Responsible Conduct of Research

A critical and early requirement for any new graduate student in the sciences and engineering is appropriate education concerning ethical conduct in research. All BTP Trainees are required to take a course entitled “Science, Integrity and Me”. This course is open to all graduate students from participating programs (including BTP Associate members), but it is capped at 20 participants for each session to ensure active participation and interaction. Several BTP Faculty have developed and presented ethics curriculum for a variety of courses at UMA and beyond, including Roberts, Thayumanavan, Hardy, Garman, and Osborne. These faculty have collaborated with additional BTP Faculty to design a course (described below) that prepares students to be conscientious scientists and engineers in a biotechnology context. The NIH Policy on Training in the Responsible Conduct of Research (RCR) has been carefully reviewed and the five instructional components are addressed here.

The course format consists of four two-hour sessions, taught annually during the winter intersession. The BTP program requires all participants to read the book published by The National Academy of Scientists entitled “On Being a Scientist: Responsible Conduct in Research” prior to the start of class. This booklet presents the social and historical context of science, including credit for scientific discovery, issues surrounding publication, and human values and biases, providing students with a baseline understanding of what constitutes responsible research. Additionally, each participant will be required to watch the short video that accompanies this publication that provides a concise introduction to research ethics. Each session is taught by one member of the BTP Training Faculty. Teaching of this class is annually rotated to ensure all members of our Training Faculty assume a leadership role in educating students in responsible conduct of research. All sessions incorporate case studies both relevant to the ethical topic at-hand and to biotechnology. To place the research ethics training in a biotechnology context,some case studies are incorporated from ethical dilemmas relevant to modern biotechnology including selective breeding, environmental implications of genetically modified organisms, study and use of stem cells and human genomics. A number of both general scientific and biotechnology-related case studies are available from online resources including the Iowa State Bioethics Program, National Center for Case Study Teaching in Science at the University of Buffalo and the Illinois Institute of Technology Center for the Study of Ethics in the Professions. Before each class period, case studies are distributed to students as required reading. Students are provided with guidelines on how to effectively analyze case studies to help them prepare their talking points prior to the class period. Small groups (~4 students) are tasked with choosing a student presenter to present the case to the class-at-large. Presenters will introduce the case study, summarize key points and suggest appropriate actions. This format enables active learning, encourages all students to participate, and exposes students to “real-life” situations they may encounter in their research careers.

The subject matter of the class covers a variety of topics that address conflict of interest, data acquisition, authorship and publication, collaborative research, human subjects/vertebrate animals and responsible mentorship. The four class meetings each have a theme that encompasses a major aspect of responsible conduct of research. BTP develops curricular materials from Responsible Conduct of Research resources, available online at: http://bioethics.od.nih.gov/researchethics.html. The four central themes and proposed topics to be addressed in each theme are outlined below. Also included are initial faculty leaders.

1)    Mentor/Mentee Relationships (Hardy)

  • How do I choose an advisor? What constitutes a good mentor/mentee relationship?
  • How is authorship assigned in this laboratory? How are author conflicts resolved?
  • What steps should be taken if the relationship is compromised or disintegrates?
  • What constitutes a conflict of interest?
  • How can I position myself to graduate with a strong letter of recommendation?

2)    Data Acquisition and Management (Schiffman)

  • Who owns the data? Whose job is it to ensure the accuracy and security of the data?
  • What is intellectual property and why is it important that I understand regulations concerning IP?
  • How can I ensure data are accurate? What are the standards for reproducibility and statistical significance in biomedical research?
  • Can I share my data with others in my lab, at my university or with anyone outside my lab?
  • What constitutes unacceptable data handling/manipulation?

*Note: we will invite the Director of the UMA Commercial Ventures and Intellectual Property Office as a guest lecturer for this unit.

3)    Research Misconduct and Policies Regulating Misconduct (Thayumanavan)

  • What is plagiarism and how do I recognize and avoid it?
  • How do I deal with suspected misconduct?
  • What are my University policies covering misconduct?
  • Are there federal policies that deal with misconduct?

4)    University and Federal Policies Managing Human Subjects, Vertebrate Animals (Alfandari)

  • What is IACUC and why is it important?
  • How do I write an IACUC protocol?
  • What considerations should be taken in designing an animal-based experiment?
  • What regulations address research with Human Subjects?
  • Why is it important that I know about IACUC and Human Subjects if I work with yeast or coli?

*Note: students are required to complete the online training module “Protecting Human Research Participants” offered at the NIH Office of Extramural Research.

Additionally students are provided with the UMass Graduate Student Academic Honesty Policy and Honor Code and specifically present UMA processes and procedures (including relevant campus offices and personnel) for reporting ethical misconduct so that students have knowledge and resources to handle ethical dilemmas if they arise during their graduate career. There are several ethics courses offered at UMA in various STEM disciplines. A complete list will be provided to trainees who wish to obtain additional or refresher training.

sample case study, one of several that will accompany Topic III: Research Misconduct and Policies Regulating Misconduct, is adapted from The Resources for Research Ethics Education website (http://research-ethics.net/), an excellent site that provides numerous resources for research ethics education.