What do you do as an undergraduate researcher?
Some common types include working with faculty on their research, enrolling in a research program and conducting your own studies, or even creative endeavors. The actual nature of your research could carry you to the lab to conduct experiments and dissections or across the world to study poaching of endangered animals.
What type of research needs IRB approval?
FDA regulations generally require IRB review and approval of research involving FDA-regulated products (e.g., investigational drugs, biological products, medical devices and dietary supplements) (21 CFR Part 56).
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.
What is the role of the IRB in research?
What is an Institutional Review Board (IRB)? In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
Who has an IRB?
Who Serves on an IRB? An IRB consists of at least five members of varying backgrounds. IRB members should have the professional experience to provide appropriate scientific and ethical review. An IRB must have at least one scientist member and at least one member whose primary concerns are nonscientific.
How long should an expedited IRB decision take?
one to three weeks
What is an expedited IRB review?
Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. The reviewer(s) may exercise all the authorities of the IRB, except disapproval. Research may only be disapproved following review by the full committee.
Which IRB is used for behavioral research?
The Behavioral/NonMedical IRB (IRB02) is responsible for reviewing and monitoring a subset of the research with human subjects conducted at the University of Florida.
What is an expedited protocol?
The writers of the federal regulations mandating IRB review recognized that not all research rises to the level of full board review. In some cases, a protocol needs IRB approval but the level of risk in the protocol is considered minimal and the review can be expedited.
Which study might qualify for an expedited IRB review?
The list of research categories eligible for an expedited review: (1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required.
When can expedited review process be used?
OHRP policy provides that any institution with an OHRP-approved Assurance may use expedited review for initial or continuing review of HHS-supported or conducted research and for review of minor changes in previously approved research as described in 45 CFR 46.110(b)(2).
What is an exempt protocol?
No full board review: An exempt protocol does not need full board review; modifications do not need to be reviewed at a full board meeting unless the protocol modifications change the exemption status.
What is a protocol deviation?
Protocol deviation. A protocol deviation occurs when, without significant consequences, the activities on a study diverge from the Institutional Review Board-approved protocol, e.g., missing a visit window because the subject is traveling. Not as serious as a protocol violation.
What are the 3 main GCP principles?
Three basic ethical principles of equal importance, namely respect for persons, beneficence, and justice, permeate all other GCP principles.
What is an important protocol deviation in clinical research?
“Important protocol deviations are a subset of protocol deviations that may significantly impact the completeness, accuracy, and/or reliability of key study data or that may significantly affect a subject’s rights, safety, or well-being.