INCTR Establishes Ethical Review Committee

The INCTR established an Ethical Review Committee (ERC) in January. The ERC includes scientists, medical experts, ethicists, patient representatives and laypersons, all of whom volunteer their services to the INCTR. At least two members of the committee will have first-hand experience in clinical practice or conducting research in developing countries.

The ERC functions similarly to an institutional review board (IRB) in the USA or a French "Comité consultatif pour la protection des personnes dans la recherche biomédicale" (CCPPRB). The specific tasks of the committee are:

• to provide guidance, advice and decision (in the form of approval/disapproval) of research protocols sponsored by or otherwise significantly engaged in by the INCTR;
• to provide ethical guidance and advice on specific ethical issues presented to it by the INCTR staff; and
• to develop and/or review, as requested, ethical guidelines for the INCTR.

All protocols that the ERC approves will also need to be approved by national and/or local ethics committees prior to implementation in participating centers in developing countries.

The INCTR is fortunate to have, as committee chairman, Dr Francis P Crawley, Chair of the Ethics Working Party of the European Forum for Good Clinical Practice. The ERC recently met to decide upon its procedures for decision-making and to review the INCTR-Osteosarcoma Strategy Group protocol for the treatment of patients with newly diagnosed metastatic osteosarcoma.