Email Blasts Archives

External IRB Submissions: Important Reminders

Be sure to review the consolidated submission guidance under the “Emory Relying on External IRBs” tab on our collaborative research page when Emory is relying on an external IRB.

Note that we streamlined the institutional sign-off process November 2021, below is a recap:

Submit an external study application in eIRB (one marked that Emory is relying on an external IRB) only after the study is approved by the reviewing IRB and documentation of the following is in included in the submission (as applicable):

• EPEX number (the number Emory’s Compass system uses to track grants/contracts)
• Confirmation of the “in case of injury option” from RAS/OSP, listed in eCTS (Not needed for non-profit and federally-funded studies - these use Option 1)
• Completed External Consent Checklist and tracked site-specific consent forms. If sponsor requires their review of site consent forms, route to sponsor for review before submitting to the Emory IRB.
• Approvals from ancillary review committees (e.g. Radiation Safety, Biosafety, PRMC, OIT)
• Required CITI training for all study team members (click "View CITI Training" on the left menu in the study workspace, to confirm)

You can create a study in eIRB in advance to get a Study ID number for routing and to work on the smartform, but all of the above must be in place before the PI clicks "Submit." 

Form A is no longer required for WCG or Advarra studies.

Protocol and Assent Template Updates: What's Inside

Please see our updated protocol and assent templates. Always use our most up-to-date templates available for new submissions.

Protocol Revisions:

• Objectives: questions on algorithm/AI/clinical decision tool development
• Procedures: question on local lab processing of specimens for EHSO ancillary review purposes
• Population: reminder to provide rationale for exclusion of non-English speakers
• Data Management and Confidentiality: questions about third party data sharing and security review
• Multi-site: questions about external collaborators

Assent Revisions:

• The cover page has added clarification in the option for when the child may be unable or unwilling to provide informed assent for non-age related reasons. It clarifies that the study must hold out the prospect of direct benefit to health and wellbeing of the child.

Enrolling Cognitively Impaired Adults: Plan Ahead

Sometimes, a study team encounters a potential adult participant who meets most eligibility criteria, but is not cognitively capable of consenting for themselves, If this wasn’t already considered in the IRB-approved protocol, then a Modification is needed prior to moving forward. We recommend that study teams seriously consider this possibility when writing the initial protocol. There needs to be a rationale for enrolling participants unable to consent for themselves, along with other additional protections. Please see our Cognitively Impaired Checklistto see what the IRB needs to review.

IB (Investigator Brochure) Updates: Late is not Great!

If you are submitting documents that include a new or increased risk, such as a new SAE described in the protocol and/or informed consent, new risks in an IB, etc.), the IRB requires these changes to be submitted within 10 business days of the document receipt from the sponsor.

If an IB is not submitted within 10 business days, an RNI will be required. Other changes as described above may also require an RNI, if there is a delay in submission.

Please see our section on ‘Delays Submitting Study Documents’ in the Modifications section of our eIRB page level help for guidance as to when an RNI may be needed.

Modification Summaries: Keys to Efficient IRB Review

Your Emory colleagues who serve on the IRB have a small request to help them be much more efficient when reviewing Modifications:

Please include an overview of the changes in the “Summarize the Modifications” section of the MOD/CR smartform. The IRB staff will remind you as well.

Emphasize changes that significantly impact risk or study design. For minor changes like formatting or typos, you can summarize as something like “Other minor format and grammatical changes throughout.”

In addition, be sure to follow our modification instructions for how to submit updated documents. The system can automatically track changes across versions, but that only works if updates are done in a certain way.  

Upcoming Holidays and Associated eIRB Submission Considerations

As the holiday season approaches, please submit early and anticipate longer turn-around times.

• If your study is expiring prior to Friday January 13^th or close to holiday period, please submit complete continuing reviews 45 days or more in advance considering the holidays. For new study submissions and modifications, please submit as early as possible and alert the analyst about any external deadlines.

Please be sure to use our required protocol and consent templates and review our page level guidance. Please see our committee meetings page for meetings that will be shifted due to the holidays.

• October 2022:
  • The B1 meeting on October 5th has been cancelled due to it falling during Yom Kippur.
  • There may be minor delays with some Biomedical reviews due to our members’ involvement in the EPIC/OnCore roll out.
  • Monday October 10^th – Wednesday October 12^th: The Emory IRB staff will be attending ORA Research Week and will be checking inboxes intermittently.
• November 2022: Emory IRB will be closed Thursday November 24^th – Friday November 25^th
• December 2022 – January 2023: Emory IRB will be closed Friday December 23^rd through Monday January 2^nd.

Lay Summary Guidance Update

Please see our updated lay summary guidance which outlines the required essentials in eIRB’s Brief Description Section.

Reminder: Please update your lay summary during modifications if your lay summary is missing, incomplete, or does not provide all the required information.

Emory IRB Templates Reminders

• You must always use the latest Emory IRB Templates available on our website.
• Please do not repurpose an old study protocol or consent form in a new study submission.
• Also, please avoid copy/pasting our template in a new Word document as that will remove the headers/footers/version dates. 

Best Practices for Contacting Emory IRB

• We've found that when people send the same question to multiple staff in a short timeframe, it can cause confusion and redundant work. So, please always make it clear if you have already reached out to others.
• For any question related to an active eIRB submission already assigned to an IRB analyst, please reach out to the IRB analyst.
  • If you do not receive a response within 2 business days or if you have an urgent issue, IRB leadership is standing by to help!
• For questions related to education, noncompliance, RNIs, complaints, etc., please reach out to a Q team member.
• After reviewing our Collaborative Research page, reach out to irb.reliance@emory.edu with questions regarding reliance/collaborative research.
• For all other inquiries, use our IRB inquiry form. 

New FDA Guidance on Clinical Decision Support Software

There is new FDA guidance on “Clinical Decision Support Software.” Per the guidance, a software function must meet all four criteria below to be considered a Non-Device CDS.*

1. The software function does NOT acquire, process, or analyze medical images, signals, or patterns.
2. The software function displays, analyzes, or prints medical information normally communicated between health care professionals (HCPs).
3. The software function provides recommendations (information/options) to a HCP rather than provide a specific output or directive.
4. The software function provides the basis of the recommendations so that the HCP does not rely primarily on any recommendations to make a decision.

*If all four criteria are met, the software function may be non-device CDS. If a study includes software that does not meet the above criteria, we will apply typical device determinations (e.g. "non-significant risk device").

Non-Human Subjects Research (NHSR) Determination Form Reminder

Use our Non-Human Subjects Research (NHSR) Determination Form when you aren’t sure whether the project you are working on is human subjects research.

The NHSR tool is available on our ‘Does My Project Need IRB Review?’ page.

The form will indicate if the study needs an IRB submission. Ensure the responses in the form are accurate as the determination is specific to the responses provided in the form.

Site Consideration Reminders Former Dekalb Medical Facilities, Multisite Federally-Funded Research with Tribal Nations

• Emory Decatur Hospital (EDH) and other former Dekalb Medical Facilities: There continue to be strict limitations on the types of human research that can occur at these sites. Stay tuned for updates, as limitations will gradually be lifted with the roll out of EPIC and OnCore. Currently, only minimal risk, observational studies and Covid-related clinical trials may take place there, and only with special permission.
  
• Multisite Federally-Funded Studies requiring a single IRB: Talk to our Reliance Team and review this page as far in advance as possible, especially if Emory is the prime awardee.
• Tribal Nations: Consult the IRB early when you are planning to conduct research with or within Tribal Nations. As a reminder, Tribal Nations are independent governments with their own rules and regulations. No research may take place with or within Tribal Nations (or their sub-districts) prior to confirming exactly what approvals are needed, possibly with advice from outside legal counsel.   

Non-Emory Study Team Members, and Interns/Students/Volunteers

The IRB needs to be clear when non-Emory personnel are working on studies, if they will be covered by our IRB review.

Sometimes, non-Emory people have sponsored Emory accounts, and they are added in a way that makes them appear to be Emory personnel. This can create compliance problems.

Thus, we ask that you always do the following:

• List such personnel in the “External team member information” section of the smartform.
  • This includes interns and volunteers, and those with sponsored accounts.
  • You only need to list people engaged in human subjects research, who are not already covered by another IRB’s review.
• Alert the IRB analyst that you are adding non-Emory personnel. 
• List them using this template, to show what each person will do on the study.

Please also see our new FAQ about Interns/Students/Minors/Volunteers on Research Teams!

August IRB Webinar on IRB Post-Approval Monitoring

Tune in for our next webinar on IRB Post-Approval Monitoring on Thursday August 11^th at noon which will cover monitoring activities undertaken by the IRB including record reviews and informed consent process monitoring.

GDPR and PIPL (China) – Legal Considerations for Research in Europe and China

Please be aware that consent form language and other considerations will apply if you will conduct any human research in the European Union or China, due to strict privacy laws. The IRB may need to consult with Compliance and/or legal colleagues for certain studies. Please consult with Compliance early in planning stages if possible.

Lay Summaries in Migrated Studies

If your lay summary is cut off or missing in eIRB, because the study migrated from our old system, please update it in your next modification. The IRB has started requiring this in order to make subsequent reviews more efficient.

Cost Options in the Consent Forms: Streamlined Process!

Good news! You can now use default “Costs” language to explain potential costs to subjects in consent forms, without the IRB waiting for OCR’s input.

• For studies that involve any billable items and procedures, use “Option 2”
• For studies with no billable items or procedures, use “Option 1” instead

These default Options are appropriate in most cases, so waiting on confirmation from OCR introduced an unnecessary delay. If OCR completes their review and finds an exception, they will notify the IRB, who will then request a Modification.

Note: We are still working on a streamlined procedure for Department of Pediatrics studies where the PRA is not handled by OCR.

OIT Security Review Reminder

If your study will use any technology/software that requires Emory OIT, CHOA, or Grady IT Security review, submit a security review request to IT with all the required information as soon as possible and provide your IRB analyst with the security review ticket number. Security reviews can take a while, depending on the study.

You can see the guidelines/requirements in advance here, under “Data Security"

The IRB is not part of the Security Review process, and we do not set the requirements or guidelines, but we do try to stay updated on the progress of the reviews.

New COI/COC Disclosure System Coming Fall 2022

eDisclose is a new cloud-based enterprise-wide system for disclosing financial interests and requesting approval for external activities. eDisclose will replace eCOI and go live in Fall 2022. eDisclose offers an improved user experience, will streamline enterprise-wide processes, and facilitates compliance with new U.S. regulations. As a Huron SaaS (Software as a Service) product, new functionality and features are released on an ongoing basis to meet evolving federal regulatory requirements and reporting improvements will provide more reliable data to make informed business decisions. 

eDisclose will be utilized by faculty, staff, and sometimes students, who are required to disclose financial interests and request approval for external activities. This change will impact all schools,  

Emory Healthcare​, Office of Compliance​, Risk Management​, Office of Technology Transfer (OTT)​, Office of Sponsored Programs (OSP)​, Institutional Review Board (IRB)​, Institutional Care and Use Committee (IACUC)​, and Research Administration Services (RAS)​. 

A townhall will be held Tuesday, August 9 at 12PM. The purpose of this townhall is to provide an overview of eDisclose, discuss how processes are being streamlined in eDisclose, discuss the training plan, provide a live eDisclose demo, and answer questions. 

How to Register: This Zoom registration event has passed.

Submit Advance Questions: You may submit questions in advance to be answered during the webinar. To submit questions in advance, please submit them here: https://www.surveymonkey.com/r/FVFZKN8.  Please note that advance question submission will close on  Monday, August 8^th @ 4PM. You may also ask questions live during the webinar.  

Please visit the eDisclose SharePoint site for more information or contact edisclose@emory.edu. 

Updated Consent Template Language for Clinical Trials

We’ve added a new option for clinicaltrials.gov language for NIH-funded clinical trials that are not “Applicable Clinical Trials.” See margin comments for some additional guidance about which statement to use. Stay tuned for more information regarding this update impacting external IRB studies. Please see our updated consent templates in our consent toolkit.

We will begin screening for the correct language going forward.

How to Speed-up Review of Your Study Modifications

1. Summarize the changes on the first page of the Smart Form
   • Example: Instead of saying "Protocol Amendment #4," say "Revising protocol to include an additional scan, and to increase the age range to 75."
   • If applicable, also explain why changes are being made
2. Always use the "Update" button to submit revised documents
   • This will automatically create a tracked-changes copy for the IRB, no need to upload that separately
   • Caveat: does not work for PDFs (for those, upload tracked-changes and clean copies)
3. Use this as an opportunity to remove all outdated study documents
4. Finally, do not submit Mods adding new NIH grants/contracts without first consulting the IRB.
   • The default for any new grant is a new IRB submission. Doing a Mod instead can result in delays that can impact your Just In Time requirements.
   • In some limited cases, new grants can be added to existing IRB protocols. We need all of the information found in this guidance before we can approve: Guidance Adding Grants to IRB Approved Protocols (PDF)

Data and Specimen Storing/Sharing Reminder

Data/specimen banking sections in protocols should be used for any study saving/storing data or specimens for future research use, and this should match in the Informed Consent section, "Storing and Sharing Your Information." Please address plans for storing/sharing data (identifiable or de-identified) long-term, beyond the conclusion of the current study, including any potential use in future research.

IRB Webinars will return in August 2022

The monthly IRB webinar series will be on hiatus for the summer. Our next IRB webinar will be Thursday August 11^th at noon. Have a wonderful summer!

Updated Data and Safety Monitoring Plan Requirements

Please see our updated Data and Safety Monitoring Plan (DSMP) requirements (PDF), which originally went into effect last year. Please note the change from 3 high complexity categories to 2. Please also see the new monitoring questionnaire and monitoring tables (DOCX) to put the requirements into practice and document your monitoring plan in the protocol. All more than minimal risk studies that are investigator-initiated or Emory-led multi-site studies, or other multi-site studies that are not monitored by a CRO will be required to use the questionnaire and monitoring tables:

• The completed questionnaire should be uploaded as a separate document in the Basic Study Information section of eIRB for more than minimal risk studies (alongside the protocol)
• The completed monitoring table should be pasted into the protocol's DSMP section.

These requirements apply to all new study submissions as of 1/25/2022.

Updated Protocol Templates

Please see our updated protocol templates which now include the checklists at the end instead of as a separate document. They also include new guidance in some of the “population” sections, and new requirements to include a monitoring table in some more than minimal risk studies (see above section). These protocol templates are required for all new study submissions as of 1/25/2022.

Student Research Reminder

Please submit early if you plan to conduct research this spring or summer. As a reminder, we cannot provide retroactive approval for Human Subjects Research conducted without IRB approval.

IRB Webinar on Important Protocol Template Updates

Our upcoming webinar, Thursday January 13th at noon, will present our protocol template updates.

The link to the live webinar and recordings of past webinars can be found on our Webinars page of the IRB website.

Update for Research in China

In November, the Chinese government passed a new privacy law that impacts research data collected there. Emory compliance and legal offices are working on formal guidance, but for now, please consult with the IRB early if you plan to conduct research in China. Currently the IRB is providing additional language for informed consent forms, letting participants know the limitations to their privacy. Depending on the nature of the study, it is possible that paid legal counsel will be required.

Collaborative Research Reminder

As a reminder, please see our collaborative research guidance page linked below in helpful links and submit to Emory IRB once everything is in place.

Emory IRB Website Update

You will soon see major changes to the IRB's website, similar to other Emory sites. The same information, guidance, and resources will be available but the visual user experience will be different. We have kept most of the same information bucketed together to make the transition as easy as possible. We hope it will be an improved experience, but welcome your feedback!