Structure of your proposal

Preliminary Sections

1. Title
2. Abstract
3. Table of contents (optional)
4. Glossary (optional) 

Research Background & Justification

5. The research problem
6. Literature review / Discussion
7. Objective(s), research question or hypothesis
8. Feasible scope / Limitations

Methodology

9. Type of study: detailed methodology
10. Population and sample
11. Data collection
12. Data processing and analysis
13. Pre-test of the methodology

Management

14. Ethical considerations (if appropriate)
15. Potential risks
16. Programme: chronogram and budget

Supplementary Sections

17. References
18. Appendices (optional)

Exciting Title!

Title and abstract will be written at the end. Begin with a “working title” that will be adapted as you redefine your objectives and impact.

The title needs to:

1. Waken the interest of reviewers
2. Be specific to the work to be accomplished (what, where, when)
3. Balance conciseness and explicitness (long enough to distinguish it from other studies in the field, but not too long to bore the reader).

Effective Abstract

The abstract is the first part that the reviewers will read (and maybe the only one!)

It is the initial impression of the request. It is an argument; it should convince the reviewers to take the time to read the entire proposal. It is NOT an introduction, NOT a list, NOT an unsolved mystery.

Often < 250 words. Make every word count! (Look for every word: do you need it? Save words by eliminating passive voice).

Tip: It may contain the same information as the last paragraph of the introduction and the first paragraph of the Justification or rationale.

Remember:

• Never include information that is not presented elsewhere in the proposal
• Do not include a reference citation in abstract
• Make it clear! Read it out loud to someone else that is not so familiar with what we are doing and see if they understand

The research problem

The problem identification is the starting point. It is the recognition of a challenge, need or gap in knowledge.

Can you match this problem with what the funding body is asking for? If yes... Continue with the problem analysis, where a deeper understanding of the question and the problem is developed.

Identify the causes of the problem and associated factors.  The analysis can be based on knowledge, literature review, local or national priorities, or discussion with the team.

Identify the frequency, intensity, and geographical distribution of the problem to show the importance of addressing the problem.

With this, we can construct the problem tree:

1. What the central problem is?
2. What is causing the problem?
3. Which are the consequences or effects of that problem? This will justify why it is important to address the problem.

Problem tree example

Background: literature review

A good and up-to-date literature review is essential to:

• Provide context, justification, and support for your research question
• Understand the extent of the problem
• Identify the causes and factors that influence the problem
• Identify the gap in the current published works

Reading literature in your field allows you to stay on top of your game. If you’re in a field you’re interested in, this should not be too arduous.

The reading must go from the start to the end of the research process. If not, it can happen for example that by the time you publish there will be already a similar article published!

Type of Literature

Steps for the bibliographic search:

1. Define the search question properly: It may not be the research question, it may, for example, be a search for each cause related to the problem
2. What are the keywords for that research question? Identify the main term.
3. Define synonyms for the keywords.
4. Use a search strategy: you can combine the keywords using AND (for keywords), OR (for synonyms), or NOT (e.g. if you want to exclude something, for example, you don't want to include clinical trials/case series articles).
5. Define the language of the search (most of the literature is published in English). In Spanish, for example, the search will be limited, or you will only find abstracts.
6. Save the strategy to re-apply it in the future. Record: date of search, data sources selected, search terms used, limits applied (date, language, age range), search results, numbers of articles you read, how many you evaluated, how many you have included
7. Use Reference Managers. For example, Zotero, JabRef, Mendeley, and EndNote to store the information, organise your bibliographic references, and to be able to share them. They help to make the automatic insertion of citations and the generation of bibliographies in our work documents in different styles easily.

Rationale and Impact:

This section addresses why the proposed work is important in the field and answers the question: “so what?”.

Objective(s) or research question or hypothesis

Then you must set out the objectives:

• The overall objective of a study states what the researchers hope to achieve with the study in general terms.
• They should be closely related to the problem statement. When evaluating the project, objectives are contrasted with results. If the objectives are not clearly stated, the evaluation cannot be done.

Why should we formulate research objectives?
It will help you to:

• Focus on the study (by narrowing it down to its essential points).
• Avoid collecting data that is not strictly necessary to understand and solve the problem you have identified.
• Organise the study into clearly defined parts or phases.

Specific objectives: quantifiable results at a specific time for the project. Concrete measures to respond to the big question.
List your specific objectives as a chronological sequence or logical flow: objective 1/ objective 2/ objective 3. Avoid listing activities that will be included in the methods part.

Keep in mind that not all research projects have hypotheses. Research objectives can be descriptive, methodological (evaluation of a lab technique), differential, or relational (comparing factors that influence x).

To learn more about developing your research question you can access this free training:

https://globalhealthtrainingcentre.tghn.org/research-question/

Feasible scope / Limitations

Explain your limitations – weaknesses and what can be done if something happens. It is better if you mention your limits before, so they know you are being realistic.
You can list them, for example, sequential activities: “if it breaks, then…”, “if social instability in the region, then…”), and “if periodic costs and inflation rate soars”.

Find in this chart the different study methods

1. Quantitative study: Precise and delimited. Focused on variables that are as exact and concrete as possible. Targeted. Based on a review of the literature. They are oriented towards testing theories, hypotheses, and/or explanations, as well as evaluating the effects of some variables on others (correlational and explanatory).
2. Observational study: researchers observe the effect of a risk factor, diagnostic test, treatment, or other intervention without trying to change who is or isn’t exposed to it.
3. Descriptive/exploratory study: Answer to “What happens?”. Allows describing the occurrence of health events in a population in terms of person, time, and place. They do not allow associations to be established; their main advantage is to generate hypotheses for future studies. They require a relationship (e.g. there is more serious falciparum malaria in X compared to X). In their analysis, they calculate ratios a/b, proportions a/a+b, and rates: events/person time of exposure.
4. Case study:  an intensive, systematic investigation about a person, a group of people, or a unit, which is aimed to generalize over several units.
5. Case series report: a collection of patients with common characteristics used to describe some clinical, pathophysiological, or operational aspects of a disease, treatment, or diagnostic procedures
6. Survey: the collection of information from a sample of individuals through their responses to questions
7. Analytical study/ comparative: Answers the question “Why does it happen?” They allow building comparison scenarios, who have/who has not. They intent to prove the hypothesis.
8. Case-control study: a group with an existing condition (“cases”) and a similar group without it (“controls”) will be identified and then compared with respect to exposure or exposures.
9. Cohort study: follow-up of populations with some characteristics in common. They are generally longitudinal over time and prospective but can be followed up retrospectively. To compare what happens to members of the cohort that have been exposed to a particular variable to what happens to the other members who have not been exposed.
10. Cross-sectional/ Transversal study: analyzes data of variables collected at one given point in time across a sample population or a pre-defined subset.
11. Ecological study: The term ecological derives from the frequent use of geographical areas as a basis for defining units of analysis, such as populations or groups of people rather than individuals. In their analysis, correlation coefficients are calculated. They generate hypotheses, and establish relationships but do not necessarily help to determine causes.
12. Experimental study:  researchers introduce an intervention and study the effects.
13. Randomized study: A study design that randomly assigns participants into an experimental group or a control group. As the study is conducted, the only expected difference between the control and experimental groups in a randomized controlled trial (RCT) is the outcome variable being studied. 
14. Nonrandomized study: trials where the investigator controls allocation without randomization. 
15. Field study: A study conducted in a real setting with real practitioners with the aim to understand different aspects of the practice or phenomena that occur. 
16. Community Trial  An Experiment in which the unit of allocation to receive a preventive, therapeutic, or social intervention is an entire community or part of an organization ref: Porta (2014) Dictionary of Epidemiology.
17. Qualitative study: They are based on a literature review, but also on experience, context, and intuition. They are oriented towards learning from the experiences and points of view of individuals, assessing processes, and generating theories based on the participants' perspectives.
18. Grounded theory: inductive, comparative methodology that provides systematic guidelines for gathering, synthesizing, analyzing, and conceptualizing qualitative data for the purpose of theory construction. 
19. Ethnographic study: intended to describe, understand and explain a social system. For example a community, ethnic group, city, marginalized group, or organizational culture.
20. Narrative study: when detailed stories help to understand the problem.
21. A phenomenological study: seeking to understand people's experiences of a phenomenon or multiple perspectives on it.
22. Research/action study: when a community problem needs to be solved and change is sought, and the community participates during the research process 

You can also have multi-method research, which is a combination of single-approach designs, e.g., first an experiment and then a separate survey; or a mixed method which includes concurrent designs, integrative designs, and sequential designs.

From whom will you collect the information?

People, crops, experiments, secondary analysis, vital statistics...

• Population: the entire group that you want to draw conclusions about.
• Sample: the specific group that you will collect data from. The size of the sample is always less than the total size of the population.
• Representative sample: contains all important characteristics of the study population. E.g. if we want to evaluate the quality of care in a hospital and we only ask the patients who are attending the hospital, it is not representative. You would have to ask those who did not return to the hospital anymore as well.

How do you know if you need to take a sample or the whole population?

This depends on these criteria:

1. Budget: one of the biggest constraints is how many resources we have available in money/time and staff.
2. What is the study design? Is it going to be quantitative/qualitative or mixed?
3. How large is the population I will have access to? If it is a population of 300 people, that population is not that large, I would not think of taking a sample. If it is 2 million people, it is necessary to take a sample.
4. What will be the scope of my objectives? Is it to explore, predict, describe, generalize, or compare?

Steps

1. Define your eligible population (who we want to do the study on) according to the inclusion and exclusion criteria. Don’t forget to mention those criteria!
   Inclusion: what are the characteristics that a person must have to enter the study?
   Exclusion: after meeting the inclusion criteria, what are the reasons for excluding a participant?

2. According to the size of the population, you can define the sample size and sampling. If you will choose 200 samples over 4000, how will you select them? We need the sample to resemble the population, so the sample must capture the variability of the population.

Possible sampling biases: To study only the volunteers or the enrolled patients. Accessibility bias.
Remember: A small well-selected (representative) sample is better than a large biased one

Probabilistic or non-probabilistic sample?

Probability sampling is a method that involves randomly selecting a sample or a part of the population that you want to research.
Non-probability sampling uses non-random criteria like the availability, geographical proximity, or expert knowledge of the individuals you want to research in order to answer a research question.

What is the sample intended to measure?

Review objectives and be clear if they are descriptive or comparative.

• Ex 1: to evaluate the adult emergency department of a health institution: descriptive.
• Ex 2: to analyse the competencies of primary care nurses in neonatal care: descriptive.
• Ex 3: identify the factors associated with the implementation and development of a telerehabilitation service: comparative.

Is it just a population or is there a comparison?

• Define parameters to be estimated
• Define the comparison groups

Data Collection

1. Define the data to be collected according to the research question and objectives. Avoid taking unnecessary data, take only data that is useful, feasible, and ethical.
2. Identify the data source:
   • Available information: low cost.
   • Observation: selection, monitoring, and systematic recording of behaviour and characteristics of living beings, objects, or phenomena.
   • Interviews: individual or group interviews.
   • Written questionnaires: mailed or directly applied.
   • Focus group discussions: to explore concepts, insights, and ideas of the group in more depth.
3. Write a detailed account of the methodology you will adopt for the collection of data.

Biases during data collection:

Bias at the collection stage means that the data you have gathered is not representative of the group or activity you want to say something about.
Biases should honestly be reported. You cannot always control for biases; you should say for example that you have standardised to X extent but that Y biases could not be controlled for Z reason. 
Variables are observable or measurable characteristics that are expected to vary from one individual to another (e.g. if we are doing a study on pregnancy, we will not ask patients if they are female, because it is a constant).

What will you do with the data collected?

Make a data processing and analysis plan.

It should include:

• Classification of the data
• Checking for quality control
• Processing
• Analysis: consider the validity (truth value) of the results. Internal and external validity are concepts that reflect whether the results of a study are trustworthy and meaningful. While internal validity relates to how well a study is conducted (its structure), external validity relates to how applicable the findings are to the real world (Citation: https://www.verywellmind.com/internal-and-external-validity-4584479 p/). Precision is also needed and achieved by randomisation, replication, and the control of experimental error.
• Name of the statistician and the suitable software that will be used.

How to determine if the data collection methods are correct before conducting the study?

Doing a:

1. Pre-test: small-scale testing of a particular research component, or a
2. Pilot test: a preliminary study of the entire research procedure, but only with a small sample.

If you have done so, including the results in your proposal makes it much stronger!

Ethical Considerations

Research ethics involves the application of fundamental ethical principles to research activities which include the design and implementation of research, respect towards society and others, the use of resources and research outputs, scientific misconduct, and the regulation of research (Citation: https://www.stir.ac.uk/research/research-ethics-and-integrity/understanding-ethics/)

The proposal must describe the measures that will be undertaken to ensure that the proposed research is carried out in accordance with the declaration of Helsinki. (Citation: https://cioms.ch/wp-content/uploads/2017/12/CIOMS-EthicalGuideline_SP_INTERIOR-FINAL.pdf )

Guidance for the ethical review of a proposal 
(Citation: Emanuel, Wendler, and Grady, “What Makes Clinical Research Ethical” JAMA 2000; 283:2701-11):

1. The social value of the proposal
2. Scientific validity
3. Fair selection of subjects
4. Favourable risk-benefit balance
5. Independent review
6. Informed consent
7. Respect for participants

Potential risks

Personal misbehaviour

1. If a junior scientist makes a poor decision to discard outlying samples from the analysis. Misbehaviour.
2. If a senior professor sends samples to a collaborator to test for influenza and the collaborator tested the samples for antibodies to HIV which was not agreed upon. Misbehaviour.

These would be misbehavior but not a fraud.

Scientific Fraud

1. A senior professor purposefully uses the same data in an engineering publication that was published in a chemistry publication. Fraud.
2. If a young scientist specifically says the samples were negative when the positive control also was negative. Fraud.

Budget

Don’t leave your budget to the last minute!
You need to be as accurate as possible with true expected research costs and, some agencies require multiple signatures for responsible parties to sign off on the budget and their specific contributions to the project.
A well-thought-out financial plan helps to create confidence in the proposal and helps reviewers to determine how the project will be conducted. Give a detailed breakdown of costs.

Advice

1. Separate your budget table by categories and then items
2. Justifying your costs by methods can be a useful approach
3. Identify additional funding sources and outline their contributions
4. Know the restrictions of the funding agency per item
5. Understand the reallocation margin between items -what is ok to modify later and what is not? In the end, you can add clarifications like: currently, this will cost x but maybe we can find it for less, and will need to switch this money from this item to the other.
6. If multiple partners (partners are important and well-seen), include columns by each partner.
7. Include details.

Budget categories (will be according to the agency’s restrictions):

1. Personnel/Staff
2. Capital equipment (vehicles, computers -explain very carefully why you need one, don’t you have one in the institution already? building, etc.-)
3. Supplies (expendable /consumable, consider price variation – add a 10% just in case)
4. Travel (they should be very well justified) and allowances: why this number of trips? Who will be traveling and why these in particular?
5. Communications (mail, national/international legislation)
6. Printing and publishing (including journal publishing costs)
7. Indirect costs (usually between 8-15%), administration support, miscellaneous, etc. Explain as narrative.
8. Third-party services (consultants, equipment maintenance, etc.)

Budget Personnel Justification Example (Download .pdf)

Chronogram/Timeline

A timeline is a graphical representation of the chronological sequence of events, integrating all project activities.
It must be coherent, to demonstrate that all activities are properly linked to the successful completion of the project.

Tips

• Recommended to have it on one page, a picture.
• Take this opportunity to show that you’re familiar with the methods (if you’re familiar with them, you know how long it will take).

Example

References

• A list of references is to be included. Only relevant, no more than 30 in general.
• This section typically is not counted in the page limitation of the research description.
• The references must particularly apply to the text, they must support it.
• The style of the bibliographical item itself depends on the disciplinary field and guidelines.

Appendices

• Occasionally used for cover letters, letters of endorsement (ask for letters with time in advance!), or collaboration, and reprints of relevant articles if they are not available electronically.
• Other uses may be data tables, surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents as allowed by the sponsor.
• Sometimes the financial institution requires ethical approval or a letter that shows that you have submitted to ethical institutions.

You can include a Biographical Sketch/CV

• It is a one to three-paragraphs description of your professional identity that shows you are competent.
• It includes the research team’s education, professional positions, publications, work record, and the most valuable publications.
• It is an opportunity to highlight your expertise and experience related to the proposed work, mention the professional community to which you belong, and briefly describe the steps you have taken to join that community.