Instruction in the Responsible Conduct of Research
All trainees in the BIRCWH Program will be required to complete instruction in the responsible conduct of research. This will include didactic and hands-on training in bioethics, scientific integrity, and the responsible conduct of research. These topics are incorporated into the core curriculum of the BIRCWH via the MSCR Program. Additional training in this area will be offered by different departments/venues on the Emory campus including the Emory Humans Subjects Education Program, a bioethics course from the Center for Bioethics, and course from the GDBBS program.
Program Goals for Responsible Conduct of Research:
- Educate Emory BIRCWH Scholars on the ethical issues, Federal, State and local regulations and guidelines that support the proper conduct of clinical research in the U.S.
- Educate Scholars on the role of the Institutional Review Board (IRB) in assuring the proper conduct of clinical research throughout Emory University.
- Educate Scholars on the guidelines and standard operating procedures of the IRB of Emory University.
- Educate Scholars on their responsibilities as defined by Federal regulations, ICH guidelines and Emory University research procedures before, during, and after completion of a clinical research study or trial.
- Provide an ongoing educational process to continue the education and training of Scholars and ensure the continual protection of human subjects engaging in clinical research
Didactic Coursework: All scholars are encouraged to enroll in MSCR 593 Ethical, Legal, and Social Issues of Responsible Clinical Research, a one-credit course (15 hours of classroom instruction; seminar and lecture style) that addresses the ethical conduct of scientific research and covers the six areas of instruction mandated by the NIH for its National Research Service Award trainees, namely, data management, policies and procedures for handling misconduct, authorship and credit, conflicts of interest, the use of human subjects in research, and the use of animals in research. Topics include: the responsible collection, retention, sharing, and interpretation of data; research misconduct – data manipulation; responsible authorship; responsibilities in the editing and reviewing of journals and grant applications; the supervisor-trainee relationship; sexual harassment; conflict of interest; collaboration; peer review; the ethics of stem cell research; the ethics of using animals in research; ethical challenges in research with human biological material. The objectives of the course are:
- To meet federal requirements for training in ethical scientific conduct
- To improve behavior outcomes related to ethical decision making
- To improve moral reasoning
- To increase knowledge of ethical theory
- To develop core competencies in the responsible conduct of research
- To increase appreciation for ethical guidelines, standards, and etiquette
- To increase awareness of ethical guidelines, rules, and regulations related to research
- To increase the understanding of making and responding to allegations of misconduct
Emory Human Subjects Education: Depending on the nature of their research, scholars will be encouraged to participate in the following trainings;
- Emory University sponsored research training including key concepts in clinical research offered by the Office for Clinical Research, Emory conflict of interest training and certification, and Emory Center for Ethics lectures series on research ethics http://ethics.emory.edu/Events/CFE_Speaking.html.
- Protecting Human Research Participants training offered by the NIH Office of Extramural Research (available at http://humansubjects.energy.gov/ doe-resources/nih-trng.htm) and the Protecting Human Subjects Training offered by the US Department of Health and Human Services Office Health Resources and Service Administration (available at https://www.hrsa.gov/publichealth/clinical/HumanSubjects/training.html).
- Receive one‐on‐one mentoring from their primary mentors in the responsible conduct of research as part of the implementation of the mentee’s research project, including discussions about ethical challenges in conducting research on vulnerable populations such as HIV‐infected and pregnant or incarcerated populations, conflict of interest, responsible authorship, policies for handling misconduct, data management, and data sharing.