ORA Events Calendar

Susan Reverby to Speak at Emory
2-13-2012

Susan Reverby, PhD will be speaking at Emory on her discovery of unethical experiments on Guatemalen subjects by the U.S. Public Health Service in the 1940s. Dr. Reverby, who previously wrote about the Tuskeegee Syphilis study, will discuss the moral and scientific issues of the Guatemala study, as well as in the field of medical research in general.

The talk will be held in the School of Medicine building, room 120, on Thursday, March 1st at 5:00 PM. For more details, please contact Sarah Putney or Kathy Kinlaw.

Some researchers have contacted the IRB about problems occuring when trying to download certain files from the IRB website. The affected files (.docx and .xlsx) are being automatically saved as .zip files. This is a known issue with Internet Explorer and is purely a client-side issue, not a server problem.

To solve the problem, the downloaded files can simply be renamed to the correct extension (e.g. .zip to .docx) with no loss of functionality. The problem can be avoided by using a different browser (Chrome, Firefox, etc.).

Participant Compensation Survey
10-11-2011

As part of an Emory Business Process Improvement project the IRB is conducting a short paper survey asking participants about their preferred method of compensation.  We need study teams who will help us to better understand how study subjects prefer to receive compensation—prepaid cards, cash, checks, etc.  Will you help?  You can do so by handing out the paper survey to study participants at their study visits, and sending the surveys to the IRB, OR by permitting one of the IRB staff to hand out the surveys at your study site at an appropriate time.  We expect to conduct the survey during October.  Questions and responses should be directed to Sean Kiskel.

eIRB Upgrade
11-14-2011

Over the weekend, the IT staff upgraded eIRB to the latest version of the software. Many of the changes are behind-the-scenes updates and tweaks, but end-users may notice new and improved features as well.

The IRB welcomes feedback from users with regards to any usage or performance changes they might notice. Please send your comments on the upgrade to the IRB.

Participant Compensation Survey
10-11-2011

As part of an Emory Business Process Improvement project the IRB is conducting a short paper survey asking participants about their preferred method of compensation.  We need study teams who will help us to better understand how study subjects prefer to receive compensation—prepaid cards, cash, checks, etc.  Will you help?  You can do so by handing out the paper survey to study participants at their study visits, and sending the surveys to the IRB, OR by permitting one of the IRB staff to hand out the surveys at your study site at an appropriate time.  We expect to conduct the survey during October.  Questions and responses should be directed to Sean Kiskel.

Clinical Trial Checklist Clarification
8-25-2011

An incomplete Office of Quality Checklist for a clinical trial will not delay when a study goes for IRB review, nor would it be a pending issue for approval. Validated consent and HIPAA documents, however, will not be released by the IRB to the study team until the checklist is complete.

The Checklist is available on the IRB Forms & Tools page and can also be obtained from Laura Deane of the Office of Quality at ldeane@emory.edu.  Please direct questions about the Checklist to Ms. Deane, who will be notifying the IRB staff when your study's Checklist is complete.

Emory IRB Youtube Channel
8-25-2011

The Emory IRB has put up the first of many instructional videos on our new Youtube Channel. The video, which deals with the proper and improper ways to go through the informed consent process with a new subject, will be followed by future material dealing with eIRB, CITI, and more.

Advance Notice of Changes to Humans Subjects Research Regulations
8-11-2011

The Federal Government is proposing broad changes to the regulations that govern research with human subjects. These changes are designed to conform with the changing nature and practice of research, as well as improve regulatory efficiency and effectiveness.

The first open comment period will end on September 26th, but until then unabriged comments may be logged at Regulations.gov.

The Department of Health & Human Services has a full explation of the changes on their website.

Changes to eIRB
8-1-2011

A new patch to eIRB was installed on Friday night (7/29). The patch includes several updates to eIRB functionality that should help streamline new study submissions and on-going studies.

Most importantly for Investigators will be the removal of the requirement to have all Co-Investigators accept their role on a new study. This change, in addition to several clarifications of text in eIRB, should help study teams progress more quickly through the steps to submit a new study to the IRB.

A more detailed account of the changes will be available in the next up-coming IRB newsletter, to be sent later this month. Questions may be sent to irb@emory.edu or via phone at 404-712-0720.

Institutional Conflict of Interest Policy

On March 1, 2011 Emory enacted a new Institutional Conflict of Interest Policy for Human Subject Research. The policy was required for re-accreditation of the Emory Institutional Review Board by the Association for the Accreditation of Human Research Protection Programs. The policy applied to all greater than minimal risk human subject research as defined by IRB policies. The policy covers both financial interest of Emory and personal financial interest of Institutional Leaders - those responsible for the review, approval, and oversight of human subject research. 

Following AAHRPP's site visit, the policy has been slightly revised to cover all human subjects research, including minimal risk studies. The final policy may be found here.

The investigator COI policy (Emory Policy 7.7) remains unchanged. An announcement for investigators may be found here.