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1S 621/2017First published in the Government Gazette, Electronic Edition, on 30 October 2017 at 5.30 pm. No. S 621
HUMAN BIOMEDICAL RESEARCH ACT 2015
(ACT 29 OF 2015)
HUMAN BIOMEDICAL RESEARCH REGULATIONS
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How to fill out human biomedical research act

How to fill out human biomedical research act
01
First, familiarize yourself with the Human Biomedical Research Act (HBRA) and its regulations.
02
Understand the purpose and objectives of the HBRA, which include regulating biomedical research involving human participants and ensuring their safety and ethical treatment.
03
Identify the specific research project you are working on or planning to conduct.
04
Ensure that your research project meets the criteria and requirements set forth by the HBRA.
05
Obtain the necessary approvals and permits from relevant regulatory bodies before initiating the research.
06
Develop a comprehensive study protocol outlining the research methodology, participant recruitment process, data collection procedures, and ethical considerations.
07
Adhere to the guidelines and ethical principles set by the HBRA during every stage of the research.
08
Ensure that the participants provide informed consent covering all aspects of their involvement in the research.
09
Implement appropriate measures to protect the privacy and confidentiality of the participants' data.
10
Maintain regular communication with the regulatory authorities and report any adverse events or non-compliance issues that may arise during the research.
11
Conduct the research according to the approved study protocol and make necessary adjustments as required.
12
After completing the research, analyze the collected data, draw conclusions, and prepare a comprehensive report.
13
Submit the research findings, along with the final report, to the relevant regulatory bodies for review and evaluation.
14
Comply with any additional requirements or requests from the regulatory authorities regarding the research findings or the conduct of the study.
15
Regularly update your knowledge and keep abreast of any changes or updates in the HBRA and its regulations.
Who needs human biomedical research act?
01
The Human Biomedical Research Act is primarily needed by researchers and institutions involved in biomedical research with human participants.
02
Government regulatory bodies responsible for overseeing biomedical research also utilize the act to ensure compliance and protect the rights and well-being of research participants.
03
Ethics committees or Institutional Review Boards (IRBs) rely on the act to evaluate and approve research protocols before initiation.
04
Participants in biomedical research studies also benefit from this act, as it sets standards for their protection, informed consent, privacy, and ethical treatment.
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What is human biomedical research act?
The Human Biomedical Research Act is a legislation that governs the ethical conduct of research involving human subjects.
Who is required to file human biomedical research act?
Researchers and institutions conducting human biomedical research are required to file the Act.
How to fill out human biomedical research act?
The Act must be filled out with detailed information about the research study, including potential risks and benefits to participants.
What is the purpose of human biomedical research act?
The purpose of the Act is to protect the rights and welfare of human research subjects.
What information must be reported on human biomedical research act?
Information such as study protocols, participant consent forms, and data collection methods must be reported on the Act.
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