Writing Research Proposals
Margarita Alegria, Professor Harvard
Medical School,
Cambridge Health Alliance
Academy Health
June 4, 2007
I. Overviews of research branches and support
mechanism
II. Formulations of research problem
A. Good idea of research priorities of funding
institute
1. Concepts paper, pre-proposal
B. Get acquainted with literature review
C. Contact with researchers in the area
III. Thinking about theory/concept: development of a
theoretical/conceptual framework and rationale for
research proposal
IV. Selecting critical issues
A. Narrowing the topic
B. Selecting the target population
C. Aims and preliminary studies
Databases with NIH Information
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CRISP (Computer retrieval of information on
Scientific Projects)
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Contains information on research projects and
programs funded by DHHS including NIH, CDC,
FDC, HRSA and AHRQ
Useful for identifying the appropriate institute
to fund a grant, the best study section to
review it, and the most appropriate funding
mechanism.
NIH Guide for Grants and Contracts
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contains weekly announcements detailing
extramural funding programs and policies of
the NIH and other public service entities.
Do Some Homework
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According to studies, as many as 80% of all applications
are misdirected or inappropriate.
Become familiar with a source before applying. If a phone
number or email address is provided, call and discuss
whether your work matches their interests.
The Foundation Center is a major publisher of non-federal
funding opportunities and has current and historical
information on every foundation in the U.S.
Review Criteria
I.
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B.
C.
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E.
F.
G.
H.
Scientific significance of idea
Originality/Innovation
Rigor of design and
methodology
Data analysis strategy
Human subjects
Research environment
Investigative team
Budget
Review Criteria and rating of unsolicited
research grant and other publications
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Significance
 Does this study address an important problem?
 How will scientific knowledge be advanced and what effect
will the study have on the concepts or methods that drive
this field? More and more seen in applied terms
Approach:
 Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and
appropriate to project aims?
 Does the applicant acknowledge potential problem areas
and consider alternative tactics?
Innovation:
 Is the project original, employing novel concepts,
approaches or methods?
 Does the project challenge existing paradigms or develop
new methodologies or technologies?
Developing the Research Question
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Statement of the problem
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What do you want to do?
What questions are you asking in the research?
What are your goals?
State your objectives clearly. Be specific and
concrete (use measurable concepts).
State your objectives in declarative form.
List your objectives in order of priority or as
building blocks and follow this order
throughout proposal (i.e., use parallel
structure).
Example of Specific Aims of R01
The central aims of NLAAS are:
1. To estimate the lifetime and 12-month
prevalence of psychiatric disorders and the
rates of mental health services use for
Latino and Asian American populations,
adjusting for age and gender effects using
nationwide representative samples of
Latinos and Asian Americans.
2. To estimate the relation of social position,
environmental context, and psychosocial
factors with the prevalence of psychiatric
disorders and utilization rates of mental
health services in nationwide
representative samples of Latinos and
Asian Americans.
Example of the Research Problem
Project Objectives: We will compare the cost,
sustainability and effectiveness of 3 innovative
strategies to improve the treatment of depression
in primary care. The three strategies are: 1)
financial incentives for providers; 2) a program
designed to help patients communicate more
effectively with their physicians regarding their
depression; 3) the use of volunteer aides who act
as peer support counselors and advocates with
the care team .
Significance of Research Problem
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Why are your questions and answers
important?
Theoretical significance: contribution to
basic knowledge
Methodological significance: new
methods will be developed or old methods
adapted
Applied significance: solution of a specific
real-world problem
Social significance: benefits to society at
large
Example of Significance of Research Problem
Considerable evidence exists in the clinical research
literature supporting the view that Attention-Deficit
/Hyperactivity Disorder (ADHD) is a disabling disorder that
affects individuals across the lifespan (Barkley, 2003).
However, it is not clear whether the correlates,
comorbidity, and impairment of the disorder in probability
treatment referral samples are similar to those identified
in probability community samples. These variables have
not been systematically compared in the two populations
using the same methods. This comparison is important
since findings from convenience or probability treatment
samples can be consonant with clinician’s experience but
biased and unrepresentative of the general population
with the disorder. This discrepancy was coined by Cohen
and Cohen (1984) as “the clinician’s illusion” i.e., the
attribution of the characteristics of patients with a disorder
identified through clinical experience (one could also add,
through non probabilistic treatment samples) to the entire
population with the disorder.
Review of Relevant Literature
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How have these questions been
answered before? [Have the questions
been asked? Have related questions
been asked (e.g., with different
populations)? What answers have been
obtained?
What are the limitations of past
research?
How will you build on past strengths
while overcoming limitations? Why is
your research worthwhile and necessary?
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Your review of previous research
should be critical and evaluative
synthesizing rather than
comprehensive. Show that you know
the past research so well that you can
summarize its major themes, findings,
strengths, and weaknesses.
Maintain parallel structure in this
section. Discuss the literature relevant
to your first aim/question (and
hypothesis) first, then discuss the
literature for your second
aim/question, and so on.
Hypothesis
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What answers are you proposing for the
research question?
A hypothesis describes a relationship
between two or more variables.
In your hypotheses, the variables must
be identifiable conceptually and capable
of empirical observation.
Similarly, the relationship among the
variables (and changes in those
relationships) must be identifiable
conceptually and operationalizable.
Your hypotheses must be testable.
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Order your hypotheses to correspond to
your already-stated research questions.
Develop alternative hypotheses whenever
possible. In predicting a particular
relationship between variables (or
explanation for a particular variable),
consider alternative explanations and test
for them in your research. Anticipate
alternative explanations for your expected
results and devise additional tests to falsify
those competing hypotheses.
Conceptual Framework
Background factors
Age
SES
Marital Status
Employment
Education
T1 Stress
Individual
Psychological distress
Physical illness
Attitudes towards
deviance
History of conduct
problems
Social
Family/Friends attitudes
and modeling of drugs
Role/Life stressors
Perceived educational
and job opportunities
Childhood victimization
Cultural
Neighborhood norms and
trends
Family affiliative values
T2 Mediators
T2 Outcomes
T2 Mediator
T2 Mediator
Social support
Family support
Friend support
Institutional Support
Human service
programs
Drug treatment
Incarceration
Drug Use
Use/No use
Severity
Frequency
T3 Outcomes
Problem behaviors
Criminal behavior
Property crimes
Drug dealing
Prostitution
High Risk Sexual Activity
Condom Use
Number of partners
Marital Violence
Health Outcomes
HIV/STDs
Functional Impairment
Hypotheses of Remission From Drug Dependence Symptoms and
Drug Use Cessation
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Overall, low socioeconomic
status, comorbid
psychiatric conditions, and
lack of family and social
supports are consistent
markers of noncompliance with
treatment, and relapse
following treatment
completion (Daley & Marlatt
1992).
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For women in particular,
symptoms of depression
are believed to play an
important role in
persistence of substance
abuse (Galaif, Nyamathi, & Stein,
1999; Wang, Collins, DiClemente,
Wingood, & Kohler, 1997; Zuckerman,
Amaro, Bauchner, & Cabral, 1989).
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Relationships with drug
using partners are
strongly associated with
relapse of drug use (Tuten &
Jones 2003) and post-treatment drug
use continuation (Amaro & HardyFanta 1995; Grella, Scott, Foss, Joshi,
& Hser, 2003).
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Moreover, childhood
experience of sexual
abuse is a significant
predictor of drug use
disorder, as well as a risk
factor for unsuccessful
treatment and eventual
relapse (Snow & Anderson 2000).
Study Design
1.
2.
3.
Are the design and measurement strategies
the best ones for testing the hypotheses in
terms of sensitivity to processes under study,
experimental control, and statistical power?
Are independent and depend variables and
covariates clearly specified?
Has any preliminary (pilot) work been carried
out to help document feasibility of recruitment
and methods, and the validity of the
measures?
Is sample adequately described? Is sample
representative of population or subpopulations
of interest? Has subject attrition been
considered? Are criteria for inclusion/exclusion
clear and complete?
4.
5.
6.
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8.
Are the manipulations of independent
variables potent enough to result in
changes in outcome (dependent) variables?
If some of measures are based on selfreport, are there other measures that
would help to establish their external
validity?
Have all possible confounds been
considered, such that the results will test
the effects of the manipulation or process
of interest?
Is the study replicable in terms of sampling
strategies and measurement methods?
Are results likely to be generalizable, and
what conclusions will be drawn?
9. Have the investigators considered
limitations and potential problems, and do
they indicate how they will deal with these
problems? Have sources of bias been
considered (testers blind to group
placement, recall response bias)? If testing
is repeated, are measures susceptible to
practice effects or reactivity?
10. Does the proposal reflect a process of
“thinking through” the issues under
investigation from the available research
literature to the testable hypotheses,
operational measurement, expected
results, and interpretation of alternative
findings?
Study Design of Inner City Latina Drug
Use Study (ICLDUS)
Three-wave longitudinal research project to study drug use
patterns and correlates among low-income inner city
Latina women, ages 18 to 35. Women were interviewed at
baseline (Wave I) and at two follow-ups (Wave II and III)
with an average of fourteen months between data
collection periods. Two groups of women were studied: a
sample of 275 crack/cocaine or heroin drug-using women
and a sample of 443 community women living in the same
neighborhoods, extended metro San Juan area.
Two groups of women were recruited for the study:
cocaine/crack and injecting drug users from drug copping
areas (e.g., crack houses or shooting galleries where
drugs are sold), and non-drug users who lived within a
one-mile radius of the copping areas.
Study Design-Continuation
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ICLDUS survey instrument was administered in 1996-1997
to a sample of 718 women, for a response rate of 81.4%.
The first follow up was conducted with a total of 696
women between July 1998 and June of 1999. A total of
681 women were re-interviewed for the second follow up
during July of 1999 through November of 2000.
Respondents who remained in the study for the three
waves as compared to those who dropped out from Wave
I to Wave II (n=54) or from Wave II to Wave III (n=29)
were more likely to be from the copping sample, older
(30-38 years of age), returned migrants to the island,
self-reported drug users, HIV positive, and women
practicing sex work.
Outcome Measures
Last year arrest -established by asking respondent if they
had been arrested (yes=1) within last 12 months.
Practicing sex work by query asking if respondent had
engage in any sexual practices in last 12 months in
exchange for money, drugs or other personal favors; (1)
if yes, 0 if otherwise.
An item asked if they had committed any suicide attempt
in the last year, which was coded 1 for those who said
yes, 0 if otherwise.
Intimate partner violence- recount of times, during the
last 12 months, their partner/spouse responded to
domestic conflict through inflicting physical of
psychological harm using the Conflict Tactic Scale (Straus
1990a; Straus 1990b).
Death was assessed by reports of death of the respondent
and later confirmed with death certificate or by
testimony of family and friends.
Study Design of System Cost
Effectiveness and Managed Care
The objective of study is to evaluate the cost
effectiveness of managed care as compared to
public health system care on the treatment of
depression. Tracking depression Tx allows us
to assess system effects in the distribution of
resources to untreated, ineffectively treated
and effectively treated cases proportional to
costs. Is managed care able to provide more
effective depression Tx for the same costs as
the public health system?
Definition of Appropriate Treatment
• No Treatment:
Persons who did not receive any formal mental health
treatment (no visits w/in a 12 month period to mental
or general health provider to discuss mh problem).
• Not Effective Treatment:
Persons who received minimal counseling (less than 4
visits) or those without antidepressant medication, or
those that report no visits but do report receiving
antidepressants under no medical supervision.
• Effective Treatment:
Persons who received effective counseling (4+) with
no effective medication or received minimal or
effective counseling (1-3 visits) and antidepressants.
V. Ten (10) hints
A. Read instructions
B. Follow page limitations – make use of appendices
C. Use as an example another successful proposal in
the area of interest
D. Develop a team – if you do not have experts, get
consultants
E. Don’t assume reviewers will know – be very
specific (if no pilot data, you are in trouble)
F. Clear concise writing style
a. Keep together related ideas
b. Shorten long sentences
c. Eliminate redundant ideas
G. Allow time for thorough editing – send your
proposal to experts (try to get critical input upfront rather
than back end)-Do not submit a proposal for consultation
H. Include potential pitfalls and limitations
I. Contact member of program review for advice
J. The situation for new applicants is difficult, but not
impossible
VI. Fatal mistakes in grant writing
A. Let’s get a grant to pay for treatment or services
B. Signing up for the wrong race (do what you do
best)
C. Trust me - I’m an expert (skipping the details or
concrete information)
D. Ignoring the pink sheet
E. I’m going to develop ….
F. Excuses – explaining why the study can’t be done
the right way
G. Not re-submitting
H. Being out of sync w the field-only found through
networking (eg. one more study in depression in
primary care)