An ad hoc committee will plan and host a 1.5-day public workshop to examine current issues in human subjects protections in cancer research. The workshop will feature panel discussions and invited presentations from experts and advocates in clinical cancer research and oversight. A major goal of the workshop will be to examine current regulatory provisions that may not adequately protect patients or may be hindering research, and to discuss potential strategies and actions to address those challenges.

Participants will be invited to discuss topics that may include:
· Use of central institutional review boards for multi-center cancer studies,
· Use of materials and data (including genomic data) stored in biobanks for cancer research,
· Informed consent and authorization forms,
· Risk-based oversight of clinical effectiveness assessment in a learning health system, and
· Potential changes to the Common Rule delineated in the recent ANPRM.

An individually authored workshop summary will be prepared in accordance with institutional policy and procedures by a designated rapporteur based on the information gathered and the discussions held during the workshop.