Postgraduate Diploma in Experimental Protocols and Research Ethics
Online 800-hour Postgraduate Diploma in Experimental Protocols and Research Ethics. 8 modules with the Declaration of Helsinki (WMA), Law 14/2007 on Biomedical Research and R. Assigned tutor and open enrolment.
Postgraduate Diploma in Experimental Protocols and Research Ethics — studying from Ireland
Ireland is a significant centre for medical technology and pharmaceuticals, with many international device manufacturers and a strong cluster of biomedical research in Galway, Limerick and Dublin. Biomechanics, wearable sensing and occupational health technologies are developed by companies, hospitals and research institutes such as the National University of Ireland Galway's research groups. Engineers in this area design medical devices, rehabilitation systems and safety monitoring solutions under strict regulatory requirements. Oversight comes from the Health Products Regulatory Authority and the Health and Safety Authority.
Fees for Ireland: €895 (Euro), with instalments and employer sponsorship available.
Relevant bodies in Ireland
Typical roles
Questions from Ireland
Will this qualification be recognised by professional bodies in Ireland for this area?
SEIUM's qualifications are private qualifications, not official state degrees, and they are not accredited by any national body. Recognition is decided by individual employers or the relevant body. In Ireland, engineers in this field may look to Engineers Ireland for professional membership, but completing a SEIUM programme does not by itself grant membership of any body. Check requirements directly with the body concerned before enrolling.
How might this training be used by employers in Ireland working in this area?
Employers in Ireland decide for themselves how much weight to give a private online qualification. Many assess it alongside your existing experience, the final project and your portfolio. Roles in medical devices, occupational health and workplace safety may value specialist knowledge, but there is no guarantee of recognition or of any salary or promotion outcome. Ask prospective employers whether they would accept the qualification.
Can I study this alongside a full-time job, and does my employer need to fund it?
Programmes are fully online and taught in English, so you can study from home at your own pace around work. Master's programmes are 1,900 hours, postgraduate diplomas 800 hours and specialist courses 300 hours, so plan your weekly commitment accordingly. Fees can be paid in instalments, and employer sponsorship is possible if your company agrees. Each student is assigned a technical tutor for support.
Take the controls.
Run a real engineering trade-off from this field. Move the sliders, watch the model react in real time and beat the challenge.
What you will be able to do
Apply the scientific method to experimental design.
Write complete and reproducible experimental protocols.
Select measurement instruments and estimate their uncertainty.
Analyse the ethical principles of research involving people.
Prepare the documentation required by ethics committees.
Develop clear informed consent processes.
Communicate results with transparency and scientific integrity.
Who it's for
- Experimental researcher who wants to specialise in Experimental Protocols and Research Ethics.
- Research ethics committee coordinator who wants to specialise in Experimental Protocols and Research Ethics.
- Research management technician who wants to specialise in Experimental Protocols and Research Ethics.
- Scientific integrity officer who wants to specialise in Experimental Protocols and Research Ethics.
- Research methodologist who wants to specialise in Experimental Protocols and Research Ethics.
- R&D project manager who wants to specialise in Experimental Protocols and Research Ethics.
- Engineering or science graduates looking to enter universities and research centres.
What you'll work with
- Declaration of Helsinki (WMA)
- Law 14/2007 on Biomedical Research
- Regulation (EU) 536/2014 (clinical trials)
- Oviedo Convention (human rights and biomedicine)
- Regulation (EU) 2016/679 (GDPR)
- Directive 2010/63/EU (protection of animals used in research)
- SPIRIT Guidance (trial protocols)
8 modules · 800 h
1.1Formulating questions and hypotheses1.2Independent, dependent and control variables1.3Internal, external and construct validity1.4Between-subjects and within-subject designs1.5Factorial designs and interactions1.6Counterbalancing and order effects1.7Quasi-experimental designs1.8Pilot and feasibility studies1.9Study preregistration1.10Case study: redesigning an experiment with validity threats
2.1Structure of the research protocol2.2SPIRIT guidelines for protocols2.3Inclusion and exclusion criteria2.4Sample size calculation and power2.5Randomisation and allocation concealment2.6Blinding of participants and assessors2.7Standard operating procedures2.8Data management plan2.9Managing protocol deviations2.10Workshop: complete protocol for a biomechanical study
3.1Selecting valid and reliable instruments3.2Calibration and traceability of equipment3.3Motion capture and force platforms3.4Physiological signals: EMG, ECG and EEG3.5Questionnaires and validated scales3.6Device synchronisation3.7Data quality control3.8Measurement error and its propagation3.9Documentation of instrumentation3.10Laboratory: calibration and synchronisation of a capture system
4.1Nuremberg Code and Declaration of Helsinki4.2Belmont Report: respect, beneficence and justice4.3Oviedo Convention4.4Minimal risk and benefit-risk balance4.5Vulnerable populations4.6Research with minors and persons lacking capacity4.7Deception and debriefing in experiments4.8Compensation of participants4.9Scientific integrity and conflicts of interest4.10Case study: ethical analysis of an experiment involving deception
5.1Law 14/2007 on biomedical research5.2Research ethics committees (CEI)5.3Regulation 536/2014 and clinical trials5.4Clinical investigations of medical devices, ISO 141555.5Good clinical practice, ICH E65.6Data protection: GDPR in research5.7Biological samples and biobanks5.8Insurance and liability5.9Documentation for the committee5.10Practice: complete application to an ethics committee
6.1Elements of valid consent6.2Participant information sheet6.3Plain language and readability6.4Consent in online studies6.5Broad consent for future uses6.6Withdrawal and data removal6.7Assent in minors6.8Assessment of understanding6.9Consent in AI and data research6.10Workshop: drafting and readability testing of an information sheet
7.1Pre-specified statistical analysis plan7.2Parametric and non-parametric tests7.3Mixed models for repeated measures7.4Effect size and confidence intervals7.5Multiple comparisons7.6Open science and FAIR data7.7Reporting guidelines: CONSORT and STROBE7.8Authorship and questionable practices7.9Communicating results to participants7.10Practice: analysis of a within-subject experiment using mixed models
8.1Research question and hypothesis8.2Experimental design and variables8.3Sample size calculation8.4Procedures and instrumentation8.5Statistical analysis plan8.6Ethical and risk assessment8.7Documentation for the ethics committee8.8Data management and opening plan8.9Report and presentation8.10Final review with the tutor
How you'll learn
Fully 100 % online study on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. No fixed timetables: students progress at their own pace within the intake, which makes it compatible with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is R, G*Power, REDCap, IBM SPSS, in free, academic or evaluation versions. Clinical trials are studied through real procedures: drafting protocols for ethics committees, sample size calculation in pilot studies, and designing informed consent forms. Assessment is continuous by module plus the final integrative project.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Apply the scientific method to experimental design.
Write complete and reproducible experimental protocols.
Select measurement instruments and estimate their uncertainty.
Analyse the ethical principles of research involving people.
Prepare the documentation required by ethics committees.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. No university degree is required.
- Internet connection and a computer capable of running the programme's software.
- Sufficient English to follow technical regulatory texts.
Ready to start?
Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.
Frequently asked questions
The programme comprises 800 hours in total, spread over 6 to 8 months. That is between 10 and 15 hours per week on average, compatible with a full-time job.
The course uses R, G*Power, REDCap, IBM SPSS. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.
An own diploma from SEIUM upon passing continuous assessment and the integrative project. This is in-house training, not an official title from the Ministry.
Yes. Modules passed in a course or postgraduate diploma in the same area are recognised in the advanced programme. Check the recognition policy when you enrol.
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