Updates


December 2017

eIRB Changes Coming Along With New Common Rule

As you may have heard, DHHS has put forth the first changes to the Common Rule since the regulations were created in 1981. These are the regulations that apply to all federally funded human subjects research that is not FDA regulated (FDA expects to harmonize their regulations with the new Rule soon).

We will be doing a webinar on the changes in early January. Unfortunately, the effective date of the new Rule is up in the air at this time; it may be January 18, 2018, or all or some parts may be delayed by a year to allow more time for institutions to adjust. Meanwhile, to be prepared for either case, we are making some minor changes to eIRB which will be released in January. You will automatically be presented with the Old or New Common Rule version of the submission form depending on when you create and submit your study. If your study was created prior to the new Rule effective date, but you submit right before or any time after the effective date, you may be asked to make minor changes to adapt to the new forms.

New consent form templates will also be released shortly, that include the additional required elements of consent under the new Rule. They are good items to cover regardless of when the new Rule becomes effective, so please use them once we release them.

For more on the changes in the new Rule, please see: Final Revisions to the Common Rule

New Version of IRB Policies and Procedures

We have posted a new version of our Policies and Procedures. This version includes changes to align with the latest Emory HIPAA policy for research, to reflect the current FDA guidance and instructions for expanded access use of investigational drugs and devices, to allow for non-Emory CITI (or other) training for non-Emory collaborators, to clarify policies when entering into IRB reliance agreements with other institutions, as well as to update Legally Authorized Representative rules in accordance with changes in Georgia state law. Note that most of the information researchers need to know is better accessed via the guidance on our IRB website. For questions about these changes, please email Maria Davila at maria.davila@emory.edu.

Informed Consent Document Archiving and Organization

When submitting your study’s next amendment in eIRB, consider clearing out your study’s informed consent documents section. You can delete outdated documents and save them only in your local study files, making IRB review more quick and accurate. In case of over-zealous cleaning, know that documents deleted via amendment can still be retrieved by the IRB.

The IRB Welcomes our New Reliance Specialist, Hannah Allen, JD

Ms. Allen is currently training to be the contact person for single IRB reliance agreements. Please contact her at (404) 712-8689 or hannah.allen@emory.edu with questions about reliance agreements beginning in mid-January 2018.

October 2017

Effective October 1, 2017, all new and ongoing NIH-funded research meeting certain criteria is deemed to be issued a Certificate of Confidentiality (CoC) via a new NIH policy. (Previously, researchers had to proactively apply to the NIH for a CoC, and only if the study was collecting sensitive information from participants.) For more information about the change in policy, please see this notice.

What is a Certificate of Confidentiality?

NIH grants Certificates of Confidentiality to research studies, to protect identifiable research records from forced disclosure.

What research is now covered automatically by a CoC?

  • Funded by NIH and was commenced or ongoing on or after December 13, 2016, and:
  • Is “human subjects research” as defined by federal regulations, including exempt research where data is identifiable;
  • Or, is research involving the collection or use of biospecimens that are individually identifiable or for which there is at least a very small risk that some there is some way to deduce the identity of an individual;
  • Or, is research that generates individual level, human genomic data from biospecimens, or the use of such data, regardless of whether the data is “identifiable” per the Common Rule; or
  • Or, is any other research that involves information about an individual for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that the subject’s identity could be deduced

What does the research team have to do?

For studies that obtain informed consent, the human subjects must be informed that their information is protected by a CoC. The IRB provides language in its consent form (ICF) template to be used in all new submissions meeting the above criteria. The IRB will also provide an addendum to be used when consenting prospective subjects in ongoing research studies, until the study team updates the ICF to include the CoC language (more to come on when that will be required).  

Will the CoC cover data already collected in our ongoing study?

Yes. Once in place, the CoC applies to all data collected in the study, including data collected before the CoC was issued.

Will I receive an actual “Certificate?”

No. The NIH will not be sending out certificates.

2017 IRB Holiday Meeting Schedule

The IRB meeting schedule has been revised to accommodate university holidays. Please remember to submit continuing review submissions early to avoid lapses in IRB approval with the upcoming schedule changes. The updated schedule for November and December, with revised meeting dates noted with an asterisk (*) is below:

November 2017 IRB Committee Meetings

Date      Day                     Panel

11/1      Wednesday       B1

11/8      Wednesday       A1

11/9      Thursday            B2

11/13*  Monday             A3 (moved from the end of the month)

11/15    Wednesday       A2

11/16    Thursday            Q

NOTE: No “regular” meetings the week of 11/20

11/28   Tuesday              B3

December 2017 IRB Committee Meetings

Date      Day                     Panel

12/4*    Monday             A3 (moved from the end of the month)

12/6      Wednesday       B1

12/12*  Tuesday             B3

12/13    Wednesday       A1

12/14    Thursday            B2

12/20    Wednesday       A2

12/21    Thursday            Q

NOTE: No “regular” meetings the last week of December

IRB Webinar – “Reportable Events at Continuing Review: What do I need to submit to the IRB?”

On October 12, 2017 at 12:00 pm, the Emory IRB will deliver a webinar focused on Reportable Events at Continuing Review: What do I need to submit to the IRB? 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 of the IRB website.

New Comprehensive Device Guidance on the IRB Website

Are you confused about how medical devices are regulated for research? Please see our new comprehensive guidance document on the New Submission Guidance page of the website.

2017 Jul-Sep

Upcoming Emory IRB Webinar: NIH Single IRB Policy and New Revised Common Rule

On September 14, 2017 at 12:00 pm, the Emory IRB will deliver a webinar focused on NIH Single IRB Policy and New Revised Common Rule. 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 of the IRB website. Also, see the end of this newsletter for a segment about the NIH policy.

Email communication with Study Subjects

You should not email sensitive information or the informed consent form to a study participant who does not have an Emory-affiliated email address unless you are encrypting your Emory email communication. To learn more about how to encrypt email to external parties (those without an emory.edu or emoryhealthcare.org address) with Outlook 365, check out this information from LITS. You should never use personal email (e.g. Hotmail, Gmail) for communication that involves sensitive information, including blank consent forms if those might expose private information (e.g. a health condition).

Reminder: consult the IRB only for questions about Cost/In Case of Injury Language

Please check with your IRB study analyst if you want to follow up about your study’s Cost or In Case of Injury language, rather than going directly to OCR or OTT. Our analysts will follow up with those offices if needed to confirm if a determination has been made. Thanks!

New brief guidance for screening consent/HIPAA

The IRB has recently published some brief guidance on our website about when your study may require a screening consent. This applies when study subjects will have to provide identifiable information as part of screening but before signing the main informed consent/HIPAA. There is also some handy advice for how to avoid the need for a screening consent. Please check out the template under the heading “Screening Consent” on our Consent Toolkit page and follow the link for more guidance.

FDA Guidance for waiving informed consent in minimal risk studies

Previously, there was no option to waive consent for FDA-regulated research. Now, in keeping with the 21st Century Cures Act, the FDA has released guidance for waiving or altering informed consent in studies involving no more than minimal risk. Please see the published guidance for reference. The IRB reviewer(s) will ultimately determine if consent can be waived for your study.

Information about the coming NIH Single-IRB Review Policy

In January, most new NIH grant proposals for multisite research will need to use a single IRB of record. Per the NIH: "This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.  It does not apply to career development, research training or fellowship awards."

See policy here: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html and an FAQ here.

After lengthy internal discussion and analysis of resources, Emory IRB has determined that we cannot serve as the reviewing IRB for multisite clinical research studies. (We may be able to serve as the single IRB of record for multisite minimal risk studies.)

If Emory is the lead site on an NIH grant, and is asked to take on the IRB responsibility, then the Emory IRB will work with you to obtain a quote from an independent IRB to serve as the single IRB of record. We have consulted with the NIH, who have confirmed that this option is acceptable, and we have also heard from various peer institutions that they will be taking the same path.

What this means for you: Early in the proposal stage for multisite studies, where Emory is asked to take on IRB responsibility, you must work with OSP and the Emory IRB to identify the IRB solution, and to ensure that it is worked into the proposed budget. Consult with our IRB as early as possible to avoid complications. And thank you!

2017 Apr-Jun

New Resource for Mobile Medical Apps- Federal Trade Commission’s Mobile Medical App Tool

The Federal Trade Commission has a website full of resources for Mobile Medical App developers. The website briefly goes over all of the laws that might apply and has an interactive tool that can help you determine which laws apply to the app as you intend to use it. Check out the website here.

New NIH e-Protocol Writing Tool and Clinical Trial Template for Phase 2 and 3 IND/IDE Studies

NIH has recently released two new resources for investigators. The first is a complete Clinical Trial Template for FDA-regulated Phase II and III studies using an investigational drug or device. This tool helps study teams efficiently prepare documents to promote a quick review by both IRBs and FDA. There is also a new collaborative electronic protocol writing tool that has been released. This new tool allows investigators to nominate a protocol writing team where each member is assigned writing and reviewing roles. Check out both new resources on the Office of Science Policy website.

REMINDER: The use of most mobile apps and/or certain software tools in research requires IT review prior to IRB approval

Testing and use of mobile apps in the context of research has increased greatly in the last couple years. Likewise, so have investigations of other types of software tools in healthcare delivery.

Often, the research involves collection or transmission of sensitive information (health-related or otherwise). Please remember that the IRB relies on input from LITS or your School’s IT department to assess risks to confidentiality, and to determine if the apps/software are compliant with School policy and (if applicable) HIPAA requirements. Your IRB analyst can help point you to the right contact for the LITS review, which can take quite a while. If you already obtained IT input during development of your research protocol, please document that in your IRB submission. Mobile apps and software tools (especially tools hosted external to Emory) include additional risk to participants, which the IRB needs to assess, and to ensure is well-described in the consent materials.

Important caveat: LITS review may be avoided if you use a tool already deemed acceptable. See the official list of tools here: LITS approved apps for research

2017 Jan-Mar

New NIH policy for GCP (Good Clinical Practice) training became effective on January 1, 2017

Emory already required GCP training for investigators on FDA-regulated clinical trials, in addition to the IRB’s human research ethics training requirement. Now, NIH requires GCP training for personnel on studies that meet the NIH definition of clinical trial as well, if NIH provides the funding:

“A clinical trial is defined by NIH as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”

Note: Unlike our existing clinical research training policy, NIH requires GCP training to be refreshed every three years.

For ongoing grants: The Emory IRB will try to contact you to let you know if you are now required to take GCP training, for existing grants that we review.

For new grants: Emory will need to make sure the required training is in place at Just In Time stage; the IRB may verify as well. The training must be renewed every three years while the research is actively funded.

Current options for GCP basic course (for those who have never taken Emory’s Key Concepts or CRC course):

  • The CITI GCP module satisfies the NIH requirement, as well as Emory’s existing requirement for FDA-regulated studies.
  • Sociobehavioral researchers: The National Center for Advancing Translational Sciences (NCATS) has developed a GCP training program geared to behavioral clinical trial investigators. This will not satisfy Emory’s existing requirement for FDA-regulated studies. CITI may also release their own version this Spring.

Current options for GCP refresher course: CITI’s GCP refresher course is now available for those who need to recertify every three years. We are looking at other options, however, that may streamline your refresher training requirements for GCP and IRB.

Why the Policy? And Who Does it Cover?

Per the NIH policy website:

“The principles of GCP help assure the safety, integrity, and quality of clinical trials. GCP provides a standard for ensuring clinical trial compliance, implementation, data collection, monitoring, and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data), and outline the responsibilities of Institutional Review Boards (IRBs), investigators, sponsors and monitors.  GCP addresses elements related to the design, conduct and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data) of clinical trials….

This Policy applies to NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials. GCP training includes the Principles of ICH GCP found in Section 2 of ICH E6….

Clinical trial staff:  Individuals identified by the investigators, who are responsible for study coordination, data collection and data management. The central focus of clinical trial staff is to manage participant recruitment and enrollment, to maintain consistent study implementation, data management, and to ensure integrity and compliance with regulatory and reporting requirements. These individuals may also seek informed consent from prospective participants, enroll and meet with research participants, and collect and record information from research participants. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.”

New tool available to help in the informed consent process- OHRP Newsletter

The Office for Human Research Protections announced the launch of its new public outreach website: About Research Participation, http://www.hhs.gov/about-research-participation. The resources on the website were created to help research participants understand research and determine whether they want to participate in studies. The website’s content can also serve as resources for research staff to improve the informed consent process. The website includes short informational videos, questions for participants to ask of research teams, and additional resources such as news articles.

New Common Rule Changes for Regulation of Human Subjects Research (under temporary moratorium)

Finally, a major revision to the Common Rule governing human subjects research was published on January 19, 2017. These changes were meant to modernize and increase the effectiveness of the Common Rule. The changes were slated to go into effect in January of 2018 but are now under review by the new administration as part of the moratorium on new regulation. Stay tuned for more updates. Click here to access a press release regarding the changes from HHS that includes an overview of the important elements of the rule. You can view the published rule in pdf format here. (Of note, the final Rule does not treat all biospecimens as identifiable.)

NIH requirement to use a single IRB for multisite research effective September 2017

Reminder that the NIH requirement to use a single IRB for multisite research (where all sites are carrying out the same protocol) is not effective until September 2017, and that any investigators writing multisite research grant applications should consult with the Emory IRB before deciding on a single IRB option. The Emory IRB will generally not serve as the single IRB of record for multisite studies due to the significant additional resources required to do so. Other options are available.

Reminder: Select only one Department for Departmental Approval

Only one departmental approval should be selected in eIRB unless you’ve heard from your department that more than one is required; and always select a department with an asterisk (*) at the beginning of the name. The asterisk indicates that the department has approvers associated with it (usually the Chair or other leader). Please see this table showing which departments currently have approvers to aid in your selection. More guidance can be found in our FAQs.

Reminder: CTRC reviews ALL Cancer-Related Research at Emory

Reminder that ALL cancer-related research requires CTRC review at Emory, even chart reviews and secondary data analyses, and including studies outside the School of Medicine which involve cancer. Please select “Cancer Related Research” from the Biomedical Research section to trigger the required pre-IRB review. If the section does not appear in the smartform (as in the case of chart reviews), you can jump to it via the Drop-Down menu at the top of the smartform, and just fill in that one checkbox. If all else fails, the IRB staff will endeavor to catch it during screening. The IRB cannot issue final approval until CTRC approval is in place.

Reminder for Amendments- Show the Changes

  •  The IRB must always receive a track-changes and a clean copy of revised documents;
  • For revisions to multisite protocols and Investigators Brochures (IB’s), a “Summary of Changes” document may suffice.
  • The track-changes version must show the specific wording being changed, not wholesale replacement of large sections.

IRB members curse their poor computer screens if they cannot easily tell which changes they must review. Thank you!

Using Technology to Store or Transmit Identifiable Human Subjects Data or Obtain Informed Consent- IT Review Needed

Major reminder that any use of technology to transmit identifiable human subjects data or obtain informed consent must normally be vetted by LITS or your departmental IT representative. LITS has provided the IRB with this list of vetted technologies (housed on the IRB’s New Submission Guidance webpage) for use in research studies. Approval of a different technology can take some time, so please get started with LITS review while you are developing your research idea; you do not need to wait until you begin your IRB submission.

For electronic informed consent, we have a new guidance document to assist you in submitting new review requests

2016 Nov-Dec

  • New Guidance for Using Family Members as Interpreters
  • New Biomedical Informed Consent Templates as a result of changes to HIPAA
  • Reminder to log in to eIRB to check communications
  • Selecting the correct reviewing department for Department Review
  • Reminder: More studies now go to Western IRB- and a minor change in the process

New Guidance for Using Family Members as Interpreters

The Emory IRB, consistent with Title VI and the CLAS Standards from the office of Minority Health, considers that people with limited English proficiency must have the opportunity to understand what they are being asked to do in the context of a research study. Using a friend or family member as an interpreter introduces conflicts of interest that may adversely impact the rights and welfare of potential study participants. The IRB is now offering guidance for Using Family Members as Interpreters during Research Consent Process in Emory Research.

New Biomedical Informed Consent Templates as a result of changes to HIPAA

The IRB has created two new informed consent templates as a result of changes to HIPAA at our institution. As a reminder, HIPAA does not apply to research records in studies where treatment is not taking place, or where treatment may be taking place but billing is not done electronically. There is a new informed consent template available for biomedical studies to which HIPAA does not apply. There is another informed consent template for studies that require HIPAA authorization to collect information from a covered entity, but where HIPAA does not apply to the subsequent research use of the data. Both of the new templates can be found on our website in the Consent Toolkit.

Reminder to log in to eIRB to check communications

If you feel your study review is taking longer than expected, please check for communication about the study from your study analyst in eIRB. Even if the study is not under your ‘Inbox’ tab clearly awaiting your action, you can view the study via the “IRB” tab to ensure that your analyst hasn’t posted any questions for you, for which you may have missed an email notification.

Also, when communicating with your analyst in eIRB, please remember to select “Log Comment to IRB Staff” and not “Log Comment to Study Team.” The latter does not send any notification to your analyst.

Selecting the correct reviewing department for Department Review

All new IRB submissions are first routed through Departmental Review, to the department displayed on the “Required Reviews” page of the smartform. The smartform defaults to the PI’s department as listed in eIRB, which may not be the right one. When selecting a department that will review your study, it is good to first ask department colleagues or administrators which one to use. Also, select only departments that begin with an asterisk (*) - these are the ones that have approvers associated with them. Finally, remove any incorrect Departments from your smartform before proceeding - selecting multiple departments may delay your submission since both approvals must be received before the IRB can begin its review.

If you see your study remain in “Departmental Review” status for more than a couple days, please contact the IRB listserv at irb@emory.edu or call 404-712-0720, and we can help.

Reminder: More Studies now go to Western IRB-and a minor change in process

First, Emory expanded our use of Western IRB (WIRB) to include Phase I and II studies – so now all industry-sponsored drug and device clinical trials go to WIRB (with certain exceptions, including COI and CHOA involvement). 

Second, our process for maintaining records of WIRB-eligible studies has changed! After you submit “Form A” to verify WIRB eligibility, we no longer require “Form B” via email. Instead, we request that study teams complete a specialized submission in eIRB for the study. Please see this webpage for further instructions.

Note: One you have a WIRB account, WIRB staff are available by phone to walk you through submitting their electronic forms (in lieu of advance group training, they have found this more effective).

2016 Sept-Oct

  • IRB Webinar- Setting up Databases, Registries, and Sample Repositories: Important Guidelines
  • Updates to training certificates accepted by the IRB
  • Compressed holiday IRB meeting schedule
  • Reminders of prior announcements

IRB Webinar- Setting up Databases, Registries, and Sample Repositories

On October 13, 2016 at 12 pm, the Emory IRB will deliver a concise webinar on guidelines for setting up databases, registries, and sample repositories. 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 webinars page.

Updates to training certificates accepted by the IRB

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 maria.davila@emory.edu.

Compressed holiday IRB meeting schedule

The regular IRB meeting schedule will be condensed due to the upcoming holidays in November and December. Study teams are advised to review their expiration dates and submit renewals up to 60 days in advance in order to ensure timely review.

Reminders of Prior Announcements

  1. 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):

  1. 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)
  2. “Form B” is no longer used; instead WIRB studies will submit their information to Emory IRB via eIRB

More information:

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.

Change to eIRB to include Office of Quality/Nursing Checklists

As of October 4, the eIRB “Office of Quality” smartform section is expanded to include the Office of Quality and Nursing clinical research readiness checklists. This is in addition to the Clinical Research Key Points Summary form that had already been present. (See “Background” below if you are unfamiliar with the Office of Quality and their initiatives.)

You may have also received notice about this time-and-effort-saving change from OCR.

NOTE: The change affects new studies going forward,  but you will also be affected if you have any applicable studies currently undergoing IRB review. If the IRB sends the study back to you for any changes, the new Office of Quality questions will show as required, and you will not be able to resubmit the study until you answer them.

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.

2. Changes to Emory HIPAA policy effective date: September 1, 2016

As previously announced, major Emory HIPAA policy changes were to be effective pending changes to the HIPAA sections of our electronic IRB submission system.  The testing is now concluded and the effective date of the updated HIPAA policy was 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. 

2015 Mar-Apr

Things to Know

  • Staff Changes and Required Training
  • Research Use of Newborn Blood Spots
  • NIH Genomic Policy Update
  • Planning Ahead for Data Sharing in ALL Research Studies
  • Grant Applications as Protocols
  • HIPAA Question in the eIRB Smartform
  • Certificates of Confidentiality
  • Departmental Review and You
  • Lay Summaries: Content & Style

Staff Change Requests

Since April 2014, the IRB has transitioned to receiving and implementing the majority of staff change requests through our website.  After submitting a request, you will receive an emailed receipt which clarifies that the change is effective immediately and the new staff can begin conducting research as long as applicable training has been completed. IRB staff will log notices in eIRB to confirm when the technical changes have been made and the new personnel can access eIRB. If a new study team member needs immediate access to eIRB, please contact the IRB listserv to alert us to this need.

With few exceptions, all staff changes should be made through the online tool, and not amendments. The exceptions which still require an amendment are:

  • Adding non-Emory affiliated study personnel
  • Changes to VA studies
  • Any change of Principal Investigator
  • Removal of a Co-Investigator on more than minimal risk studies
  • Adding any study personnel with a financial conflict of interest

Please note: adding non-Emory study staff (except for CHOA personnel) should not be done through the online tool. Adding outside personnel may require a formal agreement to be established beforehand. Please contact your study analyst before adding non-Emory study staff.

Research Use of Newborn Blood Spots

On 3/16/2015, the reauthorized Newborn Screening Saves Lives Act went into effect. The reauthorization of this bill specifically addressed the use of newborn dried blood spots in research. This law made two important changes for research funded by the DHHS:

  1. Newborn dried blood spots are now always considered human subjects, regardless of the identifiability of the specimen
  2. IRB’s may no longer waive informed consent in research involving newborn dried blood spots

The Emory IRB will be updating its policies and procedures accordingly, and providing further information to the research community as we do.

NIH Genomic Policy Update

Effective 1/25/2015, the NIH has instituted new policy covering data sharing for large-scale genomic research.

 

Does this policy affect me? 

                Yes, if you are doing;

  • NIH-funded research that generates large-scale human or non-human genomic data, OR uses such data for subsequent research
    • Large-scale data include Genome-Wide Associate Studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenetic, and gene expression data, among other study designs. (Complete listing here.)

What do I need to do differently?

  • Funding proposals: Work with OSP as you prepare your research proposal, to ensure that the data-sharing and human subjects plans are in line with the new policy
  • Share the data, once it is ready to be shared (timelines are discussed in the policy)

INFORMED CONSENT: 

  • Investigators are encouraged to seek the broadest possible sharing permissions from participants for future research use of their data
  • You can no longer comply with the data sharing requirements from the NIH if you do not have prior consent from the research subjects – even for use of discarded samples
  • See sample consent language at NIH’s “genome.gov” site: http://www.genome.gov/27026588 (bottom of page) and *coming soon* in our Emory consent templates

How can I comply with the policy if I am only using discarded human specimens, with no way to consent the donors?

  • This is a tough issue that the NIH said they plan to address soon in guidance. How can you be expected to obtain consent for data sharing if you do not have any identifiers?
  • Per NIH website: "For some research, while informed consent is not required by federal regulations, it may still be appropriate. […] In particular, NIH, under the NIH Genomic Data Sharing (GDS) policy, expects that after the effective date of the GDS Policy, researchers generating large-scale human genomic data use specimens or cell lines for which consent was obtained for future research purposes and broad sharing."
  • Work with Emory OSP and the NIH’s Genomic Program Administrators early in your application process, to see if they might be able to grant you an exception from the requirement for informed consent. If the science is important and there is no way to do it should consent be required, they may work with you.

Link to press release: http://www.nih.gov/news/health/aug2014/od-27.htm

Link to Policy: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html#policy

Contact Genomic Program Administrators: http://gds.nih.gov/04po2_2GPA.html


Planning Ahead for Data Sharing in ALL Research Studies

The Emory IRB has seen many requests to re-use data from previous research studies, either from the same PI, or from other researchers. Often this is problematic, because the new research is outside the scope of the original study’s consent and HIPAA authorization. 

Ethical issue: Human subjects who agree to offer their time, private information, and biological specimens do so with a particular study in mind. Unless explicitly described in the consent form, they did not agree to have that information shared for other purposes or with other researchers, and their wishes must be respected. 

We can often approve sharing when the data and materials to be shared are completely deidentified, with no way to link them back to individuals, but even in those cases we make sure that the original consent is consistent with that sharing.

Informed Consent Tip: When drafting your consent and HIPAA authorization forms, please think about the potential that someday, others might want to use the data or specimens generated by your research study, and consider including an option for future research sharing in those forms. 

The language must be specific about what type of future research might be done (scope can be very broad), who might receive the data/samples, with what identifiers, and whether the subject can later change their mind about sharing (if identifiers will be kept, then the answer should normally be “yes”).  

Any future use of the data/samples must have separate IRB submissions, unless completely deidentified (consult the IRB for a “not human subjects” determination in that case).

NOTE: tacking on a data sharing option for a specific study is different from setting up a data and/or specimen repository. Repositories must be under their own, stand-alone IRB submissions, and include detail about the oversight of the repository as well as the policies and procedures for distributing the data/samples to other researchers. 

More protocol guideline and sample consent language for the above scenarios will be coming to the IRB website.

Grant Applications as Protocols

The IRB asks that protocol documents be in line with our protocol guidelines, and, generally, will no longer accept excerpts from grant applications as study protocols. 

Verbatim grant applications, we have found, can be time-consuming for our reviewers to parse as they look for what the IRB needs to know - which is what specifically will happen with human subjects. Some background information about the science is important. But the rest of the protocol document must clarify things like: recruitment methods, inclusion/exclusion criteria, human subject procedures, potential risks and benefits, how data will be handled and protected, how data and safety will be monitored, statistical basis for number of subjects, and bibliography. Feel free to cut and paste liberally from your grant application, but please use our protocol formats so that we can be sure to get the information we need.

HIPAA Questions in the eIRB Smartform: “That doesn’t really apply to me

Many submissions have come in lately where “No” is answered for all the “HIPAA Determination” questions, even though the researchers are clearly affiliated with the Emory “covered entity.” This prolongs the review process, since further required HIPAA questions are then skipped. 

We truly acknowledge that HIPAA is an awkward fit with many research studies, but if it applies, the IRB has to make certain findings recorded in the eIRB forms.

Does it apply to me? 

 1.0 *

Will you be receiving or disclosing any information about a person's health, healthcare or payment for healthcare that has any associated identifiers? 

( )Yes  (X)No  Clear

If you will access or create any health information that contains any of the 18 HIPAA identifiers (See List of Possible Identifiers), then you must answer “Yes” to question #1.

 2.0 *

 

Is there any person on the study (Study Staff) that is part of the "RWHSC Covered Entity"?

( )Yes  (X)No  Clear

If you or any of your study team members are affiliated with Emory’s “covered entity”* you must answer “Yes” to question #2 – even if the study does not use PHI (because we need to get the lack of PHI clearly "on the record”). 

*School of Medicine, Emory Healthcare, Emory School of Public Health. You’d also answer “Yes” if your study involves our partner covered entities (e.g. CHOA, Grady, St. Joseph’s, Johns Creek), since we may be serving as the Privacy Board for those sites as well.

 3.0 *

Will any protected health information (PHI) be provided by any component of the "RWHSC Covered Entity"?

( )Yes  (X)No  Clear

3. If you will be asking for any PHI from one of the above covered entity components, even if just to ascertain eligibility for a study, then you’d need to answer “Yes” to #3. 

Any “yes” answers will trigger further HIPAA-related questions, which we need to review in order to ensure compliance with HIPAA.

Certificates of Confidentiality

Certificate of Confidentiality (CoC) can act as additional protection for the subjects in research involving sensitive or potentially damaging subjects. Though granted by the NIH, a study does not need to have NIH funding to apply for a CoC. The NIH’s CoC Kiosk is the place to start an application.

Please note, that while a CoC does need to be signed by an Institutional Official, these applications must go through the IRB offices. DO NOT send the application directly to Emory’s Institutional Official, this will only cause delays. Instead, contact the IRB analyst for your study or the IRB listserv at irb@emory.edu.

More information is available on the IRB’s CoC page.

Departmental Review and You

Before the IRB can review a study, the PI must first submit the protocol to their department for a review of the design and scientific merit of the proposed study. In eIRB, submitting a study for departmental (or faculty advisor) review occurs before the study reaches the IRB. Delays can occur in the review of a study at this stage if there are multiple departments that need to grant approval or if the department listed has not designated a reviewer. If your study has spent more than a week in departmental/advisor review, you may contact either your department head to confirm there are reviewers available, “your faculty advisor, or the IRB.

Note: studies in departmental review are not in the IRB’s inbox. The IRB will not and cannot review a study until the departmental reviewer or faculty advisor has granted approval. Please check on your studies regularly to confirm that they have not stalled in “Departmental Review” or  “Faculty Review”.

Lay Summaries: Content & Style

Lay summaries submitted to the IRB should follow the guidance on biomedical and sociobehavioral summaries. They should, in plain language, briefly describe protocol procedures and the involvement of human subjects. They should not just be a “background” section from the protocol, or only describe the problem of interest. A lay summary must also be in terms that do not require specialized subject-matter knowledge in order to understand. The better the lay summary, the more efficient the IRB can be in its reviews, especially of renewals and amendments.  

2014 Nov-Dec

Things to Know

  • Staff Changes and Required Training
  • Retrospective Chart Reviews: Enrollment Numbers and Dates
  • Enrollment Goals to Avoid Noncompliance
  • New Guidance on Reporting Multiple Events

Staff Change Requests

Since April 2014, the IRB has transitioned to receiving and implementing the majority of staff change requests through our website.  After submitting a request, you will receive an emailed receipt which clarifies that the change is effective immediately and the new staff can begin conducting research. 

IRB staff will, within two weeks, acknowledge the staff change request and update the eIRB protocol. If a new study team member needs immediate access to eIRB, please contact the IRB listserv to alert us to this need.

All new staff being added must still have the requisite training and access before they can be added to a study (i.e., prior to sending the request). Staff changes will be assessed at Continuing Review and the addition of study team members who have never completed the necessary training will be considered POTENTIALLY SERIOUS NONCOMPLIANCE.

The IRB strongly encourages study teams to review past staff changes made through the website to ensure all new personnel were eligible when added. Be sure to ensure that those with CITI certification have the correct courses (biomedical or sociobehavioral) for the study they are joining. If non-eligible individuals were added, this should be promptly reported to the IRB.

Please note: The online form should not be used for VA. Staff changes for studies taking place at the AVAMC require an amendment. Other restrictions on who may submit a request and who may be added may apply. Please consult the staff change request page for details. If the required steps have not been taken prior to the submission of the request, personnel changes may be delayed.

Retrospective Chart Reviews: Enrollment Numbers and Dates

The IRB no longer requires retrospective chart review studies to submit an expected “enrollment” number and these studies should no longer submit an exact number to the IRB. IRB analysts will work with new submissions to make sure they meet this new policy. Existing retrospective chart reviews will be asked to submit amendments removing exact enrollment numbers from their IRB protocols prior to, or with, their next continuing review.

This change applies only to retrospective chart reviews; and while the enrollment number has been removed, the IRB still requires these protocols have a specific start and end date from which the data will be reviewed.

Enrollment Goals to Avoid Noncompliance

For all studies, other than retrospective chart reviews, the IRB still requires a specific enrollment number. This number should take into account the possibility of screen failures and subjects lost to follow-up. Note that the IRB considers a subject to be “enrolled” immediately upon signing the consent form, regardless of continued participation. As such, the IRB recommends that researchers be generous in their estimation of how many subjects will be needed to complete their project. If this causes the limit in the submission to differ from the number noted in the protocol, you can simply make a note in the submission to explain that the limit has been increased to account for screen failures.


New Guidance on Multiple Reportable Events

The IRB has created a new guidance document for investigators who have several events to be reported simultaneously for a study. When multiple events need to be reported, these should be combined into a single submission in eIRB (the “Protocol Deviation” choice under the Reportable Event module is preferred). Events should be combined into a single submission even if they are not related. The submission should contain a description of each individual event. The guidance document lists what pertinent information should be included.

2014 Sep-Oct

Things To Know

  • Staff Changes and Required Training
  • New Consent Form Templates
  • Expiration Dates and the Stamping Header
  • Expanded Criteria for WIRB Studies
  • New Guidance on Expanded Access and More
  • IRB Holiday Meeting Schedule
  • Short Form Consent Procedure

Staff Changes and Required Training  **Important Compliance Implications for PI’s**

Since April 2014, the IRB has transitioned to receiving and implementing the majority of staff change requests through our website.  After submitting a request, you will receive an emailed receipt which clarifies that the change is effective immediately and the new staff can begin conducting research.  Within the following days, the IRB will make the administrative change in eIRB so that the new staff names will appear in the study, and they will then have eIRB access as well.  Because the new personnel may begin research activities immediately upon submission of the form, it is crucial to ensure that all necessary training has been obtained and the form was completed accurately. 

The responsibility for ensuring fully trained study personnel rests, as it always has, with the Principal Investigator.  Any discrepancies will be discovered during the next Continuing Review, at which point a situation where personnel engaged in research without ever having obtained the necessary training will be considered PRESUMPTIVELY SERIOUS NONCOMPLIANCE.

This presumption of serious noncompliance will go into effect on January 1, 2015.  In the interim, the IRB strongly encourages study teams to review past staff changes made through the website to ensure all new personnel were eligible when added. If non-eligible individuals were added, this should be promptly reported to the IRB before January 1st; it will likely be determined noncompliance, but it may avoid the presumption of serious noncompliance.

New Consent Form Templates

New biomedical ICF/HIPAA templates have been released for Emory, CHOA, Grady, and SJHA studies. The templates now incorporate standard language on GINA, required pharmacy language for drug studies, and notice that participation in one treatment study may preclude participation in other studies. Numerous small edits have been made as well, in order to bring the template language in line with recently issued FDA guidance on consent forms. In addition, a standard cover sheet has been incorporated to facilitate subject education on their rights and role in the research. The new templates are dated version 9-29-2014 and may be found on the Consent Toolkit page of the IRB website.

Expiration Dates and the Stamping Header

The IRB previously removed the requirement to have a stamped expiration date on consent and HIPAA authorization forms. Expirations dates may still be stamped on documents if that is the study team’s or sponsor’s preference. All documents must have the stamped approval date, however, in order to be valid. Use of a consent/HIPAA form without a stamped approval date is considered the same as using an unapproved consent/HIPAA form. The best practice is to download a copy of the form from eIRB for each new subject. But if using a photocopied form, and you are not sure which is the currently-approved version, please look up the study in eIRB to see what is shown the ‘Documents’ tab, or at least use the consent form with the most recent “Approved on” date in the header. Rarely, the ‘Documents’ tab will contain multiple versions of your study’s consent form, because we neglected to remove the outdated version(s). Please do not hesitate to bring this to your IRB analyst’s attention, and in the meantime use the one with the most recent approval date in the header.

Expanded Criteria for WIRB Studies

Additional studies may now be referred to the Western IRB for review. As before, Phase III drug/device studies may go to WIRB for review. Additionally, drug/device studies in Phase IIB or Phase IV may now also be referred to WIRB. Please note, CHOA and VA studies may NOT be sent to WIRB.

New Guidance on Expanded Access and More

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. The Emory IRB webinar on Single Use Expanded Access IND/IDE studies is now available as well.

IRB Holiday Meeting Schedule

The regular IRB meeting schedule will be condensed due to the upcoming holidays in November and December. Study teams are advised to review their expiration dates and submit renewals up to 60 days in advance in order to ensure timely review.

Update on Enrolling Unexpected Non-English Speaking Participants via the “Short Form”

The Emory IRB now offers a selection of “short form” consent forms in various languages. These are basic forms with no study-specific information (other than title and contact information), via which the participant can attest that the whole English consent form was orally translated for them, and they agree to be in the study. See the cover sheet of the short form for more detailed instructions for use.

In the past, an IRB amendment was needed in order to enroll a participant using a short form. Now, if you request that option at initial submission, and use one of our posted short-forms, no amendment is needed.

To request this ability, you must check off “Non-English Speaking Subjects” in the “Study Population” section of the eIRB smartform. When eIRB presents you with questions about that population, state that you do not expect any particular language to be strongly represented in your target population, and would therefore like to be able to use the short form (instead of excluding non-English speakers, or alternatively translating the entire English consent form). You can ignore questions that are not relevant to you. NOTE: If you DO expect many, for example, Spanish speakers, then the full translation would be required.

The IRB may stipulate that the full consent be translated after you do enroll someone via short form, but for now that will be rare. New FDA draft guidance, if formalized, may make that a requirement in the future for FDA-regulated studies.

IF YOU DID NOT REQUEST THAT OPTION AT INITIAL SUBMISSION then you will need to submit an amendment if you wish to enroll any non-English speaking subjects via a short form, even if you use one of our posted forms. The amendment would be to check off “Non-English Speaking Subjects”, and the IRB would review to ensure that your study is an appropriate candidate for this consenting procedure.

2014 Jul-Aug

New and Updated Forms

Consent Template Updates Are Coming

Pending final review of the language, some minor changes to the consent templates will be forthcoming. The revision will add template language to cover genetic risks under GINA, as well as template language on pharmacy information and storage of samples. Some edits to the language and guidance are also being made in accordance with the FDA’s guidance on informed consent. These changes are being made in conjunction with Emory’s Office of Research Compliance and will apply to all relevant consent templates offered by the Emory IRB.

 

Getting Pre-Approval to Use the Short Form Consent

A short form consent is used to enroll non-English speaking subjects when a version of the consent form translated into the subject's language is not available. For the short form to be used in a study, the IRB must review and approve the potential enrollment of non-English speakers. Previously, study teams have been expected to submit amendments for use of the short form when its use became necessary. The IRB has revised its approach to the use of the short form, however, and will now be asking all studies with the potential need to use a short form to request permission before the need arises. Specifically, under question 5.0 on the Population page in eIRB, teams should check “Subjects who are not able to clearly understand English.” This should be done during the initial submission for new studies, or done via an amendment for existing studies. If you foresee the possibility of ever needing to use a short form, you may wish to go ahead and submit amendments now to avoid hassle in the future.

The IRB will consider the study complexity and the amount and duration of participant involvement when determining if using the short form consent process is appropriate and can be approved. The IRB will also consider whether a significant number of people who speak the language in question would be expected to enroll, and may request a translation of the full consent (and HIPAA form, if separate) instead.

If the investigators wish to use a translated short form provided by the IRB, then those forms do not need to be submitted to and approved by the IRB prior to use. If the investigators wish to create and translate their own Short Form(s), those, including the English version, must be reviewed and approved by the IRB prior to use.

If a non-English speaking participant is initially consented for a study through an approved short form process, to the extent the study includes ongoing interventions or interactions with the participant, investigators and the IRB may assess the feasibility of translating the full English consent, as well as other study-related documents, into the participant’s language whenever possible.

 

Does Your Study Need IRB Review? Use the IRB Website to Find Out.

The IRB has built a submittable form on its website for sending in requests to determine if a particular project requires review. The form incorporates prompts for the basic information an IRB analyst would need to determine whether or not a particular project falls under the purview of the IRB. Previously, researchers asked for a determination by emailing irb@emory.edu; this new form helps ensure that important information is included in the initial request and therefore helps expedite the process.

New Reportable Event Assessment Form

The External and Internal event assessment forms have been combined into a single document. Investigators may use this form to determine whether a particular event needs to be reported to the IRB. The document also contains guidance on when an event needs to be reported.

 

Updates and Info

What You Should Know About Retrospective and Prospective Chart Reviews

The Emory IRB defines a retrospective chart review as a study where all the data has been recorded prior to the submission of the protocol to the IRB. Often, this type of chart review is eligible for a waiver of consent and HIPAA authorization from the patient, due to the fact that the data contained has already been collected prior to the study team receiving it. While there may be the option to extend final date of collection of data, this is generally permitted only in a small number of cases.

The Emory IRB defines a prospective chart review as a study where some of the data is collected after the submission of the protocol to the IRB. While this may be eligible for a full waiver of consent and HIPAA authorization from the patient, prospective reviews most typically require written consent and authorization from the subject. If the study team offers a sufficient explanation as to why obtaining consent from subjects is impracticable, a reviewer may provide a full waiver for the collection of prospective data.  Please keep in mind that while you may provide an explanation for why it is impracticable for your study team to consent the subjects, it is ultimately up to the reviewer regarding whether or not to provide a waiver of consent and HIPAA authorization.

IRB Education Sessions Available!

Do you want your department or school’s researchers to have a smoother and easier IRB experience? Having the IRB come give a specifically tailored education session can be the first step. Outreach and education are two of the most important tools the IRB has to ensure that Emory remains a leader in the field of human subjects research. As such, the Emory IRB is committed to a vigorous schedule of visiting the various schools, departments, and other groups that make up the Emory community for tailored educational sessions, ranging from auditorium-filling presentations to informal Q&A sessions. If your particular department or research group would like to jump to the head of the line, please contact Shara Karlebach at swilli7@emory.edu, or by phone at 404-712-0727, to schedule a session.

2014 May-Jun

Updates and Info

Leadership Transition at the IRB

Sarah Putney, IRB Director since November 2007, accepted a new position in April as Director of Administrative Compliance with the Emory Internal Audit Division. 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 during the search for someone to fill the position. Please direct IRB inquiries that previously would have been addressed to Sarah to the Emory IRB listserv or to Rebecca Rousselle.


Reporting Responsibilities for Emory Sponsor-Investigators

As a reminder, Emory Sponsor-Investigators are required to report to the IRB any serious adverse events and serious suspected adverse reactions that occur at external sites, as well as those that occur at Emory. This applies to events and reactions that do not constitute unanticipated problems. The standard timeframe for reporting these items applies.

New Look for the IRB Website

The IRB website, along with the other websites of the Office of Research Administration, have updated their web presences and now proudly sport the Emory colors. All the content previously available on the IRB website is still available, though the exact location may have changed; please update any links accordingly.

 

As with any transition, some things may not translate smoothly. Please report any broken links, formatting errors, or simply being unable to find something to the IRB listserv, irb@emory.edu.

 

Webinar: Overcoming Obstacles to Research with Pregnant Women

(Rescheduled from the previous April date)
 
Date:  Wednesday, June 19, 2013
Time:  1:00 PM – 2:30 PM EST
Location:  WHSCAB Auditorium

Join us for a special webinar presentation from Public Responsibility in Medicine & Research entitled Overcoming Obstacles to Research with Pregnant Women. For a full description, including how to register, please see the end of this message.

IRB Education Sessions Available!

Do you want your department or school’s researchers to have a smoother and easier IRB experience? Having the IRB come give a specifically tailored education session can be the first step. Outreach and education are two of the most important tools the IRB has to ensure that Emory remains a leader in the field of human subjects research. As such, the Emory IRB is committed to a vigorous schedule of visiting the various schools, departments, and other groups that make up the Emory community for tailored educational sessions, ranging from auditorium-filling presentations to informal Q&A sessions. If your particular department or research group would like to jump to the head of the line, please contact Shara Karlebach at swilli7@emory.edu, or by phone at 404-712-0727, to schedule a session.

New and Revised Forms and Templates

IMPORTANT: Consent & HIPAA Authorization Template Updates

The BiomedicalGrady, & CHOA consent templates have all been updated. The changes include:

  • 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.
In addition, the IRB has created two new templates to assist in obtaining verbal consent and HIPAA authorization from subjects for participation in a study or screening for a study.  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.

 

Updates to the Policies and Procedures

The new version is dated May 24, 2013. Updates to the P&Ps include:

    • 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 in P&P 68 to obtain HIPAA authorization for Emergency Use protocols.
    • In P&P 70, 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 Guidance Document on Using Dietary Supplements in Research

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.

2014 Mar-Apr

Consent Document Changes

The end of expiration dates on consent documents
As of 4/11/2014, the Emory IRB will no longer be requiring consent documents to bear the study expiration date and our consent templates have been updated accordingly. On-going studies who wish to revise their existing documents may do so via an amendment. If you have any questions, you may contact the analyst for your study or reach the IRB Office at 404-712-0720 or irb@emory.edu.

Externally funded studies should confirm the Sponsor does not require expiration dates on consent documents before opting to use, or change to, the new templates.

For questions about this, please contact Sean Kiskel at skiskel@emory.edu or 404-712-0766.

 

Some staff changes no longer require amendments

As of 4/11/2014, the IRB will no longer require amendments for certain staff changes. Instead, Investigators and Coordinators should make these changes through a submittable form on the IRB website. Study staff to be added must still have an eIRB account and must still meet all relevant training requirements.

Please note the following regarding this new system:

  • Changes may only be made by current Investigators and Coordinators on the study.
  • Changing the Principal Investigator still requires an amendment.
  • Removing a Co-Investigator from a more than minimal risk study still requires an amendment.

As a reminder, the Emory IRB requires all personnel on studies to hold current CITI certification. Investigators on clinical trials additionally need to complete the Key Concepts training provided by the Office of Clinical Research.

Upon clicking the “submit” button, an email will automatically be sent to the IRB listserv with the relevant information. An IRB analyst will make the change to the study and log a comment notifying the study team the request has been completed.

As of now, the staff change form supports only one change at a time. The ability to make multiple staff additions or removals at once will be forthcoming.  For questions about this, please contact Sean Kiskel at skiskel@emory.edu or 404-712-0766.

NOTE: The above does not apply to VA studies. All staff changes for VA studies still require the submission of an amendment.

 

Updates & Info

New IRB Policies & Procedures version
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. Updated templates are available on the IRB website.
  • 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. 

 

Website re-design
The IRB slightly altered the layout of the IRB Website. The Members and Participants links have been moved to the top navigation bar. The Researchers section has been merged into existing sections, most notably the Forms & Guidance section and the Policies section. If you have questions about the website, you may contact Sean Kiskel at skiskel@emory.edu or 404-712-0766.

 

Online eIRB training
The IRB has discontinued its monthly eIRB classes in favor of online instructional videos. The videos will provide a flexible way to train on the eIRB system, as well as serving as an easy reference as you work with the system. Presentations covering How to Access eIRB; How to Submit a New Study in eIRB; and How to Submit an Amendment in eIRB are available now the eIRB and Training pages of the IRB website. Presentations on Continuing Reviews, Reportable Events, and Not Human Subjects Research Determinations will be forthcoming.

Individual and groups of investigators may still schedule training and educational sessions with IRB staff on a variety of topics, including eIRB (see below: IRB Education Sessions Available).

Sponsor requests for the IRB membership roster
Sponsors occasionally request copies of an IRB’s membership roster, often as one way of ensuring compliance with FDA regulations or ICH guidelines. The Emory IRB, rather than providing an updated membership letter to Sponsors over the months, or years, a study is under review, instead provides a standard letter. The letter affirms that the Emory IRB is in compliance with the relevant regulations and guidelines. For Sponsors requiring a direct list of Emory IRB members, a periodically updated list may be found on the IRB’s website.

 

IRB Education Sessions Available!
Do you want your department or school’s researchers to have a smoother and easier IRB experience? Having the IRB come give a specifically tailored education session can be the first step. Outreach and education are two of the most important tools the IRB has to ensure that Emory remains a leader in the field of human subjects research. As such, the Emory IRB is committed to a vigorous schedule of visiting the various schools, departments, and other groups that make up the Emory community for tailored educational sessions, ranging from auditorium-filling presentations to informal Q&A sessions. If your particular department or research group would like to jump to the head of the line, please contact Shara Karlebach at swilli7@emory.edu, or by phone at 404-712-0727, to schedule a session.

2013 Nov-Dec

Contents

  • Affiliated Nonscientist Members needed!
  • Holiday Review Schedule
  • Planning to do Research at St. Joseph’s Hospital or Johns Creek?
  • Online eIRB Training
  • Combined ICF/HIPAA for NCI CIRB Studies
  • IRB Education Sessions Available!
  • FDA Guidance on Design Considerations for Pivotal Clinical Investigations for Medical Devices
  • Study Tips
  • FDA Guidance on Mobile Medical Applications
  • Verbal Consent & Screening Templates

Updates and Info

Affiliated Nonscientist Members needed!

If you are, or know, a nonscientist who is affiliated with Emory, CHOA, VA, CDC, Morehouse, or GA Tech, please consider IRB membership. Contact Director Rebecca Rousselle if interested, and thanks!

Holiday Review Schedule

The final Full Board meeting agendas of 2013 are now closed. While expedited reviews for new studies, continuing reviews, and amendments will continue to take place, Full Board review will resume in January when the IRB returns to its regular Committee Schedule. If your study will expire before then, please remember that all human subjects research activity must stop unless you let us know that certain activities are necessary for the health or safety of subjects.

Planning to do Research at St. Joseph’s Hospital or Johns Creek?
Please keep in mind that, for all Emory research taking place at St. Joseph’s Hospital or Johns Creek, the SJHA Research Oversight Committee must also review the protocol to determine if it meets local institutional requirements or is exempt from those requirements. Study teams should contact the ROC Administrator, Kristi McGinnis, at kristi.mcginnis@emoryhealthcare.org for additional information regarding SJHA requirements.

Note about The Emory Clinic at St. Joseph’s: In eIRB, all research at St. Joseph’s Hospital itself should list as a study site “Emory St. Joseph’s Hospital.” Research taking place at the Emory Clinic at St. Joseph’s should ALSO list the study site under “Other” as “TEC at St. Joseph’s.”

The St. Joseph’s Consent Template: Studies taking place at St. Joseph’s itself should use the Emory-St.Joseph consent template available on the IRB website. Studies taking place at the Emory Clinic at St. Joseph’s may use the standard Emory Biomedical consent template.

Questions regarding Emory research studies at SJHA or Johns Creek may be directed to the Emory IRB. Both Olga Dashevskaya (olga.dashevskaya@emory.edu/404-727-3508) and Andrea Goosen (andrea.c.goosen@emory.edu/404-712-6596) are available to field questions on this matter.

Online eIRB Training

The IRB has discontinued its monthly eIRB classes in favor of online instructional videos. The videos will provide a flexible way to train on the eIRB system, as well as serving as an easy reference as you work with the system. Presentations covering How to Access eIRB; How to Submit a New Study in eIRB; and How to Submit an Amendment in eIRB are available now the eIRB and Training pages of the IRB website. Presentations on Continuing Reviews, Reportable Events, and Not Human Subjects Research Determinations will be forthcoming.

Individual and groups of investigators may still schedule training and educational sessions with IRB staff on a variety of topics, including eIRB (see below: IRB Education Sessions Available).

Combined ICF/HIPAA for NCI CIRB Studies
As a reminder, Emory studies which are being reviewed by the NCI CIRB should be using the current Emory Biomedical combined ICF/HIPAA Authorization template. This document can be found on the Forms page of the IRB website.

Questions regarding NCI CIRB studies should be directed to either Olga Dashevskaya (olga.dashevskaya@emory.edu/404-727-3508) or Andrea Goosen (andrea.c.goosen@emory.edu/404-712-6596).


IRB Education Sessions Available!
Do you want your department or school’s researchers to have a smoother and easier IRB experience? Having the IRB come give a specifically tailored education session can be the first step. Outreach and education are two of the most important tools the IRB has to ensure that Emory remains a leader in the field of human subjects research. As such, the Emory IRB is committed to a vigorous schedule of visiting the various schools, departments, and other groups that make up the Emory community for tailored educational sessions, ranging from auditorium-filling presentations to informal Q&A sessions. If your particular department or research group would like to jump to the head of the line, please contact Shara Karlebach at swilli7@emory.edu, or by phone at 404-712-0727, to schedule a session.

Regulation News

FDA Guidance on Mobile Medical Applications

The FDA has released its official guidance on mobile apps used in health care, prevention, and delivery. In clarifying the agency’s oversight of this technology, the FDA states that it will “focus only on the apps that present a greater risk to patients if they don’t work as intended and on apps that cause smartphones or other mobile platforms to impact the functionality or performance of traditional medical devices.” Regardless, though, research on/using mobile medical applications will likely be considered “FDA regulated.” More information can be found on the FDA website, where the official guidance is available as a PDF.


FDA Guidance on Design Considerations for Pivotal Clinical Investigations for Medical Devices

The FDA has released its official guidance on study design for clinical studies intended to support premarket submissions for medical devices. Different study design principles and their relevance to device trials are covered. More information can be found on the FDA website, where the full guidance is available.

 

New and Revised Forms and Templates

Verbal Consent & Screening Templates

The IRB’s templates for combined verbal Consent/HIPAA Authorization for participation in studies and screening for studies have been updated. The new versions reflect feedback from Investigators and incorporate HIPAA requirements to get explicit permission for use of PHI in sub-studies. Both forms can be found on the IRB Forms page.

Please note, verbal consent requires a waiver of documentation from the IRB. Studies should not use these forms unless that waiver has been granted.

 

Study Tips

It’s the little things that count when submitting a new study or an amendment in eIRB. Here are couple things that can help ensure smooth sailing:

  • Uploading training documents (CITI, Key Concepts, etc.) when adding staff. IRB staff can look up CITI records if needed, but we require the study team to upload copies of Key Concepts/Clinical Research training for study team members.
  • Submitting both a clean and tracked-changes version of changed study documents (or a summary of changes from the sponsor for Industry protocols).

2013 Aug-Sep

New Online eIRB Training
The IRB has discontinued its monthly eIRB classes in favor of online instructional videos. The videos will provide flexibility to study team members at all levels a flexible means of familiarizing themselves with the eIRB system while also acting as an easy reference for working within the system. The first video, How to Submit a New Study in eIRB, is available now. Future videos on a variety of more specific topics will be forthcoming, so keep an eye on the eIRB and Training pages of the IRB website. Individual and groups of investigators may still schedule training and educational sessions with IRB staff on a variety of topics, including eIRB (see below: IRB Education Sessions Available).

IRB Education Sessions Available!

Do you want your department or school’s researchers to have a smoother and easier IRB experience? Having the IRB come give a specifically tailored education session can be the first step. Outreach and education are two of the most important tools the IRB has to ensure that Emory remains a leader in the field of human subjects research. As such, the Emory IRB is committed to a vigorous schedule of visiting the various schools, departments, and other groups that make up the Emory community for tailored educational sessions, ranging from auditorium-filling presentations to informal Q&A sessions. If your particular department or research group would like to jump to the head of the line, please contact Shara Karlebach at swilli7@emory.edu, or by phone at 404-712-0727, to schedule a session.

Meet the New Boss, Same as the Old Boss
Interim IRB Director, Rebecca Rousselle, has officially accepted the position of IRB Director. Ms. Rousselle joined the Emory IRB from Harvard in 2008 and previously served as Emory’s Assistant IRB Director before being appointed to the interim position. Rebecca’s position as IRB Director ensures that our office will continue to provide the excellent quality our researchers have come to expect, as well as upholding our on-going efforts for constant improvement.

Upcoming Webinars

Overview and registration instructions for both webinars are located at the end of this email.

Biobanking: When Issues with Tissues Come a’Knockin’
Date:  Thursday, October 3, 2013
Time:  2:00 PM – 3:00 PM EST
Location:  WHSCAB Auditorium
 
Protecting Human Subjects in Qualitative Research: Ethical Considerations for IRBs and Researchers
Date:  Thursday, October 24, 2013
Time:  1:00 PM – 2:00 PM EST
Location:  WHSCAB Auditorium

New and Revised Forms and Templates

New Assent Template
A streamlined version of the Assent Template has been created. This version clearly states Emory policy regarding obtaining assent from minors in research studies, while eliminating unnecessary verbiage which could prove distracting to investigators and subjects alike.

The new document, dated 9-10-2013, may be found on the Forms page of the IRB website.

New Combined Consent/HIPAA Template

In the past, the IRB recommended that consent forms and HIPAA authorizations be separate documents. We felt that keeping the more legalistic HIPAA language out of the consent would help subjects focus on the research procedures, risks, and benefits. Furthermore, a combined form has been shown to avoid compliance issues where the consent may be signed, but HIPAA Authorization not obtained.

Our new combined template for Emory Biomedical studies, dated 9-23-2013, can be downloaded directly from this link and can also be found on the Forms page of the IRB website. Additional templates with required Grady Health System and Children’s Healthcare language will be forthcoming.

This template will be required in all new studies going forward.

Existing studies that have separate forms can remain that way, but if you wish to submit an amendment to combine the forms, please do so.

2013 May-Jun

Leadership Transition at the IRB
Sarah Putney, IRB Director since November 2007, accepted a new position in April as Director of Administrative Compliance with the Emory Internal Audit Division. 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 during the search for someone to fill the position. Please direct IRB inquiries that previously would have been addressed to Sarah to the Emory IRB listserv or to Rebecca Rousselle.


Reporting Responsibilities for Emory Sponsor-Investigators
As a reminder, Emory Sponsor-Investigators are required to report to the IRB any serious adverse events and serious suspected adverse reactions that occur at external sites, as well as those that occur at Emory. This applies to events and reactions that do not constitute unanticipated problems. The standard timeframe for reporting these items applies.

New Look for the IRB Website

The IRB website, along with the other websites of the Office of Research Administration, have updated their web presences and now proudly sport the Emory colors. All the content previously available on the IRB website is still available, though the exact location may have changed; please update any links accordingly.

As with any transition, some things may not translate smoothly. Please report any broken links, formatting errors, or simply being unable to find something to the IRB listserv, irb@emory.edu.

 

Webinar: Overcoming Obstacles to Research with Pregnant Women

(Rescheduled from the previous April date)
 
Date:  Wednesday, June 19, 2013
Time:  1:00 PM – 2:30 PM EST
Location:  WHSCAB Auditorium

Join us for a special webinar presentation from Public Responsibility in Medicine & Research entitled Overcoming Obstacles to Research with Pregnant Women. For a full description, including how to register, please see the end of this message.

IRB Education Sessions Available!
Do you want your department or school’s researchers to have a smoother and easier IRB experience? Having the IRB come give a specifically tailored education session can be the first step. Outreach and education are two of the most important tools the IRB has to ensure that Emory remains a leader in the field of human subjects research. As such, the Emory IRB is committed to a vigorous schedule of visiting the various schools, departments, and other groups that make up the Emory community for tailored educational sessions, ranging from auditorium-filling presentations to informal Q&A sessions. If your particular department or research group would like to jump to the head of the line, please contact Shara Karlebach at swilli7@emory.edu, or by phone at 404-712-0727, to schedule a session.

New and Revised Forms and Templates

IMPORTANT: Consent & HIPAA Authorization Template Updates
The BiomedicalGrady, & CHOA consent templates have all been updated. The changes include:

  • 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.

In addition, the IRB has created two new templates to assist in obtaining verbal consent and HIPAA authorization from subjects for participation in a study or screening for a study.

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.

 

Updates to the Policies and Procedures

The new version is dated May 24, 2013. Updates to the P&Ps include:

  • 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 in P&P 68 to obtain HIPAA authorization for Emergency Use protocols.
  • In P&P 70, 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 Guidance Document on Using Dietary Supplements in Research

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.

 

Webinar Information

Overview

Pregnant women have historically been excluded from participation as subjects in biomedical research, but there is increasing recognition in the research community of the importance and of the vast potential benefits to allowing their participation. This webinar will address the significance of conducting research with pregnant women and the protections that are in place for this vulnerable population.

Topics for discussion will include:

Importance of conducting research with pregnant women

The first part of the presentation will address the benefits of involving pregnant women as subjects in research and the shift in perception of such research from protecting pregnant women from research to protecting them through research.

Subpart B of 45 CFR 46: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research

This part of the presentation will feature an analytical breakdown of the relevant regulations, including duties of IRBs, in connection with research involving pregnant women, and, specifically, research that presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women that is not otherwise approvable.

Myths and misinterpretations

With references to specific cases, this part of the webinar will focus on the studies that have been initially denied, and will segue into a discussion on understanding risk, minimal risk, and benefit in this population.  Examples will focus on problem solving to move projects forward with balanced justification.

New approaches and summary of key points

Presenters will discuss strategies for addressing issues that arise during the approval process, including novel study designs and approaches to negotiating with IRB members in order to gain approval allowable by regulations.

Audience:

This intermediate-level webinar may be of interest to anyone involved in the conduct and review of research with pregnant women, including IRB members, chairs, administrators, and staff, as well as researchers.

Registration information:

To register for this course, follow the steps below:

Non-Emory employees, please send an email to irb@emory.edu .

Emory employees can register for this course by following the steps below.

  1. Log into the Emory LMS – you can follow this link (https://elmprod.emory.edu )
  2. Select: Browse Catalog<IRB<IRB Webinar (215002)
  3. Then, select ‘Enroll’ next to the session you would like to attend

This webinar can only be viewed at the designated time/place above. It will not be broadcasted to individual workstations.

2013 Mar-Apr

CITI Changes

The CITI Program, which Emory uses for Human Subjects Research training and certification, will be making some changes to the organization of its offered courses on March 31, 2013. While the Emory IRB does not anticipate any future complications from this move by the CITI Program, Investigators with currently unfinished courses may wish to complete those programs before the above date to avoid any possible loss of effort from the re-organization.

You may contact The Emory IRB about CITI Program questions at irb@emory.edu or 404-712-0720.

Reminder to Thesis/GFE/Etc. Reminder

To Graduate and Honors Students from the College, GSAS, and RSPH (and their advisors): The surfeit of IRB submissions for thesis and GFE projects is starting to come in. Be sure to get your proposals in to us ASAP - don't wait until the last minute! Once you submit, keep in touch with your analyst regarding your deadline.

Note that complete review can take approximately one month.

Finally, if you are not sure if your project needs IRB review, send us your proposal via email to irb@emory.edu.

Our staff thanks you!

2013 Jan-Feb

Mandatory Training for Key Personnel in Clinical Trials Deadline

The School of Medicine, the Clinical Trials Operations Committee, and the Clinical Trials Executive Committee have set forth training requirements for key personnel on clinical trials. This training requirement applies to all investigators, as well as clinical research coordinators and research nurses participating in clinical trials at Emory.

What’s next if training is required?

  • For the classroom environment, review the ORA Google Calendar (www.ora.emory.edu) for course dates, times, and locations. Course details will be sent upon registration.

  • For the on-line environment, please complete and submit course pre-requisites to ocr@emory.edu. Course details will be sent upon verification of the pre-requisites.

  • The deadline for completion of the mandatory training requirements is March 7, 2013.

 If you have any questions, please contact OCR at ocr@emory.edu or 404-778-4960.

Upcoming Webinars

A number of webinars from PRIM&R that may be of interest to the Emory human subjects research community are coming up in the next few weeks, the details are below.

  • On February 28, PRIM&R will host a webinar titled Key Decision Points: Is it Research Involving Human Subjects? Is it Exempt? Is IRB Review Required? Using case studies, presenters will discuss the process for determining when an activity constitutes research involving human subjects, and when such research is exempt, qualifies for expedited review, or must undergo full institutional review board (IRB) review.   
  • On March 4, a webinar titled PRIM&R’s Primer on the HIPAA/HITECH Act Omnibus Final Rule will address aspects of the just-released Final Rule that are of particular relevance to IRBs. Presenters will outline the major changes, review effective and compliance dates, and explore the aspects of the new Rule that allow compound authorizations and authorizations for use of protected health information in future research. 
  • On March 12, PRIM&R will offer a webinar titled Online Research, Social Media, and the IRB: Assessing Ethics, Norms, and Risks. The emergence of online communities and research on and through social media has presented challenges to IRBs that assess novel recruitment methods, data collection, and diverse forms of risk. This webinar will offer IRBs techniques to address questions of social norms in online communities and social media fora and strategies for estimating baseline risks to subjects.

eIRB Inbox Bug Patch

On Friday, February 15, 2013 from 8 PM to 9 PM, the eIRB system will be taken offline for maintenance to correct the inbox display issue that some customers have been experiencing since last November.  Please email us at irb@emory.edu if you find that your inbox display has not been corrected.  Thank you for your patience with this process!

IRB Education Sessions Available

Outreach and education are two of the most important tools the IRB has to ensure that Emory remains a leader in the field of human subjects research. As such, the Emory IRB is committed to a vigorous schedule of visiting the various schools, departments, and other groups that make up the Emory community for tailored educational sessions, ranging from auditorium-filling presentations to informal Q&A sessions. If your particular department or research group would like to jump to the head of the line, please contact Shara Karlebach at swilli7@emory.edu, or by phone at 404-712-0727, to schedule a session.

Timing of Continuing Renewal Submissions

As a reminder, continuing renewals may be submitted to the IRB up to 90 days prior to the expiration date. Early submissions allow analysts and study teams to identify and solve any issues that may result in delays in approval.