Are There Barriers to the Release of Paraffin Blocks for Clinical Research Trials? A College of American Pathologists Survey of 609 Laboratories

Context.—The number of paraffin blocks submitted for patients enrolled in clinical research trials appears to be declining. Objective.—To obtain information on laboratory policies and procedures in complying with requests to submit paraffin blocks for research. Design.—A questionnaire was sent to members of a voluntary market research panel composed of pathologists representing a broad spectrum of experience and practice settings. The questions addressed departmental policies and the likely responses to requests to submit pathology materials for patients enrolled in clinical trials. Results.—The survey was completed by 609 of 762 pathologists (80%) who responded to the invitation. More than 90% of respondents stated that they comply with these requests. Although 14% have a policy precluding the release of blocks for research, 84% of those will send limited tissue samples in lieu of blocks. When tumor is confined to a single block, most laboratories will not release the block but will send unstained slides. Very few laboratories require reimbursement before releasing tissues. Conclusions.—Pathologists attempt to comply with requests for materials but usually refuse to release the only diagnostic paraffin block so that materials are retained for possible future needs. Other problems identified in this survey include difficulties in getting blocks returned when needed and poor communication between researchers and laboratories. Lack of reimbursement and inadequate consent are not significant barriers to release of materials.