Did you know that you can encrypt the emails you send outside our walls?
The process is very easy and you can use the same method if you are using the UAMS or ACH email systems. Simply put [secure] as the first thing in the subject line of your email. This will send a special email to your recipient with instructions on how to access your message. In these days of hackers and other malicious activity take a moment to use this method of email each time you send sensitive information outside our community. It is easy and free; try it today!
HIPAA REQUIREMENTS FOR ACTIVITIES PREPARATORY TO RESEARCH
Do you ask for personal health information (PHI) from ACH Information Technology or Medical Records when you are preparing for your latest research project?
Federal regulations and ACH policy (N05)* require that any personal health information (PHI) gathered during “preparation for research” activities requires a certification signed by the individual gathering this information. To better enforce this policy, information technology and medical records will now be asking for a certification form from anyone requesting PHI. For your convenience this form is available on the ACHRI web site (in the forms section) at: http://achri.archildrens.org/resources/HIPAA_Forms/Reviews%20Prep%20Form.doc.
If you have any questions, feel free to contact Tanda Grisham, Esq. ACHRI Human Protections
Administrator/Contracts Attorney at 364-3571 or Margie Brackeen, ACHRI Regulatory Compliance Specialist at 364-3586.
*ACH Policy N05 can be found in the policy vault (in My ACH) and the ACHRI HIPAA policy can be found at: http://achri.archildrens.org/resources/policies/HIPAA.pdf.
The University of Arkansas for Medical Sciences (UAMS) announced on March 14, 2008 via their Research Support Center publication Clinical Research Newsletter that eleven Institutional Review Board (IRB) policies have been revised and two new policies (12.5 & 12.6) have been added. If you conduct human subject research on the ACH/ACHRI campus you are governed by the UAMS IRB policies. The ACHRI Human Subjects Protections area publishes a webpage located at: (http://achri.archildrens.org/guidebook/clinical_news.html ) to help keep you informed of IRB policy changes. This helpful webpage gives you a basic outline of the policy along with highlighted copies so you can see at a glance what the revisions entail. Check it out!
The new Collaborative Institutional Training Initiative (CITI) program on our campus has been going very well since its inception on the UAMS & ACH/ACHRI campuses in September 2007.
As of February 29, 716 people have completed the CITI Program Human Subject Protection online courses, including 128 at ACH and 588 at UAMS.
We are still working to integrate this program into our processes here at ACHRI and UAMS. Until we get the CITI program fully integrated with ARIA you will still need to print out your completion certificate and fax it to the IRB. (Fax attention to Bethany Lehman at 501-686-7265) We will keep you informed as we go about this process.
CONFLICT OF INTEREST POLICY CHANGES
The UAMS and ACHRI Conflict of Interest policies have been revised. These revisions will affect:
1. The way that you report conflicts of interest.
2. The types of gifts you can accept.
3. How institutional officials handle these conflicts
To ensure your compliance with these new policies please review them as soon as possible.
UAMS Policy 4.4.11 for non-academic staff:
http://www.uams.edu/orsp/COI%20Other%20employees%20FINAL.pdf
UAMS policy 4.4.10 for academic staff:
http://www.uams.edu/AdminGuide/PDFs/4.4.10.pdf.
The ACHRI policy:
http://achri.archildrens.org/resources/policies/ConflictofInterest.pdf
It is a new year and we take the time to look forward to the activities of the months to come. While you are reviewing your assets and commitments for the coming year, take a moment to make sure that you do not have any new conflicts of interest. ACHRI’s Conflict of Interest policy can be found at: http://achri.archildrens.org/resources/policies/conflict_interest.doc
UAMS their Conflict of Interest policy in November 2007 and it can be found at: http://www.uams.edu/orsp/COI%20policy%2011%201%2007%20final%20academic.pdf
You have completed your clinical study, and you are ready to close it out with the IRB; congratulations! So, what do you do now? If you have completed your data analysis, you need to complete a study closure form in ARIA. Do not just let your study expire with the IRB. If this happens, the IRB will take official action to close the study. This is not a good thing! Terminations by the IRB will be reported to your funding source and the governmental oversight bodies relevant to your study, such as OHRP and FDA. This could result in complications when you try to secure funding and approval for your next trial. So, take a few minutes to fill out that study closure form, and celebrate another study successfully completed.
Arkansas
Children's Hospital Research Institute
1120 Marshall Street
Little
Rock, AR 72202
(501) 364-7373
Fax (501) 364-2705