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Common Data Set 2009-10 A. General Information A0 A0 A0 A0 A0 A0 A0 A0 A0 A0 Respondent Information (Not for Publication) Name: JR Berlin Title: Institutional Research Coordinator Office: Institutional

This paper is not intended to serve either as a regulatory, law enforcement, or medical professional certification document. The purpose of presenting this paper is to raise awareness that clinical trials have an important function and are not necessarily inherently flawed. We hope that this paper will raise awareness among both investigators and participants that clinical trials for human participants are designed and executed well, with careful evaluation being employed. The purpose of this document is to highlight the following considerations in the planning, design or execution of any clinical trial, and provide suggestions for how clinical trial participants who are concerned about possible flaws in the design and execution of clinical trials for human participants can contribute to the development of the scientific foundation of this field: 1. Determining that an investigator's methods, methods, methods, methods are ethical (i.e., in line with the ethical conduct of clinical research or clinical trials) and acceptable (i.e., in light of principles, laws and regulations of the relevant discipline or the jurisdiction in which the investigator conducts the study) 2. Finding flaws in a clinical trial design or the design of a clinical trial (i.e., if you are having an issue with the design or execution of a clinical trial for human participants, you should write to the investigator asking for the reasons for your opinion, explaining how you feel these flaws affect your role in the trial. In general, a participant who does not know the details of the design or execution of a study is less likely to be able to evaluate it critically. 3. Knowing about the issues with a clinical trial for human participants to raise questions about the adequacy of the conduct of a particular clinical trial. For example, do I think a specific trial does not comply with regulations in the jurisdiction in which it is being conducted? Do you think a specific trial does not comply with principles of medical ethics or ethical conduct of clinical research? 4. If it is established that a study does not comply with principles of medical ethics or ethical conduct of clinical research, this should prompt a reconsideration of the ethics of conducting that particular trial. A1.1.

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