U.S. Army Medical Research and
Material Command (USAMRMC)
Safety Requirements and Grant
Application Assistance
The University of Iowa
Date(s) Revised: 11/2009
The U.S. Army Medical Research and Materiel Command (USAMRMC) requires grant recipients to
follow specific safety standards and notification requirements. This instruction guide is intended
to provide assistance to investigators applying for USAMRMC grants. The requirements are also
applicable when applying for grants through the Congressionally Directed Medical Research
Programs (CDMRP). It will also assist with maintaining ongoing grant requirement compliance.
The USAMRMC grant requirements include a facility safety plan, a Certificate of Environmental
Compliance, and assurance by both individual investigators and The University of Iowa that safety
programs are in place and hazards have been identified and controlled.
General information on USAMRMC grants application requirements are obtained from UI Division of
Sponsored Programs, from USAMRMC (http://www.usamraa.army.mil/pages/baa_paa/mrmcbaalist.cfm)
or CDMRP https://cdmrp.org/ ).
INSTRUCTIONS
The steps below show you how to prepare the health, safety and environmental portion of the application.
1. Complete “Form A. Research Health and Safety Hazard Assessment.” This form is intended to
guide you through the identification of safety and health hazards that may be associated with your
proposed research project. The form also lists the Health and Safety Programs that address each
hazard. Include a date and initial for each program addressing a hazard associated with your project.
You are required by USAMRMC to communicate the project hazards to UI Environmental Health &
Safety (EHS) and, in step 3 below, you are required to sign an assurance that you are responsible for
all safety and health aspects of your project. Alternately, you may use Form A as an explanatory
guide to complete Form B.
Form A. is an internal form and is not submitted with the grant application. If you have questions,
contact LuAnn Hiratzka at EHS (LuAnn 335-7564; EHS 335-8501).
2. Complete “Form B. University of Iowa Principal Investigator Health and Safety Assurance.”
This is an internal form submitted only to EHS. With this Principal Investigator Assurance form, the
investigator declares that safety programs are in place to address hazards associated with the
research being planned or conducted. Contact EHS with any questions.
3. You will be requested by USAMRMC (or CDMRP) to complete “Form C. Principal Investigator
Assurance”. Depending on how you submit your application, you may be required to submit it with an
online application or you may be contacted later by the funding organization. A sample form is
included with these instructions for your review. (Note that in the first and fourth bulleted paragraphs,
you are assuring that you have involved and will report to the Facility Safety Director/Manager; this
refers to UI EHS.)
4. Contact the University’s Environmental Compliance Manager (Michael Valde, 335-6190) to arrange a
meeting to discuss the environmental impacts of your research project and obtain a signed copy of
“Form D. Certificate of Environmental Compliance”. You will be requested to submit this form with
your application to USAMRMC. It will be included with your application materials and a sample form
is included here for your review. Be prepared to discuss the questions on “Form E. Environmental
Compliance Assessment” with the Environmental Compliance Manager. Form E is an internal form
that will allow proper assessment of the environmental aspects of your project. Once the “Certificate
of Environmental Compliance” is signed, return it to the Division of Sponsored Programs.
5. Send a copy of the following completed documents to EHS for review –
1. Form A. Research Health and Safety Hazard Assessments (optional),
2. Form B. The University of Iowa Principal Investigator Health and Safety Assurance
(required);
3. Form C. Principal Investigator Assurance (required). An EHS representative will
contact you to schedule and conduct a lab/area site visit, discuss proposed research
activities, and to discuss the facility safety plan. Your research project will be discussed
again during your annual EHS bio/chemical lab review visit.
6. Once the USAMRMC grant is funded, the PI is required to notify EHS of any changes in the
research activities that may involve new or different health, safety, or environmental impacts.
A status notification is required to be submitted to EHS annually by June 30th of each year. The
status notification assists EHS with preparation of the Facility Safety Plan Annual Status Report
required by USAMRMC. Complete “Form F. Research Safety Plan Status Report” and submit to
EHS – 100 EHS, Attention LuAnn Hiratzka, or via e-mail to luann-hiratzka@uiowa.edu by June 30th of
each year. A reminder will be sent to you to complete Form F.
Form A – Research Health and Safety Hazard Assessment – Submit to EHS Only.
ANIMAL USE IN RESEARCH
Potential Project Hazards
Animal Welfare
and
Caretaker
Hazards
Health/Safety Program that Addresses the Hazards
Completed
Initial
1. Possess IACUC-Approved Protocols per UI Animal Research.
2. Complete USMRMC protocols and information at
http://www.usamraa.army.mil/pages/baa_paa/mrmcbaalist.cfm
3. Complete Appropriate Training
BIOLOGICALS
Potential Project Hazards
Health/Safety Program that Addresses the Hazards
Biological Agents
4. Biosafety Plans and Procedures in Place as per UI Biological Safety Manual.
Bloodborne Pathogens
5. Bloodborne Pathogens Control Plan Template.
6. Bloodborne Pathogens Safety Training.
Recombinant DNA
7. rDNA Registration.
8. Procedures as per UI’s rDNA Guidelines
Select Agents
9. Must Possess CDC Registration.
10. Procedures as per UI’s Requirements for Select Agent Use.
Completed
Initial
Completed
Initial
Completed
Initial
CHEMICALS
Potential Project Hazards
Allergens (latex, animal, enzyme, etc.)
Anesthetic Agents
Flammable
Carcinogens
Compressed Gases
Corrosive
Neurotoxins
Other Toxics
Reactive
Reproductive Toxins
Shock Sensitive
Health/Safety Program that Addresses the Hazards
11. Chemical Hygiene Plan in written form for each lab.
12. Lab Chemical Safety Training.
13. Site-Specific Lab Safety Topics (topics checklist found within online Lab
Chemical Safety Training)
ENVIRONMENTAL and WASTE MANAGEMENT
Potential Project Hazards
Biological Waste
Chemical Waste
Radiological Waste
Health/Safety Program that Addresses the Hazards
14. Comply with UI Environmental Policy and Responsibilities.
15. Implement EHS Waste Management Procedures.
16. Possess a certificate of environmental compliance signed by the UI
Environmental Compliance Officer (Form D included with USMRMC grant
proposal forms and with this procedure). Contact Mike Valde, UI Environmental
Compliance Manager, at 335-6190.
Environmental Compliance
GENERAL LAB SAFETY
Potential Project Hazards
Health/Safety Program that Addresses the Hazards
General Lab Safety Procedures
17. Lab Safety Procedures in place per the Chemical Hygiene Plan.
18. Emergency Preparedness Procedures in place per the Chemical Hygiene Plan.
19. Potential electrical/fire hazards for project addressed – see fact sheet.
Personal Protection Equipment
(PPE)
20. Complete Written Certification of PPE Hazard Assessment.
21. Complete Basic PPE Compliance and Awareness Training Course.
22. Complete Site-specific PPE compliance and awareness instruction.
Respirator Use
23. Must have a Respiratory Protection Program in place.
24. If necessary, complete the UI’s Respiratory Program template. This includes
respirators and dust masks used for exposure control or comfort use.
25. Complete appropriate training.
Completed
Initial
IONIZING RADIATION – Human Use
Potential Project Hazards
Health/Safety Program that Addresses the Hazards
Brachytherapy Sources
Diagnostic X-ray Machines
Linear Accelerators (LINAC)
Radiopharmaceuticals
Completed
Initial
Completed
Initial
Completed
Initial
26. UI and/or Iowa Department of Public Health Registration and Authorization.
27. Compliance with Radiation Protection Guide for Medical Use of Radioactive
Materials and Radiation-Producing Machines.
28. Appropriate Radiation Safety Training.
IONIZING RADIATION – Non-Human Use
Potential Project Hazards
Analytical X-ray Machines
Radioactive Materials
Health/Safety Program that Addresses the Hazards
29. UI and/or Iowa Department of Public Health Registration and Authorization.
30. Compliance with Radiation Protection Guide for RAM Use in the Basic Sciences.
31. Appropriate Radiation Safety Training.
NON-IONIZING RADIATION
Potential Project Hazards
Lasers
MRI
32. Health/Safety Program that Addresses the Hazards
33. Registration through EHS.
34. Compliance with Laser Safety Manual.
35. Appropriate Laser Safety Training (Medical or Non-Medical Use). Call 335-8503.
36. Contact Gordon Axt, EHS, at 335-8503 or gordon-axt@uiowa.edu
Form B – Principal Investigator Health and Safety Assurance Form
(Internal form submitted only to EHS.)
The University of Iowa Principal Investigator Health and Safety Assurance Form.
Principal Investigator
Department
Research Location
Proposal Title
I am aware of The University of Iowa health and safety programs listed below and on Form A. I
understand, will follow, and enforce the requirements of those programs applicable to my research. I will
ensure that all personnel involved in my research have been trained before research begins and will
follow the policies and procedures specific to my research.
I have provided a date and initial indicating that the requirements of the health and safety programs listed
below and on Form A applicable to my research (those not applicable are designated as N/A) have been
met. Note: You may submit a completed Form A with this assurance or complete the items below.
Program
Laboratory Chemical Safety Program
 Chemical Hygiene Program (general and site-specific)
Biological Safety Program




Biological Agents (general)
Recombinant DNA
Bloodborne Pathogens
Select Agents
Radiation Safety Program
 Ionizing Radiation
 Non-Ionizing Radiation (lasers, MRI)
General Laboratory Safety
 General Safety, Fire Prevention, Emergency Preparedness
 Personal Protective Equipment Program
 Respiratory Protection Program
Environmental and Waste Management
 Hazardous Waste Management
 General Environmental Compliance
Animal Use in Research (IACUC-approved protocols)
Initials
Date
N/A
Reference – Please use the most current form included with your application materials.
ATTACHMENT 4
Form C – Principal Investigator Assurance
(USAMRMC Research Proposal Safety Information – Safety Program)
 I assure that I have involved the Facility Safety Director/Manager in the planning of this research
proposal, discussed with him/her all aspects of the proposal that relate to occupational health and
safety, and will help him/her prepare the annual Facility Safety Plan Status Report.
 I assure that I will comply with my institution’s safety program and its requirements.
 I understand that I am directly responsible for all aspects of safety and occupational health
specific to my research protocol.
 I assure that I will report to the Facility Safety Director/Manager any changes in the safety or
occupational health practices due to changes in my originally planned research.
 I assure that hazards associated with my research have been identified, eliminated and/or
controlled.
 I assure that all Facility Safety Plan requirements are in compliance with Local, State, and
Federal general industry standards.
 If applicable, I assure Biological research programs will follow the recommended guidelines
established in the latest editions of the CDC-NIH publication Biosafety in Microbiological and
Biomedical Laboratories (BMBL); Army Regulation 385-10, Chapter 20 (Biological Safety); and
DA Pam 385-69 (Safety Standards for Microbiological and Biomedical Laboratories).
Name of Principal Investigator (print)
Signature of Principal Investigator
Date
Mailing Address:
Street
City
Phone Number:
Fax:
E-mail Address:
JUNE 2009
State
Zip Code
Reference – Please use the most current form included with your application materials.
ATTACHMENT 3
Form D – Certificate of Environmental Compliance (CEC)
The Certificate of Environmental Compliance should be executed by the institution’s official responsible for
environmental compliance. The Council on Environmental Quality (CEQ) regulations (40 CFR 1500-1508) that
implement the National Environmental Policy Act (PL 91-190, as amended) require all federal agencies to examine
possible environmental consequences of their proposed and ongoing actions. The U.S. Army Medical Research
and Materiel Command (USAMRMC) examines all medical research and development projects, whether inside or
outside the United States, for their potential environmental impacts. (Note: This form is not required for institutions
which solely perform work involving proposal/protocol management, conference coordination, data
mining/interpretation/entry/research, and/or classroom training; as long as the operations do not use any hazardous materials—
as defined by OSHA, nor do they involve any processes which will generate medical waste – such as needles, blood stained
gauze/bandages, etc.)
1.
One CEC (this form) must be submitted for each site conducting research under the submitted research
proposal. This includes all subcontractors.
2.
If you have any questions concerning the generation or applicability of a CEC, please e-mail or call (310619-2004) the USAMRMC Command Environmental Coordinator.
The offeror currently ____ IS ____ IS NOT (check appropriate category) in compliance with applicable national, state,
and local environmental laws and regulations. (If not in compliance, attach details and evidence of approved
mitigation measures.) The offeror has examined the activities encompassed within the proposed action for
compliance with environmental laws and regulations. (Enter Research Proposal Title)
Principle Investigator:
The offeror states that the conduct of the proposed action:
1. WILL NOT violate any applicable national, state, or local environmental law or regulation; and
2. WILL NOT have a significant impact on the environment.
The offeror agrees that if the work required under the proposed action at any time results in a significant impact on
the environment or a violation of any applicable environmental law or regulation, the offeror will immediately take
appropriate action, to include notifying and/or coordinating with the appropriate regulatory agencies as required by
law and notifying the Contracting/Grants Officer.
Name and Title of Official Responsible for Environmental Compliance (Printed)
Signature
Name of Organization (Printed)
JUNE 2009
Date
Form E – Environmental Compliance Assessment
(Internal form to be used for discussion with the UI Environmental Compliance Manager)
 Briefly describe your research project.
 Will the project include any source of emissions or exhausts to the atmosphere such as:
Fume hoods
Boilers
Generators
Sterilizers
Combustion sources
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No (list the source and the fuel)
 Will any equipment use ozone depleting substances such as freon,
hydrochlorofluorocarbons, chlorofluorocarbons (e.g., chillers, freezers)
 Will you have 55 gallons or more of oil of any kind in any containers or equipment?
 If any of the following will be discharged into the sewer, check the appropriate box(es).
Flammable or explosive pollutants
Corrosives
Solid or viscous pollutants that may cause obstructions of flow
Pollutants capable of releasing fumes or vapors
Pollutants of high biological oxygen demand
Oil of any kind
 Will any pollutants of any kind be discharged into a surface water?
 Will hazardous waste be generated?
Yes
How will it be handled and disposed of?
No
 Will any mercury containing equipment be used?
 Will any pesticides be used?
 Will hazardous materials be present?
Yes
No
Has Hazardous material storage been addressed?
Meeting and Review with Environmental Compliance Manager
Signature
(date)
Signature
(date)
Form F – Research Safety Plan Status Report
(Internal form submitted only to EHS)
A Research Safety Plan Status Report must be submitted annually to the Environmental Health &
Safety Department (EHS) no later than JUNE 30th. Please provide a brief description of any
changes in research that had safety, health, or environmental impacts during the past 12 months.
(Additional pages may be attached.)
During the past 12 months:
1. Have any change(s) in Research Operation Safety Procedure(s) been made?
Yes
No
If yes, briefly describe:
2. Have any modifications to the facility, equipment, and description (e.g., new equipment purchased,
hood ventilation certification) been made?
Yes
No
If yes, briefly describe:
3. Hazard Analysis: Have any new hazards been identified for any of the awards supported by the
USAMRMC?
Yes
No
If yes, provide a hazard analysis for each new hazard.
4. Radioactive Materials: Have any significant change(s) occurred in the use of the radioactive
materials?
Yes
No
If yes, briefly describe:
Are there any additional radioactive materials in use?
Yes
No
If yes, list additional material(s).
I certify that all of the above statements are correct to the best of my knowledge, and I assure that
the research area provides a safe environment for my employees working in accordance with UI’s
health and safety programs for laboratories. I provide employee safety training and periodic
laboratory inspections in an effort to minimize, eliminate, or control potential hazards to the
employees and the public.
I understand that the Safety Office, USAMRMC, may conduct periodic site visits in order to
ensure the indicated elements are in compliance with regulatory requirements.
Principal Investigator
Date
Department
Research Location
Phone Number
Emergency Phone Number
Proposal Title