During the past year, Memorial Sloan-Kettering Cancer Center (MSKCC) used the funding received from the Human Subjects Research Enhancement Program Grant to enhance our program involving human subject research in non-therapeutic trials. The focus involved (1) Data and Safety Monitoring, (2) Third Party Rights, (3) Informed Consent Process and Document, and (4) Subject Participation in Clinical Research. Activities in each of these areas have improved processes, and produced new templates and assessment tools. Funding for an additional year would enable us to validate specific instruments and to apply and evaluate the proposed improved processes. As described in this application, we plan to accomplish this in collaboration with the City College of New York (CCNY), a public university with a primary minority enrollment, located in Manhattan This proposed collaboration will be achieved without difficulty based on prior relationships between the instuitions resulting from a NCI U56 award. During the next year, working with CCNY, we will continue activities in three of the four areas of focus previously described and replace """"""""Subject Participation in Clinical Research"""""""" with """"""""Educational Program on Human Subjects Issues in Cancer Research."""""""" Working groups comprised of members from both MSKCC and CCNY will: (1) validate the Data and Safety Monitoring Risk Assessment Tool in a series of protocols from both intuitions, (2) develop supporting educational materials for Third Party Rights based on developed guidelines and implemented programs, (3) pilot and assess the new consent templates designed for non-therapeutic research in MSKCC/CCNY collaborative studies, and (4) strengthen the capacity of the CCNY IRB to monitor and oversee research in cancer related studies by working jointly to develop and conduct educational programs for CCNY investigators.
| 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 |
