Should We Pilot Our Protocols Before Submitting Them?

This year, thanks to the changing of the system of the counseling process, there was a lot of delay in the starting of the post-graduation courses in general. In some cases, the residents joined in as late as July! Keeping this in mind, and the Delhi University rules, we really had to hurtle through the whole process of writing and submitting our theses. Now, whether the dates should have been pushed back and an exception made this year is a matter for an entirely different debate, but the truth remains that there was a lot of uncertainty and dithering in the minds of the residents prior to submission of their theses protocols. Which brings me to the next point of contention: should we have to pilot our studies before submitting the protocol?

Keeping in mind that the protocol is pretty much set in stone once it gets submitted and presented before the college authorities, I believe, in many ways, the protocol is of more importance than is accorded to it. It’s not like we can amend it every time we hit a hurdle. With some topics, especially with the ones from the socio-medical branches, it can be quite difficult to anticipate the possible hurdles, even by hardened researchers, and as newbie researchers, it is difficult for us to envision all the problems that we might possibly face in the process of executing our theses work. The best possible way to deal with this is when we do a short piloting of the study. This may be less important for the laboratory-based disciplines, like Pathology, Biochemistry, etc., but they do carry a significant amount of importance for the ones involved in clinical or community-based studies.

So, naturally, the question arises: should we be given the time and/or option to pilot our studies? And if so, then how do we frame the rules and guidelines to ensure that the student is not just abusing the longer time period given to him for developing a pilot study? As a resident struggling with a topic dealing with a marginalized population, shortage of time (owing to a prolonged leave due to poor health), multiple ethical, methodological and statistical complications, all I can say is that I would probably have been able to submit a more well-rounded protocol had I been able to pilot my protocol.

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About Pranab Chatterjee

Skeptic Oslerphile, Scientist at the Indian Council of Medical Research, National Institute of Cholera and Enteric Diseases. Opinions own. Interests include: Emerging Infections, Public Health, Antimicrobial Resistance, One Health and Zoonoses, Diarrheal Diseases, Medical Education, Medical History, Open Access, Healthcare Social Media and Health2.0. Opinions are my own! Also at: http://infectionscapes.wordpress.com

2 thoughts on “Should We Pilot Our Protocols Before Submitting Them?

  1. Restless Wanderer

    I have this same problem with my undergraduate level research project. When I started going out to the wards for filling the pre planned questionnaire, I found that the facts that were being elicited from the patients might be of importance in the data collection but had no clause as such in the questionnaire. So I went on adding those questions to the proforma and showed them to my guide and he was pretty happy with the additions. But if this is the case with the Protocol, then I guess its not possible to change what has been already approved. In view of this I second your idea, that a short term, maybe one month piloting can be done for all projects to check the feasibility of operations and the actual scenario that the researcher is going to face in the population.

    Reply

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