What does the University of Kerala ethics committee want to see in your analysis plan?
The University of Kerala runs a University Level Ethics Committee on Research Involving Human Subjects (ULECRIHS). Its standard operating procedures say it reviews proposals from university departments and affiliated colleges, socio-behavioural studies included. They also say it has applied for registration with the National Ethics Committee Registry (application EC/NEW/INST/2022/2586). Its submission checklist lays down the proposal format. Several of its headings are statistical decisions in disguise.
| Item in the ULECRIHS research proposal format | What it means for the analysis |
|---|---|
| Study design and setting; study population | The design you name decides which tests are legitimate later |
| Inclusion and exclusion criteria, sample size | The committee sees your sample size before any data exist, so it needs a basis you can explain |
| Sampling method and study duration | Probability or non-probability sampling limits how far results can be generalised |
| Study variables: exposure and outcome | Your independent and dependent variables, fixed in writing |
| Study tools and techniques, in English and Malayalam | The questionnaire in both languages, which then needs its own reliability check |
| Plan of analysis and statistical tests | The tests you promise here are the ones examiners expect to see in the results chapter |
| Participant information sheet and informed consent, in English and Malayalam | Whatever the consent says about anonymity binds how you store and share the data file |
The practical rules around it matter as much. The proposal goes in with a certificate from your Doctoral Committee. Your supervisor and the Committee’s chairman sign it. The fee is ₹1,050. Protocols must reach every member at least 10 days before the meeting. References follow Vancouver or another approved style. You also sign a declaration with three promises. You won’t start the research until clearance comes. You won’t deviate from the approved protocol. And you’ll seek the committee’s written approval for any change.
That last promise is where analysis plans go wrong. Say you told the committee you’d run a chi-square test and a logistic regression. Then you collect data that only support something else. You are now changing the protocol. So settle the design, the sample size and the choice of tests before submitting, not after the data come in. The members listed in the SOP include clinicians and a legal expert. There are social scientists from Sociology and Philosophy alongside the scientists. Write the plan in plain language.
How do SCTIMST’s ethics committee and thesis guidelines shape a health-science analysis chapter?
SCTIMST’s Institutional Ethics Committee FAQ draws the line for “research” low. A study needs IEC approval if participants are randomised, if you plan to generalise the findings, or if you take data from three or more subjects. Retrospective use of clinical records or leftover tissue needs approval. So does an interview-based study with no intervention. There, the committee reviews the consent process and the questionnaire before you begin. Student projects are not exempt. The Technical Advisory Committee reviews the science first. But a study can’t start on TAC approval alone. If the start is delayed by more than a year after approval, you may need a fresh one.
The FAQ is specific about consent forms. They should be simple enough for someone who left primary school. The English and Malayalam versions carry the same substance, and a literal translation is not expected. The FAQ also warns that IEC members are not specialists in your topic. Write the application simply.
The institute’s thesis guidelines then govern how results appear:
- Material and Methods must describe the statistical analysis and the tests performed.
- Results report observations with statistics, tables and graphs. They must mention negative results as well as positive ones.
- The same data shouldn’t appear as both a graph and a table. The text shouldn’t repeat every value a table already gives.
- Use SI units throughout. Table titles go above tables, and figure captions go below figures.
- In tables, numbers are right-aligned with consistent decimal places and text is left-aligned. Rules appear only under the header rows, and headers repeat on every page of a long table.
Default SPSS output breaks most of those table rules. Plan to rebuild every table rather than paste it.
Where do biostatistics and research methodology enter KUHS, KTU and Kerala University PhDs?
KUHS. The KUHS PhD regulations put statistics at almost every gate. The entrance examination is multiple choice, with about 60 marks on research methodology and aptitude, 20 on biostatistics and 20 on research ethics. One Doctoral Committee member comes from outside your department. That member is to be a specialist in the related field, in research methodology or in biostatistics (clause 7.3). At the end of the first year, Paper I of the qualifying examination covers research methodology and academic writing, biostatistics, social science and research ethics. Next comes your protocol. The Doctoral Committee and your centre’s Institutional Ethics Committee clear it first. Then it goes before a three-member Protocol/Methodology Approval Committee, which includes an expert in research methodology, biostatistics or social science. Biostatisticians are also among those invited to the pre-submission seminar. At one of the city’s medical colleges, your analysis will be questioned more than once before the thesis is written.
KTU. Clause 13.2 of the 2023 regulations asks for a research proposal within two years of registration. It needs a conceptual model or hypothesis, specific objectives, detailed methodology and a year-wise time chart. Research methodology is a compulsory course unless your qualifying degree included it. KTU’s 2025–26 entrance syllabus lists statistical tools, design of experiments, hypothesis testing, and correlation and regression under research methodology. Management scholars at KTU centres often end up with survey data and structural equation models. If that’s you, name the method in the proposal.
University of Kerala. Coursework under the PhD Regulations 2022 carries 14 credits. That includes a research methodology course and Research and Publication Ethics. The Department Doctoral Committee is charged with guiding your study design and methodology. The March 2024 coursework notification sets four papers: Research Methodology, Research and Publication Ethics and two in your area. M.Phil. holders are exempt from the methodology paper. You get two chances, the first after six months. Our coursework and RPE guide covers the national picture. For the city’s social-science options, see our social sciences in Thiruvananthapuram guide.
At RGCB, the Institute Human Ethics Committee publishes separate forms for initial, expedited and exemption review. Check which one fits your study before you draft the analysis section. Our general guide to ethics approval explains the categories.
Working with us from Trivandrum
We start with a video call on your objectives, design and data. You send the dataset along with the instrument or codebook. Where you are in the approval process decides the order of work:
- Before ethics review. This covers a Kerala University ULECRIHS submission, an SCTIMST TAC and IEC application or a KUHS protocol presentation. We help you write the sample size justification and the plan of analysis in plain terms. That way, the tests you promise are ones your data can support. Translating the questionnaire and consent forms into Malayalam stays with you. We check that the English version you translate from is final. We also plan a reliability check for the Malayalam instrument.
- After data collection. We run and explain the analysis and keep a log of every recode. You get the SPSS syntax, R script or AMOS or SmartPLS model file. Has the analysis drifted from the approved plan? We point it out, so you can take it back to your committee before the thesis, not after.
- Writing up. For SCTIMST scholars we rebuild tables to the institute’s layout. For KUHS scholars we prepare you for the biostatistics questions that come at the methodology committee and the pre-submission seminar.
The walk-through session at the end is by video call, with your own output on screen, so you can explain every number at the viva.
Scope, stages, quality checks, timelines and pricing are the same wherever you are: Statistical Analysis (SPSS, R, AMOS, SmartPLS).
Sources
- University of Kerala, ULECRIHS checklist for submission of research protocols, with the proposal format and fee (PDF)
- University of Kerala, University Level Ethics Committee standard operating procedures (PDF)
- University of Kerala, Regulations for Award of Ph.D. Degree, 2022, clauses 9 and 10 (scanned PDF)
- University of Kerala, Ph.D. coursework examination notification, No. CSS/C/1/2113/2024, 2 March 2024 (PDF)
- SCTIMST, Institutional Ethics Committee frequently asked questions (PDF)
- SCTIMST, Guidelines for PhD thesis preparation and submission: methods, results and table layout (PDF)
- Kerala University of Health Sciences, PhD regulations, Kerala Gazette of 22 October 2021, clauses 6, 7, 9 and 11 (PDF)
- KTU, Regulations for the award of the Degree of Doctor of Philosophy, 2023, clauses 10 and 13 (PDF)
- KTU, PhD admission notification 2025–26 with the entrance syllabus (PDF)
- Rajiv Gandhi Centre for Biotechnology, Institute Human Ethics Committee page
FAQ
Questions scholars in Trivandrum ask
Do I need ethics clearance for an online survey at the University of Kerala?
If it involves human participants, the University Level Ethics Committee reviews it, social and behavioural studies included. Your Doctoral Committee will tell you whether to apply. The proposal must include the sample size and a plan of analysis. So the statistical design comes first.
My questionnaire is in Malayalam. Does that change the analysis?
It adds a step. The committee wants study tools in English and Malayalam. But the Malayalam version is the one your respondents actually answer. So check and report its reliability, for example Cronbach’s alpha for each scale. Our questionnaire design guide covers the translation checks.
I am at SCTIMST and my study is a chart review of 40 patients. Is IEC approval really needed?
According to the SCTIMST IEC FAQ, yes. Research on clinical records needs approval even when it is retrospective, and taking data from three or more subjects already counts as research.
Can you collect or fill in survey responses to reach my sample size?
No. Collecting the data is yours, and filling in responses would be fabrication. We can help you design the instrument, plan the sample and prepare the data you collect. Our ethics policy explains the line.
SPSS or R for a KUHS or SCTIMST thesis?
Whichever your guide and the biostatistics expert on your committee can follow. Standard tests give the same answers in both. We can work in either and hand over the files for both if you want them.

