Compliance
Training Required for Shipping Infectious and Diagnostic Substances
Although there have long been
regulations regarding the shipment of hazardous materials, the events of September
11, 2001 have caused renewed interest and enforcement of those regulations
by the Department of Transportation and the International Aviation Transportation
Association. These regulations require the proper training and certification
of staff who package and arrange for the shipping of hazardous materials,
including blood, urine, or tissue, via a common carrier, e.g. Fed Ex, US Postal
Service. Penalties for noncompliance are severe. Violations could result in
fines of $27,500 per occurrence and criminal penalties of up to $500,000 and
imprisonment.
While not all blood samples and biological materials
are considered "hazardous", there are specific procedures that must
be followed when packaging and shipping infectious and biologic specimens.
Additional requirements apply if dry ice is used. It is the responsibility
of the employer to provide proper training for site personnel. This training
must include (1) general awareness/familiarization training, 2) function-specific
training, and 3) safety training. Evidence of training must be kept on file.
The IUPUI Office of Research and Sponsored Programs
(R&SP) acknowledges that all research site personnel who prepare and/or
ship potentially dangerous biological specimens via a common carrier must
be trained. Therefore, an IUPUI committee including research and environmental
safety personnel will be developing specific training materials and testing
criteria for IUPUI employees in the near future.
There is, however, a need for immediate training.
Therefore, as an interim measure, the Clinical Trials Program in cooperation
with the Ruth Lilly Medical Library has agreed to make available a training
CD from a private vendor that meets the training criteria. The CD will be
available for loan in early November from the Ruth Lilly Library.
The training modules conclude with a final exam.
According to Dr. Mark Brenner, IUPUI Vice Chancellor for Research and Graduate
Education, a score of 75% will be considered the pass criteria. The employee
must print and retain the final exam results and the Certificate of Training
Document for future reference. Individual divisions or departments may also
wish to retain copies to be included in employee training records. R&SP
will NOT be maintaining these records at this time.
Additional questions may be directed to:
Clinical Trials Program (278-3858)
Dr. Sharon Moe, Medical Director (278-2870)
Pam DeWeese, Administrative Director (278-2865)
IUPUI
IBC Guidelines for TAT Protein Use
IUPUI Institutional Biosafety Committee
Minimum Guidelines for TAT Protein Use
TAT Protein use may be pursued at IUPUI if the
guidelines listed below are followed:
A. Laboratory Containment, Practice, and Technique
for TAT (or similar) protein studies (BL2):
1. TAT Protein must be handled as a potentially
hazardous material.
2. Some proteins are more toxic and/or immunogenic
and should be identified.
3. Plastic backed absorbent lab paper should
be used on all laboratory bench surfaces to absorb spills and splashes. All
things that come in contact with TAT proteins should be regarded as contaminated.
4. Biological safety cabinet (preferred) or designated
space is recommended.
5. Avoid aerosol-generating activities or use
appropriate safety equipment such as biological safety cabinets and sealed
centrifuge tubes.
B. Personal Protection required:
1. Mouth pipetting is NOT allowed.
2. Lab coats must be worn.
3. Disposable latex, nitrile, or equivalent gloves must be used.
4. Safety goggles must be worn.
5. Avoid direct contact with the skin, cuts, mucous membranes.
6. Wash well after working with TAT material.
C. Decontamination Procedures:
In the event of a spill, while wearing gloves,
lab coat, and safety glasses:
1. Decontaminate work surfaces using a detergent
with a protease enzyme (like Terg-A-Zyme) for 10-20 minutes.
2. Wash with water and then wipe with a 70% ethyl alcohol solution.
D. Disposal Procedures:
1. Deactivate and dispose of TAT solutions and cultures using standard
autoclave procedures.
2. Dilute solutions can be deactivated using
a 1:10 dilution of bleach (sodium
hypochlorite solution) in a 1:1 mixture with the TAT solution, let sit for
five to
ten minutes. Dispose by sewer drain with copious amounts of water.
E. TAT Protein research approval:
TAT Protein research must be approved by the
IBC prior to its initiation. When any revision to an approved protocol is
desired, an amendment must be filed with the IBC. The IBC reserves the right
to approve exceptions to the above guidelines on a case-by-case basis. A protocol
or an amendment to an existing protocol must be submitted to purchase, synthesize
or express TAT proteins.
The protocol or amendment must indicate:
1. What peptide you are linking on to
2. What you are using as target cells
3. What are the harmful consequences, if any, when expressed?
References:
Becker-Hapak M, McAllister SS, Dowdy SF. TAT-mediated
protein transduction into mammalian cells.
Methods. 2001 Jul;24(3):247-56. Review.
Schwarze SR, Hruska KA, Dowdy SF. Protein transduction:
unrestricted delivery into all cells?
Trends Cell Biol. 2000 Jul;10(7):290-5. Review.
Backus, B.D., Dowdy, S.F., Boschert, K.R., and
Richards, T.L, Becker-Hapak, M. (2000). Safety Guidance for Laboratory Personnel
Working with Trans-Activating Transduction (TAT) Protein Transduction Domains.
American Chemical Society Journal of Chemical Health and Safety (submitted).
NIH
Policy on Reporting Race and Ethnicity Data: Human Subjects in Clinical Research
The revised minimum standards include two ethnic
categories (Hispanic or Latino and Not Hispanic or Latino) and five racial
categories (American Indian or Alaska Native, Asian, Black or African American,
Native Hawaiian or Other Pacific Islander, and White).
For
additional information, visit: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html
For any NIH-funded study, this data will need
to be reported on the IRB continuing review form beginning with January continuing
reviews.
Openings
for Research Compliance Coordinators -RESEARCH
AND SPONSORED PROGRAMS
Research Compliance Coordinator PA 11
Description: Provide administrative support to assure regulatory compliance
with research programs. Compose and edit correspondence, meeting minutes,
and maintain records related to research projects. Excellent organizational,
communication, decision-making and interpersonal skills are essential. Personal
computer and high level of keyboarding skills required. Required: Associates
degree with a minimum four years of related experience, or Bachelors degree
with a minimum two years of related experience. SUBMIT RESUME IDENTIFYING
SPECIFIC POSITION OF INTEREST.
[ 019304L ] Full Time
Research Compliance Coordinator - Methodist PA
11
Description: Provide administrative support to assure regulatory compliance
with research programs. Compose and edit correspondence, meeting minutes,
and maintain records related to research projects. Excellent organizational,
communication, decision-making and interpersonal skills are essential. Personal
computer and high level of keyboarding skills required. Required: Associates
degree with a minimum four years of related experience, or Bachelors degree
with a minimum two years of related experience. SUBMIT RESUME IDENTIFYING
SPECIFIC POSITION OF INTEREST
[ 019069L ] Part Time
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Research and Sponsored
Programs
UN 618
General - 274-8285
Research Compliance - 274-8289
Sponsored Program Development - 278-0249
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