Are studies involving human subjects viewed differently than non-clinical studies?
Special concerns arise when human subjects are involved, as the subjects may be placed at additional risk because of an investigators financial interests. Situations which warrant additional consideration by the ISRC include those where an investigator has a financial interest in the sponsor or manufacturer of a product being tested on human beings, or in which the investigator is the inventor of the product. In such situations, the ISRC will review the role of the investigator with the financial interest in the project (is he/she involved in recruiting or consenting human subjects?) and the structure of the clinical study (is it a single-site, investigator-initiated study vs. a multicenter study with oversight provided by a sponsor or other third party?). The ISRCs recommendations for managing any conflict of interest will depend on the specifics of each case, but examples of typical management strategies include prohibiting the investigator who has a financial interest from participa
