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Key Points Summary & Sensitive Studies

7-15-2011

As part of Emory's continuing drive to ensure quality in research and patient safety, Emory Healthcare and the Office of Clinical Research have begun a new initiative. As of July 1, 2011, clinical trial participants at Emory Healthcare facilities will have a "key points summary" placed in their Emory electronic medical record (EeMR). The document will contain basic study and safety information (e.g. contraindicated procedures).

In recognition that certain research studies may be of a sensitive or stigmatizing nature, the Office of Clinical Research has developed an alternative key points summary for these trials. This document will maintain important information for the subject's safety, but will exclude information indicatinga specific study. Only the IRB protocol number will be included as link between the subject and the study.

Both version of the summary, and letter from the Dean's office further explaining the new initiative, may be found on the IRB's Forms & Tools page.

New Consent Form Templates

5-11-2011

The Emory IRB is pleased to announce the release of revised versions of our Consent Templates. The biomedical consents have been updated to encompass the FDA's requirement that clinical trials reference ClinicalTrials.gov in their consent forms, as well as clarifying how studies with sensitive information may keep the consent form out of the medical record. Numerous other small formatting and textual changes were also made. The Emory Biomedical, Grady, CHOA, and WIRB templates have all been updated to reflect these changes

The Sociobehavioral consent template has also been given a thorough revision. The new version is designed to specifically address the needs and concerns of non-biomedical investigators as they conduct research at Emory.

All of the updated forms can be found on the Forms & Tools page of this website. If you have questions about the new templates, please contact the Emory IRB at irb@emory.edu or 404-712-0720.

Clinical Research Readiness Checklist

4-22-2011

Beginning April 18, 2011, the Emory IRB will be facilitating a new clinical research readiness Checklist to assist the Emory Healthcare (EHC) Office of Quality with this initiative, designed to promote the safety and well-being of research subjects. 

Principal Investigators on new research studies involving EHC facilities or personnel for clinical procedures will have to complete the Checklist and submit it to the Office of Quality before the IRB can release validated, approved consent and HIPAA documents. For WIRB Studies the Emory IRB will notify WIRB when the checklist is complete, WIRB will then release the validated forms.

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.

AAHRPP Visits Emory

2-25-2011

The Association for the Accreditation of Human ResearchProtection Progams (AAHRPP) will be visiting Emory from March 23 through March25. AAHRPP is an accrediting organization for human research protectionprograms and has set the standard for quality in those programs.

The upcoming visit is part of Emory University'sre-accreditation process, during which AAHRPP has asked to interview IRBmembers and staff, Investigators, and other individuals from the Office ofResearch Administration (ORA), including Vice President David Wynes. The IRBhas been pleased to work with our Emory colleagues to ensure the Universityremains at the forefront of quality research. Wewould like to thank all the study teams, investigators, andORA staff for their help and participation during the visit from AAHRPP.

Changes to eIRB Login

10-7-2010

The Office of Research Administration, InformationTechnology Unit (ORA-IT) has been working hard over the past weeks to integratethe eIRB login authentication with Emory University’s system. They havesuccessfully completed beta tests and plan to merge the eIRB login system intothe University-wide system. The date for this to be complete is October 15th.Once this merger is complete eIRB users will be able to log in using the sameusername and password used throughout the rest of the University system.

Any eIRB user without an Emory University NetID (e.g. EmoryHealthcare users) will need to get a sponsored account in order to havecontinued access to eIRB. Instructions for getting a sponsored account can befound on the IRB website (under the section: Sponsored Accounts for Non-EmoryUniversity or Non-Emory Users). The accounts should be sponsored by a PrincipalInvestigator or designee, but the sponsor of the account must be a full timeEmory University employee.

If you have questions about this process please contact SeanKiskel. The IRB can always be reached for general questions at irb@emory.edu or404-712-0720.

New Biomedical Consent Form Templates

The Emory IRB is pleased to announce the arrival of newbiomedical consent templates for all Emory sites, as well as Grady Healthcareand Children's Healthcare of Atlanta. The new templates clarify that a medicalrecords will be created for subjects who have any test or procedure at theabove sites.

The new templates can be found on the Forms & Toolspage.

Questions about the new templates? Contact Sean Kiskel. TheIRB can always be reached for general questions at irb@emory.edu or404-712-0720.

New IRB P&P Revision

9-21-2010

The IRB Policies & Procedures have gone throughextensive revisions to reflect the improvements made to IRB's workflow over thepast few months, as well as to improve clarity and formatting. The new versiondate is 9-7-10, replacing the 5-11-10 version.

A summary of changes may be found here, while a shortlist ofsubstantive change may be found here.

New Research Participant Survey

9-7-2010

The IRB is pleased to announce our new survey for researchparticipants is up and running. If you have taken part in research at Emory,Grady, the Atlanta VA, or other sites where the Emory IRB provides oversight,please take a few moments to share your experience. Your answers will help the EmoryIRB continue to improve the quality of human subjects research.

Changes in eIRB Logins

8-24-2010

The IRB and ORA-IT have been working hard to integrate eIRBlogin information with the main University system. Within the next few weeksthe merger should be complete. Once this change is complete, Emory employeesand students with a current eIRB account will find their eIRB login andpassword to be the same as their Emory University login and password.

New Emory University employees and students will still needto request an eIRB account. Non-Emory University research staff will need tohave their account sponsored by the Principal Investigator, or designee, of thestudy they are joining. Instructions on how to get a new Emory or SponsoredeIRB account can be found here.

OHRP is now on YouTube

7-15-2010

The Office of Human Research Protections now has a varietyof informational videos up as part of the Department of Health and HumanServices YouTube channel. The OHRP playlist can be found here, and the DHHSchannel here.

New Biomedical Consent Form Templates

The Emory IRB is pleased to announce the arrival of new biomedical consent templates for all Emory sites, as well as Grady Healthcare and Children's Healthcare of Atlanta. The new template is a complete overhaul and includes new guidance on costs and injuries to subjects. The new templates can be found on the Forms & Tools page.

Questions about the new templates? Contact Sean Kiskel at skiskel@emory.edu or 404-712-0766.

IRB Co-Chair recognized by Emory

Aryeh Stein, the Emory IRB Co-Chair and Associate Professor at the Rollins School of Public Health, has received the Thomas F. Sellers Award. The award is presented to the faculty member of Rollins School of Public Health who exemplifies the ideals of public health and who serves as a role model and mentor to his or her colleagues. The award is given annually to an individual who, like the man for whom it was named, represents the best qualities of collegiality

New Policies and Procedures

The Emory IRB has updated its Policy and Procedures. The new version is dated 5-11-10, and replaces the 8-3-09 version.

A summary of changes can be found here.

Courtesy Renewal Reminders

The IRB has experienced some technical and training difficulties with its courtesy reminder notification systems for paper and eIRB, neither of which is fully automated.Some researchers have not received timely renewal reminders.The IRB and ORA-IT team are working with F&A IT Support to resolve the issue.Investigators can help by retaining responsibility for timely IRB submissions.We recommend that you routinely set several Outlook or other calendar reminders based on the approval date in your last approval letter. Continuing renewal requests should be submitted to the IRB at least 45 days prior to the study's expiration date to ensure adequate IRB review and approval time.

eIRB Enhancements Update

Effective Sunday, April 11, 2010, several enhancements to eIRB were launched.Some will not be obvious because they manifest behind the scenes.Here are the changes that will manifest to you as a user:

• Study staff can access the approved documents listed under theDocuments tab.This means the IRB staff won't have to upload the approved documents in a logged comment to make them accessible anymore.
• IRB staff can access the close-out documents on current and previous closeouts (summary documents and published articles).This means they won't have to ask study staff to upload the documents in a logged comment anymore.
• A warning has been added that the system will not allow studies to be approved if there is outstanding review required (for example, radiation safety committee approval).

If you have any questions about these changes, please email us at irb@emory.edu.We continue to work with IT teams to make more improvements in eIRB.Upcoming projects include: installing monitors that will help identify the causes of system slowness, allowing log-in with Emory username and password, and workflow streamlining.We appreciate your patience!

Is billing compliance an IRB matter?

Yes.Careful attention to billing accuracy helps to protect the dignity and welfare of study participants.Conversely, billing confusion can cause anxiety for study participants. Read here about the new billing system the OCR is piloting to streamline clinical research billing! The Emory IRB encourages all Emory research personnel to address promptly any billing issues identified by our colleagues in the Office for Clinical Research (OCR).Thank you!

Regulatory Tip for Investigators on FDA-regulated Studies

The FDA requires that the informed consent document mention the Food and Drug Administration specifically as one of the persons or entities that may view study records.Usually this should appear in the Confidentiality section.You will find that our biomedical informed consent templates include the FDA.Please be sure not to delete it from the template if your study is FDA-regulated.

Cost and Injury policies

Emory's subject injury and extra costs policies for externally sponsored research with human subjects are now posted here.

Part 11 Compliance

Sponsors often inquire whether the Emory IRB is compliant with the FDA's regulations on electronic signatures at 21 CFR 11 (known as "Part 11 Compliance").  The Emory IRB's electronic system of record is Part 11 compliant, according to the vendor, Click Commerce:  "Click Commerce’s eResearch Portal product meets or exceeds the requirements in 21 CFR Part 11 for “closed” systems by providing manageable name/password administration, strong passwords with rotation options and electronic signature components that are only executable by, and designed to be used only by, specified individuals for specific approval actions."

For more information:

• Click Commerce Statement on Part 11
• FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures -- Scope and Application (August 2003)

A Spanish translated HIPAA authorization form is now available on our forms and tools page.

OHRP Educational Videos

The OHRP has released two short educational videos on hot topics.Each video runs for 20 to 25 minutes and is free.You will need to use Real Player software, which can be downloaded from a window that will open when you click on the link.Or you can download it here:  http://www.real.com/player/index.html?src=downloadr

• Research Use of Human Biological Specimens and Other Private Information
• Reviewing and Reporting Unanticipated Problems and Adverse Events