Do Case series require IRB approval?

Do Case series require IRB approval?

Although IRB approval is not required to write a case report or a limited case series, certain HIPAA Privacy Rule requirements still apply to the use and disclosure of PHI. However, because case reports are usually interesting or unique cases by definition, it is very difficult to completely de- identify a case report.

What studies do not need ethical approval?

Some studies that do not require ethical approval include those involving information freely available in the public domain (e.g. published biographies, newspaper accounts), and the analysis of datasets, either open source or obtained from other researchers, where the data are properly anonymised and informed consent …

What requires ethical approval?

The requirement for ethical approval applies not only to interventions like clinical trials but also to a range of other activities such as questionnaires, case note reviews, telephone surveys, and collecting samples or data.

Is a case series experimental?

The Dictionary of Epidemiology defined a case series as – a collection of patients with common characteristics used to describe some clinical, pathophysiological or operational aspects of a disease, treatment or diagnostic procedures [2]. Case series is an observational, descriptive research design.

What type of study is case series?

A case series (also known as a clinical series) is a type of medical research study that tracks subjects with a known exposure, such as patients who have received a similar treatment, or examines their medical records for exposure and outcome.

Do cohort studies have a control group?

Cohort studies differ from clinical trials in that no intervention, treatment, or exposure is administered to participants in a cohort design; and no control group is defined. Rather, cohort studies are largely about the life histories of segments of populations, and the individual people who constitute these segments.

Which is better case-control or cohort studies?

Retrospective cohort studies are NOT the same as case-control studies. In retrospective cohort studies, the exposure and outcomes have already happened. Therefore, cohort studies are good for assessing prognosis, risk factors and harm. The outcome measure in cohort studies is usually a risk ratio / relative risk (RR).

What is the difference between cohort and case-control?

Whereas the cohort study is concerned with frequency of disease in exposed and non-exposed individuals, the case-control study is concerned with the frequency and amount of exposure in subjects with a specific disease (cases) and people without the disease (controls).

Why are cohort studies better than Case-Control?

Cohort studies work well for rare exposures–you can specifically select people exposed to a certain factor. But this design does not work for rare diseases–you would then need a large study group to find sufficient disease cases. Case-control studies are relatively simple to conduct.

What are the disadvantages of case-control studies?

The disadvantages are the following.

• They are prone to selection bias and recall bias.
• It is difficult to establish temporal causality.
• Case-control studies are not suitable for studying rare exposures because it would be difficult to recruit the required sample size.

Why can’t you use Relative Risk Case-Control?

In a case-control study, you cannot measure incidence, because you start with diseased people and non-diseased people, so you cannot calculate relative risk. Case-control studies are particularly useful when the outcome is rare is uncommon in both exposed and non-exposed people.

Are case-control studies reliable?

Case-control studies are often used to provide early clues and inform further research using more rigorous scientific methods. The main problem with case-control studies is that they are not as reliable as planned studies that record data in real time, because they look into data from the past.

What are the advantages and disadvantages of case-control studies?

Advantages and Disadvantages of Case-Control Studies

• They are efficient for rare diseases or diseases with a long latency period between exposure and disease manifestation.
• They are less costly and less time-consuming; they are advantageous when exposure data is expensive or hard to obtain.

How many controls are in a case?

Investigators planning case-control studies are usual- ly advised to include no more than four or five controls per case because little statistical power is gained by fur- ther increasing this ratio (1,2).

What makes a good case-control study?

Use of newly diagnosed over prevalent cases is preferable, as the latter may alter risk estimates and complicate the interpretation of findings. Controls should be selected from the source population from which cases arose. Potential confounding should be addressed both in studies of environmental and genetic factors.

Which of the following is a characteristic of case-control studies?

A major characteristic of case-control studies is that data on potential risk factors are collected retrospectively and as a result may give rise to bias. This is a particular problem associated with case-control studies and therefore needs to be carefully considered during the design and conduct of the study.

How do you control recall bias?

Strategies that might reduce recall bias include careful selection of the research questions, choosing an appropriate data collection method, studying people to study with new-onset disease or use a prospective design, which is the most appropriate way to avoid recall bias.

How does a case-control study work?

A study that compares patients who have a disease or outcome of interest (cases) with patients who do not have the disease or outcome (controls), and looks back retrospectively to compare how frequently the exposure to a risk factor is present in each group to determine the relationship between the risk factor and the …

What are the advantages of selecting controls from the same hospital as cases?

The advantages of using controls who are patients from the same facility are: They are easier to identify. They are more likely to participate than general population controls. They minimize selection bias because they generally come from the same source population (provided referral patterns are similar).

What are the variables in a case-control study?

In a case-control study, ” participants are selected and categorized on the basis of the dependent variable (the outcome of interest). The purpose of the study is to test hypotheses about factors in the past (independent variables) that may explain the outcome” (Meininger, 2017).

Are case-control studies qualitative or quantitative?

Researchers using quantitative techniques usually see themselves as doing science. Experiments done in a laboratory will almost certainly be quantitative. In a health care context, randomised controlled trials are quantitative in nature, as are case-control and cohort studies.

What is the meaning of case-control study?

Listen to pronunciation. (kays-kun-TROLE STUH-dee) A study that compares two groups of people: those with the disease or condition under study (cases) and a very similar group of people who do not have the disease or condition (controls).

How do you choose a control group in a case-control study?

Selection of the Controls

1. The comparison group (“controls”) should be representative of the source population that produced the cases.
2. The “controls” must be sampled in a way that is independent of the exposure, meaning that their selection should not be more (or less) likely if they have the exposure of interest.