What's New?

Condensed Meeting Schedules Nov-Jan
9/2/2014 

The IRB will have condensed meeting schedules during the months of November, December, and January.  If you have a study that will be expiring during this time period, we highly recommend that you submit a Continuing Reviewer early to ensure ample time for our evaluation and approval.  If you have any questions or concerns, please feel free to contact us.

Webinar on IRB Reporting Requirements
9/2/2014 

On September 11, 2014, at Noonthe Emory IRB will deliver a webinar on the topic of reporting requirements for events such as unanticipated problems, noncompliance, and protocol deviations.  A link to the live webinar, as well as recordings of each webinar, are available on the Webinars page.

Keeping Your Consent Forms Current!
8/12/2014 

If your study has not updated its consent/HIPAA form for the last year or so, here are things you may wish to or need to do before your study is renewed:

  • Assent forms can now be signed by minors through age 18, so the 17-year old assent signature line should be removed from the parental permission form. Until this is complete and approved by the IRB, you may continue to use the 17-year-old assent line.
  • Separate consent and HIPAA forms? If you will be enrolling for more than another year, please combine by using our latest combo template (prevents HIPAA compliance issues). 
  • Does your project have optional substudies? These must be reflected in separate sections of the HIPAA form, as shown in our template (combine with a move to the combo consent/HIPAA form if you still have separate forms).
  • Expiration dates may be removed from all consent headers (on the unstamped documents), no need to update version date or do an amendment for this; this is considered an administrative change. IRB staff can assist with this at renewal time. Please let your analyst know if the sponsor requests that expiration date remain.

Remember, using new version dates is the best way to keep track of of changes to approved consent documents.

Webinar on Internet Research Ethics
8/14/2014 

On August 14, 2014, at Noon the Emory IRB will deliver a webinar on the topic of internet research ethics. A link to the live webinar, as well as recordings of each webinar, are available on the Webinars page.

Webinar on How to Document Informed Consent
6/9/2014

The IRB will deliver a concise webinar on the topic of correctly documenting the informed consent process. The presentation will show common errors as well as best practices. The presentation will take place on Thursday June 12, at 12:00 pm (noon). A link to the live webinar, as well as recordings of each webinar, are available on the Webinars page.

Emory IRB Webinar Series
4/22/2014 

The IRB will begin hosting short webinars intended to provide additional assistance with topics and questions we frequently receive. The webinars will be hosted monthly, starting on May 8 with the first session, “Getting your ICF approved on the first try!”  

The webinar will air live between 12-12:45pm, and then be available on the IRB website. The recorded presentation is available at any time here, and all of the webinars may be found on the IRB website.
 
If you have questions or comments about the webinar series, please contact Maria Davila, MD, at maria.davila@emory.edu or 404-712-0724.

New FDA Financial Disclosure Form
4/1/2014 

ORC has replaced the financial disclosure forms on their FDA regulated studies FAQ pages. For more information continue reading here for a drug study and here for a device study. NOTE: The FDA financial disclosure form is different from and in addition to any financial disclosure forms required by the NIH.

New Policies & Procedures Version
2/27/2014 

Several updates to existing P&Ps have been made; the new version is dated February 26, 2014. Of particular note to the Emory research community:

  • The requirement to stamp expiration dates on consent documents has been removed. IRB staff will no longer include expiration dates on new consent documents. Existing studies wishing to revise their documents should contact their study's analyst.
  • The sections on obtaining informed consent from non-English speakers has been expanded and made into its own P&P chapter.
  • Requirements for international research have been clarified, particular in regards to minimal risk and more than minimal risk studies.
  • Assent policy has been changed to no longer require 17 year old subjects to sign the main consent (with parent/guardian), instead signing a written assent form. This harmonizes Emory and CHOA assent requirements.
  • The P&P chapter on mandatory reporting has been expanded and revised to better reflect current Georgia law.
  • Language regarding what student research projects require review has been revised for clarity.
  • The Expanded Access letter templates in the IND section have been updated to the FDA's most current format and content.
  • Various edits made throughout the P&P document were made to clarify when reporting periods are in business or calendar days. 

eIRB update installation from 9 pm Friday, September 26 - 6 pm Saturday, September 27. Downtime from 6 pm - 10 pm, Saturday, September 27.

During the installation of the update eIRB will be available, but slower than usual. Please note that work done during the update process may be lost if any issues are encountered and the server needs to revert to a previous state. The IRB recommends only using eIRB during this period of time for urgent matters.

Webinar Announcement: "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

Overview

Julie Simpson, PhD , director of research integrity services at the University of New Hampshire, will provide an introduction to qualitative research; discuss ethical challenges inherent in conducting and reviewing this type of research; and offer strategies to address them.

In qualitative inquiry, researchers study phenomena in their natural settings, where the purpose is contextualization, interpretation, and/or understanding the perspectives of others. The role of qualitative researchers in a study is characterized by personal involvement and empathetic understanding. The challenges specific to this research domain, for both researchers and institutional review boards (IRBs), include the emergent nature of qualitative research, a researcher’s relationships with research subjects, obtaining informed consent, and confidentiality and privacy. 

Additionally, IRB members’ gaps in understanding qualitative inquiry may stand in the way of correctly identifying problematic aspects of a proposed study, or result in what is often viewed as inappropriate changes to the study design. Qualitative researchers are often frustrated by this perceived lack of understanding of qualitative inquiry. These gaps in understanding may also result in IRBs not correctly identifying problematic aspects of a proposed study.  Further, qualitative researchers may not fully grasp the ethical concerns that their studies raise vis-à-vis human subjects protections, such as the potential effects of a researcher’s dual roles in a setting, or that informed consent is a process. They may also not understand how to mitigate such concerns and/or to communicate effectively with IRBs about how to address these challenges within the regulatory framework.  

The goal of this webinar is to provide IRB members with a better understanding of the issues that qualitative researchers face and introduce strategies to address these issues while recognizing the unique characteristics of the qualitative research process. Topics for discussion will include:

•Differences between qualitative and quantitative research paradigms.

•Ethical issues that qualitative research methodologies may present to study participants.

•Strategies for IRB members and qualitative researchers to minimize harm to study participants.

 Audience

This webinar will be of interest to researchers involved in qualitative studies, and to IRB members, directors, and staff that review qualitative research protocols.

 Continuing Education credits are offered for this presentation.

Registration:  To register for this course, follow the steps below:

Non-Emory employees, please send an email to 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

 

Webinar Announcement:  "Biobanking:  When Issues with Tissues Come a Knockin' 

Date: Wednesday, November 20, 2013 
Time:  2:00 - 3:00 pm EST
Location:  Brown Auditorium (Emory Clinic A, Tunnel Level)

Overview

Presenter:  Carol J. Weil, a lawyer and medical ethicist by training, has worked in the US Department of Health and Human Services for over 20 years.  She served as senior counsel to the Inspector General from 1994-1999, followed by a ten year stint in the HHS Office for Human Research Protections working on a broad spectrum of human subject compliance and guidance issues.  She came to the National Cancer Institute in 2010 where she oversees ethical and regulatory policy implementation pertaining to clinical trials and research biorepositories, including issues of consent, tissue collection/storage/access and custodianship, data sharing, and the return of research results.   

Carol’s talk will focus broadly on current ethical and regulatory controversies involved with the collection, storage and research use of biospecimens.  Issues covered include informed consent frameworks, privacy concerns, the identifiability of genomic data, different models of data sharing, and the return of research results.

 Audience

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

Registration:  To register for this course, follow the steps below:

Non-Emory employees, please send an email to 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

Emory Passwords Expire September 10th at noon – including eIRB passwords
9/4/2013

Please go to http://it.emory.edu/password/ to change your password before the deadline. If you access eIRB via a Sponsored Account because you are not affiliated with Emory, your password will also expire on the above date. If you find you are no longer able to log into eIRB, please call the Emory Helpdesk at (404) 727-7777. If they are unable to verify your identity and help you, then you the person who sponsored your account will need to request help on your behalf. Please ask Helpdesk to give you that person’s name. We apologize for the inconvenience.

eIRB will be down for maintenance on September 10 from 6:00 pm - 8:00 pm.  
8/29/2013 

New Policies & Procedures Revision
5/24/2013 

Several updates to existing P&Ps have been made, including:

  • Changes to language in P&P 17 to clarify the review process for new and continuing studies, as well as reportable events. Other revisions include clarifications on the role of the VA RCO and VA Representative, deferral to Emory for non-human subjects research determinations, and protocol closures/suspensions/terminations. An additional change to language in P&P 43 was also made to clarify the role of a witness to consent in VA studies.
  • Updates to P&Ps 72. 73, and 75 to harmonize the language of those sections with upcoming changes to HIPAA.
  • A new section in P&P 13 regarding reliance agreements for Exempt research
  • Revisions in P&P 60 to the review process for noncompliance and unanticipated problems by the Emory IRB Compliance Review group.
  • Removed the requirement to obtain HIPAA authorization for Emergency Use protocol that was in P&P 68.
  • In 70, P&P Clarified that SAEs at external sites which are not unanticipated problems must still be reported at renewal for Emory Sponsor-Investigator studies.
  • Added language to P&P 79 to note that students (including post-doctoral) should not be IND/IDE holders.

Tracked changes versions of the P&Ps are available upon request.

Consent & HIPAA Authorization Template Updates
5/15/2013  

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 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.

New Guidance Document on Using Dietary Supplements
5/7/2013

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.

Leadership Transition at the IRB
4/5/2013

There will be a transition in leadership at the IRB office in April 2013. Sarah Putney has accepted a new position as Director of Administrative Compliance with the Emory Internal Audit Division, after serving as IRB Director since November 2007. In her new position, Sarah will be focusing on building Emory's compliance and ethics program in a variety of areas across campus to complement existing programs at Emory in healthcare and research. While we at the IRB are sad to see Sarah go, we are glad that we will continue to have opportunities to work with her.

Vice President for Research Administration David Wynes has appointed IRB Assistant Director Rebecca Rousselle as Interim IRB Director pending a search. After April 12, 2013, please direct IRB inquiries that previously would have been addressed to Sarah to the Emory IRB listserv or to Rebecca Rousselle. Thank you!