The practice of ethics committees

A brief news note welcomes the publication in September 1984 of a useful report, Guidelines on the Practice of Ethics Committees in Medical Research, by the Royal College of Physicians of London. One important recommendation in the Guidelines is that committees should be notified of adverse or unforeseen circumstances arising out of a study and should be sent abstracts or reprints of publications. If it emerges that clinical investigations have been conducted without reference to ethical review concerns, the committee should relay the facts to the institution it serves.     

Ethics consultants and ethics committees

To address moral questions in patient care, hospitals and health care systems have enlisted the help of hospital ethicists, ethics committees, and ethics consultation services. Most physicians have not been trained in the concepts, skills, or language of clinical ethics, and few ethicists have been trained in clinical medicine, so neither group can fully identify, analyze, and resolve clinical ethical problems. Some ethics committees have undertaken clinical consultations themselves, but liability concerns and variable standards for membership hinder their efforts. An ethics consultation service comprising both physician-ethicists and nonphysician-ethicists brings complementary viewpoints to the management of particular cases. If they are to be effective consultants, however, nonphysician-ethicists need to be "clinicians": professionals who understand an individual patient's medical condition and personal situation well enough to help in managing the case. Ethics consultants and ethics committees may work together, but they have separate identities and distinct objectives: ethics consultants are responsible for patient care, while ethics committees are administrative bodies whose primary task is to advise in creating institutional policy.     

Grassroots grappling: ethics committees at rural hospitals

Institutional ethics committees are a well-established mechanism for dealing with ethical dilemmas at large health-care institutions. The presence of these committees at small rural hospitals is a recent phenomenon. Because such hospitals are nonspecialized and isolated and have limited resources, they do not naturally encourage the development and growth of ethics committees. The experience of larger institutions with such committees is not readily adaptable, and role models are lacking. The experience of rural Vermont hospitals with ethics committees shows that these committees can function fully at small hospitals and have three stages of development. To accelerate the evolution of ethics committees at small rural hospitals, networking between these hospitals and an association with academic centers are needed. State medical societies can also support these committees by endorsing and sharing resources.     

Research ethics committees and public dissemination of clinical trial results

Biomedical research involving human beings is subject to codes of ethical conduct that mandate review, approval, and monitoring of clinical trials by research ethics committees (RECs). The role of RECs in public dissemination of results of research is not addressed explicitly in international codes or national regulations governing human research. I contend that RECs should have a prominent role in ensuring that trial results are publicly disseminated. I also propose specific responsibilities and actions that should be assumed and implemented by RECs to promote this objective.     

The prevalence and design of ethics committees in nursing homes

A dramatic increase in the number of ethics committees in long-term care facilities (LTCFs) has occurred since 1970 in the 487 nursing homes in Minnesota. Ten percent of the LTCFs had ethics committees which were mostly formed by administrators and nurses. The committees are most often found in large urban facilities with a high percentage of skilled-level beds and a religious name. The committees are multidisciplinary with a median of nine members including two to three nurses, a physician, a social worker, a minister, an administrator, and three other members. Nearly all committees were involved in policy development and staff education. Additional functions included resident care consultation and retrospective case review. More than half of the committees are accountable to administration. Nearly all committees kept minutes. Though all committees incurred costs, only one had a formal budget. Informal evaluation is done in only six committees. No committee had referred cases to the courts.     

Assessment by human research ethics committees of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research

Background: Conflicts of interest arising from pharmaceutical industry sponsorship of clinical research have the potential to bias research outcomes and ultimately prejudice patient care. It is unknown how Australian Human Research Ethics Committees (HREC) assess and manage such conflicts of interest. We aimed to gain an understanding of how HREC approach the problem of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research. Method: We conducted a survey of HREC chairpersons in New South Wales. Results: HREC vary widely in their approaches to conflicts of interest, including in their use of National Health and Medical Research Council guidelines, which were often misinterpreted or overlooked. Many committees rely primarily on researchers disclosing potential conflicts of interest, whereas a majority of HREC use disclosure to research participants as the primary tool for preventing and managing conflicts of interest. Almost no HREC place limitations on researcher relationships with pharmaceutical companies. Conclusion: These findings suggest reluctance on the part of HREC to regulate many potential conflicts of interest between researchers and pharmaceutical sponsors, which may arise from uncertainty regarding the meaning or significance of conflicts of interest in research, from ambiguity surrounding the role of HREC in assessing and managing conflicts of interest in research or from misinterpretation or ignorance of current National Health and Medical Research Council guidelines. Further review of policies and practices in this important area may prove beneficial in safeguarding clinical research and patient care while promoting continuing constructive engagement with the pharmaceutical industry.