Under CPSP’s new policy, all FCPS trainees must publish a research paper before their final exam. This seems great and easy in theory. The trainee selects a topic, drafts a synopsis with their supervisor and then submits it, but in reality, it’s a different story. The trainee is not answering to one body. They are answering three bodies. And they don’t always talk to each other. The first is the College of Physicians and Surgeons of Pakistan (CPSP). Here, the trainee gets the synopsis approved. CPSP has its own format, time frame, and methodology review committee. This can take months, and in some cases, years. While the CPSP is reviewing the same synopsis that was submitted to the second door, the hospital’s Ethical Review Committee or Institutional Review Board (IRB). The IRB has its own format, forms, and reviewers. Both committees are reading the same synopsis. Both come back with different opinions. This is where the trouble begins. CPSP may approve a sample of 200. The hospital IRB may want it set at 350, or may find the inclusion criteria too restrictive. CPSP may accept a non-probability convenience sample. The IRB may say it should be random, or vice versa. CPSP may approve a study as a descriptive case series, but the hospital IRB wants to label it as a prospective cohort study. The trainee is caught in the crossfire. Any change one body demands could be incompatible with the other’s approval. Every revision requires a new application, a new wait and a delay to data collection. Overseas evidence suggests this is not a new issue. Driscoll et al., reported that 15 of the 27 IRBs audited in Australia required a full review when national guidelines did not, and 12 of the 15 used different application forms, resulting in a 6- to 8-month delay in starting the study.1
Time is always ticking on for the trainee. FCPS training is time-bound. Clinical work never stops. The resident on a 24-hour call who returns to the wards in the morning and then sits at night to write the synopsis for the third time understands this. A survey of otolaryngology residents worldwide found the three most common barriers to research were lack of time, lack of funding, and lack of research training, and this was the case in both high- and low-income countries.2 A study of surgery and anaesthesia residents in Uganda found that 64% felt the dissertation was a financial burden and that lack of protected research time was a major challenge.3 In Pakistan, the situation is the same, except for one additional factor: the triple approval process. After a few months, once both approvals are obtained, the trainee begins data collection. Months pass. The paper is written. Enter the third door, the journal. And the cycle continues. A peer reviewer may want to know why a particular cut-off was used and request that it be changed. A statistical reviewer may want a different statistical test, a sensitivity analysis or a subgroup analysis that was not in the original protocol. The reviewer may want variables that were not included in the CPSP synopsis or the IRB-approved protocol. The trainee cannot return to collect them. The protocol is closed. The data set is final. Asking the journal for a waiver is often a no. It is not possible to start again.
This is the silent injury of the system. The trainee is not failing because the science is poor. The trainee is failing because three separate bodies, each acting in good faith, have failed to agree on a common standard. It is made worse by a lack of mentorship. A narrative review of 49 studies on training in physician-researchers found that mentoring and institutional support are the factors that translate interest into output, and a fragmented research environment is one of the reasons for the lack of evidence-based practice.4 In Pakistan, supervisors have heavy clinical commitments. They may not be able to give proper time to each trainee’s research project. The trainee has to find his own way through CPSP, the IRB and the journal, and figure things out as he goes. Occasionally, institutions have developed programs. CPSP conducts only a 3-day research workshop once, but that is not sufficient for full learning and experience. A radiation oncology triad mentorship between Toronto and African residency programmes involved a year-long mentorship and a research seminar that improved both research and trainee experience in low-resource settings.5 There is no such program in Pakistan that offers a year-long mentorship to trainees, which could help them every step.
What can be done? The fixes are not technical. They are administrative. CPSP and the major hospital IRBs must get together to agree on a common synopsis form. One submission. One review window. One set of comments. If one regulator has signed off on a point in the methodology, the other should sign off unless there is a safety or ethical issue. Journals that publish FCPS-related research should recognise that the methodology was agreed upon at the synopsis stage and reviewed by two regulators. Any requests beyond what was approved should be considered an exception. If additional analyses are needed, they should be considered study limitations. These steps can help end the ping-pong. Mentorship is the responsibility of training institutions. No trainee should be working on a synopsis alone at midnight following a 30-hour shift. Half-days for research, workshops on research methodology, and a research supervisor for each paper are essential. They are not luxuries but are necessities. There’s a reason for the research requirement: to ensure doctors who can read, carry out, and believe in research. At present, the country is producing doctors who complete research papers solely to meet degree requirements and may never want to publish or learn the process again. And it is a loss that the nation cannot afford. Students working on papers are also the doctors on the ward, in the labour room and in the theatre. The price of the current model is in their sleep, morale and confidence in academic medicine. The solution isn’t to compromise quality. It’s about agreeing on one standard. Three doors. One key. It should be that simple.
References
- Driscoll A, Currey J, Worrall-Carter L, Stewart S. Ethical dilemmas of a large national multi-centre study in Australia: time for some consistency. J Clin Nurs. 2008;17(16):2212–20. https://doi.org/10.1111/j.1365-2702.2007.02219.x
- Fournier I, Stephenson K, Fakhry N, Jia H, Sampathkumar R, Lechien JR, et al. Barriers to research among residents in Otolaryngology-Head & Neck Surgery around the world. Eur Ann Otorhinolaryngol Head Neck Dis. 2019;136(Suppl 3):S3–7.
- Elobu AE, Kintu A, Galukande M, Kaggwa S, Mijjumbi C, Tindimwebwa J, et al. Research in surgery and anesthesia: challenges for post-graduate trainees in Uganda. Educ Health (Abingdon). 2015;28(1):11–5. https://doi.org/10.4103/1357-6283.161826
- Mokhtari B, Badalzadeh R, Ghaffarifar S. The next generation of physician-researchers: undergraduate medical students’ and residents’ attitudes, challenges, and approaches towards addressing them. BMC Med Educ. 2024;24(1):1313. https://doi.org/10.1186/s12909-024-06166-8
- Wong RK, Vanderpuye V, Yarne J, et al. Clinical research mentorship programme (CRMP) for radiation oncology residents in Africa-building capacity through mentoring. Ecancermedicalscience. 2021;15:1210. https://doi.org/10.3332/ecancer.2021.1210