Ethical Issues in Clinical Research
Good Clinical Practices at the Bluestone Center for Clinical Research
Researchers have responsibilities for honesty and integrity on all phases of research process.
It is not ethical to involve
subjects
in a study, with potential risks to them,
when a study has little chance of making a scientific contribution.
At the Bluestone Center we have a commitment to protect the rights and dignity
of our research patients or normal research subjects according the federal regulations
ICH and the
Guidelines of Good Clinical Practice.
Informed Consent
Consent to participate in a research study must be conducted on a volunteer basis. The most important ethical principle in studies that involve human subjects is an individual’s ability to agree to participate with full understanding of what will happen to him or her. Research
subjects
must be given their consent before taking part in a study.
The informed consent will
be used so that the subject:
- Can understand the information given to him/her by the research group
- Understands the potential risks and benefits of the research study
- Is able to question the procedures at any time during the course of the study
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