VOLUME 1 ISSUE 3
FEBRUARY, 2007
New IRB Application Forms
The Institutional Review Board (IRB) has jurisdiction over all human subjects
research that involves any form of social/behavioral/educational research to
include both experimentation and investigation (e.g., research involving paper or
on-line questionnaires, surveys, interviews, focus groups, etc). Additionally, the
IRB has jurisdiction over participation of human subjects in any type of
biomedical/clinical research.
As IRBs are sensitive to specific aspects of both biomedical and
social/behavioral/educational research in their review of protocols, new IRB
project application forms have been implemented. The IRB has created two
separate IRB application forms specific to biomedical research and
social/behavioral/educational research. These new forms are available online at:
http://www.southalabama.edu/com/research/humansubjects/irb.shtml
The IRB will continue to update these application forms as a way to improve the
clarity of the questions asked and the format for providing information to the IRB
for review.
Keep in mind that providing well-organized and concise application forms are
likely to assist IRB staff and board members conduct a comprehensive review
and assess the criteria necessary for facilitating IRB approval in a timely fashion.
As a reminder, federal regulations exempt some types of research involving
human subjects from the normal review process of the IRB. The IRB requires
exempt research to be completed on the “IRB Request for Exemption Review”
form and will be adminstratively reviewed to determine if exemption status is
warranted. Exempt activities include those that present no more than minimal
risk to subjects which are defined as “the probability and magnitude of harm or
discomfort anticipated in the research are not greater in and of themselves than
those ordinarily encountered in daily life or during the performance of routine
physical or psychological examination or test”. The research study must fall into
one of the six categories in the regulations’ list of procedures that qualify for an
expedited review process. The use of vulnerable subjects such as minors,
prisoners or pregnant women in the study automatically exclude the research
from exempt status.
Inside This Issue
PAGE
Human Subjects:
New IRB application forms
1
Regulatory Binder Documents
2
Closure of study protocol
2
Biosafety Report:
2006 Inspection Findings
Animal Care and Use:
NIH Policy on Allowable Costs
for Grant Activities
ILAR online journal
Contact us at:
CSAB 128
251-460-6625 (Office)
dlayton@usouthal.edu
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3
3
Articles on Research Ethics: 4
Office of Research Compliance
Research activities involving human subjects that are exempt from IRB review
are identified in 45CFR 46.101(b)(1)-(6). This information is available on the
Office of Human Research Protections website at:
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.101
3
Regulatory Binder Documents
Principal Investigators conducting research with human subjects need
to maintain a regulatory binder for their IRB approved protocols. The
regulatory binder helps to effectively organize the study documents as
are required by federal regulations and good clinical practices.
Information to be included in the binder (where applicable):
1. Monitoring log (sponsor audits) and subject enrollment log
2. Training certificates: Human subjects, HIPAA in Research
(when adding personnel to the study, they must complete the required
training prior to participating in the study)
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
CVs/COIs/FDA 1572
Copies of all IRB approvals (initial, renewal, amendments)
Informed consent (all IRB approved versions)
Copy of the IRB protocol application form
Copies of any advertisement(s) and IRB approval
Copies of all IRB related correspondence
Protocol and Investigator’s Brochure
Protocol violations/deviations
Adverse Events
Lab certificates for studies utilizing laboratories for specimen
testing
13. Statement of Regulatory Compliance:
Contact the Office of Research
Compliance and Assurance for additional
assistance in the preparation
of regulatory documents
Label the binder with the protocol number,
Investigator name and study site
http://www.southalabama.edu/com/research/pdf/compliancestatement04.pdf
14. Copy of grant application, if applicable
Remember, investigators must retain signed consent forms, assent
forms for all research subjects for a minimum of three years after study
closure. These forms should be maintained in a secure location and
separate from the data for the study.
When to Close Out a Study Protocol
Suggestions for newsletter
improvements or
contributions are
welcomed – please email
the Office of Research
Compliance and
Assurance:
dlayton@usouthal.edu
Study closure is defined as the termination of the conduct of the study. This does
not include a study that is no longer accruing subjects, as those studies may still
follow subjects and receive incentives. As a general rule of thumb, you should
submit a final report form when:
enrollment of subjects is closed, and
data collection is complete, and
there is no additional research beyond the original use of the data
The federal definition of research involving human subjects includes analysis of
data or secondary use of the data if they still contain individually identifying
information.
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2006 Biosafety Inspection Findings
The Institutional Biosafety Committee (IBC) carries out annual biosafety inspections
during the month of December. These inspections are directed at ensuring our
research laboratories employ appropriate safety precautions and containment to protect
our employees and the environment from potential risk emerging from those procedures
involving genetically modified or pathogenic organisms. As of the 2006 calendar year,
47 labs totaling 136 active biohazardous and/or recombinant DNA registrations were
inspected. There were no major shortcomings noted during the inspections. However,
there were concerns to be addressed in one facility involving equipment performance
and facilities control systems. Nineteen or 40% of labs attained full compliance as
compared to 38% in year 2005. Overall, the inspection process indicated that research
involving biohazarouds materials are being performed in accordance with required
safety precautions and procedures.
NIH Policy on Allowable Costs for Grant Activities
Involving Animals when Terms and Conditions are not Upheld
“A new notice, entitled Guidance Addressing the NIH Policy on Allowable Costs for Grant Activities Involving
Animals when Terms and Conditions are Not Upheld, has been published in the NIH Guide for Grants and
Contracts on January 26, 2007 as Notice Number NOT-OD-07-044. This is a joint Notice from the Office of
Policy for Extramural Research Administration (OPERA) and Office of Laboratory Animal Welfare (OLAW). The
NIH Guide for Grants and Contracts is the official publication for NIH medical and behavioral research grant
policies,ofguidelines
funding
opportunities”.
The August
notice 2006
can be accessed at:
Source
Information:and
Report
on Research
Compliance,
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html
Source: NIH, Office of Laboratory Animal Welfare
Institute for Laboratory Animal Care Research (ILAR) Journal Online
ILAR is published quarterly by the Institute for Laboratory Animal Care Research,
National Council and are peer-reviewed and approved by the Editorial board before
publication. ILAR e-Journal is an electronic companion to the print journal that provides
information for the scientific community, IACUCs and veterinarians through publishing
topics devoted to animal research. In order to access the ILAR e-Journal, you must use
an USA IP address (e.g., campus PC), as our subcription is linked to the insitution. The
online web address is: www.national-academies.org/ilar
The ILAR recently published an article entitled, “Verification of IACUC Approval and the
Just-in-Time Process. The article can be assessed at:
http://dels.nas.edu/ilar_n/ilarjournal/instpdf/47_2_E-1_2006_Mann.pdf
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Articles on Research Ethics
“Leading By Example”, Nature 445, 229 (18 January 2007)
The primary safeguard against scientific misconduct is the example set every day by thousands of senior researchers in
the laboratory.
“Breeding Cheats”, Nature 445, 242-243 (18 January 2007)
Understanding the social and psychological factors behind scientific misconduct will enable bad practice to be
minimized, but never eliminated, says Jim Giles.
Academic Medicine, Journal of the Association of American Medical Colleges, January 2007, Volume
82, Issue 1.
The edition has several articles related to research ethics. Learn more at
http://www.academicmedicine.org/pt/re/acmed/currenttoc.htm;jsessionid=FrzTtwM5h4nyghgt0mfHNrtXQMLnGZYYRt1y
RPpvL5vZnJJwlnWx!2118075020!-949856145!8091!-1
“House Challenges Bush on Stem Cells, Again”, Jeffrey Brainard, The Chronicle of Higher Education,
January 12, 2007.
The U.S. House of Representatives re-approved a bill to expand federal spending for research on human embryonic
stem cells, but not by a large enough margin to overturn an expected veto by President Bush. Learn more
at http://chronicle.com/daily/2007/01/2007011202n.htm.
Newsletter archives are available through the Office of Research Compliance website at:
http://www.southalabama.edu/com/research/
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