HB Prospective Observational Consent Form Template 2025

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There is no uniformity regarding the requirement of approval from the Ethical Committee for an observational study design among scientific journals. A few journals require it even for case reports, or case series, while others do not require it even for prospective observational studies.
However, there is likely an expectation of obtaining consent in a bounded observational space, such as, a classroom, a homeless shelter, or a hospital emergency room. In most cases, you will need to obtain informed consent from those you are studying.
Obtaining informed consent in medicine is a process that should include describing the proposed intervention, emphasizing the patients role in decision-making, discussing alternatives to the proposed intervention, discussing the risks and benefits of the proposed intervention, and eliciting the patients preference,
The Consent Form used in a study should be edited to match requirements of the specific study: It should include information about the investigator, the topic under study, and a clear description of purpose, risks, and benefits.
As Dan Brock puts it, The rule that, with a few exceptions, research with humans should not take place without participants informed consent is a settled ethical and legal principle.

People also ask

I participant name, agree to participate or agree to participation of my child participant name in the research project titled project title, conducted by researcher(s) name who has (have) discussed the research project with me. I have received, read and kept a copy of the information letter/plain language statement.
If consent is an obstacle for conducting the study, the Board may consider waiving consent but otherwise for observations that dont meet the exemption qualifications, the Board will require that the researcher obtain consent from participants.

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