LLAW6250 The Regulation of Biomedical Research

1.1 Course details

Course code: LLAW6250 / JDOC6250
Course name: The Regulation of Biomedical Research
Programme offered under: LLM Programme / JD Programme
Semester: Second
Designated research course: Not applicable
Specialization: Not applicable
Prerequisites / Co-requisites: No
Credit point value: 9 credits / 6 credits

1.2 Course description

The course is aimed at students seeking a understanding of the framework of legal and ethical regulation (both locally and internationally) of biomedical research in all its common aspects, particularly in the context of international standards for clinical trials (pharmaceutical trials); direct human experimental and biomedical research involving human subjects; ‘non-invasive’ epidemiological and other studies involving only the use of data; human tissue banking; cohort studies; biobanking; genetic testing and screening, genomic research; the use of ‘legacy’ diagnostic tissue or data collections; the sharing of personal, medical and genomic information; public ‘diseases registries’ and the use of medical information for public health purposes; the legal and ethical regulation of multi-centre and multi-jurisdictional collaborative biomedical research; international standards for ethical governance of biomedical research at the institutional level (through IRBs, ECs, HRECs); EMR (electronic medical records) databases; data-mining and the implications of migration to large-scale national health records systems.

Fundamental concepts such as the informed consent of subjects (at common law and under ICH rules) with particular emphasis on the consent given by or on behalf of minors, incompetent subjects and vulnerable populations, return of benefits to research subjects or research subject populations, assessment of risks, randomized controlled trial (RCT) and clinical equipoise will be considered in the context of clinical trials, as well as the impact and requirements of international guidelines.

The course seeks to help legal practitioners understand and keep abreast of developments (and to enable them to advise the medical and biomedical research sector) in the rapidly developing field of biomedical research, and to equip them with the basic language and vocabulary necessary to follow and keep abreast of legal and ethical developments in the field. The particular focus of the course is biomedical research carried out by biomedical researchers who are also registered physicians, on research subjects (or personal or medical data relating to such subjects) who are also the patients of the physicians.

1.3 Course teachers

Name E-mail address Office Consultation
Course convenor Calvin Ho cwlho@hku.hk TBA By email


2.1 Course Learning Outcomes (CLOs) for this course

CLO 1 Describe and explain the differences between the relationships of physician-patient, and that of researcher-subject, with special attention to the conflict of interests which may arise where the physician also acts as researcher, and where the patient is also the subject, or the source of the subject research tissue or data. Propose and describe measures for the management and resolution of such conflicts in specific settings, such as that of the registered physician who is at once a practicing clinician as well as a biomedical researcher in a research and teaching hospital.

CLO 2 Critically examine the approaches to the taking of consent from research subjects, particularly in the context of clinical trials, minors, incompetent persons, or vulnerable populations.

CLO 3 Describe and explain the international framework for the conduct of clinical trials under the ICH Guidelines regime.

CLO 4 Critically examine and analyze current international developments in the legal and ethical regime for the sharing of medical and genetic information as well as of research tissue and genetic samples.

CLO 5 Consider what regulatory gaps exists in Hong Kong that needs to be filled from the legal and ethical perspective, with a view to establishing Hong Kong as a leader internationally the field of biomedical research, particularly in the field of tissue banking, biobanking and genomic research.

2.2 LLM Programme Learning Outcomes (PLOs)

PLO A On successful completion of the curriculum, students should be able to demonstrate a solid understanding of the body of legal knowledge and the capacity to conduct research on, critically analyse and evaluate legal principles, at a level required to meet the standards and expectations of the legal profession and the community at large.

PLO B On successful completion of the curriculum, students should be able to apply their legal knowledge and research skills to practical situations or theoretical challenges, and utilise their comparative understanding of the law and its political, social and cultural contexts to provide original and creative insights to legal problems.

PLO C On successful completion of the curriculum, students should be able to apply the knowledge, lawyering skills and legal reasoning to real and novel situations in life, with a view to resolving issues, problems and disputes within the legal parameters.

PLO D On successful completion of the curriculum, students should be able to demonstrate the ability to present effectively legal arguments in the professional context, as well as conveying and explaining the law effectively to lay clients and members of the larger community.

PLO E On successful completion of the curriculum, students should be able to appreciate the underlying moral values of the law and ethics in the profession and the legal system in the broad social, economic, political and cultural contexts: justice, the Rule of Law, and protection of rights and liberties which form the fabrics of a civilised society, and the importance of upholding these values by the legal community.

PLO F On successful completion of the curriculum, students should be able to develop a strong awareness of social issues and conditions, and utilise analytical abilities and rhetorical advocacy to provide leadership for the betterment of the human community.

2.3 Programme Learning Outcomes to be achieved in this course

CLO 1  ✓
CLO 2  ✓  ✓
CLO 3  ✓  ✓  ✓
CLO 4  ✓  ✓  ✓
CLO 5  ✓  ✓  ✓

3.1 Assessment Summary

Assessment task Due date Weighting Feedback method* Course learning outcomes
Class participation TBC 30% 1, 2, 3, 4, 5
Take home exam TBC 70% 1 1, 2, 3, 4, 5
  *Feedback method (to be determined by course teacher)
1 A general course report to be disseminated through Moodle
2 Individual feedback to be disseminated by email / through Moodle
3 Individual review meeting upon appointment
4 Group review meeting
5 In-class verbal feedback

3.2 Assessment Detail

To be advised by course convenor(s).

3.3 Grading Criteria

Please refer to the following link: http://www.law.hku.hk/course/grading-criteria/

4.1 Learning Activity Plan

Seminar: 3 hours / week for 12 teaching weeks
Private study time: 9.5 hours / week for 12 teaching weeks

Remarks: the normative student study load per credit unit is 25 ± 5 hours (ie. 150 ± 30 hours for a 6-credit course), which includes all learning activities and experiences within and outside of classroom, and any assessment task and examinations and associated preparations.

4.2 Details of Learning Activities

To be advised by the convenor(s).

5.1 Resources

Reading materials: Reading materials are posted on Moodle
Core reading list: TBA
Recommended reading list: TBA

5.2 Links

Please refer to the following link: http://www.law.hku.hk/course/learning-resources/

By the publication of the course profile on-line, the Faculty deems the student as having been notified of the course requirements.