Home About this Guide

About this Guide

This guide serves as a summary and analysis of the ethical issues involved in medical center collaborations with commercial tissue repositories. Research tissue repository companies are commercial entities interested in establishing agreements with medical centers to collect patients' donated tissue and related clinical information for future distribution to bio-medical researchers. Repositories typically contact medical center pathologists at the starting point of such initiatives and interested pathologists, in turn, seek out legal and ethical counsel. Early in the process, medical centers typically consult with the Institutional Review Board (IRB) regarding ethical issues of patients as tissue donors. The IRB is charged with protecting the rights of human subjects (participants) in research. Collecting tissue for research is not itself research. Similarly, tissue donors are not human subjects. These two points make a review of a commercial collaboration proposal challenging for an IRB. It is well-documented that medical center IRBs often are overworked, understaffed. Acquiring additional training to address new proposals in these areas can be a daunting task. Many IRB members may feel ill equipped to devote the time needed to learn about these new collaborations in detail, as well as in the new field of research (clinical genomics and proteomics) and new area of commerce (commercial research tissue repositories). Even for those IRBs who have the time for self-education, it is difficult to find any useful information regarding the new ethical issues associated with such proposals.

This guide was written by Julien Murphy, Ph.D., Director of the Bioethics Project at the University of Southern Maine and Karen Rasmussen, Ph.D., Director of Clinical Genetics, at the Maine Center for Cancer Medicine, Scarborough, Maine. We received our funding from the Greenwall Foundation. We did not receive any funding or other financial incentives from commercial repositories. We appreciate those members of medical center IRBs and commercial repositories who generously shared their knowledge with us. The guide reflects our understanding of the ethical issues in these new collaborations. The views expressed in this guide are our own. We do not claim to have the definitive approach or analysis of the relevant ethical issues. What we offer in this guide is not intended to encourage or discourage collaborations between medical centers and commercial repositories. Rather, the goal is to identify and discuss the major ethical issues. Given that the field is continually evolving, this guide represents a framework for decision-making. While every collaboration is no doubt unique, along with the institutional structure of each medical center, we assume a typical repository proposal in the discussion that follows. Our hope is that whatever decision a particular IRB or individual makes is better informed as a result of using this guide. We intend to keep the guide updated. We welcome your comments.

Who is this Guide meant for?

This guide is designed to inform and elicit discussion on the key ethical issues of collaborations between medical centers and commercial research tissue repositories. It is designed to be used by:

• Institutional Review Board Members
• Pathologists
• Medical Center Ethics Committees
• Bioethicists
• Researchers who obtain tissue or data from repositories
• Ethics/Policy Committees of Research Repositories who may wish to review their policies and procedures
• Policy makers who wish to safeguard protections for participants in medical research
• and others involved in decisions about establishing human tissue repositories for research

The guide lists the steps of standard discussions inherent in repository decision making. We begin with the most basic, fundamental questions, (e.g., Is research on excised human tissue a type of human subject research?). The questions progress to more refined issues that need only be discussed if a medical center decides to go forward with a collaborative commercial tissue repository (e.g., Should there be oversight committees?)

The guide offers an overview of ethical issues to consider in assessing specific collaborations with commercial research tissue repositories, including specific types of repositories, a discussion of enhanced patient informed consent ; risks and benefits to patients to researchers, and medical centers. We also discuss the impact on patient care and the potential impact on medical centers' missions. There is an assessment criteria for collaborating medical centers who wish to re-assess their agreements.

Writing an ethics guide for IRBs on this topic is a daunting task. There is little published information available and some of it is contradictory or vague. In addition, the regulatory climate is uncertain. The current regulations were written before the genome was mapped and before commercial repositories were established. We hope that the guide will be of use to you. We also hope that through your comments and our updates, the guide can function as an interactive forum on ethical changes in the use of research tissue. Please e-mail us your comments. (See: Contact Us).