Updates to our Human, Animal, and Recombinant DNA Research Compliance Programs
Summer 2011
In this update:
1. ORC Educational Opportunities:
- IACUC and IBC Application and Submission Basics (8/30/11)
- Proving Compliance: Proper Documentation in Study Records (9/15/11)
- Clinical Investigator Responsibilities in FDA-regulated Studies (9/26/11)
2. Good News for IBC Investigators
4. IRBNet Enhanced User Tools (all investigators)
- Training and Credentials Management
- Project Tags
- Project Archiving
1. ORC Educational Opportunities:
For IACUC and IBC investigators:
Topic: IACUC and IBC Application and Submission Basics
Date: Tuesday, August 30th
Time: 1:00-2:30 p.m.
Location: Office of Research Compliance Conference Room, Melville Library, 5th Floor, W5530
Who Should Attend: Investigators and study coordinators who are new (or need a refresher) to the IACUC and IBC process.
Why you should attend: Investigators will learn how to navigate the IACUC and IBC application, submission, and review processes, the materials required for submissions, helpful hints for successful completion of paperwork, and use of the IRBNet system.
For CORIHS Investigators:
Topic: Proving Compliance: Proper Documentation in Study Records
Date: Thursday, Sept 15th
Time: 1:00-2:30 p.m.
Location: Office of Research Compliance Conference Room, Melville Library, 5th Floor, W5530
Who Should Attend: This session will be invaluable to all investigators, particularly those conducting investigator-initiated studies.
Why you should attend: You will learn how to ensure your study records will be considered compliant upon monitoring or audit by ORC, sponsors, or federal oversight agencies.
Topic: Clinical Investigator Responsibilities in FDA-regulated Studies
Date: Monday, September 26th
Time: 1:00-2:30 p.m.
Location: Office of Research Compliance Conference Room, Melville Library, 5th Floor, W5530
Who Should Attend: Investigators involved with studies under FDA jurisdiction (involving experimental drugs, devices, biologics, and certain studies involving experimental use of approved drugs etc.)
Why you should attend: Investigators will learn important requirements in the compliant conduct of studies regulated by the FDA.
RSVP to jmatuk@notes.cc.sunysb.edu Be sure to indicate which session(s) you would like to attend. And, of course, you will be fed delightful snacks and beverages. Seating is limited, so act now!
2. Good News for IBC Investigators
Ongoing ORC discussions with helpful faculty offering constructive criticism have resulted in an important change in the IBC submission/approval process. Assessment of EH&S training compliance will now be conducted when a project is first received by the virtual IBC Office, so that we may alert you to training issues (and you can rectify them) sooner. This will help speed up our ability to approve your project once committee concerns relating to the recombinant DNA activity have been addressed.
3. Good News for IACUC Investigators who utilize birds, rats (of the genus ‘Rattus’) and Mice (of the genus ‘Mus’) bred for use in research*
*species not covered by USDA regulation.
Ongoing ORC discussions with helpful faculty offering constructive criticism have resulted in yet another (!) important change in the calculation of IACUC continuing and tri-annual review approval periods, specifically for studies that are not under USDA jurisdiction.
The anniversary dates of a study’s full committee review are the dates to keep in mind in order to maintain continued, compliant IACUC approval.
An example:
A study reviewed by the full IACUC committee on July 19, 2011 will need to:
- ·Obtain approval for a first continued review by July 19, 2012.
- ·Obtain approval for the second continued review by July 19, 2013.
- ·Obtain approval for the tri-annual full committee review by July 19, 2014.
What’s so great about that? Well, bottom line: The anniversary dates of the full committee review drive the yearly deadline to obtain the annual approvals (not the actual date you obtain formal IACUC approval). This can be good and not-so-good. Let’s use examples based on above:
Your study is reviewed at the 7/19/11 meeting.
No matter when you get final approval, be it at the meeting or anytime after, you will need to obtain your first renewed approval on or before 7/19/12, i.e., which is the anniversary date of the 7/19/11 meeting. Good if you were approved at that meeting (i.e., you get a full year approval), not so good if you obtained final approval after that (your approval period will be less than a year).
Now, your 2nd renewed approval must be obtained on or before 7/19/13. Again, good if you were granted first renewed approval ‘early’, say in May or June of 2012 (no shrinking approval period; you ‘get’ more than a year). Not so good if you are delinquent in getting that renewal to the IACUC, or other factors slowed down your 2012 approval.
Your triannual approval must be obtained on or before 7/10/14. Same good/not-so-good rules apply.
Why can’t we do this for studies with USDA-covered species? Because USDA requires studies under their jurisdiction to be reviewed at least once annually. If you are reviewed on 7/19/11, and renew early and get your application reviewed in May of 2012, the IACUC has to review it within a year from that date, by May 2013. You experience approval period shrinkage (thanks to the USDA, not us).
4. IRBNet Enhanced User Tools (all investigators):
You may have noticed some new ‘tweaks’ when you log on to IRBNet for your submissions to the IRB, IACUC, IBC, and/or SCRO committees. These new features include:
Training and Credentials Management: This feature enables us to manage and track Training and Credentials (T&C) for investigators. As a service to our investigators, ORC staff are currently uploading current human subjects/HIPAA training information for all listed investigators when a CORIHS project comes into the virtual CORIHS office (note: we hope to expand this feature in the near future to include EH&S biosafety training for IBC investigators, and Occupational Medicine clearances and DLAR training for IACUC –stay tuned). That information automatically populates into all projects on which the investigator is listed. If you have full or write access on a project, you can see the current training status of your co-investigators. You just need to follow a couple of simple steps:
1. Once a study is shared with your team, go into the designer.
2. Under step 2 in the designer, there is an option to Link Records. Click on link records (make sure the training records you would like to track are checked)
3. Click on Save
4. Then at any time you want to check training status (ie. submitting a new study or a renewal), you can go to your designer, back to Step 2 and click on VIEW ALL LINKS. You will be able to see all training dates.
Project Tags
This function enables you to more actively organize and manage your My Projects portfolio. All investigators may create Project Tags for themselves and can, if they have write or full access, share tags with their co-investigators. Project Tags are visible on the My Projects page.
- ·Each user can create his/her own personalized tags for use on My Projects.
- ·Any individual with access to a project may add their own Personal Tags to the project. Personal Tags are not seen by any other individual.
- ·Any individual with Write or Full access to a project may add their own Tags as Shared Tags. Shared Tags can be seen by every individual with access to the project. Any individual with Write or Full access may also remove a Shared Tag.
- ·Investigators may:
- · utilize enhanced search capabilities by combining search terms with Custom Tag filters (drop-down).
- · directly click on a tag to search for all tags of that type.
Project Archiving
This new feature allows investigators to archive projects so that they no longer appear by default in their personal My Projects list of active projects. The ability to archive projects will further streamline the use of the My Projects page and help you organize your projects.
- ·Any project may be Archived. Archived projects no longer appear by default in the user’s personal My Projects list.
- ·Users still have access to all archived projects, and can view them at any time by clicking the Show Archived Projects link.
- ·If a user receives a message relating to an archived project, that project will automatically appear in the default list on the My Projects page until the reminder is cleared.
Any questions or comments on this update, or any issue pertaining to our research compliance programs, please feel free to contact Judy Matuk, AVP, Research Compliance, at 632-9036, or by e-mail: jmatuk@notes.cc.sunysb.edu.
