What is a retrospective research protocol?

What is a retrospective research protocol?

Thus the criteria to meet retrospective status are: Protocol must be research involving materials such as data, documents, records or specimen that have been collected for non-research purposes. Protocol must include specific dates of data/information that will be used.

Does a retrospective study require IRB approval?

Do I need IRB approval to do a retrospective chart review? As a general matter, there is no retrospective IRB review. However, you should submit an application to the IRB for approval and include an explanation for why you did not think you needed IRB approval.

What is retrospective study in data collection?

A retrospective study investigates outcomes specified at the beginning of a study by looking backwards at data collected from previous patients. Patients are enrolled after the clinical event of interest or exposure has occurred: this is usually conducted by re- view of the medical notes.

What is a retrospective clinical review?

The retrospective chart review (RCR), also known as a medical record review, is a type of research design in which pre-recorded, patient-centered data are used to answer one or more research questions [1].

What is a retrospective chart review study?

Retrospective Chart Review- evaluates patient data that is existing at the time the protocol is submitted to the IRB for initial approval. This type of chart review uses information that has usually been collected for reasons other than research.

What makes a cohort study retrospective or prospective?

The cohort required for a prospective study is usually a set of people who have not experienced the event before, but are just prone to it. A retrospective study requires a cohort that has experienced the event in the past.

Are retrospective studies exempt from IRB review?

While retrospective chart review research that involves only minimal risk to human subjects is sometimes exempt from full Institutional Review Board review, it is still subject to administrative review to determine eligibility for exemption.

Does retrospective study need ethical approval?

Although recently published Code of Clinical Research declared that retrospective archive studies do not need ethics approval, all institutional ethics committee instructions still ask it for submission of scientific publication in our country (5).

What is retrospective study example?

For example, we could have a retrospective cohort study whereby the investigators go back several decades to get the records of the factory workers from a manufacturing company. These workers could be investigated on how exposure to particular radiation from the machines affected them over the years.

What kind of study is a retrospective study?

A retrospective study is performed a posteriori, using information on events that have taken place in the past. In most cases some or most of the data has already been gathered and stored in the registry.

Why do a retrospective study?

Retrospective studies help define prognostic factors to be used so that the therapeutic strategy may vary depending on the predicted risks. Those studies are extremely helpful to assess the feasibility of prospective studies and to help in their design.

What kind of design is retrospective study?

In a retrospective study, the outcome of interest has already occurred at the time the study is initiated. A retrospective study design allows the investigator to formulate ideas about possible associations and investigate potential relationships, although causal statements usually should not be made.

What type of study is retrospective?

A retrospective study uses existing data that have been recorded for reasons other than research. A retrospective case series is the description of a group of cases with a new or unusual disease or treatment.

What is an example of a retrospective cohort study?

An example of a retrospective cohort study will be interviewing a cohort of people who are HIV positive, ask about their lifestyle choices and medical history to study the origins of the disease.

Do retrospective studies require ethical approval?

Do you need IRB approval for retrospective chart review?

If the intent of a retrospective review of medical charts does not fit those defined above, the retrospective chart review should be considered research and must receive prospective IRB approval. No matter the review category, waivers of informed consent and HIPAA regulations may be requested.

What is retrospective ethics approval?

RETROSPECTIVE RESEARCH ETHICS REVIEW Retrospective ethics review is, therefore, not permitted. It is the responsibility of the principal investigator or, in the case of a student project, the supervisor, to ensure that ethics review is undertaken in good time. There are no exceptions to this principle.

Is informed consent required for a retrospective study?

Generally not. Most retrospective chart reviews involve a large number of records, and therefore the IRB would consider it impracticable (not possible) to do the study if informed consent and authorization were required. However, the investigator must answer the waiver of consent/authorization questions (section IV.

How do you identify a retrospective study?

What type of study is a retrospective study?

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).