Email Blasts Archives

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 Use this as an opportunity to remove all outdated study documents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 newIRB submission. Doing a Mod instead can result in delays that can impact your Just In Time requirements.
• In some limitedcases, 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

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!

IRB Webinar Hiatus in December 2021

The Emory IRB will be taking a webinar hiatus in December 2021. Our next webinar will be Thursday January 13, 2022, and we will update information regarding that webinar when we are closer to that date.

Recordings of past webinars can be found on our Webinars page of the IRB website.

Emory IRB closed during Emory University Winter Recess

As a reminder, the Emory IRB will be closed during the Emory winter recess between Friday December 24, 2021 – Monday, January 3, 2022. We need enough time before the break to screen submissions before they are reviewed! Please see below for submission deadlines.

Continuing Reviews: To allow enough time for your CR to be screened and processed, please submit your CR by Friday 12/10/2021 if your study expires before 1/28/22. To avoid delays in processing, review the information provided last year for accuracy and confirm CITI training for study staff before submitting to the IRB. Provide CTAC auto reply email and DSMB reports if applicable.

New Study Submissions and Modifications: Please submit as early as possible and alert the analyst about any external deadlines. Be sure to use our required protocol templates and page-level help to allow for a more efficient review.

Please contact our staff leadership if you have any questions.

OIT-Approved Technology for Research

As a reminder, you should only use OIT-approved technology for any technology solution being used to collect, store, or transmit PHI/IIHI/or identifiable sensitive information. Anything not already approved that is being used as described above will require OIT Security Review. For more information, review our guidance materials (PDF) on when a security review is needed. Submit early (and completely!) to avoid study processing delays.

Note: Studies taking place at Children's Healthcare or Grady require security review from that facility. See the data security section of our study submission guidance for contact details.

Consent and HIPAA Authorization Template Updates– Required As of 11/19/21

You may have noticed some updates to our consent toolkit page. Any studies submitted after 11/19/2021 will be expected to use the revised templates. You do not have to update consents for already-approved studies.

Here are the key highlights:

• HIPAA and Confidentiality language: You will now paste the appropriate language in from a separate document
  • Choose the applicable language based on your completed HIPAA Applicability and Waiver Worksheet (DOCX), which you also upload in the smartform.

NOTE: We are aware that certain document links do not open from our eIRB smartform. This is due to updated security features in browsers. The vendor is working on this.

The documents are still on our website. You can copy the link address by right-clicking, selecting “Copy link address,” then pasting into a new browser tab or window.

• Optional substudy section(s) must now be after the main signature lines
  • This change is driven by ethical best practice, to have people decide about overall participation before being asked to sign on for specific activities.
• “How will my study drug be provided”? - informs participants that only licensed clinicians can address certain types of questions that would be considered drug counseling
• Storing and Sharing your Information - clarification on how specimens may be stored or shared
• Costs sections provide additional clarification.

WCG/WIRB Studies Process Update and Updates/Reminders on External Studies

We are rolling out a more streamlined process for WCG studies! The new process aligns with the "Lean" idea of getting the right things, to the right place, at the right time.

Before submitting to the Emory IRB

1. Review the guidance posted on our website.
2. Complete “Form A” as usual.
3. Upload the WCG initial approval letter for the study and approved master consent in the Study Related Documents section of our smartform.
4. Obtain the following and include in your submission in eIRB:
   1. EPEX number
   2. Confirmation of “Costs” option from OCR or Peds RAS
   3. Confirmation of “in case of injury” option from RAS/OSP (listed in eCTS)
   4. Confirm required CITI and GCP training for study team members
   5. Approvals from ancillary review committees

5.Complete the External IRB Consent Checklist and insert Emory language into the master consent form approved by WIRB, using tracked changes. Upload in the Local Documents section.

All of the above must be in place before the PI clicks “Submit.” You can still create an eIRB study in advance, to get a Study ID number for routing, and work on the smartform.

Before submitting to WIRB:

CITI Reminder: For initial submissions as well as continuing reviews, click “View CITI Training” on the left menu in eIRB to confirm CITI is current for all study team members before submitting. Submitting without current CITI training will prevent delays in processing.

Bonus Streamlining Measure: WIRB will not let Sponsors change Emory’s “Costs” or “in case of injury” language. This will avoid a major source of delays in Emory institutional sign-off. WIRB is aware of the language in our external IRB consent checklist.

Study Approval Expiring during Winter Recess? Submit Continuing Review Early!

Emory IRB will be closed for Thanksgiving November 24^th – 25^th and for Winter Break December 24^th – January 3^rd.

To allow enough time for your CR to be screened and processed, please submit your CR by Friday 12/3/2021 if your study expires before 1/21/22. To avoid delays in processing, review the information provided in last year’s CR for accuracy and confirm CITI training for study staff before submitting to the IRB. Provide CTAC auto reply email and DSMB reports if applicable.

Thank You for Your Patience!

Thank you for your patience given our significant recent staff turnover. We are working hard on hiring and training, and hope to be fully staffed again soon. Meanwhile, if you have special circumstances that require prioritized review, you may contact our IRB staff leadership at the numbers/emails found at IRB Contacts. Please note: Emory IRB is undergoing an onsite interview with AAHRPP for reaccreditation all day on Monday 11/8 and Tuesday 11/9. Expect delays in response, but we will do everything we can to get back to you as soon as we can. We appreciate your patience and understanding!

Emory IRB Webinar Today at Noon: Research Misconduct and Human Subjects Research

The IRB will host a webinar today at noon to present Research Misconduct and Human Subjects Research. The presentation will last approximately 30 minutes, including a moderated question and answer session. You can find a link to the live webinar, as well as recordings of past webinars on our Webinars page of the IRB website.

More Clarifications to Emory's Data and Safety Monitoring Plan Requirements

The IRB published important clarifications to our Data Safety Monitoring Plan Requirements (PDF) on 8/24. You can get a better sense of what specifically will be needed for your study. The guidance now provides details for three categories of "high-complexity" studies: A, B, and C. Category C studies (clinical studies using FDA-approved products in accordance with their indication, or using other products not under an IND/IDE or an abbreviated IDE) may use self-monitoring. Other high-complexity studies are still required to have an independent monitor. Please see the linked document for more details!

Don't Commit Emory IRB to Review for Other Sites without Reliance Team Agreement First!

We have noticed an uptick of study submissions that indicate that Emory will serve as Single IRB for external sites. As a reminder, investigators must receive approval from the Reliance Team prior to submitting a grant or committing to collaborators that the Emory IRB will serve in this role. Please see the Collaborative Research section of our website for more guidance.

IRB Webinar on Required Templates for Submission - Save Time and Frustration!

Our upcoming August 12th webinar will present the latest on required templates for submission, e.g. protocol and informed consent. We still see some submissions not on our protocol template, and we hate sending them back.

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

"Simplify Simplify Simplify": Protocol Checklists To Be Incorporated into Protocol Templates

Our required protocol templates will soon include the required protocol checklists within the same Word document file, to make it harder to forget to upload the checklist. Going forward, simply upload the Word document, with the checklist included, to the "Basic Study Information" section of the smartform.

Get ‘em Fresh! - Download Submission Tools Directly from the IRB Website to Ensure They're Up-to-Date

As a reminder, always download the latest protocol and consent templates, checklists, and other submission tools from the IRB website each time you need them. This will prevent delays in IRB review.

Reminder to Keep IRB Records Up-To-Date, Even for Studies that Don't Expire

Don't forget to submit modifications, reportable new information, and close-outs for expedited studies that don't have an expiration date! Exempt studies need to submit close-outs and substantive changes should be submitted via modification (see the end of our IRB Review Type webpage - Exempt Research for examples of substantive changes).

Planning an Investigator-Initiated Clinical Trial? Check with the IRB Before Budget Finalization!

Please check in with us early if you plan an investigator-initiated clinical trial, before you finalize your budget. It is important to make sure your data and safety monitoring plan is adequate, and FDA considerations are addressed, before your plans are finalized. This is important even if you don't think you need an IND or IDE. Contact Shara Karlebach or Rebecca Rousselle, and loop in Julie Martin if plans include multiple institutions with federal funding (since single IRB review may be required).

Sponsor Using a Single IRB? Check for WCG or (new!) Advarra

For industry-sponsored multisite trials, we now accept both WCG (formerly WIRB) and Advarra as central IRBs for multisite industry trials. Check to see which IRB your sponsor used for your study. NOTE: If they used neither WCG nor Advarra, then Emory will rely on WCG IRB. Make sure you submit using the information linked above and on our Collaborative Research page.

Thank You for Your Patience!

Thank you for your patience given our significant recent staff turnover. We are working hard on hiring and training, and hope to be fully staffed again soon. Meanwhile, if you have special circumstances that require prioritized review, you may contact our IRB staff leadership.

Exempt Studies: When to Submit a Modification (MOD)

Modifications are only required for exempt studies when substantive changes are being made that could alter the original review determination.

How to tell if your study is "Exempt":

• Your initial IRB determination letter states that it is "Exempt"

Examples of substantive changes are changes to:

• subject populations (like adding a vulnerable population category, such as minors or prisoners),
• data collection methods, or
• identifiability of data (where data were previously de-identified).

Examples of changes unlikely to alter the Exempt determination (so can be done without further IRB review):

• altering study instruments or recruitment materials
• changing the target enrollment number

If unsure, log a comment or email your study analyst. (Remember to check the box to notify the IRB coordinator if logging a comment.)

Improved External IRB Tools!

We've been hard at work improving our external IRB tools. Check out the following:

• Revised external IRB consent checklist (DOCX) - to be used for all external IRB submissions (except CIRB)!
• A new “Form A” to use for both WIRB and Advarra submissions. You no longer need to use a reliance request form for Advarra studies!

Advarra is used by some industry sponsors for their multisite clinical trials. To improve efficiency, we can now rely on either WIRB or Advarra for these studies. If the Sponsor uses neither, then Emory will use WIRB.

Stay tuned for more updates! We're continuing to work on streamlining the process, tools, and guidance on our Collaborative Research page in the coming weeks..

Important Reminder for Single IRB Studies

Planning to submit a grant for a multi-site research study or to be a participating site in another researcher's grant funded research? If so, avoid delays by discussing the single IRB of record with the Emory IRB early in the process.

We need complete and accurate information to execute reliance agreements with other institutions. Discrepancies cause confusion and unnecessary delays. Help us make the process as easy as possible for you!

Accurate information also informs our decision of whether single IRB review is feasible or not. We generally only enter reliance agreements when they are required by funder or regulations. This is due to the time and resources involved for both the IRB and the study team.

Updates to Reportable Event Assessment Form and Protocol Deviation Assessment Form

We've updated two assessment forms on the IRB website: the Reportable Event Assessment Form (DOCX) and the Protocol Deviation Assessment Form (DOCX). You can find the updated versions, on our Reportable New Information page.

IRB Staff Comings and Goings

We bid a fond farewell to two IRB team members at the end of May:Amaree Lawrence and Clarissa Blackmon. Amaree has left the IRB to pursue further education, and Clarissa has joined the School of Medicine's cardiology division as a Senior Program Coordinator. We're grateful for the contributions Amaree has made to the IRB's reliance team and for Clarissa's dedication to the IRB's QA and Education team. We wish them both continued success and we're thankful that Clarissa will be staying within the Emory family!

On June 14th, Maria Davila will take a new role as Director of Research Compliance and Regulatory Affairs in Emory's Office of Research Administration. Maria joined IRB staff in 2010 and been has been instrumental in leading the IRB's QA and Education team, as well as managing department-wide initiatives. We look forward to continuing to pick her brain on regulatory and compliance matters in her new role. Congratulations, Maria!

We are actively working on backfilling the IRB's open positions and will update you all with more information once our new staff is fully trained. We are working hard to stay within our posted turnaround times, but please bear with us as we work to address our staffing needs during this time.

Updates to COVID-related Research Policies - Coming Soon

The IRB is working with other Emory offices to update our Research Ramp-Up Guidance (PDF) for all research and our Attestation Form (DOCX) requirement for non-treatment research visitors at Emory as soon as possible, given the changing landscape of the pandemic. Until new guidance is released, please continue to follow the published requirements. We will send out revisions via email as soon as they go into effect. Thank you for your patience!

Investigator Initiated Studies: Be Budget Prepared! Formal Monitoring Plans Required for High-Complexity Studies

As a reminder, studies with high complexity will need formal monitoring, not self-monitoring (DOC).

High complexity studies are defined in our guidance (PDF) as studies that are greater than minimal risk and meet one of the following categories:

• Phase I – III interventional studies, and all studies under an Investigational New Drug [IND] or Investigational Device Exemption [IDE] with the FDA, or

Other studies that may not be under an IND or IDE, where a participant is exposed to risk for an extended period or for which the risk might change with time.

These studies are expected to have a monitoring plan in the protocol that specifies who will serve as the study monitor and the frequency and percentage of the files to be reviewed.

Investigator-initiated studies: Please ensure that your research budget is adequate to meet this requirement. See our guidance (PDF) for more details! We

Summer Webinar Hiatus

We will be pausing our monthly webinar series during June and July. Please join us again in the fall when we resume the series. Until then, you can review any of our previously recorded webinars on our Webinars page.

Save the Date! Coffee and CMEs is Back on May 20th

Please join the IRB via Zoom on Thursday, May 20th from 9:30-10:30 AM for Coffee and CMEs with the IRB. This quarter's event is entitled "The Reliance Process at the Emory IRB." Registered attendees who complete the post-presentation survey will receive one credit hour of Continuing Medical Education. Please register here!

eIRB Outage Wednesday 5/5 Beginning 6 PM and Lasting Overnight

eIRB is scheduled to go offline this Wednesday 5/5/2021 at 6 PM and is expected to come back online around 9 AM Thursday, 5/6/2021. Please save all work and exit the system prior to 6 PM on Wednesday.

This outage is related to upgrades in the eIACUC system, and our vendor determined it would be safer for our system to go down too, since the systems share information. We apologize for any inconvenience.

DocuSign Training from Emory's Office of IT

Emory's Office of IT is excited to offer DocuSign training for the Emory community. There are 4 courses planned starting with the basic DocuSign functionality to advanced topics like Templates and Powerforms. Each course will be recorded and shared with the community if you cannot attend the training live.

If you would like to stay up to date on DocuSign information or participate in the Emory DocuSign community, please join the Yammer group and Listserv. To subscribe to the Listserv, please follow these steps to subscribe to the list. The list name is DOCUSIGN-USERS and emails for posting to the list should be sent to DOCUSIGN-USERS@LISTSERV.CC.EMORY.EDU.

Request for Feedback and Questions for Upcoming IRB Webinar

We’re planning to cover social media recruitment in our upcoming May webinar. In 2019, we published our first Guidelines for Using Social Media to Recruit Research Participants (PDF). We will cover the information in the guidance document during the webinar, but we know social media has changed since the guidance was published! Are there new social media platforms or techniques for using social media you think we should cover? Submit your feedback or questions in advance of the webinar.

Please tune in May 13th at noon for the May webinar! You can find a link to the live webinar, as well as recordings of past webinars on our Webinars page of the IRB website.

Recruitment, Retention, Engagement Resources

Here are some resources for engaging communities in a meaningful way, and can supplement our upcoming webinar:

• Trial Innovation Network Recruitment and Retention Toolbox: Find toolkits around building community partnerships, recruitment and retention best practices, and more!
• Faster Together Cultural Humility Coursera Course: Learn about recruiting, retaining and engaging research participants in a culturally humble way. This course has a specific emphasis on recruiting individuals from historically disadvantaged communities.
• MRCT Plain Language Guide: Learn how to create easy-to-understand recruitment and study materials.

IRB Webinar moved to April 15

Please tune in April 15th at noon for General Updates from the Emory IRB that will include new protocol templates, and clarified DSMP guidance, among other important updates. You can find a link to the live webinar, as well as recordings of past webinars on our Webinars page of the IRB website.

Continuing Review Reports for External IRB Studies

To ensure compliance with local Emory policies throughout the life of each study, we now require all External IRB studies to provide information to the Emory IRB at least annually, until the study closes out.

Once your site has received continuing review (CR) approval from the Reviewing IRB, do the following based on who will complete the activity:

• If you are the PI, select "Report Continuing Review Data" on the left menu in the study workspace in eIRB, and submit the required information found on the Collaborative Research page under the “Continuing Reviews” section.

• If you are not the PI, submit the required items via "Log Comment" and select that you want to notify the IRB Coordinator. The IRB Coordinator will process the continuing review on your behalf.

Annual updates to study team members: When you are reporting Continuing Review Data (see the Collaborative Research page under the continuing review tab), it is your responsibility to notify the Emory IRB of study staff changes since the last continuing review via an Update/Modification (here is guidance on how to add personnel to a external study under the Modifications tab). In cases where a staff member needs to access the study in eIRB immediately, you need to submit the Update in real time. Whenever the Update is made, the IRB will verify that applicable training is up to date. CITI training can be viewed in the study workspace.

Adding Non-Emory Study Team Members/Sites to Emory-IRB-approved Studies

External collaborators and/or sites should only be added to the Emory IRB smartform in the following circumstances:

• (a) the people/site(s) are truly “engaged” in the human subjects research, and
• (b) the Emory IRB has agreed to be the IRB of record for those people/sites; or,
• (c) for external research locations, the Emory PI oversees the research at the location.

Otherwise, external collaborators and sites should only be referenced in the protocol.

Before adding external collaborators or institutions, follow these steps:

• Confirm if the other institution considers that the team member is “engaged” in research. You can use the Engagement Determination Checklist (PDF) for guidance. We suggest getting confirmation in writing (even email) from the other IRB.
• If the external collaborator/institution is “engaged” and wishes to rely on our IRB, complete the reliance request form (DOCX) and submit it to the reliance listserv at irb.reliance@emory.edu.
• The reliance team will let you know if Emory agrees to the reliance request and will provide you with instructions for the next steps. Hold off on submitting until you hear back from the reliance team.

Email-Related Potential Breaches of Confidentiality Are Reportable to the IRB

Sometimes, well-intentioned email communication can go awry. This may appear as unexpected email communication between study participants, or accidentally including participants in a CC line instead of the BCC line of an email.

Any email irregularities involving potential breaches of confidentiality should be reported to the IRB via Reportable New Information (Video) submission.

PLEASE, as required by Emory policy, also make sure to always send encrypted emails to your research subjects if sending sensitive or health-related information (including blank consent documents!).

Which Emory DocuSign Account Should I Use: Enterprise or Part 11?

FDA Guidance requires that FDA-regulated studies (all studies using approved or unapproved drugs, devices or biologics) comply with “Part 11” requirements.

• If your study is required to comply with Part 11 use Part 11 DocuSign accounts.
• Emory study teams that don’t require Part 11 compliant signatures can use Enterprise DocuSign accounts. These accounts are now free for Emory users and meet HIPAA compliance requirements!
• REDCap is another option for electronic signature when there is no Part 11 requirement.

New Attestation for Monitoring Reports at Continuing Review

Emory has always required you to submit site monitoring reports, such as those generated by a sponsor’s monitor, to the Clinical Trials Audit and Compliance (CTAC) office at ctcompliance@emory.edu.

To ensure compliance, the IRB staff will request records showing that all external monitor and/or self-monitoring reports (if self-monitoring is approved as part of a DSMP) have been reviewed by CTAC before the CR is reviewed.

Revised Required Protocol Templates Now Available

We have updated many of the required protocol templates for use in eIRB. We added guidance, and hopefully formatting will be easier!

Each protocol template includes instructions at the top that must be deleted before submission. Our Study Submission webpage now also includes more guidance on selecting the appropriate template. Remember that these updated protocol templates and checklists are required for new study submissions.

Reminder to Check Logged Comments in eIRB

When there is a submission in process in eIRB, remember to check for any comments added by your IRB analyst. Logged comments are the primary means of communication between IRB staff and study teams. It is in your best interest to be responsive so that the study can be moved to the next step. If submissions linger without responses for too long, they will be withdrawn if no response in 30 days.

Emory IRB Webinar on Reporting Obligations for External Studies: When and How to Report to the IRB

The IRB will host a webinar on Thursday, 2/11 at 12:00 pm to present Reporting Obligations for External Studies: When and How to Report to the IRB. The presentation will last approximately 30 minutes, including a moderated question and answer session. You can find a link to the live webinar, as well as recordings of past webinars on our Webinars page of the IRB website.

Pro Tips for Adding External Study Staff to Ongoing Studies

Knowing whether to add external study staff to ongoing studies can be tricky.

External staff members only need to be added if both of the following are true:

1. The staff member is actually engaged in human subjects research (PDF) (interacting with human subjects, analyzing identifiable data, etc.),
2. The staff member will not obtain IRB approval from their home institution (if they have one) and will rely on Emory IRB's review via a formal reliance agreement (see our Collaborative Research page for more information).
   1. Note that the Emory IRB will not enter into a reliance agreement for exempt research; each institution would make their own exemption determination. We also cannot have a reliance agreement with a foreign institution, though foreign individual investigator agreements may be executed in some situations.

In rare cases, an external staff member needs to view or edit eIRB directly (e.g. CHOA coordinators). In these cases they will need an Emory sponsored account (instructions found under the external users tab). Generally though, non-Emory personnel should always be listed as “External” local study team members, and only when we are their IRB of record.

Last tip: Always use our template (DOCX) (found in Page-Level Help) to provide us with your list of External study staff.

Is Your CITI training missing from eIRB? Update Your Email Address with CITI!

Does CITI show “No Training Data” for a user who has valid, current CITI training certification? The user's CITI account email address may be to blame. Follow our instructions to update your CITI account's email address (PDF) to solve the problem.

Also, a reminder to ALWAYS choose “LOG IN THROUGH MY ORGANIZATION” in CITI, to use Emory's single sign on.

Emory Box to Emory OneDrive – Is An eIRB Modification Needed?

As you already know, Emory is moving away from Box and toward Microsoft OneDrive for Emory's business needs (more information on Box Migration here). Here's how the IRB plans to handle the change:

• Ongoing Studies:

  • We do not require a modification to state that you will switch from Emory Box to Emory OneDrive.

  • If you are transitioning to any storage solution other than Emory OneDrive, please submit a modification to obtain prospective IRB approval of the change.

• New Studies:

  • New studies will not be approved with references to Emory Box in the protocol. Please use one of the OIT approved apps for research using identifiable information, if you will store data with associated identifiers.

Emory Zoom: IRB Staff's Preferred Method of Communication with Study Teams

We want to be able to assist everyone working on-campus or remotely, including our colleagues working internationally. Zoom allows all of us to communicate efficiently and cost-effectively! Audio calls can also be made via Zoom for those who are camera shy. Please let us know your preferences for setting up a Zoom call and we will accommodate your wishes.

The IRB office will be closed during the Emory Winter Recess from 12/24/2020 through 1/3/2021. We need enough time before the break to screen submissions before they are reviewed! Please see below for submission deadlines.

New study and Modification Submissions

If your study or modification requires full board review before the start of the winter break, please submit new eIRB submissions by 12/4/2020 (if clarifications are requested during screening, please submit your response by 12/11/2020 for it to be reviewed before the break).

For new studies and modifications that need to be reviewed in the first meeting in January (1/6/2021), submit in eIRB by 12/11/2020 (if clarifications are requested during screening, please submit your response by 12/18/2020 for it to be reviewed in the first meeting of the new year).

Contact our staff leadership if you have any questions.

Continuing Review Submissions

Review this list (Excel File) or check your expiration dates in eIRB for studies expiring

• between 12/24/2020 and 1/17/2020 if the study is no more than minimal risk, or
• 12/24/2020 and 1/24/2020 if your study is reviewed by the Full Board

Please plan to submit by 12/4/2020 for Full Board studies, or 12/11 for other studies – but the earlier the better!

Reportable New Information Submissions will be reviewed on an ongoing basis.

Reminder about the Required Attestation Form

As of 11/12/20, most research participants must now sign this attestation form (DOCX) upon their first in-person visit, per the latest Emory Visitor Policy. This includes visits to Emory Healthcare spaces. The attestation form is not required if the research visit is combined with a clinical care visit (same day/same facility). The form is required on the first study visit after the effective date, only, and investigators should keep the forms in their records. For more information on conducting research in-person during this time, please see our COVID-19 Guidance page.

Thank You, Emory Researchers - We are Grateful for Your Hard Work!

The IRB would like to share our gratitude to the Emory research community for the hard work that has taken place this year. We are honored to play a small supporting role in the life-changing research taking place on our campus and with our collaborating partners across Atlanta and beyond. We are especially grateful to those working to address the pandemic by testing vaccines and therapeutics, developing diagnostic tools and tests, and tracking the spread of the virus. Thank you for all that you do! Please enjoy a happy and safe Thanksgiving!

Study Approval Expiring during Winter Recess? Submit Continuing Review Early!

Review this list (Excel File) or check your expiration dates in eIRB for studies expiring between 12/24/2020 and 1/17/2020 (if the study is no more than minimal risk) or 12/24/2020 and 1/24/2020 (if your study is reviewed by the Full Board). The IRB office will be closed during the Emory Winter Break that runs from 12/24/2020 through 1/3/2021. We need enough time before the break to screen studies and get them reviewed. Please plan to submit by 12/4/2020 for Full Board studies, or 12/11 for expedited studies – but the earlier the better!

New Research Participant Attestation Form Required for Most Subjects, per Emory Visitor Policy

As of 11/12/20, most research participants must now sign this attestation form (DOCX) upon their first in-person visit, per the latest Emory Visitor Policy. This includes visits in Emory Healthcare spaces. The attestation form is not required if the research visit is combined with a clinical care visit (same day/same facility). The form is required on the first study visit after the effective date, only, and investigators should keep the forms in their records. For more information on conducting research in-person during this time, please see our COVID-19 Guidance page.

Delay in Staff Change Modification Review

There has been a delay in staff change modification review. We are working on getting caught up on these requests as soon as possible! As a reminder, new staff cannot begin work on a study until the staff change modification is fully approved.

Update on Faculty Advisor Reviews in New eIRB

Faculty Advisor reviews are now only required for Rollins School of Public Health student projects. For the College and other graduate schools, the faculty advisor should instead be listed as Principal Investigator and the student should be listed as a Co-Investigator. These studies should undergo department review. There is no separate faculty advisor approval required for these studies.

For RSPH only: The faculty advisor should be listed as a Co-Investigator in the smartform. The faculty advisor should log a comment in the study history regarding their approval of the research study. The study will not require department review.

Temporary Issue eIRB in RX ("old eIRB")

Some documents (like approval letters) and data in the old eIRB are temporarily unavailable. Access should be restored soon!

Temporary Issues in new eIRB

Currently there are problems approving modifications for certain migrated studies. The Vendor is working with us on those now and urgent modifications can be fixed individually as we work on the larger issue.

We are also aware that a handful of studies migrated with the wrong designation for local vs. external IRB review. We are working on the best solution for that as well.

Reminders in New eIRB

• Remember to remove outdated documents when submitting modifications, to keep things clear and streamlined, and use the "Update" function to provide revised versions of documents in the smartform!
• PI's: remember to use "Assign PI Proxy" and "Assign Primary Contact" when creating new studies, or at any time during the life of the study. Note: These activities are in the main study workspace (not within modifications or continuing review workspaces).
• Remember to use our Page-Level Help for the new eIRB, which offers guidance on every smartform question!

Emory IRB Webinar on Interpretation and Translation Services Under Section 1557 of the ACA

The IRB will host Toby Morgan, Director of Compliance with Emory Healthcare, this Thursday 10/8 at noon to present "Interpretation and Translation Services Under Section 1557 of the ACA." The presentation will last approximately 40 minutes, including a moderated question and answer session. You can find a link to the live webinar and recordings of past webinars on the Webinars page of the IRB website. The webinar will be recorded for future viewing and should be posted to the Webinars page within a week of the live presentation.

Coffee and CMEs with the IRB: Come Recruit With the IRB

Join us via Zoom on Thursday, October 22, 2020 at 9:30 AM for Coffee and CMEs with the IRB. This quarter's event covers the topic of Research Recruitment. Registered attendees will receive one credit hour of Continuing Medical Education. Please register here. Registered attendees will receive the Zoom link shortly before the presentation.

New eIRB Report Provides List of Studies You're On

Need a list of studies for which you serve as study staff? What about a list of studies for which you serve as PI? We have a custom report for that!

The new report, entitled 'ORAIT_Find studies that YOU (logged on user) are on,' can be found on the custom reports tab of eIRB, using three clicks from your inbox as shown below. As noted in the title, this report can only be run by oneself; teammates cannot run the report for a different eIRB user. Thanks to our ORA-IT colleagues for building this custom report for us!

Upcoming Emory Visitor Policy for Research Subjects in Non-Treatment Studies

As part of Emory's work on a "Visitor Policy" during the pandemic, the Emory IRB is drafting an attestation form for the certain research participants to sign at their first visit. This will be required for all on-campus research, except for inpatient or outpatient research activities when the purpose of the visit is also clinical treatment at an Emory Healthcare facility. In the attestation, the visitors agree to follow Emory's policies for face coverings, social distancing, handwashing, and to report any diagnosis of COVID-19 if it occurs within a certain time frame of a study visit, among other requirements. We will circulate the form as soon as the Visitor Policy is finalized. Stay tuned for more updates!

Emory IRB Staff Comings and Goings

Brandy Covington, BBA, CIP will depart from her position with Emory IRB Staff as a Senior Research Protocol Analyst. Brandy has worked with the Emory IRB for over a decade and we are grateful for her service! Brandy's last day will be October 9, 2020.

The IRB has also hired two new Analyst Assistants that will join our team October 19, 2020. We will be updating our Staff and Members page with their contact information as soon as the new hires have completed training.

Clarissa Blackmon Will Join the Introduction to Clinical Research Trainers

We'd like to welcome Clarissa Blackmon as the newest IRB trainer for the Office for Clinical Research's Introduction to Clinical Research Course! Clarissa has four years of experience with the Emory IRB and is ready to share her knowledge of the informed consent process with incoming Clinical Research Coordinators starting this fall.

Reminder: Check "IRB Coordinator" When Logging Comments to IRB Analysts

If you want your study analyst to receive a notification about your logged comment, you must check the IRB coordinator option while logging the comment. This applies to all eIRB submissions throughout their lifecycle. The system does not provide any notification to analysts about newly logged comments outside of this method. Please verify you select the IRB coordinator when sending messages to us to prevent delays in review. You can re-log your comment with the IRB coordinator option checked if you forget the first time.

eIRB Outage Starting This Friday, 9/11, at 5 PM

Friday September 11, 2020, eIRB will be down for maintenance and the eIACUC upgrade beginning at 5 PM. We anticipate eIRB will be accessible in the later evening on Saturday, September 12, 2020.

Emory IRB Webinar this Thursday at noon: Q&A with the Emory REDCap Manager and Other IRB News

The IRB will host a webinar on Thursday, 9/10 at 12:00 pm to present “Q&A with the Emory REDCap Manager and Other IRB News.” Some IRB updates will be presented at the beginning of the presentation. The presentation will last approximately 40 minutes, including a moderated question and answer session. You can find a link to the live webinar and recordings of past webinars on our Webinars page of the IRB website.

We Need to Know! Promptly Submit Risk-Related Updates from Sponsors

The IRB has observed that some protocol amendments, revised IB’s, and other important updates are submitted long after the version dates on the documents. In some cases, these delays may constitute noncompliance, for which we may require an RNI, in addition to the modification.

Not everything is urgent. But the IRB promptly needs to see any new information that

1. reflects a new or increased risk, or
2. that otherwise might affect a subject’s desire to stay in the study, and
3. where current or future human subjects are affected 

Soon, we will be posting new target timeframes for when different types of changes need to be submitted to the IRB, and when we would require RNI’s for delays.

(Note: This topic is separate from our Timeframes for Reporting Adverse Events, Protocol Deviations, and UPs) [PDF])

Documents that include a new or increased risk:

• Should be submitted to the IRB within 10 business days of receipt from the Sponsor
• If submitted later: the IRB will continue our review but will ask about the delay and the status of current study subjects (e.g. any actively receiving study intervention? Study closed to enrollment?)
• If more than 10 days after receipt from the Sponsor, and current or new subjects may be affected, we may request an RNI.
• We will also look at the version date of updated documents to see if there was a Sponsor delay in sending out updates
• Before issuing an approval letter, the IRB must receive a response, and an RNI if needed.
• The RNI should include a root cause of the delay, a corrective/preventive action plan, and, if applicable, documentation of when the Sponsor sent the updates to our site.

Avoid Delay for Urgent Modifications: Submit Time Sensitive Requests Separately from Renewals

Urgent Modifications (Mods) should be submitted separately from Continuing Reviews (CR’s). For example, we funnel study-team-change-only Mods to dedicated IRB staff who can review and approve them quickly. If the staff change Mod is tied to changes in “other parts of the study” or a CR, it has to wait until the CR is reviewed. As a reminder, you must wait for modification approval before new staff can begin human subjects research work on your study.

So, for faster turnaround times, keep things separate as much as possible.

Submitting RNI’s- Anyone on the Team Can Create AND Submit

Every eIRB user has the ability to create and submit RNI’s. Once an RNI has been created in the system, it can be submitted by the person who created the RNI.  There is no need to wait for a PI to log in and submit the RNI.

Help for PI’s: Assign a PI Proxy/Primary Contact

Assigning a PI Proxy and a Primary Contact for your study helps with study submissions, initially and throughout the study lifespan. The PI Proxy can create and submit Modifications and Continuing Reviews, and make changes requested by the IRB.

Both roles also receive eIRB-related notifications, relieving burden on the PI.

• There can be multiple PI Proxies, but only one Primary Contact.
• Note: These assignments must be done by the PI in the main study workspace (cannot be done from within a Modification or Continuing Review).
  • Use "Assign PI Proxy" and “Assign Primary Contact” activities

• We have the Assign a PI Proxy and Primary Contact video to assist with this process

Emory SCORE webinar: How to Incorporate Sex as a Biological Variable in Your Research

The Emory Specialized Center of Research Excellence in Sex Differences (Emory SCORE) is presenting a virtual webinar on How to Incorporate Sex as a Biological Variable in Your Research. The presentation will take place on Wednesday, December 2, 2020 from 8 AM to 12:45 PM via Zoom. Register for the webinar

Very Brief eIRB Outage Today at 5 pm

Today at 5:00 PM, eIRB is scheduled to be rebooted. This process is expected to take only a few minutes, but please save all work and exit the system before 5:00 PM.

Education Opportunity: Coffee and CMEs with the IRB- When is IRB Review Needed?

Join us via Zoom on Wednesday, July 22, 2020 at 9:30 AM for Coffee and CMEs with the IRB. This quarter's event is entitled "When is IRB Review Needed? The Common Rule, FDA regulations, Funding Considerations, Institutional Policies, and Using the IRB's Non-Human Subject Research Determination Tool." Registered attendees will receive one credit hour of Continuing Medical Education. Please see our flyer (PDF) and register here.

Scheduled eIRB Outage 7/23 at 7 PM

eIRB will be unavailable for about one hour on Thursday, July 23, 2020 beginning at 7:00 PM. We are applying a patch to address some known issues in the system. Please save all work and exit the system before 7:00 PM on 7/23. We will send an additional email reminder before the outage.

Only the PI Can Assign the "PI Proxy"

When creating studies, please do not assign yourself as a PI Proxy with the intention of submitting the study for someone else. We need the PI listed in the submission to assign the proxies themselves. We have video instructions to help with this process. If the PI proxy assignment was not made by the PI (based on the study’s activity history), we will send the submission back to you asking for an email to prove that the PI has assigned the proxies listed before we can review your study.

We do encourage the use of PI Proxies. Otherwise, only the PI can submit changes back to the IRB, along with Modifications and Continuing Reviews.

Please note that this activity needs to be done in the main study workspace and not in a follow-on submission (i.e. not in a Modification or Continuing Review). It can be done any time, however, and once assigned, the PI Proxy will be in effect even for in-progress follow-on submissions!

Reminder: Check "IRB Coordinator" when Logging Comments to IRB Analysts

IRB analysts are now referred to as "IRB Coordinators" by the new eIRB system. If you want your analyst to receive a notification about your logged comment, you must check the IRB coordinator option. The system does not provide any notification to analysts about newly logged comments outside of this method. Please verify you select the IRB coordinator when sending messages to us to prevent delays in review.

New Versions of Consents and Assents

Look for them already published in our Consent Toolkit with version dates 6-16-2020. Changes include:

• Added IRB# to the initial study information
• Small change in Option 1 of the In Case of Injury Option Language
• Change in the contact information to clarify who should be called (study team vs. IRB)
• Update to the IRB Research Subject Survey URL

Emory IRB Webinar on Electronic Informed Consent - Today at noon!

Today at 12:00 pm, the Emory IRB will present a webinar entitled "Electronic Informed Consent." The presentation will last approximately 40 minutes, including time for questions and answers. A link to the live webinar, as well as recordings of past webinars, can be found on the Webinars page of the IRB website.

eIRB Outage This Friday- Saturday 5/15 - 5/16

New eIRB will be unavailable beginning at 4 pm on Friday May 15, 2020 for final data migration of closed studies. The system should be back up mid-day on Saturday, 5/16.

Spring Cleaning: Remove Outdated Documents During Modifications

Always remove outdated versions of documents when you submit a study modification. IRB staff can no longer remove or rename document titles on your behalf, so the best way to keep current documents organized (and faster for IRB reviewers to find!) is to remove old documents. You can easily find old uploaded documents in the Snapshots tab in the new system, so there is not a risk of losing study documents over time. IRB analysts will begin requesting clarifications on modifications that are not time-sensitive to have older versions of documents removed or renamed with "ARCHIVED" at the beginning of the title.

Remember that you are required to keep a copy of your documents for your research file. The eIRB system should not be used as your regulatory binder.

Resuming In-Person Research- IRB Guidance Coming Next Week

The IRB Chairs are working with the Schools to provide input on about resuming in-person "non-essential" research activities! We will post guidance next week. We can field specific questions in the meantime" contact your analyst or IRB staff leadership. The guiding principles are minimizing risk, weighing risks against benefits to subjects and to science, and following all EHSO and School/facility safety guidelines when in-person interaction is indicated.

Reminder: Specify Notifications for Logged Comments

As a reminder, the new eIRB only sends email notifications when comments are logged if a party has been selected to be notified within the comment. If you intend your comment to generate an email notification to your study analyst, be sure to select "IRB Coordinator" when logging your comment.

Updated COVID-19 IRB Researcher Guidance

We have published updated Researcher Guidance: COVID-19 and IRB Review. The revision includes a table with specific examples of COVID-related study changes and how to report them to the IRB (whether by RNI, logged comment, modification, etc.) Going forward, we do not require you to submit an RNI or a modification if you use Zoom to conduct telemedicine for research. Instead, please log a comment in the study history.

DO NOT USE: "Add Related Grant" in New eIRB

Please do not use the "add related grant" button in New eIRB. This function doesn't notify the IRB about your change and we can't document IRB approval of the new funding. Instead, please submit a modification (or a to obtain IRB approval for an updated or a new grant. And always remember to review our guidance (PDF) before trying to add new grants to approved studies. Your funding might need to be submitted as a new study, instead! You must follow all requirements in the guidance document in order to avoid your submission being sent back to you for changes.

Funding Source Not Found? Contact Us!

If you can't find your study's funder, please select "other" and send an email to the IRB with the name of your funding source and your study number. You can go ahead and submit your study for review. The IRB will work on getting your funding source added to the system so we can correct the omission during initial review.

Continuing Review Reminders - Where did you go?

New eIRB is not sending continuing review reminders for some studies. We apologize for the inconvenience and are working with the vendor to correct this issue. In the meantime, please double check your expiration dates and set your own reminders if necessary!

Continuing Review Reminders for Studies Without Expiration

To make up for the lack of reminders for some studies, New eIRB is sending expiration reminders for studies under the new Common Rule that do not have expiration dates. We also know about this issue and we're working with the vendor to turn those reminders off until they can be fixed.