BIOM 641: Legal and Regulatory Issues and Bioethics and Institutional Review Board

2 semester credits, REQUIRED

This course is intended to provide a broad base of information about the legal and regulatory issues of the clinical research enterprise. Legal aspects of research with human participants will include the development of federal and state rules and regulations promulgation and implementation. Special topics concerning international harmonization and good clinical practice efforts will be discussed. Legal issues, such as the participation of children, women, prisoners, and impaired participants in clinical research, will be presented. Special attention will be given to stem cell and genetic therapy research. Information will also be provided about bioethical issues concerning the participation of human subjects in the clinical research enterprise. Ethical issues in clinical research such as voluntary participation, minimal risk, justice, and beneficence, will be presented. Text will include Dr. Bernard Lo’s Resolving Ethical Dilemmas, 2nd ed., Lippincott, Williams & Wilkins, 2000.

Professor: Assistant Professor Zoe H. Hammatt, JD, MPhil, and guest lecturers

Course Number : BIOM 641

Course Title : Legal and Regulatory Issues, Bioethics, and the Institutional Review Board

Course Credit : 2 semester credits

Prerequisite : MD, PhD, DDS, other clinical doctorate, or permission of instructor

Course Description

Through case discussions, students learn to identify and resolve ethical dilemmas that arise in clinical research, comply with local and federal regulations related to research involving human subjects, avoid research misconduct, and ensure protection of research participants’ safety and privacy. Students resolve the ethical considerations in the research protocol developed in the “Designing Clinical Research” course and learn to prepare human subjects sections of NIH applications. This course meets the NIH requirements for training in research ethics.

Learning Outcomes

Upon completion of this course, students will be able to perform the following:

  • apply ethical principles to the design and conduct of clinical research;
  • meet legal and regulatory requirements, including the HIPAA Privacy Rule, in the development and implementation of clinical studies;
  • avoid pitfalls in the research process, including scientific misconduct;
  • develop data safety monitoring plans and complete human subjects requirements for NIH applications;
  • grasp concepts related to genetic screening and stem cell research;
  • address authorship and IP issues in the context of research;
  • prepare proposals for IRB review;
  • recruit participants, obtain informed consent, conduct research and follow-up, store data, and disseminate findings in an ethical and responsible manner; and
  • maintain scientific integrity and professionalism in accordance with relevant policies and laws.

Topical Outline

General ethical principles relevant to clinical research

Protection of human subjects: legal and regulatory requirements

HIPAA privacy rules and human research

Sexual harassment, workplace harassment in the research setting

Responsible conduct of clinical research

Data safety monitoring plans, role of the research subjects advocate

Patient recruitment and consent to participate in clinical trials

Stem cell research and gene therapy, use of human tissues

Ethical use of animals in research, NIH requirements

Mechanisms and ethics of patenting in clinical research

Data record keeping and data management, authorship and IP issues

Preparation and review of grant applications and scientific papers

Institutional Review Board review

Scientific misconduct

Professional ethics and scientific integrity, university and federal policies

Required Text : Dr. Bernard Lo’s Resolving Ethical Dilemmas , 3 rd ed., Lippincott, Williams & Wilkins, 2005

Learning Experiences : Lecture, Case Studies, Discussion, Participation


Completion of Human Subjects Section of the NIH Application 40%

Preparation of Informed Consent 20%

Data Safety Monitoring Plan 20%

Participation 10%

Evaluation 10%