Clinical Research: A Reaffirmation of Trust Between Medical Science and the Public Proclamation and Pledge of Academic, Scientific, and Patient Health Organizations
Whereas the future of medicine and health depends on an enduring collaboration and trust between scientific researchers and patients, and
Whereas recent, widely reported problems in clinical research have shaken public trust, and
Whereas research integrity is paramount to achieving good science and valid results, and
Whereas the ethical and responsible conduct of research involving human beings is essential in order to develop tomorrow's therapies and cures, and
Whereas by volunteering to participate in clinical research, patients make an essential and irreplaceable contribution to science and society, agreeing to take part in procedures that often have no known direct benefit to them as individuals while at times putting themselves at some measure of risk, and
Whereas in return for this contribution and for the trust that they place in researchers, research volunteers have a right to expect that they be treated with beneficence, justice, and respect, and
Whereas the health and welfare of patients must always be placed above all other concerns,
BE IT THEREFORE RESOLVED that the undersigned medical schools, teaching hospitals, patient groups, health care associations, scientific societies, and other organizations reaffirm their commitment to the safe and ethical pursuit of the new knowledge necessary for the development of treatments and cures. We are committed to the protection and preservation of the right and welfare of all the individuals who volunteer to participate in human subjects research.
We pledge ourselves, our institutions, and our researchers to uphold and ensure:
The principles of beneficence, justice, and respect for individuals;
The rights of patients and the responsibilities of researchers;
The inviolable trust of informed consent, freely given by anyone who volunteers to participate in research. Informed consent means:That patients are informed of any reasonably foreseeable risks and benefits of participating in the research activity; and
That patients understand that research procedures are not necessarily treatment and, in given instances, may not benefit themselves in any way and may possibly harm them.
That no coercion whatsoever, financial or otherwise, is used to induce patients to enter into or to remain in a research project; and that patients have complete freedom of choice as to whether to withdraw from a research activity;
The central importance of, and adherence to, the procedures mandated by federal human subjects regulations, which prescribe a process by which research protocols are reviewed with attention to safety, ethics, and the protection of human participants;
That the potential benefits to the individual and society exceed any known risks before studies involving human subjects research begin;
The provision of adequate resources, training, and oversight for, and the creation of, a climate of support and respect for Institutional Review Boards (IRBs), which play a critical role in ensuring the integrity of human subjects research and in the federally-mandated process for monitoring research protections; and
Respect for and adherence to other rules, laws, and recognized codes that guide the ethical conduct of research generally. Such rules include those pertaining to conflicts of interest, misconduct, privacy and confidentiality, genetics research, and others.