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Preparation of a research project

The purpose of writing a research project (PI) is to communicate to the competent authority or any public or private institution the contents and organization of a scientific activity for its ethical review, its administrative record, the evaluation by peers or to request financing aids. It usually constitutes the initial part of any investigation and must offer a panoramic vision of the work that is wanted to realize, of its justification and organization, of the plan of execution and of the forecast of costs, allowing a fast analysis and an evaluation of its main aspects.

A PI is not a protocol, although the protocol on which the different steps of the investigation are carried out must appear as clearly as possible among its contents. The protocol is the technical detail of the procedure to perform the investigation: the how; and its main objective is the reproduction of the research. On the other hand, the PI must also explain what is to be investigated and why, for what and by whom; it is the protocol plus its context. A PI is also not a summary or a synopsis of what you intend to do.

Knowing your general organization is mandatory for all clinical pediatricians who think about doing research, although it will be helpful for all those who, without having a direct dedication to this activity, aspire to practice medicine as close as possible to the original sources of information.

Together with the sections referring to the research activity that is proposed, the PI usually includes a summary such as Curriculum Vitae (CV) of the professional career of the team members who endorse their capacity and suitability, especially their leader or principal investigator.

Organization of the document

Any PI will enter an evaluation circuit in which the breach of the main premises of the call and the formality required therein may lead to its penalty or be sufficient for its rejection, sometimes from the same secretariat of the convening institution and without reaching the evaluators. In fact, in the most prestigious calls a high percentage of the projects are returned to their authors without being evaluated. Therefore, the first step will be a careful reading of your demands and recommendations. For the same reason, if there is a predefined format we must stick to it, completing each of its sections according to the proposed standards.

When writing your presentation, it must also be taken into account that each call has a “profile”, and that we must promote those aspects that most identify our interests with those of the convening institution. For example, the experience or experience of the group may be an exclusion criterion, since many calls are aimed at creating new groups and encouraging new researchers. It is also important to know that the evaluation process has an organization -in general common to all the calls-, from the reception and allocation of the projects to the awarding and communication of the grants. The time of this review is variable, but almost always less than 3 or 4 weeks.

In the regional calls and private medical societies there is usually no limitation in the number of pages or in the format, although the minimum sections are usually established. If it is not defined, the adequate extension will be that which allows to present all its sections in a sufficient way, without its reading becoming heavy and without the reviewer being able to miss some basic information. To give a reference, in the number of pages this could be put -for a clinical study- in no less than 5 and no more than 20. Sometimes there are limitations; thus the FIS (Sanitary Research Fund) admits a maximum of 3 pages for both the background and the methodology. These pages must be numbered, and apart from the cover, an index with the main sections can be included, which will not only facilitate reading but also transmit an image of order and neatness about our work.

The PI should have the following basic components: cover, title, summary, background and current status of the topic, justification of the project, objectives and working hypotheses, methodological framework, ethical aspects, group experience, budget, bibliographic references and annexes.

On the cover, next to the title, the date and place (institution) of completion must be included, as well as the identification of the researchers. The first question that arises here is that of defining the principal investigator. Sometimes it is interesting that this has a certain profile: within the group you can choose the one that best meets the requirements of the call, which will not always be the one with more research experience (calls for new researchers or MIR). The principal investigator is, in general, the person who contributes the most to the development of the research, who is in charge of communicating with the convening institution and modifying the manuscript in response to the comments of the arbitrators. The other researchers (secondary or collaborators) are placed in order according to the importance of their contribution, alphabetically, or randomly: it does not have to be clinical, not even medical (they can be statisticians, epidemiologists, pharmacists, nurses …). Sometimes it is not a minor issue to decide who is the principal investigator, since it must be recognized and accepted as such by the rest of the group. The rest of the people who participate in the realization, some of great importance, as the technical advisors have to be considered part of the group but are not strictly part of the research team; they do not sign the communications, but they can – and should – be cited in the acknowledgments. All researchers must approve their inclusion, the order of their names on the cover and the content of the final manuscript. Some institutions allow or recommend including academic titles (eg, Dr, MD, Ph.D, etc.) before or after the names of the authors, but most IPs do not include them; in case of not being sued they should not appear.

IPs usually have a mentor – a senior researcher with a recognized scientific background – whose function is a reference, and which can be external (that is, not included in the project) or appear as one of the collaborators. Their work is of support and encouragement (moral, economic, from sources of information), receiving as a reward: first – and for the honest researcher the main one – the success of the study; and, in addition, having the information first hand and being a partner in communications and publications.