gwhap said
Not that I doubt you Susie, but why would the ethics committee nix a (any) study?? incompletness, bias, methodology, relevancy????
Ethics committees in the US will not allow research on human subjects if they could be harmed during a study.
The Declaration of Helsinki requires that all medical research be submitted to and approved by an ethics committee. It states: The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins. It is well understood that legal and ethical requirements for research vary from one country to another. Thus, in its review, an ethics committee will take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration.
Why the requirement for ethics review? The answer is straightforward. Research involving human subjects puts people at risk. The risks may be physical, psychological, social, economic, legal, or dignitary; a single study may also pose more than one type of risk to subjects. Of course, people are exposed to risks all the time, whether it is at work, in the doctor's office, or driving a car. The difference in research is that people are exposed to risk in large part for the benefit of others, be they other patients, the health system, or society at large. It is this feature of research that drives the need for independent ethics review. While the integrity of researchers remains an important protection for research subjects, researchers themselves may not be in a good position to make the best judgement regarding the ethical acceptability of a research study. Ethics committees ensure that the liberty and welfare interests of research subjects are protected, and that national and international ethical and legal requirements are upheld.
We understand the Declaration of Helsinki to require that all research involving human subjects be submitted to an ethics committee for review and approval, or to be determined exempt from the need for review. Unfortunately, the Declaration of Helsinki leaves some key terms undefined. Research may be usefully defined as a class of activities designed to develop or contribute to generalizable knowledge. A human subject is a living individual about whom an investigator (whether professional or student) obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. Therefore, any study that involves intervening upon people (e.g., a complex intervention involving educational sessions), interacting with them (e.g., conducting an interview or administering a questionnaire), or collecting identifiable private data (e.g., abstracting data with identifiers from a medical record) for the purpose of contributing to generalizable knowledge must be submitted to an ethics committee. This applies to studies involving healthcare providers as research subjects just as much as it does to studies involving patients. Therefore studies (with or without a research intervention) require ethics review if they involve interaction with human subjects or the collection of identifiable private information. Research using social, behavioural, or economic research methods may not include a research intervention, but such research exposes human subjects to risk nonetheless. Studies in which people are interviewed may pose psychological risks by asking sensitive questions or risks resulting from a breach of confidentiality. When researchers only collect identifiable information from patient medical records risks from a breach of confidentiality remain.
The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics.
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Too much shit involved. 😉
That's not an acceptable answer to a serious medical research question.