory so there is no model consent approved by the reviewing IRB.) then attach all consent, consent/HIPAA, and assent forms using our templates, as applicable.  For WIRB studies,  use our current WIRB Emory Consent Checklist.  If you have the consent form, please attach it here.  For CIRB studies,  use our Site-Specific Consent-HIPAA Addendum plus the CIRB approved consent form.  More information about collaborative research can be found here: http://www.irb.emory.edu/forms/external-irbs/index.html.

Question 2- For studies that will be reviewed by an external IRB, you do not need to provide recruitment materials.   However, you are still responsible for adhering to Emory’s policies. Review our Advertising and Recruitment: Guidance & Information and Guidelines for Using Social Media to Recruit Research Participants for current information.  We have other recruitment guidance under our study submission guidance page, in the Advertisement, Recruitment and Compensation section.

Question 3-Other attachments: attach other related documents as detailed in the submission.  For WIRB studies, please attach here your Form A.  To get a Form A for your study, complete this form, submit it and save and attach here a PDF copy. If Emory will serve as the reviewing IRB for external sites and you completed a reliance request form in word, upload the form here.

Local Site Documents

Question 1- Attach all consent, consent/HIPAA forms, and assent form using our templates.  For studies that will be reviewed by an external IRB, attach the site-specific consent, consent/HIPAA and assent forms created using the model forms already approved by the reviewing IRB. Note that all site-specific changes to the model forms are to be made using tracked changes.

Translated Consent documents  You are not required to submit translated consent/assent documents with the initial submission.  They may be submitted via a modification after the study is approved. Review Emory IRB Policy & Procedure #45, Informed Consent of NON-ENGLISH-SPEAKING PARTICIPANTS for further requirements regarding translated consent/assent documents. 

Question 2- Attach only the most recent versions of all recruitment materials. Review our Advertising and Recruitment: Guidance & Information and Guidelines for Using Social Media to Recruit Research Participants for current information.  We have additional recruitment guidance under our study submission guidance page, in the Advertisement, Recruitment and Compensation section.

Question 3-Other attachments: Attach other related documents as detailed in the submission. For studies that will be reviewed by an external IRB other than WIRB and CIRB, attach reliance documents for your site that may be provided by the reviewing IRB such as the local context review form, institutional profile and reliance agreement.

For research conducted internationally, you will either need to provide your in-country ethics review board approval OR a Letter of Cultural Context; and as required study site permission.

Waiver Requests and Ancillary Considerations

These are Emory specific questions that will allow us to ensure that Emory policies are being followed.  

For the HIPAA-related questions, please review our current guidance.  All studies need to complete the HIPAA Applicability and Waiver Worksheet. If you are not requesting a partial or complete HIPAA waiver, you only need to answer the HIPAA applicability part of the form.  For studies that will be reviewed by an external IRB other than WIRB or CIRB, attach documentation of all waivers granted by the reviewing IRB for the study as a whole (not for the Emory site which has not yet been approved by the reviewing IRB.)

For Ancillary review information, check the section above ("Overview: Submitting a study in eIRB") for more information on what you need if answering "yes" to any of these questions.  

For the "Clinical Research/Expanded Access Only" section: if you are submitting an expanded access request, review our current guidance.  The single-use request may not need full IRB approval.  You still need to submit a Clinical Research Key Points Summary and attach it under question 4 in this section.  

Making Document Changes After Staff/IRB Member Review

Remember the following:

  • Modifying Microsoft Word documents (protocol, consents, etc): Tracked changes versions are no longer required
    • The system creates a comparison document for the IRB reviewer.
    • PDF and other document types must come with a tracked version, however.