The written information that will be presented to a potential study candidate, as required by the FDA, must include a comprehensive description about the study drug, including the potential benefits and risks associated with the study, as well as notification of alternative treatments available besides the study. This regulatory requirement of obtaining written informed consent from a potential study participant is central to the regulatory and ethical guidelines for involving humans in biomedical research. In order to make an informed choice, as to whether or not a person wishes to participate in a study, they must first be given an opportunity to read and understand what they are committing to. Equally important, a study participant can always withdraw from study participation, for any reason, without any penalty or loss of benefit. However, it is always advisable to exit from study participation in the same orderly fashion as described in the enrollment process above.

Once an individual decides that they want to take part in a study, their health history is thoroughly reviewed and their current medical state is assessed to determine if they meet selection criteria for study enrollment. A patient that is enrolled into a study is followed under the direction of a licensed medical doctor for the duration of the study or until such time that they withdraw for personal or medical reasons. All studies vary in the type of participant being sought, the medical indication and timeframe. However, the regulatory and ethical requirements related to clinical research apply under every circumstance regardless if the study is for a nuisance symptom, like athletes’ foot, or a life threatening condition such as cancer.

Individuals who participate in clinical research with our clinic are provided with study-related clinic visits, diagnostic tests and study treatment at no cost. In addition, study participants are paid a pre-determined amount of money for completing planned study visits. This payment is intended to reduce or eliminate any out-of-pocket costs associated with time and travel. Clinical research studies make no claim of benefit to a study participant, as in being able to relieve or cure a medical condition, but under no circumstances would a participant be continued in a study if it is not in their best interest from a medical perspective. If the condition under study does not improve, or even worsens, the participant would be discontinued and every effort would be made to facilitate a conventional treatment plan using currently available medications or therapies. Ultimately, any benefit an individual study participant derives is of their own determination, sort of like beauty being in the eye of the beholder. If the study medication relieves symptoms or improves one’s quality of life, that may be considered a benefit. If the no cost healthcare received by a study participant is of value to the individual, this too may be considered a benefit. However, any perceived or realized benefit from study participation is entirely subjective.