Research Compliance Adopts IRBNet® for Compliance Management:
Brings Streamlined Electronic Process for Submission, Review, Approval and Tracking
of Research Protocols
The Office of Research Compliance has moved to a new web-based system for
management of human subjects, animal subjects and biosafety protocol
submissions. IRBNet is expected to make the submission process easier and more
convenient for researchers who need approval of regulated research activities.
The online management system will help both committee administrators and
member’s process, review, and act on the proposals more efficiently. Additionally,
of benefit is that IRBNet provides researchers with the ability to track the status of
applications online and receipt of electronic notification of committee actions.
The Institutional Animal Care and Use Committee (IACUC) and Institutional
Biosafety Committee (IBC) have fully adopted the use of IRBNet and requires the
electronic submission of all affiliated research protocols. NOTE: The Institutional
Review Board (IRB) has encouraged the use of electronic submissions, however
beginning January 1, 2012 all IRB applications must be submitted electronically.
Keep in mind, first time users are required to register in IRBNet and create a user
profile. The ‘new registration” link will walk you through the steps to create your
account; just make sure you select University of South Alabama as your
organization. Once you've created your account you will receive an activation
email, make sure to click on the link in the email to activate your account.
When submitting your project package be careful to submit to the correct
committee(s), as the IRB, IACUC and IBC all use the same submission system.
Submission of a new project involves five simple steps: 1) create a new project in
“designer” page which all documents for the project can be assessed from this
page (use this page to attach, manage and edit documents), 2) share the project
package with other IRBNet users, 3) sign the project package, and 4) submit for
review to the respective committee(s). Once the project package has been
submitted to the respective committee, the office will screen the submission to
determine if it is complete and whether any additional information or
documentation is required prior to committee review. If it is determined that
additional information is required, the status of the project will be changed to
“Information Required” and the office will upload a document into IRBNet detailing
the additional information/documentation needed. The package will remained
unlocked so that the researcher may upload additional materials. The project
package will be locked prior to review, and the package will be permanently
locked. For changes that that the researcher is required to make resulting from
committee review will be submitted as a separate project package. The packages
will have the same base IRBNet ID as the initial submission package but instead of a
-1, will have -2, -3, etc following the base IRBNet ID. In order to make changes/edits
to the initial project submission, researchers log into IRBNet, click on the
appropriate study title, click on “designer” and add new/revised documents into
the second package. The researcher will sign the project package and submit.
Please use our IRBNet resource page at:
http://www.southalabama.edu/researchcompliance/irbnet.html which contains
guidance materials to walk you through the submission process. We have posted
an online tutorial demonstrating the submission and post submission process on the
IRRNet webpage for additional guidance. If hands-on instruction is needed please
contact the Research Compliance staff, however, we encourage you to refer to
our existing resources as a starting point.
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FALL 2011
Inside This Issue
PAGE
IRBNet System:
Submission, Review, Approval of
Research Protocols
1
Training Sessions Scheduled
2
Faculty Advisors Signature for
IRB new project submissions
3
Department Chairs and Administrators
Review and Signature of New Project
Submissions
3
IRBNet Q&A’s
4
Export Controls:
Updates
5
Conflict of Interest:
NIH COI Rules Finalized
6
Items of Interest:
7
Contact us at:
Office of Research Compliance
CSAB 120
251-460-6625
dlayton@usouthal.edu
IRBNet System Training
During the months of September and October the Office of Research Compliance held a series of
training sessions on the new online management system IRBNet. Over 150 people attended the
introductory hands-on training session. During these sessions an IRBNet Guide was provided, this step by
step instructional guide and other materials are now available on our IRBNet resource page at:
http://www.southalabama.edu/researchcompliance/irbnet.html. As part of an ongoing effort to
educate faculty and staff, we will continue to offer introductory training for researchers and their staff
beginning in Spring, 2012 to accommodate new faculty and those who may be new to the process of
submitting research protocols. Also, for those that have submitted or who have attended an
introductory session, additional “continuing education” on IRBNet providing enhanced instruction on
various topics will be discussed in greater detail in the Part 2 session to include amendments, renewals,
sharing, and linking training. Whether or not you have already attended a previous IRBNet training
session, all researchers and staff are welcome to attend.
We have appreciated the feedback we have received so far and are always open to ideas on how to
improve. Please don’t hesitate to contact us for questions as we all become integrated in web
management.
For questions, contact:
IBC- Alison Henry ahenry@usouthal.edu
IACUC- Danny Housley dhousley@usouthal.edu
IRB- SuzAnne Robbins srobbins@usouthal.edu
Training Sessions: Biomedical Library Room 222B
January 11
IRBNet Researcher Training (Intro) 10:00 am
IRBNet Research PART 2
11:00 am
February 6
IRBNet Researcher Training (Intro) 1:00 pm
IRBNet Research PART 2
2:00 pm
March 29
IRBNet Researcher Training (Intro) 10:00 am
IRBNet Research PART 2
11:00 am
Seats are limited, so please email ahenry@usouthal.edu to register for an IRBNet training session.
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IRBNet Info: Attention Faculty Advisors, Department Chairs and Supervisors
Importance of Faculty Advisor
Signature for IRB New Project
Submissions
Keep in mind when you sign a new project
submission in IRBNet, you are notifying the IRB
Office that you have reviewed all documents
submitted and the submission is complete and
ready for review. It is the responsibility of the
faculty advisor to confirm the project is
adequate in fulfilling course objectives and
meets guidance set forth within the curriculum.
In brief, common documents affiliated with
student research projects that should be part
of the IRBNet project package submission:
-
-
Online Document Application (Part A)
Exempt -OR- Expedited/Full Board
Application (Part B)
Supporting documents such as
recruitment materials,
consent/information sheet, survey
instrument, acknowledgement letter if
study conducted off-site, etc.
Training documentation, if applicable
Additional guidance for Faculty Advisors is
posted on the IRBNet webpage:
http://www.southalabama.edu/researchcomp
liance/pdf/USA_IRBNet_MentorsGuide.pdf
Note to Department Chairs, Supervisors
and Administrators: Electronic Review
and Signature of New Project
Submissions
IRBNet is a hosted service that can be accessed
anytime, anywhere at https://www.irbnet.org
Thus, researchers can obtain appropriate
signatures remotely for new project submissions
which will speed up the routing process. New
users can create an IRBNet account by clicking
on the "New User Registration" link located just
under the log-in field in the upper right-hand
corner of the page. This link will walk you through
the steps to create your account; just make sure
you select University of South Alabama as your
organization. Once you've created your
account you will receive an activation email, be
sure to click on the link in the email to activate
your account. If you have problems activating
your account, contact IRBNet support at
support@irbnet.org
Department Chairs and Administrators will not be
able to electronically sign an IRBNet project
package until he/she signs creates an IRBNet
account with a USA affiliation and is granted
shared access by the Principal Investigator.
Appropriate signatures must be obtained prior to
the researcher submitting to IRBNet, otherwise this
will delay the review process.
Attention Department Chairs and Administrators:
How will I know when a IRBNet project
package needs my attention?
Remember, an automatic email will be sent to you from the researcher (faculty or student investigator)
alerting you that you have a study ready for review. When you log in IRBNet, you will see an index
named Study Submission Manager (My Projects) with a list of studies. You can sort by status (at the
arrows next to the word), and anything you see indicating “work in progress” requires your review. If the
status shows “pending review”, or any other status, the investigator has already submitted to the
respective committee for processing. If the project package has been submitted without appropriate
review(s), the package will be returned to the investigator to secure required signatures.
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IRBNet
Q&A’s
Q: I have forgotten my password and can’t get into
my IRBNet account. What do I do? Should I call
Research Compliance for my password?
A: No. We do not have access to your IRBNet
password. Go to the IRBNet login page, and click on
“Forgot your password?” in the upper right hand
corner of the screen. Enter your IRBNet User Name or
one of your contact email addresses and IRBNet will
email your password to you.
Q: I have an amendment and a Continuing Review Report to submit at the same time. Can
these be submitted in one package via IRBNet?
A: No. Submit one action (submission category) per project package.
Q: Can I submit more than one package at a time on the same study?
A: Yes. Different actions can be submitted for the same study simultaneously. Just make sure
they are submitted in different packages.
Q: How do I re-lock a package once the requested revisions have been completed?
A: Once you have made your revisions, click on “Mark revisions complete” at the top of the
designer page. This will re-lock the package and send the IRB office an automated e-mail that
the revisions are completed.
Q: If a package has been locked, can the package still be signed?
A: Yes. You can continue to obtain signatures on a locked package.
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Export Controls Update
Along with the ongoing push to update the laborious (and that is a nice word) export control system,
there have been some additional improvements implemented in an effort to simplify the system. To
begin with, a section of the United States Munitions List (USML) is being moved over to the Commerce
Control List (CCL). Such a move makes those items potentially available to the flexibility (free licensing,
exemptions, etc) of the CCL. The USML is fairly rigid and costly, so this new section of the CCL, dubbed
the “600 Series” from its former location on the USML, will make it easier to ship and deal with deemed
export issues.
Equally helpful is a new license exemption on the CCL, the Strategic Trade Authorization (STA).
Recognizing the good relationship held with many European nations, the STA provides exemptions to a
large of number of trade partners. A specific group of 20 plus nations now can be exempted if the STA is
listed under the ECCN number.
As a university that is mostly concerned with deemed export issues (aka foreign person conducting
research) it is a big help to have the nation of India moved to Country Group B. What does this mean?
There are fewer restrictions on that country, and correspondingly, those on our campus that are
conducting research from there.
The bottom line, of course, is that efforts are being made to reform export controls to aid in the free flow
of goods and services while protecting our citizens and keeping certain information and items out of the
hands of those that would use them to nefarious ends. Questions about export controls should be
directed to Alison Henry at 460-6509 or ahenry@usouthal.edu.
An Introduction to U.S. Export Control Law:
Investigations of Export Control Violations
Check out this Bureau of Industry and Security Publication at:
http://www.bis.doc.gov/complianceandenforcement/dontletthishappentoyou_2010.pdf
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NIH Conflict of Interest Rules Finalized
On August 25th the National Institutes of Health finalized financial conflict of interest regulations that carry
significant new requirements for researchers and research staff working on federally-funded projects.
Compliance with the new rules goes into effect on August 24, 2012. Potential risks which can
compromise the objectivity of research must be identified and managed, as the scientific integrity is
most critical to the conduct of science. The need to strengthen transparency and accountability has led
to a more rigorous approach to investigator disclosure, management of conflicts and oversight by the
federal government.
Major changes from the current federal conflict of interest rules are:
•
•
•
•
A change in the de minimis threshold that the federal government considers to be a “significant”
personal financial interest from $10,000 under the old rule to $5,000 under the new rule. However,
institutions are required to defer to the Institution’s conflict of interest policy if it has more stringent
financial disclosure requirements. USA’s policy does not place a monetary threshold on financial
interest, and thus includes anything of monetary value.
A requirement for disclosure of ALL reimbursed travel by researchers and research staff that is not
sponsored by a federal agency, state or local government, or a U.S. academic teaching hospital
or university-affiliated research institution
A requirement that each researcher and research staff member complete formal conflict of
interest training prior to engaging in PHS-funded research and re-training every four years
A requirement that the university make certain conflict of interest information is publicly
accessible which can either be website or written response to requests.
NOTE: The University of South Alabama’s current financial conflict of interest policy and
disclosure process will continued to be followed under the current federal regulations until
a new policy is implemented prior to the compliance date. These changes will be
provided as new University’s processes are developed.
For detailed information on the new NIH Conflict of Interest regulations, see summary of changes listed
at: http://grants.nih.gov/grants/policy/coi/
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* * Items of Interest * * *
Opinion: Ghostwriting is Fraudulent A legal remedy is needed to curb unethical “guest authorship” in
medical journals. The Scientist. November 2, 2011.
http://the-scientist.com/2011/11/02/opinion-ghost-writing-is-fraudulent/
New Draft Guidance on Exculpatory Language in Informed Consent Documents. August, 2011.
The Office for Human Research Protections (OHRP) is collaborating with the Food and Drug
Administration (FDA) to produce a new joint guidance on exculpatory language in consent documents
for research. Availability of the draft guidance was announced on 7-September, 2011. The finalized
version will supersede OHRP’s 1996 guidance on this topic; the FDA Information Sheets
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM271036.pdf
DHHS Office of Research Integrity June 2011 Newsletter
Does your NIH application involve the proposed use of animals?
The NIH Office of Extramural Research (OER) has produced a new podcast that discusses
what must be included in an application if vertebrate animals are included in the research?
To hear the Writing Your Vertebrate Animal Section podcast, please click the following link:
http://grants.nih.gov/podcasts/All_About_Grants/ and navigate to “Prepare a Successful
Grant Application: Writing Your Vertebrate Animal Section.
Are the Federal Human Subjects Regulations Changing?
Health and Human Services (HHS) and the Office of Science and Technology Policy (OSTP) jointly issued
Advanced Noticed of Proposed Rule Making (ANPRM) for the federal human subject’s regulations. The
proposed changes would represent a significant shift in the oversight of research involving human
participants. The ANPRM can be found at: http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/201118792.htm
Have a Question or a Comment?
Dusty Layton
Director, Research Compliance
460-6625
dlayton@usouthal.edu
Alison Henry
Assistant Director, Research Compliance
460-6509
ahenry@usouthal.edu
SuzAnne Robbins
IRB Compliance Specialist
460-6308
irb@usouthal.edu
Danny Housley
IACUC Compliance Specialist
460-6863
iacuc@usouthal.edu
Newsletter archives are posted on the Office of Research Compliance website at:
http://www.southalabama.edu/com/research/
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