Full Text OD-97-001
 
INFORMED CONSENT IN RESEARCH INVOLVING HUMAN PARTICIPANTS
 
NIH GUIDE, Volume 25, Number 32, September 27, 1996
 
RFA:  OD-97-001
 
P.T. 34

Keywords: 
  Human Subjects Policy 

 
National Cancer Institute
National Center for Human Genome Research
National Institute on Aging
National Institute on Alcohol Abuse and Alcoholism
National Institute of Allergy and Infectious Diseases
National Institute of Child Health and Human Development
National Institute on Drug Abuse
National Institute of Mental Health
National Institute of Nursing Research
Office of Extramural Research
Department of Energy
Department of Veteran Affairs
 
Application Receipt Date:  March 11, 1997
 
PURPOSE
 
The National Cancer Institute (NCI), the National Center for Human
Genome Research (NCHGR), the National Institute on Aging (NIA), the
National Institute on Alcohol Abuse and Alcoholism (NIAAA), the
National Institute of Allergy and Infectious Diseases ((NIAID), the
National Institute of Child Health and Human Development (NICHD), the
National Institute on Drug Abuse (NIDA), the National Institute of
Mental Health (NIMH), the National Institute of Nursing Research
(NINR), the Department of Energy (DOE), and the Department of
Veterans Affairs (VA) invite applications for a three year research
grant program to stimulate investigations into the informed consent
process in scientific research.  There is an ethical as well as a
legal responsibility to ensure that individuals both consent to and
understand their participation in research.  For consent to
participate in research to be truly informed, the information
imparted to potential participants must clearly explain study
procedures, distinguish research from treatment, realistically
portray the potential for medical or other benefits from
participation and the nature of potential benefit, carefully explain
the potential for discomfort, toxicity, or other risks that may
accompany participation in the research, and clearly delineate the
participant~s rights and limits regarding confidentiality and
withdrawal from participation.
 
The sponsoring organizations are jointly issuing this Request for
Applications (RFA) because voluntary informed consent is the defining
aspect of interactions between researchers and participants, and is
integral to the conduct of  the scientific research funded by all of
these organizations.  One of the goals of this RFA is to bring
together perspectives of these different agencies, since their
different research foci reflect a diversity of issues relating to
informed consent.  Of course, many facets of understanding the
informed consent process are shared, and hence a combined effort is
efficient for the agencies and scientists alike.
 
Little empirical work exists to document the degree of understanding
achieved by research participants regarding: (1) identity of the
sponsoring federal agency or agencies; (2) purposes for which  the
research is being conducted; (3) comprehension of a study's methods
and procedures; (4) relative risks and benefits (including financial)
of deciding to consent or refuse participation; (5) confidentiality
and any exceptions to confidentiality; (6) the implications of
withdrawal from a study and (7) planned and other possible use of the
data.  Such data should be useful in designing informed consent
procedures that are readily comprehended by prospective participants
and impart all critical information.  The goal of the present
initiative is to develop and test alternative strategies for
obtaining informed consent in diverse populations and determine
optimal ways to obtain informed consent for research participation.
 
ELIGIBILITY
 
Applications may be submitted by any domestic or foreign, for-profit
or non-profit organizations, public or private, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, or eligible agencies of the Federal government.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.
 
MECHANISM OF SUPPORT
 
This RFA will use the NIH individual research project grant (R01)
mechanism of support.  However, specific application instructions
have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME"
procedures being used under an NIH Reinvention Initiative.  The
modular grant concept established specific modules (increments) in
which direct costs may be requested as well as a maximum level for
requested budgets.  Only limited budgetary information is required
under the approach.  The just-in-time concept allows applicants to
submit certain information only when there is a possibility for an
award.  It is anticipated that these changes will reduce the
administrative burden for the applicants, reviewers, and government
staff.
 
For this RFA, funds must be requested in $50,000 direct cost modules
and a maximum of four modules ($200,000 direct costs) per year may be
requested.  A feature of the modular grant concept is that no
escalation is provided for future years, and all anticipated expenses
for all years of the project must be included within the number of
modules being requested.  Only limited budget information will be
required and any budget adjustments recommended by the Initial Review
Group will be in modules of $50,000.
 
In accordance with JUST-IN-TIME procedures, instructions for
completing the Biographical Sketch have also been modified.  In
addition, Other Support information and the application Checklist
page are not required as part of the initial application.  If the
initial review suggests that there is a possibility for an award, the
necessary budget, Other Support, and Checklist information will be
requested by NIH staff.  The APPLICATION PROCEDURES section of this
RFA provides specific details of modifications to standard PHS 398
application kit instructions.
 
FUNDS AVAILABLE
 
It is anticipated that for fiscal year 1997, $2,250,000 total funds
(direct and indirect costs) will be available. Award of grants
pursuant to this RFA is contingent upon receipt of such funds for
this purpose.  Between 8 to 11 awards are anticipated.  The exact
amount of funding awarded will depend on the quality of applications
and the availability of funds.
 
Applicants are requested to furnish estimates of the time required to
achieve the objective of the proposed research project.  Applicants
may request support for up to three years.  The usual PHS policies
governing grants administration and management will apply.  Annual
awards will be made, subject to continued availability of funds and
progress achieved.  This RFA is a one-time solicitation.  At the end
of the official award period, competitive renewal applications may be
submitted for peer review and competition for support through the
regular grant programs of the NIH.  It is anticipated that awards
resulting from RFA OD-97-001 will begin October 1, 1997.
Administrative adjustments in project period of amount of support may
be required at the time of the award.  Since a variety of approaches
would represent valid responses to this RFA, it is anticipated that
there will be a range of costs among the grants awarded.  All current
policies and requirements that govern the research grant programs of
the NIH will apply to grants awarded in connection with this RFA.
 
RESEARCH OBJECTIVES
 
Background
 
This RFA is a joint effort of the  Department of Health and Human
Services, the Department of Energy, and the Department of Veterans
Affairs.  The co-sponsoring organizations share a common vision of
how research should be conducted, as indicated by their support of
the common rule (45 CFR Part 46, Subpart A: June 18, 1991).
 
This program is being coordinated under the auspices of the Office of
Extramural Research (OER) Office of the Director, of the National
Institutes of Health.  The OER is responsible for developing
regulations, policies, and procedures concerning the  NIH extramural
program, including the oversight of the protection of human subjects
for the entire Department of Health and Human Services.
 
Several of NIH's  Institutes and Centers have joined together in the
support of this project, and each seeks to encourage research related
to its own mission.  The NCHGR supports research activities that
address the ethical, legal, and social issues that may arise from
human genetics research, and is especially interested in research on
informed consent as it pertains to participation in genetics
research, the role of IRBs in dealing with genetics research, the
involvement of individuals and families in genetics research,
policies related to maintaining privacy and confidentiality of
genetic information obtained through genetics research participation,
issues raised by the commercialization of products from genetics
research, and issues surrounding the development and use of
experimental gene-based diagnostic tools and therapies.  The National
Cancer Institute seeks to advance understanding of the informed
consent process by supporting research to simplify the process,
improve comprehension, and to identify methods to provide
study-specific information to diverse populations in cancer
prevention and treatment trials.  The National Institute on Aging
conducts and supports biomedical, social, and behavioral research and
training related to the special needs and capacities of elderly
participants in research, and is particularly interested in the role
of cognitive function in aging,  and the ability of the elderly to
understand and remember so that information related to the consent
process is meaningful.  The National Institute on Alcohol Abuse and
Alcoholism is interested in research designed to improve the informed
consent process for clinical research, especially with regard to
special populations such  as women of child bearing age, alcohol
dependent individuals, and individuals with a family history of
alcohol problems.  The National Institute of Allergy and Infectious
Diseases supports research to prevent and treat allergic and
immunologic diseases and disorders, and is interested in research to
enhance the process of informed consent for participation in a
variety of clinical trials, including asthma, transplantation,
sexually transmitted disease, and HIV therapies, vaccines and other
preventative measures.  The National Institute of Child Health and
Human Development supports research on biological and behavioral
human development, including reproduction and population studies,
perinatal biology, maternal and infant well-being, congenital
defects, developmental biology and nutrition, human learning and
behavior, mental retardation  and developmental disabilities, and
medical rehabilitation.  The National Institute of Drug Abuse
supports research on the causes and consequences, prevention, and
treatment of drug abuse and addiction, and is interested in research
to understand and improve the informed consent process for
participation in clinical research.  The National Institute of Mental
Health conducts and supports research on mental illness and mental
health, including studies of the brain, behavior, and mental health
services, and is interested in research to understand and enhance the
informed consent process for participation in clinical mental health
research.  Finally, the National Institute of Nursing Research is
interested in establishing better approaches to promoting health and
preventing disease; and to improving clinical environments by testing
interventions that influence patient health outcomes and
participation in clinical research.
 
Joining the NIH in funding this RFA is the Department of Energy
(DOE), Office of Health and Environmental Research (OHER) which
supports fundamental science to identify, understand, and anticipate
the long-term health and environmental consequences of energy
production, development, and use. With respect to this  RFA, the DOE
is particularly interested in consent issues arising in research
related to mapping the structure of the human genome, developing
advanced medical technologies and radiopharmaceutical. and
determining biological structure and function at the molecular and
cellular level.
 
Also co-sponsoring this RFA is the Department of Veterans Affairs
(VA), which conducts biomedical, health services, and rehabilitation
research related to the special needs of veterans. The VA seeks to
ensure that clinical research in its medical centers is conducted in
full compliance with the spirit and letter of the common rule, and is
interested in research relevant to any component of informed consent
or other requirements for the protection of human subjects.
 
 Full consideration of the components of informed consent is an
essential part of every research project involving human subjects.
Indeed, the Code of Federal Regulations (45 CFR Part 46, Subpart A:
June 18, 1991) requires that "...no investigator may involve a human
being as a subject in research...unless the investigator has obtained
the legally effective informed consent of the subject or the
subject's legally authorized representative."  As stated in 45 CFR
Part 46:
 
(a) ...in seeking informed consent, the following information shall
be provided to each subject:
 
1) A statement that the study involves research, an explanation of
the purposes of the research and the expected duration of the
subject's participation, a description of the  procedures to be
followed, and identification of any procedures which are
experimental;
 
2) A description of any reasonably foreseeable risks or discomforts
to the subject;
 
3) A description of any benefits to the subject or to others which
may reasonably be expected from the research;
 
4) A disclosure of appropriate alternative procedures or courses of
treatment, if any, that might be advantageous to the subject;
 
 5) A statement describing the extent, if any, to which
confidentiality of records identifying the subject will be
maintained;
 
6) For research involving more than minimal risk, an explanation as
to whether any compensation and any medical treatments are available
if injury occurs and, if so, what they consist of or where further
information may be obtained;
 
7) An explanation of whom to contact for answers to pertinent
questions about the research and research subjects' rights, and whom
to contact in the event of a research-related injury to the subject;
 
8) A statement that participation is voluntary, refusal to
participate will involve no penalty or loss of benefits to which the
subject is otherwise entitled, and the subject may discontinue
participation at any time without penalty or loss of benefits to
which the subject is otherwise entitled.
 
(b) Additional elements of informed consent. When appropriate, one or
more of the following elements of information shall be provided to
each subject:
 
1) A statement that the particular treatment or procedure may involve
risks to the subject (or to the embryo or fetus, if the subject is or
may become pregnant) which are currently unforeseeable;
 
 2) Anticipated circumstances under which the subject's participation
may be terminated by the investigator without regard to the subject's
consent;
 
3) Any additional costs to the subject that may result from
participation in the research;
 
4) The consequences of a subject's decision to withdraw from the
research and procedures for orderly termination of participation by
the subject;
 
5) A statement that significant new findings developed during the
course of the research which may relate to the subject's willingness
to continue participation will be provided to the subject; and
 
6) The approximate number of subjects involved in the study.
 
  While 45 CFR Part 46 is quite specific about the content of
informed consent, the responsibility for ensuring that this
information is presented and understood is left to the researcher and
his or her Institutional Review Board.  It is clear that informed
consent involves much more than a signature on a consent form.
Willingness to participate in research may wax and wane depending on
a participant~s expectations and satisfaction.  This may be further
complicated by changes in cognitive abilities and judgment over time.
In some instances, obtaining consent from a legally authorized
representative may be a requirement, as with research on children,
comatose patients, or older participants with advanced dementias.
The issues of substituted judgment  can be germane as well, if an
individual's competency to consent is in question.  Finally, the
research setting may play a role in the informed consent process.
For instance, the degree of risk is affected by whether a study
involves inpatients or outpatients, how closely these participants
are monitored, and by different legal requirements in community,
clinical, and institutional research settings.  Since these and other
complex issues have an impact on informed consent, there is much to
be learned and understood about this process.
 
Research Goals and Topics
 
Through this RFA, the NIH,  DOE, and VA seek to encourage research
designed to gather empirical data on the informed consent process,
particularly with respect to studies involving research populations.
Possible research topics are listed below. This list should not be
considered exhaustive; it is expected that applicants will identify
other topics as well.
 
 This RFA encourages research with a focus on:
 
 o Evaluating the degree of comprehension and reasoning ability
required to understand and consent to specific experimental
procedures and risks (e.g., placebo controls, stored tissue),
differentiate between research and standard treatment, and
distinguish between discretionary and obligatory activities
 
o  Applying existing knowledge in basic behavioral, cognitive
neuroscience, social, and educational research to develop methods for
efficiently assessing comprehension and reasoning ability in a
research setting
 
o  Identifying the cognitive processes underlying complex decisions,
and evaluating methods for enhancing the decision making process
 
o  Identifying the determinants for participation, retention, and
satisfaction in research (e.g., altruism, remuneration,  hopes for
new or better treatment, closer follow up, free care, interest in
science, risk-taking behavior)
 
 o  Developing and assessing innovative methods for clearly and
efficiently conveying consent information that 1) meets basic
requirements, and  2) offers extra material for the active
information seeker (e.g., audio-visual aids, computer-assisted
instruction)
 
o  Developing and evaluating outcome measures to monitor progress in
improving the consent process (e.g., resource use, number and type of
procedural reviews, incidence of injuries, exposure to unwarranted
risk, educational outcomes)
 
o  Assessing whether a participant understands experimental
procedures over time, including assessment throughout the full
duration of participation in a study; developing methods to inform
patients of new relevant information during participation In a trial
 
 
o  Determining if appropriate inclusion of a participant's relatives
or friends in the consent process changes participation and retention
rates within a study or alters the reported satisfaction with
participation in research
 
o  Determining the impact of families, communities of interest,
limited -English proficiency, durable powers of attorney, or advance
directives on participation and outcomes
 
o Identifying and developing ways to address special issues related
to records (e.g., protection of confidentiality while providing a
mechanism for future patient notification of unanticipated benefits
or risks resulting from study participation)
 
o  quantifying and defining comprehension of social harms, and
improving participant understanding of the risk of social harms
associated with research participation (e.g.,  discrimination by
insurance companies or in employment resulting from participation in
HIV treatment or vaccine research, genetics research)
 
 o  Identifying and determining the impact of special age-related
issues related to informed consent in research involving: 1) children
and adolescents (e.g., parental responsibilities and consent,
autonomy issues in adolescents, emancipated or institutionalized
minors, additional protections from risk and meaning of minimal risk,
young children~s ability to understand in relation to giving assent,
sense of altruism in children volunteering for research to help
others), and 2) older individuals whose cognitive states may affect
their abilities to fully comprehend the conditions of the experiment
 
 o  Examining the role of cultural and educational differences,
ethnicity, and gender on the informed consent process and
participation in research
 
 o  Identifying and determining the impact of special issues related
to informed consent in specialized populations such as women of child
bearing potential, drug abusers, HIV positive, mentally ill,
institutionalized, alcohol dependent, terminally ill,  or comatose
individuals, individual with genetic disorders, and individuals with
questionable competence  (e.g., worsening of cognitive impairment
over the course of a study, durable power of attorney)
 
o  Assessing the impact of special informed consent issues in
research involving individuals in specialized settings such as
emergency care, the workplace, the military,  prisons,  and outer
space (e.g., potential for confusion resulting from similarity of the
research project to routine duties and procedures; effect of
generalized deference to authority; effect of presence or absence
during recruitment of unit officers,  prison guards or other official
personnel)
 
 o  Examining how the research setting, timing, presence of an
ombudsman, and qualities of the individual obtaining informed consent
(e.g., cultural similarity, gender) affect the process.
 
ANNUAL MEETINGS AND COLLABORATION
 
Successful applicants will be asked to participate in yearly meetings
to report progress, discuss problems, and share information related
to the conduct of their grants.  It is  recommended that costs
associated with attendance at these meetings, to be held in the
Washington DC area, be included as a part of the budget proposal.
Previous experience with meetings of this kind has shown that they
can provide an opportunity  to work collaboratively with other
Investigators on various issues, which might include common core
instruments, joint publication, sharing of protocols and data, or
other avenues of collaboration that may arise.
 
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS
 
It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH-supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of the Public
Service Act, added by Public Law 103-43) and supersedes and
strengthens the previous policies (Concerning the Inclusion of Women
in Study Populations, and Concerning the Inclusion of Minorities in
Study Populations) which have been in effect since 1990.  The new
policy contains some new provisions that are substantially different
from the 1990 policies.
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research," which has been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted
in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume
23, Number 11.  Investigators may obtain copies from these sources of
from the program staff or contact the person listed below.  Program
staff may also provide additional relevant information concerning the
policy.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit by January 30, 1997, a
letter of intent that includes a descriptive title of the proposed
research and identification of any other participating institutions.
Such letters are requested only for the purpose of providing an
indication of the number and scope of applications to be received:
Therefore, their receipt is usually not acknowledged.  A letter of
intent is not binding, and it will not enter into the review of any
application subsequently submitted, nor is it necessary to have sent
a letter of intent to submit an application. The letter of intent is
to be sent to:
 
        Referral Office
        Division of Research Grants
        National Institutes of Health
        MSC 7720
        6701 Rockledge Drive
        Bethesda  MD  20892-7720
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research and may be obtained from
the Office of Grants Information, Division of Research Grants,
National Institutes of Health, 6701 Rockledge Drive, Room 3034--MSC
7762, Bethesda, MD 20892-7910, telephone 301/435-0714, E-mail:
girg@drgpo.drg.nih.gov.
 
 This RFA use the Just-in-Time" concept.  The following modifications
must be made to the standard PHS 398 application instructions
(applications not conforming to these  Guidelines will be considered
unresponsive to this RFA and will be returned  without further
review):
 
o  INITIAL BUDGET PERIOD - Only the names of personnel and level of
effort must be itemized in the Personnel section of the "Detailed
Budget for the Initial Period" (Form Page 4).  In addition, list
consultants, equipment, supplies, travel, patient care activities,
alterations and renovations, and other needs, as appropriate.  Costs
are not to be indicated for these individual items or categories.  If
subcontracts are involved, state the name(s) of collaborating
institutions in the "Consortium/Contractual Costs" section and
provide individual budgets as detailed in the "SUBCONTRACTS section
below.  The "Total Direct Costs" line at the bottom of the page must
be completed based on the number of $50,000 modules being requested.
Applicants may not request a change in the amount of each module.  A
maximum of four modules ($200,000 direct costs) per year may be
requested.  Any large one-time purchases, such as large equipment
requests, must be accommodated within these limits.
 
o  FUTURE BUDGET PERIODS - It is anticipated that direct cost budgets
will remain the same for each year of the period of award (i.e., the
same number of modules requested for each and every budget period).
Any necessary escalation must be considered when determining the
number of modules to be requested.  However, in the event that the
number of modules requested must change in any future year,
appropriate justification must be provided.  The "Budget for Entire
Proposed Project Period" (top section of Form Page 5) must include
Total Direct Costs requested for each year and the Total Direct Costs
for the Entire Proposed Project Period.  The Justification section
must be completed based on instructions provided on Form Page 5.
 
o  SUBCONTRACTS - If collaborations or subcontracts are involved that
require transfer of funds from the grantee to other institutions, it
is necessary to establish formal subcontract agreements with each
collaborating institution.  A letter of agreement from each
collaborating institution must be submitted with the application.
Initial and future year budgets for subcontracts must be prepared
using the same guidelines as for the main grant except that total
subcontract costs need not be in $50,000 modules.  Requested amounts
must be based on individual needs of the subcontract and must reflect
both direct and indirect costs.  The subcontract costs are included
in the total budget request, which must conform with the number of
$50,000 modules requested.
 
o  BIOGRAPHICAL SKETCH - In addition to the standard information
requested on Form Page 6, the applicant has the option of providing
the title and source of any sponsored support relevant to the
proposed research.
 
o  OTHER SUPPORT - No other support information is required on "Other
Support" pages (Form Page 7).  Selected other support information
relevant to the proposed research may be included in the Biographical
Sketch as indicated above.  Complete other support information will
be requested by NIH staff if there is a possibility for an award.
 
o  CHECKLIST - No "Checklist" page is required as part of the initial
application.  A completed Checklist will be requested by NIH staff if
there is a possibility for an award.
 
o  The applicant must provide the name and phone number of the
individual to contact concerning fiscal and administrative issues if
additional information is necessary following the initial review.
 
Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources may wish to identify the GCRC as a resource for conducting
the proposed research.  If so, a letter of agreement from either the
GCRC program director or principal investigator could be included
with the application.
 
To identify the application as a response to this RFA, the RFA title
"Informed consent in research involving human participants," and
number "OD-97-001," must be typed under item 2 of the face page of
the application form, and YES box must be checked.  The RFA label
available in the PHS 398 application kit must be affixed to the
bottom of the face page of the original copy of the application.
Failure to use this label could result in delayed processing the
application such that it may not reach the review committee in time
for review.
 
Submit a signed, typewritten original of the application and four
signed, exact photocopies, in one package to:
 
Division of Research Grants
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At time of submission, an additional copy  of the application must
also be sent under separate cover to:
 
Susan D. Solomon, Ph.D.
Office of Extramural Research
National Institutes of Health
Building One, Room 156
One Center Drive, MSC 0155
Bethesda, MD  20892
 
All applicants must provide a Protection of Human Subjects Assurance
Identification/Certification/Declaration as specified in the policy
described on the Optional Form 310.  If there is a question regarding
the applicability of this assurance, contact the Office for
Protection from Research Risks of the National Institutes of Health
at (301) 496-7041.
 
Applications must be received by March 11, 1997.  If an application
is received after that date, it will be returned to the applicant.
The Division of Research Grants (DRG) 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.  The DRG will not accept any application that is
essentially the same as one already reviewed.  This does not preclude
the submission of substantial revisions of applications previously
reviewed, but such applications must include an introduction
addressing the previous critique.
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by DRG,
and for responsiveness by the NIH, DOE, and/or VA program staff.
Incomplete applications will be returned to the applicant without
further consideration.  In addition, if program staff find that the
application is not responsive to the RFA, it will be returned to the
applicant without review.
 
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened in accordance with NIH peer review procedures.
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 applications under review, will be discussed, and
assigned a priority score; those with the potential for funding will
receive a second level review by the National Advisory Council of the
relevant NIH institute.
 
Applications will be judged on the following criteria:
 
o  scientific, technical, or medical significance and originality of
proposed research;
 
o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;
 
o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;
 
o  availability of the resources necessary to perform the research;
 
o  appropriateness of the proposed budget and duration in relation to
the proposed research;
 
o  adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
 
Plans for the recruitment and retention of subjects will also be
evaluated.  The initial review group will also examine the provisions
for the protection of human participants and the safety of the
research environment.
 
Receipt and Review Schedule
 
Application Receipt Date:  March 11, 1997
Initial Review:            June/July
Advisory Council Review:   September
Earliest Start Date:       October 1, 1997
 
AWARD CRITERIA
 
Funding decisions will be made on the basis of scientific and
technical merit as determined by peer review, program priorities and
balance, potential policy and practice relevance, and the
availability of funds.
 
INQUIRIES
 
Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.
Program staff of the NIH, DOE, and VA are available for consultation
concerning application development before or during the process of
preparing an application.  Potential applicants should contact
program staff as early as possible for information and assistance in
initiating the application process and developing an application.
 
Inquiries regarding programmatic issues may be directed to:
 
Eric Meslin, Ph.D.
National Center for Human Genome Research
38 Library Drive, Room 617, MSC 6050
Bethesda, MD  20892-6050
Telephone:  (301) 402-4997
FAX:  (301) 402-1950
Email:  Eric_Meslin@nih.gov
 
Leslie G. Ford, M.D.
National Cancer Institute
6130 Executive Boulevard, Room 300
Rockville, MD  20852-7343
Telephone:  (301) 496-0265
FAX:  (301) 496-8667
Email:  Fordl@DCPCEPN.NCI.NIH.GOV
 
Andrew A. Monjan, Ph.D., M.P.H.
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 3C307 - MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-9350
FAX:  (301) 496-1494
Email:  MonjanA@GW.NIA.NIH.GOV
 
Theodore Pinkert, M.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 505 - MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-1206
FAX:  (301) 443-8774
Email:  tpinkert@willco.niaaa.nih.gov
 
Amy R. Sheon, PhD, MPH
Division of AIDS
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, MSC 7620
Bethesda, MD  20892-7620
Telephone:  (301) 496-6177
FAX:  (301) 402-3684
Email:  as31r@nih.gov
 
Sarah L. Friedman
National Institute of Child Health and Human Development
Building 61E, Room 4B05
Bethesda, MD  20892
Telephone:  (301) 496-6591
FAX:  (301) 402-2085
Email:  SF2@NIHCU(BITNET)
 
Dorynne Czechowicz, M.D.
Division of Clinical and Services Research
National Institute on Drug Abuse
5600 Fishers Lane, Room 10A-08
Rockville, MD  20857
Telephone:  (301) 443-0107
FAX:  (301) 443-2317
Email:  Dczechow@aoada2.ssw.dhhs.gov
 
John K. Hsiao, M.D.
Division of Clinical and Treatment Research
National Institute of Mental Health
Parklawn Building, Room 18C-14
Rockville, MD  20857
Telephone:  (301) 443-3524
FAX:  (301) 443-6000
Email:  jhsiao@helix.nih.gov
 
June Lunney, Ph.D., RN
Division of Extramural Programs
National Institute of Nursing Research
Building 45, Room 3AN-12
Bethesda, MD  20892-6300
Telephone:  (301) 594-6908
FAX:  (301) 480-8260
Email:  Jlunney@ep.ninr.nih.gov
 
Susan L. Rose, Ph.D.
U.S. Department of Energy
ER-72/OHER
19901 Germantown Road
Germantown, MD  20874-1290
Telephone:  (301) 903-5468
FAX:  (301) 903-8521
Email:  Susan.L.Rose@oer.doe.gov
 
Dennis Roth
Department of Veterans Affairs
Office of Research and Development (12)
810 Vermont Avenue, N.W., Room 775J
Washington, DC  20420
Telephone:  (202) 273-8284
FAX:  (202) 273-6526
Email:  Roth@mail.va.gov
 
Direct inquiries regarding fiscal matters to:
 
Jean M. Cahill
Grants and Contracts Management Branch
National Center for Human Genome Research
38 Library Drive, Room 613 - MSC 6050
Bethesda, MD  20892-6050
Telephone:  (301) 402-0733
FAX:  (301) 402-1951
Email:  Jean_Cahill@nih.gov
 
Eileen Natoli
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496 7800 ext 256
FAX:  (301) 496 8601
Email:  natolie@gab.nci.nih.gov
 
David Reiter
National Institute on Aging
7201 Wisconsin Avenue, Room 2N212
Bethesda, MD  20892-9205
Telephone:  (301) 466-1472
FAX:  (301) 402-3672
Email:  reiterd@gw.nia.nih.gov
 
Linda Hilley
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 505, MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-4703
FAX:  (301) 443-3891
Email:  lhilley@willco.niaaa.nih.gov
 
Jane Unsworth
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 4B22
Bethesda, MD  20892-7610
Telephone:  (301) 496-7075
FAX:  (301) 480-3780
Email:  Jane_Unsworth@nih.gov
 
Douglas E. Shawver
Grants Management Branch
National Institute of Child Health and Human Development
Building 61 E, Room 8A 17F
Bethesda, MD  20982
Telephone:  (301) 496-1303
FAX:  (301) 496 0915
Email:  Douglas_Shawver@nih.gov
 
Gary Fleming, J.D., M.A.
Office of Planning and Resource Management
National Institute on Drug Abuse
5600 Fishers Lane, Room 8A-54
Rockville, MD  20857
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  gfleming@aoada2.ssw.dhhs.gov
 
Diana Trunnell
Grants Management Branch
National Institute of Mental Health
5600 Fishers Lane, Room 7C-08
Rockville, MD  20857
Telephone:  (301) 443-3056
FAX:  (301) 443-6885
Email:  diana_trunnell@nih.gov
 
Jeff Carow
Grants and Contracts Management Branch
National Institute of Nursing Research
Building 45, Room 3AN-32
Bethesda, MD  20892-6301
Telephone:  (301) 594-5074
FAX:  (301) 480-8256
Email:  JCAROW@ep.ninr.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance Nos. 93.172 (NCHGR), 93.242 (NIMH), 93.273 (NIAAA), 93.279
(NIDA), 93.361 (NINR), 93.395 (NCI), 93.856, 93.855 (NIAID), 93.865
(NICHD), and 93.886 (NIA).  Awards are made under authorization of
section 301 and Title IV (42 USC 241 and 281) of the Public Health
Service Act, and are administered under PHS grants policies and
Federal Regulations 42 CFR Part 52, and 45 CFR Part 74. This program
is not subject to the intergovernmental review requirements of
Executive order 12372, or Health Systems Agency Review.  Awards by
PHS agencies will be administered under PHS grants policy as stated
in the Public Health Service Grants Policy Statement (April 1, 1994).
 
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the nonuse 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.
 
.

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