Responsible Conduct of Research

Responsible Conduct of Research

Responsible Conduct of Research

Responsible Conduct of Research

Synopsis

This is a comprehensive introduction to the ethical issues at stake in the conduct of biomedical research, with extensive use of case examples. Its content parallels the recommendations of the Commission on Research Integrity, and deals with ethical issues in the use of animal and humans in research. It includes chapters on intellectual property, authorship, peer review, and conflicts of interest. As of October 2000, all personnel involved in research supported by the Public Health Service, including NIH, must receive the equivalent of 15 hours of training and education in research ethics. This book will be a convenient text for such short courses or seminars, and an excellent guidebook for all.

Excerpt

In the last decades of the twentieth century, media headlines featuring research misconduct in American universities focused public attention on the dramatic ethical problems that can arise in research. In some instances, investigators have been accused and occasionally found guilty of falsifying, fabricating, or plagiarizing data. Other cases have involved such allegations as the theft of ideas from grant applications and the abuse of human subjects in research protocols. There is widespread concern that public confidence in the scientific research establishment has been undermined. In the current atmosphere of accountability, the once-exempt research enterprise is now under increased scrutiny by the media, congress, and the public. In response to these pressures, there have been congressional hearings, legislative remedies, policies to manage conflicts of interest, policies to deal with research misconduct, national conferences on a variety of themes, the creation of the U.S. Commission on Research Integrity, the Office of Research Integrity (or ORI), and a proliferation of university-based research ethics courses and other less formal academic experiences.

Aside from concerns about research misconduct, the economic and commercial aspects of research have increased ethical problems and dilemmas in research and have heightened public awareness. Research and development (R&D) has become a big business with huge financial investments at stake. Money spent on public and private R&D in the United States alone now exceeds $200 billion per year, and the 2001 federal budget requests call for $95 billion per year in R&D spending. With all of this money at stake, conflicts of interest, sharing data, and intellectual property are prominent in R&D, whether conducted in a private laboratory or at a public university. The lines between academia and industry have blurred, as universities have entered into various agreements and arrangements with private companies. These public–private partnerships can have profound effects on the intellectual and moral climate of the university and can undermine protections for human and animal subjects.

New ethical issues dilemmas arise in research almost daily due to rapid and breathtaking advances in biotechnology and biomedicine, such as genetic engineering of plants and animals, genetic testing, gene therapy, in vitro fertilization, surrogate pregnancy, prenatal testing, preimplantation, genetic diagnosis, mammalian cloning, stem cell research, gene patenting, and the sequencing and mapping of the human genome. These breakthroughs raise important ethical, theological, and political questions for researchers and clinicians, as well as for society at large.

For some years, all trainees (students, fellows, and others) on grants from the National Institutes of Health (NIH) have been required to have some ex-

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