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Central Research Ethics Committee; CECAL 02/ v.3.0 Certificate of Approval 1. 2560OFFICE: CENTRAL RESEARCH ETHICS COMMITTEE (CREC) 5th Fl Building 2, The National Research Council of Thailand Paholyothin
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Start by clearly stating the purpose of the study protocol and consent form.
02
Provide detailed information on the study procedures, including any risks and benefits involved.
03
Include a section on participant eligibility criteria and how participants will be recruited.
04
Clearly outline the voluntary nature of participation and provide information on how to withdraw from the study.
05
Include sections on confidentiality and data security to protect participant information.
06
Ensure that the language used is clear and easily understandable by the target audience.
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Have a qualified individual review the protocol and consent for accuracy and completeness before implementation.

Who needs study protocol and consent?

01
Researchers conducting studies that involve human participants.
02
Institutional Review Boards (IRBs) or Ethical Review Committees that oversee research involving human subjects.
03
Funding agencies that require documentation of study protocols and consent procedures.
04
Participants in the study who need to understand their rights and responsibilities before agreeing to participate.
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Study protocol is a detailed plan of a clinical research study outlining its objectives, methodology, and procedures. Consent is the agreement given by participants to voluntarily participate in the study after understanding all relevant information.
Researchers or investigators conducting a research study are required to file the study protocol and consent form.
Study protocol and consent forms are typically filled out by researchers or investigators following specific guidelines provided by the research institution or ethics committee.
The purpose of study protocol and consent is to ensure the protection of participants' rights, safety, and well-being during the research study.
Study protocol and consent forms must include details about the study objectives, methodology, risks and benefits, confidentiality, contact information for inquiries, and the voluntary nature of participation.
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