HELSEF4510 – Medical and Health Related Research Ethics

Schedule, syllabus and examination date

Course content

Research ethics is a sub-discipline of bioethics and deals with the normative rules of play of doing research. Its institutionalisation in research ethics committees and research governance frameworks impinges on the lives and activities on many researchers and research participants every day. This module provides an introduction into the history and development of medical and health related research ethics, its core normative principles and the application of these principles in quantitative and qualitative research involving human beings (patients, healthy research subjects, informants) and/or the use of personal data stored in biobanks and health registries. In addition, it provides knowledge about relevant national and international ethics guidelines and regulations, and discusses issues pertaining to research integrity and breaches of good research practices (scientific misconduct); fabrication, falsification plagiarism, conflicts of interest, conflicts surrounding authorship etc. Finally, it addresses challenges pertaining to safe storage of sensitive data (TSD), and preparation of REC applications and applications to the Norwegian Social Science Data Services (NSD).

Learning outcome

Knowledge

  • good understanding of the history of research ethics
  • know the core ethical principles and norms guiding medical and health related research
  • know the national and main international guidelines and regulations pertaining to medical and health related research
  • know the responsibility of a researcher when involving human subjects
  • know what is needed to gain approval from REC or from the Norwegian Social Science Data Services (NSD)
  • know what safe storage of sensitive data (TSD) entails

Skills

  • be able to interpret and apply ethical principles and norms in local research practices
  • understand ways to protect human participants during a study
  • be attentive to how to include vulnerable groups in research
  • know what is correct citation and use of scientific references

General Competence

  • familiarity with central events and factors that led to the development of medical and health care research ethics
  • familiarity with the function and role of research ethics committees
  • familiarity with the pitfalls of scientific misconduct and ways to avoid such conduct

Admission

Students who are admitted to study programmes at UiO must each semester register which courses and exams they wish to sign up for in Studentweb.

If you are not already enrolled as a student at UiO, please see our information about admission requirements and procedures.

This course is only available for students at the following master's programmes: 

Teaching

Five days course (during one week). Total 30 hours.

Topical introductions and group assignments. Work in interdisciplinary groups.

80 % attendance is required to be eligible to take the exam. Attendance will be registered.

Examination

Individual home exam

Writing of a 5-10 pages essay on a selected topic in research ethics.

80 % attendance is required to take the exam.

Grading

The Board at the University of Oslo has decided to introduce detailed guidelines for all examinations, which take place at the University. The description of the grading should be clear and transparent. This is done to ensure alignment between learning outcomes, assignments, and grading. The Faculty of Medicine has developed a web page with information regarding exams and the grading procedures (norwegian version).

Submit assignments in Inspera

You submit your assignment in the digital examination system Inspera. Read about how to submit your assignment.

Use of sources and citation

You should familiarize yourself with the rules that apply to the use of sources and citations. If you violate the rules, you may be suspected of cheating/attempted cheating.

Language of examination

You may write your examination paper in Norwegian, Swedish, Danish or English.

Grading scale

Grades are awarded on a pass/fail scale. Read more about the grading system.

Explanations and appeals

Resit an examination

Withdrawal from an examination

It is possible to take the exam up to 3 times. If you withdraw from the exam after the deadline or during the exam, this will be counted as an examination attempt.

Special examination arrangements

Application form, deadline and requirements for special examination arrangements.

Evaluation

The course is subject to continuous evaluation. At regular intervals we also ask students to participate in a more comprehensive evaluation.

Facts about this course

Credits
5
Level
Master
Teaching
Every spring
Examination
Every spring
Teaching language
English