IRB Webinar on Research With Children's Healthcare of Atlanta
On March 9, 2017 at 12:00 pm, the Emory IRB will deliver a webinar focused on Research with Children’s Healthcare of Atlanta. The presentation will last approximately 20 minutes, including time for questions and answers. A link to the live webinar, as well as recordings of past webinars, will be found on the Webinars page.
The Common Rule is Revised -- but under temporary moratorium
DHHS's revised "Common Rule" governing human subjects research was finally published, and will become effective January 19, 2018 (except for the single-IRB requirement for cooperative research, which is two years later). However, there is a 60 day moratorium in effect at the moment. For summaries of the very significant changes (including removal of continuing review requirement for most minimal risk studies), please see these links:
PRIM&R's website for the revised common rule: http://www.primr.org/commonrule/
- Includes a quick summary guide.
- Redline of the old vs new rules
- A Social Scientist's Guide to the New Rulel
IRB Webinar on Certificates of Confidentiality: Protecting Privacy and Confidentiality
On February 9, 2017 at 12:00 pm, the Emory IRB delivered a webinar focused on Certificates of Confidentiality: Protecting Privacy and Confidentiality. The presentation lasts approximately 20 minutes. A link to the webinar, as well as recordings of other past webinars, can be found on the Webinars page.
IRB Webinar on Family Members as Interpreters
On January 12, 2017 at 12:00 pm, the Emory IRB will deliver a webinar focused on Family Members as Interpreters: Review of Emory Guidance. The presentation will last approximately 20 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.
Some IRB meetings will be re-scheduled around the holidays in November and December. Study teams with submissions that may require full board review should take note of the compressed meeting schedule in order to avoid delays in review.
eIRB Briefly Offline on Friday (9/23/16) at 5 PM
Please be aware that eIRB will be briefly offline starting at 5 PM on Friday, September 23, 2016. The system is expected to be available again around 10 p.m. on Friday, though it could take until early Saturday morning. Users are advised to save all work and exit the system prior to 5 PM to avoid losing any work. After that time, a login will be unavailable until it is safe to reenter the system. If you have questions about eIRB maintenance, you may contact the IRB at email@example.com or 404-712-0720.What is the IRB accepting as valid Clinical Research Training Certificates (formerly Key Concepts/Intro to Clinical Research)?
The IRB is still requiring the submission of Key Concepts/Intro to Clinical Research training certificates with IRB applications. The IRB will accept CITI GCP or CITI Clinical Coordinators training certificates from research staff who took the training after June 1, 2016. For people who did not take GCP after June 1, 2016, or never took Key concepts training/certification has expired, they may provide an older GCP training certificate only if it was taken after June 1, 2013. If you have any questions, please contact Maria Davila at firstname.lastname@example.org.
IRB Webinar on Genetic Research and Informed Consent
On September 8. 2016 at 11 am, the Emory IRB will deliver a concise webinar on general informed consent considerations in genetic research. The presentation will be about 30 minutes long with a live question and answer session. A link to the webinar, as well as recordings of each webinar, will be available at the webinar's page.
Major Change to WIRB Submission Process and Scope of Studies – Effective 10/4/2016
Two major changes are being made related to studies reviewed by Western IRB (WIRB):
- Emory will now also send Phase I and Phase IIa trials to WIRB, if they meet the other criteria for WIRB review (previously we sent only Phase IIb-IV trials)
- “Form B” is no longer used; instead WIRB studies will submit their information to Emory IRB via eIRB
As you have seen in the letter from Office of Clinical Research last week (attached), the Office of Quality and EHC Nursing Checklists will now be submitted via eIRB (as part of the newly- expanded “Clinical Research Key Points” part of our smartform).
In order for this streamlined flow to work for all studies, we will no longer use “Form B” to gather needed information about your WIRB-reviewed studies. Instead, we will ask you to submit the information via eIRB. If we did not make this change, WIRB-reviewed studies would not be able to use the new, faster Checklist flow. You will continue to submit “Form A” first, to our WIRB listserve, to confirm that your study is indeed destined for WIRB.
We have created a WIRB-specific eIRB template for you to use to capture just the information Emory IRB needs for our records.
Note: submitting in eIRB does not mean that Emory will be doing an actual IRB review. We are already using this process for studies reviewed by NCI’s CIRB, and going forward, we will be using it for all multisite research relying on a single IRB. It allows Emory to keep study information all in one place, for use by other offices (such as other oversight committees, OCR, OSP, etc), and allows us to work in time-savers like the new Office of Quality information.
Please see our website at http://irb.emory.edu/forms/external-irbs/WIRB.html for detailed instructions about WIRB submissions, including the template, Form A, fee list, contacts, and consent template.
Submissions already in progress: If you have already submitted a “Form B,” you’ll continue with our old workflow and will not submit in eIRB. If you’ve only submitted “Form A,” and do not submit “Form B” by the end of this week, we’ll ask you to use the new eIRB process.
Phase I and IIa studies currently in presubmission in eIRB: study teams have the option of continuing to use the Emory University IRB as the IRB of record or submitting a Form A and using WIRB.
Training is available upon request for WIRB submissions. Please send a request to the WIRB listserve with your team's availability.
Changes to Emory HIPAA policy effective date: September 1, 2016
As previously announced, major the Emory HIPAA policy changes were to be effective pending changes to the HIPAA sections of our our electronic IRB submission system. The testing is now concluded and the effective date to the updated HIPAA policy will be September 1, 2016. All studies created on or after this date will fall under the updated Emory HIPAA policy. For more information about the changes, please refer to our webinar. Note that if you believe an upcoming study will no longer fall under HIPAA rules per the updated policy, you may choose to withdraw anything in "pre-submission" state and start fresh to benefit from the updated smartforms. If you wish to discuss HIPAA implications for studies already in the midst of IRB review, please contact the Director or a Team Lead.
IRB Webinar on Emory HIPAA Policy Changes
On August 11, 2016, the Emory IRB and the Office of Compliance will deliver a webinar focused on explaining the changes in the Emory HIPAA policy affecting research studies. 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 in the Webinar's page.
New Version of Emory IRB Policies and Procedures
There is a new version of the Emory IRB Policies and Procedures. Chapter 52 (Research with Children) was modified to align with changes in GA law involving HIV testing in minors without parents/legal authorized representative (LAR) permission. Chapter 45 (LARs and Surrogate Consent) was also modified by adding additional groups of people who can serve as LAR for medical treatment. The new version date is July 1, 2016.
Changes to Required Clinical Research Training
You may have received a letter from Dr. Jeffrey Lennox, summarizing changes to the required training for researchers working on clinical trials. That training is now partially conducted via CITI, the same site that provides our IRB-required ethics training. However, until further notice, the IRB will still require your proof of completion to be uploaded in eIRB for new submissions, or upon request for staff added after initial approval. This is because the IRB often may not know which training/system to check for each individual, which is based on their role, their prior experience, and their training history (i.e. ELMS vs. CITI, or investigator vs. coordinator course). The Office for Clinical Research is the final arbiter. Questions about the changes to training requirements for clinical research should be directed to Bridget Strong email@example.com or 404-778-2975.
IRB Webinar on Non-Human Subjects Research Determinations
On May 12, 2016 at 12 pm (Noon), the Emory IRB will deliver a concise webinar on non-humnan research determinations. The presentation will be about 20 minutes long with a live question and answer session. A link to the live webinar, and well as recordings of each webinar, will be available on the Webinar's page.
Updated Consent Template
The Emory Biomedical, Grady, CHOA, and SJHA consent/HIPAA templates have been updated. The new version date for all documents is 4-15-2016. Changes include a clarification to the guidance comments regarding medical records, Additional language for Cost Option 1 regarding what subjects may be liable for covering, and a small typo fix to the ClinicalTrials.gov statement. In addition, all study teams are reminded to distinguish between research vs non-research procedures listed in the consent form.
IRB Webinar on Close-Outs
On April 14, 2016 at 12 pm (Noon), the Emory IRB will deliver a concise webinar on the process of closing a study with the IRB. The presentation will be about 20 minutes long with a live question and answer session. A link to the live webinar, and well as recordings of each webinar, will be available on the Webinar's page.
Please Bear With Us!
Several IRB staff members will be unavailable in the next few weeks due to medical leave, and submissions are being reassigned as needed. Please contact the following people if you would need a status update or have a concern about an urgent submission: Carol Corkran (404-712-8545), firstname.lastname@example.org), Michael Deryck (404-712-0782), email@example.com), Maria Davila (404-712-0724), firstname.lastname@example.org or Rebecca Rousselle (404-712-078)5, Rebecca.email@example.com).
IRB Webinar on Informed Consent Process Documentation
On January 14, 2016 at 12 pm (Noon), the Emory IRB will deliver a concise webinar on Informed Consent Process Documentation, including what to do when you consent a subject remotely. The presentation will be about 20 minutes long with a live question and answer session. A link to the live webinar, and well as recordings of each webinar, will be available on the Webinar's page.
IRB Webinar on Prisoner Research
On November 12, 2015 at 12 pm (Noon), the Emory IRB will deliver a concise webinar on Prisoner Research, including what to do when your subject is incarcerated. The presentation will be about 20 minutes long with a live question and answer session. A link to the live webinar, and well as recordings of each webinar, will be available on the Webinar's page.
eIRB Update and Downtime
Starting at 3 PM on Friday, Nov. 6, eIRB will go offline for a major update. The system is expected to return online on the morning of Saturday, Nov. 7.
The update will result in a slightly different login process and, more significantly, an integration of eIRB accounts with the Emory University and Healthcare systems. New users will no longer have to submit a request to create an eIRB account. Instead, logging into eIRB with University or Healthcare credentials will automatically create an eIRB account.
Questions about this update may be sent to the IRB at our email, firstname.lastname@example.org.
IRB Holiday Meeting Schedule
Some IRB meetings will be re-schedule around the holidays in November and December. Study teams with submissions that may require full board review should take note of the compressed meeting schedule in order to avoid delays in review.eIRB Outage Monday (10/12) 6pm-8pm
eIRB will be unavailable during those hours due to scheduled maintenance. Please ensure all work in the system has been saved prior to that time.
IRB Webinar on the NPRM changes to the Common Rule
On October 8 at 12:00 pm (Noon), the Emory IRB will deliver a concise webinar on the NPRM changes to the Common Rule. The presentation will be about 15 to 20 minutes long with a live question and answer session afterwards. A link to the live webinar, as well as recordings of each webinar, will be available on the Webinars page.
Not Human Subjects Research Determination Outage
A technical error with the NHSR Determination webform led to an outage between 9/14 and 9/18. If you submitted a request between those days and have not received a response, please re-submit at your earliest convenience.
Policies and Procedures Update
The IRB P&P's have been slightly updated to clarify the independece of the IRB's decisions with regards to other institutional officials.
IRB Webinar on Collaborative Research
On September 10 at 12:00 pm (Noon), the Emory IRB will deliver a concise webinar on collaborative research considerations. The presentation will be about 35 to 45 minutes long with a live question and answer session afterwards. A link to the live webinar, as well as recordings of each webinar, are available on the Webinars page.
Informed Consent Template Update
The IRB's ICF/HIPAA templates have been updated to include a small new section prompting for the insertion of language regarding certificates of confidentiality, genetic research, incidental findings, and other topics. As these topics are not applicable to all studies, the language has placed on a separate document for modular use. In addition to the creation of the modular language, the signature page has been re-formatted for clarity and style. Study teams are not required to update their consent forms to the new templates, provided they already have language in their consent documents adequately covering things like genetic research, certificates of confidentiality, etc. The new version date for the Emory Biomedical, Grady, CHOA, and SJHA consent documents is 7-20-2015.
IRB Policies and Procedures Update
The IRB P&Ps have been updated, with the changes primarily focusing on internal IRB procedures. New chapters have also been added to cover research conducted under the auspices of the Department of Energy, Department of Justice, and the Environmental Protection Agency. The new version date is 6-9-2015.
IRB Policies and Procedures Update
The IRB P&Ps have been updated in order to be in accord with the current version of the VA Handbook. Numerous small changes and clarifications have been made to Chapter 17 and throughout the P&Ps generally. The new version date is 5-14-2015.
IRB Webinar on International Research Considerations
On May 14 at 12:00 pm (Noon), the Emory IRB will deliver a concise webinar on international research considerations. The presentation will be about 20-30 minutes long with a live question and answer session afterwards. A link to the live webinar, as well as recordings of each webinar, are available on the Webinars page.
CITI Certification Now Good for Three Years
As of May 15, 2015 CITI training certification for researchers on Emory studies will be extended to three years (previously it was two years). The renewal intervals will be updated in the CITI system and any certificate that was earned less than three years ago will be extended to be valid for three years. So those certificates that expired at two years, but were completed less than three years ago will be valid.
Important: NIH Policy in effect Jan. 25, 2015
Important new NIH policy for anyone conducting a defined scope of “large-scale genomic research” using human or non-human specimens/data. This policy requires data sharing plans to be included in applicable grant proposals, as well as in informed consent forms. The GDS Policy takes effect for competing grant applications submitted for the January 25, 2015, receipt date; contract proposals submitted to NIH on or after January 25, 2015; and for intramural projects generating genomic data on or after January 25, 2015.
Please see the NIH’s website for information: http://gds.nih.gov/03policy2.html and http://gds.nih.gov/13faqs.html. Information on informed consent for genomic research: http://www.genome.gov/27026588 (general homepage) and http://www.genome.gov/27559024 (considerations and sample language)
New guidance on obtaining Certificates of Confidentiality for your study
Please see the Certificates of Confidentiality page for better guidance on obtaining Certificates of Confidentiality for your studies. One highlight: your request for signature should be sent to your IRB analyst, and should not be sent directly to Emory's Institutional Official.
Condensed Meeting Schedules Nov-Jan
Please see our adjusted holiday meeting schedule. The IRB will have condensed meeting schedules during the months of November, December, and January. If you have a study that will be expiring during this time period, we highly recommend that you submit a Continuing Review early to ensure ample time for our evaluation and approval. If you have any questions or concerns, please feel free to contact us.
New Guidance for Drug/Device Studies
The IRB has created new guidance documents for investigators working with FDA regulated products. These documents, which may be found on the New Submission Guidance page, cover in vitro diagnostic devices, Emory sponsor-investigators, and expanded access use of drugs and devices.
Webinar on IRB Reporting Requirements
On September 11, 2014, at Noon, the Emory IRB will deliver a webinar on the topic of reporting requirements for events such as unanticipated problems, noncompliance, and protocol deviations. A link to the live webinar, as well as recordings of each webinar, are available on the Webinars page.
If your study has not updated its consent/HIPAA form for the last year or so, here are things you may wish to or need to do before your study is renewed:
- Assent forms can now be signed by minors through age 18, so the 17-year old assent signature line should be removed from the parental permission form. Until this is complete and approved by the IRB, you may continue to use the 17-year-old assent line.
- Separate consent and HIPAA forms? If you will be enrolling for more than another year, please combine by using our latest combo template (prevents HIPAA compliance issues).
- Does your project have optional substudies? These must be reflected in separate sections of the HIPAA form, as shown in our template (combine with a move to the combo consent/HIPAA form if you still have separate forms).
- Expiration dates may be removed from all consent headers (on the unstamped documents), no need to update version date or do an amendment for this; this is considered an administrative change. IRB staff can assist with this at renewal time. Please let your analyst know if the sponsor requests that expiration date remain.
Remember, using new version dates is the best way to keep track of of changes to approved consent documents.
Webinar on Internet Research Ethics
On August 14, 2014, at Noon the Emory IRB will deliver a webinar on the topic of internet research ethics. A link to the live webinar, as well as recordings of each webinar, are available on the Webinars page.
Webinar on How to Document Informed Consent
The IRB will deliver a concise webinar on the topic of correctly documenting the informed consent process. The presentation will show common errors as well as best practices. The presentation will take place on Thursday June 12, at 12:00 pm (noon). A link to the live webinar, as well as recordings of each webinar, are available on the Webinars page.
Emory IRB Webinar Series
The IRB will begin hosting short webinars intended to provide additional assistance with topics and questions we frequently receive. The webinars will be hosted monthly, starting on May 8 with the first session, “Getting your ICF approved on the first try!”
The webinar will air live between 12-12:45pm, and then be available on the IRB website. The recorded presentation is available at any time here, and all of the webinars may be found on the IRB website.
If you have questions or comments about the webinar series, please contact Maria Davila, MD, at email@example.com or 404-712-0724.
New FDA Financial Disclosure Form
ORC has replaced the financial disclosure forms on their FDA regulated studies FAQ pages. For more information continue reading here for a drug study and here for a device study. NOTE: The FDA financial disclosure form is different from and in addition to any financial disclosure forms required by the NIH.
Several updates to existing P&Ps have been made; the new version is dated February 26, 2014. Of particular note to the Emory research community:
- The requirement to stamp expiration dates on consent documents has been removed. IRB staff will no longer include expiration dates on new consent documents. Existing studies wishing to revise their documents should contact their study's analyst.
- The sections on obtaining informed consent from non-English speakers has been expanded and made into its own P&P chapter.
- Requirements for international research have been clarified, particular in regards to minimal risk and more than minimal risk studies.
- Assent policy has been changed to no longer require 17 year old subjects to sign the main consent (with parent/guardian), instead signing a written assent form. This harmonizes Emory and CHOA assent requirements.
- The P&P chapter on mandatory reporting has been expanded and revised to better reflect current Georgia law.
- Language regarding what student research projects require review has been revised for clarity.
- The Expanded Access letter templates in the IND section have been updated to the FDA's most current format and content.
- Various edits made throughout the P&P document were made to clarify when reporting periods are in business or calendar days.
During the installation of the update eIRB will be available, but slower than usual. Please note that work done during the update process may be lost if any issues are encountered and the server needs to revert to a previous state. The IRB recommends only using eIRB during this period of time for urgent matters.
Julie Simpson, PhD , director of research integrity services at the University of New Hampshire, will provide an introduction to qualitative research; discuss ethical challenges inherent in conducting and reviewing this type of research; and offer strategies to address them.
In qualitative inquiry, researchers study phenomena in their natural settings, where the purpose is contextualization, interpretation, and/or understanding the perspectives of others. The role of qualitative researchers in a study is characterized by personal involvement and empathetic understanding. The challenges specific to this research domain, for both researchers and institutional review boards (IRBs), include the emergent nature of qualitative research, a researcher’s relationships with research subjects, obtaining informed consent, and confidentiality and privacy.
Additionally, IRB members’ gaps in understanding qualitative inquiry may stand in the way of correctly identifying problematic aspects of a proposed study, or result in what is often viewed as inappropriate changes to the study design. Qualitative researchers are often frustrated by this perceived lack of understanding of qualitative inquiry. These gaps in understanding may also result in IRBs not correctly identifying problematic aspects of a proposed study. Further, qualitative researchers may not fully grasp the ethical concerns that their studies raise vis-à-vis human subjects protections, such as the potential effects of a researcher’s dual roles in a setting, or that informed consent is a process. They may also not understand how to mitigate such concerns and/or to communicate effectively with IRBs about how to address these challenges within the regulatory framework.
The goal of this webinar is to provide IRB members with a better understanding of the issues that qualitative researchers face and introduce strategies to address these issues while recognizing the unique characteristics of the qualitative research process. Topics for discussion will include:
•Differences between qualitative and quantitative research paradigms.
•Ethical issues that qualitative research methodologies may present to study participants.
•Strategies for IRB members and qualitative researchers to minimize harm to study participants.
This webinar will be of interest to researchers involved in qualitative studies, and to IRB members, directors, and staff that review qualitative research protocols.
Continuing Education credits are offered for this presentation.
Registration: To register for this course, follow the steps below:
Non-Emory employees, please send an email to firstname.lastname@example.org .
Emory employees can register for this course by following the steps below.
Date: Wednesday, November 20, 2013
Time: 2:00 - 3:00 pm EST
Location: Brown Auditorium (Emory Clinic A, Tunnel Level)
Presenter: Carol J. Weil, a lawyer and medical ethicist by training, has worked in the US Department of Health and Human Services for over 20 years. She served as senior counsel to the Inspector General from 1994-1999, followed by a ten year stint in the HHS Office for Human Research Protections working on a broad spectrum of human subject compliance and guidance issues. She came to the National Cancer Institute in 2010 where she oversees ethical and regulatory policy implementation pertaining to clinical trials and research biorepositories, including issues of consent, tissue collection/storage/access and custodianship, data sharing, and the return of research results.
Carol’s talk will focus broadly on current ethical and regulatory controversies involved with the collection, storage and research use of biospecimens. Issues covered include informed consent frameworks, privacy concerns, the identifiability of genomic data, different models of data sharing, and the return of research results.
This intermediate-level webinar may be of interest to anyone involved in the conduct and/or review of research with biorepositories, including IRB members, chairs, administrators, and staff, as well as researchers.
Registration: To register for this course, follow the steps below:
Non-Emory employees, please send an email to email@example.com .
Emory employees can register for this course by following the steps below.
Please go to http://it.emory.edu/password/ to change your password before the deadline. If you access eIRB via a Sponsored Account because you are not affiliated with Emory, your password will also expire on the above date. If you find you are no longer able to log into eIRB, please call the Emory Helpdesk at (404) 727-7777. If they are unable to verify your identity and help you, then you the person who sponsored your account will need to request help on your behalf. Please ask Helpdesk to give you that person’s name. We apologize for the inconvenience.
Several updates to existing P&Ps have been made, including:
- Changes to language in P&P 17 to clarify the review process for new and continuing studies, as well as reportable events. Other revisions include clarifications on the role of the VA RCO and VA Representative, deferral to Emory for non-human subjects research determinations, and protocol closures/suspensions/terminations. An additional change to language in P&P 43 was also made to clarify the role of a witness to consent in VA studies.
- Updates to P&Ps 72. 73, and 75 to harmonize the language of those sections with upcoming changes to HIPAA.
- A new section in P&P 13 regarding reliance agreements for Exempt research
- Revisions in P&P 60 to the review process for noncompliance and unanticipated problems by the Emory IRB Compliance Review group.
- Removed the requirement to obtain HIPAA authorization for Emergency Use protocol that was in P&P 68.
- In 70, P&P Clarified that SAEs at external sites which are not unanticipated problems must still be reported at renewal for Emory Sponsor-Investigator studies.
- Added language to P&P 79 to note that students (including post-doctoral) should not be IND/IDE holders.
Tracked changes versions of the P&Ps are available upon request.
- New language regarding known and unknown risks to the mother, fetus, and/or embryo in the case of pregnancy while on study.
- Revision of Sensitive Study verbiage noting that reasonable steps will be taken to keep consent/HIPAA documents out of the subject's medical record.
The HIPAA Authorization template has also been updated. The revisions reflect changes to HIPAA that will require consent to disclose PHI for use in any substudies in addition to consent to disclose for the main study.
All of the new documents are linked here, and may also be found on the Forms & Tools page.
The IRB, in conjunction with other Emory offices overseeing clinical research, is pleased to offer guidance to help investigators determine when the use of dietary supplements may require an IND. This joins an updated guidance document on determining when the use of a drug or device in a study may require an IND or IDE. Both documents are located on the Forms & Tools page, under Drugs & Devices section of the Other Researcher Tools tab.
There will be a transition in leadership at the IRB office in April 2013. Sarah Putney has accepted a new position as Director of Administrative Compliance with the Emory Internal Audit Division, after serving as IRB Director since November 2007. In her new position, Sarah will be focusing on building Emory's compliance and ethics program in a variety of areas across campus to complement existing programs at Emory in healthcare and research. While we at the IRB are sad to see Sarah go, we are glad that we will continue to have opportunities to work with her.
Vice President for Research Administration David Wynes has appointed IRB Assistant Director Rebecca Rousselle as Interim IRB Director pending a search. After April 12, 2013, please direct IRB inquiries that previously would have been addressed to Sarah to the Emory IRB listserv or to Rebecca Rousselle. Thank you!