IRB Determination Form - Phoebe Putney Memorial Hospital 2025

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The document is an IRB Determination Form from Phoebe Putney Memorial Hospital, designed to assess whether a research activity involves human participants as defined by federal regulations. It outlines the necessary information for principal investigators, including details about the study, data collection methods, and ethical training. The form helps determine if IRB review is required and provides guidelines for activities that may not constitute human subjects research.

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What is an IRB letter?

A project requires Institutional Review Board (IRB) review if it includes both research and human subjects. An IRB protocol is a group of documents that conveys all the necessary information about your research with human subjects to IRB reviewers (e.g., consent form, IRB application).

What is an IRB determination?

The IRB makes the determination if a study is Exempt, Expedited, Greater Than Minimal Risk, or Not Human Subjects Research.

Where can I get an IRB approval letter?

Once your IRB protocol has been approved, you can view or save the approval letter by opening the protocol in Streamlyne. 1) Login to Streamlyne. 2) Search under: Main Menu IRB and click All My Protocols a. You can also search using the IRB Protocol lookup feature by clicking the word IRB Protocol.

What is an IRB and what is its purpose?

The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.

Is Phoebe Putney Memorial Hospital a Teaching Hospital?

Phoebe Putney Memorial Hospital, Albany, Georgia Our flagship hospital is a 691-bed teaching hospital and a regional center for cancer treatment, cardiac medicine/surgery, gastrointestinal disease and neuroscience.

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Does every hospital have an IRB?

Although institutions engaged in research involving human subjects will usually have their own IRBs to oversee research conducted within the institution or by the staff of the institution, FDA regulations permit an institution without an IRB to arrange for an outside IRB to be responsible for initial and continuing

What gets submitted to the IRB?

The IRB Application consists of several parts: The Application Document written by the investigator that is an official account of the planned project. Supporting DocumentsDocuments attached to the application when submitted in one PDF file.

What is an IRB determination letter?

The letter documents the IRBs approval of the application. The letter may include administrative comments or conditions that must be met in the conduct of the research.

IRB Determination Form - Phoebe Putney Memorial Hospital 2025

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