- The Dietitian reviews the
protocol and attends an in service presented by the investigator prior to the
start of the study. She verifies the protocol and the
diet order, interviews the patient for a meal as tolerated within the
limitations of the study, and instructs the patient on a Cardiac Low Sodium,
Diabetic diet or as appropriate. Also, a diet instruction for oral
anticoagulants as it relates to food and drug interaction is given. She prepares and presents an in service to the food service cooks prior to the start
of the study.
The kitchen staff prepares the
diet as written by the dietitian, and cooks, prepares, and serves it as
written. If a written menu is not individualized by the dietitian, the kitchen
staff follows the standard cardiac low sodium, diabetic diet. They monitor and
record all foods consumed by the patient.
*** No more than 5
pages to this point ***
GCRC
Utilization table for past year*
Protocol Utilization of GCRC 12/1/2000 - 11/30/2001
|
|
Inpatient A Days
(non-veterans) |
|
|
Inpatient B Days (veterans) |
|
|
Inpatient C Days |
|
|
Inpatient D Days
(drug-company sponsored) |
|
|
Outpatient A Visits
(non-veterans) |
|
|
Outpatient B Visits
(veterans) |
|
|
Outpatient C Visits |
|
|
Outpatient D Visits
(drug-company sponsored) |
|
GCRC Utilization table –
projected for next year (Dec. 2002 - Nov. 2003)
Protocol Utilization of GCRC 12/1/2001 - 11/30/2002
|
|
Inpatient A Days
(non-veterans) |
|
|
Inpatient B Days (veterans) |
|
|
Inpatient C Days |
|
|
Inpatient D Days
(drug-company sponsored) |
|
|
Outpatient A Visits
(non-veterans) |
|
|
Outpatient B Visits
(veterans) |
|
|
Outpatient C Visits |
|
|
Outpatient D Visits
(drug-company sponsored) |
|
Investigators’ peer-reviewed funding
-
Grant/Contract Number
-
Organization Name (if not
Federal funds)
-
GCRC Investigator Name
-
PI Name
-
PI Institution
-
Project Period - Start date
& End date
-
Kind of grant (Federal,
Foundation, Industry, PVAS, SCC, Other)
-
Agency (if Federal) - (DOD,
NASA, NSH, PHS, USDA, VA, Other)
-
Total funds for current or
most recent year
Protection of Human Subjects -
addressing the four Evaluation Criteria below:
1. Risks To
The Subjects
Human subjects involvement and
characteristics
Describe the proposed involvement
of human subjects in the work outlined in the Research Design and
Methods section. Describe the characteristics of the subject population,
including their anticipated number, age range, and health status.
Identify the criteria for inclusion or exclusion of any subpopulation.
Explain the rationale for the involvement of special classes of
subjects, such as fetuses, neonates, pregnant women, children,
prisoners, institutionalized individuals, or others who may be
considered vulnerable populations.
Sources of materials
Identify the sources of
research material obtained from individually
identifiable living human subjects in
the form of specimens, records, or data.
Indicate whether the material or data will be
obtained specifically for research
purposes or whether use will be made of
existing specimens, records, or data.
Potential risks
Describe the
potential risks to
subjects (physical, psychological, social, legal,
or other) and assess their likelihood and
seriousness to the subjects. Where
appropriate, describe alternative treatments and
procedures, including the risks and
benefits of the alternative treatments and
procedures to participants in the
proposed research.
2. Adequacy Of Protection Against Risks
Recruitment and informed consent
Describe plans
for the recruitment of subjects and
the process for obtaining informed
consent. Include a description of the
circumstances under which consent will be sought and
obtained, who will seek it, the nature of
the information to be provided to prospective
subjects, and the method of documenting
consent. The informed consent
document need not be submitted to the PHS
unless requested.
Protection against risk
Describe the planned
procedures for protecting against or minimizing
potential risks, including risks to
confidentiality, and assess their likely effectiveness.
Where appropriate, discuss plans for
ensuring necessary medical or professional
intervention in the event of adverse
effects to the subjects. In studies that involve
clinical trials (biomedical and behavioral
intervention studies), describe the plan for
data and safety monitoring of the research
to ensure the safety of subjects.
3. Potential Benefits Of The Proposed Research To The Subjects And Others
Discuss the
potential benefits of the research to
the subjects and others. Discuss why
the risks to subjects are reasonable in
relation to the anticipated benefits to
subjects and others.
4. Importance Of The Knowledge To Be Gained
Discuss the
importance of the knowledge gained or to
be gained as a result of the proposed
research. Discuss why the risks to subjects
are reasonable in relation to the importance of
the knowledge that reasonably may
be expected to result.
Note:
If a test article (investigational new drug, device,
or biologic) is involved, name the test
article and state whether the 30-day interval
between submission of applicant
certification to the Food and Drug Administration
and its response has elapsed or has
been waived and/or whether use of
the test article has been withheld or
restricted by the Food and Drug
Administration.
Rationale for the Inclusion of Women -
If you are
conducting clinical research, create a
section heading entitled “Inclusion
of Women”
and a
separate section heading entitled,
“Inclusion of Minorities.” Place these sections
immediately after the Human Subjects Research
section in your application. Address each of the
items identified below with respect to your plans
for the “Inclusion of Women” and the “Inclusion
of Minorities” as they relate to the proposed
research. Although no specific page limitation
applies to these sections of the application,
be succinct.
Applications that fail to address the Inclusion of Women and
Minorities as subjects in clinical research will be
designated as incomplete and will constitute grounds for the PHS
to return the application without peer review.
NIH policy
requires that women and members of minority
groups and their subpopulations be included in
all NIH-supported biomedical and behavioral
clinical research projects involving human subjects
(see
http://grants.nih.gov/grants/guide/noticefiles/
NOT-OD-02-001.html
and also
definition in Section III A.,
"DEFINITIONS"; p. 37)
The inclusion
must be addressed in developing a research
design appropriate to the scientific objectives of
the study. Inclusion is required unless a clear
and compelling rationale shows that inclusion
is inappropriate with respect to the health of
the subjects or that inclusion is inappropriate
for the purpose of the study. Exclusion
under other circumstances may be made based on
a compelling rationale and justification.
Cost is not an acceptable reason for exclusion
except when the study would duplicate data
from other sources. Women of childbearing
potential should not be excluded routinely from
participation in clinical research. This policy
applies to research subjects of all ages.
Provide
information on the composition of the proposed study
population in terms of sex/gender and
racial/ethnic group and provide a rationale
for selection of such subjects in terms of the
scientific objectives and proposed study design.
The description may include (but is not limited
to) information on the population
characteristics of the disease or condition under study,
national and local demography, knowledge of
the racial/ethnic/cultural
characteristics of the population, prior experience and
collaborations in recruitment and retention
of the populations and subpopulations
to be studied, and the plans, arrangements
and letters of commitment from relevant
community groups and organizations for the
planned study.
This section
of the research plan must include the following
information:
Rationale for the Inclusion of Minorities
There are five racial
categories:
American Indian or Alaska Native;
Asian; Black or African American;
Native Hawaiian or Other Pacific Islander; and
White. Reports of data on race and ethnicity
shall use these categories. NIH is required to
use these definitions to allow comparisons to
other federal databases, especially the
census and national health databases. The
following definitions apply for the ethnic and racial categories (OMB
Directive 15).
Ethnic
Categories:
Hispanic or Latino:
A person of
Cuban, Mexican,
Puerto Rican, South or Central American, or
other Spanish culture or origin,
regardless of race. The term, “Spanish
origin,” can be used in addition to “Hispanic or
Latino”.
Not Hispanic
or Latino
Racial
Categories:
American Indian or Alaska Native:
A person having
origins in any of the original peoples of
North, Central, or South America, and
who maintains tribal affiliation or community
attachment.
Asian:
A
person having origins in any of the original
peoples of the Far East, Southeast
Asia, or the Indian subcontinent including, for
example, Cambodia, China, India, Japan,
Korea, Malaysia, Pakistan, the Philippine
Islands, Thailand, and Vietnam.
(Note: Individuals from the
Philippine
Islands have been recorded as Pacific
Islanders in previous data collection strategies.)
Black or
African American:
A person having origins
in any of the black racial groups of
Africa. Terms such as “Haitian” or “Negro” can
be used in addition to “Black or
African American.”
Native
Hawaiian or Other Pacific Islander:
A person
having origins in any of the original
peoples of Hawaii, Guam, Samoa, or
other Pacific Islands.
White:
A
person having origins in any of the original
peoples of Europe, the Middle East, or North
Africa.
Standards for Collecting Data.
When an investigator
is planning data collection items on ethnicity and
race, categories identified above should be
used. The collection of greater detail is encouraged.
However, more detailed items should be
designed in a way that they can be aggregated
into these required categories.
Self-reporting or
self-identification using two separate
questions is the preferred method for collecting
data on ethnicity and race. When ethnicity and
race are collected separately, ethnicity
shall be collected first. Respondents shall be
offered the option of selecting one or more racial
designations. When data on ethnicity and
race are collected separately, provision
shall be made to report the number of respondents in
each racial category who are Hispanic or
Latino. When aggregate data are presented, the
investigator shall provide the number of
respondents who selected only one category, for
each of the five racial categories. If data on
multiple responses are collapsed, at a minimum the
total number of respondents reporting
“more than one race” shall be made available.
Federal agencies shall not present data on
detailed categories if doing so would compromise
data quality or confidentiality standards.
Targeted/Planned Enrollment Table
(pdf
version) or (RTF version - can be
filled in using MS Word)
Provide
the study title
and plans for the total number of subjects
proposed for the study. Also provide the
distribution by ethnic categories and by sex/gender
according to the format in the
Targeted/Planned Enrollment Table. If there is more
than one study, provide a separate table
for each study. List any proposed
racial/ethnic subpopulations below the table. If
the proposed research uses existing data,
then applicants must use the formats for
Competing Continuations, Competing
Supplements and Annual Grant Progress
Reports.
Inclusion Enrollment Report
(pdf version)
or (RTF version - can be filled in using MS Word)
The Inclusion Enrollment Report
contains two parts: part A is for all subjects and
part B is for Hispanics or Latinos. For Part A
provides the distribution of subjects by ethnic and
racial categories and by sex/gender according to the format in the Enrollment
Report Table. Part B should include information on
the race of all Hispanics (or Latinos)
enrolled in Part A. If there is more than one study,
provide a separate table for each study. List
any proposed ethnic/racial subpopulations
as an attachment to the table.
In filling out
the 5/01 Inclusion Enrollment table, the
investigator should not assume or guess a subject's
ethnic or racial affiliation. The investigator
should collect the data using instruments
that, at a minimum, allow all respondents to
select their ethnic and racial affiliation
separately. Under racial affiliation, subjects must
be provided the option of selecting more
than one race. When reporting these data to
NIH, subjects who selected only one of the
five racial categories should be designated in
that category. Subjects who selected more
than one racial category should be reported in
the "More than one race" category. For
previously funded studies that used an
earlier NIH reporting format, the earlier reporting
format is NOT directly transferable to the new
format. Investigators should review the instructions
and frequently asked questions about using
the new format at
http://grants.nih.gov/grants/guide/notice-files/NOTOD-01-053.html
Rationale for the Inclusion/Exclusion of Children
NIH policy
requires that children (i.e., individuals
under the age of 21) must be included in
all human subjects research, conducted or
supported by the NIH see
http://grants.nih.gov/grants/funding/children/children.htm
for additional
information), unless there are
clear and compelling reasons not to include them.
Therefore, proposals for research involving
human subjects must include a description of
plans for including children. If children will
be excluded from the research, the application or
proposal must present an acceptable
justification for the exclusion.
NIH POLICY AND
GUIDELINES ON THE INCLUSION OF CHILDREN AS
PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS
http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Applications that fail to address the Inclusion of Children will be
designated as incomplete and will constitute grounds
for the PHS to return the application without peer review.
In the section
entitled “Inclusion of Children”, the applicant
should provide either a description of the plans
to include children or if children will be excluded
from the research, the application or proposal
must present an acceptable justification
(see below) for the exclusion. If children
are included, the description of the plan should
include a rationale for selecting or excluding a
specific age range of children. When children
are included, the plan also must include a
description of the expertise of the investigative
team for dealing with children at the ages
included, of the appropriateness of the available
facilities to accommodate the children, and the
inclusion of a sufficient number of children to
contribute to a meaningful analysis relative to
the purpose of the study.
Scientific
Review Groups will assess each application as
being “acceptable” or “unacceptable”
with regard to the age appropriate inclusion or
exclusion of children in the research
project.
Justifications for Exclusion of Children
It is expected
that children will be included in all research
involving human subjects unless one or more of the
following exclusionary circumstances
can be fully justified:
1. The
research topic to be studied is not relevant to
children.
2. There are laws or
regulations barring the inclusion of children in the
research.
3. The knowledge being
sought in the research is already
available for children or will be obtained from
another ongoing study, and an additional
study will be redundant. Documentation of
other studies justifying the exclusions
should be provided. NIH program staff
can be contacted for guidance on
this issue if the information is not readily
available.
4. A separate, age-specific
study in children is warranted and preferable.
Examples include:
a. The relative rarity of
the condition in children, as compared to
adults (in that extraordinary effort would
be needed to include children, although
in rare diseases or disorders where
the applicant has made a
particular effort to assemble an adult
population, the same effort would be
expected to assemble a similar child
population with the rare condition); or
b. The number of children is
limited because the majority are
already accessed by a nationwide
pediatric disease research network; or
c. Issues of study design
preclude direct applicability of hypotheses
and/or interventions to both adults
and children (including
different cognitive, developmental, or disease
stages or different age-related
metabolic processes).
While this
situation may represent a justification
for excluding children in some instances, consideration should be
given to taking these differences into
account in the study design and expanding
the hypotheses tested, or the
interventions, to allow children to be
included rather than excluding them; or
5. Insufficient data are
available in adults to judge potential risk in
children (in which case one of the research
objectives could be to obtain sufficient
adult data to make this judgment). While
children usually should not be the initial
group to be involved in research
studies, in some instances, the nature and
seriousness of the illness may warrant
their participation earlier based on careful
risk and benefit analysis; or
6. Study designs aimed at
collecting additional data on
pre-enrolled adult study subjects (e.g., longitudinal
follow-up studies that did not include
data on children); or
7. Other special cases
justified by the investigator and found
acceptable to the review group and the Institute Director.
Definition of a Child
For the purpose of
implementing these guidelines, a child is
defined as an individual under the age of 21 years. The definition of child
described above will pertain to these guidelines
(notwithstanding the FDA definition of a child as
an individual from infancy to 16 years of age,
and varying definitions employed by some
states).
Generally, State laws define
what constitutes a “child,” and such
definitions dictate whether or not a person can legally
consent to participate in a research study.
However, State laws vary, and many do not address when
a child can consent to participate in
research. Federal Regulations (45 CFR 46,
subpart D, Sec.401-409) address DHHS
protections for children who participate in research,
and rely on State definitions of “child” for
consent purposes. Consequently, the children
included in this policy (persons under the
age of 21) may differ in the age at which their
own consent is required and sufficient to
participate in research under State law. For
example, some states consider a person age 18 to
be an adult and therefore one who can
provide consent without parental permission.
Data
Safety and Monitoring Plan
– If you have one in place, please include it
with your summary – if not, please submit your summary without it and
provide the DSMP to the GCRC by June 1, 2002.
Please
note that this format must be followed. It is contained in the NIH
Guidelines for the GCRC Program – Supplement I. To view the details of this
summary, please see the following website:
http://www.ncrr.nih.gov/clinical/crguide2001/guidenov2001.pdf along with
the specific information for the inclusion of women/minorities and children
from the NIH PHS 398 instructions:
http://grants.nih.gov/grants/funding/phs398/phs398.html.
If
you have any questions, please call Susan Stappenbeck at (UT) 7-4629 or (VA)
4703.
