All scholars in the Women’s Reproductive Health Research (WRHR) program are required to receive training in bioethics, the ethical conduct of research and protection of human subjects. At a time when ethical issues are gaining increased attention and scrutiny in academia and society at large, it is vital that scholars are formally exposed to information about accepted practices and invited to participate in ongoing debate.
All WRHR scholars will be required to complete the Course in the Protection of Human Subjects (CITI) Certification Program, designed to meet the new National Institutes of Health (NIH) requirements for training and education on the use of human subjects in research. The program includes online training on regulatory issues and policies and procedures associated with the use of human subjects in research, including a test designed to demonstrate knowledge of the materials. The certification program consists of the following modules: 1) History and Ethical Principles; 2) Basic Institutional Review Board (IRB) Regulations and Review Process; 3) Informed Consent; 4) Social and Behavioral Research for Biomedical Researchers; 5) Records-Based Research; 6) Genetic Research in Human Populations; 7) Research With Protected Populations — Vulnerable Subjects; and 8) FDA-Regulated Research.
All WRHR scholars will also be required to complete the HIPAA certification program, which is an online educational program for researchers covering federal regulations and other issues regarding privacy rights of patients and the handling of Protected Health Information. Ethical and Legal Issues in Clinical Research is a required course for all fellows. In addition, journal clubs and research seminars include discussions and presentations that focus on ethics and morality, as well as instruction in data collection, management and reporting. The goal of these discussions and presentations is to avoid misconduct resulting either from unintentional neglect or malicious plagiarism and fraud.
As part of the WRHR program, we will provide a yearly lecture series (four to five one-hour sessions) with handout materials, books, videos and open interaction between fellows and mentors about aspects of ethical conduct of research. A variety of topics will be covered, including:
- Humans as research subjects: The human subjects review process, the informed consent process, right-to-know issues, confidentiality of data, patient’s right to refuse participation, what happens if a patient refuses to participate, appropriate use of patient incentives and other pertinent topics.
- Inclusion of women, minorities and children in research involving human subjects: Policy of the NIH to include women and members of minority groups and their subpopulations in all NIH-supported biomedical, behavioral and health services research projects involving human subjects; policy of the NIH that children must be included in all research conducted or supported by the NIH unless there are scientific and ethical reasons not to include them.
- General issues germane to the conduct of science (humans, animals or solely bench research): These issues will also be dealt with explicitly including confidentiality of data, policies regarding authorship, the peer-review process, the trainee-mentor relationship, use of trainees in research, academic freedom and scientific misconduct.
The interactive lecture series on the responsible conduct of research will be given on a yearly basis. Lectures are based on several resource materials including: The AAMC Handbook, Instruction for Teaching the Responsible Conduct of Research, the booklet On Being a Scientist — Responsible Conduct in Research, and a video series called Integrity in Scientific Research (American Association for the Advancement of Science, 1996).
A final component of the training in the responsible conduct of research will include attendance at several IRB meetings. After observing a meeting, a “debriefing” or discussion between the scholar and mentor will occur to record observations and emphasize important points and lessons learned from the experience. This interaction will also include a brief assessment of the scholar’s understanding of major principles in the responsible conduct of research. Results will be documented in writing and placed in the scholar’s file. This assessment will evaluate whether the scholar has acquired the necessary knowledge and understanding to become an independent and ethical investigator.