INCIDENCE OF NEEDLESTICK AND SHARPS INJURIES AND MEDICAL SAFETY DEVICE
AVAILABILITY/USE AMONG NON-HOSPITAL HEALTH CARE WORKERS
Release Date: February 28, 2000
RFA: OH-00-004
National Institute for Occupational Safety and Health (NIOSH)
Centers for Disease Control and Prevention
Letter of Intent Receipt Date: March 28, 2000
Application Receipt Date: April 27, 2000
PURPOSE
The National Institute for Occupational Safety and Health (NIOSH),
Centers for Disease Control and Prevention (CDC), invites
cooperative agreement applications for studies that will
contribute to the understanding of the risks of exposure to blood
borne pathogens among health care workers in non-hospital
settings. Such information will contribute significantly to an
understanding not only the risk for such injuries but the
development of effective intervention strategies. Because little
is known about the incidence of this injury in these workers, this
RFA has an emphasis on research that examines the incidence of
exposures to blood, risk factors associated with such exposures,
and the availability and use of medical safety devices.
A special feature of this RFA is encouraging applications from
researchers and from membership organizations comprised of health
care workers, such as unions and professional organizations, and
collaboration among these groups.
HEALTHY PEOPLE 2010
CDC is committed to achieving the health promotion and disease
prevention objectives of Healthy People 2010, a national
activity to reduce morbidity and mortality and improve the quality
of life. This announcement is related to the focus area of
occupational safety and health. For information on the conference
on Healthy People 2010, visit the internet site:
http://www.health.gov/healthypeople.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by public and private nonprofit and
for-profit organizations and by governments and their agencies;
that is, universities, colleges, research institutions, hospitals,
other public and private nonprofit and for-profit organizations,
State and local governments or their bona fide agents, including
small, minority and/or women-owned businesses. Applications from
minority and women investigators are encouraged.
MECHANISM OF SUPPORT
The administrative and funding instrument to be used for this
program will be a cooperative agreement (U01), an "assistance"
mechanism (rather than an "acquisition" mechanism), in which
substantial NIOSH scientific and/or programmatic involvement with
the awardee is anticipated during performance of the activity.
The awardee will be responsible for the planning, direction, and
execution of the proposed project and interrelated activities.
The NIOSH purpose is to support and/or stimulate the recipient's
activity by involvement in and otherwise working jointly with the
award recipient, but it is not to assume direction, prime
responsibility, or a dominant role in the activity. Details of
the responsibilities, relationships and governance of the study to
be funded under cooperative agreement(s) are discussed later in
this document under the section "Terms and Conditions of Award."
The total project period for an application submitted in response
to this present RFA may not exceed 3 years. The anticipated award
date is September 1, 2000. The award and level of support depends
on receipt of applications of high scientific merit. Although
this program is provided for in the financial plans of NIOSH, the
award pursuant to this RFA is contingent upon the availability of
funds for this purpose.
FUNDS AVAILABLE
Approximately $325,000 is available in FY 2000 to fund one award.
The maximum amount that maybe requested is $325,000 total cost
(direct and facilities and administrative (F&A) costs) per year.
Continuation award within an approved project period will be made
on the basis of satisfactory progress as evidenced by required
reports and the availability of funds.
USE OF FUNDS
Recipient should allocate funds for travel for two project staff
to attend an semi-annual one to two day meeting in Cincinnati,
Ohio for each year of the project.
PREAPPLICATION CONFERENCE
Applicants are invited by NIOSH to attend a pre-application
technical assistance conference on Tuesday, March 14, 2000 at 1:00
PM (Eastern time) to discuss: programmatic issues, potential
research partners, how to apply; and other questions regarding the
content of the RFA. This conference is expected to last
approximately two hours. The conference will be held at the NIOSH
Alice Hamilton Laboratory located at 5555 Ridge Avenue,
Cincinnati, Ohio, 45213. Applicants may also participate by
telephone. The conference name is NIOSH Needle Stick Injuries.
The telephone bridge number is (800) 311-3437. Participants will
need the conference code, 408178, to be connected.
RESEARCH OBJECTIVES
Background
There are nearly seven million health care workers employed in the
United States; approximately half work in non-hospital settings.
Health care workers are at risk of infection from blood borne
pathogens, particularly human immunodeficiency virus (HIV),
hepatitis B virus, and hepatitis C virus. As of June 1999, the
CDC was aware of 55 health care workers in the U.S. who had been
documented as having sero-converted to HIV following occupational
exposures. Approximately 83% of exposures to blood reported by
hospital-based health care workers are by percutaneous injury
(i.e., needlestick and sharps injuries). Mucous membrane exposure
accounts for about 13%, skin 3%, and bite 1%. Precise national
data are not available on the annual number of needlesticks and
other percutaneous injuries among health care workers since it has
been estimated that about half of these injuries go unreported.
Virtually all of the information on the occurrence of needlestick
and sharps injuries is based on hospital workers. However it has
been estimated that 600,000 to 800,000 such injuries occur
annually. In addition to the serious health consequences of this
injury, the emotional impact of a needlestick injury can be severe
and long lasting, even when a serious infection is not
transmitted.
In order to address this public health problem in the context of
occupational injuries, past studies have shown that certain
information about blood exposures need to be considered in a
survey design, including relevant demographic information about
survey respondents, general information about past exposures to
blood, and details about the circumstances of recent exposures.
For recent exposures to blood, a least eight critical areas of
information have been shown to be important. These include: 1)
route of exposure, 2) activity during and timing of exposure, 3)
specific medical device being used, 4) relevant characteristics of
the source patient, 5) reasons why the exposure either was or was
not reported, 6) suggestions on how to improve reporting of
injuries, 7) whether respondents obtained post-exposure
prophylactic treatment, and 8) precautions that would have
prevented the exposure.
Another critical area for inclusion in such studies is an
assessment of past injuries experienced by employees and, in order
to assess under-reporting, the percentage of injuries reported to
the worker’s employer via standard procedures. Valuable new
information would be contributed by a study that provided a
comparison of injury incidence density rates among health care
workers in the same occupations (e.g., RNs versus RNs) but
employed in either hospital or non-hospital settings by using the
same denominator (such as person-hours worked) for both groups.
NIOSH has set a goal to describe the occurrence of exposure to
blood among non-hospital health care workers in order to
subsequently identify appropriate interventions to reduce the
future incidence of exposure to blood borne pathogens. This RFA
is the first step to accomplish this goal.
Research Goals and Objectives
The objective of this RFA is to support research on the incidence
of and risk factors for exposures to blood among health care
workers employed outside hospitals. Among the issues that need to
be understood are the significant factors that affect blood
exposures such as rate of exposure from needlestick and sharps
injuries, other routes of exposure, and the prevalence and use of
medical safety devices. Research projects should address this
occupational issue in an integrated and comprehensive manner in
order for the risk for this injury in non-hospital workers can be
understood. In designing their studies, applicants may consider
the inclusion of these data elements in the study design: the
incidence rate of exposure to blood from needlestick and sharps
injuries and other routes of exposure among health care workers
who work in non-hospital settings; risk factors for these
injuries; and the prevalence of medical safety device availability
and usage. Non-hospital settings include, but are not limited to,
public and private clinics, nursing homes and other long-term care
facilities, non-hospital-based hospices, emergency medical
services, home care, and correctional facilities. Because there
is little quantitative data on these injuries in non-hospital
workers, the applicant should address in the application the basis
for the selection of occupations chosen for inclusion in the
study. In addition, the applicant should justify the survey
sample size.
One approach investigators may wish to consider, is to survey,
either retrospectively or prospectively, an entire population of
non-hospital health care workers or a random sample thereof in
order to estimate numbers of injuries and injury/exposure
incidence rates by occupation, setting, and medical device, as
well as the availability and usage of medical safety devices. An
important element that investigators may wish to include in the
study design is a comparison of risk factors, rates of injury, and
availability/use of medical safety devices between non-hospital
and hospital health care workers in the same occupations; however,
the focus of this RFA is on non-hospital settings.
Investigators may also wish to include in the study design
approaches for estimating the availability and usage of medical
safety devices in non-hospital institutions.
Another element that investigators may wish to consider is the
rate of vaccination against hepatitis B virus and compliance with
recommendations for post-exposure prophylaxis for hepatitis B
virus and human immunodeficiency virus. Because the well-known
problem of under-reporting of needlestick injuries could bias a
study, applicants should consider in the study design methods for
data collection that do not rely solely upon employers or health
services records. However, an investigator may wish to
supplement a survey of health care workers with a review of injury
records kept by employers.
USEFUL REFERENCES
National Institute for Occupational Safety and Health. National
Occupational Research Agenda. Cincinnati, OH: U.S. Department of
Health and Human Services, Public Health Service, Centers for
Disease Control and Prevention, National Institute for
Occupational Safety and Health, DHHS (NIOSH) Publication No.96-115
(http://www.cdc.gov/niosh/nora.html).
SPECIAL REQUIREMENTS
Applications should include, at a minimum, descriptions of the
following:
o The source of recruitment for the population studied and
letters of agreement;
o A detailed timetable for the proposed study.
UNIQUE CAPABILITIES
Applicants should highlight unique expertise and/or unusual
opportunities related to the purpose of this RFA.
TERMS AND CONDITIONS OF AWARD
The Terms and Conditions of Award, below, will be incorporated in
all awards issued as a result of this RFA. It is critical that
each applicant include specific plans for responding to these
terms. These special Terms of Award are in addition to and not in
lieu of otherwise applicable OMB administrative guidelines, HHS
Grant Administration Regulations at 45 CFR Parts 74 and 92, and
PHS Grants Policy Statement. The administrative and funding
instrument used for this program is a cooperative agreement (U01),
an "assistance" mechanism (rather than an "acquisition" mechanism)
in which substantial NIOSH scientific and/or programmatic
involvement with the awardee is anticipated during performance of
the activity.
Under the cooperative agreement, the NIOSH purpose is to support
and/or stimulate the recipient's activity by involvement in and
otherwise working jointly with the award recipient in a partner
role, but it is not to assume direction, prime responsibility, or
a dominant role in the activity. Consistent with this concept, the
dominant role and prime responsibility for the activity resides
with the awardee for the project as a whole, although specific
tasks and activities in carrying out the studies will be shared
among the awardees and the NIOSH Project Scientist where
appropriate, including the following.
1. Recipient (Applicant) Responsibilities
The applicant will coordinate project activities, scientifically
and administratively, at the awardee institution and at other
sites that may be supported by sub-contractors to this award. The
applicant will have primary authority and responsibility to define
objectives and approaches, and to plan, conduct, analyze, and
publish results, interpretations, and conclusions of studies
conducted under the terms and conditions of the cooperative
agreement award. Recipient will
a. enroll and follow-up the study participants and establish and
maintain mechanisms to ensure that data collection and management
procedures have necessary quality control and confidentiality of
data,
b. provide study participants with individual notification
letters when medical tests are performed,
c. develop and submit semiannual progress reports in a standard
format that is agreed upon at the initial planning meeting after
an award is made,
d. disseminate the scientific findings,
e. provide program management and oversight for the project,
f. notify study participants of the overall study results, and
g. participate in semi-annual meetings to provide information on
program status.
2. NIOSH Responsibilities
The NIOSH Project Scientist may, at the request of the recipient,
provide substantial scientific-programmatic involvement during
conduct of this activity, through technical assistance, advice,
and coordination.
a. provide technical assistance as a scientific liaison between
the awardee and other program staff at NIOSH who have experience
in the occupational health issues of health care workers,
infection control, and epidemiology;
b. provide expert consultation in the area of occupational
epidemiology;
c. provide technical advice on monitoring of field data
collection, developing operating guidelines, quality control
procedures, and developing policies/protocols for dealing with
recurrent situations;
d. facilitate collaborative efforts to compile and disseminate
program results through presentations and publications,
e. assist in the development of human subjects protocols for the
CDC Institutional Review Board (if required) and in the
preparation of OMB clearances that may be required during the
conduct of the study.
PAPERWORK REDUCTION ACT
Projects that involve the collection of information from 10 or
more individuals and funded by cooperative agreement will be
subject to review and approval by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act.
HUMAN SUBJECTS REQUIREMENTS
If a project involves research on human subjects, assurance (in
accordance with Department of Health and Human Services
Regulations, 45 CFR Part 46) of the protection of human subjects
is required. In addition to other applicable committees, Indian
Health Service (IHS) institutional review committees also must
review the project if any component of IHS will be involved with
or will support the research. If any American Indian community is
involved, its tribal government must also approve that portion of
the project applicable to it. Unless the awardee holds a Multiple
Project Assurance, a Single Project Assurance is required, as well
as an assurance for each subcontractor or cooperating institution
that has immediate responsibility for human subjects. The Office
for Protection from Research Risks (OPRR) at the National
Institutes of Health negotiates assurances for all activities
involving human subjects that are supported by the Department of
Health and Human Services.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS
It is the policy of the Centers for Disease Control and Prevention
(CDC) to ensure that individuals of both sexes and the various
racial and ethnic groups will be included in CDC-supported
research projects involving human subjects, whenever feasible and
appropriate. Racial and ethnic groups are those defined in OMB
Directive No. 15 and include American Indian or Alaska Native,
Asian, Black or African American, Hispanic or Latino, Native
Hawaiian or Other Pacific Islander. Applicants shall ensure that
women, racial and ethnic minority populations are appropriately
represented in applications for research involving human subjects.
Where clear and compelling rationale exist that inclusion is
inappropriate or not feasible, this situation must be explained as
part of the application. This policy does not apply to research
studies when the investigator cannot control the race, ethnicity,
and/or sex of subjects. Further guidance to this policy is
contained in the Federal Register, Vol. 60, No. 179, pages
47947-47951, and dated Friday, September 15, 1995.
NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS
PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the
age of 21) must be included in all human subjects research,
conducted or supported by NIH, unless there are clear and
compelling reasons not to include them. This policy applies to
all initial (Type 1) applications submitted for receipt dates
after October 1, 1998. This policy will be followed by NIOSH for
this announcement.
All investigators proposing research involving human subjects
should read the "NIH Policy and Guidelines on the Inclusion of
Children as Participants in Research Involving Human Subjects"
that was published in the NIH Guide for Grants and Contracts,
March 6, 1998, and is available at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators may also obtain copies of the policy from the
program staff listed under INQUIRIES. Program staff may also
provide additional relevant information concerning the policy.
LETTER OF INTENT
Prospective applicants are asked to submit, by March 28, 2000, a
letter of intent that includes a descriptive title of the proposed
research, name, address, and telephone number of the principal
investigator, identities of other key personnel and participating
institutions, and number and title of the RFA in response to which
the application may be submitted.
Although a letter of intent is not required, is not binding, and
does not enter into the review of subsequent applications, the
information allows NIOSH staff to estimate the potential review
workload and to avoid conflict of interest in the review.
The letter of intent is to be sent to:
Ann M. Cronin
National Institute for Occupational Safety and Health (NIOSH)
Centers for Disease Control and Prevention
1600 Clifton Road, NE
Mailstop D40
Building 1, Room 3070B
Atlanta, GA 30333
Telephone: 404/639-2277
Fax: 404/639-0035
Email: axc2@cdc.gov
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 4/98) is to be
used in applying for this cooperative agreement. Applications
kits are available at most institutional offices of sponsored
research and may be obtained from the Division of Extramural
Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone
301/710-0267, E-mail: grantsinfo@nih.gov. Applications are also
available on the web at: grants.nih.gov/grants/forms.htm.
The RFA label available in the PHS 398 (rev. 4/98) application
form must be affixed to the bottom of the face page of the
application. Failure to use this label could result in delayed
processing of the application such that it may not reach the
review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the
application form and the YES box must be marked.
The sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been
modified to allow for this change. Please note this is in pdf
format.
Submit a signed, original of the application, including the
Checklist, and three signed photocopies, in one package to:
CENTER FOR SCIENTIFIC REVIEW (CSR)
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the
application must also be sent to:
Ann M. Cronin
National Institute for Occupational Safety and Health (NIOSH)
Centers for Disease Control and Prevention
1600 Clifton Road, NE
Mailstop D40
Building 1, Room 3070B
Atlanta, GA 30333
Applications must be received by April 27, 2000. If an
application is received after that date, it will be returned to
the applicant without review. The Center for Scientific Review
(CSR) will not accept any application in response to this RFA that
is essentially the same as one currently pending initial review,
unless the applicant withdraws the pending application. CSR will
not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of a
substantial revision of an application already reviewed, but such
an application must follow the guidance in the PHS Form 398
application instructions for the preparation of revised
applications, including an introduction addressing the previous
critique.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by
CSR and responsiveness by NIOSH. Incomplete and/or non-responsive
applications will be returned to the applicant without further
consideration. Those applications that are complete and
responsive, will undergo further scientific merit review in
accordance with the criteria stated below for scientific/
technical merit by an appropriate peer review group convened by
NIOSH. The second level of review will be provided by the NIOSH
Secondary Review Panel.
All applications will be judged on the basis of the scientific
merit of the proposed project and the documented ability of the
investigators to meet the RESEARCH OBJECTIVES of the RFA.
Although the technical merit of the proposed protocol is
important, it will not be the sole criterion for evaluation of a
study. Access to the study population and ability to achieve the
initiative’s goals will also be part of the evaluation criteria.
As part of the initial merit review, all applications will receive
a written critique and undergo a process in which only those
applications deemed to have the highest scientific merit,
generally the top half of the applications under review, will be
discussed, assigned a priority score, and receive a second level
review by the NIOSH Secondary Review Panel.
PEER REVIEW CRITERIA
Applicants are encouraged to submit and describe their own ideas
about how best to meet the goals of the RFA, and are expected to
address issues identified under "SPECIAL REQUIREMENTS FOR THE
RFA." The peer review group will assess the merit of the
applications and related factors as follows:
Significance: Does the proposed research project satisfy an
important public health, occupational health, or infection control
need?
Approach: Are the conceptual framework, design, methods, and
analyses adequately developed, well integrated, and appropriate to
the aims of the project? Does the applicant acknowledge potential
problem areas and consider alternative approaches? Will the
research project be able to provide reliable estimates of the
incidence rate of exposure to blood, particularly needlestick and
sharps injuries? Will the research project be able to identify
risk factors for exposures to blood? Will the research project be
able to estimate the availability and use of medical safety
devices among the facilities employing the respondents? Does the
applicant include health care workers in occupations with
potentially the highest incidence rates of needlestick injury?
Does the applicant demonstrate access to health care workers who
are at high risk of occupational exposure to blood, including
letters of support from organizations facilitating access to these
workers? Does the applicant justify the proposed sample size and
statistical power calculations?
Innovation: Does the project employ novel concepts, approaches,
or methods? Is the project original and innovative? Does the
project develop new methodologies?
Investigators: Are the principal investigator and her/his
collaborators appropriately trained and well suited to carry out
this work? Do they have adequate experience in the areas of
occupational health, infection control, epidemiology, and project
management to carry out this work? Is the work proposed
appropriate to the experience level of the principal investigator
and her/his collaborators?
Environment: Are the applicant’s facilities, equipment, and other
resources adequate for the performance of this project? Is there
evidence of institutional support? Are the methods for assuring
privacy and maintaining confidentiality of participant records,
including specific protections for Internet-based data systems
adequate?
In addition to the above criteria, all applications will also be
reviewed with respect to the following:
The reasonableness of the proposed budget and duration in relation
to the proposed research.
The adequacy of plans to include both genders, minorities and
their subgroups, and children as appropriate for the scientific
goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated.
The adequacy of the proposed protection for humans, animals, or
the environment, to the extent they may be adversely affected by
the project proposed in the application.
AWARD CRITERIA
Applications recommended by the NIOSH Secondary Review Panel will
be considered for award based upon (a) scientific and technical
merit, (b) availability of funds and (c) prevalence of these
injuries in the study population.
SCHEDULE
Letter of Intent Receipt Date: March 28, 2000
Application Receipt Date: April 27, 2000
Anticipated Award Date: September 1, 2000
INQUIRIES
Written and telephone inquiries concerning this RFA are
encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Michael J. Galvin, Jr. Ph.D.
Research Grants Program
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Building 1, Room 3053, MS D-30
Atlanta, GA 30333
Telephone: 404/639-3343
FAX: 404/639-4616
Email: mtg3@cdc.gov
Direct inquiries regarding fiscal matters to:
Sheryl L. Heard, Grants Management Specialist
Grants Management Branch, Procurement and Grants Office
CDC Announcement Number 00038
Centers for Disease Control and Prevention
2920 Brandywine Road, Mail Stop E-13
Atlanta, Georgia 30341
Telephone: 770-488-2723
Email address: slh3@cdc.gov
LOBBYING RESTRICTIONS
Applicants should be aware of restrictions on the use of HHS funds
for lobbying of Federal or State legislative bodies. Under the
provisions of 31 U.S.C. Section 1352, recipients (and their sub-
tier contractors) are prohibited from using appropriated Federal
funds (other than profits from a Federal contract) for lobbying
congress or any Federal agency in connection with the award of a
particular contract, grant, cooperative agreement, or loan. This
includes grants/cooperative agreements that, in whole or in part,
involve conferences for which Federal funds cannot be used
directly or indirectly to encourage participants to lobby or to
instruct participants on how to lobby.
In addition no part of CDC appropriated funds, shall be used,
other than for normal and recognized executive-legislative
relationships, for publicity or propaganda purposes, for the
preparation, distribution, or use of any kit, pamphlet, booklet,
publication, radio, television, or video presentation designed to
support or defeat legislation pending before the Congress or any
State or local legislature, except in presentation to the Congress
or any State or local legislature itself. No part of the
appropriated funds shall be used to pay the salary or expenses of
any grant or contract recipient, or agent acting for such
recipient, related to any activity designed to influence
legislation or appropriations pending before the Congress or any
State or local legislature.
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic
Assistance No.93.262. Awards are made under authorization of the
Public Health Service Act, Title IV, Part A (Public Law 78-410, as
amended by Public Law 99-158, 42 USC 241 and 285) and administered
under CDC grants policies and Federal Regulations 42 CFR Parts 52
and 45 CFR Part 74 [and Part 92 when applicable for State and
Local governments].
SMOKE-FREE WORKPLACE
The CDC strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all
tobacco products. In addition, Public Law 103-227, the
Pro-Children Act of 1994, prohibits smoking in certain facilities
(or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early
childhood development services are provided to children. This is
consistent with the PHS mission to protect and advance the
physical and mental health of the American people.
Weekly TOC for this Announcement
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