Over the past several years, Memorial Sloan-Kettering Cancer Center (MSKCC) has implemented formal policies to strengthen the oversight of our human subjects research programs. The policies are detailed and specific with the intent of ensuring the protection of human subjects participating in our diverse and voluminous clinical research program. Through the implementation and monitoring of the new policies, we have determined that the procedures outlined do not always apply directly to the active protocols in our diverse clinical research program. The area of greatest concern is non-therapeutic (e.g., behavioral, epidemiologic, etc.) clinical research and therefore that will be the focus of this RFA application. Social science and behavioral researchers are forced to comply with the existing and enhanced regulatory requirements for human subjects research; however the regulations are modeled after standard biomedical clinical trials research. The non-therapeutic clinical investigators at MSKCC have identified several areas within our new policies that do not appropriately address their specific types of research (e.g., surveys, control-subjects, etc.) and, in some cases, adds an extra layer of reporting that is not relevant (e.g., reporting a breast cancer death as an adverse event to a behavioral intervention trial) to their research objective. It is our opinion, that there are four areas that are critical to the concerns of human subjects research and deserve further evaluation to enhance and strengthen the oversight of MSKCC's clinical research programs. The four areas of focus are: Informed Consent Process and Document, Third Party Rights, Data and Safety Monitoring, and Subject Participation in Clinical Research. MSKCC will use the resources provided by this application to evaluate the existing procedures for human subjects protection in non-therapeutic clinical research, and establish new policies and procedures to address the issues outlined in the application while improving the overall protection of the human subjects participants and producing the highest quality clinical research.
| Lounsbury, David W; Reynolds, Thomas C; Rapkin, Bruce D et al. (2007) Protecting the privacy of third-party information: recommendations for social and behavioral health researchers. Soc Sci Med 64:213-22 |
