Monday, 27 June 2022, 11:33 AM
Site: EUPATI Open Classroom
Course: EUPATI Open Classroom (EUPATI Open Classroom)
Glossary: Glossary
R

Research Ethics Committee

Research Ethics Committee

Respect for persons

Respect for persons is the concept that all people have the right to exercise their full autonomy. In research, this principle seeks to ensure that a participant's wishes are respected, even if they differ from those of the researcher.

Response Variable

A response variable is a measured outcome within a trial which can be influenced by other factors. For example, a trial might test if a new medicine is effective at reducing a certain heart disease symptom. In this case, the reduction in this symptom will be measured and this measurement will be a response variable (also known as a dependent variable). In contrast, the new medicine is known as the independent variable, which is tested to determine if it has caused a change in the dependent variable.

Retrospective Case Control Study

A retrospective case control study is one that uses existing data to compare two groups. For example, people who have developed a disease might be compared with a group of people who have not. The researcher will look at whether there is any difference in the two groups in their previous exposure to possible risk factors. This type of study is useful when studying risk factors for rare diseases, and is often used to create new hypotheses which can then be tested.

For example, there are fewer than 300 confirmed cases of new variant Creutzfeldt-Jakob disease (CJD), a degenerative, invariably fatal brain disorder. A cohort study that follows healthy people over time to see what risk factors lead to developing the disease would need to recruit a huge number of people in order for just one to develop symptoms (around 200,000). It would also take a very long time, because the period between infection and showing symptoms is thought to be between 10 and 30 years. A much better approach in this case would be to carry out a case control study, starting with people who already have a diagnosis of new variant CJD, and comparing their past exposure to possible risk factors with a group of people who do not have the disease.

Rigour

The quality of being extremely thorough and careful. Scientific rigour is judged by how narrow, concise, and objective the design and analysis techniques of a research project are and how scrupulously the rules have been adhered to and applied to all decisions.

Risk

Risk is the probability of harm or injury occurring as a result of using a treatment in clinical practice or as part of a research study. The harm or injury may be physical, but can also be psychological, social, or economic. Risks may include experiencing side effects of the treatment, or taking a medication that is not as effective as the standard treatment (during a trial). In a trial, a new treatment may have side effects or risks that researchers do not expect. This is more likely in the early stages of clinical trials.

No clinical trial is risk free. Participants should be aware of both the benefits and the risks before they make a decision about whether or not to take part (see informed consent).

Risk assessment

Risk assessment is one of the three pillars of risk management (together with safety specifications and the risk minimisation plan). It contains both routine and additional pharmacovigilance activities to characterise the safety profile of the medicinal product including what is known and not known. It does NOT include actions intended to reduce, prevent or mitigate risks.

Risk Evaluation and Management Strategy

Risk Evaluation and Management Strategy

Risk Evaluation and Mitigation Strategy

A Risk Evaluation and Mitigation Strategy (REMS) is used in the United States, and is similar to the Risk Management Plan (RMP) in the EU.

Risk factor

A risk factor is a characteristic, condition or habit that increases a person™s chances to develop a particular disease or injury, for example, physical inactivity may, over time, contribute to weight gain, high blood pressure and high cholesterol levels. Risk factors include:

  • behavioural (poor diet, smoking, alcohol consumption),
  • biomedical (high weight, high blood pressure),
  • environmental (social, economic, cultural),
  • genetic (chromosomal abnormalities),
  • demographic (age, gender, ethnicity).