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This document provides guidelines and requirements for researchers submitting proposals to the Institutional Review Board at Heidelberg University. It includes instructions on ensuring the ethical
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How to fill out Heidelberg University Institutional Review Board Instructions & Forms

01
Begin by downloading the Heidelberg University Institutional Review Board (IRB) Instructions & Forms from the university's official website.
02
Carefully read through the guidelines provided in the instructions to understand the purpose and requirements of the IRB process.
03
Complete the initial application form by entering the necessary information regarding your research project, including title, abstract, and research methodology.
04
Clearly outline the objectives and significance of your research, as well as the potential risks and benefits involved.
05
Include detailed information on how you will obtain informed consent from participants, ensuring compliance with ethical standards.
06
Address any privacy and confidentiality issues by explaining how you will safeguard participants' data.
07
Review the completed application for accuracy and completeness before submission.
08
Submit the application electronically or via the specified method outlined in the instructions.
09
Be prepared to respond to any revisions or additional questions from the IRB after your initial submission.

Who needs Heidelberg University Institutional Review Board Instructions & Forms?

01
Researchers conducting studies involving human participants at Heidelberg University.
02
Faculty members and students planning to undertake research projects that require ethical review.
03
Any individual or group seeking approval for research activities to ensure compliance with ethical standards.
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Composition of the IRB The IRB is composed of at least five voting members. Alternates and non-voting members may also be appointed, with alternates authorized to vote at convened meetings only in the absence of the member for whom they are the designated alternate.
The first step of the process is to plan the research project involving human participants or subjects. This needs to be well conceptualized before the process can go forward. If it is a student project, a faculty advisor must be included for consultation in the development of a protocol to be submitted to the IRB.
Under the Common Rule, IRBs must have at least five members and include at least one scientist, one non-scientist, and “one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution”(§ 46.107(d)).
The Code of Federal Regulations (Title 45, Part 46) and the Belmont Report (PDF) specify three basic ethical principles which must guide all human subjects research: respect for persons, beneficence and justice.
IRB Review Process: The IRB review process is in place to protect the rights and welfare of humans participating as subjects in research studies. IRB approval is required when research involving human subjects: Receives federal funds either directly or indirectly. Takes place at a university or hospital.
IRB Process Submission of Research Proposal: Researchers submit their research proposal to the IRB. Initial Review: Exemption Determination (if applicable): Expedited Review (if applicable): Full Board Review (if applicable): Approval Decision: Ongoing Oversight:
An IRB must: have at least five members with varying backgrounds to promote complete and adequate review of the research activities commonly conducted by the institution; make every nondiscriminatory effort to ensure that the membership is not composed of entirely men or entirely women;

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Heidelberg University Institutional Review Board Instructions & Forms provide guidelines and documentation necessary for researchers to submit their research proposals to the university's Institutional Review Board (IRB) for ethical review.
All faculty, staff, and students conducting research involving human subjects at Heidelberg University are required to file these forms for IRB approval.
To fill out the forms, researchers must complete all required sections with detailed information about their research project, including the purpose, methodology, and how they will protect participants' rights and welfare.
The purpose is to ensure that all research involving human subjects is conducted ethically and in compliance with federal regulations and university policies.
Researchers must report information including the research title, study objectives, methodology, participant recruitment strategies, informed consent procedures, and measures for ensuring the confidentiality and safety of participants.
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