Postgraduate DiplomaHealth, Biomechanics, Wearables & Operational Safety Applications open

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.

Duration800 h
ModeOnline
LanguageEnglish
Start datesSet by the faculty
AwardSEIUM Institute diploma
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Learning outcomes

What you will be able to do

01

Apply the scientific method to experimental design.

02

Write complete and reproducible experimental protocols.

03

Select measurement instruments and estimate their uncertainty.

04

Analyse the ethical principles of research involving people.

05

Prepare the documentation required by ethics committees.

06

Develop clear informed consent processes.

07

Communicate results with transparency and scientific integrity.

Profile

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.
Standards & tools

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)
Syllabus

8 modules · 800 h

  1. 1.1Formulating questions and hypotheses
  2. 1.2Independent, dependent and control variables
  3. 1.3Internal, external and construct validity
  4. 1.4Between-subjects and within-subject designs
  5. 1.5Factorial designs and interactions
  6. 1.6Counterbalancing and order effects
  7. 1.7Quasi-experimental designs
  8. 1.8Pilot and feasibility studies
  9. 1.9Study preregistration
  10. 1.10Case study: redesigning an experiment with validity threats
  1. 2.1Structure of the research protocol
  2. 2.2SPIRIT guidelines for protocols
  3. 2.3Inclusion and exclusion criteria
  4. 2.4Sample size calculation and power
  5. 2.5Randomisation and allocation concealment
  6. 2.6Blinding of participants and assessors
  7. 2.7Standard operating procedures
  8. 2.8Data management plan
  9. 2.9Managing protocol deviations
  10. 2.10Workshop: complete protocol for a biomechanical study
  1. 3.1Selecting valid and reliable instruments
  2. 3.2Calibration and traceability of equipment
  3. 3.3Motion capture and force platforms
  4. 3.4Physiological signals: EMG, ECG and EEG
  5. 3.5Questionnaires and validated scales
  6. 3.6Device synchronisation
  7. 3.7Data quality control
  8. 3.8Measurement error and its propagation
  9. 3.9Documentation of instrumentation
  10. 3.10Laboratory: calibration and synchronisation of a capture system
  1. 4.1Nuremberg Code and Declaration of Helsinki
  2. 4.2Belmont Report: respect, beneficence and justice
  3. 4.3Oviedo Convention
  4. 4.4Minimal risk and benefit-risk balance
  5. 4.5Vulnerable populations
  6. 4.6Research with minors and persons lacking capacity
  7. 4.7Deception and debriefing in experiments
  8. 4.8Compensation of participants
  9. 4.9Scientific integrity and conflicts of interest
  10. 4.10Case study: ethical analysis of an experiment involving deception
  1. 5.1Law 14/2007 on biomedical research
  2. 5.2Research ethics committees (CEI)
  3. 5.3Regulation 536/2014 and clinical trials
  4. 5.4Clinical investigations of medical devices, ISO 14155
  5. 5.5Good clinical practice, ICH E6
  6. 5.6Data protection: GDPR in research
  7. 5.7Biological samples and biobanks
  8. 5.8Insurance and liability
  9. 5.9Documentation for the committee
  10. 5.10Practice: complete application to an ethics committee
  1. 6.1Elements of valid consent
  2. 6.2Participant information sheet
  3. 6.3Plain language and readability
  4. 6.4Consent in online studies
  5. 6.5Broad consent for future uses
  6. 6.6Withdrawal and data removal
  7. 6.7Assent in minors
  8. 6.8Assessment of understanding
  9. 6.9Consent in AI and data research
  10. 6.10Workshop: drafting and readability testing of an information sheet
  1. 7.1Pre-specified statistical analysis plan
  2. 7.2Parametric and non-parametric tests
  3. 7.3Mixed models for repeated measures
  4. 7.4Effect size and confidence intervals
  5. 7.5Multiple comparisons
  6. 7.6Open science and FAIR data
  7. 7.7Reporting guidelines: CONSORT and STROBE
  8. 7.8Authorship and questionable practices
  9. 7.9Communicating results to participants
  10. 7.10Practice: analysis of a within-subject experiment using mixed models
  1. 8.1Research question and hypothesis
  2. 8.2Experimental design and variables
  3. 8.3Sample size calculation
  4. 8.4Procedures and instrumentation
  5. 8.5Statistical analysis plan
  6. 8.6Ethical and risk assessment
  7. 8.7Documentation for the ethics committee
  8. 8.8Data management and opening plan
  9. 8.9Report and presentation
  10. 8.10Final review with the tutor
Methodology, software & labs

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.

Accreditable laboratories(EN ISO/IEC 17025) with rotor test rig, EMC/Lightning pre-compliance, HIL/SIL, vibration/acoustics.
Evidence-driven Master's Thesis:safety case, test plan, compliance dossier and operational limits.
Industry-mentored:lecturers with experience in training, , eVTOL/UAM and flight test.
Flexible format(hybrid/online), international cohorts and support from SEIUM Career Services.
Ethics and safety:safety-by-design approach, ciber-OT, DIH and compliance as pillars.
Capstone project

Build it end to end

Your final project follows the real engineering workflow, step by step, reviewed by your tutor.

Research question and hypothesis

Apply the scientific method to experimental design.

Experimental design and variables

Write complete and reproducible experimental protocols.

Sample size calculation

Select measurement instruments and estimate their uncertainty.

Procedures and instrumentation

Analyse the ethical principles of research involving people.

Statistical analysis plan

Prepare the documentation required by ethics committees.

Career opportunities

Where this takes you

Experimental researcherResearch ethics committee coordinatorResearch management technicianScientific integrity officerResearch methodologistR&D project manager
Admissions & scholarships

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 Spanish 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.

FAQ

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.

Postgraduate Diploma in Experimental Protocols and Research EthicsEnrol
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