What are the 4 important ethical issues IRB guidelines address?

What are the 4 important ethical issues IRB guidelines address?

IRB’S must be guided by principles outlined in Belmont Report:

• Respect for persons: respect for patient autonomy.
• Beneficence: maximize benefits and minimize harm.
• Justice: Equitable distribution of research burdens and benefits.

Who regulates IRB?

Department of Health and Human Services

What qualifies for IRB exemption?

Research can be approved as “exempt” if it is no more than “minimal risk” and fits one of the exempt review categories as defined by federal regulation 45 CFR 46. Studies that may qualify for “Exempt” must be submitted to the IRB for review. Exempt reviews are conducted by a member of IRB staff.

What type of IRB review does not require approval?

“Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.

How long is IRB training?

How long will it take to complete the course? Each CITI module has text to read and a quiz to complete. The average learner spends approximately 4.5 hrs in the Basic Course site and approximately 1.5 hours if your site requires additional modules. The Refresher Training will take approximately 2 hours.

Do you need IRB approval for a survey?

A. Yes, all research projects, including those that you think will be exempt, must be submitted to the IRB for initial review. Some types of research are exempt from the regulations that govern and empower IRBs, and the regulations allow other types of research to be reviewed in an expedited process.

What type of study is chart 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 type of study is a retrospective analysis?

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 a prospective design?

Prospective. A prospective study watches for outcomes, such as the development of a disease, during the study period and relates this to other factors such as suspected risk or protection factor(s). The study usually involves taking a cohort of subjects and watching them over a long period.

What are different study designs?

Types of Study Designs

• Meta-Analysis. A way of combining data from many different research studies.
• Systematic Review.
• Randomized Controlled Trial.
• Cohort Study (Prospective Observational Study)
• Case-control Study.
• Cross-sectional study.
• Case Reports and Series.
• Ideas, Editorials, Opinions.