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Get the free Minimal Risk Protocol Template [irb 10429.010]

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This document outlines the protocol for a clinical trial aimed at enhancing cancer symptom control through an electronic health record-facilitated intervention. It details the study\'s objectives,
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How to fill out minimal risk protocol template

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How to fill out minimal risk protocol template

01
Begin by writing the title of the project at the top of the template.
02
Provide a brief description of the study objective and research questions.
03
Identify the population involved in the study, including inclusion and exclusion criteria.
04
Outline the procedures for data collection, including any surveys, interviews, or observations.
05
List potential risks to participants and explain why they are considered minimal.
06
Describe how confidentiality will be maintained throughout the study.
07
Include information about the informed consent process.
08
Provide contact information for the principal investigator or research team for any questions or concerns.
09
Review the template for completeness and clarity before submission.

Who needs minimal risk protocol template?

01
Researchers conducting studies that involve human participants with low-level risks.
02
Institutional Review Boards (IRBs) assessing research proposals for minimal risk.
03
Academic institutions that require documentation of ethical research practices.
04
Organizations or entities funding research that stipulates adherence to ethical standards.
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A minimal risk protocol template is a standardized document used to outline research or projects that pose no more than minimal risk to participants. It includes information on the study's methods, procedures, and safeguards to ensure participant safety.
Researchers, institutions, or organizations conducting studies that involve human subjects and fall under the jurisdiction of Institutional Review Boards (IRBs) are required to file a minimal risk protocol template.
To fill out a minimal risk protocol template, researchers should provide detailed information about the research objectives, methodology, participant selection criteria, consent process, data collection methods, and measures to protect participants' privacy and confidentiality.
The purpose of the minimal risk protocol template is to ensure that research involving human subjects is conducted ethically and safely, while also streamlining the review process for studies that do not pose significant risks.
The information that must be reported on a minimal risk protocol template includes the study title, principal investigator's details, study purpose, eligibility criteria, recruitment methods, potential risks, benefits, data handling and confidentiality measures, and informed consent procedures.
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