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102 RPP POLICIES AND PROCEDURES Research Compliance Services Human Research Protections Institutional Review Board Policy # 5.002 Research Involving Pregnant Women, Title: Human Fetuses, and Neonates

How to fill out human research protections

How to fill out human research protections:

1. Begin by familiarizing yourself with the relevant regulations and guidelines for human research protections. This may include reviewing institutional policies, federal regulations (such as the Common Rule), and guidance documents from the Office for Human Research Protections (OHRP) or other regulatory bodies.
2. Determine the appropriate level of review required for your research. Depending on the nature and risk level of the study, it may require review by an Institutional Review Board (IRB) or an independent ethics committee. Contact your institution's research administration office for guidance on the review process.
3. Complete all necessary application forms or protocols for the review. This typically includes providing detailed information about the study design, study population, data collection methods, potential risks and benefits to participants, and how informed consent will be obtained.
4. Ensure that you have all the required supporting documents ready for submission. This may include recruitment materials, consent forms, data collection instruments, investigator qualifications, and any other relevant documentation specific to your study.
5. Submit your application along with all supporting documents to the appropriate review body. Follow any specific submission instructions and deadlines provided by the IRB or ethics committee.
6. Address any feedback or revisions requested by the review body. They may provide additional questions or clarification requests that need to be addressed before approval can be granted.
7. Once approved, ensure that you adhere to all the requirements and conditions set forth by the IRB or ethics committee. This may include periodic reporting, maintaining documentation for a specified period, and informing the review body of any changes to the study protocol.
8. Regularly monitor and evaluate the progress of your research, ensuring participant safety and compliance with the approved research plan. Promptly report any unanticipated issues or adverse events to the responsible review body.

Who needs human research protections?

1. Researchers conducting studies involving human subjects need human research protections. This includes scientists, academics, healthcare professionals, and other individuals involved in designing and implementing research studies that involve human participants.
2. Institutions where the research is conducted, such as universities, hospitals, or government agencies, also have a responsibility to ensure the protection of human subjects. They typically have policies and procedures in place to review, approve, and oversee research involving human participants.
3. Research sponsors or funding agencies may also require researchers to comply with human research protections as a condition for receiving funding or support. This helps ensure that ethical standards are upheld and participant rights are respected in the research they fund.

Note: It is important to consult with the specific regulations and guidelines applicable to your country and institution, as human research protections may vary.

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What is human research protections?

Human research protections are regulations and guidelines put in place to ensure the safety, rights, and well-being of individuals participating in research studies.

Who is required to file human research protections?

Researchers and institutions conducting human research studies are required to file human research protections.

How to fill out human research protections?

Human research protections can be filled out by following the guidelines provided by the Institutional Review Board (IRB) or the relevant regulatory authorities.

What is the purpose of human research protections?

The purpose of human research protections is to protect the rights, safety, and well-being of research participants and ensure that research is conducted ethically.

What information must be reported on human research protections?

Information that must be reported on human research protections includes details about the study protocol, potential risks and benefits, informed consent process, and measures to protect participant confidentiality.

How can I get human research protections?

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