Plan for Instruction in the Responsible Conduct of Research on National Research Service Award (NRSA) Applications
Office of Scientific Affairs
Sara Rockwell, Ph.D., Director
SHM I202
Telephone: 203/737-1870
Fax: 203/737-1771
September 30, 1999
Every National Research Service Award (NRSA) trainee must receive instruction in the responsible conduct of research. Each training grant application must include a description of the plan to provide trainees with formal and informal instruction on scientific integrity and ethical principles in research. Although NRSA does not specify a curriculum or format for this instruction, it does suggest that certain areas be considered, including conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management.
Because the training programs at the Yale University School of Medicine are exceedingly diverse, it is not feasible to develop a single, institution-wide curriculum that would fully meet the needs of each and every program. Moreover, the School recognizes that training in the responsible conduct of research is most effective in the context of the day to day activities of the trainees. Each training grant application, therefore, should include a plan that has been developed to meet the specific needs of the trainees in that program.
A rich array of institutional resources is available to program directors to assist them with their training efforts and to supplement courses and lectures given within the program. These resources are described below. Investigators writing NRSA training grants may incorporate any or all of this information into their applications, as fits their needs.
Yale University and the School of Medicine have developed principles and practices to ensure the highest possible standards for conducting biomedical research. Policy Statements describing these principles and practices are distributed to every investigator and trainee. Copies are also available in the Office of Scientific Affairs, in the library, and in some cases on the Internet through the Grant and Contract Administration/Scientific Affairs home page. The Guidelines for the Responsible Conduct of Research at Yale University School of Medicine, published in 1991, defines the responsibilities of researchers and institutional officials and describes accepted standards for the conduct of research. This document specifically discusses issues related to the management of data, authorship of scientific papers, and the evaluation of research. Policies and Procedures for Dealing with Allegations of Academic Fraud at Yale University, revised in 1989, describe institutional policies and procedures in this area. The Yale University Copyright Policy, the Yale University Patent Policy, and the Yale University Policy on Conflict of Interest and Conflict of Commitment all describe institutional policies of importance to the responsible conduct of research. Institutional guidelines and informal practice related to the responsible conduct of research are also summarized in the Faculty Handbook and in the Information Guide for Junior Faculty.
Yale University and the School of Medicine have developed policies and procedures for ensuring the responsible review, approval, performance, and oversight of research involving human or animal subjects. These are reviewed and refined continually, and manuals describing them are available to all Yale researchers, including trainees. Policies to approve the use of radioactive isotopes and to ensure the safe use of radiation are likewise in place and undergo constant internal review and refinement by the Radiation Safety Committee and the Office of Health and Environmental Safety. Policies on research involving chemical hazards, biological hazards, and recombinant DNA are treated analogously. Specialized training programs are offered by the University for researchers who plan to perform studies which involve these areas. The training programs include didactic lectures, required and supplementary readings, and supervised laboratory experiences, as appropriate for the specific situation. Before an investigator can begin active research at Yale in the areas described above, participation in the appropriate training programs is required; in some situations periodic retraining and recertification is also required.
The educational activities of individual departments and training programs in the responsible conduct of research are supplemented by lectures and workshops offered on a School-wide basis. Programs include speakers from Yale at brown-bag lunches and the Institute for Social and Policy Studies as well as visitors from other institutions. All programs are widely advertised within the Yale community by fliers, by notices on institutional websites, by announcements mailed to researchers, and by publication in the Yale University and Medical Center calendars. Frequent sponsors of such programs include the Office of Scientific Affairs, the Office of Academic Development, the Dean's Office, the Program for the Humanities in Medicine, and the Office for Women in Medicine. Such programs occur frequently (at least once per month); attendance varies with the format, topic, and speaker, from small discussion groups to large audiences of 100-200 people. The Medical Library holds extensive collections of publications on ethical issues in research and in medicine. Copies of several publications on research ethics are available in the Funding Resource Center, including On Being a Scientist and Ethics and Regulation of Clinical Research.
October, 1999