HELSEF4510 ¨C Medical and Health Related Research Ethics

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 course 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 Agency for Shared Services in Education and Research (Sikt).

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 Agency for Shared Services in Education and Research (Sikt)
• 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 to the course

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

• International Community Health (master)
• Tverrfaglig helseforskning (master)
• Folkehelsevitenskap og epidemiologi (master)

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.

Teaching

Five days course (during one week).

Topical introductions and group assignments. Work in interdisciplinary groups.

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

A student who has completed compulsory instruction and coursework and has had these approved, is not entitled to repeat that instruction and coursework. A student who has been admitted to a course, but who has not completed compulsory instruction and coursework or had these approved, is entitled to repeat that instruction and coursework, depending on available capacity.

Examination

Individual home exam.

Writing of a 5 page essay on a selected topic in research ethics.

80 % attendance is required to take the exam.

Examination and grading at The Faculty of Medicine.

Language of examination

The examination text is given in English. You may submit your response in Norwegian, Swedish, Danish or English.

Grading scale

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

More about examinations at UiO

• Use of sources and citations
• Special exam arrangements due to individual needs
• Withdrawal from an exam
• Illness at exams / postponed exams
• Explanation of grades and appeals
• Resitting an exam
• Cheating/attempted cheating

You will find further guides and resources at the web page on examinations at UiO.